Chronic myeloid leukemia (CML) in China presents a huge challenge for healthcare providers but is a considerable opportunity for drug manufacturers. The launch of Novartis’s Glivec (imatinib), an ABL kinase inhibitor, revolutionized CML treatment and has become the first-line gold-standard therapy for CML. Follow-on therapies include Novartis’s Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib), which are approved as second- or third-line therapy. Two generic versions of Glivec from domestic companies (Jiangsu Chia Tai Tianqing and Jiangsu Hansoh) launched in China in 2013, and a Sprycel generic version (Jiangsu Chia Tai Tianqing) was also approved in 2013. In addition to these recently launched products, a range of future market entrants, including Pfizer’s Bosulif (bosutinib) and Jiangsu Hansoh’s flumatinib, will start to crowd the CML market. This report examines the prescribing barriers that high-cost targeted therapies for CML will face, as well as strategies to overcome these obstacles. We explore physician and payer attitudes and behaviors concerning currently marketed brands versus newly launched generics and also explore their expectations for emerging therapies.

Questions Answered in This Report:

  • Explore Current and Evolving Prescribing Trends: How do prescribing patterns differ between agents (Glivec, Tasigna, Sprycel)? How does drug reimbursement status influence prescribing patterns? How are the BCR-ABL gene expression and mutation tests used and reimbursed?  What are the policy changes and government initiatives that may affect the prescription of costly targeted therapies for CML? How may patient assistance programs for targeted therapies enhance drug uptake?  What are the key drivers for the prescribing of one targeted therapy over another? How do differences in prescribers’ perceptions of major brands versus generics impact prescribing?  How do hematologists expect their prescribing of currently marketed targeted agents to evolve by the end of 2017?

  • Assess Payer Attitudes Toward Approved High-Cost Therapies for CML: Which agents are included on the National Reimbursement Drug List (NRDL) or Provincial Reimbursement Drug Lists (PRDLs)? What are the restrictions on the reimbursement of formulary-listed drugs? How might reimbursement of key CML therapies change in the near future? What therapies do payers expect to be included in the new NRDL and/or PRDLs? How might the new non-essential drugs tendering and other new government initiatives affect the pricing and reimbursement of CML therapies? How are generics perceived by payers? Will the presence of generics lead to a price cut on branded ones? How might the launch of generics affect the reimbursement of CML branded targeted therapies?

  • Explore the Outlook for Emerging Agents: What are the greatest unmet needs for CML treatment? How are the emerging drugs Bosulif and flumatinib perceived? How do physicians expect to prescribe them? What are payers’ expectations regarding access to emerging therapies? How will payer policy impact their uptake? How will market access barriers evolve and what challenges are companies likely to face in the future? What clinical and commercial factors would most likely persuade payers to grant emerging agents coverage or advantageous positioning? How will inclusion in government formularies/drug lists impact uptake of emerging therapies?

Scope:

This Emerging Markets Physician & Payer Forum report explores the national and regional market access factors that will impact the treatment of CML in China over the next two to three years. This report draws on insights from 50 surveyed hematologists and 3 interviewed payers who influence reimbursement at a national or regional level and include the following:

- Member, Ministry of Human Resources and Social Security (MOHRSS) for updating of the PRDL, Shanghai.

- Member, MOHRSS for updating of the PRDL, Jiangxi.

- Member, MOHRSS for updating of the PRDL, Beijing.

Author(s): Michelle Zhou, M.B.B.S., Ph.D.