Facts

Parties and proceedings: The appellant is [A. GmbH] as marketing authorisation holder of the medicinal product [B.] (active substance [C.] ), which is no longer patent-protected, has been listed on the Specialities List (SL) since xxx and is used for the treatment of [E.] . The respondent is the Federal Office of Public Health (FOPH). The prior instance was the Federal Administrative Court (decision of 6 May 2020, C-6087/2018), which dismissed the appeal against the FOPH decision. The subject matter is health insurance, specifically the three-yearly review of the listing conditions under the SL.

Facts: The FOPH subjected [B.] to the three-yearly review and requested data on efficacy, appropriateness and cost-effectiveness, in particular on the therapeutic cross-comparison (TQV) and the foreign price comparison (APV). The appellant compared the medicinal product with the off-patent preparation [D.] (active substance [G.] ) and based the comparison on the smallest pack not used for titration ([B.] Caps xxx mg xxx pcs; [D.] Caps xxx mg xxx pcs). The FOPH, by contrast, used the smallest available pack of xxx tablets of xxx mg, which according to the specialist information could also serve as a possible maintenance dose. As no agreement was reached, the FOPH determined the public retail prices and ordered a reduction of xxx % with effect from xxx.

Applications: Before the Federal Supreme Court, the appellant applied for a reduction of the ex-factory price (FAP) and the public retail price (PP), alternatively for remittal for recalculation. The FOPH applied for dismissal.

Issue: Whether the prior instance violated federal law by confirming the TQV carried out by the FOPH on the basis of [B.] xxx mg (pack of xxx tablets), in particular whether this dosage strength and pack serve only as a titration pack at the start of therapy and therefore do not allow an adequate comparison.

Specialist information: [B.] is taken at the start of therapy at xxx mg daily; after three to seven days the dose may (possibly) be increased to xxx mg daily, if needed up to a maximum dose of xxx mg. Long-term therapy ranges between xxx and xxx mg, with a mean maintenance dose of xxx mg. [D.] is taken with an initial dose of xxx mg, with a maintenance dose of xxx to xxx mg divided into three single doses.

Considerations

Standard of review: The Federal Supreme Court applies the law of its own motion but in principle only examines the complaints raised (Art. 106 para. 1 FSCA; BGE 141 V 234 consid. 1). The factual findings of the prior instance are binding, unless they are manifestly incorrect or based on a violation of law (Art. 105 paras. 1 and 2, Art. 97 para. 1 FSCA). The WZW criteria (Art. 32 para. 1 HIA) and the periodic review (Art. 32 para. 2 HIA) form the legal framework, as do the principle of economy (Art. 43 para. 6 HIA) and the SL (Art. 52 para. 1 lit. b HIA).

Cost-effectiveness review and TQV: Cost-effectiveness is assessed by the APV and the TQV, which are each weighted equally (Art. 65b HIO, paras. 2 lit. a and b, 5). The TQV is an indirect cost-benefit comparison with medicinal products used to treat the same disease (Art. 65b para. 4bis HIO; BGE 142 V 26 consid. 5.3). In principle, the marketing authorisation or specialist information is decisive. The term gamme refers to the various dosage strengths and pack sizes of a medicinal product; a separate APV and TQV is carried out for each gamme (SL Manual, Section E 1.3). The FOPH has a broad margin of discretion in selecting the comparator products; it must be examined whether this discretion was exercised appropriately (BGE 143 V 369 consid. 5.3.3).

Relevant basis for comparison: Under Art. 65d para. 3 HIO and Art. 34f HIBO, the TQV is carried out on the basis of the smallest pack and lowest dosage, unless this does not allow an adequate comparison owing to different dosages at the start of therapy or different pack sizes. Larger packs and higher dosage strengths often carry price surcharges, which leads to distortions. Recognised exceptions are: (1) the smallest pack/dosage is used for a comparator medicinal product only at the start of therapy (up-titration); (2) the smallest dosage serves only a dose reduction defined in the specialist information or the treatment of specific patient groups with comorbidities; (3) a comparator product is not offered in any small pack.

Application to the case: It is undisputed that the third exception does not apply. The second exception also does not apply, as the appellant has not substantiated it. What remains to be examined is the first exception, i.e. whether [B.] xxx mg serves only for titration.…