The Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union on health technology assessment became effective in January 2022. As foreseen by the Regulation issued by the European Commission in 2021, a coordination group has been established within the European Network for Health Technology Assessment (EUnetHTA) consortium to perform joint clinical assessments (JCAs) of new health technologies. EUnetHTA is composed of advisors from 12-member State HTA agencies, including the Netherlands, Spain, Italy, Austria, Germany, France, Portugal, Belgium, Ireland, Hungary, Norway, and Sweden.
The EUnetHTA aims to achieve a high level of patient health protection and establish a framework to support member state cooperation on the clinical assessment of health technologies. As part of the new “HTA regulation”, joint scientific consultations can be arranged with the appointed assessors of the latest technology, where advice can be given on clinical trial design (e.g., the appropriate endpoints and patient subgroups) or comparator choice.
The summary reports prepared by the assessors of JCA will not predetermine national reimbursement decisions and will not have a legally binding effect, meaning national HTA bodies are welcome to draw their conclusions on the clinical added value of new medicines. As part of the decision-making process, they may request further evidence.
The new joint procedure is projected to reduce the duplication of submissions with different evidence requirements and procedural times required at a country level, thus simplifying workflows and reducing administrative burden. With the implementation of this new regulation, the JCA is intended to reduce the time to access drugs across EU countries and to facilitate the reimbursement process in markets with no pricing and reimbursement infrastructure.
The new joint procedure will be launched in 2025 for medicinal products with new active substances for oncological indications and Advanced Therapy Medicinal Products (ATMPs) and will be extended to orphan drugs on 13 January 2028. By 13 January 2030, JCAs will be carried out on all medicinal products approved under the EU centralized procedure. Vaccines, biosimilars and generics are not in the scope of the regulation.
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