EU Health Technology Assessment Regulation (EU HTAR)

Therapy development Reimbursement and access (Netherlands)
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I would like to learn more about the implementation of the EU Health Technology Assessment Regulation (EU THAR) in the Netherlands. Where can I find more information about the implementation process?

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Hi Marlous,

You can find more information on the website of Zorginstituut Nederland in Dutch (including a video) or in English.

“From 12 January 2025, the National Health Care Institute will use European legislation for the evaluation of medicines and medical devices. This Act is called EU HTAR and should lead to a more efficient process, ensuring the right care can be delivered to the right patient more quickly. The EU HTAR rules will have an effect on the work of the National Health Care Institute.”

Also, more information can be found on the website of the European Commission.

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Hi Rosa,

Thanks for your reply. I have a follow-up question: Does the EU HTAR apply to all types of medication? And how about medical devices, for example, medical apps to help patients with their medication intake?

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I also found this recently published white paper Zorginstituut Nederland regarding recommendations for surrogate endpoints.

Surrogate endpoints are biomarkers or other intermediate outcomes that predict a treatment effect on a final clinical outcome. Over the past 30 years, more than half of new drug and biological treatment approvals by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were based on trial evidence of treatment effects on a biomarker endpoint as an acceptable surrogate.

My question is: what does the new EU THAR tell us about using surrogate endpoints for treatment approvals in upcoming years? Will surrogate outcomes remain suitable for half the cases?

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