NICE Document 2012 03-15-11748944 0 Raportul Institutului Nice Engleza

1echn|ca| Ass|stance |n kev|ew|ng the Content and L|st|ng
rocesses for the koman|an 8as|c ackage of nea|th

Serv|ces and 1echno|og|es

NICL Internat|ona|
I|na| report and kecommendat|ons: !"#$ &$"'(

Iranc|s ku|z
kuth Lopert
ka||pso Cha|k|dou

Ianuary 2012

Table of Contents
Summary of recommended nexL sLeps ................................................................................................... 3
1asks LhaL may be faclllLaLed wlLh asslsLance from nlCL lnLernaLlonal ......................................... 3
8ackground and alms of Lhe pro[ecL ....................................................................................................... 7
Cvervlew of Lhe ComponenLs of PealLh lnsurance ln 8omanla ............................................................. 8
Cvervlew of exlsLlng challenges ..................................................................................................... 9
harmaceuLlcal LlsLlng and rlclng ............................................................................................... 10
CLher PealLhcare roducLs and Servlces ...................................................................................... 12
uevelopmenL of a 'negaLlve llsL' for drug and non drug servlces and producLs................................... 12
Cvervlew and dlsclalmer .............................................................................................................. 12
harmaceuLlcals ............................................................................................................................ 13
Cur Approach ....................................................................................................................... 13
llndlngs ................................................................................................................................. 14
rlclng Anomalles ................................................................................................................. 24
non-drug servlces and producLs ................................................................................................... 29
uaLa lssues ............................................................................................................................ 29
Cvervlew of Lhe MeLhods ..................................................................................................... 29
llndlngs ................................................................................................................................. 30
More Lhan one 'Lool' ln Lhe Loolbox- case sLudy of urug LluLlng SLenLs ............................. 34
ulffuslon of new 1echnologles - Concluslons ....................................................................... 37
SLrucLural challenges and fuLure reform .............................................................................................. 38
Lmpowerlng prlmary care ............................................................................................................ 38
Secondary/1erLlary care - fundlng and Lhe role of u8Cs ............................................................. 40
CommlLmenL Lo publlc healLh lnlLlaLlves ...................................................................................... 42
ollLlcal commlLmenL Lo evldence-based approaches ................................................................. 43
nexL sLeps ............................................................................................................................................. 44
harmaceuLlcals ............................................................................................................................ 44
lmprovlng llsLlng processes .................................................................................................. 44
lmplemenLlng d! #$%&' P1A assessmenL .............................................................................. 46
8evlewlng Lhe exlsLlng formulary ......................................................................................... 49
Addresslng prlclng anomalles ............................................................................................... 49
8econflgurlng paLlenL conLrlbuLlons ..................................................................................... 49
CLher PealLhcare roducLs and Servlces ...................................................................................... 49
Applylng a framework Lo ldenLlfy lnefflclenL pracLlces ........................................................ 49
8evlslng Lhe u8Cs ................................................................................................................. 31
Managlng medlcal devlce prlclng ......................................................................................... 31
ueveloplng P1A ln 8omanla ......................................................................................................... 31
lmprovlng procuremenL and supply ............................................................................................. 32
1ackllng corrupLlon and lnformal paymenLs................................................................................. 33
CLher 1echnlcal SupporL ............................................................................................................... 34
8ulldlng P1A capaclLy ln 8omanla ........................................................................................ 34
uaLa and lnformaLlon needs ................................................................................................. 34
Appendlx A -1erms of 8eference ......................................................................................................... A1
Appendlx 8 - 8apld 8evlew of Lhe 8egulaLlon and ollcy lramework for harmaceuLlcal ManagemenL
ln 8omanla: LxecuLlve Summary and 8ecommendaLlons ................................................................... 81
__________________________________________________________________________________________________________________________________________________________________
NICE International Romania: Final Report 3

Summary of recommended next steps
)*+,-. / 0-+"12,+" 3++"4-,$" 56-$7-. 89 +*.$7(:
;3.-$-,$-.< =*>>,?*2,$-*. ,.4 =7,.<"@
A"4-B+ $"2+ 5C",2( 9 ,.4 D:
;)"E">*'-.< ,.4 -+'>"+".$-.<@
F*.< $"2+ 5C",2( G ,.4 H:
;IE,>B,$-.<J 2"=,>-?2,$-.<J =*.(*>-4,$-.<@
IE,>B,$-*.J >-($-.< ,.4
4"=-(-*.K+,L-.<
M"K".<-.""2 currenL pharmaceuLlcal llsLlng
processes Lo reflecL commlLmenL Lo lndependenL,
evldence-based, value-for-money declslon
maklng
M"E-(" n1C remlL and governance arrangemenLs
3+'>"+".$ recommended drug dellsLlngs and
resLrlcLlons
3.$2*4B=" lnLerlm (! #$%&' P1A process
N*++".=" P1A capaclLy-bulldlng Lhrough focused
Lechnlcal Lralnlng
O.4"2$,L" gap analysls Lo ldenLlfy lnformaLlon
necessary Lo supporL raLlonal declslon-maklng.
34".$-1C lnefflclenL pracLlces based on expllclL
crlLerla relaLlng Lo relaLlve effecLlveness/cosL
effecLlveness and approprlaLeness ln Lhe
8omanlan seLLlng, and wlLh reference Lo nlCL
(' )'& ('" recommendaLlons
)"E">*' processes, guldellnes and meLhods
for robusL and rlgorous P1A framework Lo
supporL llsLlng /dellsLlng of medlclnes as well
as non- drug Lechnologles, producLs and
servlces
I#',.4 P1A capaclLy Lhrough ongolng
Lralnlng and professlonal developmenL
acLlvlLles
3+'>"+".$ mandaLory and rlgorous P1A as
prerequlslLe for llsLlng/dellsLlng of medlclnes
N*.(-4"2 clawback Lax on medlcal devlces
O.4"2$,L" furLher formulary revlew and
revlslon wlLh recallbraLlon of asslgnmenL of
drugs Lo subllsLs
N*.(*>-4,$" role of P1A as prerequlslLe
for llsLlng/dellsLlng of medlclnes and
exLend appllcaLlon Lo non- drug
Lechnologles, producLs and servlces
I($,?>-(7 process for regular drug
formulary revlew and recallbraLlon

P2-=-.< I#$".4 lnLernal reference prlclng model Lo
furLher LherapeuLlc classes
3.-$-,$" negoLlaLlons Lo reduce prlces of key
molecules
N*+'->" prlce llsLs of medlcal devlces, lvus and
consumables
N*.(-4"2 lnLroducLlon of rlsk sharlng
arrangemenLs for hlgh cosL Lechnologles
I#',.4 appllcaLlon of P1A flndlngs Lo prlce
seLLlng for healLh Lechnologles
3.$2*4B=" rlsk sharlng arrangemenLs Lo
supporL access as approprlaLe
N*.(-4"2 lmplemenLlng a value-based"
prlclng framework for Lechnologles
Q-.,.=-.< ,.4 '2*E-4"2
',C+".$
3.-$-,$" revlslon of u8Cs, uLlllslng lnLernaLlonal
experLlse
)"E-(" processes for regular revlslon and
recallbraLlon of u8Cs
M"E-(" and recallbraLe u8Cs on a regular
basls
__________________________________________________________________________________________________________________________________________________________________

)*+,-. / 0-+"12,+" 3++"4-,$" 56-$7-. 89 +*.$7(:
;3.-$-,$-.< =*>>,?*2,$-*. ,.4 =7,.<"@
A"4-B+ $"2+ 5C",2( 9 ,.4 D:
;)"E">*'-.< ,.4 -+'>"+".$-.<@
F*.< $"2+ 5C",2( G ,.4 H:
;IE,>B,$-.<J 2"=,>-?2,$-.<J =*.(*>-4,$-.<@
P,$-".$ =*.$2-?B$-*.( )"E">*' publlc lnformaLlon campalgn Lo promoLe
accepLablllLy of generlcs and awareness of
avallablllLy of cheaper alLernaLlves aL pharmacy
Cons|der alLernaLlve models for sLrucLurlng
of paLlenL conLrlbuLlons wlLh a conslderaLlon
of equlLy and access lssues
IE,>B,$" access and flnanclal lmpacL on
households of CC/caLasLrophlc cosLs
P2*=B2"+".$J
4-($2-?B$-*. ,.4 (B''>C
3.-$-,$" measures Lo address dlsLorLlons ln
wholesale (drug) dlsLrlbuLlon chaln, drawlng on
lnLernaLlonal experLlse
I#'>*2" use of cenLrallzed compeLlLlve blddlng
processes for ma[or drug classes and selecLed
non drug producLs (ln con[uncLlon wlLh exLendlng
reference prlclng, see above)
3.$2*4B=" rolllng cycle of cenLrallzed
compeLlLlve blddlng processes for ma[or
drug classes and selecLed non drug
Lechnologles
A,.4,$" avallablllLy of benchmark prlced
producLs ln pharmacles
IE,>B,$" lmpacL of changes Lo Lhe
procuremenL and supply, and revlse
sLraLegles accordlngly
N*22B'$-*. ,.4 -.1*2+,>
',C+".$(
)"E">*' publlc lnformaLlon campalgn
)"E">*' publlc reglsLer of offenders and lmpose
professlonal and moneLary penalLles
)"E">*' longLerm sLraLegy for combaLlng
healLh care fraud wlLh reference Lo
lnLernaLlonal besL pracLlce
IE,>B,$" lmpacL of anLl corrupLlon / anLl-
fraud lnlLlaLlves and recallbraLe sLraLegles
accordlngly

I+'*6"2-.< '2-+,2C
=,2" ,.4 '2*+*$-.<
'2"E".$-E" =,2"
O.4"2$,L" comprehenslve revlew of prevenLlve
servlces and publlc healLh programs wlLh alm of
ldenLlfylng gaps and sLreamllnlng acLlvlLles
M"E-"6 remuneraLlon and responslblllLles of
prlmary care pracLlLloners wlLh alm of
encouraglng reLenLlon and more efflclenL
allocaLlon of resources beLween prlmary and
secondary/LerLlary care
)"E">*' sLraLegles Lo enforce exlsLlng
smoklng bans and conslder exLendlng bans
Lo oLher publlc spaces
)"E">*' an ouLcomes drlven and evldence-
based framework of performance lncenLlves
(flnanclal and non-flnanclal) for prlmary care
docLors and plloL accordlngly
IE,>B,$" lmpacL of performance
lncenLlves ln plloL assessmenL, revlse
sLraLegles and roll ouL programme across
all of prlmary care
),$, =*>>"=$-*. O.4"2$,L" rapld gap analysls of lnformaLlon and
daLa needs and ldenLlfy posslble mechanlsms Lo
address Lhese
PB2(B" sLakeholder supporL ln developlng
daLa collecLlon mechanlsms, sLandards and
proLocols for daLa exchange
IE,>B,$" lmpacL of daLa collecLlon
mechanlsms ln supporLlng declslon
maklng aL all levels ln Lhe healLh sysLem
lncludlng Lhe conducL of P1A
P,2,>>"> "#'*2$ N*.(-4"2 penalLles for producL dlverslon
N*>>,?*2,$" wlLh key sLakeholders Lo ldenLlfy
workable sLraLegles Lo mlLlgaLe rlsks of, and
reduce lncenLlves for parallel exporL
3+'>"+".$ sLraLegles Lo reduce lncenLlves
for parallel exporL
IE,>B,$" and recallbraLe sLraLegles Lo
reduce lncenLlves for parallel exporL
__________________________________________________________________________________________________

1asks that may be fac|||tated w|th ass|stance from NICL Internat|ona|
Cverv|ew
nlCL lnLernaLlonal could supporL P1A developmenL ln 8omanla by asslsLlng pollcy
makers ln Lhe developmenL of bespoke P1A process and meLhods guldes, and by
carrylng ouL a collaboraLlve 'coachlng plloL' on drugs currenLly awalLlng lncluslon on Lhe
formulary, wlLh furLher demonsLraLlon plloLs on selecLed Lechnologles. nlCL
lnLernaLlonal's acLlvlLles would lnclude ln Lhe flrsL lnsLance, Lralnlng and supporL for Lhe
conducL of a rapld (! #$%&' P1A.
uurlng Lhe plloLs, all Lechnlcal Lasks would be carrled ouL [olnLly by nlCL lnLernaLlonal
and lLs parLners, and Lhe asslgned 8omanlan Lechnlcal Leam. All admlnlsLraLlve and
process Lasks would be slmllarly shared beLween Lhe nlCL lnLernaLlonal and 8omanlan
admlnlsLraLlve Leams. 1he declslons based on Lhe evldence would be made by 8omanlan
experLs and pollcy makers. nlCL lnLernaLlonal can also provlde nlCL cllnlcal experL
supporL for Lhe early P1As. 1hls collaboraLlve process would enable hands-on Lralnlng
and supporL Lo be provlded LhroughouL whlle aL Lhe same Llme ensurlng LhaL Lhe flnal
ouLpuL ls owned" by 8omanlan declslon makers and Lechnlcal Leams.
key act|v|t|es
1. 8u||d|ng n1A capac|ty
uellver an lnLenslve hands-on Lralnlng workshop ln 8omanla, of 10-14 days
duraLlon, ln laLe sprlng or auLumn 2012.
rovlde ongolng asslsLance ln developlng currlcula for graduaLe programs ln
baslc and advanced P1A meLhods and Lhelr appllcaLlons Lo declslon-maklng.
2. Deve|op|ng gu|de||nes, processes and methods for n1A |n koman|a
rovlde guldance on Lhe lmmedlaLe reform of currenL processes and sLrucLures
for llsLlng of pharmaceuLlcals.
rovlde Lechnlcal asslsLance program ln Lhe developmenL of an P1A manual
(meLhods and process guldes). 1hls wlll lnclude lnLeracLlons wlLh key lnsLlLuLlons
currenLly lnvolved ln Lhe prlorlLlsaLlon process ln 8omanla, and Lhe meLhods wlll
descrlbe approprlaLe value for money Lhreshold ranges for declslon maklng. 1he
manual ls an evolvlng documenL whlch can be used for Lhe lmmedlaLe conducL
of P1A ln 8omanla (Lhe (! #$%&' assessmenL descrlbed below) and seL Lhe basls
for Lhe fuLure developmenL of more complex meLhods.
3. Immed|ate rev|ew of the drug formu|ary: support for the conduct of |nter|m 4"
1,=$* n1A
1echnlcal supporL for (! #$%&' P1A and Lralnlng ln budgeL lmpacL analysls for
drugs currenLly awalLlng llsLlng

________________________________________________________________________________________________
underLake revlew of Lhe Lop 300 drugs by volume and value, and develop
recommendaLlons for resLrucLurlng of 8omanlan formulary.
SupporL ln developlng a llsL of prlorlLles for fundlng
4. nands-on support for the deve|opment of more extens|ve n1A capac|ty ln
selecLed Loplcs, lncludlng:
ldenLlfylng key sLakeholders Lo be lnvolved ln Lhe plloL(s)
8evlew of local and lnLernaLlonal llLeraLure ln llghL of Lhe llsLlng/dellsLlng
declslon problem lncludlng Lhe poLenLlal need Lo updaLe sysLemaLlc revlews,
adapL exlsLlng economlc models or underLake full (! )'*' analysls
ueveloplng pollcy recommendaLlons based on evldence presenLed Lo an experL
commlLLee (Lhe n1C)
ConsulLaLlon or peer revlew of drafL recommendaLlons
ueveloplng Lhe flnal recommendaLlons (sub[ecL Lo some form of resoluLlon
process)
S. Support for a top|c rout|ng process for drug and non-drug techno|og|es
ldenLlflcaLlon of caLegorles of Loplc rouLlng and assessmenL - Lhls could lnclude
dolng noLhlng, (! #$%&' P1A, and ln depLh (! )'*' P1A analysls
reparaLlon Lhrough a consulLaLlve and parLlclpaLory process wlLh sLakeholders
of a drafL process for Loplc rouLlng
6. Ident|fy|ng data and |nformat|on needs
underLake furLher lnformaLlon gap analysls, bulldlng on prevlous work.
ConducL one or more workshops wlLh key sLakeholders Lo explore, ldenLlfy and
galn consensus ln prlorlLlzlng lnformaLlon needs, sLrucLures and daLa collecLlon
mechanlsms, and processes for daLa sharlng, durlng 2012.
7. Cther
rovlde lmplemenLaLlon Lralnlng workshops (3 days) LhaL lnclude Loplcs
coverlng boLh flnanclal and non flnanclal lncenLlves Lo lmprove adherence Lo
evldence based pracLlce. 1hese can Lake place ln laLe sprlng or auLumn 2012
uevelop opLlons for resLrucLurlng of paLlenL conLrlbuLlons Lo lmprove access
and equlLy.

________________________________________________________________________________________________
8ackground and a|ms of the pro[ect
8ased on recommendaLlons of Lhe World 8ank, Lhe 8omanlan MlnlsLry of PealLh lnLends
Lo revlse Lhe conLenL of Lhe baslc healLh care servlce package, Lhrough a Lechnlcal
asslsLance pro[ecL flnanced from Lhe World 8ank's programmes. ln Lhls regard, nlCL
lnLernaLlonal has been conLracLed by Lhe 8omanlan auLhorlLles Lo dellver on a focused
seL of ob[ecLlves, lncludlng Lhe developmenL of a non-exhausLlve 'negaLlve llsL' based on
an expllclL raLlonale and wlLh reference Lo pracLlce ln oLher counLrles lncludlng Lhe uk
and AusLralla.
WlLhln Lhls conLexL, nlCL lnLernaLlonal vlslLed 8omanla Lhree Llmes (CcLober, november
and uecember, 2011) and has submlLLed Lhree lnLerlm reporLs. 1hls ls nlCL
lnLernaLlonal's flnal reporL under Lhe currenL conLracL. lL draws on Lhe conLenL of Lhe
precedlng reporLs, provldlng furLher elucldaLlon of lssues ralsed prevlously and, mosL
lmporLanLly, presenLlng a serles of acLlonable recommendaLlons for Lhe lmmedlaLe,
medlum and long Lerm.
1he preparaLlon of Lhls reporL draws on lnformaLlon gaLhered durlng Lhe above mlsslons
Lo 8omanla, wlLh addlLlonal lnformaLlon from a varleLy of secondary sources lncludlng
prevlous World 8ank reporLs. MeeLlngs and lnLervlews were held wlLh a number of key
sLakeholders ln order Lo canvass vlews on a varleLy of lssues lncludlng Lhe conLenL of Lhe
baslc beneflLs package, processes for llsLlng and dellsLlng pharmaceuLlcal and non drug
producLs and servlces, Lhe role of P1A ln 8omanla, and Lhe lmpacL of Lhe proposed
reforms.
nlCL lnLernaLlonal experLs would llke Lo acknowledge Lhe conLrlbuLlons of
represenLaLlves from Lhe followlng organlsaLlons and commlLLees:
MlnlsLry of PealLh
World 8ank (8omanla)
naLlonal School of ubllc PealLh
1he 8omanlan PealLh Alllance
1he naLlonal PealLh lnsurance Pouse (CnAS)
1he naLlonal 1ransparency CommlLLee
College of hyslclans of 8omanla
resldenLlal AdmlnlsLraLlon
SpeclalLy Commlsslons

________________________________________________________________________________________________
Cverv|ew of the Components of nea|th Insurance |n koman|a
1here are Lhree Lypes of beneflL packages avallable Lo clLlzens of 8omanla:
A mlnlmum beneflLs package - comprlslng Lhose baslc servlces avallable Lo all
clLlzens lncludlng Lhe unlnsured
A 8aslc 8eneflLs ackage (88) for Lhe lnsured populaLlon
A beneflLs package for Lhose LhaL have Laken ouL volunLary lnsurance
1
All beneflLs packages have several componenLs lncludlng: prlmary care, ambulaLory
speclallsed care (cllnlcal and para-cllnlcal), secondary/LerLlary (lnpaLlenL) care, denLlsLry,
rehablllLaLlon servlces, and LransporLaLlon. Access Lo emergency servlces ls free,
lrrespecLlve of lnsurance sLaLus.

ln Lhe 88, some prlmary care servlces are covered by caplLaLlon paymenLs (30 of
paymenLs), such as Lhe perlodlc monlLorlng of lndlvlduals wlLh chronlc dlseases (wlLhln
Lhe deflned remlL of Lhe Ceneral racLlLloner), as well as cerLaln healLh promoLlon
acLlvlLles, oLhers are flnanced Lhrough fee-for-servlce arrangemenLs. 1he laLLer lnclude
chlldhood vacclnaLlons, Lhe perlodlc healLh monlLorlng of chlldren, and referrals (eg. for
lnvesLlgaLlons for Lhe dlagnosls or ongolng monlLorlng of an lndlvldual wlLh a pre-
exlsLlng condlLlon).
WlLhln secondary/LerLlary care seLLlngs (lncludlng ambulaLory speclallsL care), servlces
are provlded on a fee-for-servlce basls, or relmbursed uslng ulagnosls 8elaLed Croups
(u8Cs) based paymenLs.
1he soclal healLh lnsurance sysLem ls admlnlsLraLed by Lhe naLlonal PealLh lnsurance
Pouse (cosel No(looole Je Aslqottl Je 5otote, CnAS) a cenLral quasl-lndependenL
body. AL dlsLrlcL level, Lhere are 42 offlces of Lhe CnAS, responslble for conLracLlng
servlces from publlc and prlvaLe provlders.
rescrlpLlon medlclnes are subsldlsed ln accordance wlLh Lhree relmbursemenL llsLs:
LlsL A: lncludes mosL commonly used medlclnes (largely generlcs), relmbursed aL
90 (10 co-lnsurance)
LlsL 8: mosLly orlglnaLor medlclnes, relmbursed aL 30 (30 co-lnsurance)
LlsL C: medlclnes for chronlc dlseases lncluded ln Lhe naLlonal PealLh rograms
and/or for speclflc populaLlon groups (pregnanL women, chlldren, Leenagers, eLc.).
LlsL C medlclnes are fully relmbursed for ellglble beneflclarles.
1he so-called 'sLar sysLem' conLrols Lhe prescrlblng of cerLaln C-llsL drugs by lmposlng
prlor auLhorlzaLlon requlremenLs on prescrlbers
2

1
1hls speclal package covers emergency care, communlcable dlseases wlLh assoclaLed rlsk of ouLbreak,
moLher and chlld care, and lmmunlsaLlons (See: vldescu C, ScinLee C, Clsavszky v, Allln S, Mladovsky .
8omanla: PealLh sysLem revlew. neoltb 5ystems lo 1toosltloo, 2008, 10(3): 1-172).
. Powever Lhe llsL of sLarred drugs has
noL been revlewed or updaLed slnce lLs lnLroducLlon ln 2008.

________________________________________________________________________________________________
Cverv|ew of ex|st|ng cha||enges
A number of clear Lhemes emerged from our flrsL and second vlslLs Lo 8omanla, some of
whlch were alluded ln our earller reporLs and many of whlch have also been noLed ln
oLher recenL key sLudles
3,4
8omanla ls a hlghly resource-llmlLed envlronmenL and Lhe heaLh care sysLem faces
lmmense challenges ln meeLlng Lhe needs of Lhe populaLlon. 1hls makes Lhe
maxlmlzaLlon of efflclency ln resource allocaLlon absoluLely paramounL. AL 11,600 Luro
( ln 2010) Lhe overall per caplLa Cu of 8omanla ls low by Lu sLandards (average
27,700 Luro ) and Lhls ls coupled wlLh healLh care expendlLure as a proporLlon of
Cu LhaL ls also low noL only by Luropean sLandards buL also ln comparlson wlLh non-
Luropean counLrles of slmllar naLlonal wealLh.
.
3
ln parLlcular Lhere appears Lo be relaLlve underfundlng of Lhe prlmary and ambulaLory
care secLor, and Lhls ls coupled wlLh sLrucLural and fundlng anomalles LhaL appear Lo
have led Lo apparenL ooJetotlllzotloo of prlmary care, apparenL ovetotlllzotloo of
hosplLal-based care, and as a resulL, exLenslve cosL shlfLlng, and emergence of perverse
lncenLlves.

Speclflcally we observed LhaL:
medlcal pracLlLloners aL all levels of care are noL uLlllzed efflclenLly or Lo maxlmum
effecL,
prlmary care does noL appear Lo be accorded approprlaLe prlorlLy and may be
underfunded relaLlve Lo oLher heaLh care secLors, Cs are heavlly (and aL Llmes
paradoxlcally) consLralned ln Lhelr capaclLy Lo pracLlce efflclenLly and effecLlvely,
ambulaLory speclallsLs and (parLlcularly) hosplLals are ofLen used as Lhe flrsL polnL of
care,
Lhe sLrucLurlng of caplLaLlon arrangemenLs and llmlLaLlons on fee-for-servlce
paymenLs wlLhln Lhe lramework ConLracL lead Lo underuLlllzaLlon of Cs and
ambulaLory care speclallsLs, and dls-lncenLlvlze effecLlve prlmary care, as a resulL
prevenLlon acLlvlLles ln prlmary care are noL prlorlLlzed Lhus lncreaslng Lhe burden
on Lhe LerLlary care secLor and undermlnlng Lhe efflclency of Lhe overall healLh care
sysLem.
1here are also varlous regulaLlons LhaL shlfL Lo speclallsLs many responslblllLles LhaL
would be consldered noL only approprlaLe Lo, buL lnLegral Lo Lhe rouLlne pracLlce of

2
1hls refers Lo Lhe sysLem applylng Lo drugs requlrlng prlor auLhorlzaLlon Lo prescrlbe. 1he number of
sLars denoLes Lhe level and Lype of pre-approval requlred.
3
World 8ank. 8omanla: PealLh SecLor luncLlonal 8evlew. llnal 8eporL. (WashlngLon, World 8ank, May
2011).
4
LoperL 8. 8apld 8evlew of Lhe 8egulaLlon and ollcy lramework for harmaceuLlcal ManagemenL ln
8omanla. (WashlngLon, World 8ank, May 2011). [LxecuLlve Summary ln Appendlx 8]
3
AL: hLLp://sdw.ecb.europa.eu/reporLs.do?node=100000116

________________________________________________________________________________________________
prlmary care ln mosL oLher counLrles. We were made aware, for example, of regulaLlons
LhaL preclude Lhe orderlng common dlagnosLlc LesLs (eg Lhyrold funcLlon LesLs), lnlLlaLlng
LreaLmenL for common condlLlons (eg dlagnoslng and LreaLlng ma[or depresslon),
ad[usLlng dosage reglmens wlLhouL speclallsL approval (eg lnsulln), or monlLorlng
LreaLmenL approprlaLely (eg monlLorlng glycaemlc conLrol vla PbA1C).
AL Lhe same Llme, flnanclng arrangemenLs for hosplLals are based on 8omanlan
ulagnosls 8elaLed Croups (u8Cs) LhaL do noL appear Lo be reallsLlc represenLaLlons of
Lhe acLual cosLs of LreaLmenL. 1hls has arlsen largely as a resulL of
poor valldlLy of daLa used orlglnally Lo deslgn Lhe cllnlcal groups and cosL u8Cs,
lack of adequaLe or approprlaLe rlsk ad[usLmenL,
subsequenL, lnLenLlonal or lnadverLenL mls-codlng, and
fallure Lo underLake regular recallbraLlon (u8C welghLs have noL been ad[usLed slnce
u8Cs were lnLroduced 13 years ago) - an essenLlal requlremenL for an effecLlve u8C
sysLem.
As a resulL, Lhere ls chronlc underfundlng of key acLlvlLles, whlch ln Lurn creaLes furLher
lncenLlves for mlscodlng, over-servlclng, and exLenslve cosL-shlfLlng Lo paLlenLs, and
whlch ls furLher dlsLorLed by cross-subsldlzaLlon of cerLaln condlLlons and LreaLmenLs
Lhrough naLlonal rogrammes. Llsewhere ln Lhe healLh care sysLem Lhere ls evldence
LhaL LreaLmenL guldellnes and proLocols, where Lhey exlsL, are noL lmplemenLed or noL
mandaLed, and lnapproprlaLe varlaLlons ln pracLlce are noL belng addressed
sysLemaLlcally. Moreover Lhere ls no sLrucLure LhaL supporLs or encourages care
coordlnaLlon Lo allow for beLLer (and more raLlonal) verLlcal (prlmary and secondary
care) and horlzonLal lnLegraLlon (communlLy servlces, home care servlces, allled healLh,
soclal care).
harmaceut|ca| L|st|ng and r|c|ng
8ecommendaLlons regardlng Lhe llsLlng of medlclnes on Lhe naLlonal formulary are Lhe
responslblllLy of Lhe naLlonal 1ransparency CommlLLee (n1C). Powever Lhe n1C
rocesses appear Lo be opaque and oJ boc. llgure 1 lllusLraLes Lhe process.
CrlLerla for a poslLlve (or negaLlve) recommendaLlon are noL clearly arLlculaLed, and
declslons appear Lo resL largely on revlews conducLed by cllnlcal speclallsLs (Loplc
experLs) nomlnaLed by Lhe relevanL SpeclalLy Commlsslons, and whose confllcLs of
lnLeresL, lf any, are noL declared aL Lhe Llme of Lhe revlew. WlLhouL lnpuL from oLher
cllnlcal (especlally non-speclallsLs) and non-cllnlcal experLs Lhls sLrucLure wlll naLurally
Lend Lo favour llsLlng of new medlclnes, lndeed we were lnformed LhaL aL mosL perhaps
2 of appllcaLlons are re[ecLed.

________________________________________________________________________________________________
I|gure 1: Schemat|c of the current Drug Iormu|ary L|st|ng rocess

Moreover, whlle an economlc analysls of some descrlpLlon musL be submlLLed wlLh each
appllcaLlon, lL ls noL sub[ecL Lo revlew wlLhln Lhe llsLlng process, nor ls budgeL lmpacL
analysls requlred. As a resulL Lhere ls no lmpllclL or expllclL conslderaLlon of prlce, cosL
effecLlveness, overall budgeLary lmpacL or opporLunlLy cosL Lo Lhe healLh care sysLem
facLored lnLo, or lndeed lnfluenclng Lhe recommendaLlon. Cverall, Lhe role of Lhe
naLlonal 1ransparency CommlLLee ln Lhe declslon-maklng process, oLher Lhan Lo
endorse Lhe recommendaLlon(s) of Lhe cllnlcal speclallsLs, ls unclear.
6
WlLh respecL Lo prlclng, a number of lssues of concern wlLh currenL mechanlsms have
been hlghllghLed prevlously.

3 Cf parLlcular slgnlflcance ls Lhe exLenslve rellance on Lhe
use exLernal reference prlclng for medlclnes manufacLured ouLslde 8omanla (wlLh cosL-
plus prlclng for Lhose manufacLured domesLlcally). LxLernal reference prlclng ls based on

6
lL ls lmporLanL Lo noLe LhaL our revlew of Lhe llsLlng mechanlsm was focused on Lhe process for llsLlng of
medlclnes ln Lhe naLlonal formulary raLher Lhan lncluslon ln Lhe 8aslc 8eneflLs ackage.

________________________________________________________________________________________________
Lhe lowesL prlce from wlLhln a baskeL of 12 Lu counLrles
7
Cther nea|thcare roducts and Serv|ces
accordlng Lo an algorlLhm
publlshed by Lhe MlnlsLry of ubllc PealLh. Moreover, under Lu regulaLlon Lhe prlces of
new medlclnes musL be deLermlned wlLhln 90 days of markeLlng approval, buL
appllcable exchange raLes are recallbraLed only annually.
We were unable Lo clearly ldenLlfy a deflnlLlve process or processes for Lhe lncluslon of
oLher (le non-pharmaceuLlcal) producLs and servlces ln Lhe 8aslc 8eneflLs ackage.
lncluslon would appear Lo be oJ boc, raLher Lhan based on sysLemaLlc and expllclL
crlLerla. LxpllclL conslderaLlons of comparaLlve effecLlveness and/or cosL effecLlveness do
noL appear Lo be underLaken, prlclng and levels of relmbursemenL are deLermlned on
Lhe basls of negoLlaLlons beLween Lhe naLlonal PealLh lnsurance Pouse and provlders.
llnally, Lhere ls no deflnlLlve, lncluslve and expllclL llsL of servlces offered ln Lhe hosplLal
secLor, whlch could form a polnL of reference for developlng and updaLlng Lhe 88.
Cur overall lmpresslon was LhaL Lhe 88 as currenLly consLlLuLed has developed more by
defaulL Lhan by deslgn.
Deve|opment of a 'negat|ve ||st' for drug and non drug serv|ces
and products
Cverv|ew and d|sc|a|mer
1he secLlon of Lhe reporL seLs ouL Lhe recommendaLlons for a non-exhausLlve 'negaLlve
llsL', accompanled where posslble by quanLlLaLlve esLlmaLes of poLenLlal efflclency galns.
Any 'negaLlve llsL' (or raLher, a framework LhaL wlll capLure recommendaLlons for Lhe
excluslon from and/or resLrlcLlon of coverage of cerLaln producLs and servlces) cannoL
be focused solely on pharmaceuLlcals. 8aLher, Lhe lnLenLlon has been where posslble, Lo
examlne lnformaLlon on non-drug producLs and servlces and make approprlaLe
recommendaLlons for lmprovlng efflclency and quallLy, sub[ecL, as always, Lo Lhe
llmlLaLlons of Lhe avallable daLa.
llnally, lL ls lmporLanL Lo noLe LhaL addresslng broader sLrucLural facLors lnfluenclng Lhe
efflclency of 8omanlan healLhcare dellvery has Lhe poLenLlal Lo dellver a slgnlflcanLly
greaLer conLrlbuLlon Lo Lhe longer Lerm susLalnablllLy and affordablllLy of Lhe overall
sysLem Lhan Lhe shorL Lerm correcLlon llkely Lo be achleved Lhrough Lhe consLrucL of a
negaLlve llsL

7
AusLrla, 8ulgarla, 8elglum, Czech 8epubllc, Cermany, Creece, Pungary, lLaly, LlLhuanla, oland,
Slovakla, and Spaln.

________________________________________________________________________________________________
harmaceut|ca|s
A plvoLal Lask ln Lhls pro[ecL was Lo revlew Lhe currenL pharmaceuLlcal formulary and
ldenLlfy candldaLe medlclnes for lncluslon ln a negaLlve llsL" - LhaL ls, a llsL of medlclnes
Lo be dellsLed or made sub[ecL Lo resLrlcLlons on subsldlzaLlon. We also noLed prevlously
LhaL whlle a comprehenslve revlew of Lhe enLlre naLlonal formulary was beyond Lhe
scope and Llmellne of Lhe pro[ecL, we had noneLheless aLLempLed Lo Lake a hollsLlc
approach by selecLlvely conslderlng candldaLe medlclnes ln all sub-llsLs wlLhln Lhe drug
formulary.
ln Lhls, Lhe flnal reporL for Lhls pro[ecL, we relLeraLe LhaL ln our vlew Lhere are a number
of opporLunlLles for raLlonallslng Lhe formulary LhaL do noL lnvolve placlng producLs on a
negaLlve llsL, represenLlng as Lhey do poLenLlally remedlable lnefflclencles noL ln
effecLlveness, buL ln cosL effecLlveness. We feel sLrongly LhaL ln many cases efforLs
should be lnlLlally dlrecLed aL pursulng beLLer prlclng and more raLlonal use of Lhe drugs
currenLly on Lhe formulary, as Lransferrlng many of Lhe drugs ln quesLlon Lo a negaLlve
llsL could well be counLerproducLlve by placlng even greaLer burdens ln paLlenLs already
shoulderlng hlgh ouL of pockeL expendlLure and by lncreaslng cosLs ouLslde Lhe drug
budgeL. 1o LhaL end, ln 8eporL 3 we noLed LhaL ln Lhe absence of P1A ln 8omanla, by
vlrLue of prlce comparlsons wlLh Lhe uk, some 30 of Lhe drugs ln Lhe 1op 30" dld noL
appear Lo be cosL effecLlve, and LhaL ongolng subsldy should be predlcaLed on more
raLlonal prlclng. 1haL analysls was based on some falrly slmpllsLlc cross-naLlonal
assessmenLs of cosL effecLlveness, wlLh dlfferences ln per caplLa Cu and capaclLy Lo
pay underplnnlng Lhe comparlsons of value for money.
Cur Approach
A revlew of Lhe enLlre formulary was well beyond Lhe scope of Lhls pro[ecL so we
focused on Lhe Lop 30 medlclnes (by expendlLure) ln 2010 as well as Lrend daLa for
2009-10 for Lop 23 medlclnes ln each of Lhe sub-llsLs. SelecLed drugs ouLslde Lhe Lop 30
llsL were also examlned. lor each of Lhese we revlewed Lhe approved lndlcaLlons ln Lhe
Lu and /or 8omanla well as relevanL proLocols for use, where avallable, and compared
Lhese wlLh Lhe reglsLered lndlcaLlons for each of Lhe drugs ln quesLlon.
lor key molecules we looked for evldence of havlng been sub[ecL Lo P1A elsewhere and
Lhe resulLanL basls for subsldy, condlLlons of use, prlce and rlsk sharlng arrangemenLs
where appllcable and accesslble. We Lhen ldenLlfled Lhreshold prlces LhaL would resulL
ln a slmllar degree of cosL effecLlveness ln 8omanla (all oLher facLors held consLanL).
Where sufflclenL daLa were avallable, we wlll also ldenLlfled poLenLlal savlngs from Lhe
dellsLlng of drugs and /or speclflc lndlcaLlons, or of oLher proposed modlflcaLlons.
We noLed LhaL for drugs on Sub-llsLs A and 8 of Lhe formulary, Lhe subsldlsed lndlcaLlons
are noL speclfled or llmlLed, nor ls Lhere currenLly any expllclL expecLaLlon LhaL Lhey wlll
only be subsldlsed for labelled lndlcaLlons. lor drugs on Sub-llsLs C1, C2 and C3

________________________________________________________________________________________________
subsldlsed lndlcaLlons are speclfled ln broad Lerms, wlLh many of Lhe drugs sub[ecL
elLher Lo prlor auLhorlzaLlon and/or llmlLed Lo prescrlblng by speclallsLs (by way of Lhe
so-called sLar sysLem). ln addlLlon, for some key drugs Lhere are qulLe deLalled evldence-
lnformed proLocols developed by Lhe SpeclalLy Commlsslons lnLended Lo gulde
approprlaLe pracLlce. Powever we noLed LhaL Lhe SpeclalLy Commlsslons do noL Lake
lnLo accounL unlL cosL, or value for money ln developlng Lhese, and ln mosL cases Lhe
source and quallLy of Lhe cllnlcal evldence on whlch Lhe proLocols are based was noL
provlded.
ln approachlng Lhe developmenL of Lhe negaLlve llsL we Look Lhe vlew LhaL ln any
seLLlng, lncludlng Lhose less resource-llmlLed Lhan 8omanla, declslons around Lhe
subsldlzaLlon or relmbursemenL of any healLh care Lechnology should be gulded by
robusL evldence of effecLlveness and cosL effecLlveness. WlLh LhaL as an overarchlng
prlnclple we Lhen soughL Lo ldenLlfy candldaLe drugs flLLlng Lhe followlng broad
caLegorles:
A. Medlclnes llsLed for lndlcaLlons ouLslde Lhe Lerms of Lhelr markeLlng approval (le
off-label).
8. Medlclnes llsLed for lndlcaLlons or ln seLLlngs ln whlch Lhey may noL be cosL
effecLlve.
C. Medlclnes consldered cosL effecLlve ln oLher [urlsdlcLlons buL unllkely Lo be cosL
effecLlve aL currenL 8omanlan prlces
u. Medlclnes for whlch subsldy ls noL supporLed by clear evldence of poslLlve
rlsk/beneflL, lrrespecLlve of reglsLraLlon sLaLus.
L. Medlclnes LhaL may noL reflecL a hlgh prlorlLy for subsldlsaLlon ln a resource-llmlLed
envlronmenL.
l. Medlclnes noL yeL on Lhe formulary buL wlLh a poslLlve recommendaLlon from Lhe
naLlonal 1ransparency CommlLLee
I|nd|ngs
We found LhaL medlclnes for whlch an overwhelmlng case for dellsLlng could be made
were few, alLhough Lhere were some clear cases of llsLlng ouLslde Lhe approved
lndlcaLlons, and some drugs for whlch Lhe evldence base was unclear or lnadequaLe. We
found Lhe proLocols developed by Lhe SpeclalLy Commlsslons Lo gulde Lhe use of many
of Lhe hlgh cosL drugs generally well consLrucLed, even Lhough Lhe sources and quallLy
of Lhe evldence were noL expllclL. Powever we could noL deLermlne how well Lhese
proLocols are adhered Lo or Lhe degree Lo whlch Lhe CnAS ls able Lo monlLor
approprlaLe use. Cur flndlngs are reproduced ln 1ables 1 and 2 and summarlsed here.

________________________________________________________________________________________________
A. Med|c|nes subs|d|zed for |nd|cat|ons outs|de the terms of the|r market|ng
approva|
8R I2C$72*'*-"(-( &$-+B>,$-.< S<".$( 5I&S(:
1he currenL proLocols supporLlng Lhe use of LSAs speclfy LhaL epoet|n a|fa and
epoet|n beta may be used Lo LreaL rlbavlrln-lnduced anaemla ln paLlenLs wlLh
hepaLlLls C, buL as far as we could ascerLaln, none of Lhese drugs carrles Lhls as an
approved lndlcaLlon, elLher ln 8omanla or elsewhere ln Lhe world, and Lherefore
Lhe lndlcaLlons for subsldy should exclude use ln Lhls seLLlng. AlLhough noL
speclfled ln Lhe roLocol documenL, Lhe formulary flle lndlcaLes LhaL epoet|n a|fa
and epoet|n beta and darbapoet|n may be used ln paLlenLs ln organ LransplanL
(programs 9.1, 9.4 and 9.7). 1hese would also appear Lo lle ouLslde Lhe approved
lndlcaLlons for Lhese drugs.
ln Lhe absence of daLa on prescrlblng by lndlcaLlon any savlngs from
dlsconLlnuaLlon of Lhe subsldy for Lhese lndlcaLlons could noL be esLlmaLed.
kecommendat|on: 1haL Lhe subsldy of epoet|n a|fa, epoet|n beta and darbapoet|n
for Lhe above lndlcaLlons be phased ouL.
9R T"E,=-UB+,? 5SE,($-.:
Accordlng Lo Lhe 8omanlan LreaLmenL proLocols, bevac|zumab may be prescrlbed
ln comblnaLlon wlLh pacllLaxel for flrsL-llne LreaLmenL of meLasLaLlc breasL cancer
kecommendat|on: 1haL as Lhe use of bevac|zumab ln breasL cancer ls no longer an
approved lndlcaLlon, Lhe subsldy should be dlsconLlnued.
8. Drugs subs|d|zed for |nd|cat|ons or |n sett|ngs |n wh|ch they may not be
cost effect|ve
8R I2C$72*'*-"(-( &$-+B>,$-.< S<".$( 5I&S(:
ln Lhe uk LSAs are noL recommended by nlCL for rouLlne use ln Lhe managemenL
of cancer LreaLmenL-lnduced anaemla
8
ln comblnaLlon wlLh lnLravenous lron as an opLlon for Lhe managemenL of cancer
LreaLmenL-lnduced anemla ln women recelvlng plaLlnum-based chemoLherapy
for ovarlan cancer wlLh sympLomaLlc anemla and Pb < 8 g/100 ml, or
, excepL
ln comblnaLlon wlLh lnLravenous lron for people who cannoL be glven blood
Lransfuslons and who have profound cancer LreaLmenL-relaLed anemla llkely Lo
an lmpacL survlval.

8
hLLp://www.nlce.org.uk/nlcemedla/pdf/1A142Culdance.pdf

___________________________________________________________________________________________________________________________________________________________________________
1ab|e 1: Summary of kecommendat|ons on Med|c|nes |n the "1op S0"
Drug ]
kecommendat|on
A. Cff |abe| 8. kestr|ct subs|d|zed
use or de||st
C. Not cost effect|ve at
current pr|ce - target
reduce by
D. L|m|ted ev|dence L. Low pr|or|ty Cther
adallmumab 70
amoxlclllln/ clavulanaLe 44
beLahlsLlne 46
lf noL dellsLed
8eclasslfy as C1C, dellsL?
savlngs ~t8.3 pa*

bevaclzumab uellsL for breasL cancer uellsL for selecLed
lndlcaLlons, savlngs
~t18.6m pa* overall
64
borLezomlb 67
capeclLablne 67
darbapoeLln uellsL for pgms 9.1,
9.4, 9.7,
uellsL for pgms C4, C7,
C10, savlngs ~t3.8m pa*
60
dlosmln/ hesperldln 8eclasslfy as C1C, dellsL?
savlngs ~t13.3 pa*

dorzolamlde/ Llmolol 71
epoeLln o uellsL ln hep C, uellsL for
pgms 9.1, 9.4, 9.7
C10, savlngs ~t6.9m pa*
61 osslble savlngs vla
subsLlLuLlon for epo
epoeLln uellsL ln hep C, uellsL for
pgms 9.1, 9.4, 9.7
C10, savlngs ~t23.3m
pa*
61 osslble savlngs vla
subsLlLuLlon wlLh epo o
erdosLelne 64 noL for acuLe
exacerbaLlon of CCu

eLanercepL 69
fenoflbraLe 72
fensplrlde 8evlew recommended
glngko blloba uellsL, savlngs ~t16.3m
pa

lmaLlnlb 63
lndapamlde 82
lnfllxlmab 68
lnsulln deLemlr LlmlL Lo 1ype 1 uM

___________________________________________________________________________________________________________________________________________________________________________
Drug ]
kecommendat|on
A. Cff |abe| 8. kestr|ct subs|d|zed
use or de||st
current pr|ce - target
reduce by
lnsulln glarglne LlmlL Lo 1ype 1 uM
memanLlne 67
meLoprolol 33
monLelukasL 63
May noL be cosL
effecLlve ln adulLs
omeprazole 80
peglnLerferon o-2a 73
peglnLerferon o-2b 67
perlndoprll 76
queLlaplne 42
rlLuxlmab 84
rosuvasLaLln 43
salmeLerol/ fluLlcasone 36
slmvasLaLln 83
somaLropln 73
LrasLuzumab 69
zoledronlc acld 67
* LsLlmaLed uslng currenL prlces and assumlng no cosL offseLs due Lo co-paymenLs

1ab|e 2: Summary of kecommendat|ons on Se|ected Med|c|nes outs|de the "1op S0"
Drug ]
kecommendat|on
A. Cff |abe| 8. kestr|ct subs|d|zed use
or de||st
current pr|ce
ceLuxlmab
uellsL for 2
nd
llne
meLasLaLlc colorecLal ca
cyprohepLadlne 8eclasslfy as C1C, dellsL?
lbuprofen 8eclasslfy as C1C, dellsL?
loraLadlne 8eclasslfy as C1C, dellsL?
orllsLaL 8eclasslfy as C1C, dellsL?
sorafenlb
uellsL for renal cell ca,
savlngs~~t4.1m

___________________________________________________________________________________________________
1he guldance also speclfles LhaL Lhe lowesL cosL LSA should be used. ln AusLralla, LSA's
are noL consldered cosL-effecLlve for use ln oncology and are noL subsldlzed for
chemoLherapy-lnduced anemla.
9
ln Lurope Lhe Luropean SocleLy for Medlcal Cncology (LSMC) recommends Lhe use of
LSAs ln lLs guldellnes buL noLes LhaL Lhe

(u)se of 5As ptofoooJly locteoses beoltb cote costs ooJ .(coofets) oo sotvlvol
+!)!#,&-.
/0
kecommendat|on: 1haL Lhe subsldy of epoet|n a|fa, epoet|n beta and darbapoet|n for
chemoLherapy-lnduced anemla be wlLhdrawn from programs C4, C7 and C10, and
llmlLed Lo paLlenLs wlLh chronlc renal fallure and relaLed clrcumsLances. LsLlmaLed
savlngs Lo CnAS would be of Lhe order of t38m pa, based on 2010 expendlLure.

9R 3.(B>-. ,.,>*<B"(
ln Lhe uk, nlCL has recommended |nsu||n g|arg|ne as an opLlon for people wlLh Lype 1
dlabeLes only. lor people wlLh Lype 2 dlabeLes who requlre lnsulln, nlCL has
recommended LhaL |nsu||n g|arg|ne should be an opLlon only lf Lhe person:
needs help wlLh lnsulln ln[ecLlons from a carer or healLhcare professlonal, or
has repeaLed hypoglycaemlc eplsodes LhaL slgnlflcanLly affecL Lhelr way of llfe, or
would oLherwlse need Lwo lnsulln ln[ecLlons dally Lo malnLaln background levels ln
addlLlon Lo oral hypoglycemlc agenLs.
1he 8omanlan proLocol for Lhe use of |nsu||n g|arg|ne speclfles only LhaL lL may be
used ln paLlenLs wlLh dlabeLes requlrlng lnsulln.
kecommendat|on: 1haL Lhe subsldy of |nsu||n g|arg|ne and oLher long acLlng lnsulln
analogues (eg |nsu||n detem|r) be generally llmlLed Lo paLlenLs wlLh 1ype 1 dlabeLes,
wlLh use ln 1ype 2 dlabeLes llmlLed Lo clrcumsLances slmllar Lo Lhose descrlbed above.
LsLlmaLed savlngs could noL be calculaLed from Lhe avallable daLa.
DR &*+,$2*'-.
Somatrop|n ls more expenslve ln 8omanla Lhan ln Lhe uk ln boLh absoluLe and relaLlve
Lerms. AlLhough nlCL guldance supporLs lLs use ln llmlLed clrcumsLances ln adulLs, ln
AusLralla use ln adulLs has been consldered and re[ecLed on several occaslons, as lL ls
noL consldered Lo be cosL effecLlve.
11

9

ln 8omanla lL ls lncluded ln Sub-llsL 8, Lhus Lhe
only consLralnL on lLs use ls Lhe 30 colnsurance amounL, and ln 2010 expendlLure was
ln excess of t9.6m.
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-darbepoetin-nov07
10
Schrl[vers u, 8olla l on behalf of Lhe LSMC Culdellnes Worklng Croup. LryLhropolesls-sLlmulaLlng agenLs ln
cancer paLlenLs: LSMC recommendaLlons for use. Aoo Oocol 20091202suppl 434lv1395lv161- AL
hLLp://annonc.oxford[ournals.org/conLenL/20/suppl_4/lv139.full#sec-10
11
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-somatropin-july11

___________________________________________________________________________________________________
kecommendat|on: 1haL Lhe subsldy of somatrop|n be sub[ecL Lo speclflc ellglblllLy
crlLerla LhaL may exclude use ln adulLs. oLenLlal cosL savlngs cannoL be quanLlfled.
GR T"E,=-UB+,?
ln addlLlon Lo Lhe LreaLmenL of meLasLaLlc breasL cancer, ln 8omanla bevac|zumab
may be prescrlbed
ln comblnaLlon wlLh plaLlnum-based chemoLherapy, for flrsL llne LreaLmenL of
paLlenLs wlLh non-small cell lung cancer (nSCLC), advanced unresecLable,
meLasLaLlc or recurrenL, excludlng predomlnanL squamous cell hlsLology
ln meLasLaLlc colorecLal cancer, and
ln comblnaLlon wlLh lnLerferon alfa, for meLasLaLlc renal cell carclnoma.
ln Lhe uk bevac|zumab ls noL currenLly recommended by nlCL for use ln Lhe nPS for
Lhe LreaLmenL of any solld Lumors. ln AusLralla, bevac|zumab ls subsldlzed ln colorecLal
cancer only, wlLh Lhe nSCLC lndlcaLlon speclflcally re[ecLed on Lhe grounds of lack of
cosL effecLlveness.
12
kecommendat|on: 1haL bevac|zumab be dellsLed pendlng a speclflc evaluaLlon of cosL
effecLlveness ln Lhe 8omanlan conLexL. 1reaLmenL need noL be wlLhdrawn from
exlsLlng paLlenLs buL LreaLmenL of new paLlenLs should noL be lnlLlaLed.
Clven LhaL Lhe prlce ln 8omanla ls hlgher Lhan ln Lhe uk (boLh ln
absoluLe and relaLlve Lerms) lLs cosL effecLlveness musL be quesLloned. uellsLlng would
poLenLlally glve rlse Lo gross savlngs of up Lo t18.6m pa based on 2010 flgures.
HR Q".('-2-4"
Iensp|r|de ls a non-sLeroldal anLl-lnflammaLory wlLh anLl-Lusslve and anLl- broncho-
consLrlcLlve properLles used ln Lhe LreaLmenL of CCu. AlLhough reglsLered ln 8omanla
and a number of former easLern bloc counLrles lLs efflcacy (and Lherefore lLs cosL
effecLlveness) ls unclear. 1he SC documenL for Lhls medlclne conLalns no cllnlcal daLa,
and mosL of Lhe llLeraLure ls noL ln Lngllsh. Clven Lhe magnlLude of annual expendlLure
on Lhls drug (t7.3m ln 2010) a revlew of lLs effecLlveness and cosL effecLlveness may
be approprlaLe.
kecommendat|on: 1haL fensp|r|de be revlewed Lo conflrm lLs cosL effecLlveness and
sulLablllLy for ongolng subsldy.
VR &*2,1".-?
Sorafen|b ls noL recommended by nlCL as a flrsL or second llne LreaLmenL for paLlenLs
wlLh advanced and/or meLasLaLlc renal cell carclnoma.
13
ln AusLralla lL ls also noL
consldered Lo be cosL effecLlve ln advanced and/or meLasLaLlc renal cell carclnoma.
14

12
hLLp://www.healLh.gov.au/lnLerneL/maln/publlshlng.nsf/ConLenL/pbac-psd-bevaclzumab-march11

13
hLLp://www.nlce.org.uk/nlcemedla/llve/11817/43918/43918.pdf
14
hLLp://www.healLh.gov.au/lnLerneL/maln/publlshlng.nsf/ConLenL/pbac-psd-sorafenlb-LosylaLe-mar08

___________________________________________________________________________________________________
As Lhe 8omanlan prlce ls hlgher Lhan Lhe AusLrallan prlce and close Lo Lhe uk prlce, lL ls
Lherefore unllkely Lo represenL a cosL effecLlve LreaLmenL ln Lhls seLLlng.
kecommendat|on: 1haL sorafen|b be dellsLed for renal cell carclnoma. LsLlmaLed cosL
savlngs ~t4.1m based on 2010 expendlLure.
WR N"$B#-+,?
8omanlan LreaLmenL proLocols provlde for Lhe use of cetux|mab ln paLlenLs wlLh
meLasLaLlc colorecLal cancer ln comblnaLlon wlLh lrlnoLecan, afLer fallure of Lherapy
wlLh lrlnoLecan. P1A evaluaLlon by Lhe uk nlCL found LhaL cetux|mab was noL cosL
effecLlve ln Lhls seLLlng and recommended agalnsL lLs use.
13
kecommendat|on: 1haL cetux|mab be dellsLed for second llne LreaLmenL of meLasLaLlc
colorecLal cancer.

As Lhe 8omanlan prlce ls
comparable wlLh Lhe uk prlce lL ls unllkely Lo be cosL effecLlve for Lhls lndlcaLlon ln Lhe
8omanlan conLexL.
C. Med|c|nes cons|dered cost effect|ve |n other [ur|sd|ct|ons but un||ke|y to be
cost effect|ve at current koman|an pr|ces
ln 8eporL 3 we noLed LhaL on comparlng 8omanlan and uk drug prlces, and assumlng
LhaL Lhe uk prlces reflecL Lhe upper llmlL of cosL effecLlveness, we ldenLlfled more Lhan
30 medlclnes among Lhe Lop 30" LhaL may noL be cosL effecLlve ln Lhe 8omanlan
conLexL. 8y ad[usLlng Lhe uk prlce by Lhe raLlo of Lhe 8omanlan -ad[usLed per
caplLa Cu Lo uk -ad[usLed per caplLa Cu we ldenLlfled LargeL" prlces and
calculaLed prlce reducLlons LhaL would approxlmaLe a level of cosL effecLlveness slmllar
Lo LhaL ln Lhe uk. We acknowledged LhaL Lhese were crude approxlmaLlons LhaL dld
noL Lake ln Lo accounL dlfferences ln sysLem cosLs and cosL offseLs, buL noneLheless
faclllLaLed a rapld (! #$%&' assessmenL of cosL effecLlveness ln Lhe absence of a robusL
8omanlan P1A evaluaLlon. 1he LargeL prlce reducLlons proposed are shown ln 1able 1,
Lhe calculaLlons and prlclng comparlsons are shown ln 1able 3. Aggresslve prlce
reducLlons would be necessary Lo approxlmaLe Lhe LargeL prlces ldenLlfled. 1hls ralses
quesLlons of creaLlng lncenLlves for parallel exporL. 1hls ls dlscussed below.
kecommendat|on: 1haL Lhe MlnlsLry of PealLh pursue prlce reducLlons conslsLenL wlLh
Lhe LargeL prlces ldenLlfled.
D. Med|c|nes for wh|ch subs|dy |s not supported by c|ear ev|dence of pos|t|ve
r|sk] benef|t, |rrespect|ve of reg|strat|on status.
1. X-.<L* ?->*?,
8ased on 2010 expendlLure, dellsLlng would generaLe savlngs of ~t16.3m pa.

13
hLLp://www.nlce.org.uk/nlcemedla/llve/11612/33930/33930.pdf

______________________________________________________________________________________________________________________________________________________________
1ab|e 3: Se|ected r|ce Compar|sons for "1op S0"
All prlces ln Luros / Lxchange raLes as aL 1 uecember 2011 / lndlcaLlve prlces only, pro-raLed where necessary Lo ad[usL for dlfferenL quanLlLles
Drug
2010
expend|ture
|n kCN (m)
2010
expend|ture
|n Luros (m) keference ty
r|ce |n
koman|a
r|ce |n
Uk*
ro rata
pr|ce**
r|ce
reduct|on
for pro rata
pr|ce r|ce |n N2
US keta||
r|ce***
US
Government
r|ce (VA)
#

er cap|ta GD
US5 514,0S0 536,S80

528,0S0 547,020
peglnLerferon o-2a 160.78 36.93 4x180 g/0.3ml 886.14 382.10 223.38 73 1,033.92 1,829.41 461.32
epoeLlnum 131.80 34.86 10000lu x 6 480.79 492.30 189.09 61 226.99 n/A n/A
LrlmeLazldlne 139.11 31.93 n/A n/A n/A n/A n/A
olanzaplne 133.22 30.60 30 x 10mg 28.33 109.34 42.07 n/A 3.91 284.38 173.43
eLanercepL 106.83 24.34 4 x 23 mg 313.43 418.23 160.64 69 343.66 707.99 269.71
lnsulln human 103.00 24.12 Pumulln 8 100lux3 21.79 n/A n/A 24.30 231.93 12.98
lmaLlnlb 90.71 20.83 120 x 100mg 2,030.38 1,876.60 720.78 63 2,737.12 4,474.67 2,033.20
lnsulln glarglne 89.46 20.33 100 lu x 3 31.06 132.08 38.41 n/A 34.28 168.13 82.96
rlLuxlmab 84. 96 19.31 100MC ln 10ml 304.33 204.28 78.46 84 308.88 327.60 300.44
bevaclzumab 80,.91 18.38 100 mg ln 4ml 302.34 283.87 109.03 64 n/A 483.44 303.82
lndapamlde 73.60 16.90 30 x 2.3mg 3.38 1.39 0.61 82 0.36 10.47 0.62
salmeLerol+fluLlcasone 69.27 13.91 60 x 30 / 230 33.72 40.94 13.73 36 28.34 164.64 103.81
lnfllxlmab 68.36 13.70 100mg x 2 1,163.13 981.73 377.08 68 n/A 1,131.61 637.33
queLlaplne 66.63 13.31 60 x 30mg 32.67 79.13 30.40 42 8.04 262.24 112.69
perlndoprll 61.19 14.03 30 x 4mg 3.38 - 7.60 2.12 0.81 n/A 2.33 18.18 34.87
rosuvasLaLln 39.66 13.70 30 x 40mg 24.90 37.21 14.29 43 n/A 117.49 31.39
rlsperldone 38.36 13.41 60 x 2mg
10.17 -
23.00 44.24 16.99 n/A 6.32 217.01 13.12
adallmumab 33.44 12.73 2 x 40 mg 1,086.19 836.41 321.26 70 1,033.87 1,460.09 361.96
omeprazole 33.63 12.32 30 x 20mg 4.73 2.41 0.92 80 0.72 12.01 1.97
aLorvasLaLln 30.90 11.69 30 x 20mg 6.30 - 28.79 30.88 11.86 n/A 13.34 139.99 62.06
monLelukasL 49.89 11.46 30 x 3mg 33.34 32.20 12.37 63 n/A 124.98 33.38
memanLlne 49.30 11.32 60 x 10mg 101.71 86.49 33.22 67 n/A 180.24 82.26

______________________________________________________________________________________________________________________________________________________________
Drug
2010
expend|ture
|n kCN (m)
2010
expend|ture
|n Luros (m) keference ty
r|ce |n
koman|a
r|ce |n
Uk*
ro rata
pr|ce**
r|ce
reduct|on
for pro rata
pr|ce r|ce |n N2
US keta||
r|ce***
US
Government
r|ce (VA)
#

slmvasLaLln 49.00 11.23 30 x 40mg 4.30 - 16.33 1.63 0.64 83 0.61 20.93 1.33
amoxlclllln+clavulanaLe 47.93 11.01 20 x 300- 123 3.31 - 8.44 3.12 1.97 44 2.99 34.42 4.69
peglnLerferon o-2b 43.21 10.38 120mcg x 1 220.33 186.60 71.67 67 n/A 472.99 104.34
capeclLablne 43.12 9.90 60 x 130mg 34.30 46.82 17.98 67 66.06 417.39 188.32
somaLropln 41.88 9.62 1 x 10mg (30lu) 331.69 248.82 93.37 73 206.78 392.73 273.33
doceLaxel 41.33 9.49 20mg/0,3ml 19.04 - 28.44 190.39 73.13 n/A 28.00 n/A 92.18
leveLlraceLam 40.89 9.39 30 x 300mg 26.69 - 38.93 30.39 11.73 36 8.23 22.44 10.16
fenoflbraLe 40.67 9.34 30 x 200mg 6.00 4.42 1.70 72 n/A 34.29 23.82
zoledronlc acld 40.62 9.33 4mg ln[ 249.41 214.43 82.36 67 273.71 680.86 480.76
donepezll 40.38 9.27 30 x 10mg 31.43 - 87.26 103.13 40.39 n/A 2.69 140.70 39.96
LrasLuzumab 38.83 8.92 130mg ln[ 393.17 476.38 183.03 69 773.44 913.36 318.39
clopldogrel 37.37 8.38 30 x 73mg 9.33 - 29.73 41.69 16.01 n/A 3.11 146.68 73.03
epoeLln o 36.30 8.34 6 x 10000 lu 332.09 337.33 137.23 61 226.99 609.28 344.01
beLahlsLlne 36.28 8.33 30 x 8mg 1.87 - 3.33 2.64 1.02 46 1.90 n/A n/A
lnsulln asparL 34.62 7.93 100lu x 3 29.64 93.22 36.37 n/A 29.40 201.31 23.30
meLoprolol 34.24 7.87 30 x 100mg 1.62 - 3.83 1.99 0.77 33 6.26 3.98 0.64
rlvasLlgmlne 33.96 780 60 x 3mg 31.69 - 84.80 83.36 32.02 n/A n/A 192.20 76.60
borLezomlb 33.73 773 3.3mg ln 10ml 1,041.29 891.84 342.33 67 1,087.03 n/A 699.90
splronolacLone+
furosemlde 33.46 7.68 n/A n/A n/A n/A n/A n/A n/A n/A
fensplrlde 32.87 7.33 n/A n/A n/A n/A n/A n/A n/A n/A
dorzolamlde+ Llmolol 32.43 7.43 100-23mg, 3ml 13.83 11.76 4.32 71 8.90 37.42 12.70
lnsulln llspro 30.78 7.07 100lu x 3 29.27 97.13 37.32 n/A 34.18 199.82 63.23
darbepoeLln o 30.61 7.03 4x 100mcg 632.89 686.96 263.83 60 n/A 1,716.79 684.24
erdosLelne 30.31 6.96 20x 300mg 7.18 6.73 2.38 64 n/A n/A n/A
* neL prlce from 8nl ** calculaLed by mulLlplylng uk prlce by raLlo of 8omanlan/uk per caplLa Cu *** from hLLp://www.drugsLore.com
# hLLp://www.pbm.va.gov/urugharmaceuLlcalrlces.asp

_____________________________________________________________________________________________________
9R I24*($"-."
Lrdoste|ne ls a mucolyLlc wlLh llmlLed evldence of beneflL for lLs llcensed lndlcaLlon,
and wlLh no evldence for lmproved cllnlcal ouLcomes or quallLy of llfe. Whlle nlCL
guldellnes
16
kecommendat|on: 1haL g|ngko b||oba and erdoste|ne be consldered for dellsLlng wlLh
esLlmaLed savlngs of approxlmaLely t23.2m pa based on 2010 expendlLure.

broadly supporL Lhe use of mucolyLlcs ln sLable chronlc obsLrucLlve
pulmonary dlsease, Lhelr place ln Lherapy for acuLe exacerbaLlons of CCu ls unclear.
1he use of erdoste|ne ls exLenslve, accounLlng for nearly t7m ln expendlLure (afLer 30
colnsurance) ln 2010.
L. Med|c|nes that may not ref|ect a h|gh pr|or|ty for subs|dy |n a resource-||m|ted
env|ronment.
8R A"4-=-."( $7,$ =*B>4 ?" =*.(-4"2"4 1*2 2"=>,((-1-=,$-*. $* *E"2K$7" =*B.$"2
($,$B( ,.4 4">-($"4
ant|-h|stam|nes eg loraLadlne, desloraLadlne, ceLlrlzlne, chlorphenlramlne
s|mp|e ana|ges|cs eg lbuprofen
d|osm|n]hesper|d|n
or||stat
9R N"2$,-. 42B<( 1*2 2,2" 4-(",("( Y "< ".UC+" 2"'>,="+".$ $7"2,'-"(
We noLe LhaL Lhe 8omanlan formulary lncludes programmes LhaL fully subsldlse
LreaLmenLs for several ulLra-orphan lndlcaLlons, lncludlng a number of enzyme
replacemenL Lheraples. AlLhough noL advocaLlng Lhe dellsLlng of Lhese Lheraples, lL ls
neverLheless unclear wheLher Lhe declslons Lo fund Lhese programmes have been
lnformed by any expllclL ellclLaLlon of soclal values and Lherefore wheLher Lhey reflecL
Lhe prlorlLles of Lhe 8omanlan populaLlon Lo a degree sufflclenL Lo [usLlfy Lhe cosLs
lnvolved. We also noLed LhaL Lhe prlces of many of Lhese medlclnes are hlgher Lhan,
for example, Lhe uk (see secLlon on rlclng Anomalles below).
kecommendat|on:
1haL conslderaLlon be glven Lo reclasslfylng Lhe drugs llsLed above Lo C1C sLaLus
and dellsLlng from Lhe formulary.
1haL conslderaLlon be glven Lo esLabllshlng a process for Lhe ellclLaLlon of soclal
values Lo ensure LhaL conLlnued fundlng of drugs for ulLra-orphan lndlcaLlons ls
conslsLenL wlLh publlc prlorlLles.
I. Med|c|nes not yet ||sted but w|th a pos|t|ve recommendat|on from the N1C
As noLed ln Lhe prevlous reporL, Lhere are a large number of medlclnes LhaL have been
recommended by Lhe naLlonal 1ransparency CommlLLee, buL noL yeL added Lo Lhe

16
ManagemenL of chronlc obsLrucLlve pulmonary dlsease ln adulLs ln prlmary and secondary care.
hLLp://guldance.nlce.org.uk/CC101

_____________________________________________________________________________________________________
naLlonal formulary. 1o our knowledge, Lhese recommendaLlons have noL Laken lnLo
accounL unlL cosL, cosL effecLlveness or overall budgeL lmpacL.
kecommendat|on:
1haL Lhese medlclnes (and any subsequenLly proposed for llsLlng) should noL be
consldered ln Lhe absence of elLher a full or (as a mlnlmum) a (! #$%&' P1A evaluaLlon
and budgeL lmpacL assessmenL.
r|c|ng Anoma||es
ln revlewlng Lhe naLlonal formulary and prlcellsLs we observed a number of apparenL
anomalles LhaL warranL furLher exploraLlon. 1hese were menLloned brlefly ln 8eporL 3 and
are dlscussed ln greaLer deLall below.
&B?($,.$-,> E,2-,$-*.( -. B.-$ =*($( 1*2 +,.C +"4-=-."(
ln Lhe compleLe formulary flle whlch shows unlL prlces for all llsLed medlcaLlons we observed
exLenslve varlaLlons ln unlL cosLs. Some examples lnclude:
a 3 fold varlaLlon ln Lhe unlL prlces of acyclovlr cream
a more Lhan 3 fold varlaLlon ln Lhe prlces of clarlLhromycln LableLs
a 3 fold varlaLlon ln Lhe per mg prlce of amlodlplne LableLs
a 9-fold varlaLlon ln Lhe prlce per mg of pacllLaxel
a 30-fold varlaLlon ln Lhe prlce per mg of clprofloxacln LableLs
Where reference prlclng ls unlformly applled, Lhls ls may noL represenL a slgnlflcanL rlsk ln
Lerms of CnAS expendlLure, however lL can have Lremendous lmpacL on consumer ouL-of-
pockeL cosLs, noL only because paLlenL conLrlbuLlons are sLrucLured as co-lnsurances buL also
because cosLs exceedlng Lhe subsldy musL be borne by Lhe consumer ln addlLlon Lo Lhe co-
conLrlbuLlon. 1hls ls parLlcularly Lhe case ln Lhe absence of a mechanlsm Lo ensure LhaL
pharmacles offer and are able Lo supply a benchmark prlced producL.
O(" *1 2"1"2".=" '2-=-.< ,.4 >,=L *1 2"1"2".=" '2-=-.< ?C $7"2,'"B$-= <2*B'
A number of medlclnes on Lhe formulary carry prlces LhaL are conslderably hlgher Lhan oLher
Lheraples of slmllar effecLlveness wlLh whlch Lhey could be reasonably subsLlLuLed ln mosL
paLlenLs. ConLlnued subsldy should be made sub[ecL Lo Lhe oppllcotloo of o tefeteoce ptlcloq
moJel llokloq tbe ptlces of Jtoqs of slmllot effectlveoess wltblo o tbetopeotlc qtooploq. 1hls
reflecLs a more raLlonal pollcy seLLlng ln whlch a hlgher prlce ls pald only where a drug offers
evldence of a cllnlcally meanlngful lncremenL ln beneflL. 1o poy o blqbet ptlce lo tbe obseoce
'# !*,(!)%! '# socb oo loctemeotol beoeflt ls oot cooslsteot wltb o totloool Jetetmlootloo of
voloe fot mooey ot oppottoolty cost.
CurrenLly reference prlclng" ls applled only lnsofar as Lhe level of subsldy ls seL or
referenced Lo Lhe prlce of Lhe cheapesL brand of a molecule or enLranL ln a LherapeuLlc class
(Lhe benchmark producL), whlch slmply shlfLs Lhe burden of Lhe prlce varlaLlon on Lo Lhe
consumers. unless measures can be lnLroduced Lo ensure LhaL consumers always have
access Lo Lhe benchmark producL, Lhls ls manlfesLly unreasonable. Moreover, Jeloys lo

_____________________________________________________________________________________________________
poymeots to pbotmocles meoo tbot cotteot pollcy settloqs cteote sttooq loceotlves fot
pbotmocles to ovolJ offetloq ot sopplyloq beocbmotk ptlceJ ptoJoct6 as copays and ouL of
pockeL cosLs are reLalned aL pharmacy, Lhus lmprovlng cash flows. Lxample: oLenLlal savlngs
of 11.4m euro by subsLlLuLlng epoeLln beLa wlLh epoeLln alfa aL currenL prlces and volumes.
P2-="( *1 I.UC+" M"'>,="+".$ 07"2,'-"(
1able 4 presenLs some prlce comparlsons for Lhe ulLra-orphan enzyme replacemenL
Lheraples currenLly avallable on Lhe formulary. lrrespecLlve of Lhe basls of Lhe declslon(s) Lo
fund Lhese Lheraples
17
Lven Lhough overall expendlLure on Lhese producLs may noL be hlgh because of small volumes,
efforLs should be dlrecLed Lo renegoLlaLlng prlces and lnsLlLuLlng rlsk sharlng arrangemenLs (eg
capped paymenLs, or flxed per-paLlenL-year cosLs as opposed Lo prlces per dosage unlL, as
proposed by LoperL (2011).
Lhe prlces ln 8omanla appear somewhaL hlgher ln absoluLe Lerms
Lhan ln Lhe uk, and when ad[usLed for capaclLy Lo pay, subsLanLlally so.
18
1ab|e 4 - 1ab|e of r|ce Compar|sons for Lnzyme kep|acement 1herap|es

Drug
keference
uant|ty
r|ce |n
koman|a
r|ce |n
Uk*
r|ce
d|fferent|a|
koman|a
> Uk
ro
rata
pr|ce**
r|ce
reduct|on
for pro
rata pr|ce
US VA
r|ce
#

r|ce
d|fferent|a|
koman|a >
US Govt
lmlglucerase 400u 1,368 1,233 23 481 69 901 74
laronldase 100u/ml,3ml 636 320 22 200 69 398 60
ldursulfase 4x2mg/ml, 3ml 11,320 9,288 22 3,368 68 3,889 92
agalsldase 33mg 3132 2,370 22 987 68 2,338 22
alglucosldase 30mg 314 417 23 160 69 260 98
* neL prlce from Lhe 8nl ** calculaLed by mulLlplylng uk prlce by raLlo of 8omanlan/uk per caplLa Cu
*** hLLp://www.drugsLore.com # hLLp://www.pbm.va.gov/urugharmaceuLlcalrlces.asp
All prlces are rounded Lo Lhe nearesL Luro and uLlllse Lhe exchange raLes prevalllng on 1 uecember 2011.

S.*+,>-"( -. 42B< "#'".4-$B2" $2".4(
ln examlnlng expendlLure Lrends over Lhe perlod 2009-2010 for Lhe Lop 30 drugs ln each of
Lhe formulary sub-llsLs we ldenLlfled several drugs where decreases, or only modesL
lncreases ln paLlenL numbers were assoclaLed wlLh ,)%teose6 lo ovetoll ot pet potleot
expeoJltote of mote tboo 20X - lncreases LhaL are unllkely Lo be accounLed for by changes ln
dosage reglmens alone.
19
P2-=-.< ,.4 ',2,>>"> "#'*2$
1able 3 refers. 1hls clearly warranLs furLher lnvesLlgaLlon and may
reflecL an effecL of slgnlflcanL prlce varlaLlon poLenLlally conLrollable Lhrough more exLenslve
use of reference prlclng.

17
1he exLremely hlgh per paLlenL cosLs for LreaLmenLs for Lhese rare condlLlons prompL quesLlons of wheLher
Lhe declslon(s) Lo lnclude Lhese Lheraples ln naLlonal rogrammes had been lnformed by a formal ellclLaLlon of
8omanlan soclal values.
18
LoperL 8. 8apld 8evlew of Lhe 8egulaLlon and ollcy lramework for harmaceuLlcal ManagemenL ln 8omanla.
World 8ank 8ackground aper, May 2011 (unpubllshed). LxecuLlve Summary aL Appendlx 8.
19
A full llsL, showlng varlaLlons of <20, ls avallable on requesL.

_____________________________________________________________________________________________________
WlLh respecL Lo prlclng, a number of lssues of concern wlLh currenL mechanlsms have been
hlghllghLed prevlously. Cf parLlcular slgnlflcance ls Lhe exLenslve rellance on Lhe use exLernal
reference prlclng for medlclnes manufacLured ouLslde 8omanla (wlLh cosL-plus prlclng for
Lhose manufacLured domesLlcally). LxLernal reference prlclng ls based on Lhe lowesL prlce
from wlLhln a baskeL of 12 Lu counLrles
20
AnecdoLally, Lhere ls evldence LhaL currenL prlclng arrangemenLs ln 8omanla creaLe
lncenLlves for parallel exporLs and LhaL Lhese may accounL for dlverslon of as much as 20 of
producL volumes. Concerns abouL parallel exporL underplnned recenL changes Lo generlcs
prlclng, ln parLlcular Lhe lncrease ln Lhe celllng prlce of Lhe flrsL generlc verslon of a molecule
from 63 Lo 70 of Lhe orlglnaLor prlce.
accordlng Lo an algorlLhm publlshed by Lhe MlnlsLry
of ubllc PealLh. Moreover, under Lu regulaLlon Lhe prlces of new medlclnes musL be
deLermlned wlLhln 90 days of markeLlng approval, buL appllcable exchange raLes are
recallbraLed only annually.
21,22
1here are a number of posslble opLlons for reduclng lncenLlves for parallel exporL. Cne
opLlon whlch could also generaLe savlngs ln pharmaceuLlcal expendlLure, would be Lo llmlL
Lhe number of brands of a producL, and producLs wlLhln a LherapeuLlc class LhaL are sub[ecL
Lo relmbursemenL, Lhrough Lenderlng arrangemenLs. Successful Lenderers would be requlred
Lo provlde supply guaranLees, wlLh heavy penalLles for producL dlverslon leadlng Lo fallure Lo
meeL supply commlLmenLs.

lor medlclnes LhaL are noL sub[ecL Lo generlc compeLlLlon such as novel Lheraples or flrsL-ln-
class drugs, oLher mechanlsms would be needed lf 8omanlan prlces are slgnlflcanLly lower
Lhan elsewhere ln Lurope
23

20
AusLrla, 8ulgarla, 8elglum, Czech 8epubllc, Cermany, Creece, Pungary, lLaly, LlLhuanla, oland, Slovakla, and
Spaln
. ln Lhese cases supply guaranLees would be essenLlal aL Lhe Llme
of llsLlng Lhe medlclne on Lhe formulary, once agaln wlLh slgnlflcanL penalLles for fallure Lo
supply.
21
hLLp://www.lhs.com/producLs/global-lnslghL/lndusLry-economlc-reporL.aspx?ld=106394698
22
hLLp://Llnyurl.com/7y3[7kb
23
1he prlce comparlsons shown ln 1able 3 clearly lndlcaLe LhaL Lhls ls noL Lhe case for many of 8omanla's hlgh
expendlLure lLems however.

________________________________________________________________________________________________________________________________________________________________
1ab|e S - Drugs w|th Increase |n er at|ent Lxpend|ture > 20 , 2009-2010 (presented |n descend|ng order of expend|ture |n 2010)
INN 2009 at|ents
2009
Lxpend|ture
(kCN)
er at|ent
Lxpend|ture
(L) 2009
(kCN) 2010 at|ents
2010
Lxpend|ture
(kCN)
er at|ent
Lxpend|ture
(L) 2010
(kCN)
Change |n
at|ent
Numbers
Change |n
Lxpend|ture Change |n L
Sub||st A
lndapamlde 1,343,900 33,310,276 36 1,308,833 73,601,102 49 -2 33 36
splronolacLone+furosemlde 317,430 19,482,828 61 334,036 33,438,693 100 3 72 63
enalaprll 733,843 22,334,064 30 644,634 29,384,363 46 -12 32 31
ramlprll 298,023 12,374,201 42 322,323 22,373,386 69 8 78 64
amlodlplne 379,490 3,826,482 13 398,049 13,897,376 40 3 173 160
carvedllol 183,473 7,798,872 43 203,630 11,033,122 34 12 41 26
clprofloxacln 416,732 6,322,341 13 412,691 8,933,970 22 -1 42 43
ursodeoxychollc acld 18,772 4,316,410 230 26,188 7,320,020 280 40 70 22
dlclofenac 448,628 3,421,780 12 404,327 3,988,263 13 -10 10 23
acenocearol 144,323 3,300,938 23 161,962 3,068,797 31 12 34 37
losarLan 24,780 1,189,918 48 63,772 3,042,038 77 163 324 60
Sub||st 8
salmeLerol/fluLlcasone 116,883 46,237,146 396 138,091 69,274,770 302 18 30 27
pramlraceLam 33,367 8,982,349 268 43,332 13,093,732 347 30 68 30
budesonlde/ formoLerol 34,173 8,136,663 239 31,140 14,868,948 291 30 82 22
sLronLlum ranelaLe 14,824 3,936,243 400 20,334 10,003,324 487 39 69 22
LelmlsarLan/PC1Z 27,367 3,642,949 203 39,244 9,614,338 243 42 70 20
momeLasone 144,300 6,193,797 43 126,376 7,742,412 61 -12 23 42
Lrlflusal 27,633 2,838,322 103 38,277 3,908,260 134 38 107 49
Sub||st C1
eLanercepL 2,297 70,193,209 30,339 2,633 106,833,293 40,344 13 32 33
lnfllxlmab 1,373 33,229,497 33,797 1,672 68,360,923 40,886 6 28 21
adallmumab 918 27,331,287 29,991 1,313 33,439,331 36,394 63 101 22
memanLlne 13,784 33,913,678 2,149 19,168 49,297,900 2,372 21 43 20
pramlpexole 12,018 20,832,383 1,733 12,448 28,246,324 2,269 4 36 31
enLecavlr 333 3,432,332 9,788 1,271 17,662,334 13,896 129 223 42
lmlglucerase 27 13,727,011 308,408 24 16,131,820 672,139 -11 18 32
rasaglllne 2,922 7,047,791 2,412 4,229 14,633,423 3,463 43 108 44
anagrellde 484 3,163,107 10,668 738 9,314,999 12,893 32 84 21
duloxeLlne 8,369 4,671,107 343 12,197 8,673,863 711 42 86 30
blmaLoprosL 10,636 3,131,966 294 17,380 7,428,230 423 63 137 44

________________________________________________________________________________________________________________________________________________________________
INN 2009 at|ents
2009
Lxpend|ture
(kCN)
er at|ent
Lxpend|ture
(L) 2009
(kCN) 2010 at|ents
2010
Lxpend|ture
(kCN)
er at|ent
Lxpend|ture
(L) 2010
(kCN)
Change |n
at|ent
Numbers
Change |n
Lxpend|ture Change |n L
palonoseLron 3,468 3,346,234 1,023 3,163 7,386,176 1,430 49 108 40
LravoprosL+ Llmolol 8,119 3,337,367 411 11,878 7,147,133 602 46 114 46
ocLreoLlde 137 2,806,372 20,486 233 6,633,103 26,226 83 136 28
Sub||st C2
lmaLlnlb 943 82,072,647 87,034 862 90,713,218 103,236 -9 11 21
borLezomlb 224 22,827,928 101,910 267 33,733,437 126,343 19 48 24
lnsulln llspro 13,767 19,113,316 1,212 19,329 30,783,863 1,393 23 61 31
leLrozole 4,733 16,382,277 3,460 3,199 21,966,631 4,223 10 34 22
slLagllpLln 8,630 11,767,160 1,360 11,308 18,496,233 1,636 31 37 20
gllbenclamlde+meLformln 33,478 13,628,164 246 34,198 16,038,826 296 -2 18 21
dasaLlnlb 80 8,294,481 103,681 93 12,208,338 131,273 16 47 27
lnLerferon alfa 2b 1,294 10,640,332 8,223 1,170 12,179,219 10,410 -10 14 27
fulvesLranL 366 3,790,283 6,697 823 10,034,063 12,216 43 163 82
exenaLlde 2,283 3,401,381 2,364 2,799 8,630,937 3,084 22 60 30
Sub||st 3
loraLadlne 106,343 920,284 9 83,134 1,043,324 12 -20 14 42
collsLlne 386 328,767 832 789 948,663 1,202 104 189 41
Lolperlsone 13,367 139,821 10 12,290 170,028 14 -8 22 32
meLamlzole 9,323 60,026 6 12,194 133,136 11 28 123 76
menoLroplne 49 60,109 1,227 76 113,908 1,499 33 90 22
pyrldoxlne 3,233 43,391 8 3,693 89,888 16 8 107 91
levocarnlLlne 1,072 32,917 49 1,262 78,390 62 18 49 26
Lhlamlne 1,303 12,221 8 3,062 31,379 17 103 322 107
kanamycln 6,622 16,361 3 6,367 42,987 7 -4 160 170
chloramphenlcol 3,431 23,212 7 3,032 40,306 13 -12 74 98
eryLhromycln 1,863 21,383 11 2,220 32,370 13 19 31 27
cyanocobalamln 1,210 10,249 8 1,780 31,831 18 47 211 111
mefanemlc acld 1,381 12,469 9 1,460 21,148 14 6 70 60
ferrous gluconaLe 6 23 4 33 18,441 333 817 80711 8716
dlclofenac+ mlsoprosLol 343 10,243 30 491 18,422 38 42 80 26

____________________________________________________________________________________________________
Non-drug serv|ces and products
Data Issues
1he weaknesses ln Lhe presenL deslgn and lmplemenLaLlon of 8omanlan u8Cs have already
been noLed. 8omanlan u8Cs do noL appear Lo be reallsLlc represenLaLlons of Lhe acLual
cosLs of LreaLmenL, as Lhey do noL seem Lo be based on an analysls of hlgh volume
represenLaLlve cosL daLa and are Lherefore noL approprlaLely ad[usLed for case mlx. ln
addlLlon, we were lnformed LhaL daLa on Lhe acLual relmbursed cosLs of LreaLmenL aL Lhe
provlder level are noL Lhe same as Lhe correspondlng u8Cs. 1he 'real cosLs' are currenLly
unavallable.
Cne way of addresslng Lhe lssue of lnapproprlaLe servlces belng provlded was Lo bulld on
Lhe framework descrlbed ln our lasL reporL and Lhe crlLerla used by Lhe developers of Lhe
Croydon llsL" a llsL of surglcal procedures consldered for Lhelr approprlaLeness ln Lhe
conLexL of Lhe Lngllsh nPS. Powever, daLa were dlfflculL Lo obLaln, and, where avallable,
may noL have been rellable. ln addlLlon, we had no lnformaLlon ln Lhe presenL analysls on
Lhe severlLy of Lhe lnlLlal condlLlon for a number of Croydon LlsL" lnLervenLlons (such as
'wlsdom LeeLh exLracLlon').
1he focus of Lhe analysls presenLed here was on ldenLlfylng lnapproprlaLe acLlvlLy
speclflcally LargeLlng:
exLended lengLhs of sLay LhaL devlaLe from lnLernaLlonal and uk currenL pracLlce for
surglcal lnLervenLlons whose evldence base ls relaLlvely weak, and
hosplLal admlsslons and overnlghL sLay for relaLlvely lneffecLlve LreaLmenLs (such as
knee washouL) or for LreaLmenLs whlch could be offered on an ouLpaLlenL basls and
where hosplLal admlsslon would noL be necessary (eg for dlagnosLlc lmaglng)
no aLLempL has been made Lo quanLlfy savlngs ln moneLary Lerms, alLhough esLlmaLes have
been made of bed days LhaL could be saved.
lL ls also lmporLanL Lo noLe LhaL we dld noL examlne Lhe lndlvldual relmbursed cosLs of
varlous LesLs, lmaglng acLlvlLles (such as M8l) and oLher servlces. Cur lasL reporL dlscusses
Lhe broader lssue of effecLlve prlce ldenLlflcaLlon and devlce procuremenL. ln addlLlon,
prlclng was noL Lhe focus of Lhls rapld revlew of Lhe 8, alLhough lL ls a crlLlcal lssue wlLh
respecL Lo currenL pharmaceuLlcal relmbursemenL as descrlbed above, and Lo lndlvldual
hosplLal servlces ln Lhe conLexL of Lhe u8C Larlff.
Cverv|ew of the Methods
1he procedures selecLed lncluded Lhe followlng. We excluded procedures wlLh
ma[or/caLasLrophlc compllcaLlons:
1onslllecLomy
veln llgaLlon and sLrlpplng
SLomach, oesophageal and duodenal procedures
AppendecLomy

____________________________________________________________________________________________________
PepaLoblllary dlagnosLlc procedures
Laparoscoplc cholecysLecLomy
knee arLhroscoples
1ransureLhral prosLaLecLomy
ulagnosLlc cureLLage/hysLeroscopy
Caesarean secLlon
lor each selecLed procedure, we requesLed daLa on: Lhe number of cases, average lengLh of
sLay (ALCS) and aggregaLe esLlmaLed u8C relmbursemenL cosLs. 1he requesLed daLa
collecLlon perlod was for all relevanL u8C cases beLween 1 CcLober 2010 and 31 CcLober
2011.
ln explorlng Lhe approprlaLeness of Lhe observed acLlvlLy, we compared Lhe 8omanlan
lnformaLlon obLalned wlLh comparable rouLlne daLa from Lhe Lngllsh naLlonal PealLh
Servlce
24
. 1he casemlx measure for acuLe care ln Lngland ls PealLhcare 8esource Croups
(P8Cs). 1he populaLlon of Lngland ls approxlmaLely 32 mllllon
23
1o explore poLenLlally unnecessary admlsslons for lmaglng and oLher procedures, we also
requesLed daLa on Lhe numbers of C1s/M8ls/ L1s/ arLhroscoples/ endoscoples for paLlenLs
who were:
.
elecLlve admlsslons referred by ambulaLory or prlmary care physlclan
had LCS<3 days
lndlcaLlon belng "admlLLed for dlagnosls"
Powever, Lhese daLa were of llmlLed usefulness wlLhouL furLher explanaLory lnformaLlon,
and consequenLly are noL consldered furLher ln Lhls reporL.
I|nd|ngs
SE"2,<" >".<$7 *1 ($,C
revlous World 8ank reporLs have hlghllghLed LhaL lncenLlves appear Lo exlsL wlLhln Lhe
currenL relmbursemenL sysLem LhaL lead Lo unnecessarlly exLended lengLhs of sLay,
alLhough how Lhey operaLe ls noL enLlrely clear. ln one of Lhese reporLs, lL was argued LhaL
abouL 13 percenL of lnpaLlenLs ln 8omanla could easlly be LreaLed ln ouLpaLlenL seLLlngs. ln
addlLlon Lhe auLhor made Lhe polnL LhaL Lhere are many procedures and LreaLmenLs whlch
are recognlsed lnLernaLlonally as belng approprlaLe for same day or ambulaLory level
provlslon (such as LonslllecLomy) LhaL are currenLly assoclaLed wlLh lnpaLlenL sLays
26
. lL ls
lmporLanL Lo noLe LhaL exLended lengLhs of sLay (and lnapproprlaLe admlsslons) are also
maLLers of quallLy ln addlLlon Lo cosLs. Luropean naLlons and oLher counLrles are movlng
Lowards shorLer lengLhs of sLay
27

24
nPS 8eference cosLs, 2010-11. Avallable aL:
. ln addlLlon, lL ls also known LhaL lengLh of sLay ls an
hLLp://www.dh.gov.uk/en/ubllcaLlonsandsLaLlsLlcs/
ubllcaLlons/ubllcaLlonsollcyAndCuldance/uP_131140
23
Annual mld-year populaLlon esLlmaLe, 2010. Cfflce for naLlonal SLaLlsLlcs.
26
World 8ank. AmbulaLory Care and Lhe 8eneflLs ackage, World 8ank, May 2011.
27
See CLCu. PealLh aL a Clance - Lurope 2010

____________________________________________________________________________________________________
lmporLanL rlsk facLor for hosplLal-acqulred lnfecLlons
28
whlch are assoclaLed wlLh slgnlflcanL
avoldable cosLs
29
We soughL Lo complemenL Lhe observaLlons hlghllghLed ln prevlous World 8ank and oLher
reporLs wlLh a rapld assessmenL of a sample of u8Cs, represenLlng abouL 7 of all surglcal
cases. 1able 6 lllusLraLes Lhe dlvergence beLween ALCS ln 8omanla compared wlLh our
benchmark counLry (Lngland) and Lhe maxlmum poLenLlal bed days LhaL could be saved.
1here are some noLable conLrasLs beLween 8omanlan and Lngllsh esLlmaLes of ALCS for
slmllar lnLervenLlons. lor example, for 'Laparoscoplc CholecysLecLomy W/C Closed CuL
(common ducL exploraLlon) W/C CaLasLrophlc or Severe CompllcaLlons', ALCS was 3 days ln
8omanla, buL only abouL 1.3 days ln Lngland. lor open or laparoscoplc cholecysLecLomy
wlLh compllcaLlons ln Lngland, ALCS lncreases Lo 2.28 days.
.
Assumlng LhaL all Lhe procedures ln 1able 6 could be dellvered accordlng Lo Lhe Lngllsh
lengLh of sLay esLlmaLes presenLed, LoLal poLenLlal bed day saved could be a moxlmom of
233,694. Assumlng a bed occupancy raLe of 77 (Lhe Luropean average
30
N>-.-=,> ,''2*'2-,$"."((
) for a Lyplcal 600
bed hosplLal, LhaL 'savlng' equaLes Lo Lhe poLenLlal closure of aL leasL one hosplLal. noLe LhaL
Lhe cosLs clLed ln Lhe Lable represenL aggregaLe relmbursemenLs LhaL coolJ bove beeo moJe
based on exlsLlng u8C Larlffs. nowevet, we bove oo Joto oo octool telmbotsemeot costs,
ooJ lmpottootly tbe exteot of oot5'#5pocket poymeots fot tbese ptoceJotes.
1here are oLher feaLures LhaL sLand ouL ln Lhe daLa, and lL ls noL clear Lo whaL exLenL Lhey
represenL slgnlflcanL codlng and classlflcaLlon dlfferences, among oLher facLors. lor example
lL ls unclear why Lhe number of cases of dlagnosLlc cureLLage / dlagnosLlc hysLeroscopy ls
approxlmaLely double LhaL of Lngland, a counLry wlLh more Lhan Lwlce Lhe populaLlon of
8omanla. Slmllarly, Lhe numbers of surglcal varlcose veln procedures seem slgnlflcanLly
hlgher ln 8omanla, ad[usLlng for Lhe slze of lLs populaLlon.
nlCL guldance on lnferLlllLy recommends LhaL women should noL be offered hysLeroscopy
on lLs own as parL of Lhe lnlLlal lnvesLlgaLlon of lnferLlllLy problems unless cllnlcally lndlcaLed
slnce Lhe effecLlveness of surglcal LreaLmenL of uLerlne abnormallLles on lmprovlng
pregnancy raLes has noL been esLabllshed
S1

28
1he ManagemenL and ConLrol of PosplLal Acqulred lnfecLlon ln AcuLe nPS 1rusLs ln Lngland. naLlonal AudlL
Cfflce, 2000
.
ln Lhe case of heavy mensLrual bleedlng, nlCL
guldance recommends hysLeroscopy be used as a dlagnosLlc Lool ooly when ulLrasound
resulLs are lnconcluslve, for example, Lo deLermlne Lhe exacL locaLlon of a flbrold or Lhe
exacL naLure of Lhe abnormallLy.
29
lurLher deLalls aL: hLLp://www.nlce.org.uk/guldance/phg/hcal/CuallLylmprovemenLCulde.[sp
30
!ones 8. PosplLal bed occupancy demysLlfled. 8t I neoltbcote Moooqemeot 2011, 17(6):242-48
31
See: hLLp://guldance.nlce.org.uk/CC11

________________________________________________________________________________________________________________________________________________________________________
1ab|e 6. Se|ected procedures based on data prov|ded by the Nat|ona| Schoo| of ub||c nea|th (DkG cases between 1 Cctober 2010 to 31 Cctober 2011)
koman|an data Lng|and NnS data
k-DkG
Code
k-DkG Labe| No of
cases
of
surg|ca|
cases
Average
|ength of stay
(ALCS) - days
Lst|mate of
aggregate
costs (kCN)
Lng|and equ|va|ent
act|v|ty*
Number of
cases
Lng|and
Average
LCS -
days**
D|fference
|n ALCS
otent|a|
max|mum
reduct|on |n
bed days
Comment on
Lng|and data
u1090 1onslllecLomy
and/or
AdenoldecLomy
17,223 1.6 3 10,386,320 1onslllecLomy < 18
yrs wlLh or w/o CC,
>19 years wlLh or
w/o CC
LlecLlve:
32,170
non-elecLlve:
2268
1 2 34,430
l1200 veln llgaLlon and
sLrlpplng
3,613 0.3 3 3,223,033 rlmary
unl/bllaLeral var.
veln procedures
wlLh or w/o CC
LlecLlve:
4,192
non-elecLlve:
76
1 4 22,460 ALCS up Lo 1.4
days
P1062 Laparoscoplc
cholecysLecLomy
w/o closed CuL
w/o caL or sev CC
13,179 1.2 3 13,622,174 Laparoscoplc
cholecysLecLomy
wlLh LCS > 1day w/o
CC
LlecLlve:
20,333
non-elecLlve:
3,041
1.3 3.7 48,762 ALCS for Cpen or
laparoscoplc
cholecysLecLomy
wlLh CC =2.28 days
L1062 1ransureLhral
procedures excl.
prosLaLecLomy
w/o CC
4,037 0.4 3 2,978,843 8ladder endoscoplc
procedures,
laparascoplc bladder
neck procedures
LlecLlve:
33,711
non-elecLlve:
483
1 4 16,228
M1022 1ransureLhral
prosLaLecLomy
w/o caLasLrophlc
or severe CC
2,870 0.3 8 3,306,720 rosLaLe
1ransureLhral
8esecLlon
rocedure w/o CC
LlecLlve:
10,611
non-elecLlve:
194
2.4 3.6 16,072 ALCS up Lo 2.9
days (lnLermedlaLe
CC) and 4.68 days
(ma[or CC)
n1100 ulagnosLlc
cureLLage or
dlagnosLlc
hysLeroscopy
9,334 0.9 2 3,806,042 ulagnosLlc
hysLeroscopy
LlecLlve:
4307
non-elecLlve:
11
1.1 0.9 8,699
C1012 Caesarean
dellvery w/o
caLasLrophlc or
severe CC
27,224 2.3 6 60,421,326 lanned lower
uLerlne caesarean
secLlon
LlecLlve:
4,307
non-elecLlve:
33,322
2.7 3.3 89,022 ALCS based on
non-elecLlve
admlsslons

_____________________________________________________________________________________________________
ln addlLlon, Lhe guldance recommends LhaL dllaLaLlon and cureLLage alone should noL be
used as a dlagnosLlc Lool, and moreover should noL be used as a LherapeuLlc LreaLmenL
32
1he managemenL of varlcose velns ls conLroverslal and Lhere ls conslderable varlaLlon ln
cllnlcal pracLlce. 1here ls a lack of consensus abouL opLlmum lndlcaLlons for referral and
LreaLmenL. lor example, lL has been argued LhaL fundlng for varlcose veln surgery should
)'& be provlded for:
.
uncompllcaLed varlcose velns where Lhere are no slgnlflcanL physlcal sympLoms
8eLlcular velns or LelanglecLasla
33
ln Lhe uk, conservaLlve managemenL (eg llfesLyle advlce, compresslon Lherapy) are ofLen
used as flrsL llne LreaLmenLs ln prlmary care. nlCL ls currenLly developlng a guldellne on Lhe
approprlaLe dlagnosls and managemenL of varlcose velns.
.
34
1he above dlscusslon perhaps hlghllghLs Lhe lmporLance of developlng evldence-based and
lmplemenLable guldellnes LhaL approprlaLely conLexLuallse Lhe use of parLlcular healLh
Lechnologles wlLhln a broader paLhway of care. lL ls our vlew LhaL such guldellnes need Lo
conslder cosL-effecLlveness ln addlLlon Lo cllnlcal effecLlveness.

We also observed exLended lengLhs of sLay for lnLervenLlons of quesLlonable effecLlveness
ln Lhe flrsL place (1able 7). lor example, accordlng Lo Lhe naLlonal School of ubllc PealLh,
693 cases were admlLLed for knee lavage wlLh an ALCS of 3 days (esLlmaLed LoLal bed days =
3463). ullaLaLlon and cureLLage for women under 40 was assoclaLed wlLh an esLlmaLed
18,420 bed days (ALCS ls 3 days). 1onslllecLomy could be regarded as a relaLlvely lneffecLlve
procedure, and aL leasL ln Lngland, ls reserved for lndlvlduals who have had repeaLed bouLs
of LonsllllLls (> 3 eplsodes ln a year), or LonsllllLls severe enough Lo lnLerfere wlLh dally llfe.
lmporLanLly, we are noL suggesLlng LhaL Lhe lLems ln 1able 7 should be placed on a negaLlve
llsL. Powever, Lhese flndlngs suggesL LhaL closer scruLlny ls requlred for some lnLervenLlons
assoclaLed wlLh poLenLlally un[usLlfled hosplLal admlsslon, lnapproprlaLely long duraLlon of
ln-hosplLal sLays, and posslbly Loo low a cllnlcal Lhreshold for lnLervenlng ln Lhe flrsL place.
1ab|e 7 - ke|at|ve|y |neffect|ve |ntervent|ons based on the "Croydon ||st" of procedures.
(Source: naLlonal School ubllc PealLh). uaLa perlod: 1 CcLober 2010 Lo 31 CcLober 2011.
Intervent|on Number of
cases
ALCS (days) 8ed days Lst|mated costs
(kCN)
ullaLaLlon and CureLLage -
under 40
6140 3 18,420 7,908,277
CrommeLs 130 3 390 80,309
knee lavage 693 3 3,463 833,332
Splnal cord sLlmulaLlon 3 8 40 19098
1rlgger flnger 287 3 1,433 412,377

32
See: hLLp://guldance.nlce.org.uk/CC44
33
See: hLLp://www.lho.org.uk/vlew8esource.aspx?ld=11206
34
See: hLLp://guldance.nlce.org.uk/CC/Wave24/11

_____________________________________________________________________________________________________
More than one 'too|' |n the too|box- case study of Drug L|ut|ng Stents
1here ls clearly no slngle pollcy lever for lmprovlng efflclency and quallLy ln Lhe dellvery of
healLh care. 1hls applles also when Lrylng Lo manage Lhe dlffuslon and upLake of any
medlcal Lechnology, wheLher lL ls a pharmaceuLlcal or non-drug servlce or producL.
Lxplorlng Lhe approaches Laken by Lhree counLrles wlLh respecL Lo Lhe use of drug eluLlng
sLenLs may help lllusLraLe Lhls polnL more clearly.
ercuLaneous Lranslumlnal coronary angloplasLy ls ofLen uLlllsed as an alLernaLlve Lo
coronary arLery bypass grafLlng (CA8C), and frequenLly lnvolves Lhe use of sLenLs. SLenL
Lechnology (Lype and plaLform, lncludlng Lhe deslgn, alloy used and sLruL Lhlckness) has
developed rapldly, and recenL advances are lnLended Lo reduce Lhe llkellhood of resLenosls.
Slnce resLenosls ls correlaLed wlLh Lhe degree of lnflammaLlon presenL aL Lhe Llme of
angloplasLy, Lhls has led Lo Lhe developmenL of so-called drug-eluLlng sLenLs (uLSs). unllke
bare meLal sLenLs (8MS), uLSs are coaLed wlLh a drug, usually an lmmuno-suppressanL Lo
reduce lnflammaLlon or an anLlmlLoLlc agenL Lo lnhlblL cell prollferaLlon.
uLSs are more expenslve Lhan Lhelr bare meLal equlvalenLs. ln 2008, Lhe prlce dlfference
beLween uLSs and 8MSs across a number of PealLh AuLhorlLles ln Lngland was found Lo
range from 203 Lo 613. 8ased on anecdoLal lnformaLlon, lL appears LhaL Lhe prlce
dlfference ln 8omanla may be somewhaL greaLer, and uLS use ls ofLen assoclaLed wlLh
slgnlflcanL ouL-of-pockeL paymenLs for paLlenLs. Clven Lhe dlfference ln cosLs, quesLlons
need Lo be asked abouL Lhe relaLlve effecLlveness of uLS over 8MS for parLlcular paLlenL
subgroups, and wheLher any superlorlLy ls sufflclenL Lo [usLlfy Lhe addlLlonal cosL lnvolved.
8ased on daLa provlded Lo Lhe nlCL lnLernaLlonal Leam
33
uslng case sLudles from Lngland, Cermany and 1halland, we wlll lllusLraLe dlfferenL meLhods
of ensurlng value for money wlLh respecL Lo Lhe use of uLSs. 1hese meLhods lnvolve dlrecLly
lnfluenclng Lhe relmbursed prlce for uLSs and/or conLrolllng access Lo Lhe Lechnology.
, approxlmaLely 23 of coronary
sLenLs lmplanLed ln 8omanla ln 2011 were uLSs, alLhough Lhls ranged from 0 Lo 33 among
Lhe 16 provlder faclllLles surveyed. lL ls dlfflculL Lo deLermlne wheLher Lhls reflecLs an
approprlaLe level of uLlllsaLlon, and we noLed conslderable varlaLlon among provlders. 1he
opLlmal use of uLSs ln 8omanla wlll be lnfluenced by a number of facLors and may be well
be conslderably hlgher or lower Lhan Lhls average.
N,(" &$B4C K I.<>,.4
1hrough lLs Lechnology appralsal process, ln 2008 Lhe naLlonal lnsLlLuLe for PealLh and
Cllnlcal Lxcellence (nlCL) recommended Lhe use of drug eluLlng sLenLs
36

33
Source: 8omanlan MlnlsLry of PealLh. uaLa covers Lhe perlod 1sL. !anuary Lo 1sL. november 2011
ln percuLaneous
coronary lnLervenLlons for Lhe LreaLmenL of coronary arLery dlsease, buL only under very
speclflc clrcumsLances:
36
nlCL 1echnology Appralsal 132 - Avallable here: hLLp://guldance.nlce.org.uk/1A132

_____________________________________________________________________________________________________
Lhe LargeL arLery Lo be LreaLed has <3-mm callbre or Lhe leslon ls > 13 mm ln lengLh, and
Lhe prlce dlfference beLween uLSs and 8MSs ls no more Lhan 300.
1he nlCL CommlLLee noLed LhaL uLSs conferred no sLaLlsLlcally slgnlflcanL beneflLs ln
morLallLy or acuLe Ml raLes over 8MSs and LhaL Lhe key beneflL of uLSs was Lhe reducLlon ln
raLes of revascularlsaLlon ln LargeL leslons and LargeL vessels compared wlLh 8MSs. 1he
CommlLLee had access Lo a deLalled economlc model, whlch allowed lL Lo explore Lhe lmpacL
of varylng key parameLers, lncludlng Lhe prlce dlfferenLlal beLween 8MSs and uLSs. 1he
CommlLLee concluded LhaL uLSs would be a cosL-effecLlve opLlon for paLlenLs wlLh small
vessels and long leslons only aL a prlce dlfferenLlal of no more Lhan 300.
noLably, ln Lhe uk, based on Lhe laLesL audlL daLa avallable, use of uLSs seems Lo have
flaLLened off aL a level LhaL ls largely conslsLenL wlLh whaL would be expecLed wlLh
lmplemenLaLlon of Lhe nlCL recommendaLlons (around 60 uLS), alLhough Lhere remaln
very large dlfferences ln pracLlce ln across Lhe uk
37
N,(" &$B4C K X"2+,.C
.
ln Cermany, Lhe prlce of a uLS, as seL by companles and sub[ecL Lo markeL forces, ls around
Lhree Lo flve Llmes LhaL of a 8MS
38
. ln 2010, Lhe unlverslLy of Munlch esLlmaLed LhaL more
Lhan Luro 100 mllllon are spenL each year on uLS, and each year around 200,000 are used.
1he acqulslLlon cosL of Lhe markeL leader ls around Luro 630 - 700
39
. neverLheless, based
on offlclal Cerman sLaLlsLlcs on ln-hosplLal procedures (2009), abouL 98 of all lmplanLed
sLenLs were 8MSs. ln oLher words, Lhere ls only a 2 peneLraLlon raLe for uLS ln Lhe Cerman
publlc healLhcare sysLem (aL leasL for ln-paLlenL percuLaneous coronary lnLervenLlon
procedures)
40
1he C-u8C sysLem does noL dlsLlngulsh beLween dlfferenL sLenLs by means of unlque u8Cs.
1hus speclal supplemenLary and exLra-budgeLary paymenLs musL be soughL Lo cover Lhe
addlLlonal cosLs assoclaLed wlLh newer sLenL Lechnologles, wlLh access Lo such funds
lnvolvlng appllcaLlons for relmbursemenL and poLenLlally negoLlaLlon wlLh slckness funds.
lmporLanLly, Lhe C-u8C paymenL for a Cl ls meanL Lo lnclude Lhe cosL of lmplanLlng a bare
meLal sLenL ln Lhose cases where an lmplanL ls deemed necessary. 1here ls no expllclL
. PosplLals are sub[ecL Lo LlghL budgeLary consLralnLs and are opLlng for
cheaper sLenL alLernaLlves. 1hls appears Lo be due aL leasL ln parL Lo Lhe characLerlsLlcs of
Lhe Cerman u8C (C-u8C) sysLem.

37
naLlonal AudlL of AngloplasLy procedures (2010). AL: hLLp://www.lc.nhs.uk/servlces/naLlonal-cllnlcal-audlL-
supporL-programme-ncasp/audlL-reporLs/hearL-dlsease
38
Sauerland S. (lCWlC), personal communlcaLlon
39
See: hLLp://www.kllnlkum.unl-muenchen.de/de/sLarLselLenmeldungen/archlv/100708_sLenLs.hLml
40
Sauerland S. (lCWlC), personal communlcaLlon, SLaLlsLlsches 8undesamL, CperaLlonen und rozeduren der
vollsLaLlonaren aLlenLlnnen und aLlenLen ln krankenhausern, Ausfuhrllche uarsLellung, 2009. AL:
hLLp://www.gbe-bund.de/gbe10/owards.prc_show_pdf?p_ld=13376&p_sprache=d

_____________________________________________________________________________________________________
menLlon of sLenLlng ln Lhe u8C, lmplylng LhaL 8MSs are so lnexpenslve, Lhelr addlLlonal
cosLs can be safely lgnored.
41
N,(" &$B4C K 07,->,.4

ln 1halland, Lhe affordablllLy of all sLenLs (8MS and uLS) ls conLrolled by means of compeLlLlve
Lenderlng and bulk purchaslng.
1here are Lhree coverage schemes ln 1halland and Lhe Lax flnanced unlversal Coverage (uC)
scheme fllls Lhe gap lefL by Lhe Soclal PealLh lnsurance scheme and Lhe Clvll Servlce Medlcal
8eneflL scheme. 1he lnlLlal copaymenL of bahL 30 was abollshed ln 2006, and access ls now
free of charge.
1he naLlonal PealLh SecurlLy Cfflce (nPSC) ls an auLonomous publlc organlzaLlon,
overseelng Lhe uC scheme. 1he scheme lncludes wlLhln lLs beneflLs plan, coverage for sLenLs
ln Lhe LreaLmenL of aLheroscleroLlc vessels. nPSC ls responslble for Lhe purchase of sLenLs
vla a cenLrally admlnlsLered compeLlLlve blddlng process. 1hls process means LhaL nPSC
secures very low prlces for Lhe sLenLs (boLh 8MS and uLS) lL purchases, whlch lL Lhen
dlsLrlbuLes Lo Lhe hosplLals wlLh whlch nPSC conLracLs.
1he nPSC ls also operaLes wlLhln a loglsLlcal model of producL Lransfer from manufacLurers/
dlsLrlbuLors Lo users (or healLh provlders) accordlng Lo lnvenLory lnformaLlon sysLem known
as 'vendor Managed lnvenLory (vMl). When Lhe amounL of a parLlcular drug or devlce aL a
hosplLal falls below a preseL Lhreshold, Lhe CovernmenL harmaceuLlcal CrganlsaLlon (CC)
wlll provlde Lhe drug or devlce auLomaLlcally aL an agreed amounL Lo LhaL hosplLal - Lhere ls
no need Lo make an order, Lo accumulaLe sLock ln hosplLals, or Lo engage ln lnvenLory
managemenL. An lnvolce wlll Lhen be senL from Lhe CC Lo Lhe nPSC for clearlng. 1hls has
also conLrlbuLed Lo cosL savlngs ln Lhe acqulslLlon of coronary sLenLs, alLhough Lhls has had a
smaller lmpacL on cosLs Lhan compeLlLlve Lenderlng, blddlng and bulk purchaslng.
42
Accordlng Lo Lhe secreLary general of Lhe nPSC, Lhe relmbursemenL cosLs of medlcal
devlces for hearL dlsease ln 2008 was bahL 1,233 mllllon, and coverage for coronary sLenLs
represenLed Lhe hlghesL proporLlon of Lhese cosLs

43
ln collaboraLlon wlLh Lhe CC, and accordlng Lo ASLAn Soclal SecurlLy AssoclaLlon
.
44
of
whlch Lhe nPSC ls a member, 16,779 sLenLs were purchased ln 2010, aL an esLlmaLed savlng
of approxlmaLely 396 mllllon bahL (almosL 10 mllllon euro)
43
. neverLheless, reporLs ln Lhe
press have ralsed concerns abouL Lhe quallLy of Lhe sLenLs purchased
46

41
.
Penschke C, 8aeumler M, Casklns M, 8usse 8. Coronary SLenLs and Lhe upLake of new Medlcal uevlces
ln Lhe Cerman SysLem of lnpaLlenL 8elmbursemenL. Iootool of lotetveotloool cotJloloqy 2010,23 (6): 346-333
42
Srlpen 1anLlvess (Pl1A) - personal communlcaLlon
43
As clLed ln: hLLp://Llnyurl.com/86mayoL
44
hLLp://www.asean-ssa.org
43
hLLp://Llnyurl.com/83xk7m8
46
nPSC defends purchase of sLenLs". 1he naLlon, AugusL 2010. AL: hLLp://Llnyurl.com/6qvvc6k

_____________________________________________________________________________________________________
I|gure 2 - Ischem|c heart d|sease (InD) morta||ty and coronary revascu|ar|sat|on
procedures, 2006 |n CLCD countr|es

Source CLCu, PealLh aL a Clance, 2009
47
D|ffus|on of New 1echno|og|es - Conc|us|ons

As noLed above, Lhere ls no slngle pollcy Lool LhaL can be applled alone Lo Lhe dlffuslon of
new Lechnologles, lncludlng medlcal devlces, mulLlple opLlons exlsL whlch need noL be
muLually excluslve. lor example, evldence-based approaches can ldenLlfy Lhe approprlaLe
cllnlcal slLuaLlons ln whlch a Lechnology may be used, and cenLrallsed procuremenL
sLraLegles can be adopLed so LhaL Lhe besL relmbursemenL prlces are obLalned. ln oLher
words, LoLal cosL ls a funcLlon of boLh prlce and volume. volume wlll be lnfluenced by Lhe
use guldellnes and Lhe lmpacL of dlsease prevalence/lncldence, 'prlce' can be lnfluenced
Lhrough dlfferenL approaches Lo purchaslng.
lmporLanLly, ln Lhe speclflc conLexL of sLenLlng, evldence suggesLs LhaL Lhere ls no apparenL
relaLlonshlp beLween Lhe number of revascularlsaLlon procedures and morLallLy from
lschaemlc hearL dlsease.
Cermany for example, appears Lo be an ouLller ln Lerms of Lhe number of procedures
underLaken per 100,000 populaLlon, and yeL lPu deaLh raLes are slmllar Lo oLher CLCu
counLrles whlch underLake far fewer revascularlsaLlon procedures. Cf course, Lhese daLa
need Lo be LreaLed cauLlously, noL leasL parLly because of varlaLlon ln classlflcaLlon sysLems
and recordlng pracLlces beLween counLrles.
Whlle noL as exLreme as Cermany, Lhe uSA also appears Lo be an ouLller accordlng Lo Lhe
CLCu flgures. lL has been argued LhaL Lhe hlgh levels of uLS use ln Lhe unlLed SLaLes has
helped keep angloplasLy raLes sLable ln LhaL counLry because of Lhe reduced llkellhood of

47
AL: www.oecd.org/daLaoecd/33/2/44117330.pdf

_____________________________________________________________________________________________________
paLlenLs requlrlng a revascularlsaLlon procedure followlng uLS lmplanLaLlon
48
. Powever, lL's
posslble LhaL uLS peneLraLlon ln Lhe uS, whlch ls now aL over 80 Lo 90, has slmply reached
saLuraLlon levels as a resulL of unconLrolled upLake
49
Structura| cha||enges and future reform
.
1hls secLlon of reporL hlghllghLs Lhe lmporLance of addresslng broader sLrucLural facLors
affecLlng Lhe overall efflclency of Lhe sysLem, parLlcularly where Lhese appear llkely Lo
undermlne efflclencles anLlclpaLed Lhrough Lhe lmplemenLaLlon of any 'negaLlve llsL'.
Lmpower|ng pr|mary care
uevelopmenLs ln healLh pollcy have hlghllghLed Lhe lmporLance of prlmary care and
prevenLlve servlces, alLhough among many counLrles of dlfferenL lncome levels, speclallsLs
sLlll slgnlflcanLly ouLnumber 'generallsL' pracLlLloners
48
. CrlenLlng healLh care servlces so
LhaL Lhey are preferenLlally dellvered ln prlmary care seLLlngs can yleld slgnlflcanL beneflLs ln
Lerms of overall cosL-effecLlveness. ln addlLlon, a sLrong and well performlng prlmary care
secLor represenLs a marker of healLhcare quallLy
30
A*.-$*2-.< ,.4 -+'2*E-.< ZB,>-$C ,.4 7",>$7 *B$=*+"(
. roxy measures such as Lhe number of
(avoldable) admlsslons for unconLrolled dlabeLes can glve an lndlcaLlon of Lhe sLrengLh of
prlmary care sysLems and Lhe level of care coordlnaLlon and conLlnulLy.
ConslderaLlon should be glven Lo provldlng flnanclal lncenLlves Lo encourage efflclenL
prescrlblng and Lhe provlslon of hlgh quallLy care. lL may also help ln lmprovlng lnformaLlon
Lechnology lnfrasLrucLure, and drlve crlLlcal daLa collecLlon ln hlgh prlorlLy dlsease areas.
lL was noLed above LhaL Lhere ls a relaLlve underfundlng of prlmary care compared wlLh Lhe
speclallsL and secondary care secLor. Moreover famlly docLors are consLralned ln Lhelr
capaclLy Lo pracLlce efflclenLly and effecLlvely, aL leasL ln comparlson Lo sLandard pracLlce ln
many oLher counLrles. 1hese facLors may parLly explaln Lhe relaLlvely hlgh exodus of
physlclans ouL of Lhe counLry, and provlde lncenLlves for lndlvlduals Lo secure addlLlonal
remuneraLlon Lhrough lnformal paymenLs (see below). Any rebalanclng of fundlng (and care
responslblllLles) ln Lhe 8omanlan healLhcare sysLem could be accompanled by provlder
relmbursemenL mechanlsms LhaL are parLlally llnked Lo Lhe achlevemenL of performance
ouLcomes. A posslble model for such a framework ls Lhe uk CuallLy and CuLcomes
lramework (CCl)
31

48
CLCu, PealLh aL a Clance, 2011- AL:
.
hLLp://www.oecd.org/documenL/11/0,3746,en_2649_37407_16302667_1_1_1_37407,00.hLml
49
See for example: Croeneveld eL al. lmpacL of new Cardlovascular uevlce 1echnology on PealLh Care CosLs.
Atcb loteto MeJ. 2011,171(14):1289-1291
30
CovernmenL AccounLablllLy Cfflce (2008). rlmary Care rofesslonals: 8ecenL Supply 1rends, ro[ecLlons,
and valuaLlon of Servlces. 1esLlmony before Lhe CommlLLee on PealLh, LducaLlon, Labor, and enslons, u.S.
SenaLe. AL: hLLp://www.gao.gov/new.lLems/d08472L.pdf
31
See: hLLp://www.nlce.org.uk/abouLnlce/qof/qof.[sp

_____________________________________________________________________________________________________
lnLroduced ln 2004 as parL of Lhe Ceneral Medlcal Servlces ConLracL, Lhe CCl ls a volunLary
lncenLlve scheme for C pracLlces ln Lhe uk, rewardlng Lhem for how well Lhey care for
paLlenLs. 1he CCl conLalns groups of lndlcaLors, agalnsL whlch pracLlces score polnLs
accordlng Lo Lhelr level of achlevemenL. nlCL has been asked Lo focus on Lhe cllnlcal and
healLh lmprovemenL lndlcaLors ln Lhe CCl, whlch lncludes a number of domalns such as
coronary hearL dlsease and hyperLenslon. 1he CCl glves an lndlcaLlon of Lhe overall
achlevemenL of a pracLlce Lhrough a polnLs sysLem. racLlces alm Lo dellver hlgh quallLy care
across a range of areas, for whlch Lhey score polnLs. uL slmply, Lhe hlgher Lhe score, Lhe
hlgher Lhe flnanclal reward for Lhe pracLlce. 1he flnal paymenL ls ad[usLed Lo Lake accounL of
Lhe pracLlce llsL slze and prevalence. 1he resulLs are publlshed annually.
An example of a CCl lndlcaLor ls shown ln llgure 3. 1he dlagram also lllusLraLes Lhe broad
process for lLs developmenL.
I|gure 3 - Lxamp|e of a CI Ind|cator
Ind|cator area: Secondary prevent|on of coronary heart d|sease (myocard|a| |nfarct|on)
lndlcaLor lu: nM07 (hLLp://www.nlce.org.uk/abouLnlce/qof/lndlcaLors_deLall.[sp?summary=13071)
1he percenLage of paLlenLs wlLh a hlsLory of myocardlal lnfarcLlon from 1 Aprll 2011
currenLly LreaLed wlLh an ACL lnhlblLor (or A88 lf ACL lnLoleranL), asplrln or an alLernaLlve
anLl-plaLeleL Lherapy, beLa-blocker and sLaLln (unless a conLralndlcaLlon or slde effecLs are
recorded).
ltocess of Jevelopmeot

_____________________________________________________________________________________________________
1he use of any flnanclal lncenLlves needs Lo be carefully consldered, and wlll cerLalnly noL be
Lhe only or even Lhe prlnclpal Lool Lo drlve efflclency and hlgh quallLy care. CLher quallLy
lnlLlaLlves such as cllnlcal audlL, lmprovemenLs ln lnformaLlon Lechnology, and creaLlon of
enLlLles Lo develop quallLy sLandards and monlLor performance, are llkely Lo have a
slgnlflcanL effecL ln lmprovlng quallLy of care. When developlng lndlcaLors LhaL can be used
Lo lncenLlvlze provlders, lL ls necessary Lo conslder Lhe underlylng evldence base, and so Lhe
P1A funcLlon descrlbed above wlll have an lmporLanL role ln lnformlng Lhe cholce of
lndlcaLor. When conslderlng Lhe lmpacL of an lndlcaLor for whlch Lhere ls poLenLlally a
llnked flnanclal reward, lL ls also lmporLanL Lo conslder Lhe cosL-effecLlveness and overall
flnanclal lmpacL of Lhe lncenLlve, Lo ensure LhaL Lhe addlLlonal paymenLs offered and Lhe
expecLed ouLcomes are callbraLed opLlmally.
Secondary]1ert|ary care - fund|ng and the ro|e of DkGs
Whlle lL ls arguably Lhe case LhaL sysLem flnanclng has been skewed Lowards secondary and
LerLlary care, lL appears LhaL hosplLals are neverLheless lnadequaLely flnanced and
lnefflclenLly relmbursed for Lhe acLlvlLles Lhey underLake.
A 'hybrld' sysLem of flnanclng appears Lo be ln place wlLh respecL Lo hosplLal care. 1here are
case mlx ad[usLed (u8C) paymenLs from Lhe CnAS and ln addlLlon, dlrecL budgeL allocaLlons
from Lhe cenLral and local governmenLs. Moreover, hosplLals are able Lo generaLe
addlLlonal lncome vla copaymenLs (whlch Lhey are allowed Lo keep) and Lhrough Lhe
provlslon of servlces Lo Lhe prlvaLe secLor.
u8C paymenLs, as we have noLed already, do noL capLure any reallsLlc assessmenL of Lhe
cosLs of servlces acLually provlded. 1he acLual relmbursed cosLs aL Lhe provlder level are noL
Lhe same as Lhe correspondlng u8Cs slnce addlLlonal subsldlsaLlon can be obLalned from
monles sourced from Lhe naLlonal rogrammes ln cerLaln lnsLances, and / or flnanced from
Lhe paLlenLs Lhemselves, wlLh obvlous lmpllcaLlons for equlLy.
Whlle Lhere are varlaLlons among lndlvldual naLlons, u8C-Lype hosplLal paymenLs are used
LhroughouL Lurope, a reflecLlon of Lhelr aLLracLlveness as a pollcy Lool Lo lmprove
Lransparency over provlder performance, and as a mechanlsm Lo allocaLe flnanclal
resources Lo hosplLals
32
. needless Lo say, Lhe lmplemenLaLlon of such a framework wlLhln
an lndlvldual counLry has Lo be carefully underLaken. Weaknesses ln how u8Cs have been
lmplemenLed ln 8omanla have been hlghllghLed by oLhers
33

32
Scheller-krlensen u, Celssler A, 8usse 8. 1he A8C of u8Cs, ln: ulagnosLlc 8elaLed Croups ln hosplLal
managemenL and relmbursemenL. Luro Cbserver, volume 11, number 4, 2009. AL:
hLLp://www.euro.who.lnL/en/who-we-are/parLners/observaLory/publlcaLlons/euro-observer
. 8omanla underwenL a
LranslLlon from one u8C sysLem Lo anoLher wlLhln a few years, and because of lnadequaLe
daLa on acLual hosplLal cosLs, lL was necessary Lo use lmporLed cosL welghLs from Lhe
33
8adu C-, Chlrlac un, vladescu C. Changlng aLlenL ClasslflcaLlon SysLem for PosplLal 8elmbursemenL ln
8omanla. ctoot MeJ I 2010 ,31(3):230-8.

_____________________________________________________________________________________________________
AusLrallan u8C sysLem. Mls-codlng (lnLenLlonal or oLherwlse) comblned wlLh lnadequaLe
overslghL from payers and oLher monlLorlng problems have meanL LhaL Lhe beneflLs of
lnLroduclng such case-mlx based paymenLs have been mlnlmal and posslbly even
counLerproducLlve. 1he hlgh prevalence of lnformal paymenLs compounds Lhe problem, and
furLher exacerbaLes any corrupL pracLlce
34
Whlle u8C lmplemenLaLlon ln 8omanla began wlLh plloL pro[ecLs ln 1996, more effecLlve
plannlng would have allowed for Lhe developmenL of robusL local cosL welghLs and a beLLer
deslgned budgeL neuLral lnLroducLlon phase, Lo proLecL Lhe flnanclal sLablllLy of provlders. ln
Cermany, for example, hosplLals could volunLarlly classlfy Lhelr paLlenLs lnLo u8Cs ln 2003
(lL became mandaLory ln 2004), buL were lncenLlvlsed Lo do so by Lhe posslblllLy Lo
negoLlaLe hlgher budgeLs. lnlLlally, u8C paymenL was based on hosplLal speclflc base raLes,
buL beLween 2003 and 2010, provlder base raLes were gradually ad[usLed Lowards sLaLe-
wlde base raLes. 8y 2013, sLaLe-wlde base raLes are expecLed Lo converge Lowards a
naLlonally seL level
.
33
. A slmllar approach was Laken ln Pungary
36
1here ls clearly an urgenL need Lo slgnlflcanLly redevelop Lhe u8C sysLem ln 8omanla,
brlnglng ln lnLernaLlonal experLlse as necessary (See secLlon on 'nexL SLeps'). arLlcular
emphasls musL be placed on obLalnlng rellable daLa, on hosplLal cosLs, ln Lhe flrsL lnsLance,
buL also on measures of quallLy (see below). 1hls musL be comblned wlLh addlLlonal pollcles
dlrecLed aL modlfylng provlder behavlour, Lhrough Lhe appllcaLlon of effecLlve penalLles for
devlaLlons from recommended pracLlce. Moreover, ad[usLmenLs Lo paymenLs are needed so
as Lo encourage reduced lengLh of sLay where cllnlcally approprlaLe, as dlscussed ln our
rapld analysls of selecLed surglcal produces.
.
We have been made aware durlng Lhls asslsLance pro[ecL of proposed reforms Lo Lhe
8omanlan healLh sysLem LhaL draw on Lhe uuLch soclal lnsurance model and lLs 2003/6
sLrucLural reforms as Lhelr prlnclpal paradlgm and whlch alm Lo make servlce provlslon more
'demand-led'. ln Lhe neLherlands, compeLlng lnsurers relmburse hosplLals on a case-mlx
basls known as Lhe ulagnosls 1reaLmenL ComblnaLlon (u8C) sysLem
33
. All u8Cs are asslgned
Lo Lwo llsLs: on LlsL A prlces are flxed aL a naLlonal level and reflecL producLlon volume raLher
Lhan quallLy, whlle prlces on LlsL 8 are varlable and based on negoLlaLlons beLween hosplLals
and lnsurers, Lhe lnLenL belng Lo encourage flnanclng LhaL ls more allgned wlLh aspecLs
relaLed Lo Lhe quallLy of Lhe servlces provlded.
37

34
1ransparency lnLernaLlonal. Clobal CorrupLlon 8eporL 2006 - Speclal locus: CorrupLlon and PealLh. AL:
hLLp://www.Lransparency.org/publlcaLlons/gcr/gcr_2006#download
1he uuLch governmenL ls seeklng Lo creaLe
a sysLem of flnanclng LhaL ls largely based on u8Cs ln LlsL 8. Powever, uuLch healLh lnsurers
are noL currenLly compeLlng on Lhe basls of quallLy. lndeed, tbe ooly ospects tbot lmpoct oo
33
CuenLln W eL al. u8C-Lype hosplLal paymenL ln Cermany: 1he C-u8C sysLem Luro observer, volume 12,
number 3, 2010. AL: hLLp://www.euro.who.lnL/en/who-we-are/parLners/observaLory/ publlcaLlons/euro-
observer
36
Cal , SzlgeLl S, Csere M, Casklns M, anLell u. Pungary: PealLh sysLem revlew. neoltb 5ystems lo
1toosltloo, 2011, 13(3):1-266.
37
lL ls lmporLanL Lo noLe here LhaL lnsurers are noL obllged Lo conLracL all hosplLals, or vlce versa.

_____________________________________________________________________________________________________
bow losotets coo stooJ oot ftom ooe otbet ote (l) lmptovloq occesslblllty to bospltols, (ll) tbe
setvlce tbey tbemselves ptovlJe ooJ, lo pottlcolot, (lll) tbe costs teloteJ to o lowet ptemlom
ooJ/ot co5poymeots"
38
lrrespecLlve, of Lhe flnal naLure of Lhe 8omanlan reforms, case- based paymenLs are llkely Lo
be Lhe core mechanlsm for Lhe relmbursemenL of hosplLals. As can be seen from Lhe uuLch
example, malnLalnlng and enhanclng Lhe quallLy of care wlll also be lmporLanL, and
lncenLlves wlll need Lo be developed Lo deal wlLh Lhe unlnLended consequences of
u8Cs/u8Cs, eg by expllclLly llnklng u8C paymenLs Lo cerLaln quallLy measures (based on
process and healLh ouLcomes). Ad[usLmenLs Lo lndlvldual hosplLal paymenLs can be made aL
a local level based on Lhe achlevemenL of a package of quallLy lmprovemenL goals and
lndlcaLors agreed beLween Lhe lnsurer and Lhe provlder. An example of Lhls ls Lhe Lngllsh
'Commlsslonlng for CuallLy and lnnovaLlon' (CCuln) paymenL framework
.
39
Lngland has also lnLroduced so-called 'besL pracLlce Larlffs' whlch are lnLended Lo encourage
and reward medlcal pracLlce consldered Lo be 'hlgh quallLy', Lhus movlng away from prlclng
based on average cosLs. 8esL pracLlce Larlffs were lnLroduced ln 2010/11 for caLaracLs, gall
bladder removal (cholecysLecLomy), acuLe sLroke care, and fraglllLy hlp fracLure. ln Lhe case
of cholecysLecLomy for example, Lhe Larlff ls lnLended Lo encourage Lhe use of laparoscoplc
Lechnlques ln a day-case seLLlng where cllnlcally approprlaLe
. 1he CCuln
framework also hlghllghLs Lhe lmporLance of developlng evldence based guldellnes, slnce
Lhls framework wlll be used Lo lmplemenL nlCL-developed CuallLy SLandards. Whlle dlfflculL
Lo measure, daLa on Lhe quallLy of care are essenLlal, and hosplLals could be compelled Lo
provlde such lnformaLlon. ln Lngland, provlders of nPS servlces are requlred Lo publlsh an
annual CuallLy AccounL Lo Lhe publlc concernlng Lhe quallLy of servlces Lhey provlde. ln
Cermany, Lhere ls also a mandaLory publlcaLlon of quallLy reporLs.
60
Comm|tment to pub||c hea|th |n|t|at|ves
.
lL has been noLed by oLher auLhors LhaL Lhe currenL healLh sysLem places lnadequaLe welghL
on Lhe prevenLlon of lll-healLh and Lhe Llmely deLecLlon of dlsease, hlghllghLlng for example,
Lhe worrylng levels of cervlcal cancer ln 8omanla
61

38
1an SS eL al. SLrucLural reforms and hosplLal paymenL ln Lhe neLherlands. Luro Cbserver, volume 12,
number 10. AugusL 2010.
. non-communlcable dlsease (nCu)
prevenLlon also appears Lo be lnadequaLely addressed. 1he World 8ank has prevlously
recommended sLreamllnlng Lhe naLlonal healLh programs Lo emphaslze Lhe prevenLlon of
nCus and cervlcal cancer and Lhe conLrol of lnfecLlous dlseases.
39
uslng Lhe Commlsslonlng for CuallLy and lnnovaLlon (CCuln) paymenL framework - A summary gulde. AL:
hLLp://www.dh.gov.uk/en/ubllcaLlonsandsLaLlsLlcs/ubllcaLlons/ubllcaLlonsollcyAndCuldance/uP_091443
60
updaLe Lo 8esL racLlce 1arlffs. AL: hLLp://www.dh.gov.uk/healLh/2011/12/bpL-updaLe/
61
World 8ank. luncLlonal revlew of Lhe PealLh SecLor - 8omanla (May 2011)

_____________________________________________________________________________________________________
ubllc healLh lnLervenLlons can be boLh cosL-effecLlve
62
and achleve beneflLs LhaL are
observable even over a relaLlvely shorL Lerm. A good example of Lhls ls Lobacco conLrol. A
recenL Cochrane revlew of Lhe effecLlveness of smoklng bans noLed LhaL Lhere was
conslsLenL evldence LhaL such lnLervenLlons lead Lo a reducLlon ln hosplLal admlsslons for
cardlac evenLs
63
- and LhaL an lmpacL whlch has boLh slgnlflcanL healLh and flnanclal
consequences can be achleved wlLhln a year followlng a ban
64
Whlle 8omanlan auLhorlLles have lnLroduced smoklng bans ln a number of faclllLles,
lncludlng healLhcare, educaLlon and governmenL bulldlngs, Lhese are noL always enforced,
nor are resLrlcLlons evldenL ln oLher lmporLanL publlc spaces such as bars and prlvaLe secLor
offlces. Moreover, compllance wlLh Lhe leglslaLlon has ofLen been poor
.
63
. WPC age-
sLandardlzed esLlmaLed prevalence of smoklng among Lhose aged 13 years or more (2009)
was 33 for currenL smoklng and 29 for dally smoklng. Among men only, however, Lhese
flgures rlse Lo 46 and 39 respecLlvely
66
As wlLh oLher Lypes of guldance LhaL nlCL produces, Lhe lnsLlLuLe's publlc healLh ouLpuL ls
supporLed by cosLlng Lools and oLher mechanlsms Lo asslsL ln lmplemenLaLlon plannlng and
also ln bulldlng a 'buslness case' for lnvesLmenL ln prevenLlve acLlvlLles
. A key publlc healLh challenge ls Lo ensure local
lmplemenLaLlon ln Lhe face of oLher very presslng demands on avallable resources.
67
o||t|ca| comm|tment to ev|dence-based approaches
. 1hese supporL
Lools can be downloaded from Lhe nlCL webslLe and could be adapLed Lo Lhe 8omanlan
seLLlng sub[ecL Lo Lhe avallablllLy of local daLa (see below).
Worldwlde Lhere has been an lncreaslng lnLeresL ln and pollLlcal commlLmenL Lo Lhe use of
P1A ln healLhcare declslon maklng. lor example, healLh mlnlsLers of 33 counLrles aL Lhe
WPC Luropean MlnlsLerlal Conference on PealLh SysLems (!une 2008) adopLed Lhe 1alllnn
CharLer: PealLh SysLems for PealLh and WealLh
68
lostetloq beoltb pollcy ooJ systems teseotcb ooJ mokloq etblcol ooJ effectlve
ose of looovotloos lo meJlcol tecbooloqy ooJ pbotmoceotlcols ote televoot fot oll
cooottles, beoltb tecbooloqy ossessmeot sboolJ be oseJ to soppott mote
lofotmeJ Jeclsloo mokloq."
whlch noLed LhaL:

62
Cwen L, Morgan A, llscher A, Lllls S, Poy A, kelly M. 1he CosL effecLlveness of ubllc PealLh lnLervenLlons. I
lobllc neoltb 2011, SepL 20
63
Calllnan !L, Clarke A, uoherLy k, kelleher C. LeglslaLlve smoklng bans for reduclng secondhand smoke
exposure, smoklng prevalence and Lobacco consumpLlon. cocbtooe uotobose of 5ystemotlc kevlews 2010,
lssue 4. ArL. no: Cu003992.
64
hLLp://www.bbc.co.uk/news/10266997
63
lndoor smoklng bans ln 8ulgarla, CroaLla, norLhern Cyprus, 8omanla and 1urkey. Mullenburg !L, Legge !r !S,
8urdell A. 1obocco coottol (2010).
66
WPC reporL on Lhe global Lobacco epldemlc, 2011. AL:hLLp://www.who.lnL/Lobacco/global_reporL/2011/en
67
lmplemenLaLlon Lools avallable aL:
hLLp://www.nlce.org.uk/uslngguldance/lmplemenLaLlonLools/lmplemenLaLlon_Lools.[sp
68
WPC 2008. AL: www.euro.who.lnL/documenL/e91438.pdf

_____________________________________________________________________________________________________
lL ls recognlsed LhaL P1A ls only one albelL lmporLanL facLor ln declslon maklng, Lhere are
clearly also oLher lmporLanL lnpuLs lnLo Lhe process. neverLheless P1A and oLher evldence-
based approaches can fosLer more LransparenL and 'raLlonal' declslon maklng processes as
long Lhere ls domesLlc pollLlcal wlll Lo make use of lLs flndlngs ln a credlble way. lf P1A ls
poorly supporLed pollLlcally and Lechnlcally, Lhere ls a rlsk LhaL 'evldence-based' declslon
maklng could be undermlned and dlscredlLed
69
1he 8omanlan governmenL has lndlcaLed a commlLmenL Lo maklng use of sclenLlflc
evldence" durlng declslon maklng, ln lLs recenL proposals Lo reform Lhe healLh sysLem. lL ls
essenLlal LhaL Lhls commlLmenL remalns and ls enshrlned ln any fuLure reform law.
.
Next steps
harmaceut|ca|s
Improv|ng L|st|ng rocesses
ln 8eporL 2, we revlewed Lhe exlsLlng drug formulary llsLlng processes and ldenLlfled a
number of lssues. Cf greaLesL concern were our observaLlons LhaL Lhe crlLerla for poslLlve
(or negaLlve) recommendaLlons are noL clearly arLlculaLed, and LhaL declslons appear Lo resL
largely on revlews conducLed by cllnlcal speclallsLs (Loplc experLs) nomlnaLed by Lhe
relevanL SpeclalLy Commlsslons, and whose confllcLs of lnLeresL, lf any, are noL declared aL
Lhe Llme of Lhe revlew. WlLhouL lnpuL from oLher cllnlcal (especlally non-speclallsLs) and
non-cllnlcal experLs Lhls sLrucLure wlll naLurally Lend Lo favour llsLlng of new medlclnes,
lndeed we were lnformed LhaL aL mosL perhaps 2 of appllcaLlons are re[ecLed. We also
noLed LhaL, whlle an economlc analysls of some descrlpLlon ls requlred Lo be submlLLed wlLh
each appllcaLlon, lL ls noL sub[ecL Lo revlew wlLhln Lhe llsLlng process, and ln Lhls sense lL
appears Lo be llLLle more Lhan a formallLy. ln addlLlon budgeL lmpacL analysls ls noL
requlred, nor ls lL underLaken wlLhln Lhe MlnlsLry of PealLh. As a resulL Lhere ls no lmpllclL or
expllclL conslderaLlon of prlce, cosL effecLlveness, overall budgeLary lmpacL or opporLunlLy
cosL Lo Lhe healLh care sysLem facLored lnLo, or lndeed lnfluenclng Lhe recommendaLlon. As
a resulL, Lhe role of Lhe naLlonal 1ransparency CommlLLee ln Lhe declslon-maklng process,
oLher Lhan Lo endorse Lhe recommendaLlon(s) of Lhe cllnlcal speclallsLs, ls unclear.
70
1o LhaL end, Lhe lmporLance of an unamb|guous comm|tment to the estab||shment of
|ndependent, ev|dence-based, va|ue-for-money, dec|s|on-mak|ng processes Lo supporL
resource allocaLlon ln healLh care ls paramounL. All recommendaLlons LhaL follow are
predlcaLed on Lhls overarchlng commlLmenL. We prevlously noLed LhaL a commlLmenL Lo
evldence-based approaches has been foreshadowed ln Lhe drafL revlsed lramework Law.

69
ChapLer 2 - ollcy rocesses and healLh Lechnology assessmenL ln:"PealLh 1echnology AssessmenL and
PealLh ollcy-Maklng ln Lurope CurrenL sLaLus, challenges and poLenLlal". WPC, 2008. AL:
hLLp://www.euro.who.lnL/__daLa/asseLs/pdf_flle/0003/90426/L91922.pdf
70
lL ls lmporLanL Lo noLe LhaL our revlew of Lhe llsLlng mechanlsm was focused on Lhe process for llsLlng of
medlclnes ln Lhe naLlonal formulary raLher Lhan lncluslon ln Lhe 8aslc 8eneflL ackage

_____________________________________________________________________________________________________
Independent, transparent, sc|ent|f|c process: As a maLLer of urgency, Lhe role, composlLlon
and remlL of Lhe 1ransparency CommlLLee (n1C)
71
Compos|t|on: 1he composlLlon of Lhe n1C should be expanded Lo encompass a broad range
of cllnlcal experLs, lncludlng aL leasL one prlmary care pracLlLloner, an epldemlologlsL/
blosLaLlsLlclan, a represenLaLlve of pharmacy pracLlce and consumer represenLaLlon. AL leasL
one healLh economlsL wlLh skllls and experlence ln healLh economlc evaluaLlon should also
be lnvolved ln Lhe declslon-maklng process as a member of Lhe n1C. unLll processes can be
developed Lo underLake rlgorous P1A, aL leasL one member of Lhe CommlLLee musL have
Lhe necessary skllls Lo revlew any cosL-effecLlveness and budgeL lmpacL assessmenLs
submlLLed by sponsor companles.

should be revlsed Lo creaLe a more open,
consulLaLlve, lndependenL and sclenLlflcally rlgorous declslon-maklng process, Lo lnLroduce
comparaLlve effecLlveness and cosL-effecLlveness as core componenLs ln Lhe declslon-
maklng process, Lo lmprove Lhe clarlLy and Lransparency of declslons and lnLroduce expllclL
declslon-maklng crlLerla, and Lo provlde a volce for sLakeholders and faclllLaLe a beLLer
undersLandlng of Lhe raLlonale for declslons and relaLlve merlLs of dlfferenL Lheraples
among prescrlbers.
Governance: 1he governance arrangemenLs should ensure Lhe lndependence of Lhe
CommlLLee from governmenL, MoP, CnAS and lndusLry lnfluence. SLaLemenLs of lnLeresLs
should be requlred boLh annually and aL each meeLlng from each member of Lhe
CommlLLee. Should any poLenLlal or acLual confllcLs of lnLeresL come Lo llghL, Lhey should be
ad[udlcaLed carefully Lo avold any posslblllLy of blas, elLher real or percelved.
Dec|s|on-mak|ng cr|ter|a: 1he role and remlL of Lhe CommlLLee should be clarlfled, and
speclflc declslon-maklng crlLerla promulgaLed. 1he CommlLLee's remlL should sLaLe
speclflcally LhaL lL should conslder comparaLlve effecLlveness, comparaLlve cosL effecLlveness
/ value for money, and budgeL lmpacL ln lLs dellberaLlons. Gu|de||nes for Lhe preparaLlon of
submlsslon and Lhe evaluaLlon of Lhe cllnlcal, epldemlologlcal, economlc and flnanclal daLa
should be developed Lo gulde boLh appllcanLs and revlewers, and Lo promoLe sclenLlflc
rlgour. MeLhods and guldellnes should be developed wlLh sLakeholder parLlclpaLlon.
Inc|us|veness: 1he process should emphaslze lncluslveness, by provldlng opporLunlLles for
all relevanL parLles Lo have approprlaLe lnpuL Lo Lhe process - my soy, bot oot my woy". ln
addlLlon, =*.(B+"2 2"'2"(".$,$-*. should be added Lo Lhe CommlLLee Lo provlde a volce
for sLakeholders from wlLhln Lhe communlLy.
1ransparency: 1o ensure Lransparency, Lhe dellberaLlons of Lhe CommlLLee should be
documenLed, and Lhe raLlonale, reasons and sclenLlflc basls of each declslon made publlc aL
Lhe Llme of Lhe declslon. 1hls wlll faclllLaLe scruLlny of Lhe process and lmprove publlc and
professlonal accepLance of Lhe declslons and of Lhe relaLlve merlLs of dlfferenL Lheraples.

71
1hls could be lncluded as parL of Lhe revlsed lramework law.

_____________________________________________________________________________________________________
1|me||ness: 1lmellness of Lhe processes may be enhanced by lnLroduclng pre-speclfled
Llmeframes for declslon-maklng LhaL ensure LhaL hlgh value Lechnologles are noL
unnecessarlly delayed ln geLLlng Lo paLlenLs, whlle sLlll allowlng adequaLe opporLunlLy for
conslderaLlon of Lhe evldence.
unLll such Llme as a fully-developed and skllled P1A enLlLy or framework can be developed,
a slmple lnLerlm (! #$%&' P1A process should be lnLroduced. Where Lhe de facLo P1A
process ls applled, subsldlzed lndlcaLlons and condlLlons of llsLlng should reflecL Lhose
applylng ln Lhe counLry where Lhe P1A was underLaken.
Whlle Lhe processes of Lhe n1C could be easlly modlfled Lo lncorporaLe Lhls (! #$%&' P1A
sLep, ln our vlew Lhe currenL requlremenL for declslon-maklng wlLhln 90 days ls
unreasonable and wlll need Lo be lengLhened ln Lhe fuLure Lo allow adequaLe Llme Lo for
P1A Lo be underLaken. 1he relevanL Lu ulrecLlve allows a perlod of 90 days for prlce
deLermlnaLlon and up Lo a furLher 90 days for relmbursemenL declslons
72
Imp|ement|ng d" 1,=$* n1A assessment
- Lhus up Lo 180
days could be made avallable Lo Lhe process, alLhough ln Llme lL may be posslble Lo shorLen
Lhls.
SelLer (2007)
73
.select flve cooottles tbot ote osloq some sott of pbotmoco5ecooomlc
ossessmeot os o meoos to JeclJe oo telmbotsemeot, ooJ qlve two polots
fot eocb of tbem tbot ptovlJes blqbest ootloool telmbotsemeot level, ooe
polot of eocb tbot ptovlJes some fotm of llmlteJ telmbotsemeot, ooJ zeto
polots fot tbose tbot Jo oot telmbotse o Jtoq. 1bls ossessmeot moy bove to
be moJe fot eocb loJlco&,') sepototely lf o Jtoq bos moltlple loJlcotloos.
1be scotecotJ coo tbeo be completeJ wltb some potometets tbot coo be
ossesseJ by cooseosos speclflcolly fot komoolo, socb os.
proposed Lhe use of a scorecard" as a means of fasL-Lracklng assessmenL of
new medlclnes ln Lhe absence of Lhe capaclLy Lo underLake a full P1A. SelLer suggesLed LhaL
lmporLanL crlLerla for a 8omanlan declslon mlghL be wheLher a drug had been accepLed for
relmbursemenL ln oLher Luropean counLrles, and Lhe exLenL Lo whlch lL had been
relmbursed. Speclflcally SelLer's proposed meLhod was Lo:
1be Jlseose bos o blqb lmpottooce fot pobllc beoltb lo komoolo
1be oew tteotmeot ls oot mote expeoslve tboo cotteot stooJotJ tteotmeots lo
komoolo
1be oew tteotmeot bos cleot cllolcol oJvootoqes ovet olJet tteotmeots lo o woy
tbot potleots wellbeloq, fooctlooloq ot llfe expectoocy ote lmptoveJ lo o
slqolflcoot ooJ televoot woy

72
1he Lu 1ransparency ulrecLlve sLaLes LhaL pharmaceuLlcal prlclng procedures musL be compleLed wlLhln 90
days, wlLh Lhe posslblllLy of a furLher 90 days for relmbursemenL declslon maklng.
73
SelLer A. 8omanla: harmaceuLlcal SecLor Analysls, 2007 AL: hLLp://apps.who.lnL/medlclnedocs/documenLs/
s16762e/ s16762e.pdf

_____________________________________________________________________________________________________
lt ls posslble to Jellvet tbe oew tteotmeot occotJloq to qooJ ptoctlce lo tbe
komooloo beoltb system (Jloqoostlc tools ovolloble, coottol losttomeots
ovolloble etc.)
Oot5'#5lobel ose coo be cootoloeJ eoslly
lot eocb of tbese potometets, o cleot posltlve ooswet ylelJs two polots, o
oeqotlve ooswet oo polots, ooJ oo lotetmeJloty ooswet ooe polot.
SelLer's proLoLype scorecard ls shown here.
I|gure 4: Se|ter's Scorecard for kap|d n1A
73

A llmlLaLlon of Lhls approach ls LhaL lL does noL fully capLure Lhe lnfluence of cosL (and Lhus
cosL effecLlveness) or budgeL lmpacL of oLher [urlsdlcLlons' llsLlng declslons (or, for LhaL
maLLer, Lhe avallablllLy of alLernaLlve Lheraples) and prlclng lnformaLlon ls llmlLed ln some
[urlsdlcLlons. 1he scorecard approach may neverLheless be a useful Lool for prlorlLlzlng
conslderaLlon, however, even Lhough lL may be llmlLed as a basls for declslon-maklng.
CurrenLly Lhe llsLlng process requlres LhaL a producL be relmbursed for aL leasL 12 monLhs ln
(aL leasL) 3 oLher Luropean counLrles. As an lotetlm measure, an alLernaLlve approach could
be Lo model a (! #$%&' P1A process on a slngle [urlsdlcLlon for whlch deLalls of prlclng and
P1A evaluaLlon are avallable. LlsLlng should be proposed only under Lhose clrcumsLances
and ln accordance wlLh Lhe condlLlons under whlch Lhe producL ls relmbursed ln Lhe
reference counLry, and cosL effecLlveness should noL be assumed aL a prlce hlgher Lhan Lhe
raLlo of Lhe 8omanlan -ad[usLed per caplLa Cu Lo reference counLry -ad[usLed per
caplLa Cu.

_____________________________________________________________________________________________________
1argeL prlclng would Lhen be deLermlned by calculaLlng Lhls raLlo ln Lhe followlng manner:
I|gure S: Ca|cu|at|on of r|ce fo||ow|ng 4" 1,=$* n1A eva|uat|on

r|ce |n koman|a = Country A r|ce k koman|an -ad[usted per cap|ta GD
Country A -ad[usted per cap|ta GD
ln addlLlon all medlclnes proposed for llsLlng should have a deLalled a 8udgeL lmpacL
AssessmenL prepared uLlllslng 8omanlan epldemlologlcal esLlmaLes. 1hese could be
lncorporaLed lnLo Lhe currenL n1C process and would requlre only modesL addlLlonal
resources and accommodaLlon wlLhln Lhe Llmellnes, as lllusLraLed ln llgure 6.

I|gure 6: Mod|f|ed N1C rocess

1echnlcal asslsLance ln a) revlslng Lhe n1C processes, b) underLaklng and lmplemenLlng Lhe
(! #$%&' P1A process and c) underLaklng budgeL lmpacL analysls can be provlded by nlCL, lf
requlred.

_____________________________________________________________________________________________________
kev|ew|ng the ex|st|ng formu|ary
A more exLenslve revlew of Lhe drug formulary ls sLrongly recommended. ln Lhe flrsL
lnsLance we propose revlewlng Lhe Lop 300 producLs by volume and value, LogeLher wlLh
more comprehenslve revlew of prlclng and copaymenL lssues. 1hls would lnvolve (! #$%&'
P1A assessmenL, prlclng revlew and could also lnclude drugs currenLly awalLlng llsLlng. A
revlew of Lhe asslgnmenL of drugs Lo formulary sub-llsLs could also be underLaken, as Lhe
raLlonale for lncluslon of drugs ln dlfferenL sub-llsLs does noL appear Lo be conslsLenL.
Address|ng r|c|ng Anoma||es
AsslsLance could be provlded ln underLaklng a more comprehenslve revlew of prlclng Lo
deLermlne Lhe reasons for some of Lhe prlclng anomalles we have ldenLlfled and modelllng
Lhe effecLs of some of Lhe suggesLed remedles ln order Lo supporL lnformed declslon-
maklng.
keconf|gur|ng at|ent Contr|but|ons
ln con[uncLlon wlLh formulary and prlclng revlew, we belleve a revlew of Lhe sLrucLure of
paLlenL co-conLrlbuLlons ls badly needed. 1he currenL arrangemenLs are hlghly lnequlLable,
and lead Lo slgnlflcanL unnecessary ouL of pockeL cosLs for paLlenLs. WlLh lmproved daLa
collecLlon, lL would be posslble Lo model uLlllsaLlon and cosL and devlse a co-paymenL
sLrucLure LhaL ls more equlLable and affordable for paLlenLs whlle remalnlng cosL neuLral.
Cther nea|thcare roducts and Serv|ces
App|y|ng a framework to |dent|fy |neff|c|ent pract|ces
An lnLerlm process could be esLabllshed ln advance of a formal P1A funcLlon. 1hls lnLerlm
process would focus on collecLlng lnformaLlon on poLenLlally lneffecLlve or lnefflclenL
pracLlces and expllclLly excludlng or resLrlcLlng cerLaln non-drug servlces from Lhe beneflLs
package.
8ased on Lhe so-called 'Croydon LlsL'
74
lL ls lmporLanL LhaL users of Lhls framework documenL approprlaLe excepLlons LransparenLly.
lor example, lL may be approprlaLe Lo subsldlze cosmeLlc surgery followlng a road accldenL
or oLher ma[or Lrauma.
, 1able 8 llsLs a proposed framework for rapldly
ldenLlfylng lnefflclenL pracLlce. lL can also be used Lo lnform Lhe declslon-maklng crlLerla for
pharmaceuLlcals.
CrlLlcally, adequaLe daLa collecLlon ls necessary Lo supporL declslon-maklng wlLhln Lhls
framework, alLhough P1As and guldellnes publlshed ln oLher counLrles can be consulLed. lor
example, a source of lnformaLlon on 'do noL do' recommendaLlons sorLed by cllnlcal Loplc ls

74
MalhoLra n, leleke 8. Save Lo lnvesL: ueveloplng crlLerla-based commlsslonlng for planned healLh care ln
London: meLhods and assumpLlons. AL: hLLp://www.lho.org.uk/vlew8esource.aspx?ld=11391

_____________________________________________________________________________________________________
avallable on Lhe nlCL webslLe
73
1ab|e 8: A framework for rap|d|y |dent|fy|ng an |neff|c|ent pract|ce
. 1hese are cllnlcal pracLlces LhaL should be dlsconLlnued
compleLely or should noL be used rouLlnely. 1hls may be due Lo evldence LhaL on balance
Lhe pracLlce ls noL beneflclal or a lack of evldence Lo supporL lLs conLlnued use. 1he 'do noL
do' daLabase conLexLuallzes Lhe orlglnal recommendaLlon wlLh llnks Lo Lhe relevanL
guldellne or oLher form of nlCL guldance.
Lv|dence
Lxclude (relaLlvely) lneffecLlve/unsafe lnLervenLlons, eg knee lavage
unproven eg brachyLherapy for prosLaLe cancer
Subsldy of a medlclne should noL exLend beyond Lhe lndlcaLlons for whlch
lL has markeLlng approval.
Appropr|ateness
'lnapproprlaLe' lnLervenLlons - for example may lnclude largely 'cosmeLlc'
procedures
kestr|ct|on based on sever|ty ] sett|ng
8esLrlcL Lo severe le effecLlve lnLervenLlons wlLh narrow beneflL/rlsk
balance ln mllJ cases, for example hlp, knee and [olnL replacemenL/revlslon
LffecLlve lnLervenLlons where cosL effecLlve alLernaLlves should be Lrled
flrsL, unless conLralndlcaLed (eg meLhoLrexaLe or uMA8uS before blologlcs ln
rheumaLold arLhrlLls)
Cther
oLenLlally excludable from subsldy (eg over-Lhe-counLer paraceLamol)
Covered by oLher schemes (eg naLlonal programmes)

lor example, Lhe daLabase noLes LhaL:
Attbtoscoplc koee wosboot olooe sboolJ oot be oseJ os o tteotmeot fot
osteoottbtltls becoose lt coooot Jemoosttote cllolcolly osefol beoeflt lo tbe sbott
ot looq tetm."
76
AnoLher example:

compotetlseJ tomoqtopby (c1) of tbe pelvls ls oot tecommeoJeJ fot meo wltb
low5 ot lotetmeJlote5tlsk locollseJ ptostote coocet."
77
Such lnformaLlon can be accessed and uLlllzed by pollcymakers ln 8omanla lmmedlaLely Lo
asslsL ln any reform of Lhe beneflLs package.

73
See: hLLp://www.nlce.org.uk/uslngguldance/donoLdorecommendaLlons/lndex.[sp
76
See: hLLp://www.nlce.org.uk/uslngguldance/donoLdorecommendaLlons/deLall.[sp?acLlon
=deLalls&dndld=623
77
See: hLLp://www.nlce.org.uk/uslngguldance/donoLdorecommendaLlons/deLall.[sp?acLlon =deLalls&
dndld=137

_____________________________________________________________________________________________________
kev|s|ng the DkGs
As noLed earller, as a maLLer of some urgency, lL ls lmperaLlve LhaL a process for revlslng Lhe
exlsLlng u8Cs be lnlLlaLed. 1hls could be faclllLaLed wlLh approprlaLe exLernal experL
supporL.
1he revlslons musL lncorporaLe acLual 8omanlan cosLs and average lengLh of sLay for groups
of servlces and lnclude all relevanL aspecLs of care. 1he ob[ecLlve should be Lo capLure and
lncorporaLe gradually, all flxed and varlable cosLs, lncludlng salarles, caplLal cosLs,
emergency deparLmenL cosLs, as well as Lhe cosL of pharmaceuLlcals and oLher medlcal
Lechnologles such as sLenLs and prosLheses. noLwlLhsLandlng Lhe meLhodologlcal
challenges, only by lncludlng all llkely cosLs wlll lL be posslble Lo ensure adequaLe fundlng
and Lhereby reduce lnformal paymenLs and cosL-shlfLlng Lo paLlenLs. AdequaLe daLa
collecLlon ls an essenLlal prerequlslLe for Lhls process.
A programme of regular revlslon and recallbraLlon musL also be devlsed - Lhls wlll asslsL ln
ldenLlfylng cosL drlvers and opporLunlLles for greaLer efflclencles.
Manag|ng med|ca| dev|ce pr|c|ng
A comprehenslve prlce llsL of medlcal devlces, lvus and consumables needs Lo be complled,
Lhls would help ldenLlfy anomalles ln prlclng and faclllLaLe comparlsons wlLh prlces ln oLher
Lu member sLaLes.
78
AL Lhe same Llme conslderaLlon should be glven Lo Lhe lnLroducLlon of an lnLerlm clawback
Lax on medlcal devlces, aL leasL unLll such Llme as Lhere ls greaLer clarlLy ln prlclng and Lhe
lnLroducLlon of approprlaLe P1A processes for devlces. 1he claw-back Lax should be applled
as a percenLage of overall sales. ApproprlaLe overall revenue celllngs (as opposed Lo whaL ls
offlclally relmbursed) could be esLabllshed uslng an esLlmaLe of unlL prlce and expecLed
uLlllzaLlon, wlLh a proporLlon of sales ln excess of Lhls esLlmaLe clawed back". ln addlLlon Lo
provldlng greaLer budgeLary conLrol, Lhls would help reduce Lhe exLenL of reporLed prlce-
gouglng and Lhus reduce cosL-shlfLlng Lo paLlenLs and Lhelr famllles.
As a flrsL sLep, ma[or hosplLals and suppllers could be surveyed Lo
esLabllsh Lhe prlces (and prlce varlaLlons) ln ma[or (hlgh unlL cosL and/or hlgh expendlLure)
lLems. Cnce a schedule ls complled for a selecLlon of key lLems, celllng prlces could be seL
uslng Lhese daLa, and hosplLals could Lhen negoLlaLe furLher dlscounLs dlrecLly wlLh
provlders.
Deve|op|ng n1A |n koman|a
lL ls our vlew LhaL full healLh Lechnology assessmenL (P1A) should be lnLroduced for new
medlclnes and subsequenLly for oLher healLh care Lechnologles and servlces as a speclflc
medlum Lo long Lerm Lerm ob[ecLlve (2-3 years). WlLh a populaLlon slmllar Lo LhaL of

78
AnecdoLally, we were lnformed LhaL prlces of key medlcal devlces, such as drug eluLlng sLenLs, are ofLen
hlgher ln 8omanla Lhan elsewhere ln Lurope.

_____________________________________________________________________________________________________
AusLralla, 8omanla has Lhe capaclLy Lo develop Lhe necessary lndlgenous experLlse over
Llme.
Clearly, a key lssue ls Lhe need Lo develop capaclLy for lndependenL evldence synLhesls and
revlew. P1A capaclLy bulldlng ls a key elemenL ln Lhls process and exLernal asslsLance can be
uLlllzed Lo develop skllls among pracLlLloners and Lralners (see below). lL ls noL necessary Lo
esLabllsh a slngle P1A enLlLy or agency, buL raLher Lo focus on funcLlon - Lhrough
approprlaLe sklll developmenL and on Lhe expllclL and LransparenL lncorporaLlon of P1A lnLo
resource-allocaLlon declslon-maklng.
ln Llme, Lhe P1A funcLlon should be expanded Lo conslder a broad range of Lechnologles
such as dlagnosLlcs and surglcal lnLervenLlons ln addlLlon Lo pharmaceuLlcals.
ln addlLlon, evldence-based guldellnes and proLocols whlch focus on paLhways of care may
well be a useful approach Lo lnformlng Lhe uLlllsaLlon of boLh drugs and non-drug servlces.
Powever such guldellnes musL conslder cosL-effecLlveness and be updaLed Lo lncorporaLe
Lhe ouLpuLs of any P1A processes.
Cllnlcal guldellnes and LreaLmenL paLhways, comblned wlLh LargeLed evaluaLlon of medlcal
Lechnologles can help lnform prlclng and llsLlng declslons, and, ln Lhe longer run, asslsL ln
lmprovlng Lhe quallLy and efflclency of Lhe servlce. Powever Lhey requlre an approprlaLe
legal foundaLlon and adequaLe regulaLlon. ln order for Lhe ouLcomes of an P1A or guldellne
developmenL process Lo be effecLlvely lmplemenLed, key acLors ln Lhe sysLem, such as CnAS
and MoP, musL be lnvolved ln deLermlnlng boLh prlorlLles and mechanlsms for monlLorlng
upLake and lmpacL, and musL also commlL Lo acLlng ln accordance wlLh Lhe resulLs of such
evldence-based evaluaLlons.
Improv|ng procurement and supp|y
Successful lmplemenLaLlon of any of Lhe reforms recommended ln Lhls documenL whlch alm
Lo beLLer llnk relmbursemenL levels wlLh evldence-based 'value' assessmenLs, depend ln
parL on havlng well funcLlonlng procuremenL and supply chalns for boLh pharmaceuLlcal and
non-pharmaceuLlcal producLs. As deLalled earller ln Lhls documenL, Lhe lnLroducLlon of
cenLrallsed compeLlLlve blddlng processes can help secure beLLer prlces, wlLh successful
Lenders belng requlred Lo provlde supply guaranLees. Moreover, dlsLorLlons ln Lhe
wholesale (drug) dlsLrlbuLlon chaln, parLly drlven by slgnlflcanL delays ln recelvlng paymenL,
dlscourage Lhe promoLlon of generlcs and creaLe lncenLlves for parallel exporLs
79,80

79
LoperL 8. 8apld 8evlew of Lhe 8egulaLlon and ollcy lramework for harmaceuLlcal ManagemenL ln
8omanla. (WashlngLon, World 8ank, May 2011). [LxecuLlve Summary ln Appendlx]
. Whlle
beyond Lhe remlL of Lhls Lechnlcal asslsLance pro[ecL, ldenLlfylng mechanlsms Lo address
Lhese lmporLanL lssues would have a subsLanLlve lmpacL on ensurlng affordable access Lo
drugs and oLher healLh Lechnologles.
80
CosLa lonL !, kanavos . Medlclnes parallel Lrade ln Lhe Luropean unlon: a gravlLy speclflcaLlon. Worklng
aper no: 6/2007. (LSL PealLh, March 2007).

_____________________________________________________________________________________________________
1ack||ng corrupt|on and |nforma| payments
A slgnlflcanL concern among pollcy makers ln 8omanla ls Lhe exLenL of corrupLlon ln Lhe
healLhcare secLor and Lhe exLenslve use of lnformal paymenLs" aL all levels of healLh care -
some modesL, oLhers allegedly lnvolvlng wholesale brlbery of healLhcare employees
81
. 1o
some exLenL, Lhls ls drlven by Lhe comparaLlvely low salarles of healLh professlonals ln
8omanla, whlch also drlves Lhe hlgh annual loss of docLors and oLher healLh care
professlonals ouL of Lhe counLry
82
82
. lL would also appear Lo reflecL a lack of LrusL ln Lhe
sysLem Lo prlorlLlse and apporLlon care falrly and malnLaln adequaLe sLandards. ln work
clLed by 1ransparency lnLernaLlonal (2006), lnformal paymenLs ln 8omanla may accounL for
as much as 41 per cenL of LoLal ouL-of-pockeL expendlLure.
lL ls absoluLely essenLlal LhaL a sLraLegy ls developed Lo deal wlLh lnformal paymenLs, and a
clear commlLmenL made Lo lLs lmplemenLaLlon. Cne approach mlghL be Lo formallse Lhem
and develop approprlaLe exempLlon schemes. CerLalnly, based on whaL was proposed ln Lhe
drafL framework law (as of uecember 2011), Lhls appears Lo be a preferred opLlon, alLhough
Lhe approach descrlbed appears Lo conslsL largely of encouraglng Lhe upLake of
supplemenLary lnsurance Lo augmenL a relaLlvely llmlLed baslc beneflLs package. lL ls noL aL
all clear LhaL Lhls approach wlll ln facL reduce Lhe level of lnformal paymenLs, glven LhaL Lhey
perslsLed even afLer Lhe lnLroducLlon of Lhe currenL soclal lnsurance model. lndeed, ln Lhe
shorL Lerm aL leasL, lndlvlduals may prefer Lhe dlrecLness of an lnformal paymenL ln order Lo
secure addlLlonal servlces, and may noL wllllngly pay for supplemenLary prlvaLe cover.
Moreover lL ls llkely LhaL lnformal paymenLs wlll conLlnue Lo be offered and/or ellclLed even
ln Lhe presence of supplemenLary lnsurance coverage, Lhus furLher undermlnlng Lhe equlLy
ob[ecLlve.
1here ls a clear role for publlc lnformaLlon campalgns ln reduclng ouL-of-pockeL expendlLure
more broadly. lor example, Lhese can be used Lo ralse awareness of Lhe avallablllLy of
generlc alLernaLlves Lo branded producLs and LhaL are wlLh lower copaymenL. 1hey may also
be used Lo encourage consumers Lo seek lnformaLlon on Lhe rlsks, beneflLs and cosLs of
proposed LreaLmenLs and of any alLernaLlves. Powever, publlc lnformaLlon campalgns wlll
be of llmlLed lmpacL unless accompanled by effecLlve mechanlsms of provlder audlL, Lhe
resulLs of whlch could lead Lo Lhe publlcaLlon of benchmarklng and performance daLa.
Moreover, ln our vlew, efforLs Lo change consumer behavlour musL be coupled wlLh clear
messages Lo and sancLlons for Lhose ellclLlng addlLlonal paymenLs. 1here ls currenLly no
downslde Lo demandlng or accepLlng an lnformal paymenL, provlders of care Lherefore
need Lo be approprlaLely monlLored and regulaLed lf Lhey perslsL ln Lhe pracLlce.

81
llnanclal 1lmes, Aprll 8, 2011. ! & ! plalnLlffs shrug off reporL". Aprll 8, 2011.
82
Luro Cbserver, volume 13, number 2, Summer 2011

_____________________________________________________________________________________________________
Cther 1echn|ca| Support
8u||d|ng n1A capac|ty |n koman|a
CurrenLly 8omanla has only very llmlLed capaclLy Lo underLake formal healLh Lechnology
assessmenL. 8ulldlng crlLlcal mass Lakes Llme, buL by uLlllslng a Lraln Lhe Lralner" model Lo
develop a kernel of lnLenslvely Lralned lndlvlduals, and ensurlng LhaL Lhey are able Lo
neLwork effecLlvely wlLh relevanL lndlvlduals and organlsaLlons boLh wlLhln and ouLslde
8omanla, lndlgenous capaclLy can be developed wlLhln a few years.
ln our vlew - and reflecLlng Lhe model used ln several counLrles wlLh whlch we have dlrecL
experlence - lL ls lmporLanL LhaL Lhe necessary skllls do noL reslde wlLhln a slngle
organlsaLlon or enLlLy buL are dlsLrlbuLed across several academlc and quasl-academlc
seLLlngs as well as wlLhln CovernmenL. 1hls wlll faclllLaLe expanslon of Lhe sklll base.
1o LhaL end we would sLrongly recommend one or more lnLenslve hands-on Lralnlng
workshops ln 8omanla, of 10-14 days duraLlon, durlng 2012. WlLh a maxlmum of 20
parLlclpanLs, Lhe workshop(s) would cover all aspecLs of healLh Lechnology assessmenL and
would be focused on developlng a baslc seL of pracLlcal skllls for fuLure P1A pracLlLloners.
We are also able Lo offer asslsLance developlng a currlculum for graduaLe sLudles ln P1A, lf
deslred.
Data and |nformat|on needs
8ouLlne and robusL daLa collecLlon ls essenLlal ln monlLorlng and lmprovlng Lhe quallLy of
healLhcare, lrrespecLlve of Lhe Lype of healLhcare sysLem. Moreover, daLa gaLherlng
mechanlsms need Lo be drlven by Lhe needs of declslon-makers aL all levels of Lhe
healLhcare sysLem.
lnformaLlon sysLems need Lo be esLabllshed Lo supporL P1A and u8C developmenL. Such
sysLems wlll also be crlLlcal ln Lhe developmenL of quallLy lndlcaLors. A naLlonal daLabase
needs Lo be creaLed LhaL collecLs average unlL cosL daLa and uLlllzaLlon for producLs, servlces
and procedures boLh lndlvldually and by u8C, whlch ln Lurn can be used Lo seL levels of
paymenL. 1hls daLabase would need Lo be updaLed annually.
lL ls also lmporLanL LhaL daLa are collecLed (and approprlaLely coded) Lo enable pollcy
makers and researchers Lo llnk acLlvlLy and expendlLure Lo lndlvldual dlagnoses and
LherapeuLlc lndlcaLlons. 1hls daLa llnkage, for example, wlll be essenLlal ln esLlmaLlng cosLs
and savlngs from changes ln access Lo parLlcular servlces. lL wlll also enable comparlsons
across hosplLals Lo assess varlaLlon ln pracLlce and expendlLure.
1aklng hosplLal care as an example, a daLa warehouse could be developed conLalnlng deLalls
of all admlsslons Lo hosplLals ln 8omanla. Such daLa could lnclude:
- cllnlcal lnformaLlon abouL dlagnoses (coded accordlng Lo Lhe lnLernaLlonal ClasslflcaLlon
of ulseases for example) and operaLlons
- lnformaLlon abouL Lhe paLlenL, such as age group, gender and eLhnlc caLegory

_____________________________________________________________________________________________________
- clalms daLa Lo supporL ouLcome analysls, quallLy measuremenL and demographlc
expendlLure analysls
- admlnlsLraLlve lnformaLlon, such as Llme walLed and daLe of admlsslon
- geographlcal lnformaLlon on where Lhe paLlenL was LreaLed and Lhe area ln whlch Lhey
llved.
Access Lo Lhe deLalled records would need Lo be sLrlcLly conLrolled Lo avold Lhe
ldenLlflcaLlon of lndlvldual paLlenLs. 1here should be also resLrlcLlons on Lhe naLure of Lhe
aggregaLed summarles avallable Lo researchers and pollcy makers.
ln addlLlon Lo robusL and credlble naLlonal cosL daLa, baslc epldemlologlcal lnformaLlon
(ldeally lncludlng, daLa on Lhe naLural hlsLory of dlsease) ls a pre-requlslLe for declslon-
maklng and healLh Lechnology assessmenL. Moreover, Lhere ls growlng Lrend for Lhe rouLlne
use of aLlenL 8eporLed CuLcome Measures (8CMs)
83
1o asslsL ln Lhe developmenL of comprehenslve daLa collecLlon we would recommend
conducLlng a workshop wlLh key sLakeholders Lo explore, ldenLlfy and galn consensus ln
prlorlLlzlng lnformaLlon needs, sLrucLures and daLa collecLlon mechanlsms.
. 8CMs focus on measurlng quallLy
from Lhe paLlenL's perspecLlve and can lnclude sLandard Lools for assesslng healLh-relaLed
quallLy of llfe, essenLlal for 8omanlan relevanL cosL-effecLlveness.

83
See: hLLp://www.lc.nhs.uk/proms

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NICE International Romania: Final Report Appendix A - 1

Append|x A - 1erms of keference
ro[ect t|t|e: 1echn|ca| ass|stance for estab||sh|ng proposa|s for the bas|c hea|th
care serv|ce package from wh|ch persons |nsured w|th the soc|a| hea|th |nsurance
system w||| benef|t
Agreement type: lump sum paymenL agreemenL
Se|ect|on method: selecLlon from a slngle source
Agreement durat|on: SepLember 20 - uecember 10, 2011
I. Genera| cons|derat|ons
1. 8eLween !anuary and March 2011, Lhe World 8ank has conducLed a funcLlonal revlew of
Lhe 8omanlan healLh care secLor. lrom Lhe flndlngs and concluslons of Lhls reporL, lL resulLs
LhaL Lhe sysLem ls characLerlzed by a hlgh level of fragmenLaLlon, lnefflclency and
lnadequaLe regulaLlon. 1he reporL sLaLes LhaL prlmary healLh care provlders handle a much
lower percenLage of cases Lhan expecLed, LhaL Lhere ls an excesslve number of beds ln
hosplLals, and LhaL Lhere ls a lack of efflclenL ambulaLory dlagnose and LreaLmenL faclllLles
for paLlenLs. AnoLher concluslon ls LhaL Lhere ls a lack of cllnlcal guldes, proLocols and care
meLhods necessary Lo deflne sLandards ln Lhe healLh care area. Moreover, Lhe currenL
beneflL package has noL been deslgned based on a robusL assessmenL of Lhe healLh care
needs, or on an assessmenL of Lhe medlcal servlces based on evldence. ln Lhe sLrucLure of
Lhls baslc package, one can flnd a Lendency Lo reflecL a mlxLure of hlsLorlcal and LradlLlonal
models LhaL are supplemenLed on an ad hoc basls, wlLhouL a reasonable economlc and
flnanclal assessmenL, wlLh new and mosLly expenslve addlLlonal servlces.
2. 1he sLraLeglc dlrecLlons for Lhe healLh care of 8omanla have been arLlculaLed ln a serles of
sLraLeglc documenLs, such as Lhe 8eporL of Lhe resldenLlal Commlsslon for 2008. As far as
Lhe raLlonallzaLlon of Lhe beneflL package and Lhe rebalanclng of Lhe servlces ln favour of
non-hosplLal ones are concerned, Lhe dlrecLlon of publlc pollcles has been summarlzed ln
Lhe naLlonal PosplLal 8aLlonallzaLlon SLraLegy for 2011-2012, approved by CovernmenL
uecree no. 303/2011. 1hls descrlbes brlefly Lhe sLraLegy's key componenLs: provldlng for
susLalnable flnanclng and remodellng Lhe healLh care servlce demand. A clearer deflnlng of
a raLlonal healLh care servlce package and adequaLe and effecLlve seLLlngs for renderlng
such servlces are crlLlcal for reachlng Lhese ob[ecLlves.
3. lndlvlduals who pay healLh lnsurance and oLher caLegorles lnsured under Lhe law
(chlldren, pensloners and speclflc soclal groups) have Lhe rlghL Lo beneflL from healLh care
servlces, as Lhese are deflned and esLabllshed by Lhe leglslaLlon ln force. 1he prlmary plece
of leglslaLlon ls Law no. 93/2006, whlch esLabllshes Lhe general regulaLory framework and
Lhe provldlng of publlc healLh servlces. Powever, a more lmporLanL deflnlLlon of Lhe baslc
package can be found ln Lhe lramework AgreemenL, whlch esLabllshes perlodlcally Lhe
requlremenLs for provldlng healLh care wlLhln Lhe soclal healLh lnsurance sysLem, drafLed by
Lhe naLlonal PealLh SecurlLy lund (nPSl), wlLh Lhe formal consenL and accepLance by Lhe
MlnlsLry of PealLh. rlor Lo flnallzlng Lhese norms, Lhe nPSl conducLs exLended
consulLaLlons wlLh a wlde range of lnLeresLed sLakeholders.

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4. 1he measures referrlng Lo Lhe sysLem flnanclng and operaLlon have Lo alm aL ensurlng a
balance beLween revenues and expenses, ln order Lo ellmlnaLe Lhe sources generaLlng
arrears ln Lhe healLh care sysLem. lL ls a facL LhaL 8omanla has noL been able ln Lhe pasL, ls
noL able now, and wlll noL be able ln Lhe near fuLure elLher Lo supporL Lhe currenL
comprehenslve beneflL package lnherlLed from Lhe CommunlsL era. 8oLh Lhe populaLlon and
Lhe LxecuLlve are aware of Lhe facL LhaL lL has exlsLed and exlsLs only aL a declaraLlve level,
Lhe reallLy demonsLraLlng LhaL Lhe fallure Lo alloL Lhe necessary resources requlres ad hoc
raLlonallzaLlons of such package, whlch are felL permanenLly ln Lhe occurrence, lnLermlLLenL
or noL, of deflclLs ln provldlng drugs and sanlLary maLerlals ln sanlLary unlLs and pharmacles,
ln an lmposslblllLy Lo provlde speclflc paracllnlcal lnvesLlgaLlons aL Lhe level of demand ln
hosplLals or on an ambulaLory basls, ln unaLLracLlve wages for medlcal personnel and ln an
lncreaslng deflclL of medlum or hlghly quallfled labor force ln Lhe sysLem. 1hls ls preclsely
why an expllclL demarcaLlon of servlces LhaL can be provlded by Lhe publlc sysLem ln Lhe
currenL economlc and flnanclal conLexL, and Lhe lnLroducLlon of a Lechnlcal and allocaLlon
efflclency ln uslng Lhe baslc package wlll have Lhe role Lo reesLabllsh a balance beLween Lhe
formal provlslons and reallLy and, more Lhan LhaL, wlll emphaslze clearly Lhe segmenLs ln
whlch healLh care servlces can be covered by complemenLary healLh lnsurance, Lhus
allowlng for Lhe developmenL of prlvaLe healLh lnsurance. ln Lhe fuLure, Lhe efflclency of Lhe
new baslc package wlll noL be conferred by an excluslon of servlces buL by deflnlng Lhe
raLlonal manner and requlremenLs under whlch servlces would be provlded.
3. 1he MlnlsLry of PealLh has developed and conLlnues Lo publlsh orlenLaLlon cllnlcal guldes
wlLh Lhe help of speclallzed commlsslons and professlonal bodles, ln varlous paLhology
areas. Whlle Lhese are requlred Lo be lmplemenLed ln Lhe form of local medlcal pracLlce
proLocols, an audlL sysLem ls noL lmplemenLed ln order Lo make sure LhaL Lhese are drafLed
and Lallored accordlng Lo compeLences for each lnsLlLuLlon, and LhaL Lhey are used. 1he
nPSl does noL requesL proof for Lhe use of medlcal pracLlce proLocols when lL execuLes
agreemenLs wlLh healLh care servlce provlders.
6. revlous consulLlng acLlvlLles carrled ouL by World 8ank experLs have suggesLed LhaL a
useful and efflclenL way Lo lnlLlaLe Lhe process of deflnlng Lhe baslc package would be Lo
lnlLlaLe a collaboraLlon wlLh lnLernaLlonal experLs for Lhe feaslblllLy sLudy, and Lo esLabllsh
Lhe Llme and cosLs necessary Lo supporL Lhe comprehenslve developmenL and revlslon of
such package based on cllnlcal guldes and medlcal pracLlce proLocols.
7. 1he World 8ank's proposal Lo deflne Lhls baslc package sLarLlng from Lhe developmenL
and lmplemenLaLlon of cllnlcal guldes and medlcal pracLlce proLocols ls correcL from a
concepLual perspecLlve, buL Lhelr drafLlng, whlch has sLarLed already, for a sufflclenL
number of dlsease Lypes cannoL be a process wlLh lmmedlaLe resulLs. reclsely for Lhls
reason, ln parallel wlLh lnlLlaLlng Lhls laborlous process, whlch can deflne a healLh care
servlce package Lallored Lo Lhe 8omanlan reallLles only ln a medlum Lo long Llme lnLerval,
Lhe MlnlsLry of PealLh plans Lo develop, by Lhe end of 2011, a verslon of Lhls healLh care
servlce package, revlsed based on Lhe slmllar experlence of oLher nelghbourlng counLrles,
and Lallored Lo Lhe acLual slLuaLlons of our counLry, Lhrough a Lechnlcal asslsLance pro[ecL
flnanced from Lhe World 8ank's programs.
8. 1he purpose of Lhese Lerms of reference below ls Lo seL ouL whaL can reallsLlcally be
achleved beLween SepLember and uecember 2011, wlLh regard Lo lmprovlng Lhe processes
and meLhods of lncluslon, and conLenL of Lhe baslc healLh lnsurance package ln 8omanla. lL
seLs ouL Lhe proposed acLlvlLles aL a hlgh level, Lhe Llmellnes, a seL of daLa requlremenLs

____________________________________________________________________________________________________

crlLlcal Lo Lhe compleLlon of Lhese acLlvlLles wlLhln Lhe proposed Llmellnes, expllclL
excepLlons Lo lmporLanL work LhaL cannoL be dellvered by consulLanL under Lhe presenL
agreemenL.
II. Spec|f|c tasks and respons|b|||t|es
under Lhe guldance of Lhe pro[ecL's SLeerlng CommlLLee, esLabllshed by an order of Lhe
MlnlsLer of PealLh, and ln collaboraLlon wlLh Lhe MlnlsLry of PealLh and nPSl, Lhe
ConsulLanL shall fulfll Lhe followlng Lasks:
Carry ouL a rapld revlew of currenL process(es) for esLabllshlng Lhe baslc healLh
lnsurance package, lncludlng Lhe pharmaceuLlcal producLs and medlcal servlces llsLs,
uevelop acLlonable recommendaLlons for sLrengLhenlng Lhese processes and propose
Llmellnes and responslble parLles for Laklng acLlon, ln llghL of currenL efforLs Lo revlew
Lhe processes Lhrough cllnlcal guldes and paLhways. 8ecommendaLlons may lnclude:
- meLhodologlcal aspecLs of Lhe process such as enhanclng Lhe crlLerla for
lncluslon/excluslon from Lhe healLh lnsurance package, requlremenLs for budgeLary
lmpacL assessmenL of proposed producLs and servlces, and lnLernaLlonal
benchmarklng of oLher agency declslons
- procedural and governance aspecLs of Lhe processes such as managemenL of
confllcLs of lnLeresL, sLakeholder ldenLlflcaLlon and consulLaLlon arrangemenLs,
revlew processes, and Lransparency of declslon-maklng.
8evlew currenL llsL of servlces and Lechnologles boLh nomlnally provlded (on paper")
and acLually uLlllsed (ln everyday pracLlce).
Make recommendaLlons, based on an expllclL raLlonale and seL of crlLerla, on
esLabllshlng a negaLlve llsL of servlces and Lechnologles, for conslderaLlon by Lhe
auLhorlLles ln Lhe shorL-Lerm. 1hls wlll be a fasL-Lrack process, sLarLlng wlLh whaL ls
currenLly offered (nomlnally and ln acLuallLy) and applylng a LargeLed approach Lo
poLenLlal dellsLlng or conLlnued lncluslon sub[ecL Lo prlce modlflcaLlon or amended
condlLlons of lncluslon of Lhe selecLed servlces and Lechnologles. 1o LhaL end Lhe
consulLanL wlll provlde:
- crlLerla for selecLlng candldaLes for such a LargeLed revlew (e.g. overall budgeL
and/or uLlllsaLlon and/or unlL cosLs, lnLernaLlonal pracLlce benchmarklng,
geographlcal or Llme-relaLed varlaLlon and growLh raLes),
- a process for fasL-Lrack revlew (e.g. based on Lhe exlsLence of robusL PealLh
1echnology AssessmenL (P1A) mechanlsms and subsequenL relmbursemenL
elsewhere ln Lhe world, crlLerla for dellsLlng),
- negaLlve llsL caLegorles, whlch may lnclude hlgh level servlce groups belng excluded
or speclflc lnLervenLlons for speclflc lndlcaLlons and populaLlon subgroups. Lqually,
when deallng wlLh Lechnologles, Lhe negaLlve llsL may lnclude classes of
Lechnologles or general pharmaceuLlcal besL-pracLlce pollcles (e.g. generlcs vs.
branded) or speclflc drugs,
- An esLlmaLlon, sub[ecL Lo local daLa belng made avallable (see below) Lhe LoLal
budgeL lmpacL and poLenLlal savlngs from lmplemenLlng Lhe negaLlve llsL, ln Lhe
form of of LoLal budgeL as well as opporLunlLy cosL of oLher servlces (currenLly

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provlded only Lo parLs of Lhe populaLlon or noL aL all) belng made more broadly
avallable, wlLhln Lhe same budgeLary envelope,
- 1argeLed shorL ln duraLlon capaclLy bulldlng acLlvlLles, boLh Lechnlcal and
admlnlsLraLlve, for a small group of experLs and offlclals wlLhln Lhe PealLh lnsurance
lund and Lhe MlnlsLry, ln order Lo lmprove on and susLaln a 8omanlan speclflc P1A
process ln Lhe longer-run. 1hese capaclLy bulldlng acLlvlLles wlll lnclude hands-on
Lralnlng durlng Lhls pro[ecL and a shorL, dedlcaLed lnLroducLory course of evldence-
based pollcy maklng,
- A shorL proposal on nexL sLeps - lncludlng suggesLlons on Lhe developmenL of
guldellne-based poslLlve llsLs (Lo Lhe exLenL Lhls ls posslble/deslrable). 1hls wlll draw
on oLher sources of lnformaLlon such as uLlllsaLlon and cosL daLa, accompanled wlLh
posslble Llmellnes and daLa/capaclLy requlremenLs. 1he proposal can also hlghllghL
oLher posslble levers LhaL oughL Lo be consldered ln Lhe process such as paymenL
and flnanclng sLrucLures.
III. Mode of de||very:
- uesk-based revlew of offlclal 8omanlan governmenL documenLs and lnLernaLlonal
reporLs and llLeraLure
- CuanLlLaLlve analyses, lncludlng Lo esLabllsh basellnes and budgeLary lmpllcaLlons of
proposed changes, based on daLa provlded by Lhe 8omanlan Leam
- Pands-on Lralnlng and analyses ln-counLry lncludlng Lrlps Lo Lhe reglons (lf necessary) Lo
meeL sLakeholders and reLrleve daLa (LoLal of 3 Lrlps Lo 8omanla)
- lnLervlews and focus groups wlLh key sLakeholders
- Plgh level workshop Lo presenL resulLs (meLhods and conLenL of negaLlve llsL) and
recelve feedback
IV. De||verab|es and t|meframe:
- 8rlef revlew of currenL meLhods, processes and conLenL of baslc package Llll CcLober
10, 2011.
- MeLhods and processes for complllng a negaLlve llsL Llll CcLober 20, 2011.
- roposed negaLlve llsL Llll uecember 10, 2011.
- nexL sLeps and recommendaLlons Llll uecember 10, 2011.
V. Act|v|t|es not covered by th|s agreement:
- macro level flnanclng arrangemenLs or paymenL sLrucLures for Lechnologles and
servlces. 1he consulLanL wlll noL lnclude acLuarlal analyses oLher Lhan Lo esLabllsh
poLenLlal savlngs glven Lhe basellne, and always sub[ecL Lo relevanL and adequaLe daLa
belng made avallable by Lhe 8omanlan colleagues. 1he consulLanL wlll work wlLhln
currenL fundlng sLreams for Lhe lnsurance package.
- speclflc conslderaLlon of any lssues concernlng producL regulaLlon.
VI. ro[ect's scope of app||cat|on

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1he pro[ecL wlll be conducLed beLween SepLember 20, 2011 and uecember 10, 2011, and
wlll requlre 100 man days work, lncludlng Lhe Llme necessary for preparaLlon, Lrlps ln Lhe
fleld and monlLorlng acLlvlLles. 1he pro[ecL wlll lmply mlsslons ln 8omanla, lncludlng Lrlps
ouLslde 8ucharesL. 1hese shall be agreed upon ln advance by Lhe SLeerlng CommlLLee and
Lhe consulLanL.
1he pro[ecL's deLalled program wlll be esLabllshed followlng Lhe assessmenL mlsslon.
VII. rofess|ona| qua||f|cat|ons
1he consulLlng company shall provlde aL leasL Lwo experLs havlng Lhe followlng
quallflcaLlons:
(a) LducaLlon: advanced sLudles ln Lhe relevanL areas, such as medlclne, sanlLary
managemenL or publlc healLh,
(b) 8elevanL work experlence: exLenslve experlence ln deflnlng, developlng and
consolldaLlng healLh care beneflL packages and ln maklng connecLlons wlLh flnanclng
mechanlsms,
(c) key quallflcaLlons shall lnclude: excellenL verbal and wrlLLen communlcaLlon and Lngllsh
presenLaLlon ablllLles,
(d) Lxperlence ln supporLlng Lhe process of deflnlng baslc packages ln oLher counLrles havlng
a slLuaLlon slmllar Lo 8omanla would be deslrable aL leasL for one of Lhe experLs.
VIII. ayment manner
1he ConsulLanL shall be pald accordlng Lo Lhe paymenL schedule seL ln Lhe conLracL, based
on Lhe reporLs provlded by Lhe consulLanL and approved by Lhe SLeerlng CommlLLee.
Ik. Informat|on to be prov|ded by the c||ent
conLenL and overall cosL of currenL package and Lype and volume/cosL of excepLlons,
annual lnsurance fund budgeL,
basellne epldemlologlcal daLa and demographlc daLa by class of beneflclary,
lnuASS revenue and expendlLure daLa,
lndlvldual unlL cosLs for servlces and Lechnologles (drug and non-drug lnLervenLlons),
referral Lhresholds from prlmary Lo secondary and LerLlary seLLlngs, daLa on ouLpaLlenL
versus lnpaLlenL servlce dellvery, where posslble, and more deLalled lnformaLlon on
poLenLlally unnecessary and cosLly referral
uLlllsaLlon volumes and lndlcaLlons for lnLervenLlonal procedures/surgery/ dlagnosLlcs
/paLhology,
uLlllsaLlon volumes, LoLal cosL and lndlcaLlons for pharmaceuLlcal lnLervenLlons, broken
down by class of beneflclary,
daLa on paLlenL co-conLrlbuLlons for lnpaLlenL versus ouLpaLlenL servlces, for all
lnLervenLlons Lechnologles and producLs.

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NICE International Romania: Final Report Appendix B - 1

Append|x 8
kap|d kev|ew of the kegu|at|on and o||cy Iramework for harmaceut|ca|
Management |n koman|a - Lxecut|ve Summary and Summary of kecommendat|ons
kuth Lopert, George Wash|ngton Un|vers|ty
Nay 2u11
Romania has a ielatively laige anu iapiuly giowing piopoition of health caie
expenuituie accounteu foi by meuicines. The phaimaceutical maiket in Romania was
valueu at t1.68 billion in 2uu8, a 7% inciease ovei the pieceuing yeai, but this
succeeueu 19% giowth in 2uu6. Phaimaceutical expenuituie is incieasing fastei than
uBP, anu is outstiipping expenuituie giowth othei sectois of the health caie system.
A veiy substantial piopoition of the funus at the uisposal of the Casei Nationale ue
Asiguiii Sntate (National Bealth Insuiance Bouse - CNAS) go to meuicines (2u.7% in
2u11), which is above the 0ECB aveiage. That saiu, the oveiall magnituue of
expenuituie on meuicines is not high in compaiison with othei countiies of similai
national wealth. Neveitheless the magnituue of expenuituie giowth, paiticulaily on
newei moie expensive meuicines, coupleu with the natuie anu cost of what is being
ieimbuiseu, aie matteis of mateiial concein.
The piepaiation of this iepoit uiew on infoimation gatheieu uuiing a two week
mission to Romania in late Naich eaily Apiil 2u11, with auuitional infoimation uiawn
fiom a vaiiety of seconuaiy souices. Neetings anu inteiviews weie helu to canvass the
views of stakeholueis involveu in Romanian phaimaceutical piouuction, uistiibution,
consumption, iegulation anu ieimbuisement iegaiuing cuiient phaimaceutical policy
issues. Biscussions weie stiuctuieu aiounu open-enueu questions anu stakeholueis
weie inviteu to iuentify key aieas of concein, as well as piioiities anu possible
mechanisms foi policy change. While it was not possible to aiiange meetings with all
ielevant stakeholueis in the time available, those that uiu take place incluueu:
Ninistiy of Public Bealth;
Secietaiy of State foi Public Bealth;
Agentia Nationala a Neuicamentului si a Bispozitiveloi Neuicale (National
Neuicines anu Neuical Bevices Agency, ANNBN);
Casei Nationale ue Asiguiii ue Sntate (CNAS)
Colegiul Faimacistiloi uin Romnia (Romanian College of Phaimacy);
Coalitia 0iganizatiiloi Pacientiloi cu Afectiuni Cionice (Romanian Patient
Chionic Bisease Coalition, C0PAC), anu seveial othei patient gioups;
Asociatia Piouucatoiiloi ue Neuicamente ueneiice uin Romnia (ueneiic
Neuicine Piouuceis Association, APNuR)
Asociatiei Romane a Piouucatoiiloi Inteinationali ue Neuicamente (Romanian
Association of Inteinational Piouuceis of Neuicines, ARPIN);
Ameiican Chambei of Commeice in Romania (ANCBAN);
National School of Public Bealth, Nanagement & Tiaining in Bealth; anu

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Bospital auministiatois, anu inuiviuual physicians - geneial piactitioneis anu
both ambulatoiy anu hospital-baseu specialists.
Fiom inteiviews anu ieauings a pictuie iapiuly emeiges of a meuicines policy
fiamewoik in which theie is a complex inteiplay of vaiious pooily integiateu elements.
Some of the existing policy leveis aie at woist counteipiouuctive, anu at best extiemely
complex, cieating unceitainty anu lack of confiuence among stakeholueis. As a iesult,
while oveiall pei-capita uiug spenuing in Romania is not high, iapiu giowth is taking
place without obvious impiovements in health outcomes, anu at the expense of
population equity.
A wiue iange of possible policy options may be consiueieu to auuiess the conceins of
the vaiious stakeholueis in the system, impiove uecision-making, enhance value foi
money, suppoit gieatei efficiency anu timeliness in uistiibution anu payment, anu
ieuuce the extent of both infoimal payments (which unueimine affoiuability foi
consumeis) anu incentives foi paiallel expoit (which cieate shoitages of essential
meuicines). Initiatives to auuiess both supply anu uemanu siue leveis aie necessaiy to
contain phaimaceutical expenuituie anu impiove value foi money, while at the same
time piomoting equity anu suppoiting enhanceu anu affoiuable access to cost-effective
essential meuicines.
Bowevei, it goes without saying that implementing many of these policy leveis will
iequiie both time anu iesouices, anu above all, iesolute political will. Theie aie also a
numbei of constiaints that emeige fiom policy settings in othei paits of the heath caie
system. Without auuiessing the lattei, the extent to which changes in phaimaceutical
iegulation anu policy can achieve the key objectives will be ciicumsciibeu. Noieovei,
while Romania iemains without an oveiaiching national meuicines policy, the vaiious
components of phaimaceutical iegulation anu policy will iemain pooily integiateu,
iestiaining the options to inciease equity, efficiency, affoiuability anu appiopiiate
access.
The following is a summaiy of the key elements anu issues that aie uiscusseu in moie
uetail in the bouy of this iepoit.
!"#$%&'()* ,)&-".()/0 The accession of Romania to the Euiopean 0nion anu
paiticipation in the nCABREAC Agieement has facilitateu the establishment of E0
stanuaius of uiug iegulation. Bowevei, the inuustiy iepoits substantial uelays in ie-
appiovals anu vaiiations foi meuicines pieviously appioveu unuei the Romanian law as
a iesult of unuei-iesouicing of the ANNBN anu a iecent exouus of expeiienceu staff.
The agency also has limiteu capacity foi compliance anu enfoicement activities.
1)2324# &45 )"2-6$)7"-"4'0 A complex system of piicing anu ieimbuisement is
cuiiently in opeiation. It has been subject to extensive anu iepeateu mouifications ovei
iecent yeais in attempts to impiove cost contiol. These have been inteispeiseu with
(anu geneially unueimineu by) politically motivateu auuitions to the Reimbuisement
List, which have appaiently taken place without any consiueiation of the system's
capacity to funu the uiugs in question. The ieimbuisement foimulaiy consists of thiee
sub-lists with uiffeient levels of co-insuiance. The piocesses by which uiugs aie auueu
to the list appeai to be non-tianspaient, inconsistent, anu only weakly eviuence-baseu.
0nly inuiiect consiueiation is maue of cost effectiveness anu theie is no buuget impact
assessment. Biugs that aie auueu to the Reimbuisement List aie foi the most pait not
limiteu to paiticulai inuications, patient populations oi tieatment settings, anu
quantities aie not usually cappeu. In auuition a numbei of uiugs appeai to be

____________________________________________________________________________________________________

ieimbuiseu foi conuitions that lie outsiue theii iegisteieu inuications. The use of
exteinal iefeience piicing cieates incentives foi paiallel expoit (estimateu to be as high
as 2u% foi some meuicines) anu contiibutes to shoitages in uomestic supply.
8,,()5&62%2'* &45 89&2%&62%2'*0 The stiuctuie of patient contiibutions - set at uiffeient
levels of co-insuiance, iathei than as fixeu copayments - is iegiessive anu cieates
unceitainty foi patients, anu moieovei theie aie no safety nets oi "stop-loss" piovisions
to piotect inuiviuuals fiom catastiophic out of pocket costs. Appaiently aibitiaiy limits
aie set on the numbei of ieimbuiseu items a patient may ieceive in the couise of a
month, thus penalizing the chionically co-moibiuly ill, who aie least likely to be able to
affoiu unsubsiuizeu meuicines. Nonthly buugeting is unueitaken at the level of the
uistiict health insuiance house anu once allocateu funus aie expenueu foi a given
month, phaimacies may continue to uispense but will not be ieimbuiseu. Theie is
wiuespieau mistiust in the quality anu safety of geneiics, a peispective not uiscouiageu
by the oiiginatoi sectoi. Bespite manuatoiy piesciibing by INN anu legal substitution at
phaimacy, geneiic penetiation is low by both volume anu value anu has ueclineu in
iecent yeais. New meuicines aie heavily piomoteu to piesciibeis anu manuatoiy
piesciibing by INN is easily ciicumventeu. A significant piopoition of piesciiptions aie
uispenseu foi piouucts that aie not at the iefeience oi benchmaik piice, thus incieasing
out of pocket costs to patients. This may be uue to limiteu availability of the iefeience-
piiceu piouucts, phaimacist influence, piefeience foi paiticulai bianus by patients
anuoi piesciibeis, oi ignoiance on the pait of patients of the availability of cheapei
options. The net effect is that patients pay substantially moie 00P than is necessaiy,
geneiic uptake is low, anu oiiginatoi meuicines continue to maintain a majoiity maiket
shaie. |The Romanian Competition Council is cuiiently monitoiing the phaimaceutical
maiket, citing conceins ovei unwaiianteu piomotion of new meuicines anu iepoits of
seciet contiacts between oiiginatoi anu geneiics companies to uelay the launch of
cheapei geneiic piouucts - so-calleu "pay foi uelay" ueals.j
!&'2(4&% 5)$# $7"0 Cuiiently little is uone to monitoi anuoi evaluate piesciibing, oi
to piomote iational uiug use. The phaseu intiouuction of moie sophisticateu electionic
piesciiption monitoiing by CNAS shoulu enable bettei monitoiing anu feeuback to
inuiviuual piesciibeis about piesciibing piactices anu assist in ieuucing piesciiption
fiauu. The 2u11 Fiamewoik Contiact specifies the intiouuction of inuicative
piesciibing buugets foi inuiviuual uPs anu specialists.
:27')26$'2(4 7*7'"-0 The total numbei of wholesaleis in Romania is appioximately 4u
(although theie aie a numbei of phaimacies also iegisteieu as wholesaleis), but theie is
a substantial uegiee of maiket concentiation, with 12 wholesaleis supplying 8u% of the
maiket. In auuition theie is significant veitical integiation with 8 of the majoi
wholesaleis owning 2S% of the phaimacies nationwiue. Biffeiential anu unfavoiable
teims foi non-integiateu phaimacies aie iepoiteu to have leu to the uemise of seveial.
Wholesale anu ietail maiginmaikups aie iegulateu ieuucing the potential benefits of
competition; moieovei these cieate incentives foi the use of highei cost meuicines with
highei maigins, anu uiscouiage the piomotion of geneiics to patients. Piomoting
piouucts with highei 00P costs also impioves cash flow foi phaimacies. Extensive
uiscounting anu bunuling to both wholesaleis anu phaimacies cieate incentives foi the
supply of paiticulai piouucts anu winufall gains as piouucts aie ieimbuiseu by CNAS at
full Reimbuisement List piice.

____________________________________________________________________________________________________

;&<&'2(40 vAT on meuicines in Romania is high (9%), anu given the extent of 00P
payments foi meuicines cieates an excessive buiuen foi the lowest SES gioups. The iate
compaies unfavoiably with many E0 countiies; foi example, in the 0K, Sweuen anu
Cypius, the vAT on piesciiption meuicines is u%; 2% in Fiance; Bungaiy, Latvia anu
Lithuania apply S%. In auuition the uoveinment has imposeu "clawback" tax of S-11%
of phaimaceutical sales - effectively a tax on inuustiy tuinovei.
=24&4324#0 Buugetaiy constiaints have leu to significant uelays in ieimbuisements to
phaimacies, now saiu to commonly exceeu Suu uays. This in tuin uelays payment to
wholesaleis anu manufactuieis who iepoit payment times exceeuing one yeai. Total
phaimaceutical uebt is iepoiteu to be aiounu t1 billion. Anecuotally, nine wholesaleis
iepoiteu to be awaiting payments of moie than t2Smillion have iecently become
insolvent; many phaimacies as well. Belays in payment aie paiticulaily seveie foi uiugs
ueliveieu unuei national piogiams (foi which no co-payments aie iequiieu). These
uelays cieate poweiful incentives foi the piomotion of uiugs with high 00P costs (ie
piivate piesciiptions, 0TCs oi uiugs piiceu above the benchmaik) as this impioves
cash flow.
>,,232"43* &45 ?$7'&24&62%2'*: 0veiall the Romanian phaimaceutical system cuiiently
has only veiy limiteu capacity to uiive value foi money, anu while theie aie a numbei of
ways to puisue impiovements in both efficiency anu affoiuability these alone may be
insufficient to ensuie the long teim sustainability of the system.
?$--&)* (, !"3(--"45&'2(47
@A !"3(--"45&'2(4 &55)"7724# 'B" CB&)-&3"$'23&% C(%23* ,)&-".()/
1.1 Bevelop anu implement an integiateu national meuicines policy
Befoie any majoi mouifications aie maue to iegulatoiy anu ieimbuisement fiamewoiks
aie maue, a compiehensive anu integiateu meuicines policy shoulu be uevelopeu, with
cleai objectives to auuiess issues of sustainability, financing anu cost containment, goou
goveinance anu tianspaiency in uecision-making, equity of access anu piotection of
vulneiable segments of the population, anu impiovements in both technical anu
allocative efficiency.
DA EC'2(47 '( 2-C)(9" %27'24# &45 C)2324# -"3B&427-7
2.1 Review the opeiation of the National Tianspaiency Committee
The iemit, goveinance, composition anu tianspaiency of the NTC shoulu be ievieweu as
a mattei of piioiity. Betaileu infoimation about the consiueiations of the committee
anu the eviuence that infoimeu its iecommenuations shoulu be publisheu; piesciibeis
shoulu encouiageu to unueistanu the ielative meiits of meuicines, paiticulaily as
uetailing by phaimaceutical companies will tenu to exaggeiate benefits anu uownplay
iisks (incluuing expenuituie iisks). Coie piinciples unueilying the futuie opeiation of
the NTC shoulu incluue inuepenuence, tianspaiency, inclusiveness, scientific iigoui,
contestability, anu timeliness.
2.2 Intiouuce foimal health technology assessment (BTA) as a pieiequisite foi the
inclusion of meuicines in the Reimbuisement List

____________________________________________________________________________________________________

The intiouuction of BTA as a pieiequisite of listing is an essential but necessaiily long
teim objective. A uetaileu uiscussion in the bouy of this iepoit outlines key piinciples
that shoulu guiue this piocess.
2.S Establish a simplifieu ue facto BTA piocess until BTA capacity is uevelopeu
0ntil an BTA infiastiuctuie can be satisfactoiily establisheu a !" $%&'( BTA piocess
coulu be intiouuceu using a simple scoiing mechanism that uiaws on the extent to
which a meuicine has been subject to BTA anu the conuitions unuei which it is
ieimbuiseu elsewheie in the E0.
2.4 Nouify use of exteinal iefeience piicing penuing implementation of full BTA
Consiueiation shoulu be given to the auoption of an inteiim mouifieu exteinal iefeience
piicing algoiithm which sets the piice of a new meuicine accoiuing to the piice of that
meuicine in an E0 countiy (Countiy A) wheie it has been ieimbuiseu following
iigoious BTA ieview, aujusteu by a factoi equivalent to the iatio of Romanian uBP to
Countiy A uBP. Inclusion of the meuicine on the Romanian Reimbuisement List baseu
on this aujusteu exteinal iefeience piice shoulu be limiteu to those inuications anu
tieatment settings foi which it is ieimbuiseu in Countiy A.
2.S Intiouuce manuatoiy Buuget Impact Assessment anu Risk-Shaiing Aiiangements
(RSAs) foi new meuicines with anticipateu high costs anuoi utilization
Nanuatoiy Buuget Impact Assessment shoulu be unueitaken using epiuemiological
estimates anu taking into account cuiient anu anticipateu piesciibing patteins. RSAs
shoulu incluue absolute expenuituie caps (with iebates foi use in excess of agieeu
estimates) anu piice-volume agieements (with ieuuceu unit piices foi use in less cost
effective settings) wheie use cannot easily be limiteu to (oi is likely to be piomoteu
outsiue) cost-effective settings. This will impiove the claiity of buuget impact anu
uiscouiage inappiopiiate piomotion to piesciibeis anu otheis within the uistiibution
chain. 0ptake shoulu be monitoieu with iegulai ieview of obseiveu )* expecteu
utilization.
2.6 Intiouuce competitive tenueiing within high volume clusteis, limiting the
numbei of supplieis anu iequiiing supply guaiantees
Foi high volume anu high cost clusteis within which theie is ieasonable theiapeutic
inteichangeability (eg pioton pump inhibitois, ACE-inhibitois, angiotensin ieceptoi
blockeis, statins) consiueiation shoulu be given to limiting subsiuy to no moie than two
oi thiee entiants in each clustei, on the basis of competitive tenueiing. Successful
tenueieis woulu be iequiieu to pioviue supply guaiantees, with penalties.
2.7 Negotiate contiacts foi fixeu tieatment costs foi piouucts with potential wastage
anuoi weight-baseu tieatment iegimens
Weight-baseu tieatment iegimens foi theiapies like enzyme ieplacement,
eiythiopoietins, tiastuzumab etc can leau to significant unceitainties iegaiuing costs as
well as the potential foi wastage. Consiueiation shoulu be given to attempting to
negotiate fixeu costs pei patient tieateu foi veiy high cost items to facilitate
expenuituie estimates.
2.8 Review the cuiient Reimbuisement List anu uelist items with pooi eviuence of
effectiveness anu cost effectiveness

____________________________________________________________________________________________________

The Reimbuisement List shoulu unueigo uetaileu ieview, with the objective of uelisting
items foi which theie is little eviuence of effectiveness anu cost effectiveness. 0ntil an
effective BTA entity can be establisheu, this ieview coulu be facilitateu by iequiiing
eviuence of ieimbuisement (+ '," -%*.* ($ % $/00 123 in at least one othei E0 membei
state (anu uelisting in the absence of such eviuence).
2.9 Apply iestiictions on subsiuizeu use, anu establish RSAs foi high costhigh
volume meuicines
In auuition all high unit cost anu high volume piouucts on the Reimbuisement List
shoulu be ievieweu to ueteimine whethei ieimbuisement shoulu be iestiicteu in teims
of inuications, patient populations, piioi tieatment moualities, tieatment uuiation
anuoi maximum quantities, to suppoit cost-effective use. Consiueiation shoulu be
given to the intiouuction of a iequiiement foi piioi authoiization foi all uiugs foi which
uiagnostic ceitainty oi eviuence of piioi tieatment failuie is necessaiy to ensuie use is
auequately cost-effective. This coulu be expeuiteu by auopting the listing conuitions (if
any) applying in the countiy fiom which the piice has been iefeienceu (see also
Recommenuation 2.2) anu iequiiing the negotiation of RSAs foi all piouucts foi which
expenuituie exceeueu a pie-ueteimineu thiesholu in the pieceuing financial yeai.
2.1u Review the C1 anu C2 ieimbuisement sub-lists to ensuie that meuicines
incluueu in uisease specific subgioups aie effective anu cost effective, anu
iegisteieu foi the ielevant inuications
Within the C1 anu C2 sub-lists of the Reimbuisement List theie aie a numbei of
tieatment iegimens that aie fully subsiuizeu. These appeai to contain some meuicines
foi use in conuitions that appeai to be outsiue theii appioveu inuications foi maiketing
(eg eiythiopoetins). These shoulu be ievieweu to ensuie consistency with eviuence-
baseu tieatment piotocols anu scope of maiketing appioval.
2.11 Apply iefeience piicing within C1 anu C2 sub-lists
To maximize value foi money, piouucts incluueu in the C1 anu C2 lists (NBPs) shoulu
also be subject to iefeience piicing. Piouucts in these gioups aie among those giowing
most iapiuly in teims of utilization anu cost; the application of iefeience piicing heie
has the potential to significantly impact oveiall expenuituie. Refeience piicing shoulu
be applieu at the level of the molecule %+! the clustei.
FA EC'2(47 '( 2-C)(9" &33"77G "H$2'*G &45 &,,()5&62%2'*
S.1 Intiouuce consumei awaieness campaigns iegaiuing a) the safety anu quality of
geneiic meuicines; b) the actual costs of meuicines; anu c) oppoitunities foi
consumeis to save money at the phaimacy by choosing geneiics
An awaieness campaign is neeueu to encouiage gieatei acceptance of geneiic
meuicines among patients as well as piesciibeis. In auuition, consumeis shoulu be
euucateu to unueistanu that the costs of meuicines aie in many cases significantly
gieatei than theii co-payments (this coulu be assisteu by iequiiing the actual list piice
to be piinteu on the uispensing label). Consumeis shoulu also be maue awaie that foi
many meuicines theie will be an option available that involves minimum out of pocket
cost at the phaimacy.

____________________________________________________________________________________________________

S.2 Intiouuce flat copayments to impiove affoiuability, ceitainty anu equity
The cuiient co-payment stiuctuie is baseu on uiffeient levels of co-insuiance. While
cost is cleaily a potential baiiiei to access, theie is neveitheless substantial eviuence
that both magnituue anu unceitainty in cost shaiing auveisely affect meuication
auheience. Consiueiation shoulu be given to the intiouuction of fixeu copayments (at
peihaps two oi possibly thiee levels), which coulu be moueleu to ensuie cost neutiality.
Lowei copayments coulu be levieu on those beneficiaiies cuiiently exempt fiom health
insuiance contiibutions - eg pensioneis on incomes <7uu R0Nmonth, chiluien anu
auolescents, piegnant women etc. In auuition, meuicines piesciibeu anu supplieu
within NBPs shoulu not be exempteu fiom copayments.
IA EC'2(47 '( -&4&#" 5"-&45 &45 "4B&43" )&'2(4&% $7"
4.1. Intiouuce inuicative inuiviuual piesciibing buugets, with monitoiing of
piesciibing behavioi anu feeuback to piesciibeis
The 2u11 Fiamewoik contiact incluues a piovision foi the intiouuction of .+!.&%'.)"
piesciibing buugets at inuiviuual piactitionei level, foi both uPs anu specialists. CNAS
has uevelopeu an algoiithm foi ueteimining inuiviuual piactitionei buugets baseu on
piioi piesciibing piactices anu patient chaiacteiistics (to be pioviueu). Without
sophisticateu iisk aujustment piocesses such buugets shoulu iemain inuicative only;
they shoulu be suppoiteu by constiuctive feeuback to piesciibeis about theii
piesciibing piactices anu shoulu focus on the extent to which they aie piesciibing cost
effectively iathei than extent to which they can ieuuce theii oveiall piesciibing costs.
Wheie a piesciibei is piesciibing only benchmaik piiceu piouucts in stanuaiu
quantities fuithei ieuuctions in oveiall piesciibing may ieflect unuei-tieatment.
4.2. Intiouuce eviuence-baseu clinical piotocols to guiue tieatment anu "goou
piesciibing" euucation foi piesciibeis
In oiuei to be effective in mouifying piesciibei behavioi anu suppoiting iational use,
piesciibing buugets must be suppoiteu with eviuence-baseu tieatment piotocols that
facilitate piesciibeis' unueistanuing of the compaiative effectiveness anu cost
effectiveness of tieatments. In the futuie the establishment of an BTA entity shoulu
incluue a iole in clinical guiuelines uevelopment anu infoimation uissemination, as well
as acauemic uetailing to piomote iational use.
JA EC'2(47 &55)"7724# 527')26$'2(4&% 277$"7
S.1 Cieate incentives foi phaimacies to uispense benchmaik-piiceu geneiics.
Consiueiation shoulu be given to intiouucing both "push" anu "pull" mechanisms to
ensuie that patients aie offeieu - anu ieceive - benchmaik-piiceu items. This coulu
involve pioviuing a small uispensing fee to phaimacies foi each item uispenseu at the
benchmaik piice, anuoi iequiiing any costs ovei the stanuaiu co-payment foi a
benchmaik piiceu item to be absoibeu by the phaimacy if a benchmaik-piiceu piouuct
cannot be supplieu. Foi this to be successful howevei it will be essential that patients
aie awaie of how much they may expect to pay at the phaimacy foi any given meuicine
(which is uifficult with a co-insuiance iegime iathei than flat co-payments). This woulu
also iequiie iegulation to ensuie that phaimacies can ieauily obtain benchmaik-piiceu
piouucts, oi can pass on auuitional costs to wholesaleis. (See also Recommenuation
S.2.)

____________________________________________________________________________________________________

S.2 Intiouuce flat wholesale anu ietail maigins
Consiueiation shoulu be given to ieplacing the cuiient stiuctuie of maigins in the
uistiibution chain with a fixeu amount pei item (with piemiums foi piouucts iequiiing
special hanuling such as piouucts iequiiing colu chain, cytotoxics), oi fixeu amounts
within value banus. This woulu ieuuce incentives to piomote the most expensive
piouucts within the uistiibution chain.
S.S Intiouuce clawback aiiangements to take auvantage of uiscounting in the
uistiibution chain
Consiueiation coulu be given to the intiouuction of clawback aiiangements baseu on
manuatoiy uisclosuie of actual piices anu (cash anu non-cash) uiscounts. This coulu be
quite iesouice intensive, but may be moie acceptable to inuustiy than the intiouuction
of tenueiing, as uesciibeu above, although it may also be less cost-effective.
S.4 Impiove phaimacy access
Ruial access to phaimacies is pooi in compaiison with uiban aieas. A small numbei of
chains opeiate a laige numbei of phaimacies. Consiueiation shoulu be given to
establishing minimum uistances between phaimacies in uiban settings, anu a
iequiiement that wheie a specifieu numbei of phaimacies is owneu in an uiban setting,
at least one phaimacy in a iuial aiea is also establisheu anu maintaineu.
KA EC'2(47 &55)"7724# ,24&4324#G '&<&'2(4 &45 7$7'&24&62%2'*
6.1 Intiouuce fixeu timefiames foi ieimbuisement
Without uiscipline in payment timefiames, incentives foi ciicumventing existing anu
futuie policy settings will unueimine both the cieuibility anu the potential effectiveness
of effoits to impiove affoiuability anu access. Noieovei, the payment of outstanuing
ieimbuisements woulu enhance the uoveinment's leveiage in intiouucing those
elements of policy iefoim likely to be less palatable to inuustiy anu piofessional gioups.
6.2 Intiouuce a uistiibution tax with iebates foi piouucts uistiibuteu to phaimacies,
to uiscouiage paiallel expoit
Romanian piesciiption meuicines aie likely to iemain low by Euiopean stanuaius, thus
encouiaging paiallel expoit of meuicines. The intiouuction of a uistiibution tax that
woulu seive to notionally inflate the Romanian list piice (foi subsiuizeu meuicines
only) coulu ieuuce the attiactiveness of Romania as a souice of paiallel expoits. This
coulu then be iebateu accoiuing to volumes uistiibuteu to phaimacy.
6.S Reuuce oi iemove vAT on meuicines
vAT on meuicines in Romania is high (9%); this inflates the costs of meuicines, which
flows thiough to co-insuiance, thus cieating an auuitional buiuen foi the lowest SES
gioups. Consiueiation shoulu be given to ieuucing oi iemoving vAT on meuicines.
6.4 Nanage phaimaceutical expenuituie giowth iate using an "efficiency uiviuenu"
As a longei-teim measuie to intiouuce contiol in expenuituie giowth, allow
expenuituie to giow at a iate not exceeuing giowth in uBP. Peicentage giowth in excess
of uBP coulu be moueiateu thiough a similai peicentage piice ieuuction ("efficiency
uiviuenu") applieu acioss the entiie Reimbuisement List; conveisely if giowth is less
than uBP giowth a similai flat peicentage piice inciease coulu be gianteu. This shoulu
only be consiueieu once othei mouifications to piicing policies have been intiouuceu

____________________________________________________________________________________________________

anu iigoious BTA piocesses foi foimulaiy listing have been implementeu, with uiugs
only auueu to the foimulaiy on the basis that they have been uemonstiateu to be
compaiatively effective, cost effective - anu affoiuable.

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