How Will Physician and Payer Attitudes and Decisions Shape this Market? The treatment of metastatic colorectal cancer (mCRC) is increasingly driven by patients’ RAS mutational status of their disease: a mutation in RAS markedly reduces sensitivity to EGFR monoclonal antibody inhibitors, making them ineligible for treatment with either Erbitux or Vectibix. In the fiercely competitive RAS wild-type patient segment, Avastin competes for share against the EGFR inhibitors. While strength of clinical data and patient characteristics and preferences play an important part in treatment selection, price, reimbursement, and market access restrictions to mCRC biologics and other high-cost agents are increasingly influential in the EU5 markets. Indeed, in particularly cost-constrained, budget-restricted markets, non-clinical factors can tip the balance towards prescribing of either antiangiogenics, biomarker-driven EGFR inhibitors, or, indeed, chemotherapy alone.

Recently approved agents for mCRC have failed to impress payers in terms of differentiation and/or efficacy gains over standard of care, creating a stringent pricing landscape for new therapies. Furthermore, regional variations in drug access in some EU5 markets, and delays between EMA drug approval and the completion of country-specific pricing and reimbursement negotiations, may impact uptake. Developers of emerging therapies for mCRC should be mindful of the barriers and levers to market access for such therapies in their communications and negotiations with payers in the cost-constrained EU5.

Questions Answered in This Report:

  • What is the reimbursement status of premium-priced therapies for mCRC, and how are the drugs currently employed in the EU5 markets? How do national, regional, and local healthcare authorities regulate the prescribing of these agents?

  • What are the current drivers and barriers to prescribing angiogenesis and EGFR inhibitors for mCRC? Which factors influence the selection of agents, most notably in the RAS wild-type patient population, in the first, second, and third lines of treatment?

  • What are payers’ opinions of recent and emerging entrants to the CRC markets? To what degree do the various non-clinical factors impact EU5 market access to drug therapies?

  • How do EU5 surveyed oncologists expect prescribing of current and emerging mCRC therapies to evolve in light of anticipated regulatory approvals, reimbursement restrictions, and budgetary constraints? What lessons can be learned from the struggles of existing branded mCRC therapies to gain traction in the EU5?

  • What clinical benefit do interviewed payers expect emerging therapies for mCRC to demonstrate to secure favorable reimbursement? What do they believe to be an appropriate clinical trial comparator and primary end point for emerging therapies?

  • To what degree will surveyed physicians embrace the entry of biosimilar versions of bevacizumab and cetuximab? Will the availability of biosimilar MAbs for mCRC improve patient access? What are payer and physician expectations for the use of biosimilars within the first year of launch?

Scope:

Decision Resources Group’s European Physician & Payer Forum report The Battle Between Angiogenesis and EGFR Inhibitors in Colorectal Cancer: How Will Physician and Payer Attitudes and Decisions Shape this Market? explores the evolving reimbursement and market access landscape for therapies for the treatment of mCRC, the dynamics affecting prescribing of key oncology therapies in the cost-constrained climate, and the primary challenges facing emerging therapies aspiring to make inroads into the mCRC market.

Markets covered: France, Germany, Italy, Spain, United Kingdom.

Primary research: Online survey of 254 medical oncologists, interviews with 15 European payers. Interviewed payers include the following:
- France: Hospital formulary committee members and an ex-member of a transparency committee
- Germany: G-BA advisor, hospital pharmacy director/hospital formulary committee member, hospital pharmacy director
- Italy: AIFA advisor, AIFA advisor/ex-AIFA & CTS member, hospital/regional pharmacy director
- Spain: Hospital/regional formulary committee members and hospital/regional pharmacy directors
- United Kingdom: NICE member, hospital pharmacy director, CCG advisor/hospital formulary committee member

Author(s): Joanne Graham, Ph.D.
Laurie DiModica, M.S.

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