Articol

Navigating the nuances and complexities of the European reimbursement landscape

  • Casper Paardekooper

  • David Ringger, PHD

  • Diane Smith

  • Erika Wissinger

Small and emerging biopharmaceutical companies from the United States (US) often misconstrue the single-payer system across Europe as homogeneous. While the reimbursement environment in Europe is, in some ways, less complex than the fragmented payer system in the US, each country has its own health technology assessment (HTA) body with distinct operational practices and nuances.1 

Nevertheless, Europe’s large and diverse population, economic affluence, robust national healthcare systems, strong government investment in healthcare infrastructure and services, and efforts to cut red tape continue to make it an attractive market for the biopharmaceutical industry.2,3

A single market with separate reimbursement systems

Pricing and reimbursement in the European Union (EU) is established country by country through national HTA bodies based on different formulas, economic assessment criteria, and health system priorities. The HTA is a 2-part process, starting with the clinical assessment to determine whether the product addresses an unmet need, compare its relative effectiveness to treatments already on the market, and determine if it meets appropriate standards for use in the market.
During reimbursement negotiations with each market, several factors come into play including international reference pricing (IRP), tendering dynamics, budget impact constraints, and increasing use of managed entry agreements and joint/parallel assessment approaches. Willingness to pay and ability to pay also influence each country’s reimbursement.

Typically, biopharmaceutical companies seeking to bring their products to Europe start with the 5 largest countries: Germany, France, the United Kingdom (UK), Italy, and Spain. Often, that would be followed by northwestern European countries—the Nordics, the Netherlands, Belgium, Austria, and Switzerland—before considering countries in southeastern Europe. This strategy is based on securing the highest prices for the product and reaching the largest population.

Nevertheless, based on what we have seen through our work with manufacturers across Europe, there are cases where companies choose to launch in a smaller market first—such as Switzerland—to help secure a higher initial price.

Policy and market shifts pose challenges for Europe

More recently, several headwinds have created further challenges for companies considering the European market. 

The most significant is the Most Favored Nation (MFN) pricing model in the US, which uses IRP to align drug prices with comparable developed countries.4 The US has introduced several programs that could not only impact US pricing but also weigh on decisions about when and whether to launch in Europe, particularly from larger pharmaceutical companies. 

In response, we have learned that some manufacturers are considering innovative structural arrangements and possible alliances or partnerships that might help to address the challenges MFN poses. As the US policy is new and evolving, it remains difficult to predict its broader impact, particularly on smaller biotechnology innovators without their own manufacturing capabilities. 

Another potential challenge for industry is the requirement under the new EU pharmaceutical legislation that companies with products in one or more EU countries will be compelled to launch their product in any member state that demands it. Companies that fail to do so can lose part of their market protection,5 which poses a risk for an EU launch strategy. 

The growth of China as a key market poses further challenges. Accelerated drug approvals, large market size (including a big population with good health insurance), and a streamlined reimbursement process all make China a rising competitor for Europe.4 

A step toward greater harmonization

Despite the barriers, there remain many advantages to the 27-member EU market plus the UK and Switzerland. 

Through the EU HTA regulation, which came into effect in January 2025, the EU has taken a giant step forward in its effort to harmonize HTAs across Europe.6,7 Through the Joint Clinical Assessment (JCA), which became mandatory in 2025 for oncology therapies and advanced therapy medicinal products (ATMPs), the goal is to streamline the clinical assessment process by reducing duplication of assessments by member states and, ultimately, speed up patient access to innovative treatments. 

By fostering greater collaboration and consistency in HTA clinical evaluations, the new framework is expected to reduce the administrative burden for pharmaceutical companies, level the playing field so every country has the same clinical evaluation inputs, and support more equitable access to medicines across the EU. However, it is important for manufacturers to understand that the reimbursement element of the HTA process will continue to be handled at the country level.

The UK, meanwhile, has agreed to increase its incremental cost-effectiveness ratio threshold by April 2026 and lower the voluntary scheme for branded medicines pricing, access and growth (VPAG) rebate rate from 22.9% to 14.5%.8,9 These changes mean the UK is expected to spend more on medicines. 

Developing a strategic roadmap to support the HTA process

Any biopharmaceutical company entering the European market will need to understand the complex HTA process, what payers expect, country-specific challenges, and initiatives that can support the reimbursement process.

1. Take advantage of the JCA.

While currently only mandatory for oncology products and ATMPs, the scope of the JCA will expand to all orphan medicines in January 2028 and all other medical products by January 2030.

Despite some uncertainty as to how the PICO process (population, intervention, comparator, and outcome) will unfold, it does offer opportunities for companies to streamline their processes.10

3. Work with key stakeholders.

Companies are accustomed to collaborating with key opinion leaders and physicians, but it is vital to also involve patient organizations. The EU HTA regulation has emphasized that patients and patient organizations are key stakeholders that must be consulted during the HTA process.15

Companies will need to adopt a collaborative approach early on to ensure proper input from both patient and physician groups. 

2. Explore cross-country collaboration schemes and assess potential for joint procurement.

While price negotiation and price setting is managed at a national level, some cross-country collaboration schemes have been making strides on pricing negotiations as well as clinical evaluations. Most notably, the Beneluxa initiative (Belgium, the Netherlands, Luxembourg, Austria, and Ireland) has collaborated on pricing negotiations for several orphan medicines.11 Other cooperative schemes include Joint Nordic HTA Bodies (JNHB), which supports joint HTA assessments of medicinal products in the 5 Nordic countries,12 and the Valletta Declaration Group that brings together 10 EU nations, though this group has so far only explored ways to cooperate.13 These initiatives give countries greater buying power and give companies faster access to several markets while streamlining the process. In addition to these collaboratives, there have been examples of joint procurement by the European Commission and member states, particularly for covid-19 vaccines and treatments. Similarly, the commission has proposed supporting collaborative procurement of essential medicines.14 Although cross-border price collaborations have been held on a case-by-case basis, we believe this is the way price negotiations will head in the future. 
 

4. Prepare a strong evidence package.

Evidence planning needs to be an integrated strategy that looks at the broader evidence generation expectations of HTA bodies.

For example, PICO simulations can help companies be prepared well in advance of the JCA. Starting at the end of phase 2, designing pivotal phase 3 studies to align with European market access requirements and refining PICO predictions based on comparators around 18 months before submission can help ensure evidence is aligned with JCA requirements.

With the challenges posed by MFN, having a strong evidence package with robust data to demonstrate the value of a product will be essential to achieving a higher price in Europe, which in turn will help companies defend a higher price in the US.

5. Understand the changing legislative and geopolitical environment.

This includes the risks posed by MFN and requirements under the EU pharmaceutical legislation, as well as other developments such as the recent UK agreement on pricing and rebates. It's important to work with partners with on-the-ground expertise to navigate these complexities.10 

Preparing for changing dynamics in the European market

Europe remains an important market for biopharmaceutical companies. However, there are several geopolitical and local market reimbursement challenges that must be understood before preparing a product launch strategy. 

Best practice is to carry out scenario planning to assess the implications of launching in Europe and in which markets to start your launch strategy.

Having a trusted partner with the breadth and depth of knowledge and expertise to address the complexities of the European healthcare systems and marketplace will be central to developing a strategic market entry roadmap. 
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About the authors:

Casper Paardekooper is VP, Head of Pricing, Policy and Stakeholder Engagement, Europe at Cencora. Prior to this role, he has been responsible for the Life Sciences practice and the Value, Access & Policy Center of Excellence at strategic consultancy Vintura, for more than 10 years, where he focused on access policy, market access strategy, value demonstration and value-based healthcare in Europe. Casper is a trusted advisor to many large biopharma companies and brings more than 15 years of experience as strategy consultant in life sciences and healthcare.

David Ringger, PhD, is a Director of the Global Market Access and Pricing team at Cencora. In this role, he oversees a team focused on formulating evidence-generation plans, developing pricing and reimbursement strategies, and supporting stakeholder engagements. The team collaborates closely with Cencora’s local market access teams to ensure that the global strategies are rooted in local realities. 

Diane T. Smith, PhD, is a Director on Cencora’s Reimbursement, Policy & Insights team, focused on expanding patient access to life‑changing therapies. She brings deep expertise in reimbursement strategy, health policy, patient assistance programs, and complex patient journeys across therapeutic areas including oncology, rare disease, and cell and gene therapy. Dr. Smith has been with consulting services since 2009 and holds a PhD in Biological Sciences from the University at Albany.

Erika Wissinger, PhD is a Senior Director leading Cencora's global Evidence Generation & Strategy group, with over 15 years of experience in HEOR and market access consulting. She provides strategic oversight for integrated evidence generation projects supporting commercialization and HTA/payer submissions across multiple therapeutic areas.


Precizare:
Informațiile furnizate în acest articol nu constituie consultanță juridică. Cencora, Inc. încurajează insistent cititorii să revizuiască informațiile disponibile legate de subiectele discutate și să se bazeze pe propria experiență și expertiză în luarea deciziilor legate de acestea.
 


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Sources


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