In its judgment, the Federal Administrative Court (the Court) upheld the appeal of Cheplapharm Schweiz GmbH against two rulings of the Federal Office of Public Health (FOPH) deleting Distraneurin capsules and Distraneurin mixture from the List of Pharmaceutical Specialties. At issue was the triennial review of the admission requirements in 2021.

Distraneurin contains clomethiazole and is authorised for three indications: age-related sleep disorders, states of confusion with agitation in elderly persons, and pre-delirium, delirium tremens, and acute withdrawal symptoms under controlled inpatient conditions. The FOPH had considered efficacy and appropriateness no longer met in the outpatient setting. In its view, the main indication was limited to inpatient care, where costs were covered by flat-rate case payments. It had additionally deleted the mixture for lack of market availability.

The Court held that the information for healthcare professionals did not exclude outpatient treatment for the main indication. In exceptional cases, treatment outside hospital was permissible if qualified staff monitored the daily dosage. A Swiss recommendation co-supported by the FOPH confirmed this. The FOPH could therefore not restrict use to inpatient care on the basis of foreign guidelines, which partly rested on different authorisation regimes. The Court left open whether medicinal products used exclusively in inpatient care had to be deleted from the List of Pharmaceutical Specialties.

The Court further held that lack of market availability was not a ground for deletion under art. 68 para. 1 of the Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV). Health insurance law did not require continuous market availability. A deletion was therefore only possible if the listing ruling contained a corresponding condition or if Swissmedic revoked the marketing authorisation. The FOPH’s handbook on the List of Pharmaceutical Specialties, as an administrative ordinance, could not replace a legal basis.

The Court set aside the rulings and remanded the case to the FOPH to complete the triennial review, including a full cost-effectiveness assessment. It left open whether limitations could be imposed for the two secondary indications.

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