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Assessment of medicinal products
Assessment of medicinal products at HAS
HAS is responsible for providing recommendations, largely with regards to reimbursement of medicinal products; the latter falling within the jurisdiction of the HAS Transparency Committee (TC).
> To learn more about the medicinal product assessment process at HAS
> To learn more about the Principles of medicinal product assessments and appraisal for reimbursement purposes
> To submit an assessment file for a medicinal product (in French only)
> To consult the guidance for submission and proceeding of an early dialogue at the national level (with HAS) or at the European level (with EMA and/or other HTA bodies)
Recommendations on medicines
The TC recommendations are nonbinding and do not predict the Ministers decisions in terms of reimbursement.
A recommendation generally includes:
- an evaluation of the actual clinical benefit (ACB) to ensure legitimate listing of a medicinal product;
- a comparison of the actual clinical benefit (ACB) of a medicinal product with that of the reference therapeutic class;
- an evaluation of the clinical added value (CAV) provided by a medicinal product in relation to its comparators;
- a re-evaluation of the added clinical value (CAV) of a medicinal product for listing renewal.
