Facts
On June 27, 1991, Sandoz-Wander Pharma AG applied for the inclusion of the antimycotic LAMISIL in the Specialty List at a retail price of CHF 102.30/CHF 180 for 14 tablets/28 tablets 250mg. After a price reduction of around 10%, the application was approved by the Federal Office of Social Insurance (BSV) on December 16, 1992. On August 26, 1996, the company submitted a request to increase the prices for LAMISIL by 10% to CHF 102.10/CHF 179.65 and CHF 62.25 for 14 tablets/28 tablets 250mg and 14 tablets 125mg respectively. The request was justified by the fact that more recent studies had shown significantly better efficacy with a lower relapse rate compared to the competing product SPORANOX. The BSV rejected the request on July 14, 1997.
On September 9, 1997, Novartis Pharma Schweiz AG as the legal successor filed an appeal with the Federal Appeals Commission and requested the approval of the rejected price increase. The Appeals Commission dismissed the appeal on December 2, 1999.
Considerations
According to the case law, price increases for medicinal products already included in the Specialty List can only be approved insofar as they meet the requirement of cost-effectiveness. The same criteria as for the initial inclusion, namely efficacy, appropriateness, and cost-effectiveness, must be applied in principle.
The proof of higher efficacy of a medicinal product compared…