John L. Fox, MD, MHA: It’s interesting. Three decades ago, there was a significant shift from hospital-based chemotherapy to outpatient-based chemotherapy, from infusion in hospitals to infusion in offices. In the last decade or so, there have been a couple more paradigm shifts: one from IV-administered therapies now to oral therapies and from general chemotherapy to targeted chemotherapy or targeted agents, not just simply chemotherapy or immunotherapy. And so what impact has that had on managed care? I think it really depends on what viewpoint you’re coming from. As a health plan that’s at risk for both the medical benefit and the pharmacy benefit, these paradigm shifts from IV to oral really haven’t had an impact other than on the cost, and the shift from chemotherapy to targeted therapy again hasn’t had a major impact on how we reimburse care. It certainly changed the cost of care, although I would say that we’re certainly in favor of molecularly-targeted therapies or targeted therapies because they increase the likelihood that someone’s going to get a therapy that’s going to work and reduce the waste. In other words, the patients who get therapy don’t respond and get the side effects as their only consequence of that therapy.
Chronic lymphocytic leukemia is an interesting space because now we have at least 2 oral therapies that are rated highly, category I or category IIa, by the National Comprehensive Cancer Network; whereas before, all we had was IV therapies. I would say, though, that the changing environment here reflects greater diagnostic accuracy around what stage therapy or what stage of CLL patients have and, as a consequence, what therapy is most appropriate. And from our vantage point as a payer, whether or not IV therapy or oral therapy is most appropriate, we’re really indifferent to.
There are a number of unmet needs in CLL that probably aren’t dramatically different than any other cancer type. We need drugs or drug regimens that increase the likelihood of an early, deep, and durable remission with prolonged survival; not only progression-free survival, but long-term survival. And then for patients who do relapse, we need the same things: drugs that can induce, rather rapidly, long-term and durable remissions. But that’s true not only for CLL; it’s true for all hematologic malignancies, and it’s true for metastatic cancer or stage 4 cancer in general.
But just as important to that long-term and durable remission are drugs that are more convenient to take and, in particular, have lower toxicities. One of the oral agents in particular, in this space, has significant toxicities and increased risk of death. And while it has certain benefits in the relapse space, there are some challenges, and they’re not just specific to that drug. All drugs have toxicities. I think there is this notion that oral therapies would be safer and less toxic, and it’s not necessarily true, as this example shows.