Legal loophole will probably be closed again before the parliamentary summer recess

ALBVVG - legislator's reaction to the BSG ruling on Rapiscan®

Fri, 2023 / 04 / 21
On April 5, 2023, the Federal Government published a draft law called "Arzneimittel-Lieferenpassbekämpfungs- und Versorgungsverbesserungsgesetz" (ALBVVG), which aims to improve the supply situation in Germany with antibiotics and medicines to reduce fever in children. In addition to this main objective of the draft law, a legislative amendment is also proposed in relation to the ruling of the Federal Social Court (BSG) in the Regadenoson (Rapiscan®) case. The planned amendment is intended to close the legal loophole created by the BSG ruling.

To close this legal loophole, the ALBVVG contains a clarification of § 35a (1) S. 1 SGB V by only one word, so that this now states that "all reimbursable medicinal products" with a new active ingredient that are not eligible for a fixed amount must be subjected to a benefit assessment by the German Federal Joint Committee (G-BA) and a reimbursement amount must then be determined. During this, the G-BA must determine an appropriate comparative therapy (ACT) for the medicinal product to be assessed, which "is to be based on the health care situation as it would be without the medicinal product to be assessed". This is specified by an addition to the Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV) that, in addition to non-drug therapies, best supportive care or watchful waiting may also be determined as an ACT if no other drugs are approved or reimbursable in the indication and no non-drug treatment options exist in the statutory health insurance (SHI).

The cabinet draft thus quickly defuses the situation created by the BSG ruling that therapeutic soloists have a special position with free pricing. However, this is more of a clarification than a real change in the law, which goes back to the common practice of the AMNOG procedure before the BSG ruling.

In contrast, the draft law does not address the extent to which off-label medicinal products may be used as an ACT. Since in the ruling of the BSG the off-label use as an ACT was fundamentally restricted, with an exception: If there is a legitimisation of the off-label use of the medicinal product in the therapeutic area according to § 35c SGB V or if the medicinal product does not represent a treatment alternative under marketing authorisation law but a therapeutic alternative and competition with the medicinal product to be assessed is to be expected, the G-BA could in future fall back less frequently on off-label use medicinal products when determining the ACT.

The handling of the pricing of medicinal products for which the G-BA has determined a very low-priced ACT remains critical. From the point of view of the arbitration board, a more flexible pricing would be desirable in these cases. Low-priced or also high-priced ACTs do not always represent a suitable and fair price anchor for the reimbursement amount negotiations. This also applies against the background that suitable studies cannot always be conducted for the drug to be assessed (e.g. due to low patient numbers or no exact implementation of the ACT in the study from IQWiG's point of view) and thus no additional benefit is granted. In particular, best supportive care or watchful waiting are to be regarded as rather difficult. Of the previous AMNOG procedures in which best supportive care or watchful waiting was used as the only ACT option, an added benefit could only be proven in 38 out of 52 and 13 out of 18 cases, respectively. This corresponds to only slightly more than 70% of the cases. From the point of view of the arbitration board, solutions that address this problem are desirable, as they are bound to the ACT defined by the G-BA, the decided additional benefit as well as possibly intervening guard rails and have no possibility to set an appropriate price.

Finally, the transferability of the BSG ruling to one's own case is not always given and requires a legal dispute between the parties. However, it is possible to state in the protocol of the price negotiations as well as in the contract that negotiations are taking place under retention and to include a special right of termination, even if this should become invalid with the adoption of the ALBVVG.

SKC continues to follow the political decision-making and implementation of the draft law and includes this in the counselling of clients.

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About the author

Ihr Ansprechpartner  Lukas Heinrich Schoppmeyer
Lukas Heinrich Schoppmeyer
M. Sc. Economics
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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