Focus on France
As an aid to clients we have prepared a number of landscape pieces in which we share a summary of the key aspects which affect pricing and reimbursement rates, as well as market access in each of the markets. This article focuses on France.
In France marketing authorization for drugs can be obtained at the national or European level. The French regulatory agency for drugs is the National Agency for the Safety of Medicine and Health Products (ANSM).
There are 3 key bodies involved in the process of approving a product and agreeing pricing and reimbursement levels:
- The Transparency Committee (Commission de la Transparence, or CT)
- The Economic Committee on Healthcare Products (Comité Economique des Produits de Santé, or CEPS)
- The National Healthcare Insurances (Union Nationale des Caisses d’Assurance Maladie, or UNCAM)
- The CT is in charge of assessing the medical benefit (known as SMR) and the improvement of medical benefit (known as ASMR) of a new medicine for which a pharmaceutical company submits a request for inclusion in the reimbursable drugs formulary.
- Drug price setting is established by CEPS after negotiation with the drug company. The ASMR is one of the key items taken into account during price setting.
- The reimbursement rate is fixed by a decision from UNCAM, primarily based on SMR. The HAS (Haute Autorité de Santé) then makes the final decision regarding whether or not the drug will be registered on the list of reimbursable medicines. This registration is valid for 5 years. At the end of this period or at any time when significant new information becomes available, the CT reevaluates the SMR and ASMR levels.
It is important to note that the ASMR is mainly driven by the effect size of the benefit of the drug. Although the effect size concept is a well-defined and standardized measure of the benefit over a comparator, in France, the effect size is considered by the CT as a very subjective endpoint that relies on the expert assessment of the CT members. The lack of decision analysis framework leaves some unpredictability.
Influence from Insight:
Given the subjective nature of the CT assessment process, it is essential to undertake research throughout the development process in order to gain insights into the possible outcomes and - crucially - to understand how to influence them. This, of course, requires we recruit the right respondents:
- For projects which are primarily market access studies, the appropriate national targets would be professionals related to the CT committee – members, ex-members and advisors.
- For projects which are focused on pricing, Medicys’ recommendation would be to target CEPS advisors and ex-members, as well as payor advising KOLs in the form of senior clinicians who act as advisors to the payor body.
- If likely local uptake needs to be assessed, the local level payors for hospital drugs will be the head of pharmacy/formulary pharmacist and the budget holder/head of clinical department. Our capabilities:
We offer our clients a full and expert medical fieldwork service which includes recommendation on sample structure and size relative to clients’ objectives, recruitment, moderation, translation, reporting etc. In terms of Pricing and Market Access projects, we are not aware of anyone who has better access to National, Regional and Local level payors within the EU5 markets, although, of course, we can also access the full range of other healthcare respondents you would expect from an expert medical fieldwork partner.