The Implications Of The New EU HTA Regulation For Companies

Joint Clinical Assessments Will Become A Key Part Of The New Environment

Regulation (EU) 2021/2282 on health technology assessment (HTA) is now in force and will bring important and wide-reaching changes that pharmaceutical companies need to understand.

Arguably the most important implication of the regulation is the introduction of EU-level joint clinical assessments (JCAs) that will start to become applicable in a few years’ time. These joint assessments are essentially relative effectiveness assessments that will be conducted by designated national HTA experts at the EU level. The new procedure will impact all centrally authorized medicines and some medical devices and serve as the basis for national value assessments and price negotiations. Hence, it is of utmost importance for industry, payers and patients.

According to the European Commission, EU cooperation on HTA aims to help make innovative health technologies available to patients in Europe, make better use of available resources and improve business predictability. It said the new rules seek to ensure that when HTA is performed, the methodologies and procedures applied are more predictable across the EU and that JCAs are not repeated at national level, thereby avoiding duplication and discrepancies.

In the Q&A below, lawyer and industry expert Alexander Natz highlights the potential impact for health technologies subject to JCAs, from the choice of comparator to the importance of scientific advice.

Q: From what date will Regulation (EU) 2021/2282 be applicable to medicinal products?

A: Regulation 2021/2282, which amended Directive 2011/24/EU on cross-border health care, was published in the Official Journal of the European Union in December 2021. It came into force in January 2022 and its provision relating to JCAs will become applicable from 12 January 2025 for medicinal products with new active substances for oncological indications and advanced therapy medicinal products (ATMPs). From 13 January 2028 onwards, manufacturers of orphan drugs will have to submit a dossier for the joint clinical assessments. All other medicines approved under the EU centralized procedure will be subject to JCAs from 13 January 2030. Any marketing authorization application filed with the European Medicines Agency for these products on or after those dates will trigger the need for a JCA dossier.

*This article originally appeared on the Pink Sheet – Pharma Intelligence website. You can access the rest of the original article here.