Facts
On June 30, 1998, Pfizer AG applied for the inclusion of the drug Viagra with the active ingredient sildenafil in tablet form in various package sizes and dosages in the Specialty List (SL). The indicated use was erectile dysfunction. The Federal Office for Social Insurance (BSV), the competent authority, rejected the inclusion of Viagra in the Specialty List, among other reasons, due to the lack of enforceability and controllability of the approved indications, as well as the violation of the advertising ban for drugs on the Specialty List.
The appeal filed by Pfizer AG was upheld by the Federal Appeals Commission for the Specialty List after two rounds of written submissions, with a decision dated March 26, 2001. The Appeals Commission essentially affirmed the inclusion of Viagra in the Specialty List with the following limitations:
- For erectile dysfunction that has existed for at least six months and is attributable to specific causes.
- A maximum of four tablets per month are reimbursed.
- Prior to the dispensing of the drug, the approval of the trusted physician or trusted physician of the health insurance company must be obtained.
However, the question of cost-effectiveness from the perspective of international price comparison requires further examination.
Considerations
The Federal Office for Social Insurance (BSV) filed an administrative court appeal with the request to set aside the decision of March 26, 2001 and to reject the application for the inclusion of Viagra in the Specialty List.
The Federal Supreme Court first examines whether erectile dysfunction has the status of an illness in the legal sense. It concludes that the matter must be remanded to the BSV so that it can define the concept of erectile dysfunction in terms of the status of an illness and the need for treatment in a uniform manner.
Furthermore, the Federal Supreme…