The maker of the one of the world's most expensive drugs has been ordered to slash the price of the medication in Canada and pay back millions of dollars in revenue that the country's drug-pricing regulator has deemed "excessive."
In a landmark decision released Wednesday, a panel of the Patented Medicine Prices Review Board (PMPRB) ruled that Connecticut-based Alexion Pharmaceuticals Inc. charged more for a rare-disease treatment called Soliris than Canadian law allows.
The decision followed a rare public hearing earlier this year on allegations of excessive pricing of a drug in Canada.
In the vast majority of cases, pharmaceutical companies accused by the board of overpricing their patented drugs agree to pay back the money through voluntary agreements that are akin to out-of-court settlements.
The hearing also marked the first time that some provincial health ministries and the private health-insurance industry intervened at a PMPRB panel hearing, a sign of growing alarm about the eye-popping prices of rare-disease drugs.
Alexion fought the regulator, saying it had not raised the price of Soliris since the drug debuted in Canada in 2009 at a level the board considered acceptable for a breakthrough drug with no competitors.
The only thing that changed in the ensuing years was the foreign exchange rate, Alexion argued.
The company vowed to seek a judicial review of the ruling.
"The PMPRB Panel wants to penalize Alexion for changes to currency exchange rates, which are beyond our control, and seeks to apply a newly-invented pricing structure that is not supported by applicable law," Daniel Palmqvist, general manager of Alexion Pharmaceuticals Canada, said by e-mail.
"If upheld, the Panel's decision will have serious implications for future innovations and investments in the development and availability of therapies for Canadian patients with devastating rare and ultra-rare diseases."
Soliris is a medication that treats paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS,) a pair of chronic and life-threatening diseases that affect only a few hundred Canadians.
Soliris can cost as much as $500,000 dollars a year, depending on a patient's condition and weight.
The regulator had alleged that, beginning in 2012, Alexion started selling Soliris at the highest price among the seven countries against which the board benchmarks prices, even the United States, which generally has the highest drug prices in the world.
In its 75-page decision, the hearing panel found that Alexion's prices broke the rules. The panel ordered Alexion to immediately lower the price of Soliris to no higher than the lowest price among the seven comparator countries.
The panel also ordered Alexion to pay back the excessive revenue in an amount that has yet to be determined.
The money would go to the federal government.