How Do Payers Assess Value of Treatments in CLL?

John L. Fox, MD, MHA: The buzzword today is all about cost effectiveness. Frankly, what I’m most interested in is cost savings. I want to promote those things that actually reduce the cost of care. In this disease setting, and in cancer in general, there are very few things that are going to be cost-saving. So, we turn to cost-effective. What can produce a desirable outcome at what’s considered an affordable rate? Unfortunately, today, we don’t have definitions of what’s affordable. ICER, the Institute for Clinical and Economic Review, out of Boston and Steve Pearson have done a lot of seminal work in this space, especially in multiple myeloma, and looking at what’s considered an affordable cost. What’s the affordable cost for quality: $150,000, for example? We don’t have that data in this space.

The larger question, though, is do we care about what’s cost-effective? And, more importantly, are we, as health plans, willing to make decisions around excluding coverage for drugs that are considered to be cost-ineffective? The reality is that in 26 states, and maybe more by now, there are mandates to cover FDA-approved drugs. Even if I thought something was wildly cost-ineffective, it would limit my ability as a plan to deny coverage for that. But, again, the question is for providers, weighing the cost and the outcomes really looking at cost-effectiveness: will they make different choices especially when they’re at risk for the total cost of care?

And, again, what we’ve seen in this space, in chronic myeloid leukemia, for example, and multiple myeloma, while we have more and more drugs, there is no competition driving down the cost of care like we saw in hepatitis C drugs. With the advent of new therapeutic entities in the hepatitis C space, it drove down the cost of those drugs. We haven’t seen that in the cancer space. We haven’t seen it in chronic myeloid leukemia, multiple myeloma, nor have we seen it in CLL. So, the pressure is on everyone as to how do we provide therapy and care that patients need, but in a way that’s affordable? And increasingly, especially since CLL is a disease of the elderly, the patients have traditional Medicare and Medicare Advantage plans. Once they blow through the doughnut hole, they still have a 5% cost share. So, with Imbruvica, which costs about $150,000 a year, if you’re a Medicare beneficiary getting that drug and you’ve blown through the doughnut hole, which you will on your first month’s dose, you still have a 5% cost share, which is the equivalent of about $7500 a year.

ASCO has talked a lot about financial toxicity and the importance of talking to patients about the cost of therapy, the relative trade-offs, and the benefits. I think that’s going to be an increasingly challenging conversation for patients to have with physicians, and likewise helping patients decide which therapy is most appropriate for them.

Combination therapy has been around for decades. What’s new is that we’re using combinations of very expensive medications, whether they be biologics or expensive small molecules. The question is, what’s the additional incremental value of that? That’s to be borne out in clinical trials. But, the challenge is that we’re studying the add-on therapy. We’re studying one biologic, adding on another, and seeing if there is an incremental benefit. There is surprise if there isn’t, and most of the time there is. So, from a payer’s vantage point, if there is a clinical improvement, we’re obligated to pay for that. And so, we all have to figure out when is the most appropriate time to use combination therapy? When is the incremental benefit worth the additional cost? And unfortunately today, we don’t have those conversations. The NCCN has increasingly considered cost and its evaluations, especially as evidence blocks. All those tools are in their infancy today, but the reality is when the clinical studies show that this has a therapeutic benefit, the combination of biologics, they’re going to be covered.

The advent of oral therapies, including all-oral therapies in CLL, certainly has provided new evidence about what effective therapies are in this space. In the long term, whether the outcomes are better than all IV therapies, may be dependent on adherence to the therapy. If we look at real-world evidence, the payment under the medical benefit to the pharmacy benefit for oral therapies certainly does shift the cost from one benefit to another. Again, at our health plan, we bear the total cost regardless of what benefit it comes under. But, it also shifts the cost to the patient. As I referred to earlier, patients getting an oral cancer therapy under the Medicare benefit have not only the doughnut hole to contend with, but they also have that catastrophic coverage to deal with. So, I think regardless of the medical or pharmacy benefit, patients are going to have to contend with those costs just as we will as a health plan.