Since the first chimeric antigen receptor (CAR) T-cell therapies were approved by the U.S. Food and Drug Administration (FDA) in 2017, U.S. hospitals have been treating patients with the potentially life-saving therapy. However, few have been paid by private insurers or Medicare for these services.
The financial uncertainty around CAR T-cell therapies has existed since the agents were initially approved. List prices for the two FDA-approved CAR T-cell products (tisagenlecleucel and axicabtagene ciloleucel) are upwards of $373,000 for a single infusion, but limited experience with the therapies mean that hospitals and insurers can only estimate the true costs of the administering the treatments.
Medicare is still finalizing its payment structure for the treatments, while private insurers are responding to cases on an ad hoc basis. This can lead to long delays in both treatment and payment.
Data provided to the FDA estimates that less than 2,000 patients have been treated with an approved CAR T-cell therapy at any of the approximately 130 U.S. medical centers authorized to deliver the treatment.
The Massey Cancer Center at Virginia Commonwealth University (VCU) is one of two authorized centers in the entire state of Virginia. In STAT, Penny Trentham, vice president of managed care at VCU Health System, outlined the issues surrounding payment for gene therapies. “It’s just really hard right now, and I think everybody’s asking for specific answers, but until we get more experience with this treatment protocol, it’s hard to say [what] we would be willing to accept as a defined payment term,” she explained. “Literally, you should do hundreds of cases before you draw a conclusion. We’ve done four.”
Hospitals are also confronting costs for training staff to properly administer CAR T-cell treatment – and to manage its potentially life-threatening side effects.
Ms. Trentham and other hospital administrators who spoke with STAT believe that the payment issues will be resolved in the near future, noting that all insurance companies have agreed to cover the therapy and hospitals are actively negotiating with insurers on coverage terms.
“It’s not uncommon for a complex claim to be slower to pay,” Ms. Trentham said. “I would not conclude that there’s any problem.”
Source: STAT, March 12, 2019.