Medicare will be required to cover expensive cell therapies made by Novartis AG and Gilead Sciences Inc. under a national policy starting in mid-May if a proposal by the Trump administration is finalized in the next three months.
The Centers for Medicare and Medicaid Services on Feb. 15 issued a so-called national coverage determination describing under what conditions the agency would pay for U.S.-approved chimeric antigen receptor T cell therapies, like Novartis' Kymriah and Gilead's Yescarta.
CAR-T cell therapies involve taking immune cells from a patient's blood and re-engineering them to attack cancer cells. The processed cells are then infused back into the person's body.
The list price for Novartis' Kymriah is $475,000 for a single course of treatment, while Yescarta's list price is $373,000, though the government only reimburses about half of those amounts under its hospital payment policies.
No current nationwide policy
CMS' action sets the stage for better coverage of the products by the private insurance industry.
The regulator noted there is no national Medicare policy for covering CAR T-cell therapies, so local Medicare administrative contractors have discretion over whether to pay for the drugs.
The proposal, which is expected to be finalized by mid-May, would provide nationwide consistency in CMS' coverage of the CAR-T cell therapies, improve patient access to the drugs and ensure appropriate evidence is generated for their use, the agency said in a Feb. 15 statement.
CMS also would gain a deeper understanding of how patients in Medicare respond to the drugs, "so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks," the agency's administrator, Seema Verma, stated.
The agency is accepting public comments over the next 30 days and will make a final decision 60 days after that period ends.
CMS noted that its decision to cover CAR-T drugs was influenced by the advice it received at an Aug. 22, 2018, meeting of the Medicare Evidence Development and Coverage Advisory Committee, a panel of experts that convenes to examine the strength of the available evidence and make recommendations to the agency.
Under the proposal, Medicare would cover the CAR-T therapies nationwide when the drugs are offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years following their treatment.
To qualify for payment, the CAR-T drugs must be prescribed by the treating oncologist at a hospital to patients with relapsed or refractory cancer who are not experiencing any comorbidity that would otherwise preclude the medicine to be beneficial.
Inpatient versus outpatient use
While CMS also detailed the criteria for covering CAR-T medicines in the outpatient setting, the products are currently provided only in the hospital inpatient setting.
In November 2018, U.S. Food and Drug Administration Commissioner Scott Gottlieb raised concerns that hospitals were losing money on only being able to prescribe the drugs in the inpatient side.
"There's sort of an arbitrage between the outpatient delivery of those drugs and the inpatient delivery of those drugs," he said at a Nov. 13, 2018, forum in Washington.
Gottlieb noted that the difference between an inpatient and outpatient setting sometimes is no more than "an elevator ride one floor up."
Many outpatient infusion centers are part of academic institutions are adjacent to their hospitals, the FDA commissioner said.
Other participants at the forum, however, raised concerns about the high costs of cancer drugs overall and the burden to patients and taxpayers bearing those expenses.