Following its Action Plan for Innovative Medicines and its clarification of the health technology assessment of therapeutic value (Service médical rendu – “SMR”) conditionality, the Transparency Commission of the French National Authority for Health (Commission de la Transparence de la Haute Autorité de santé) completed the year 2020 by publishing its new doctrine on the health technology assessment of medicines for access to reimbursement.

This updated doctrine specifies the procedures for the reassessment of the therapeutic value and of the improvement in medical service rendered (Amélioration du service médical rendu – “ASMR”) on the basis of the post-registration studies and additional data that it will have previously required pursuant to the regulatory provisions introduced by the market access decree of August 25, 2020.

The French National Authority for Health is also developing its doctrine on "targeted therapies" (thérapies ciblées) by providing the methodology applicable to "basket" trials in oncology, and in particular its expectations in terms of comparison.

Authored by Charlotte Damiano