With the new European HTA regulation coming into play for medical devices and diagnostics, one of the big questions is what impact these evaluations would have on market access for IVD products.
The utility of HTA for IVD products is even more scarce than for Medical Devices.
Except for Belgium and France, other European countries do not have a link between HTA evaluation and reimbursement. In other countries, the HTA evaluations have a different degree of influence on the market access process, from very loose to a very direct impact.
The figure below provides an overview of how often different evaluations have cited the EUnetHTA reports.
It is unsurprising to see the selection of diagnostic tests, including screening and genomic tests.
Interested to learn more about this? Don’t miss our upcoming webinar on May 8th:
EU HTA for Medical Devices and IVD’s
If you want to learn more about how we can support you with the EU HTA regulation, please contact us.
These are the IVD projects from EUnetHTA and how frequently they were reported:
Number of references by country:
