In July 2021, we had heard that the G-BA had agreed to joint EU HTAs coming to Germany. Now, on 14 December 2021, the EU Parliament adopted the EU Regulation on joint HTAs. While EU member states previously had already voluntarily collaborated within EUnetHTA, this new regulation is a binding cooperation between the national HTA authorities of the EU member states. It will be applicable to new drugs, including ATMPs, but also medical devices.
While the chair of the G-BA, Prof. Hecken, sees most value of these HTAs for “member states that were previously unfamiliar with this systematic, comparative analysis of clinical data”, there will also be an impact on the early benefit assessments in Germany. In the future, the G-BA must take these joint clinical assessments at the European level into account, provided that these data are suitable for the national decision-making and meet quality requirements. However, the joint HTA at the European level will not replace the decisions on the additional benefit or on reimbursement. The additional benefit as determined by the G-BA will remain to be the basis for price negotiations between the GKV-SV and the manufacturers.
Process and methodology
The EUnetHTA21 consortium, which consists of 13 organizations, including the IQWiG and the G-BA, will be implementing the new regulation. The G-BA will develop the procedural and structural requirements as well as methods for clinical consultations. The aim is a binding agreement on the methods, e.g. on how to assess different types of evidence. While comparative controlled data will remain the best scientific basis, there is a growing need for RWE.
Timeline
The G-BA plans to roll out the inclusion of joint HTAs in the German early benefit assessments in stages. It was previously stated that it would start in 2024, but this was moved back by another year. From 2025 onwards, the G-BA will use joint clinical assessments to assess oncology drugs, including orphan drugs and ATMPs. After 3 years, this will be widened to also include non-oncology drugs. After another 2 years, the G-BA will assess all drugs, as well as medical devices, in a joint HTA.