The agency also proposed increasing the maximum new technology add-on payment from 50 percent to 65 percent for fiscal year 2020.
The Centers for Medicare and Medicaid Services is proposing to continue the extra payments it gives to the two Food and Drug Administration-approved CAR-T cell therapies based on their high costs.
In its fiscal year 2020 proposals for the Inpatient Prospective Payment System, CMS proposed continuing the new technology add-on payments for the CAR-Ts, Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). It additionally proposed increasing the maximum for new technology add-on payments for CAR-Ts from 50 percent to 65 percent, or from $185,500 to $242,450.
The policy is designed to provide additional payments for high-cost medical treatments while preserving the existing average-based payment system. That’s especially important for therapies like CAR-Ts, whose list prices alone run well into the hundreds of thousands of dollars. Yescarta and Kymriah each carry a list price in adult diffuse large B-cell lymphoma of $373,000, while Kymriah for pediatric acute lymphoblastic leukemia – a disease in which it has higher odds of being effective – costs $475,000. That doesn’t include supportive care costs for things like inpatient stays and treating potentially dangerous side effects like cytokine release syndrome and neurotoxicity, which can exceed the list prices themselves.
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In its proposal, CMS noted that it was inviting public comment on other payment alternatives for CAR-T therapies in 2020.
ALL is more common in children and young adults than in older adults, with 4-in-10 cases occurring in older adults, according to the American Cancer Society, which estimates there will be 5,930 new cases in the US this year. Kymriah is approved for children and young adults who aren’t cured through existing treatments. According to St. Jude’s Children’s Research Hospital, about 98 percent of children with ALL go into remission, and about 90 percent of them achieve a cure, defined as 10 years of remission. DLBCL occurs in 5.6 people per 100,000 per year, according to the National Cancer Institute, with 63.2 percent of patients surviving five years.
While pediatric ALL and adult DLBCL thus represent relatively small markets, CAR-T therapies are expected to see an explosion in use when they become available for solid tumor cancers, though solid tumor CAR-Ts remain far behind in development compared with blood cancers. The next disease state likely to see a CAR-T reach the market is the blood cancer multiple myeloma. For that cancer, bluebird bio and Celgene’s bb2121 is in the lead, with the FDA expected to rule on its approval next year.
Date: May 01, 2019