Pricing a drug or a vaccine is a big challenge for the Pharma industry as well as for health systems in general. The several approaches to pricing vaccines make it difficult to set a benchmark to this industry in the different European countries. The evidence considered for reimbursement and pricing evaluations leans heavily towards economic data, including cost-effectiveness and budget impact. A massive amount of data must be presented for the recommendation evaluation of a vaccine. A deep overview on the recommendation and decision-making process for each country is crucial. This article focuses on France and Germany.
Key stakeholders of France’s recommendation and reimbursement decision-making process
Comité Economique des Produits de Santé (Economic Committee for Health Products)
Negociates with manufacturers, sets the prices of vaccines prescribing restrictions
Comité technique des Vaccinations (Committee on Immunization Practices; CTV), part of the CSHPF
Issue French Guidelines for Immunization
Conseil Supérieur d’Hygiène Publique de France (Higher Council for Public Hygiene)
Provides recommendations and strategy to the Haut Conseil de la santé publique (High council for Public Health)
La Haute Autorité de Santé (Department of Health); Transparency Commission (TC)
Issues SMR, ASMR, and suggests level of reimbursement for vaccines, and publishes the list of reimbursable vaccines
Haut Conseil de la Santé Publique
Provides final vaccine recommendations, target populations, and immunization schedules
Union Nationale des Caisses d’Assurance Maladie (National Union of Sickness Funds)
Sets the level of reimbursement
France’s overall vaccine market access framework
Following the EMA (European Medicine Agency) and the ANSM (Agence Nationale de Sécurité du Médicament) approval, recommendation must be granted by the CTV, not only a scientific and technical body, but also a permanent working group of the CSHPF. The CTV relies on the expertise supplemented by those of the regulatory agencies and the National Reference Centers for Communicable Diseases. Following the CTV’s evaluation, the HCSP then provides the final vaccine recommendations, targets populations, and defines the immunization schedules. A positive recommendation by the HCSP is followed by a technical assessment for reimbursement, conducted by the TC, which specifies the medical benefit and guides the level of reimbursement. Prices are fixed by the CEPS by negotiating with the manufacturer and are based on factors including: Autonomous Sensory Meridian Response levels (ASMR level), price of the local comparators, prices of the product in major European markets (UK, Germany, Italy, Spain), sales forecasts for the next 3 years, predictable or real conditions for use, size of the target population.
Key stakeholders of Germany’s recommendation and reimbursement decision-making process
Federal Joint Committee
The G-BA decides whether to include vaccines in mandatory statutory health insurance coverage or not and is responsible for reimbursement of vaccines provided by the SHI
Robert Koch Institute
Central Federal Institution responsible for disease control and prevention
Financially and organizationally independent insurance funds
Standing Committee on Vaccination
Part of the RKI, STIKO reviews the clinical evidence and recommends immunization schedules
Germany’s overall vaccine market access framework
After licensing, STIKO provides a recommendation to the G-BA for consideration of funding. If STIKO does not make a proposition, the vaccine simply does not go through the G-BA process. The recommendation, ultimately, may or may not be accepted by the G-BA. Should the decision to fund the vaccine be accepted, the vaccine must then be implemented by the SHI funds. In the case of vaccines which are not funded, however, SHI funds can still choose to pay for them. Vaccines are reference-priced on the basis of the average prices within the basket of products in the same market category that are economically similar to Germany (France, Italy, Spain, UK).
III) Example of Rotavirus (RV) Vaccination for European Countries*
Rotaviruses are the most common cause of severe diarrhoeal disease from which young children suffer all across the globe. The EU member states are now confronted to a difficult decision about introducing vaccines against this virus to their national immunization schedules. The circumstances provide a unique opportunity for countries to assess the future impact of the introduction of a new vaccine on different aspects: epidemiological, economical, organizational, social, legal and ethical. A survey was developed in 2009/2010, to investigate the decision making-process for the introduction of RV vaccination in European countries. So far, only 5 countries have included RV vaccination into their national immunization programme. This is not the case for Germany, where vaccination against rotavirus infection has long been approved, but is not yet recommended by STIKO and reimbursed by only a few sickness funds. Nor for France, where the vaccine is not integrated into the national immunization schedule.
This 2009/2010 survey illustrates well how the decision making process occurs. It is country-dependent, meaning that the final decision can vary. Pricing is still a huge challenge for this industry and I hope this article enlightened you on the process behind it.