BURLINGTON, Mass., June 2, 2014 /PRNewswire/ -- Decision Resources Group finds that surveyed hematologists in China estimate that Novartis's Glivec (imatinib) 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. Nevertheless, 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 and Bristol-Myers Squibb's Sprycel, and new therapies such as Pfizer's Bosulif 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.
Other key findings from the Emerging Markets Physician & Payer Forum report entitled Patient Access to High Cost Therapies for CML in China: How are Payers and Physicians Shaping this Crowded and Changing Market:
- Additional market access hurdles: 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. Levers to circumvent these hurdles are discussed in the report.
- Drug choices for BCR-ABL mutations: 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 are sensitive to T315I.
- Market entry of generics: If generics are proven to be equivalent to the branded drugs in terms of both efficacy and safety, they will make significant gains in market share over the next three years, according to surveyed hematologists. The addition of generics may also drive down the cost of branded drugs, thus increasing the chances for inclusion in provincial/national formularies.
Comments from Decision Resources Group Analyst Michelle Zhou, M.B.B.S., Ph.D.:
- "High-cost tyrosine kinase inhibitors (TKIs) have dominated the China CML market. According to surveyed hematologists, more than 60 percent of their patients at any stage of disease receive TKIs. However, their high cost and the lack of reimbursement remain important hurdles for uptake. Market entry of generics is anticipated to become a threat to the current branded TKIs but will increase the penetration of this class within the CML market space."
- "Existing CML drugs have shown good efficacy and safety, except for some unique mutation sites such as T315I—this represents a clear unmet need in CML treatment. In order to maximize market share in this crowded market, it is vital for new drugs to show superior benefits or target new mutation sites, especially when generics begin to join this competition and further differentiation of the branded agents will be required."
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