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Reimbursement and Pricing of Pharmaceuticals in Europe

IGES Pharma’s brochure “Reimbursement and Pricing of Pharmaceuticals in Europe” has become a highly sought-after source of information and has therefore been newly published for the eighth time. The focus of the new edition is on the harmonized HTA procedure applicable throughout the EU, known as Joint Clinical Assessment (JCA), which came into force in January 2025 and will be gradually introduced until 2030. It already applies to cancer drugs with innovative active ingredients (including orphan cancer drugs) and Advanced Therapy Medicinal Products (ATMPs), and will then apply to all orphan drugs with innovative active ingredients from January 2028 and finally to all drugs with innovative active ingredients from January 2030.

The JCA is of great importance to the pharmaceutical industry, because even companies that have drugs in development that are not already covered since 2025 are obliged to adapt their study planning to the new procedure to be successful in the EU.

However, the JCA does not lead to a uniform, EU-wide reimbursement decision. The individual EU member states remain responsible for reimbursement and pricing. But the JCA creates a uniform clinical starting point that must be taken into account by the individual member states. The guide explains the procedure and helps readers to take it into consideration appropriately for their respective assets in late clinical development.

The guide deals not only with the large EU countries, but also with the United Kingdom. There have been changes in the reimbursement of drugs there. The Voluntary Scheme for Branded Medicines Pricing and Access (VAPS) has been renegotiated. It is now called Voluntary Scheme for Branded Medicines Pricing, Access, and Growth and will be in effect until December 31, 2028. The previous VPAS was more focused on controlling NHS expenditure but did not have the same level of focus on patient access and the promotion of growth in the sector. The new agreement acknowledges the importance of balancing cost control with encouraging innovation.

The chapters on reimbursement and pricing procedures in France, Italy, and Spain have undergone major changes and have been partially restructured to clarify the procedures applicable there. The up-dated chapter on Germany includes information on confidential prices, which can now be agreed upon.

Important market data and basic information on the social and healthcare systems of these top 5 countries are also provided. Numerous graphical illustrations facilitate understanding.
The authors of the guide are pharmaceutical market experts from IGES Pharma, a division of the athagoras group that has been supporting research-based pharmaceutical manufacturers in the areas of market access, reimbursement and HTA for many years.

Print copies of the Guide ‘Reimbursement and Pricing of Pharmaceuticals in Europe’, can be requested here free of charge:

Contact:

E-mail: pharma@iges.com

Phone: +49-(0)30-23 08 09 0