The designation practice of the G-BA of combination partners is strongly criticized.

At the oral hearing, the G-BA discussed the background to the current practice of designating combination partners and explained that this was necessary to adequately implement the statutory mandate of the GKV-FinStG. With the mandate to the G-BA, the legislator wanted to ensure that the very high costs associated with the use of combinations of new active substances were offset by an appropriate added benefit.

Prof. Josef Hecken,impartial chairman of the G-BA, emphasized that the clearly defined by the legislator medium-term financial savings potential of 185 million euros, which is expected with the combination discount, can only be achieved if almost all combinations possible under pharmaceutical law are included when designating combination therapies. However, identifying active ingredients specifically named in the therapeutic area as combinations is too restrictive in terms of the legal mandate. The G-BA further explained that in clinical practice, different active substances and active principles are combined with each other, provided that their joint use is not prohibited by the expert information. As a result of these formal designation criteria, it is possible that drugs are also designated as possible combination partners that are not or not yet used in clinical practice. This procedure, which may be irritating for practitioners, serves exclusively to ensure that the combination discount desired by the legislator can be implemented. Neither would the naming of combinations restrict the physician's scope of treatment in drug therapy, nor would it be associated with statements on the appropriateness or cost-effectiveness of the named combination in the context of the benefit assessment.

For a more detailed explanation of the G-BA's approach, read our blog post on the publication of the G-BA's approach to designating combination therapies.

The German Federal Association of the Pharmaceutical Industry (BPI) strongly criticizes this procedure its newsletter. It considers it inadmissible that the G-BA interprets the legal basis of authorization in such a way that it is called upon to name theoretical medico-therapeutically partly nonsensical combination therapies without corresponding study situation and thus without positive evidence - withholding any evaluation. Similarly, the statement of the G-BA on the appropriateness and cost-effectiveness of the use of combination therapies does not heal the obvious insufficiency of the process associated with the described procedure.

We at SKC are also critically following the designation of combination partners and the associated implementation of the legal mandate by the G-BA. The G-BA used the oral hearing to explain the current designation practice. Whether the criticism of the pharmaceutical industry will lead to a change in the designation practice is still unclear. The decision of the G-BA to adjust the pharmaceutical guideline is expected to be published in September or October 2023.

After the "Medicinal Product Supply Shortage Control and Improvement Act" (ALBVVG) came into force on July 27, the GKV-SV was asked to regulate the detailed implementation of the combination discount by October 31, 2023, in agreement with the leading organizations of pharmaceutical companies. Until then, SKC will continue to closely monitor all developments regarding the designation of combination therapies and will keep you informed of any new developments. Feel free to contact us if you have any questions regarding combination therapies, we are the market access special forces.

Sources:

• G-BA's press release on the oral hearing