The High Cost of Second-Generation TKIs for CML is an Obstacle to Effective Reimbursement and Patient Access at the National and Institutional Level in Both Brazil and Mexico

BURLINGTON, Mass., July 15, 2014 /PRNewswire/ -- Decision Resources Group finds that, despite the fact that the treatment armamentarium for chronic myeloid leukemia (CML) in Brazil and Mexico includes all three tyrosine kinase inhibitors (TKIs)—Novartis' Glivec (imatinib), Bristol-Myers Squibb's Sprycel (dasatinib) and Novartis' Tasigna (nilotinib)—due to their premium price, patient access to these agents can be challenging, especially in earlier lines of CML therapy. In the first-line setting, irrespective of the disease phase, patients predominately receive imatinib. Moreover, costly third-generation TKIs, such as Pfizer's Bosulif and Ariad Pharmaceutical's Iclusig, will soon compete with branded and generic versions of the currently available TKIs, thereby challenging payers and physicians to make tough reimbursement and prescribing decisions.

Other key findings from the Emerging Markets Physician and Payer Forum report entitled Patient Access to High-Cost Therapies for CML in LATAM (Brazil and Mexico): How Do Payers and Physicians Shape This Crowded and Changing Market?

• High uptake of TKIs in Brazil and Mexico: Premium-priced TKIs dominate the CML market in Brazil and Mexico, in both the public and the private sectors. All three currently available TKIs enjoy access in the public sector in Brazil, although with restrictions in lines of therapy, but coverage is far from universal in Mexico.
• Preferred first- and second-line treatments: While Glivec is the preferred first-line treatment for CML in both countries; Sprycel is the preferred second-line treatment, strongly ahead of Tasigna, which is likely a reflection of Tasigna's lack of approval for blast-phase CML (and national treatment guidelines in Brazil) and Sprycel's lower cost.
• Unmet need in CML treatment: Existing CML drugs have generally shown good efficacy and safety, however specific CML patient sub-populations (for example, those with T315I mutations) are currently underserved and represent an area of clear unmet need in CML treatment. The novel CML therapy, Iclusig, aims at targeting this unmet need.

Comments from Decision Resources Group Analyst Chiara Stella Cochetti, M.Sc.:

• "With current TKIs coverage and effectiveness established, it becomes increasingly difficult for new agents to penetrate the CML market in Brazil and Mexico. The need arises for patient assistance programs or cost-sharing agreements for new CML agents in order to improve chances of coverage and patient access to treatment."
• "There are high expectations that novel therapies will be cost-effective, thereby improving the level of patient access to later generation therapies. Since the large majority of patients rely on the public sector in Brazil and Mexico to access CML treatments, it is key to secure cost-effectiveness of new drugs to obtain national and institutional formularies inclusion."

About Decision Resources Group
Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597
[email protected]

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SOURCE Decision Resources Group

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