Decision 9C_534/2021 dated 4 April 2023

21 April 2023 – The appellant A. is the authorisation holder of the medicinal product C., which has been on the List of Pharmaceutical Specialties (SL) since 1 August 2014. As part of the triennial review of the conditions for inclusion of the preparations listed in the SL, A. applied to the Federal Office of Public Health (FOPH) for a voluntary price reduction of C., which then followed. At the same time, the FOPH checked whether any additional revenue had to be refunded. In this regard, A. was of the opinion that for medicinal products included in the SL before 1 June 2015, the reimbursement of additional revenues according to the transitional provisions of the Ordinance on Health Insurance (Bundesgesetz über die Krankenversicherung, KVV) and of the Ordinance on Healthcare Benefits (Krankenpflege-Leistungsverordnung, KLV) amendments in 2015 had to be made according to the regulations that had applied at the time of inclusion in the SL; these only provided for an External Reference Price (ERP; Auslandpreisvergleich, APV) ) with the exchange rates at the time of inclusion, but no Internal Reference price (IRP; Therapeutischer Quervergleich, TQV) for the calculation of additional revenues. However, the FOPH held that an IRP must also be carried out for the calculation of the reimbursement claim. Based on the reimbursement calculated in this way, the total reimbursement amount was higher. The Federal Administrative Court confirmed the FOPH's decision and dismissed an appeal by A. to this effect. The appellant appealed against this decision.

The court first noted that it had already been established in BGE 142 V 26 regarding the periodic review pursuant to Art. 32 para. 2 of the Health Insurance Act (Bundesgesetz über die Krankenversicherung, KVG) that this had to take place with consideration of an IRP. The regular consideration of the IRP within the framework of the periodic triennial review of the admission conditions was then also expressly included in the KVV and the KLV with the amendment of the legislation on 1 March 2017. According to the newly formulated Art. 65b para. 2 and Art. 65d para. 2 and 3 KVV, economic efficiency is generally no longer assessed only by means of an ERP, but also – compulsorily – on the basis of an IRP. It is also stated that the purpose of the standardised reimbursement of additional revenues is to assess, on the occasion of the review of cost-effectiveness, whether the price of the medicinal product in question was set too high to a significant extent when it was included in the SL and therefore generated objectively unjustified additional revenues. To be able to determine this, the Ex-Factory Price (EFP) at the time of inclusion of the medicinal product is to be compared with that which results from a performance audit at a later point in time. If the latter is set significantly lower, the marketing authorisation holder is obliged to return the additional revenue generated since inclusion in the SL to the financial cycle of the health insurance system and to transfer it to the Joint Body for this purpose.

From these statements, it can be concluded that already at the time of C.'s admission to the SL on 1 August 2014, not only an ERP but also an IRP should have been carried out at the triennial review, in accordance with the correct application of the law established in BGE 142 V 26, even according to the legal situation at that time.

The court further states that the transitional provisions enacted in 2015 as part of the amendments to the KVV and the KLV concern the change of the standard for the reimbursement of additional revenues from an optional provision to a mandatory provision and the expansion of the reference countries that are relevant for the ERP. The purpose of the transitional provisions is thus to ensure that the ERP is carried out in the same way, i.e. in particular on the basis of the same reference countries as at the time of inclusion in the SL, when assessing the additional revenues of medicinal products that were included in the SL before the new ordinance provisions came into force on 1 June 2015 and have not yet been subject to a periodic review. Accordingly, it does not follow from the transitional provisions in question that only an ERP is to be carried out.

Furthermore, the court states that, contrary to the complainant's objection, the reimbursement of additional revenues is therefore very much about the assessment of the economic viability of a medicinal product. This view is reinforced by the link between the reimbursement in question and the possibility for the marketing authorisation holder to voluntarily reduce the price - which is indisputably to be carried out on the basis of an ERP and an IRP. Finally, the fact that C.'s price had already been set on the basis of an ERP and a IRP when it was included in the SL also speaks in favour of the Federal Administrative Court's assessment.

Lastly, the calculation of the refundable additional revenue on the basis of an ERP and an IRP does not constitute a violation of the prohibition of retroactivity. Rather, it merely implements what would actually already have been in accordance with the legislation in 2014 (or earlier).

The appeal was dismissed.

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