evidence requirements
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HAS relaxes evidence requirements under certain conditions


In early July, the French National Authority for Health (HAS) released its annual report, highlighting a groundbreaking new doctrine from the Transparency Commission. This doctrine aims to accelerate the development of new medications, particularly for rare diseases and oncology, by adjusting evidence requirements to allow non-comparative studies and conditional market authorisations (AMM). It seeks to balance rapid clinical development with managing uncertainties to benefit patients. This shift could significantly impact how new drugs reach the market.

Key Points of the New Approach

  1. Gold Standard and Adjustments:
    • The randomized controlled trial (RCT) remains the gold standard for patient safety.
    • The commission now permits the degradation of evidence levels required for drug reimbursement under specific, justified conditions, valuing high-quality indirect comparisons.
  2. Conditions for Accepting Non-Comparative Study Results:
    • Valid reasons must be provided for not conducting a comparative trial.
    • The external comparator must be predetermined during study protocol development.
    • Strict matching is required to ensure reliable comparisons.

Implications of the New Doctrine

  • Faster market access: This new approach allows for quicker introduction of innovative treatments, particularly in areas with urgent needs such as rare diseases and oncology.
  • Strategic adaptation: Manufacturers must now focus on providing robust methodological plans and justifying indirect comparison data to meet the new requirements, including high-quality indirect evidence and pre-planned external comparators.

This new doctrine from the HAS represents a significant shift in drug development strategy, promising to speed up the delivery of critical medications to patients in need.



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