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The Transparency Committee (CT – Commission de la Transparence) is a scientific body made up of doctors, pharmacists and specialists in methodology and epidemiology. It evaluates drugs that have been granted marketing authorization, when the laboratory marketing them wishes to obtain their inclusion on the list of reimbursable drugs.
Missions
- Provide an opinion to the Ministers in charge of Health and Social Security for decisions on pricing and reimbursement by the national health insurance for medicinal products with a Marketing Authorisation. This appraisal is notably based on two scores: the clinical benefit (“service médical rendu” - SMR) and the clinical added value (“amélioration du service médical rendu” - ASMR) versus existing alternatives.
- Contribute to the proper use of medicinal products by publishing relevant and independent scientific information on medicinal products, including their intended role in the treatment pathway.
To carry out these missions, the CT relies on the principles and assessment procedures defined in its doctrine and internal rules.
The assessment is based on an application dossier submitted by the health technology developer. It is examined by the members of the CT with the support of the Medicinal Productions Division (SEM - Service évaluation des médicaments) of the HTA Department (DEAI - Direction de l’évaluation et de l’accès à l’évaluation ), and the consultation, if necessary, of external experts.
The CT publishes its appraisals on medicinal products in a dedicated area of the HAS (Haute Autorité de santé) website. For certain new medicinal products, it will also produce, in addition to its appraisal, a document summarizing the rules governing the product’s proper use (fiche de bon usage des médicaments).
Details on CT activities and assessment agenda are available on the French website.
Early Access
The Franch early access scheme provides for the temporary reimbursed use of medicinal products presumed to be innovative before the conclusion of the regular HTA pathway or even before the Marketing Authorization. These authorisations are issued by the HAS, following an opinion from the CT based on the eligibility criteria for the early access scheme. In the case of pre-authorisation early access, this opinion is given after the ANSM has given its assent to the presumed efficacy and safety of the drug.
Please refer to the doctrine for early access authorisation for more information.
Composition
- Twenty-nine members (22 full members, 7 substitutes) with voting rights, selected for their scientific expertise; including the chair (appointed among the Board members) and two vice-chairs.: expert practitioners (doctors, pharmacists), specialists in methodology and epidemiology, and two representatives of patient associations and healthcare users.
- Seven additional members participate in an advisory role: representatives of the Social Security Directorate, the Directorate-General for Health, the Directorate-General of Care Provision, the National Health Insurance Fund, the French National Agency for Medicines and Health Products Safety (ANSM - Agence nationale de sécurité du médicament et des produits de santé).
The CT members are appointed for a three-year mandate, renewable twice. The current Chair of the committee is Prof. Pierre Cochat.
Assessment Process
Access to reimbursement for medicinal products in France requires pharmaceutical companies to submit a dossier to the HAS which is responsible for the Health Technology Assessment following the granting of a Marketing Authorisation.
The dedicated appraisal committee (Transparency Committee) issues an opinion on the clinical benefit than can impact the reimbursement decision (yes/no) and the level of reimbursement by the National Health Insurance Union (UNCAM -Union nationale des caisses d'assurance maladie) – for product used in primary care and on the clinical added value that is used in pricing negotiations. The final decision for inclusion falls under the jurisdiction of the Ministers in charge of Health and of social security and is published in the Official Journal.
Rules of procedure (French only) : Commission de la Transparence
