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On the third episode, we will talk about the interactions between the EU Health Technology Assessment (#HTA) Regulation and the Pharmaceutical Package.
The (EU) Regulation 2021/2282 on health technology assessment (HTA) and the revision of the #pharmaceutical manufacturing legislation will play a key role in patients’ access to innovative therapies in the coming decades.
While the two legal reforms concern separate processes, there is also an interplay between the two, with common themes such as the concept of significant benefit, the definition of (high) unmet medical needs (HUMN), the use of adapted clinical trials and RWE, that will impact on the Joint Clinical Assessments and pricing and reimbursement procedures at national level. The use of accelerated procedures and phased review can also change how the assessment of innovative therapies is carried out, while the EMA will be able to provide scientific advice in parallel to early advice from HTA bodies. These are just some of the overlaps between the new EU HTA procedure and the Pharmaceutical Package, that together will impact on patients access to innovative therapies.
The panellists include: Antonella Cardone, CEO, Cancer Patients Europe,
Ana Palma, Senior Director Global Patient Access & Access Policy, SOBI and
Dirk van den Steen, Deputy Head of Unit C2, DG SANTE. The episode was moderated by EUCOPE's Alexander Natz