Health technology assessment of pharmaceutical products in France
The French National Health Authority (HAS, Haute Autorité de Santé) is an independent health technology assessment body in charge of technical and clinical assessment of pharmaceuticals, medical devices and medical procedures, establishment of good practice guidelines and certification of health care organizations.
The HAS Transparency Commission gives its opinion on the level medical value (SMR), the level of added medical value (ASMR) in comparison to existing reimbursed alternatives, and estimates the target population eligible for reimbursement by the National Insurance. Any assessment is done by indication.
The medical value (SMR) is rated on a 4-grade scale from “important” to “insufficient” on the basis of the following criteria:
  • risk/benefit ratio;
  • severity of the disease;
  • aim of the treatment (preventive, curative or symptomatic);
  • place of the treatment in the disease management strategy, and its potential to address an unmet medical need;
  • interest of the treatment for the public health.
The medical value level predetermines the National Insurance reimbursement rate, with “important level” leading to 65% reimbursement rate, “moderate level” to 35% reimbursement rate and “insufficient level” to no reimbursement. Some drugs considered by the Commission as indispensable and irreplaceable are recommended for 100% reimbursement by the National Insurance.
Medical value levels granted by the HAS following first-time and label extensions
assessments for pharmaceutical products in 2015

Source: 2015 French National Authority of Health (HAS) annual report.
Unless the medical value is considered to be insufficient for reimbursement, the Transparency Commission gives its opinion on the added medical value (ASMR) with regards to reference products already available in France, as well as on the target population that should benefit from the reimbursement (may be restricted to a subset of the Marketing Authorization population).
The added medical value (ASMR) is rated on the 5-grade scale from “major” to “no” added value compared to available product(s) of the same pharmacologic class. Head-to-head comparison in clinical trials is required. First-in-class products are compared to the established standard of care.
In general, three highest levels (ASMR I, II and III) require substantial mortality and/or morbidity benefit demonstrated in accurate clinical trials with superiority design and hard primary endpoint. For anticancer drugs, overall survival benefit is expected; progression-free or event-free survival without demonstrated overall survival benefit usually leads to ASMR IV (minor added value) level.
ASMR V (no added value), most frequent outcome of the HAS assessments, requires at least similar to reference product efficacy and safety profile demonstrated in non-inferiority clinical trial.
Added medical value levels granted by the HAS following first-time and label extensions
assessments for pharmaceutical products in 2015

Source: 2015 French National Authority of Health (HAS) annual report.
An HAS opinion is granted for up to 5 years; it can be reviewed at any moment following a competent health authority request, safety warning, pharmaceutical class review or HAS’s own decision. At the end of the validity period specified in the opinion, the manufacturer must submit a request for renewal. Renewal may be conditioned by providing real-world evidence or new clinical data, especially if an added value level is granted. The HAS opinions are published on the HAS website and transmitted to the Economic Committee within the Ministry of Health and Social Affairs for price determination and final registration on the reimbursement list(s).
Updated on December 15th, 2016