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PAYER PERSPECTIVES ON FUTURE ACCEPTABILITY OF COMPARATIVE EFFECTIVENESS AND RELATIVE EFFECTIVENESS RESEARCH.

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Payers expect comparative effectiveness research (CER) and relative effectiveness (RE) to influence drug access decisions. They will increasingly use policy tools and their own data to manage new drug approvals.

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Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Evidence-based medicine

Background:

  • Comparative Effectiveness Research (CER) in the US and Relative Effectiveness (RE) research in Europe are evolving frameworks.
  • Payers' evidentiary standards significantly influence new drug access and market entry.

Purpose of the Study:

  • To understand payer perspectives on the impact of CER and RE on drug access decisions by 2020.
  • To explore how evidentiary standards for new drugs may change due to CER/RE.

Main Methods:

  • Semi-structured interviews with 14 senior payer officials in the US and Europe.
  • Online survey assessing current and future use of CER/RE evidence.
  • Analysis of hypothetical cases to gauge acceptance of different study designs and methods.

Main Results:

  • Randomization remains crucial for assessing comparative/relative effectiveness.
  • Increased use of policy levers like conditional reimbursement and prior authorization is anticipated.
  • Observational data may be accepted for CER/RE when drug differences are minor (e.g., convenience).

Conclusions:

  • Industry perceptions align with findings: CER/RE will likely alter evidentiary requirements.
  • Payers' growing data investments and policy tool reliance will shape future evidence demands for new drugs.