PLFSS 2021 to bring changes in France

The French government has published a draft of its Social Security Finance Bill 2021 (Projet de loi de financement de la securité sociale, PLFSS 2021), its annual review of spending on health and social care.

The main proposals affecting market access fall under two categories:

Cost-cutting measures

The bill includes €4bn of savings aimed at improving the efficiency of the healthcare system. These include €150m in price cuts to medical devices and €640m in price cuts to medicines, as well as savings of €570m coming from a more economical approach to prescriptions.

Simplification of early access and compassionate use schemes

As part of broader simplification measures, plans are in place to simplify the schemes that permit early access to new drugs.

This simplification aims to accelerate patient access by making the process quicker and less complex. It also aims to enrich patient access by making the schemes more attractive to companies that are developing innovative medicines.

Currently, early access to new medicines is processed through six interlinking schemes, including Autorisations temporaires d’utilisation (Temporary Authorisation for Use, ATU). These six schemes will be simplified into two separate but interlinking paths:  Early access (Accès précoce); and compassionate access (accès compassionnel).

The early access route is for drugs that are in the process of being developed and are to be put on the market for a given indication. Once a drug is approved, the manufacturer can set a price which will be fully reimbursed. However, this is subject to a double-mechanism of rebates. The manufacturer must finance the collection of data, ensure the continuity of treatment and submit an MAA (Autorisation de mise sur le marché, AMM) within a determined period of time.

The compassionate access route is for off-label drugs that are not being developed for a given indication. Access is granted for a period of three years and can be renewed. Invoicing will be based on the published price if one exists, and is subject to rebates at the end of the year, which are calculated based on turnover. If no published price exists, the setting of a fixed price by ministers is possible. The prescriber must ensure the collection of data, and a platform will be put in place to facilitate the collection of this data.

MAP will monitor the passage of PLFSS 2021 through the legislative process and update MAP Online as new systems come into effect.

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Published 5. October 2020 in News, News France