As oncology increasingly moves toward personalized approaches to therapy, the use of predictive biomarkers will become more important. A plethora of biomarker-driven brands are already available for several oncology indications, including breast cancer, colorectal cancer, and non-small-cell lung cancer, and many more such therapies are in the pipeline. Biomarkers enable the selection of patient populations likely to respond to a particular therapy and thus limit treatment costs by preventing a therapy’s uptake among patients unlikely to respond to treatment. As a result, hospital and clinician funds can be allocated more efficiently. The drug labels that restrict treatment to biomarker-positive patients also allow tighter control of spending, especially in the cost-conscious EU5 countries.

Questions Answered in This Report:

  • How does the presence of a biomarker test influence payer and physician perceptions of oncology agents? How are current biomarker-driven therapies viewed by EU5 payers and physicians?

  • How do European product labeling and/or local, regional, or institutional prescribing restrictions affect prescribing of biomarker-driven agents? Do they experience any off-label use? How are biomarker tests reimbursed across the EU5? 

  • What are the main limitations of biomarker-driven agents across Europe? Do all patients get biomarker-tested? What proportion of patients receives definitive results from biomarker testing? How long does it take to receive the test results? 

  • Does the presence of a biomarker influence the reimbursement of an emerging therapy? What clinical advantages could secure reimbursement of emerging biomarker-driven agents? 

  • How might evolving healthcare reforms and cost-containment strategies affect reimbursement of novel biomarker-driven 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 exploit to better position new biomarker-driven products in the EU5? 

  • Will oncologists welcome new market entrants Zykadia, Alecensa, Selumetinib, Keytruda, AZD-9291, rociletinib, binimetinib, Kadcyla, rilotumumab, neratinib, niraparib, and olaparib?

Scope:

Decision Resources Group’s European Physician & Payer Forum report “Evolving Physician and Payer Perspectives on Biomarker-Driven Prescribing in Oncology” explores reimbursement and payer policies that influence prescribing trends for approved biomarker-driven agents in NSCLC, malignant melanoma, colorectal cancer, gastric cancer, breast cancer, and ovarian cancer. The report assesses levers and barriers that will promote or restrict market access for premium-priced novel biomarker-driven agents across the cost-constrained EU5:

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

Primary research: Online survey of 332 oncologists and interviews with 15 European payers. Interviewed payers are as follows:

- France: a hospital pharmacy director and Haute Autorité de Santé (HAS; National Health Authority) adviser; a hospital formulary committee member; and a formulary committee member/pharmacy director and HAS adviser.

- Germany: an active member of national boards, a GBA member, and a head of drug division at an association.

- Italy: an advisor to the Agenzia Italiana del Farmaco (Italian Medicines Agency) and member of the Prontuario Terapeutico Ospedaliero Regionale (PTO/PTOR); an adviser to the Agenzia Italiana del Farmaco (Italian Medicines Agency); and a PTO/PTOR advisor.

- Spain: two pharmacy directors and an area specialist pharmacist at Servicio Andaluz de Salud (Andalusian Health Service [SAS]) .

- United Kingdom: a clinical commissioning group (CCG) member and hospital pharmacy director, a hospital director, and a commissioning pharmacist in a CCG.

Author(s): Dana Gheorghe, Ph.D.

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