Based on a survey of 100 medical oncologists and 30 MCO pharmacy and medical directors, this report explores the market access challenges facing key current and emerging brands used in the treatment of NSCLC. The report focuses on the powerful contemporary issues that are driving the increasingly fragmented treatment of this complex disease: molecular testing, biomarker-driven prescribing, positioning of agents without biomarkers, and the role of high-cost maintenance therapy. Emerging classes covered include PD1/PD-L1 directed therapies, next-generation EGFR and ALK inhibitors, and antiangiogenics. To contextualize our survey findings, this special report will include findings from qualitative interviews with a small number of influential payers and pathologists.

NSCLC is often heralded as the “pin up” indication for personalized medicine in oncology. However, despite the recent FDA approval of another biomarker-associated agent, Boehringer Ingelheim’s Gilotrif (afatinib), adding to Roche/Genentech/Astellas’s Tarceva (erlotinib) and Pfizer’s Xalkori (crizotinib), the reality is that only a small percentage of NSCLC patients actually receive a therapy based on the molecular characteristics of their cancer as determined by a biomarker test. However, add to this the fact that Eli Lilly’s Alimta (pemetrexed) is approved only for patients with non-squamous cell histology, Roche/Genentech’s Avastin (bevacizumab) is contraindicated in patients with squamous histology, and increasingly drug selection is based on features of a patient’s tumor.

Questions Answered in This Report:

  • Understand medical oncologists’ current use of targeted agents in advanced/metastatic NSCLC: What are the barriers and drivers to EGFR-mutation testing? Are they the same for ALK-testing? What role does testing for KRAS mutation have? What patient and tumor characteristics do physicians use to select patients for molecular testing? What factors impact the choice of drug in the first-line setting? What factors determine the choice of targeted agent in the second- and subsequent line settings? How has the U.S. launch of Gilotrif impacted prescribing of Tarceva?

  • Uncover the extent to which pathologist attitudes to biomarker testing and practices are influencing prescribing: What are academic pathologists’ views regarding “in-house” developed biomarker tests? What are the limitations to biomarker testing from pathologist perspectives? How do they approach “multiplexing” of tests? And what type of test do they prefer? What are pathologists’ expectations for the potential biomarker tests of the future for NSCLC? For example PD-L1, c-MET, BRCA, ROS1, BRAF, MEK, IGFR-1R. How easy will it be to add more biomarker tests to a diagnosis, and what will it involve? What are the existing limitations for histological diagnosis in lung cancer?

  • Explore medical oncologists’ and payers’ attitudes towards the role of maintenance therapy: How are physicians integrating maintenance therapy into their treatment practice? How do physicians select patients to receive maintenance therapy and how do they select which agents to prescribe? Given the additional cost burden of maintenance therapy, what cost control measures do payers put in place for treatment in this setting? Has the label extension for Tarceva in the first line impacted its uptake in the maintenance setting?  What factors will most influence formulary inclusion and positioning of Avastin for NSCLC?

  • Despite many high-profile novel therapies falling by the wayside, the late-stage drug pipeline for metastatic NSCLC is extensive and varied: Which emerging agents are physicians most optimistic about? Are there any that could address underserved patient segments such as squamous-cell histology and poor performance status patients? What price could novel agents attract? What differentiating factors will emerging drugs need to demonstrate for managed care organizations to award favorable tier placements and cost controls? We probe for views on PD1/PD-L1 directed therapies, next-generation EGFR and ALK inhibitors, and antiangiogenics?

Scope:

This study delves into the complex issues facing medical oncologists, payers, and pathologists who treat or reimburse for patients with NSCLC. Although EGFR testing has become more entrenched into the treatment paradigm, it is only recently that drug labels in the United States have required that molecular testing be undertaken ahead of first-line use of Tarceva, and now Gilotrif (each with a different FDA-approved EGFR-biomarker test). Because uptake of biomarker testing is a limiting factor for drug prescribing and reimbursement, it is crucial to understand the drivers of test uptake.

Many drugs in the pipeline are being developed without biomarkers, and it is also important to understand how such agents will be embraced and positioned alongside personalized agents.

Author(s): Joanne Graham, Ph.D.

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