The Role of Medical Affairs in the Value-Based Healthcare Ecosystem

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Medical Device; Biotech; Biopharmaceutical; Manufacturing; Consumer Products; Consulting


Companies Profiled:
Abbott; AbbVie; Alcon; Alkermes; Allergan; Astellas; AstraZeneca; Bayer; Becton Dickinson; BioCryst Pharmaceuticals; Bioventus; Boehringer Ingelheim; Cadila Pharmaceuticals; CEEK Enterprises; Eisai; Ferring Pharmaceuticals; Galderma; GlaxoSmithKline ; GRAIL; Grifols; Heron Therapeutics; Ipsen; Janssen; Jazz Pharmaceuticals; La Jolla Pharmaceutical; LEO Pharma; Lundbeck; MannKind Corporation; Merck; Merck KGaA; Merck Serono; MSD; Mylan; Novartis; Orchard Therapeutics; Pacira Biosciences; Pfizer; Purdue Pharma; Roche; Sandoz; Sanofi Genzyme; Sanofi Pasteur; Santen; Sunovion; Takeda Pharmaceuticals; UCB Pharma; Ultragenyx; Vifor Pharma; ViiV Healthcare

Study Snapshot

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.

Key topics covered in this report include:

• The Effect of External Value-Based Mindsets
• Medical Affairs Role in the Value-Based Ecosystem
• Value-based Activity Prioritization
• Key Facets of External Collaboration & Engagement
• Progressing Value-Based Internal Collaborations
• Medical Affairs & Value Based Contracts
• HEI & FDAMA S114
• Success Factors & Pitfalls for Value-Centric Operations

• Four organizational emphases to the value-based ecosystem emerged:
  • Optimizing data acquisition strategy to address key value-levers
  • Developing holistic value propositions for external engagement
  • Internal value-based collaboration
  • Prioritizing patient centricity

• Priority internal collaborations start with Market Access. Top collaborations are executed by co-developing the medical value story, supporting dossier & HTA submissions.

• Different frameworks applied to the meaning of medical value by various healthcare stakeholders
• Primary and secondary facets of value across stakeholders
• Ways through which Medical Affairs can bridge the “value gap”

• Medical Affairs’ emphasis in a value-based environment
• Medical Affairs’ operation in a value-based environment - Data acquisition & RWE
• Medical Affairs’ operation in a value-based environment - Holistic value proposition
• Medical Affairs’ operation in a value-based environment - Collaboration
• Medical Affairs’ operation in a value-based environment - Prioritizing patients
• Interview verbatim on Medical Affairs’ continuous evolution to meet the needs of its constituents in the value-based ecosystem
• Areas where greatest changes occur

• Effectiveness ranking of benchmark companies’ Medical Affairs group in serving the listed value-based responsibilities
• Effectiveness vs Importance matrix for Medical Affairs activities

• Effectiveness vs Importance matrix for Medical Affairs’ collaborations with external stakeholders
• Activities performed by Medical Affairs with payers to ensure success in the value-based environment
• Interview verbatim on a key opportunity front identified with payers
• Activities performed by Medical Affairs with advocacy groups to ensure success in the value-based environment
• Interview verbatim on producing significant opportunities with decision-maker audiences
• Activities performed by Medical Affairs with formulary committees to ensure success in the value-based environment
• Interview verbatims on expanding the impact of collaboration with HTAs and formulary committees
• Activities performed by Medical Affairs with patients and caregivers to ensure success in the value-based environment
• Activities performed by Medical Affairs with providers to ensure success in the value-based environment

• Top five internal collaborations for Medical Affairs to succeed in this new value-based environment and interview narrative around it
• Perceived importance of the different activities performed by Medical Affairs with Market Access groups to ensure success in the value-based environment
• Perceived importance of the different activities performed by Medical Affairs with Clinical Development groups to ensure success in the value-based environment
• Perceived importance of the different activities performed by Medical Affairs with Patient Advocacy groups to ensure success in the value-based environment
• Perceived importance of the different activities performed by Medical Affairs with Compliance and Government Affairs groups to ensure success in the value-based environment

• Percentage of product contracts under value-based contracts within benchmarked companies
• Drivers of value-based contracts; and interview narrative around it
• Role of Medical Affairs in creating and executing value-based contracts
• Future use of value-based contracts

• Level of difficulty in gaining approval for healthcare economic information materials under FDAMA 114
• Benefits from FDAMA S114 amendments
• Importance of listed healthcare economic information types for benchmark participants’ support of physicians and payers
• Effectiveness of listed healthcare economic information types for benchmark participants’ support of physicians and payers
• Types of healthcare economic information approved for proactive use under FDAMA 114
• Impact of FDAMA S114 on Medical Affairs and pharma
• Impact of FDA’s guidance on industry
• Potential changes to FDAMA S114

• Critical success factors that allow Medical Affairs to deliver and show value
• Major pitfalls for Medical Affairs preventing value delivery