Steven Peskin, MD, MBA, FACP: [With regard to determining treatment value], we will evaluate new therapies and therapies that would forestall, or delay, the disease progression—what’s called progression-free survival or disease-free survival—for periods of time. There’s a lot of writing that’s been done on the quality-adjusted-life-year construct in evaluating new medical technologies and new medical treatments. We will certainly take into consideration what others are looking at in terms of the Centers for Medicare & Medicaid Services, NCCN (National Comprehensive Cancer Network), ASCO (American Society of Clinical Oncology), and the like.
Again, [when considering treatment appropriateness], I can’t give you any definitive answer on a particular situation because every situation is going to be evaluated on its own with a lot of careful consideration. What are the side effects, safety, and tolerability, and what is the progression-free survival amount of time? Is it 2 days or 200 days? Those kinds of things will all go into weighing the evidence and making a reasoned, rational, informed decision.
Will real-world data play a role with chronic lymphocytic leukemia (CLL) for coverage or other value decisions? The real-world data will increasingly inform not only us, but perhaps, more importantly, the clinical organizations that are providing the care—those organizations that are in value-based frameworks, not only in our oncology episode-of-care, or bundles, but in total cost-of-care models that we have with accountable care organizations and with large patient-centered medical home organizations.
So, where there is a shared focus on the clinical outcome, the total cost, and the patient experience of care—the “Triple Aim”—real-world data is and will be very important. The question is, is there any other component around CLL? I think we’ve really covered all of the key areas—the total cost for an episode, the tolerability, and the side effect profile of a particular course of treatment or type of treatment, and the ability of institutions we’re working with to adequately support that treatment, whatever that treatment may be.
So, as you’re looking at treatment alternatives, perhaps infused therapy has a leg up in certain situations because you know you’re going to give it. It’s very predictable [whereas] we’re not sure if the person is adherent to oral therapies. On the other hand, we might say, “Well, oral therapy options are much more convenient for the patient, have a better tolerability, allow people to continue to live and go to work and things like that.” So, there are a lot of what I would call “trade-off analyses.” I don’t think they go beyond the Triple Aim.
In the “Quadruple Aim” that we talk about, however, the fourth part of that is healthcare professional sustainability and satisfaction. But, that gets into different considerations about workflow, administrative burden, and things like that. So, I can’t think of anything else outside of the Triple Aim that would be influencing our decisions around CLL alternatives.