Announcement of the framework for European consultations on the JCA

With the EUnetHTA 21 service contract expiring in September 2023, the so-called EU HTA "gap years" begin – until the EU HTA regulation comes into force in January 2025 for oncology drugs and advanced therapy medicinal products (ATMPs). This is problematic for manufacturers whose products are subject to an EU HTA assessment at the beginning of the period of validity of the regulation because, for them, the urgently needed consultation within the framework of a JSC is not available in advance.

For manufacturers whose product has to undergo an EU HTA assessment as early as 2025, it is a significant problem that during the gap years there is no possibility to consult with the European HTA authorities via a JSC on the evidence required for their product as well as the respective PICO schemes. In addition, no further consultations are currently offered under the EUnetHTA 21 responsibility, as all scheduled JSC procedures are already taking place. This circumstance significantly reduces the prospects of corresponding manufacturers for a successful EU HTA process of their new medicinal product.

With its press release on July 3, the German Federal Joint Committee (G-BA) has brought clarity to the consultation process during the transition period: During the gap years, the German HTA organization, in collaboration with the European Medicines Agency (EMA), will offer pharmaceutical manufacturers the opportunity to receive advice on the PICO schemes to be used in the Joint Clinical Assessments (JCA) and other framework conditions of the EU HTA in so-called parallel procedures - "Parallel EMA/HTA body (HTAb) Scientific Advice." According to the G-BA, it will act as a central contact point and form the link between pharmaceutical companies and the individual European HTA organizations. As expected, the advisory service will start in September 2023.

The consultation appointments will be assigned to the manufacturers on an ad-hoc basis, depending on the availability of the national HTA partners. One thing is already clear: Consultation appointments will not be available for all JCA procedures expected in 2025. Due to the limited number of available consultation appointments, the allocation of appointments for the parallel consultation procedures will be prioritized based on factors such as time urgency, the Union-wide value of the drug or a high Unmet Medical Need.

For years, the G-BA together with the IQWiG, has had a major influence on the implementation of the EU-HTA Regulation through its participation in various planning groups within the framework of EUnetHTA 21. This forerunning position will be further strengthened by the task as central contact point.In the light of the few places available and the prioritization in the allocation procedure, participation in the consultations is associated with considerable uncertainties for the pharmaceutical entrepreneur. It is already known that there are many structural and content overlaps between the application form for the parallel procedure and the national G-BA consultation application.

Based on our many years of experience in the strategic planning of the application for G-BA consultation, SKC is the ideal partner to support you strategically as well as operationally in the application for a European consultation. If you are interested in accessing European advice during the gap years via the G-BA or if you are looking for a strategic partner to achieve the highest possible planning security for the EU HTA process of your product in view of the current situation, please feel free to contact us. We are the market access special forces.

Sources:

• Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
• EU-HTA: G-BA koordiniert ab September parallele wissenschaftliche Beratungen für Hersteller