EUnetHTA 21 service contract ends.

In 2006, the European Network for Health Technology Assessment (EUnetHTA) started as an informal project between a small number of European HTA agencies. Over the following years, the initiative grew throughout a collaboration and three Joint Actions, laying the groundwork for a joint European HTA procedure and the HTA regulation, while continuously cooperating with the EMA. In 2021, the European Health and Digital Executive Agency (HaDEA) then signed the service contract for the provision of joint HTA work supporting the continuation of EU cooperations on HTA with EUnetHTA 21, acting under the mandate from the European Commission. The objective of this contract was the production of guidance documents as well as a first iteration of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) to lay out the framework and methodological details of the European HTA procedure. The expiration of this contract on September 16^th marks the beginning of the gap years, the transition period until the EU HTA regulation will be in force for oncology drugs and advanced therapy medicinal products (ATMPs) on January 12^th, 2025.

During the last EUnetHTA 21 stakeholder meeting on September 8^th, the organization took the chance to sum up their achievements and to give final updates, e.g., on the number, duration, and drug categories of the JSCs that were conducted during the last two years.

Shortly before the service contract ended, EUnetHTA 21 published a long-awaited deliverable: "JCA without HTD submission". The deliverable consists of three "PICO exercises", which EUnetHTA 21 decided to perform after no Health Technology Developer (HTD) applied for the conduction of an actual JCA. The drugs for which these exercises were performed post-approval are Pluvicto (lutetium (177Lu) vipivotide tetraxetan; prostate cancer), Ebvallo (tabelecleucel; Epstein-Barr virus positive post-transplant lymphoproliferative disease), and Pombiliti (cipaglucosidase alfa; Pompe disease). The publication of this deliverable is of particular interest to all stakeholders because the number of PICOs within a single JCA has been subject to great speculation during the last months.

While most of the announced EUnetHTA 21 deliverables have thereby been provided by the end of the service contract, some central ones, like the JCA submission dossier template, are still pending and will be released in the upcoming weeks, according to the consortium.

During the gap years, health technology developers can now request Parallel EMA/HTA Scientific Advice in order to prepare for the EU HTA process of their product. Further, the EUnetHTA 21 member HTA authorities will continue to refine the EU HTA framework and methodology and eventually adopt it in the form of Implementing Acts. The first Implementing Act on Joint Clinical Assessments for medicinal products is set to be released by the end of Q4 2023.

SKC will continue to inform you in detail about all relevant developments during this crucial phase of the EU HTA maturation process. If you are interested in securing a slot for the Parallel EMA/HTA Scientific Advice or you are looking for a strategic partner to get your company EU HTA ready during the gap years, please do not hesitate to get in touch with us. We are the market access special forces.

Sources:

• The EUnetHTA 21 Consortium will cease operations on 16 September 2023 - EUnetHTA
• eTendering - Data (europa.eu)
• Publication of EUnetHTA 21 deliverable ''JCA without HTD submission'' - EUnetHTA
• Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies | European Medicines Agency (europa.eu)