Oncology is increasingly moving toward a personalized treatment approach, enlisting predictive biomarkers to guide therapy choice. This trend is already being felt in indications as varied as breast cancer, colorectal cancer, and malignant melanoma, and is affecting uptake of key brands. In addition, multiple emerging therapies in the oncology pipeline, such as Novartis’s Zykadia (ceritinib) and Amgen’s rilotumumab, hope to benefit from biomarker-driven prescribing.

Predictive biomarkers give oncologists more confidence that a patient will respond to a therapy. Biomarker testing also means that payers do not have to reimburse therapies that will not work in biomarker-negative patients, allowing funds to be allocated more efficiently. However, problems can arise in obtaining sufficient high-quality tissue from a biopsy in order to perform biomarker testing, and delays in receiving results of biomarker tests can adversely affect prescribing of biomarker-driven therapies. Furthermore, how biomarker tests are reimbursed will in turn impact uptake of biomarker-driven therapies.

Questions Answered in This Report:

  • Does having an associated biomarker change physician and payer perceptions of oncology agents? How do physicians and payers view currently approved biomarker-driven drugs? Have these agents achieved favorable formulary status? Are they preferentially prescribed? Do they experience off-label use?

  • What are the limitations of biomarker-driven therapies? What proportion of patients receive positive results from biomarker tests? How are biomarker tests reimbursed? What is the average time taken to receive biomarker test results?

  • Does biomarker-driven prescribing influence formulary placement of novel therapies? What prescribing controls are likely to be placed on biomarker-driven therapies? What will their tier placement be? What is the average out-of-pocket cost for biomarker-driven therapies?


This U.S. Physician & Payer Forum report contains insights from a survey of 100 medical oncologists and 30 MCO pharmacy/medical directors to capture their views on anticipated prescribing and reimbursement barriers in relation to current and emerging biomarker-driven agents in NSCLC, colorectal cancer, malignant melanoma, gastric cancer, breast cancer, and ovarian cancer.

Markets covered: United States.

Primary research: Online survey of 100 oncologists and 30 MCO pharmacy/medical directors.

Author(s): Daniel Roberts, Ph.D.

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