ARTICLE SUMMARY:
Clinician experts can take a company far on the road to reimbursement in Europe by advising on a robust data strategy, but a more bespoke gap analysis that weighs the idiosyncrasies of different stakeholders and authorities is often necessary to get over the finish line. Oleg Borisenko, of MTRC, discusses key considerations and pitfalls in this edition of Consultants Corner.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
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Oleg Borisenko (info@mtrcconsult.com) is the founder and director of MTRC, which provides reimbursement, health economic, and evidence synthesis services to the medical technology industry in Europe. Prior to establishing the consultancy in 2017, he wasthe Director of Market Access and Health Economics at Synergus AB. He has also previously served as an affiliate researcher at Karolinska Institute. |
The Question: Can You Have a Single EU Market Access Strategy?
Europe bills itself as a single market, and the regulatory process puts your device on a path to legally accessing the device market for all EU member countries in one (albeit, increasingly challenging) fell swoop. But when it comes to actual adoption and reimbursement for the technology, it’s a different story. Each country has its own way of doing things, its own evidence expectations, sensitivities to cost, and review procedures.
That doesn't necessarily mean, however, that a manufacturer needs to start from scratch to meet market access demands for each region where it wants to compete. “In our experience, it's more universal than local context-related,” consultant Oleg Borisenko, MD, PhD, says of the clinical evidence expectations for reimbursement and adoption in Europe.
