German Federal Social Court: added benefit assessment for therapeutic soloists unlawful

Rapiscan® was subjected to a benefit assessment by the G-BA in 2019 as a pharmacological stress trigger for the measurement of fractional flow reserve. The procedure ended in a ruling by arbitration. The pharmaceutical manufacturer initially sued unsuccessfully before the Berlin-Brandenburg Regional Social Court, but the BSG has now upheld the claim in appeal proceedings. The hearing took place on Feb. 22^nd, 2023.

The BSG considers the arbitration and the underlying benefit assessment to be unlawful because the drug is a therapeutic soloist:

"For a benefit assessment that cannot aim at the comparative assessment of an added benefit due to the lack of a comparable therapy in the area of application, Section 35a SGB V in this formulation accordingly offers no legal basis in the structure of the SGB V."

For the evidence-based proof of an added benefit, the G-BA regularly determines the ACT in the area of application of the drug to be evaluated. One of the criteria of the G-BA is the approval in the area of application. In the present case, the G-BA had designated as ACT exclusively drugs in off-label use ("pharmacological stress triggering by the physician's choice"). The BSG now does not consider this to be a legitimate ACT. According to the BSG, the G-BA had exceeded the scope of its entitled actions. The (retroactive) implications of this ruling for procedures with "therapeutic soloists" without previously approved therapeutic options in the field of application may be manifold and cannot yet be clearly estimated.

In an internal analysis, SKC identified approximately 70 drugs or associated G-BA procedures that could be affected in whole or in part by the relevant issue. In these case, the ACT was due to the lack of other options defined as „Watchful Waiting" or „Best Supportive Care". The special therapeutic position of a soloist here particularly affects rare diseases for which there are often no approved drugs in the area of application. Especially if these so-called orphan drugs have to undergo a renewed benefit assessment due to their annual sales (>€30 million), the ACT becomes relevant for pricing.

It remains open which waves the topic will now make. The G-BA and in particular the representatives of the statutory health insurances (SHI) will certainly take a position on this shortly. According to the German Pharmaceutical Industry Association (BPI), it is to be expected that the supposed "regulatory loophole" will soon be closed, as experience has shown that the responsible Federal Ministry of Health (BMG) aims to avoid such unregulated leeway. The comprehensive reasoning for the ruling by the BSG is expected in May at the earliest.

Especially in view of the Rare Disease Day, the special position of therapeutic soloists is in focus. SKC follows, analyzes and anticipates the political decisions and their respective implementations in detail and includes them directly in the consultations with clients.

Sources:

• Report of German Federal Social Court
• Benefit assessment according to AMNOG
• MAIS database