Coverage and Clinical Support in CLL Treatment

John Fox, MD, MHA: Payers are less concerned about how therapies are administered, whether it be oral or IV or a combination. What we’re most interested in is making sure that the patient is on the optimal regimen given their risk factors. In most of these regimens that are IV infusions—say, for example, Rituxan-based therapies—they’re typically just given for 6 cycles or 6 months. So, for example, with venetoclax/rituximab, rituximab is given for 6 months with continuous treatment for up to 2 years with venetoclax. So, although people argue that treatment with the oral regimens is easier on the patient, there are some downsides to that. There’s evidence that shows that missing 8 consecutive days with ibrutinib, for example, reduces progression-free survival. So, again, for us as a payer, it’s more left to the provider and the patient to understand what the optimal regimen is for that patient and what’s going to be more tolerable.

As payers, we’re very interested in ensuring that patients are compliant with their regimens because that’s associated with the best outcomes. So, for oral therapies, in our health plan, we allow 14-day fills at a time, so we know right away if a patient fails to fill and can intervene or notify the physician if a patient has failed to be compliant with their therapy. For the IV regimens, we don’t have the ability to do that, because there’s a delay in claims. So, we’re most helpful for oral therapies, but we’re not helpful at all in the IV regimens.

The hallmark for making treatment decisions in CLL, to my understanding, has always been to identify those negative prognostic, or positive prognostic, risk factors. In CLL, historically, we’ve looked at the types of deletions, at complex karyotypes, and at IGHV status. With the approval of ibrutinib in first-line treatment-naïve patients and treatment in relapsed/refractory patients, that may be less important. But nevertheless, being able to tell a patient what their prognostic factors are and whether they’re likely to do well or do poorly, I still think is important. So, I’m not sure that anybody would say, “We don’t need to understand those risk factors before treatment.” Although, again, ibrutinib can be used first line in both treatment-naïve and in relapsed/refractory patients.