The Colombian government is forcing pharmaceutical giant Novartis to lower prices of its leukemia medicine, imatinib (Gleevec).
According to abc News
, the health minister of Colombia, Alejandro Gaviria, was in negotiations with Novartis to lower the price of imatinib, which is a Bcr-Abl tyrosine kinase inhibitor that was approved by the FDA in 2001 to treat patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML). But the negotiations have failed and Gaviria plans to publish a resolution to mandate lower price of the medicine without opening the market for generic competition.
The basic compound patent on imatinib mesylate expired
on July 4, 2015, in the United States and expires this year in Europe. While several companies had their generic version of imatinib mesylate ready for submission to the FDA, Sun Pharmaceuticals was the first company to be granted approval
in December 2015, in addition to product exclusivity for 6 months before other generic makers flush the market with their product.
Interestingly, payers would still include the generic imatinib in the specialty tier (threshold is $600 for a 1-month supply), as Michael Kolodziej, MD, national medical director of Aetna, told
the Pink Sheet
. Kolodziej said that Aetna plans a fail-first strategy, in that Gleevec would be approved for treatment-naïve patients with CML only if they fail on the generic product. Gleevec remains a top-seller for Novartis, and it brought in $4.7 billion worldwide (10% of the company’s total revenue) in 2015, according to abc News.
Colombia’s dispute with Novartis could set a precedent for middle income countries as they struggle to meet the rising prices of potentially curative treatments in cancer. The dispute, according to the report, could have much broader implications on trade negotiations between the United States and Colombia.
Novartis, meanwhile, said that disagreements stemmed from the fact that price control strategies are already in place in Colombia, in addition to generic competition.
Colombia has a government-funded health system, and the ministry of health has estimated that funding the $15,000 annual course of Gleevec would cost the government $15 million per year.