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 Both Gilead's Yescarta and Novartis's Kymriah - which are part of a
class of therapies known in the medical field as “CAR-T” - were
approved in 2017. 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.
Sales of both CAR-Ts - billed as potential blockbusters at their
launch - have been slow to ramp up. Novartis, which has also
struggled to meet U.S. manufacturing specifications, posted $58
million in second quarter Kymriah sales, while Gilead is expected to
show $110 million in Yescarta sales when it reports quarterly
results on Tuesday.
The novel treatments take immune system cells from each individual
patient and re-engineer them to better fight certain blood cancers,
keeping nearly 40 percent of patients alive for more than two years,
according to some studies.
Yet the federal government's Medicare health plan for seniors,
estimated to cover more than half of lymphoma patients eligible for
a CAR-T, is still figuring out payment terms after nearly two years
of delay. Private insurers are only covering the cell therapies on a
case-by-case basis, rather than setting standard coverage guidelines
as they usually do for new drugs.
Between Kymriah's approval in May 2017 and December 2018, one
quarter of nearly 900 adult lymphoma patients treated with CAR-Ts
were enrolled in clinical trials, according to healthcare
consultancy Vizient Inc.
That is unusual since patients generally seek to first use
treatments approved by health regulators before considering an
experimental drug being tested in trials. A recent National Cancer
Institute study estimated that no more than 8 percent of all cancer
patients participate in trials.
Vizient analyzed health insurance claims from 58 major U.S.
hospitals, including most of the centers authorized to administer
CAR-Ts. The consultancy found that medical bills for clinical trial
patients, who receive the cell therapies free of charge from the
drugmaker, were about 50% percent lower than costs for people
treated with Yescarta or Kymriah on a commercial basis. CAR-T
patients are almost always admitted to a hospital to monitor for
severe side effects.
"Inadequate inpatient reimbursement, especially for Medicare
patients, can be a significant deterrent for hospitals to use
commercially approved CAR-Ts," Jennifer Tedaldi, associate principal
at consulting firm ZS Associates, told Reuters. She said some
hospitals instead refer patients to clinical trials, or choose not
to use CAR-Ts at all.
In a sign of the wide array of trial options, the Lymphoma Coalition
estimates there are 120 mid- and late-stage U.S. trials for advanced
diffuse large-cell B cell lymphoma (DLBCL), the indication that
Yescarta and Kymriah are both approved for. They include studies
that combine Yescarta or Kymriah with other treatments in the hope
of making them safer and more effective, as well as competing CAR-T
therapies and other novel approaches for attacking blood cancers.
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"CAR-T is a very active space given its potential promise as a
one-time curative therapy," Novartis said in an emailed statement.
"As part of our commercial program, we take into account a
percentage of patients that are likely to be treated via clinical
trials."
Officials at Gilead said the company is working to expand commercial
use of Yescarta, and more oncologists are referring patients as word
gets out. "Overall the percentage of patients going to clinical
trials is small," said Remus Vezan, head of clinical development, at
Gilead's Kite cell therapy unit.
A TRADE-OFF
The University of Alabama's O'Neal Comprehensive Cancer Center, said
it now refers about a quarter of its lymphoma patients to clinical
trials. The Birmingham-based center is authorized to administer
Yescarta, but has not yet used it for a paying patient for lack of
insurance coverage.
"We are actively negotiating with the payers ... this is an
expensive treatment so they want to have confidence in us," said Dr.
Amitkumar Mehta, head of the center's lymphoma program. At the same
time, "not all patients will qualify for a clinical trial. It is a
trade-off. There is a benefit on the cost, but at the same time you
are getting an experimental therapy."
The high percentage of patients heading to CAR-T trials could skew
Medicare’s reimbursement calculations, which are based on average
costs. The Centers for Medicare and Medicaid Services in April
sought public comment on “how to address the significant number of
cases involving clinical trials.”
The American Society of Hematology urged the agency to exclude trial
cases in its calculations, citing claims data showing average
pharmacy charges for clinical trial patients near $100,000, compared
to over $600,000 for non-trial cases.
Medicare has also proposed raising its maximum CAR-T payment to 65%
of estimated costs from 50%.
"There have been some promising signals, but we still do not have a
clear pathway for Medicare payment," Jack Kolosky, chief operating
officer at Moffitt Cancer Center in Tampa, Florida, told Reuters. He
said Moffitt has $12 million in unpaid Medicare CAR-T claims and
expects at least that amount in the current fiscal year that began
on July 1.
(Reporting by Deena Beasley; Editing by Michele Gershberg and Edward
Tobin)
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