2021 market access prospects for France

In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in France.

In September 2020, the French government published the draft of their annual review of spending on health and social care, which will form the basis of the Social Security and Finance Bill in 2021 (PLFSS 2021). The draft includes simplification of early access to new medicines aiming to make access faster and more attractive to companies.

France has operated six schemes that can give early access and the aim is to move to two schemes; one for early access and another for compassionate access. The former is intended for medicines for given indications. Early access can be granted with free pricing, with the potential for later rebates and also the need for development of evidence on the treatment. Compassionate access is for off-label treatments that aren’t in development for an indication. Rebates will be needed on these too as well as data collection.

“The action plan promised much, ranging from the use of conditional approvals, greater use of real world evidence and improving early engagement”

Making access earlier may be a welcome focus for the Bill, but the €640 million price cuts are less so. Those companies with immunotherapies in their portfolio may welcome the opportunity that is also outlined in the draft PLFSS 2021 to negotiate with the (Comité économique des produits de santé) CEPS on their payments. CEPS negotiates prices. 

Increased openness to outcome-based deals?

In October 2020 the national insurance body, Caisse nationale de l’Assurance Maladie (French National Health Insurance Fund, CNAM), provided recommendations to the government on the use of annuity payments for one-time curative therapies as part of outcomes-based deals. That could signal a greater willingness to find solutions that can aid market access faced with cutting edge treatments.

It may also mean access to more patients at launch; CNAM suggested that an annuity approach could avoid the phased access seen with new treatments in hepatitis C.

Yet there are still challenges to be worked through in 2021. They include how to treat the spend in the context of the L’Objectif national de dépenses d’assurance maladie (ONDAM) which is a target for national health insurance spending. 

Fruits of the action plan for innovative medicines?

In January 2020 the Haute Autorité de Santé (HAS) – widely referred to as France’s HTA agency – released its action plan for innovative medicines. The action plan promised much, ranging from the use of conditional approvals, greater use of real world evidence (RWE) and improving early engagement. Other areas of focus included improving their own efficiency, more systematic involvement of patients and consumers and improving transparency. With a nod to looking outside, the plan includes increasing European cooperation to pool knowledge.

A decree is needed to put some changes in place and that emerged in August 2020. That brought more flexibility on the timing of assessments and criteria for reassessment but for the health authorities not for companies. Now treatments won’t automatically be reimbursed for five years before renewal of their listing; that can now be sooner, or longer. Reassessment may now be prompted by listing a competitor treatment, new efficacy data or by the financial burden of the treatment. The comparator to take into account was also broadened too; allowing non-pharmaceutical treatments and off-label treatments to be considered.

2021 could start to see the results of the ambitions of the plans coming through. Commentators have already suggested that the market will become even more competitive but it may be possible to get into the market more easily and expand coverage.

About the author

Leela Barham is researcher and writer who has worked with all stakeholders across the health care system, both in the UK and internationally, on the economics of the pharmaceutical industry. Leela worked as an advisor to the Department of Health and Social Care on the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).