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 CMS, which runs Medicare - the federal government's health plan for
Americans 65 and older - said it will cover the U.S. Food and Drug
Administration-approved therapies when provided in healthcare
facilities that have programs in place to track patient outcomes.
The nationwide decision clears up "a lot of confusion" about
coverage and will help patients get access to the novel therapies,
known as CAR-T, CMS Administrator Seema Verma said during a
conference call with reporters on Wednesday.
The decision follows the agency's finalization last week of a
proposal to raise its maximum CAR-T payment to 65% of estimated
costs from 50%. Some hospitals will also be eligible for
supplemental payments in certain cases.
Both Gilead's Yescarta and Novartis' Kymriah were approved in 2017
for certain kinds of lymphoma and leukemia. But government and
private health plans have balked at their high price of at least
$373,000 for a one-time treatment before hospital costs, which can
bring the bill for a single patient to over a million dollars.
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More than half of lymphoma patients eligible for CAR-T therapy are
estimated to be covered by Medicare.
The agency said it will also cover the CAR-Ts for uses not approved
in their labels, as long as they are recommended by CMS-approved
medical guidelines.
The novel treatments remove a type of immune system cells from each
individual patient and re-engineer them to better fight certain
blood cancers, keeping nearly 40% of patients alive for more than
two years, according to some studies.
(Reporting by Deena Beasley in Los Angeles and Ankur Banerjee in
Bengaluru; Editing by Bill Berkrot
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