How Successful Will Gleevec's Generic Competitor Be?

Sun Pharmaceutical’s product Imatinib Mesylate, the generic version of the blockbuster tyrosine kinase inhibitor or TKI, Gleevec (by Novartis), is now available for sale in the US market. The generic, approved by the FDA in December 2015, will have product exclusivity for a 6-month period before other generic brands enter the playing field.

While the cost of the generic may not be low enough to escape the specialty tier (threshold being $600 for a 1-month supply), health plans like Aetna want to promote the generic drug as the preferred product for their patients. In an interview with The Pink Sheet, Aetna’s national medical director for oncology, Michael Kolodziej, MD, said Gleevec would be approved for treatment-naïve patients with chronic myelogenous leukemia only if they fail on the generic product, which is expected to be cheaper than the $10,000-per-month branded drug. This policy could affect sales of later-generation TKIs, including dasatinib and nilotinib.

This can raise a lot of debate, according to Kolodziej, who said that the second generation TKIs have fared better on secondary outcomes but not overall survival, compared with Gleevec. While, the manufacturers argue for the legitimacy of the secondary endpoints, health plans are not on board, he added. Explaining the need to identify best responders to next-generation TKIs, Kolodziej played the ball back into the manufacturer’s court saying, “Maybe this will push the manufacturers to close the loop so that we really have good evidence on superior outcomes” with the later-generation TKIs.

Novartis, meanwhile, is offering patients with private insurance discount cards to cap their monthly copayment for Gleevec at $10.

The generic drug could pose a significant cost-sharing burden on patients, with nearly 25% or more coinsurance requirements. Additionally, Sun will try to maximize on profits during the 6-month marketing exclusivity period—Kolodziej predicts that the product will initially be offered at a 10% to 15% discount, and may be priced lower once other generic competitors enter the fray.

Reference

Kelly C. Aetna's generic Gleevec approach combines specialty tiering, 'fail first' strategy. The Pink Sheet. 2016;78(4):11-12.