Board Issues Copaxone Decision

The Board issued a decision in the matter of Copaxone (Teva Neuroscience) on February 25, 2008. The decision is now available on its web site, at the following link:
http://www.pmprb-cepmb.gc.ca/english/view.aspx

Key facts of the case and Hearing decision:

• The price of Copaxone was increased by 20% in mid-2004. Board Staff alleged that the price of Copaxone was excessive since the increase exceeded that allowed under the CPI methodology in the Guidelines. The Staff also charged the company with a policy of excessive pricing.
• The Board issued a Notice of Hearing on May 8, 2006. Closing arguments were heard August 13, 2007.
• The Board considered the fact that even after the increase, the Copaxone price was the lowest of all four products in the class and among the lowest in the basket of international countries considered. Furthermore, the product had undergone several improvements since its introduction in 1997 without any price increase. This led the Board to consider section 85(2) factors (cost of making and marketing) in its deliberation. The decision reads:
  
  “The Panel…is of the view that at some point the price of a medicine relative to that of the other medicines in its class…can be so low that it flies in the face of common sense to conclude that the medicine is excessively priced merely because the increase exceeds the CPI…”

• The Board considered costs related to successive improvements in the delivery of the medicine without the need to demonstrate a direct relationship between the increase in price and the costs incurred and whether or not such costs could be attributed to Canada, because the magnitude of price increase was in the realm of the CPI increases that Teva could have taken after 1997.
• The Board allowed a price increase of 15.9% phased-in over 3 years, based on inflation dating from 1997 to June 2004. No policy of excessive pricing was found.