The Best Policy to Eliminate Barriers to Care

June 23, 2020
Dr. Brian Koffman

Advocacy Groups | <b>CLL Society</b>

Regulation changes could eliminate barriers to potentially lifesaving CAR-T cell immunotherapy for patients covered by Medicare or Medicaid.

As a personalized, next-generation therapy, chimeric antigen receptor T-cell therapy, or CAR-T, is an essential tool and a new opportunity for treating certain advanced forms of cancer. The Food and Drug Administration has approved CAR-T therapy for adults with certain lymphomas and for children and young adults with acute lymphoblastic leukemia (ALL) who have not responded to other treatments.

For many with blood cancer, the best treatment may be this therapy, which involves removing immune cells from a patient and reinfusing them after they’ve been engineered in a lab to recognize and fight cancer. For some, this costly procedure may be the only viable treatment option.

When I received a diagnosis of chronic lymphocytic leukemia (CLL) in 2005, I had been a practicing family physician for decades. CLL treatment was very different then, and I was told that my diagnosis came with a poor prognosis. My cancer was aggressive, and I needed an equally aggressive treatment, but there were few good options.

In 2018, after my third relapse, I was offered entry into an early-phase CAR-T clinical trial.

Compared with typical cancer regimens, CAR-T therapy is administered relatively quickly and offers the possibility of a durable remission that can persist long after completion. In my case, I had already spent years in treatment — receiving a bone marrow transplant and later participating in a phase 1 clinical trial for a novel drug — but with each treatment, my cancer returned.

Almost miraculously, just one month after receiving CAR-T therapy, I was told that my cancer was undetectable. Today, more than two years later, my cancer remains undetectable.

I was incredibly fortunate to have received CAR-T as part of a clinical trial. Unfortunately, despite unparalleled results, several factors inhibit broad patient access to CAR-T.

The geographic location of the patient can present a significant barrier to availability, as centers that give CAR-T treatments are primarily located in large cities in the eastern half of the United States, making it difficult or even impossible for some to receive the therapy.

In 2019, a CAR-T eligible patient insured through Medicare would have had to travel an average of 100 miles for treatment, whereas a CAR-T eligible patient with commercial insurance would have traveled an average of 66 miles for treatment. It stands to reason that adequate reimbursement could expand availability.

Patients with private insurance who need the one-time treatment that costs $373,000 are the most likely to receive it because of more generous and realistic reimbursement, while access remains elusive for those on Medicare or Medicaid.

One reason is that hospitals lose an estimated $50,000 per Medicare patient treated with CAR-T, showing that reimbursement policies have not kept pace with therapy innovation.

Patients covered by Medicaid may not fare much better. Policies differ by state, as does access. Most states do not have explicit Medicaid policies for reimbursing providers for administering CAR-T. In states where Medicaid does cover CAR-T, providers generally receive only partial reimbursement.

It is encouraging to note that in May, CMS proposed a regulation that would raise the reimbursement rate for CAR-T at hospitals treating patients covered by Medicare. Although this will not ensure access among all patients who need this therapy, including those on Medicaid, it is a step in the right direction. As both a physician and CAR-T patient, I am encouraged by this development and hope to see the rule enacted.

CAR-T offers an essential treatment option for patients. The CLL Society wants responsible policies put into place to ensure that hospitals do not have to limit access to prevent financial losses. The proposed increase in reimbursement rates for hospitals treating the Medicare-covered CAR-T population is a good step that we would like to see enacted. Because of wide variation from state to state, we are unable to recommend a specific Medicaid policy except to suggest that the rules should benefit patients.

Patients covered by Medicare or Medicaid who have CLL or other eligible blood cancers should look for medical centers that are experienced in administering CAR-T, because this treatment can be a lifesaver for those with few options.

For more information, visit cllsociety.org.

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