Steven Peskin, MD, MBA, FACP: [In regard to] the expedited FDA approval around the selection, use, and coverage [of a therapy], certainly, that designation will get our attention [as well as] other payers’ attention. In all likelihood, if something gets a prior review (expedited review), then we’re going to jointly, nimbly, and quickly develop a medical policy around that particular breakthrough therapy to allow for, or cover, its use in the indication for which it is being accelerated or expeditiously approved.

[When it comes to] something that gets an expedited approval in a relatively narrow indication that might have promise in other areas, we would be looking at the data, evidence, emerging data, abstracts, and posters from certain institutions that are working on the additional applications or uses of those medications or those immunotherapies—that would certainly influence us as it relates to the relative narrowness or the relative expansiveness.

So, I can’t really give you a one-size-fits-all [answer] as it relates to a certain therapy and a novel pathway that might have promise in colorectal as well as non–small cell lung (just to use that example). I can’t give you any hard and fast answer on how we would approach that from a standpoint of something that’s narrowly approved and might have promise in other tumor types.

[When differentiating between therapies], again, we’re going to be looking, increasingly, to our clinical partners to help us, as they’re being looked at to deliver high-value, cost-aware, quality care. We’ll certainly look at the relative value of 2 particular competing therapies, if you will, in terms of overall survival (as the number one consideration) and relative impact as it relates to safety profile and tolerability. So, the factors that have always gone into play—whether you’re talking about a drug for heart disease, or for kidney disease, or for asthma—those same factors still are resonant as we look at therapies that may be, in a sense, competing in a particular tumor type.

Do Accelerated Review and Narrow Indications Influence Payer Decisions?

In this segment, Steven Peskin, MD, MBA, FACP, highlights variables that payers consider when making coverage decisions regarding oncology treatments that go through the expedited approval process at the FDA. Dr Peskin also discusses how decisions are made in scenarios where competing therapies with similar indications are available.
Published Online: November 02, 2016
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Episode 2 Clinical Insights on Newer Immunotherapies in Lung Cancer
Episode 3 Immunotherapy in Oncology and the Role of the PD-L1 Biomarker
Episode 4 Early Biomarkers and Coverage Decisions in Immuno-Oncology
Episode 5 How Important Are Biomarkers for Treatment Selection in Lung Cancer?
Episode 6 Predictive Biomarker Testing for Immunotherapy in Melanoma
Episode 7 Health Plan Coverage of Diagnostic Tests for PD-L1 Expression
Episode 8 Distinguishing Between Companion and Complementary Diagnostic Tests
Episode 9 Clinical Pathways Should Keep Pace With New Data
Episode 10 Health Plan Perspectives on Clinical Pathways
Episode 11 Clinician Concerns with Adopting Clinical Pathways
Episode 12 Safety and Efficacy of Targeted Therapy Versus Immunotherapy in Melanoma
Episode 13 Clinical Pathway Consideration and Payer Decisions
Episode 14 Understanding Immunotherapy Efficacy and Safety
Episode 15 Combination Immunotherapies in Melanoma
Episode 16 Payer Concerns With Including Novel Immunotherapies on Clinical Pathways
Episode 17 Combination Therapies: What Works Best for Immuno-Oncology?
Episode 18 Improving Patient Access-Rapid Approval and Patient Assistance Programs
Episode 19 Health Plan Take on the Cancer Drug Approval Process and Surrogate Endpoints
Episode 20 The Unmet Need in Immuno-Oncology and New Drug Approvals
Episode 21 Value Benchmarks in Immuno-Oncology
Episode 22 Do Oncologists Contemplate Patient Cost Sharing?
Episode 23 Importance of Patient Assistance Programs in Oncology
Episode 24 Payer Stance on Immunotherapy in Oncology Care
Episode 25 Influence of Biomarkers in Immunotherapy Treatment Decisions
Episode 26 Appropriate Use of Companion Versus Complementary Diagnostics
Episode 27 Clinical Pathways
Episode 28 Do Accelerated Review and Narrow Indications Influence Payer Decisions?
Episode 29 The Value of Patient Assistance Programs
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