Physicians are praising the decision by officials at the Centers for Medicare & Medicaid Services to provide coverage of chimeric antigen receptor T-cell therapy, though they say the planned payment structure will still leave hospitals in the red when treatment is administered.
On Aug. 7, 2019, the agency issued athat outlines Medicare coverage of chimeric antigen receptor (CAR) T-cell therapies when they are provided in health care facilities enrolled in the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies program. Medicare will cover treatments for both FDA-approved indications and off-label uses that are recommended in CMS-approved .
“What you’ve seen in both the [Medicare Inpatient Prospective Payment System] rule, as well as this coverage determination, is recognition by CMS that, with CAR T cells, we are dealing with something different and something extraordinary,”, vice president of government affairs at City of Hope, Duarte, Calif., said in an interview. “For a lot of patients who suffer with non-Hodgkin’s lymphoma, the consequences of being refractory to standard therapies mean that many patients have few great prospects for moving forward with curative treatments. CAR T cells represent a really innovative set of treatments for patients.”
Anational coverage determination, issued in February 2019, would have put in place a coverage with evidence development (CED) requirement for CAR T-cell therapy, covering treatment nationwide if it was offered through CMS-approved registries or clinical studies in which patients were monitored for 2 or more years following treatment.
Physicians applauded the decision not to restrict access by imposing the CED requirement.
“I think what CMS has put out is a good thing,” said, director of the Cleveland Clinic’s blood and marrow transplant program, and president of the American Society for Transplantation and Cellular Therapy.
“Both at the Cleveland Clinic level and the society level, we have been asking CMS for something similar and we are really glad and excited that CMS did do this. The concern was that CMS might do this in the context of some other regulatory requirements like CED that they sometimes do. I am glad that CMS decided not to put that mechanism into place for the CAR T-cell therapies,” Dr. Majhail said.
Dr. Alvarnas, who also serves as chair of the American Society of Hematology Committee on Practice, agreed. “I see good. I don’t see bad. I have read through this and it strikes me as being written with fairly great clarity.”
Dr. Alvarnas added that he had been worried about potential restrictions, such as CED. “Once you put something under that whole rubric of coverage with evidence development, then what you do is you create a bottleneck around access to therapy because you have to have an accruing clinical trial for patients to, in fact, be able to participate in that form of therapy.”
By not imposing a CED requirement, it opens the door to better understanding the role CAR T cells play in treatment, Dr. Alvarnas noted.
“Over time, the number of patients for whom these therapeutics work, based upon real medical evidence, will escalate and grow at a pace that can far exceed the restrictions placed under a CED model,” he said, adding that the national coverage determination “gives us the license to deliver therapeutics to the right patients based upon medical evidence as it evolves, provided that these things get listed as part of the compendia. I think that is a fantastic recognition that new roles for drugs, agents, therapeutics ... are going to evolve at a pace far faster than what CMS can write rules about.”
While Medicare’s coverage determination garnered positive reviews, the agency’s Inpatient Prospective Payment System– which outlines reimbursement for CAR T-cell therapy and other new technologies – got a more tepid response.
In the final rule, CMS raised the payment it makes to hospitals for administering CAR T-cell therapies through its new technology add-on payment. Payments will rise from 50% of the technology to 65%, an increase from $186,500 to $242,450 for CAR T-cell therapies, beginning on Oct. 1, 2019.
But even the bump up to 65% may not be enough.
“I see the move to 65% as a new technology add-on payment as an incremental step in the correct direction, but what we’ve done to some extent is that we’ve delayed getting to some sort of more wholly conceived system,” Dr. Alvarnas said, noting that a new system will be needed as the new technology add-on payment goes away in 2021.
, of the Karmanos Cancer Institute in Detroit said it’s a challenge to cover costs for the treatment. “If you just look at the simple math, it is still going to be an economic challenge. The cells that are approved for lymphoma patients that will probably fall into the Medicare category, the list price of those cells is $373,000. Even with the 65% coverage, it’s about $235,000-$240,000 in reimbursement,” he said. “For a facility to be able to provide the care for patients, you have that delta that is still not covered. It is still going to be an economic challenge for many of the facilities to provide this care.”
, an associate professor of medicine at Duke University, Durham, N.C., said that, while the coverage determination is a positive step, it’s not clear that it will provide meaningful access to CAR T-cell therapy because of the cost.
“These products are incredibly expensive, and the total cost of providing them is woefully underestimated in only focusing on the sticker price of the product,” he said. “Doing so ignores the significant hospital care, sometimes even critical care, as well as specialized knowledge and high touch supportive care, all of which is required to safely get patients through this revolutionary yet often risky treatment. So when CMS offers to pay just 65% of the sticker price, I suspect that many institutions will still lose six figures for each patient treated.”
Dr. LeBlanc predicted that many centers will decline to provide CAR T-cell therapy despite the increase in the new technology add-on payment, though he added that “I’d love to be wrong about this.”
Dr. Majhail agreed, noting that, even with the bump in the add-on payment, hospitals “won’t be whole in terms of providing care for these patients.”
“The reimbursement piece continues to be a challenge,” he said. “It is better than what it was, but there is still more work to be done. That is something we will have to keep working with the agency on.”