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Products & Services Medical Affairs Medical Affairs Excellence

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

ID: POP-319


Features:

24 Info Graphics

22 Data Graphics

140+ Metrics

6 Narratives


Pages: 58


Published: 2019


Delivery Format: Shipped


 

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Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Leading Medical Affairs organizations are developing effective strategies to serve a new kind of value-based healthcare ecosystem where critical stakeholders such as payers, physicians, and patients increasingly prize value beyond clinical effectiveness and safety in their decision making.

Best Practices, LLC undertook this peer-driven research to examine the evolving role of Medical Affairs in the value-based healthcare ecosystem. This report benchmarks this critical space by assessing: important value-based activities, facets of internal and external collaborations, value-based contracting approaches, healthcare economic information and FDAMA S114. The report also explores the primary success factors and common pitfalls for today's value-centric Medical Affairs operations, culled from deep-dive interviews with medical executives.

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


Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • 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.

Table of Contents

Sr. No.
Topic
Slide No.
I.
Universe of Learningp. 3
II.
Executive Summaryp. 4-5
III.
The Effect of External Value-Based Mind-setsp. 6-9
IV.
Aligning Medical Affairs Role with The Value Based Ecosystemp. 10-17
V.
Medical Affairs’ Value-Based Activitiesp. 18-20
VI.
Key Facets of External Collaboration in the Value Based Ecosystemp. 21-30
VII.
Progressing Internal Collaboration in a Value Based Environmentp. 31-36
VIII.
Medical Affairs and Value-Based Contractsp. 37-41
IX.
Healthcare Economic Information and FDAMA S114p. 42-49
X.
Critical Success Factors and Major Pitfallsp. 50-57
XI.
About Best Practices, LLCp. 58

    List of Charts & Exhibits

    I. The Effect of External Value-Based Mind-sets

    • 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”

    II. Aligning Medical Affairs Role with the Value Based Ecosystem

    • 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

    III. Medical Affairs’ Value-Based Activities

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

    IV. Key Facets of External Collaboration in the Value Based Ecosystem

    • 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

    V. Progressing Internal Collaboration in a 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

    VI. Medical Affairs and Value-Based Contracts

    • 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

    VII. Healthcare Economic Information and FDAMA S114

    • 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

    VIII. Critical Success Factors and Major Pitfalls

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