The national Medicare coverage rule for CAR-T cell treatments is finally here. By changing some requirements in the previous draft version, the federal government is lifting some restrictions and burdens on health care professionals – and may in turn increase its adoption.
In a national coverage decision, Medicare will pay for CAR-T therapies, the Centers for It said Medicare and Medicaid Services on Wednesday. For Gilead Sciences and Novartis, which markets FDA-approved CAR-T treatments, respectively, Yescarta and Kymriah, the policy can help improve the drug's deficient sales now that doctors want the assurance that they can receive reimbursement for these costly therapies.
RELATED: CMS: Medicare will begin to cover CAR T-cell therapies in some facilities
"Today's decision makes it very clear that & # 39; Yes, this is covered. & # 39; We pay it not just for CAR-T, but all related services. The administration of the drug. cells and then put them back in the patient. And so did some of their outpatient or outpatient care, "said CMS administrator Seema Verma during a conversation with reporters.
The update could be "a pivotal point" for admissions to Medicare patients, Gilead's new CEO Daniel O. & # 39; Day said during a conference call last week ahead of the CMS announcement.
"We know that using Yescarta on Medicare patients also has an impact in centers on how they treat their non-medical patients," he added. "A lot to continue to innovate here, not just about science, but also for reimbursement and access programs."
Novartis applauded in a statement sent to FiercePharma on Thursday CMS & # 39; s decision to allow nationwide Medicare coverage for CAR -T therapies, but also said it "continues to encourage CMS to develop reimbursement rates in hospitalized hospital settings that fully reflect the value of these innovative and groundbreaking products. "
RELATED: ASCO: Gilead touts CAR-T franchise with Yescarta analyzes, early pipeline drug data
CMS said it would cover the therapy as long as it is administered by certified health services registered in an FDA-mandated safety program, known as Risk Evaluation and Mitigation Strategies (REMS).  It marks a welcome development for the industry. In old draft rules, only when the treatment was performed at "hospitals" would it be covered, which meant that oncologists' own clinics could be excluded.
The final rules also remove a requirement for "coverage with evidence development" (CED), which hospitals have deplored as too cumbersome. CED would have required hospitals to assess patient outcomes at baseline, at treatment, and at several points for follow-up for up to two years after treatment.
Now the burden will fall on the FDA REMS program, developed and implemented by the drug makers, namely Novartis and Gilead. The REMS programs are in place because of the risk of toxicity associated with CAR-T therapies. Both Yescarta and Kymriah are required by the FDA to undergo 15-year marketing studies to monitor their long-term toxicities.
RELATED: Novartis & # 39; Slow Rolling Kymriah Wins Coverage in Japan to $ 305K: Report
Medicare will also cover off-label use of approved CAR-T medications as long as they are recommended by CMS- approved compendiums used to determine medically accepted drug use, the agency says. Currently, Yescarta and Kymriah are both allowed to treat relapses or refractory large B cell lymphoma, and Kymriah is also approved for acute lymphoblastic leukemia.
The national Medicare decision came after CMS on Friday finalized its policy to increase the maximum allowance for CAR-T medication payments from 50% to 65%.
"The increased payment from 50% to 65% will promote patient access and reduce the uncertainty that innovators face in Medicare payment for new medical technology," the agency said. In a statement, the American Hospital Association called EVP Tom Nickels the increase for "much-needed short-term relief," but also asked for new solutions to "address the long-term sustainability of providing these expensive therapies."
Gilead has set Yescarta's list price to $ 373,000, while Novartis has marked Kymriah at the list price of $ 475,000. Despite the high costs, sales have lagged far below the threshold thresholds the industries had hoped for. Yescarta generated $ 216 million in the first half of this year, with the majority from the United States Kymriah raising $ 103 million in the same period.