In its decision of 16 October 2024, the Federal Supreme Court upheld the limitation imposed by the Federal Office of Public Health (FOPH) on the medicinal product Aldara, classifying it as a second-line treatment. The Court confirmed that the limitation was in accordance with federal law and justified within the Swiss healthcare system.

The dispute centered on the therapeutic cross comparison (therapeutischer Quervergleich, TQV) of Aldara in the context of pricing, which was conducted as part of the triennial review of pharmaceuticals. The appellant argued that Aldara should be considered a first-line treatment. However, the FOPH maintained that Aldara was only economically viable as a second-line option.

On formal grounds, the appellant first submitted that the Federal Administrative Court had inadmissibly broadened the subject-matter of the dispute by dealing not only with the question of the limitation of Aldara, which was the sole subject of its appeal, but also with the question of the suitability of Zyclara as a reference medicinal product. The court upheld the approach of the Federal Administrative Court, stating that the limitation of Aldara is based on the inclusion of Zyclara as a reference medicinal product and that the two questions cannot be answered independently of each other.

Furthermore, the court considered whether the Federal Administrative Court had erred in upholding the limitation of the FOPH. The appellant further argued that, as regards the choice of reference medicinal products, neither the law nor the principle of cost-effectiveness implies that the medicinal products had to belong to the same therapeutic class. However, the court confirmed that it is at the FOPHs discretion to decide in each case which of the eligible (i.e. comparable) medicinal products should form the basis of the TQV.

The court stated that the purpose of these limitations is to ensure the economic use of medicinal products and to prevent misuse by limiting reimbursement to cases where certain conditions are met. Therefore, limitations are not rationing, but a necessary measure to maintain cost-effectiveness and ensure that medicinal products are reimbursed only when they remain economically viable.

The appellant further claimed that the limitation violated on the fundamental rights of patients and physicians, in particular the right to freely choose treatments (article 27 of the Federal Constitution of the Swiss Confederation, FC) and the right of patients to have access to appropriate therapies (article 10 FC). However, the court ruled that the appellant did not have standing to assert these rights on behalf of third parties. It clarified that only those directly affected—patients and physicians—could claim violations of their fundamental rights. The court concluded that the limitation did not unjustifiably interfere with these rights, as it was based on legitimate economic and healthcare considerations.

For more information, see here.