Implementing Regulation

The EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January 2025 for oncology medicines, advanced therapy medicinal products and medical devices (the HTA Regulation will apply to orphan medicines from 13 January 2028, and all centrally authorised medicines from 13 January 2030).

The HTA Regulation aims to accelerate access to innovative health technologies. Currently, new technologies undergo national-level assessments to evaluate their costs effectiveness, and have to meet national pricing and reimbursement (P&R) requirements to determine if they will be made available on the national healthcare system. This is a costly process, both in economic, and time and resource terms.

The HTA Regulation seeks to increase cooperation across Europe, to ensure the efficient use of resources and strengthen the quality of HTAs. At the heart of the HTA Regulation lies the introduction of EU-level joint clinical assessments (JCAs), which are collaborative assessments, including resources and expertise from different EU Member States. With relevant data only needing to be submitted once within the EU, JCAs will minimize duplication and alleviate the workload for companies and authorities. Under the HTA Regulation, HTA bodies in the Member States are expected to consider the JCA reports in their decision-making processes, but the ultimate decision on whether a particular product will be available and reimbursed on the national healthcare system will remain the competence of the national authority.

Ahead of its introduction, several measures are being introduced, as set out in the Implementation Rolling Plan published by the Commission. These include a number of implementing acts,  IT projects and EU support such as capacity building, training and awareness raising. As part of this, in the past few weeks, the Commission has published information on the evaluation of parameters used in JCA dossiers and a draft Implementing Regulation on JCAs.Continue Reading Preparing for the implementation of the EU Health Technology Assessment Regulation