The late-stage development pipeline for non-small-cell lung cancer (NSCLC) is one of the busiest pipelines in oncology, with approximately 25 novel therapies in Phase III development. Several of these agents, including the PD-1 inhibitors Opdivo (Bristol-Myers Squibb) and Keytruda (Merck & Co.), the third-generation EGFR inhibitors AZD-9291 (AstraZeneca) and rociletinib (Clovis Oncology/Celgene), and the second-generation ALK inhibitor Zykadia (Novartis), are set to enter the European NSCLC market by the end of 2018. Novel therapies are expected to be priced at a premium and to join existing costly therapies such as Alimta (Eli Lilly), Avastin (Roche), Tarceva (Roche/Astellas), and Xalkori (Pfizer), further fragmenting an already crowded and competitive market. As therapies seek to optimize their place in medical practice, and EU5 markets strive to constrain healthcare expenditures, payers and prescribers must balance tightening budgets and evolving cost-containment policies with clinical need.

Questions Answered in This Report:

  • Product labeling and prescribing restrictions imposed by healthcare authorities impact the treatment algorithm and market landscape for NSCLC in Europe. How do European product labeling and/or local, regional, or institutional restrictions differentially impact use of key brands in NSCLC? What role do key brands play in the treatment of NSCLC in the EU5, and how do prescribing patterns vary by country? What are the barriers to biomarker testing, and how do these barriers impact prescribing?

  • Biomarker-driven prescribing has a central role in the treatment of NSCLC. How does reimbursement of approved therapies with a companion diagnostic differ from those without? How do national, regional, and local healthcare authorities regulate biomarker-driven prescribing of therapies in NSCLC?

  • Numerous therapies are in late-phase development for NSCLC, many of which are slated to launch in Europe by 2018. What are payers’ reactions to recently approved therapies? What clinical advantages could secure reimbursement for emerging drugs? How do surveyed oncologists across the EU5 embrace newly launched therapies? How will prescribing patters change with the launch of novel agents for NSCLC?

  • Impact of health technology assessments and pharmacoeconomic evaluation on access to NSCLC therapies. How will increasingly complex health technology assessments and pricing and reimbursement negotiation processes in the EU5 impact access to costly novel therapies? What role will head-to-head and pharmacoeconomic outcomes play in differentiating the reimbursement of novel, high-cost therapies versus current standards of care?

  • The market access landscape in Europe continues to evolve. 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?

Scope:

This European Physician & Payer Forum report, explores reimbursement and payer policies that influence prescribing trends of approved therapies for NSCLC. The report also assesses levers and barriers that will promote or restrict market access for premium-priced novel agents for NSCLC across the cost-constrained EU5.

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

Primary research: Online survey of with 254 medical oncologists. 15 country-specific interviews with payers, as follows:
- France: Hospital formulary committee member, hospital formulary committee member, ex-member of transparency committee
- Germany: G-BA advisor, hospital pharmacy director/hospital formulary committee member, hospital pharmacy director
- Italy: AIFA advisor, AIFA advisor/ex-AIFA and CTS member, hospital/regional pharmacy director
- Spain: Hospital/regional formulary committee members; hospital/regional pharmacy directors
- United Kingdom: NICE member, hospital pharmacy director, CCG advisor/hospital formulary committee member

Author(s): Orestis Mavroudis-Chocholis, Ph.D.

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