Three-yearly review of an SL medicinal product: admissibility of the price reduction and selection of comparator medicinal products in the therapeutic cross-comparison

Facts

Parties and lower courts: The appellant is a public limited company ([A. SA] ), the marketing authorisation holder of the medicinal product [B.] approved by Swissmedic, which has been listed on the Specialties List (SL) with prices since vvv. The active substance is [C.] . The respondent is the Federal Office of Public Health (FOPH). The lower court was the Federal Administrative Court (judgment C-303/2019 of 2 December 2020).

Subject matter: Health insurance, Specialties List, three-yearly review of the listing conditions.

Facts: By circular of 13 December 2017, the FOPH informed the marketing authorisation holder that [B.] would undergo the three-yearly review and requested data on efficacy, appropriateness and cost-effectiveness, in particular on the therapeutic cross-comparison (TQV). The appellant proposed carrying out the TQV as at the original listing, using the preparation [D.] (same active substance class). The FOPH rejected this, since [D.] is not classified in the same Gamme (range) as [B.] ([B.] in Gamme Oral, [D.] in Gamme OralRetard) and shows above-average daily therapy costs. It selected as comparator medicinal products [E.] , [F.] , [G.] , [H.] , [I.] , [J.] , [K.] , [L.] , [M.] , [N.] and [O.] . By decision of 7 December 2018, the FOPH set the public price of [B.] , applicable from 1 February 2019, at a lower level. The Federal Administrative Court dismissed the appeal. Before the Federal Supreme Court, the appellant requested remittal to the FOPH for a new determination of the prices; suspensive effect was granted by order of 4 April 2021. The FOPH requested dismissal of the appeal.

Legal question: Whether the lower court violated federal law by confirming the price reduction, in particular whether a renewed TQV is admissible in a three-yearly review and whether the FOPH lawfully exercised its discretion in selecting the comparator medicinal products.

Considerations

Scope of review: The Federal Supreme Court applies federal law of its own motion (Art. 106 para. 1 FSCA), but in principle examines only the complaints raised (Art. 42 para. 1 FSCA; BGE 145 V 57). The findings of fact are binding unless manifestly incorrect (Art. 105 FSCA). Decisive are the WZW criteria (Art. 32 para. 1 HIA), the periodic review (Art. 32 para. 2 HIA) as well as Art. 65b and 65d HIO and Art. 34d ff. HIBO. A medicinal product is considered cost-effective if it ensures the therapeutic effect with the least possible financial expenditure (Art. 65b para. 1 HIO). Cost-effectiveness is assessed by means of the foreign price comparison and the therapeutic cross-comparison, each weighted equally by half (Art. 65b para. 5 HIO).

Admissibility of carrying out the TQV anew: Decisions are only binding in the sense of legal validity, not materially res judicata, and may be revised under the circumstances of BGE 140 V 514. According to BGE 142 V 488, the three-yearly review differs from the initial listing: a price reduction in principle presupposes a change in the TQV or the foreign price comparison (APV). Since 1 March 2017, a changed legal position has applied, under which the TQV must be carried out at every review (BGE 142 V 26). Since the legal bases were subsequently changed, a subsequent legal inaccuracy exists which permits a comprehensive new performance of the TQV. The membership of the Gamme is now relevant, which is decisive here.

Change in the facts: The daily therapy costs of [D.] have risen markedly since 2006, while those of [B.] remained the same. In the proceedings before the lower court, the appellant acknowledged a mean maintenance dose of [B.] of xxx mg; its later, divergent position contravenes good faith as 'venire contra factum proprium' (BGE 134 V 306). The daily therapy costs of the other comparator medicines lie between CHF yyy and CHF yyy, whereas those of [D.] are above average. This justifies a renewed review of the cost-effectiveness criterion. The objection that the relative benefit has not changed is immaterial, since the indirect cost-benefit analysis takes place only in the second step of the TQV (BGE 147 V 194).

Selection of comparator medicinal products and discretion: The FOPH enjoys a wide margin of discretion in selecting the comparator preparations (BGE 143 V 369; BGE 147 V 194). It is not obliged to include all comparable medicinal products; medicinal products that are above average in price may be excluded. The Federal Supreme Court only examines whether discretion has been exceeded, abused or under-exercised. Decisive is not the identity of the active substances, but that the medicinal products can be used for the treatment of the same disease.…