In its judgment, the Federal Administrative Court (FAC, the Court) upheld the appeal of BioCryst Schweiz GmbH against the Federal Office of Public Health (FOPH) and annulled the FOPH's reconsideration decision (Wiedererwägungsverfügung) of 19 January 2023, by which the FOPH had tightened the reimbursement limitation applicable to the medicinal product Orladeyo on the List of Pharmaceutical Specialties (Spezialitätenliste, SL).

Orladeyo, used for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 and over, had been admitted to the SL on 15 June 2022 with a limitation that, unlike those of the competing products Cinryze and Takhzyro, did not restrict reimbursement to patients with a demonstrably severe course and a defined attack frequency. A few months later, the FOPH reconsidered that decision and aligned Orladeyo's limitation with that of Takhzyro, invoking the requirement of equal treatment and, subsequently, an alleged initial defectiveness of the admission decision. BioCryst argued that the original decision had been neither factually nor legally incorrect, that no grounds for reconsideration existed, and that the FOPH had deliberately conducted the therapeutic cross-comparison (therapeutischer Quervergleich, TQV) with Cinryze rather than Takhzyro.

The Court recalled that SL admission decisions are continuing decisions (Dauerverfügungen) that may be revisited only where one of four grounds exists: initial factual or legal incorrectness, or a subsequent change in the facts or the legal basis. It found none present. There had been no change in the facts, since Takhzyro, its price, and its limitation had all been known to the FOPH when Orladeyo was first admitted and had even been expressly referred to; the FOPH's later reliance on a "notice" that the limitations differed amounted merely to a fresh appraisal of an unchanged situation, not a new fact overlooked earlier. Nor was the original decision legally incorrect: the FOPH had exercised its discretion in setting the limitation in a defensible manner consistent with the Swissmedic authorisation, the efficacy of Orladeyo having been demonstrated in patients both below and at the threshold of two attacks per month, and the invoked principle of equal treatment did not assist the FOPH, as the limitations of the three products continued to differ in any event and holders of SL-listed products may generally not rely on equal treatment among competitors in pricing decisions.

The Court further held that a reconsideration would in any event have required a fresh, thorough assessment of all admission requirements, including a new cost-effectiveness assessment, since a change to a limitation may materially affect pricing; the FOPH had instead simply copied its earlier reasoning while reaching a different result. Finally, the Court clarified that art. 66a of the Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV), which allows the FOPH to review at any time whether the admission requirements remain met, confers only a temporal power of review and does not dispense with the need for a ground for reconsideration; since even the statutory triennial review requires such a ground, the same must apply, a maiore ad minus, to a review under art. 66a KVV. Consequently, the appeal was upheld.

For more information, see here.