Turnaround!

The G-BA received the mandate to designate combination therapies in accordance with Section 35a (3) Sentence 4 SGB V with the GKV-FinStG. According to the "Medicinal Product Supply Shortage Control and Improvement Act" (ALBVVG), the detailed implementation of the combination discount was to be regulated by October 31, 2023. This has now been done in an impressive manner: Initially, the G-BA had tended to favor the open view of the Federal Ministry of Health, to name as combination partners all those active ingredients that would be purely theoretically possible without there being a specific reference to them in the summary of product characteristics (SmPC).

Now the reversal: "After weighing all arguments and intensive deliberations, the G-BA concludes that even a narrower approach to designating combination therapies is a justifiable scope for the G-BA according to the wording of the law." - Prof. Hecken, impartial chairman of the G-BA.

For the designation of combination partners now the SmPC of the evaluated drug must at least contain information on its use as a combination therapy with another drug. If this requirement is met and the drug under consideration is approved for use in the evaluated indication, they can be listed as combination partners.

"The statement procedure during the summer and the arguments put forward by health care professionals supported the G-BA in its decision." - Prof. Hecken, impartial chairman of the G-BA.

The massive criticism of the industry and manufacturers' associations was finally understandably successful in the context of the statement procedure. In particular, the evidence-based character regularly emphasized by the HTA authorities in the transparent German system would have been led ad absurdum by the originally proposed system. In addition, specific lawsuits have already been filed against the original resolution.

The chapter on the designation of combination partners, for each of which an additional combination discount of 20% applies in the case of a prescription as combination therapy, now seems to be closed for the time being. SKC will continue to closely follow and inform about all relevant developments and decisions. Feel free to contact us if you have any questions regarding combination therapies. We are the market access special forces.

Sources:

• Pressemitteilung: G-BA regelt Benennung von Arzneimittel-Kombinationen
• G-BA Beschluss: Arzneimittel-Richtlinie/Anlage XII und XIIa: Ergänzung der Benennung von Kombinationen gemäß § 35a Absatz 3 Satz 4 SGB V in bereits gefassten Beschlüssen
• Ärztezeitung: Roche klagt gegen Kombi-Beschluss des G-BA
• SKC Blog: Die Benennungspraxis des G-BA von Kombinationspartnern wird stark kritisiert.
• SKC Blog: G-BA veröffentlicht Vorgehen zur Benennung von Kombi­na­tions­the­ra­pien