Early benefit assessment – G-BA advises on naming drug combinations

30.08.2023 12:59

The Federal Joint Committee (G-BA) is currently implementing a current legal mandate and is discussing how combination therapies should also be named in its resolutions on the early benefit assessment of new drugs. He proceeds step by step. In the oral hearing on August 28th, the G-BA also dealt with those resolutions on benefit assessment that had already been made before the statutory mandate (existing resolutions).

During the hearing, the background to the G-BA's current naming practice was discussed and it was also explained that this is necessary in order to adequately implement the legal mandate. If a theoretically possible combination - and therefore to be specified by the G-BA - is not used, the pharmaceutical company will not receive the legally stipulated financial combination discount. With the mandate to the G-BA, the legislator wants to ensure that the very high costs of using combinations of new active ingredients are offset by an appropriate additional benefit.

Prof. Josef Hecken, impartial chairman of the G-BA and chairman of the pharmaceutical subcommittee: “Immediately after the law came into force, the G-BA began to review the areas of application of the active ingredients to be evaluated with regard to possible combination therapies. However, identifying active ingredients specifically named in the area of application as combinations is too restrictive in terms of the legal mandate. Our proposed designations are therefore a complete implementation of the legal mandate. In clinical practice, different active ingredients and active principles are combined with one another, unless their use together is prohibited by the specialist information. For example, in clinical practice new active ingredients are used together to treat patients with chronic kidney failure without any reference to possible combined use being found in the specialist information.”

Hecken continues: “The medium-term financial savings potential of 185 million euros, which is clearly defined by the legislator and is expected with the combination discount, can only be achieved if almost all possible combinations under pharmaceutical law are recorded when naming the combination therapies. The legislator pointed this out to us. The G-BA has therefore adapted its initially cautious approach and now aims to fully implement the legal mandate. These formal naming criteria mean that drugs are named as possible combination partners that are not or are not yet used in clinical practice. This procedure, which may be irritating for practitioners, only serves to ensure that the combination discount desired by the legislature can be implemented. The naming of combinations does not restrict the scope of medical treatment in drug therapy, nor is it associated with statements about the appropriateness or cost-effectiveness of the named combination in the context of the benefit assessment. So if a combination is not used in practice for the same area of application, there is no combination discount for the manufacturer.”

The G-BA is now continuing its consultations on combination therapies and will discuss the arguments presented. The aim is to pass a resolution to adapt the Medicines Directive to include a new Annex XIIa and the affected resolutions on benefit assessment in September or October 2023.

Background: Combination therapies in early benefit assessment

With the Statutory Health Insurance Financial Stabilization Act, the legislature assigned the G-BA an additional task in the early benefit assessment of a new drug: it should name all drugs with new active ingredients that are also used in the area of application in a combination therapy with the evaluated drug due to their approval can. According to the law, only medicines can be named as combination partners if the G-BA has not identified any significant or significant additional benefit in its benefit assessment of the combination therapy or - after the requested examination - is expected to have it. Naming the combinations is the prerequisite for the legally required combination discount of 20 percent to be implemented.

In order to implement its legal mandate, the G-BA has also published a draft for the naming of combination therapies since June 2023 in the respective comment process for the benefit assessment of a new drug. Comments on this can be submitted as part of the statement on the benefit assessment. The above-mentioned statement procedure is currently underway for the resolutions (existing resolutions) passed by November 12, 2022.