Colombia Takes a Stand on Price of Novartis' Leukemia Drug

Colombia has decided to slash the price of imatinib mesylate (Gleevec in the United States, Glivec in Colombia), the antileukemic agent manufactured by Novartis, by nearly half. According to FiercePharma, this follows months of negotiations between the government and the drug manufacturer to reduce drug price to improve access. The annual cost of the drug in Colombia is about $15,000, which is nearly twice the country’s per capita gross income of $8000.

The blockbuster drug, which has been in use for a decade and a half, came off its basic compound patent in July 2015 in the United States. Sun Pharmaceuticals, a generics manufacturer, was prepared to file an application for approval of imatinib mesylate, which was granted in December 2015.

Following the failure of lengthy negotiations between the Colombian government and Novartis, health minister Alejandro Gaviria announced in June 2016 that he would publish a resolution to mandate a lower price of Gleevec without allowing access to the Colombian market for generic manufacturers. Gaviria has stuck to his words. According to STAT news, the decision on the final price is currently pending following a formal petition by the US Trade Representative, which in under review by the Colombian government.

A Novartis spokesperson told STAT that the company considers the Colombian government’s decision improper and damaging for patented innovative products.

“Currently all patients in Colombia who need Glivec have access to it,” the company said. "There is no public health crisis, no shortages, and no evidence of other access issues. The government exerts price controls … and has reduced the price twice in the last 3 years."

Colombia is planning to implement reference pricing—a strategy commonly used in Europe—by examining the price of the drug in 17 reference countries. The health ministry has created a policy to allow this practice to be implemented for other drugs that health officials consider important for maintaining public health.

The trade organization PhRMA, meanwhile, has sharply criticized the Colombian government’s stand, calling it a harmful global precedent.

“Ad hoc price cuts are not effective or sustainable ways to improve access or achieve other critical public health goals," PhRMA said in a statement. "Pricing systems should be based on transparent rules and fair processes that provide business certainty for pharmaceutical innovators."