Novartis’ Glivec could lose half patient population in China to generics

Hematologists in China estimate that Glivec (imatinib) from Swiss drug major Novartis (NOVN: VX) will lose nearly half of its patient share for treatment of chronic myeloid leukemia (CML) in the next three years due to the market entry of generic imatinib, according to research by Decision Resources Group.

However, imatinib (Glivec and generics) will continue to dominate the market for first-line chronic phase CML. There will be continued uptake of Novartis’s Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib), and new therapies such as Pfizer’s Bosulif (bosutinib) and Jiangsu Hansoh’s flumatinib will gain a foothold for second- and third-line accelerated or blast phase CML. However, the expected high cost of new agents and lack of reimbursement are significant hurdles for drug uptake.

The report, Patient Access to High Cost Therapies for CML in China: How are Payers and Physicians Shaping this Crowded and Changing Market, also found that the increasingly crowded market and high expectations for clinical benefits, as well as surveyed physicians’ low familiarity with emerging CML agents, are also major access obstacles for emerging therapies. Hematologists indicated that half of the patients undergoing BCR-ABL mutation analysis have a mutation, with the most common one being T315I. Tasigna and Sprycel are preferred for various mutation sites respectively; however, none of them is sensitive to T315I.

Generics will make significant gains