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Presented by:
Agenda
PharmTech Serialization & e-Pedigree 8 Myths or Lessons Learned Opportunities Next Steps Q&A
PharmTech Overview
Background
People
PharmTech
ROI
Traceability Systems
Traceability Defined
Traceability is the ability to TRACK FORWARD, (item level serialized product), the movement through specified stage(s) of the extended supply chain and TRACE BACKWARDS the history, application or location of that which is under consideration
GS1 GTSH 1.0.0 Feb-2009
Lesson: Dont pick a solution until you know the problem. Choose strategy before tactic.
Strategy
Planning
Implementation
Gap Analysis Process Mapping Business Process Analysis Current State/Future State Evaluation Review Commercial Relationships Strategic Impact Analysis Cost-Benefit Analysis Business Value Propositions Traceability Architecture Development Strategic Solutions Systems Recommendations Solutions Provider Analysis User Requirements Functional Requirements Long Term Planning & Forecasting Solutions Provider Selection Project Management GS1 Standards Conversion Internal Test & Validation Trading Partner Connection Piloting
Lesson: Begin with the end in mind. You will get the system you plan for.
Lesson: Develop a strategic business plan Understand cost, impact and workflow changes effected Strategy to full implementation 6months-3 years
Yes No Unsure
Contingencies:
Are the CMOs/Packagers on your timeline? When will they be ready to pilot? Test? Integrate? What solution will each CMO go with? Who is responsible contractually for serialization? How do you want to receive the serialized product data? How do they want to send the serialized product data? (All of them?) How important is your business to them? Them to you? Are they willing to be guided by your companyi, or do you have to accept their solution? Can your systems seamlessly integrate with 40+ technology systems
Lesson: The activities from strategic business planning are evergreen. Opportunities are found when you are looking for them.
Receiv e I ngredients
Bulk
Drug Processing
Packaging
Distribution Center
"In a world where outcomes count for everything, its not molecules that create value but, rather, the ability to integrate data, products and services in a coherent business offering.
- PwC, Pharma 2020: Supplying the Future
Lesson: Identify and quantify the non-compliance benefits Installing a business system, not a compliance project
Improved Adherence
Challenge: Manufacturer losing opportunities in a self-injectable between Physician Recommendation & Decision Day (by patient) as well as the time line between Prior Authorization & Benefit Verification.
Decision Day Physician Prior Authorization Benefit Verification Delivery
Recommendation Patient Insurance Denial Approv al Adherence
Improved Adherence
Decision Day Prior Authorization
Denial
-Provided web based education and financial assistance to patient to accelerate Decision Day choice -Integrated with EHRs and Third Party Providers to remain HIPAA compliant -Opt-in at clinic level by patients for manufacturer provided education, third party marketing and prepopulated benefits forms for benefits. -Decision Day to Prior Authorization goes from an endless loop to 20 minutes rather than 1-2 months. -Automated Prior Authorization & Benefit Verification process reducing Decline to PA Submission to Approval 30-60 days to 72 hours. -Increased clinic and patient adherence.
Benefit Verification
Physician
Delivery
Recommendation
Patient
Insurance
Approv al
Adherence
Lesson: You dont know what you dont know Proper strategic planning and allocating enough time for a full pilot is critical
Regulatory deadline
-36 months
Availability of talent
-Limited # of resources with experience
Next Steps