Legal clarification – comparative benefit assessment also for therapeutic “soloists”
01.08.2023 14:14
The Federal Joint Committee (G-BA) can legally assess the benefits of active ingredients that are currently the only approved drug in an area of application (therapeutic soloists). The Act to Combat Drug Supply Bottlenecks and Improve Care (ALBVVG), which came into force today, makes this clear in Section 35a SGB V. These clarifications by the legislature were necessary after the Federal Social Court (BSG) considered the benefit assessment for therapeutic soloists to be unlawful in spring 2023 (“Solisten judgment”, see below).
It is clear that the early benefit assessment must be applied to all reimbursable medicines and therefore also to soloists (Section 35a Paragraph 1 Sentence 1 SGB V). In exceptional cases, the G-BA can also determine the off-label use of drugs as an appropriate comparator therapy. This is possible if it has previously been considered the standard of care in an area of application based on the generally accepted state of medical knowledge. In addition, an appropriate comparative therapy can also be used
- a non-drug therapy,
- the best possible supportive therapy or
- be the observational waiting.
This is what the newly added Section 6 Paragraph 2 of the Medicines Benefit Assessment Ordinance (AM-NutzenV) provides. The G-BA welcomes the clarifying regulations. They legally support the procedural practice of the G-BA, which took care into account until the BSG ruling.
Background: The BSG’s “soloist verdict”.
In spring 2023, the BSG declared the underlying G-BA decision ineffective in a legal dispute between a manufacturer and the GKV umbrella association. The proceedings revolved around an arbitration award on the pricing of the active ingredient regadenoson (area of application: measurement of the fractional flow reserve). In its benefit assessment of the active ingredient, the G-BA included two drugs that were not approved for the area of application as suitable comparator therapies that were previously considered the standard of care in this area. The court saw no legal basis for this.