cancers, nationwide. (Jabin Botsford)
Medicare
will cover an innovative but high-priced cancer treatment nationwide, a
step Trump administration officials said Wednesday would ensure
patients have “consistent and predictable access” to a potentially
lifesaving therapy.
In announcing the decision, Seema Verma, administrator of the Centers for Medicare and Medicaid Services, said that until now, Medicare’s regional administrators had decided whether to cover the treatment, which led to confusion.
Verma
said the agency, which had scheduled this coverage decision originally
for late May, has been struggling to figure out how to cover and pay for
the treatment, called CAR T-cell therapy. The treatment costs $375,000
or $475,000, depending on whether it is used for advanced lymphoma or
pediatric leukemia. Hospital stays can add hundreds of thousands of
dollars to the cost of care.
Drugmakers note CAR T-cell therapy is designed to be
given just once and to be a potential cure for patients who have run
out of other options. But not all patients benefit from it and because
it is so new, it’s too soon to know whether it will deliver long-term
cures.
Such expensive treatments are “begging
the question of how the system is going to pay for this over the long
term,” Verma said, especially given Medicare’s considerable financial
strains. “This is something we are extremely concerned about,” she
added.
The coverage decision announced Wednesday
is different in some important aspects from an agency proposal from
February. That proposal called for “coverage with evidence development” —
which would have required hospitals to collect and report data on
patient outcomes over a long period. Hospitals said the data collection
would be overly burdensome.
CMS’ final decision dropped that requirement.
Instead, the agency said it will rely on patient information collected
by the Food and Drug Administration and the National Cancer Institute.
The FDA is requiring the two manufacturers of the therapy — Novartis and
Gilead Sciences — to follow patients for years and report on outcomes.
Such data will be put in a registry supported by NCI.
The
Medicare decision also said it will cover the therapy when it is
administered at health care facilities enrolled in an FDA-mandated
safety program requiring special training on handling side effects. That
means the treatment could be given on an outpatient basis, which would
be much less costly.
The American Society of
Hematology praised the decision, especially the elimination of the
“coverage with evidence development” requirement. It said the proposed
mandate would have prompted some hospitals not to provide CAR T-cell
therapy.
The group also praised the decision for saying
Medicare would cover all FDA-approved uses for CAR T-cell therapy and
off-label uses recommended in CMS-approved compendiums, which are used
to determine medically accepted uses of drugs and biologics.
The
Medicare decision was the second step in a week taken by CMS to bolster
CAR T-cell therapy. Last Friday, the agency said it would increase the
reimbursement for CAR T-cell therapy, but didn’t go as far as many
hospitals had wanted. Medical centers have complained they are losing
money on Medicare patients because reimbursements have been too low.
The FDA approved two versions of CAR T-cell therapy, which stands for chimeric antigen receptor T-cell, in 2017. Kymriah is made by Novartis for certain types of lymphoma and childhood leukemia, and Yescarta is manufactured by Gilead Sciences for lymphoma. Other CAR T-cell therapy products are in development.
The complicated treatment involves extracting and genetically altering
the patient’s T cells to attack a protein on the surface of cancer
cells. The cells are then infused back into the patient.
Комментариев нет:
Отправить комментарий