In its judgment, the Federal Administrative Court (FAC, the Court) dismissed the appeal of Gilead Sciences Switzerland Sàrl, the marketing authorisation holder of Descovy Oral (emtricitabine/tenofovir alafenamide), against the Federal Office of Public Health (FOPH) and confirmed the price reduction ordered for Descovy in the context of the 2022 triennial review of admission conditions for the List of Pharmaceutical Specialties (SL). The FOPH had classified the HIV medicinal product as a follow-on product without therapeutic improvement and conducted the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) with Truvada GF and Kivexa on the basis of their prices after patent expiry.

The dispute centred on whether Descovy qualified as a follow-on product within the meaning of art. 65b para. 6 of the Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV) and, if so, whether it provided a therapeutic improvement over Truvada. Gilead argued that tenofovir alafenamide (TAF) differed from tenofovir disoproxil fumarate (TDF) in chemical structure and mode of action, that its authorisation by Swissmedic as a new active substance precluded a finding of identity of active ingredient, and that Descovy offered clinically relevant advantages, particularly regarding renal safety and bone health. It therefore maintained that the TQV should have been based on the prices of the comparator products before patent expiry.

The Court dismissed the appeal, recalling that it exercises restraint in reviewing determinations requiring specialised medical and pharmaceutical expertise. It held that the FOPH had not exceeded its discretion by treating TAF and TDF as identical active substances for health insurance purposes, since in both cases the therapeutic effect is produced by the same substance, tenofovir diphosphate, of which TAF and TDF are merely prodrugs; the authorisation of TAF as a new active substance under therapeutic products law did not preclude that finding, as the two legal regimes pursue different purposes. As to the therapeutic improvement, the Court confirmed that, while art. 65b para. 6 KVV does not require proof of a significant therapeutic improvement as does the innovation premium under art. 65b para. 7 KVV, a merely marginal difference from the predecessor product does not suffice: an advantage in terms of efficacy, safety, or treatment compliance must be established by clinical studies, and statistical significance alone is not enough, the results must also be clinically relevant. The advantages identified were limited to certain patient groups and were offset by disadvantages for others, without any demonstrated effect on morbidity or mortality, and the treatment guidelines had not been adapted in favour of Descovy. The FOPH had therefore lawfully excluded research and development costs from the pricing assessment and correctly conducted the TQV using the prices of the comparator products after patent expiry.

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