The Role of Medical Affairs in the Value-Based Healthcare Ecosystem: Collaboration, FDAMA S114 and Value-Based Contracts

As payers and consumers place increasing emphasis on value beyond clinical effectiveness and safety, Medical Affairs organizations are developing effective strategies to succeed in this new value-based healthcare ecosystem.

Best Practices, LLC conducted this benchmarking research to examine the evolving role of Medical Affairs in the value-based healthcare ecosystem. In particular, this study benchmarks the key facets of internal and external collaborations, value based contracts, healthcare economic information and FDAMA S114 for value-centric Medical Affairs operations.

KEY TOPICS

• Key Facets of External Collaboration & Engagement
• Progressing Value-Based Internal Collaborations
• Medical Affairs & Value Based Contracts
• HEI & FDAMA S114

• In your experience, which external stakeholders must Medical Affairs work with and how effective is Medical Affairs in working with the mentioned external stakeholders to succeed in this new value-based environment?
• In your experience, which internal group(s) must Medical Affairs work with to succeed in this new value-based environment?
• Roughly, what percent of product contracts are value-based contracts at your company?
• What is the role of Medical Affairs in creating and executing value-based contracts?
• Does your company plan to use value-based contracts in 2020?
• How difficult has it been to gain approval for Healthcare Economic Information materials under FDAMA 114?
• Has your group so far benefited from the amendments to S114 of FDAMA?
• How effective are the listed Healthcare Economics Information types to your support of physicians and payers?
• What types of healthcare economic information is approved in your company for proactive use under FDAMA 114?
• What has been the overall impact of the FDA's S114 guidance on Medical Affairs and pharma?

• Medical Affairs takes a supportive role with Value-based contracts. VBCs are anticipated to grow for more complicated treatments, calling for greater Medical Affairs involvement.
• The primary benefit of FDAMA S114 has been increased proactivity with HEI for payers. Head-to-head trials were ID’d as the most essential HEI type, although only 52% of companies proactively share these.

Best Practices, LLC engaged 70 Medical Affairs leaders from 50 companies in this research through a benchmarking survey, focus group interviews and round-table discussion.

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