Dr Adam Olszewski Discusses Challenges With Using Ibrutinib as a First-Line Therapy in CLL

While ibrutinib is a major breakthrough in treating chronic lymphocytic leukemia, it is associated with financial burdens and medical concerns for the older patients being treated, said Adam Olszewski, MD, associate professor of medicine at The Warren Alpert Medical School of Brown University.

Transcript

What concerns might there be about using ibrutinib in the front line for patients with CLL?

Well, ibrutinib is certainly a major breakthrough in the treatment of CLL, both for older and younger patients. But there are some specific concerns when we think about deploying ibrutinib as a first-line therapy based on the results of the recently reported randomized trials to the larger population.

One concern is economic. Ibrutinib shifts treatment from oral therapy, typically limited time duration, towards long therapy, which is priced at an exorbitant level—over $10,000 per month. Most older patients in the United States, often covered by Medicare Part D plans, are shocked by these prices. And for them this often means approximately $3000 coinsurance or co-payment with the first prescription. So, there’s a concern how this might impact access to this medication, and whether the patient will actually choose this better treatment over historically less-effective, yet significantly cheaper at least from the point of view of out-of-pocket costs, therapies. So that’s one—a socioeconomic concern.

The second one is a medical concern. Long-term ibrutinib therapy is known to increase blood pressure in a significant proportion of patients. Most older patients already have high blood pressure, or a risk of it. Additionally, clinical trials have reported nontrivial rates of atrial fibrillation, which is a significant comorbidity, that often requires anticoagulation, and ibrutinib is also known to act as a form of a mild blood thinner or antiplatelet agent, if you wish, and it may increase risk of bleeding. Additionally, there are now new reports of a ventricular, rare fibrillation, ventricular arrythmias, that are occurring in patients. Probably a very, very low rate. And we don’t understand yet the risk factors for it. But for older patients these are all significant medical considerations.

So, our study [presented at the 61st American Society of Hematology Annual Meeting & Exposition] was able to alleviate the socioeconomic concern because we found there was no association between the choice of first-line ibrutinib therapy and receipt of what is called low-income subsidy, which eliminates co-payments for ibrutinib for Medicare patients. And we did not find association with this choice between any socioeconomic factor. So, it does seem that medical factors are determining the choice of treatment and allowing patients to get treatment, this is something that doctors and their support staff is able to do. We have shown in another study, though, that the vast majority of Medicare patients require assistance from co-payment foundations and charity foundations to really access expensive oral medications in hematology.