In its judgment, the Federal Administrative Court (FAC, the Court) upheld the appeal of Recordati AG against the Federal Office of Public Health (FOPH) and annulled the FOPH's decision to remove the preparation Lacdigest from the List of Pharmaceutical Specialties (Spezialitätenliste, SL), referring the matter back to the FOPH for a proper triennial review including a comprehensive cost-effectiveness assessment.

Lacdigest, containing the active ingredient tilactase and indicated for substitution therapy in cases of lactose intolerance, had been listed since 1999. In the course of the 2020 triennial review, the FOPH had concluded that the admission requirements were no longer met, taking the view that lactose intolerance was not a condition requiring treatment (behandlungsbedürftige Krankheit), being a very common and "normal" phenomenon manageable through a lactose-free diet, and that Lacdigest was therefore no longer appropriate (zweckmässig) within the meaning of the Health Insurance Act (Bundesgesetz über die Krankenversicherung, KVG). It accordingly removed the product from the SL. Recordati appealed, arguing that lactose intolerance was a medically recognised diagnosis whose disease value and need for treatment fell to be assessed by the treating physician in the individual case, and that Lacdigest, being effective and low-risk, was also appropriate.

The Court upheld the appeal. It recalled that SL admission decisions are continuing decisions (Dauerverfügungen) that may be revisited only where one of four grounds for reconsideration exists: initial factual or legal incorrectness, or a subsequent change in the facts or the legal basis. Following case law, even the triennial review requires such a ground. The Court found that none was present as regards the disease value of lactose intolerance: the FOPH had not shown that the condition had been wrongly assessed in 1999 or in later reviews, had submitted no new studies or scientific consensus to support its characterisation of lactose intolerance as a "normal state", and could point to no relevant change in the law, since the 2004 amendment to art. 3 para. 1 of the General Part of the Social Insurance Law (Allgemeiner Teil des Sozialversicherungsrechts, ATSG) concerned only the alignment of mental with physical health impairments. The same applied to appropriateness, art. 33 of the Ordinance on Healthcare Benefits (Krankenpflege-Leistungsverordnung, KLV) having remained unchanged, and lactose-free products having been available since at least 2006.

The Court added that, in any event, the disease value of lactose intolerance could not be denied: affecting only 10 to 20 per cent of the Swiss population, it constituted a deviation from the norm capable of causing at least short-term incapacity for work, and whether medication was additionally required was a matter for medical professionals. Appropriateness likewise remained established, since neither lactose-free foods nor lactase preparations sold as food supplements were "other medicinal products" that could be brought into the comparison, so that no gross disproportion between cost and therapeutic benefit was apparent. The matter was remitted to the FOPH for a triennial review including a comprehensive cost-effectiveness assessment, which had been omitted in 2020.

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