When the first therapies based on chimeric antigen receptor (CAR) T cells were launched last year, the price of the drugs led to some sharp intakes of breath throughout the medical community.
Tisagenlecleucel (Kymriah, Novartis) was priced at $475,000, and axicabtagene ciloleucel (Yescarta, Kite Pharma) was priced at $373,000.
However, these are prices for the drug products alone. On top of this comes the cost of administering and managing a patient undergoing CAR T-cell treatment, which include leukapherisis, lymphodepletion therapy, and management of the adverse effects of CAR T.
Now, for the first time, there is an estimate of the total mean cost of the treatments in the United States: $510,963 for tisagenlecleucel, and $402,647 for axicabtagene ciloleucel.
Thus, the mean additional “nondrug” costs are about $30,000 to $35,000, which represents 7% of the total cost. And that’s a “conservative” estimate, said lead author Inmaculada Hernandez, PharmD, PhD, of the School of Pharmacy at the University of Pittsburgh, in Pennsylvania.
The new estimates were detailed in an article published online April 26 in JAMA Oncology.
“The study is very important because we need to understand the total cost of this therapy,” said Samuel Silver, MD, PhD, of the University of Michigan Comprehensive Cancer Center in Ann Arbor, who was asked for comment.
But the estimate is way off the mark — the total cost for these therapies is at least $750,000, he said.
The nondrug costs are $400,000 to $450,000, which is just about equal to the drug costs, he said. Thus, these additional costs double the total cost of the therapy.
“They are underestimating the non-T-cell costs by at least fivefold,” Silver told Medscape Medical News.
They are underestimating the non-T-cell costs by at least fivefold
The total costs would include “facility costs,” such as nursing care, intensive care unit expenses, and other costs.
He said that he consulted with Michigan’s contract officer for CAR T-cell therapy, who monitors cost accounting and manages reimbursement, to verify his guesstimates.
A good example of the cost conservativism in the new study can be found in the estimates for managing an adverse event, cytokine release syndrome (CRS), suggested Silver.
According to study the investigators, severe cases of CRS, which is potentially life threatening, push the total nondrug costs as high as $56,000. But Silver said that in real-world practice, the cost of managing severe CRS can be $200,000 or more.
CRS is common with CAR T cell therapy, say both the authors and Silver. Nearly half (44%) of patients who received tisagenlecleucel in clinical trials required treatment in intensive care units for CRS.
Silver, an oncologist, has 20-plus years of experience in reimbursement policy and practice and acts as chair of the American Society of Hematology subcommittee on reimbursement.
CAR T-cell therapies are basically unchartered territory when it comes to reimbursement from payers. These are not typical therapies with respect to cost structure, he pointed out to Medscape Medical News in an interview last year.
As a consequence, all 30 US centers that currently provide CAR T-cell therapy are losing a lot of money on the treatments because reimbursement is not covering related operating expenses, said Silver.
Some help may be on the way, because the Centers for Medicare & Medicaid proposed on April 24 that CAR T-cell therapies qualify for a quadrupling of “outlier” payments (for extraordinary treatments) in its reimbursement scheme. The proposal is not yet a rule, but Silver is hopeful it will be.
Study Details
The study authors, who also include Vinay Prasad, MD, of the Oregon Health and Sciences University in Portland, and Walid F. Gellad, MD, MPH, of the University of Pittsburgh, divided the potential outcomes of patients selected for CAR-T immunotherapy into multiple scenarios. The different possibilities account for, among other things, the receipt of treatment, development of CRS, and response to CAR T-cell immunotherapy (which, if ineffective, qualifies patients for a payment refund in the case of tisagenlecleucel).
The team calculated the physician costs for leukapheresis and for administration of lymphodepletion therapy and CAR-T immunotherapy using the 2017 Medicare Physician Fee Schedule rates. Facility costs were calculated using the 2017 Medicare Hospital Outpatient Prospective Payment System amounts.
Costs of drugs other than CAR-T drugs were based on 2017 Medicare Part B payment limits; these costs were bundled into the nondrug (ie, non-T-cell therapy) calculations. The team also calculated the facility costs of hospitalizations for CRS using estimates from the Healthcare Cost and Utilization Project and from published studies. Physician costs were calculated as 26% of facility costs.
Study author Hernandez explained that the key to their relatively modest tally of total costs is in what they defined as “nondrug” costs.
“We only included costs related strictly to the administration of the therapy and the occurrence of side effects, and not costs related to the care of the patient that would have also occurred with other therapies,” she told Medscape Medical News.
“We attempted to make a conservative approach, because we did not want our estimates to be criticized for overinflating costs. And even with this conservative estimates, the budget impact is really high,” she said.
The authors and Dr Silver have disclosed no relevant financial relationships.
JAMA Oncol. Published online April 26, 2018.
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