With price tags approaching $1 million or more for delivery of certain immune cell therapies, new payment models will be needed to ensure access to these therapies and to further innovations. This was a key issue addressed at a roundtable discussion at the 2019 National Comprehensive Cancer Network (NCCN) Conference. Ensuring access to chimeric antigen receptor (CAR) T-cell therapy emerged as a top area of concern.
The price for CAR T-cell therapy constructs runs approximately $375,000 to $475,000 but this cost does not consider the cost of associated clinical care, pointed out John W. Sweetenham, MD, MBBS, Huntsman Cancer Institute, University of Utah, Salt Lake City. The final cost may be up to $1.5 million, he said, if the patient has a complex clinical course that requires admission to the intensive care unit. “Maybe the cost is reasonable,” he said, depending on the rate of cure. “What’s the cost of continuing to put someone in the hospital to give them multiple rounds of chemotherapy until they end up on hospice? It is very expensive.”
At present, CAR T-cell therapy requires delivery in a specialized center. Although outpatient CAR T-cell therapy may be on the horizon, clinicians will need to acquire expertise in managing the unique toxicities of some therapies before it becomes a reality, said Lalan S. Wilfong, MD, Medical Director of Quality Programs, Texas Oncology, Dallas.
Medicare Coverage Determination
UnitedHealth Group, which provides health benefits for 50 million Americans, recently requested a national coverage determination for CAR T-cell therapy from the Centers for Medicare & Medicaid Services (CMS). Without a national coverage, Medicare coverage for CAR T-cell therapy is determined by local Medicare administrative contractors. “Because of the very high cost of the product, it’s hard within the current Medicare reimbursement fee schedule to cover the cost of the product,” said Jennifer Malin, MD, PhD, Senior Medical Director, Oncology and Genetics, UnitedHealth Group, CA.
In the current payment model, hospital or provider reimbursement is typically 3 to 4 times the cost of the drug. “That margin approach, which was started in the early days of Medicare, maybe made sense when you were talking about doxorubicin or 5-fluorouracil,” Dr Malin said.
The multiplier on innovative therapies, however, can result in profits of hundreds of thousands of dollars. “What is a reasonable profit margin on administering a drug for a practice or hospital?” she asked. “Is $20,000 a reasonable administration cost and profit? Is it $100,000? Half a million dollars seems excessive.”
Dr Malin said that drug manufacturers and hospitals that are administering CAR T-cell therapy are currently adhering to the indications approved by the FDA. “But we anticipate that there’s going to be interest in, and there will be studies that will show that it [CAR T-cell therapy] is effective outside the FDA label,” Dr Malin said. “How do we ensure that that’s consistently applied across the Medicare population, and that we don’t see regional variation in who gets it? We don’t want to see inequities in how our members have access to therapy based on where they live.”
Coverage determination is even more problematic when patients travel outside of their state to receive CAR T-cell therapy, Dr Malin said.
The Medicare Evidence Development & Coverage Advisory Committee met in August 2018 to issue recommendations to CMS on coverage of CAR T-cell therapy, said Clifford Goodman, PhD, Senior Vice President, Comparative Effectiveness Research, the Lewin Group, Falls Church, VA, who moderated the discussion. On February 15, 2019, CMS proposed Medicare Coverage with Evidence Development (CED) for CAR T-cell therapy, Dr Goodman added.
“The proposed National Coverage Determination would require Medicare to cover the therapy [CAR T-cell therapy] nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment,” CMS said in a press release February 15, 2019.
Commenting on the CMS proposal, “The primary motivation was ensuring equity of access,” said Dr Malin. A national coverage determination based on the FDA-labeled indications and the NCCN guidelines as a course for off-label indications would work to expand access to unique situations, she noted.
“We believe that the CED is important both to ensure that there’s ongoing research as to how CAR-T therapy performs in the real world, but especially in the Medicare population,” she added. Across the clinical trials to date, few patients older than 65 years have received CAR T-cell therapy, she emphasized.
Dr Wilfong said that the hospital systems with which Texas Oncology is aligned are not using CAR T-cell therapy in its Medicare population, because “the national organizations don’t believe that the national coverage decisions covers actual cost of therapy, and they’re not willing to go into a loss for this therapy at this point in time.”
According to Frederick L. Locke, MD, Program Co-Leader, Immunology, Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, the mechanism to pay for the additional infrastructure and ancillary staff to administer CAR T-cell therapy is missing. If a DRG (Diagnosis-Related Group) code is used to determine payment of infusion of CAR T-cell therapy in the hospital, “that code is not going to give the hospital enough money to cover the cost of the product,” Dr Locke said.