John L. Fox, MD, MHA: Until recently, the only therapies that were readily available or widely used for treatment of patients with CLL, either in the initial induction or in the relapse setting, were all IV therapies. In the last couple of years, we now have oral therapies. In fact, we have all-oral combination therapies for induction treatment of CLL. So, now providers have an option, and patients have an option, between an all-oral or oral and IV. We have ibrutinib plus chlorambucil versus obinutuzumab plus chlorambucil—one oral and one IV. And the same is true in the relapsed remitting setting. Now, we have an oral and an IV combination that can be used in that setting. Providers have a larger number of possibilities for treating patients. For us as a health plan, as long as those combination therapies are part of the NCCN guidelines, we’ve agreed to cover any of those therapies. In the future, though, I would see that as the costs of these therapies continue to escalate, we’ll manage those categories differently, including benefit designs and prior authorization. But, for the time being, it’s a wide new world with the availability of oral therapies.
As a health plan, we cover drugs and regimens or combination therapies under both the medical benefit and under the pharmacy benefit. And if they span both benefits, we’ll cover those, too. Frankly, what we’re more concerned about is the relative efficacy and the safety of the regimens rather than what benefit they come under. If you’re a pharmacy benefits management company, and you’re only covering those drugs that are coming under the pharmacy benefit, your perspectives may be changed. But, from our vantage point, we’re most concerned with the evidence and not whether or not the drug comes under the medical or the pharmacy benefit. I would say, however, that in the future, we’re going to be more concerned about the relative costs of these therapies. And we may manage them differently, whether that be through step therapy or through different cost sharing in the benefit design.
There are an ever-increasing number of therapeutic options for most cancers, including CLL. And the question is, how do we help inform physicians about what the standard of care is? Many of the EMRs (electronic medical records) now have the ability to provide online decision support. Many of the guidelines distributors are providing that same thing. Some practices are developing those decision support tools themselves to help ensure that we get the right drug to the right patient, that we’re incorporating all the biomarker information, all the cytogenetics, and the karyotypes, etc. As a health plan, though, do we have any obligation to ensure that patients are provided medicines that are adherent with the guidelines? Certainly, we do. We do that in a prior authorization process. It’s not really a clinical decision support tool; it’s more like a recheck that the therapies that patients are provided are consistent with the guidelines.