ISPOR 2022: Plenary Session 1 – The Convergence of HTA and Regulation: A New HTA Reality and Collaboration with Regulatory Agencies



The first plenary session of ISPOR Europe 2022 took place this morning and it was chaired by the CEO of EUnet HTA, Marcus Guardian.

There were two focuses of the panel this first was about the integration of the Joint HTA process and the regulatory process in Europe. Speakers gave their opinions on how these processes could work fluidly together and influence one another.

The second topic was the evidence requirements and how to manage satisfying evidence requirements for the regulatory process and the regulation impact.

Convergence of HTA and Regulation

The EMA is a long-established regulatory system with a strong network of health agencies. It is helping to provide a strong basis for the formalised EU joint HTA process.

The two processes will influence each other, and greater interaction will strengthen both sides. This is because it will provide responses to the patients and connect different areas with different purposes to serve patient needs. A more integrated approach between the two processes will support a greater capacity, foster the best use of resources, and help deliver a common message.

Overall, medical innovation only matters when it reaches the patient. Currently, this is a complex route which much variety in different countries. For the joint EU HTA process to work and to make access more standardised across the EU all of the information will have to be collected to facilitate national decision-making, so as not to delay access. This must be a multi-topic and multi-stakeholder approach to ensure all bases are covered.

Countries in Central and Eastern Europe often suffer from a long access gap following marketing authorisation (for example in Germany access is after an average of 142 days whereas in Poland it typically takes over 500). Several factors are responsible for this, one of which is pharmaceutical company launch sequencing. The joint HTA will really promote the closure of this gap, however, these countries may also be concerned about the financial and budget implications of making a pricing decision will bring. There will also likely be increased pressure to make pricing decisions quickly with the joint HTA process.

Fast-track or conditional assessments from the EMA will have to be carefully considered. They will still have to satisfy all of the information requirements to be approved at the national level, so the JCA process may be a good tool to access the gaps and understand how they can be worked through.

Evidence Generation

Evidence generation must be considered at all times in the product’s lifecycle. Though randomised control trials may still be the gold standard it will be important to consider all avenues of information. Post-approval data can be a really valuable tool. The EU have the DARWIN project in place which is a pan-European network of real-world data. The aim is to help give a greater understanding of diseases, patient populations and the safety of products. This will be especially important for making decisions for products such as gene therapies with small patient populations.

Manufacturers and HTA bodies need to work together early to identify evidence gaps to take the pressure off pricing and reimbursement decisions later. This will allow a greater amount of time for HTA bodies how they can plan to access a product given its evidence gaps.

It will be really key to ensure that there aren’t any evidence gaps between the Joint HTA process and then the decisions at the national level as this will slow down access. To overcome this, a structural and strong guideline for evidence generation must be created and it must be considered from all perspectives.

3 Takeaways

  1. “Collaboration is the answer” – The EMA and the Joint European HTA body are in good stead to work together clear convergence between the two will make patient access more fluid
  2. “It’s the evidence, stupid” – Evidence must be considered across the product lifecycle and the gaps should be considered as early as possible
  3. “It’s not revolution it’s evolution”– most HTA bodies have taken over a decade to get to this stage the evolution must continue for this every country needs legislation in place in 2025 so as to not delay access

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