Article

Preparing for change: How to navigate the EU HTA Regulation for better market access

As the European Union prepares to implement the new Health Technology Assessment (HTA) Regulation, the biopharma industry stands on the brink of significant change.
In two recent interviews1,2 with Eliza Slawther from Pink Sheet —renowned for delivering business-critical policy and regulatory insights—Cencora experts Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe and Ruairi O’Donnell, EU HTA Lead, shared their expertise on the forthcoming Joint Clinical Assessment (JCA). Their insights illuminate the complexities manufacturers will face as they adapt to this evolving landscape.
Globe with communication lines from UK

Embracing the unpredictability of PICOs

The EU HTA Regulation (EU) 2021/2282) introduces a framework requiring manufacturers to respond to specific questions known as PICOs (population, intervention, comparator, outcomes). The unpredictability inherent in this process means that while companies must engage in scenario planning to anticipate these queries, they cannot foresee every PICO due to the diverse needs of 27 member states. This unpredictability poses both challenges and opportunities for manufacturers seeking to position their products effectively.

The importance of scenario planning and simulations

To navigate this new terrain, manufacturers are urged to conduct thorough simulations and research to identify potential PICOs. Companies should prioritize those that could significantly impact their product’s market entry. Given that they will have just 100 days to respond to the finalized PICOs, proactive preparation is essential for success.
business planning couple

Representation of smaller nations

A crucial concern raised is the potential for smaller EU countries to have their needs overlooked during the JCA consolidation process. While the goal is to standardize assessments, the unique challenges faced by these nations could lead to their PICOs being deselected. This raises important questions about how these decisions will affect equitable access to therapies across the EU.

Continuing relevance of national processes

The introduction of JCAs does not signal the end of national HTAs. Manufacturers must remain prepared to address specific local needs, as unselected PICOs may still hold relevance for national discussions on pricing and reimbursement. This dual approach underscores the complexity of the regulatory landscape and the need for manufacturers to engage with both EU-level and national processes.

A learning journey for all stakeholders

Implementing JCAs will be a learning experience for the entire industry. With unexpected challenges likely to arise, adaptability and vigilance will be key for manufacturers as they refine their strategies in response to evolving regulatory demands.

The insights from Cencora experts, Ruairi O’Donnell and Herbert Altmann, provide a roadmap for manufacturers as they prepare for the upcoming changes under the EU HTA Regulation. The path forward will require not only strategic foresight but also an understanding of the multifaceted nature of European healthcare systems.

For a deeper dive into these critical discussions and to further explore the implications of the EU HTA Regulation, visit Pink Sheet and access the full interview articles:

 Cencora strongly encourages readers to review all available information related to the topics discussed in this article and to rely on their own experience and expertise in making decisions related thereto. 

 
1 Pink Sheet, EU HTA Regulation: Expect the unexpected when it comes to PICOs, 23 September 2024, https://pink.citeline.com/PS155274/EU-HTA-Regulation-Expect-The-Unexpected-When-It-Comes-To-PICOs 

2 Pink Sheet, EU HTA Regulation: Some member states could be ‘deselected’ from joint assessments, 24 September 2024, https://pink.citeline.com/PS155282/EU-HTA-Regulation-Some-Member-States-Could-Be-Deselected-From-Joint-Assessments
 

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