In the second of our series of updates examining market access for vaccines, Vanya Nikolova, Senior Consultant, guides us through six of the key stakeholders that are involved in the approval of new vaccines in France, including the:

• French National Authority of Health (HAS)
• Technical Committee on Vaccinations (CTV)
• Transparency Committee (TC)
• Committee for Economic and Public Healthcare Evaluations (CEESP)
• Economic Committee for Healthcare Products (CEPS)
• French Ministry of Health

PRMA Consulting is now Avalere Health

As you can see here, there are multiple stakeholders involved in vaccine appraisal in France.

PRMA Consulting is now Avalere Health

What is the role of the French National Authority of Health in pricing and reimbursement of vaccines?

The pricing and reimbursement system in France is centralized around the French National Authority for Health (Haute Autorité de Santé; HAS). HAS coordinates a number of activities designed to improve quality of patient care and to guarantee equity within the healthcare system.

HAS activities are diverse, ranging from the assessments of drugs, vaccines, and medical devices to publication of guidelines and accreditation of healthcare organizations. HAS is an independent public body that liaises closely with government health agencies, national health insurance funds, research organizations, unions of healthcare professionals, and patient representatives.

Since 2017, HAS also participated in the development of immunization policies and issuing of vaccine recommendations based on evidence of the epidemiology of infectious diseases in France along with data on the efficacy and safety of novel vaccine candidates, and their long-term health-economic impacts.

There are 5 subcommittees of HAS that are involved in the appraisal of novel vaccine candidates in France

Multiple HAS subcommittees are involved in the appraisal of novel vaccine candidates in France and each of them considers a different aspect of the proposed immunization program.

• The Technical Committee on Vaccinations (CTV) is the French NITAG that is only responsible for the conduct of cost-effectiveness evaluations and issue of recommendation within HAS; the CTV is not involved in the appraisal of non-vaccine pharmaceutical products or medical devices. The main responsibility of the CTV is to develop or commission the development of a cost-effectiveness model, aiming to establish the economic value of a proposed novel immunization program. The CTV then considers the results from the cost-effectiveness evaluation as well as clinical benefits of the vaccine candidate to develop a positive or negative recommendation for the proposed vaccination program.
• The Transparency Committee (TC) is a HAS body that is involved in the appraisal of both vaccine and non-vaccine products. The TC appraises evidence of disease burden and unmet need, determining the medical benefit of the proposed product (known as the SMR rating). Moreover, the TC also reviews evidence of the clinical efficacy and safety of the vaccine candidate, determining its comparative clinical benefit (knows as the ASMR rating). The opinion of the TC, along with the SMR and ASMR ratings, is reflected in the final recommendation for the proposed vaccination.
• The Committee for Economic and Public Healthcare Evaluations (CEESP) is tasked with the critical appraisal of the cost-effectiveness and budget impact analyses submitted by manufacturers to support pricing and reimbursement applications for novel vaccine products. CEESP then issues an opinion on the health-economic benefits of the proposed vaccine candidate. Feedback from CEESP is also factored in the final reimbursement recommendation issued by HAS for the vaccine candidate.
• The Economic Committee for Healthcare Products (CEPS) engages in price setting negotiations with the vaccine manufacturer, taking into consideration the recommendations from the TC and CEESP. The National Association of Health Insurance Funds then sets the reimbursement rate for the vaccine product, considering the SMR rating that was awarded by the TC.

The French Ministry of Health is the final decision-maker that determines whether a novel immunization program should be incorporated into the national immunization schedule. Although the Ministry of Health is not obliged to follow the recommendations issued by HAS, it has previously implemented most of them.

Watch the full presentation: Demonstrating the value of vaccines