Lee Schwartzberg, MD, chief of the division of hematology and professor of medicine at the University of Tennessee, is troubled by the amount of variation he’s observed with payers’ approach to reimbursing for CAR T-cell therapy.
“This is transformative therapy, and we really would like to see every payer [realize] the evidence and pay for this type of therapy,” says Schwartzberg, who helped develop a white paper for the Association of Community Cancer Centers on immuno-oncology. “There shouldn’t be as much variation in coverage as we’re seeing.”
And this is despite approval by the FDA of CAR T-cell therapies to treat acute lymphoblastic leukemia and relapsed diffuse large B-cell lymphoma.
Schwartzberg acknowledges that the therapies are expensive. The drugs alone can cost between $350,000 and $500,000—and that doesn’t include the cost of treating patients in hospitals and their follow-up care. Thus, the total price tag can be as high as $1,000,000 per patient.
At that cost, covering all patients who want access to CAR T-cell therapy isn’t sustainable, says Schwartzberg. In light of this, he offers two recommendations to help payers and providers to take ownership of CAR T-cell therapy reimbursement:
1. Pick the right patients, at the right time, and “just get them covered.”
There are patients, Schwartzberg says, whose only option for a cure is CAR T-cell—and there are a significant proportion of patients treated with CAR T-cell therapies who appear to be cured of their disease or at least have achieved long-term remission status.
To support that point, he cites a study published in the New England Journal of Medicine in February that shows patients with leukemia who received CAR T-cell treatment experienced a longer medial overall survival and a lower incidence of toxicity.
2. Learn from the past.
Schwartzberg points to reimbursing for the use of stem cell transplants, which were used in concert with high-dose chemotherapy in the treatment of women with breast cancer in the 1990s.
Many payers chose not to cover stem cell treatment for these patients, and that led to lawsuits which some of the payers lost. The result, points out Schwartzberg, is those payers were then required to provide coverage. In this situation, he says, stem cells were being used widely without evidence that they could help cure patients.
By means of contrast, the evidence that CAR T-cell therapy works for a very small subset of patients—namely those with acute lymphoblastic leukemia and relapsed diffuse large B-cell lymphoma, as approved by the FDA—is very strong. Schwartzberg notes that there are thousands of patients with the latter type of cancer, based on current indications.
“These are the last-ditch patients, and everyone believes that CAR T-cells are going to be [used earlier in a patient’s treatment path]. The optimism is that they’ll be used to cure more people,” he says.
One advantage healthcare has today that it didn’t have in the 1990s is the existence of biomarkers that help determine the appropriate patients for CAR T-cell therapy, adds Schwartzberg.
“CAR T is an area where we need careful collaboration between payers and clinicians to come up with guidelines that go beyond what was just in the clinical trials, and to help clinicians pick the best patients for these therapies, if the payers are going to pay for them,” he says. “It’s still pretty early days for immunotherapy and immune-oncology, so not every health plan has the expertise, although I would argue that every health plan should make this an important priority for them because patients are losing out here.”