In its decision of 24 April 2024, the Federal Administrative Court rejected the appeal of a pharmaceutical company against the decision of the Federal Office of Public Health (FOPH) regarding the triennial review of the admission requirements regarding the list of pharmaceutical specialties (Spezialitätenliste, SL) of the medicinal product B. The appellant objected to the limitation of B. based on the criterion of expediency and claimed an unauthorised change in practice.

The court ruled that the prophylactic use of B. continued to be indicated only for specific cohorts with an increased risk of certain D. deficiencies (anonymised in the decision). The appellant sought to extend the scope of B. in the SL for prophylactic purposes to the general population, following the FOPH's decision to limit the prophylactic use to selected population groups with an increased risk of D. deficiency.

Rejecting the pharmaceutical company's appeal, the court confirmed the FOPH's prerogative to reassess the requirements of B. in the context of its triennial review and to impose limitations accordingly. The FOPH had concluded that the prophylactic use of B. in the general population was not justified and would lead to unnecessary expenditure. The appellant did not succeed in challenging this assessment on the basis of an unauthorised change in practice. The court ruled, in accordance with the decision C-2370/2021, that all legal requirements for the change in practice made by the FOPH to limit the reimbursement of D. preparations by the Compulsory health insurance - have been met, and that the change in practice was therefore permissible.

For more information, see here.