Do Accelerated Review and Narrow Indications Influence Payer Decisions?

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.