Penlac® Decision from PMPRB (Order)

Drug: Penlac®

The Patented Medicine Prices Review Board (the Board) has ordered sanofi-aventis Canada Inc. (sanofi) to pay $9.4 million for excessive revenues relating to the sale of Penlac®, a nail lacquer for treatment of a fungal infection of the nail.

Section 85(1)(b) of the Patent Act provides that one of the factors the Board shall take into consideration in determining if prices are excessive are the prices of other medicines in the same therapeutic class. The central issue in this case was whether or not Penlac® was in the same therapeutic class as two other medicines used for the same indication, Lamisil® and Sporanox®.

sanofi argued that Penlac® was in the same therapeutic class as Lamisil® and Sporanox®, which were more expensive. Board Staff argued that Penlac® should not be in the same therapeutic class, as it was significantly less efficacious than Lamisil® and Sporanox®.

The Board ruled that medicines must be “clinically equivalent” to be in the same therapeutic class for price comparison purposes. Clinical equivalence requires comparable efficacy and comparable safety.

The Board found that Penlac® was not in the same therapeutic class as Lamisil® and Sporanox®, as the evidence demonstrated that Lamisil® and Sporanox® were both reasonably effective at treating the symptoms of onychomycosis, and Penlac® was not. In doing so, the Board rejected sanofi’s argument that the therapeutic class should include any medicine with some efficacy at treating the given indication, regardless of the relative effectiveness of the medicines.