Tyrosine kinase inhibitors (TKIs) have revolutionized the management of chronic myelogenous leukemia (CML) over the last decade. However, as 2013-approved second-generation TKIs Bosulif (Pfizer’s bosutinib) and Iclusig (Ariad Pharmaceuticals’ ponatinib) join Glivec (Novartis’s imatinib), Sprycel (Bristol-Myers Squibb’s dasatinib), and Tasigna (Novartis’s nilotinib), treatment decisions are becoming increasingly challenging—especially in later lines of CML therapy—with each TKI agent offering a unique blend of benefits and risks, on top of a premium price tag.

Questions Answered in This Report:

  • What role do TKIs play in the treatment of CML in the EU5, and how do prescribing patterns vary by country?

  • How do European product labeling and/or local, regional, or institutional prescribing restrictions differentially impact use of TKIs in CML? 

  • What have been the main clinical and budgetary/reimbursement-related constraints to the uptake of Glivec, Sprycel, and Tasigna? 

  • How will hematological oncologists embrace new market entrants Bosulif and Iclusig? 

  • How does reimbursement of approved CML therapies vary between countries? How do national, regional, and local healthcare authorities regulate the prescribing of these agents? 

  • What are payers’ reactions to recently approved TKIs for CML? 

  • How are increasingly convoluted health technology assessments and pricing and reimbursement processes in the EU5 impacting patient access to these new market entrants? 

  • What clinical advantages could secure reimbursement for emerging agents? 

  • What role will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of novel, high-cost TKIs versus current mainstays? 

  • How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel agents, and to what degree will prescribing constraints present a future hurdle for emerging therapies in the EU5? 

  • What market access levers can drug developers take advantage of to better position new CML products in the EU5?


Decision Resources Group’s European Physician & Payer Forum report “Chronic Myelogenous Leukemia: EU5 Prescribing Decisions and Payer Landscape in a Crowded and Dynamic Market” explores reimbursement and additional payer policies that influence prescribing trends for approved targeted agents in CML. The report assesses levers and barriers that will promote or restrict market access for premium-priced novel agents across the cost-constrained EU5 (France, Germany, Italy, Spain, and the United Kingdom). It draws on insights from 251 surveyed hematological oncologists in the EU5 and from interviews with 15 European payers, all of whom have influence at a national or regional level. Interviewed payers include the following:

- France: Hospital pharmacy directors, members of the local formulary committee, and advisors to the Haute Autorité de Santé (HAS; National Health Authority) from northern and southeastern France; hospital pharmacy director and member of the local formulary committee from northern France.

- Germany: Ex-Krankenkassen (health insurance funds) member; GBA (Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds) member; member of national boards and ex-GBA member.

- Italy: Advisor to the Agenzia Italiana del Farmaco (Italian Medicines Agency) and member of the Prontuario Terapeutico Ospedaliero Regionale (PTO/PTOR; [regional] hospital pharmaceutical formulary) committee in southern Italy; AIFA member from northern Italy; PTO/PTOR member from central Italy.

- Spain: Hospital/regional formulary committee members from central, eastern, and southwestern Spain.

- United Kingdom: Clinical Commissioning Group (CCG) advisor and formulary committee member; CCG advisor and ex-CCG commissioner; CCG advisor and ex-advisor to the National Institute for Health and Care Excellence (NICE).

Author(s): Khurram Nawaz, M.Sc.