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Fed Up Allies Take on
Medicare
By Robert Cohen, Star Ledger Washington Bureau
October 14, 2007
Cancer doctors have lined up with drugmakers in pressing Medicare to
reverse its decision restricting reimbursement for expensive, widely
used and increasingly controversial medications to treat anemia in
patients undergoing chemotherapy.
The high-stakes battle involves concerns about patient care and safety,
the practice of medicine and the costs to the tax payers. It also has
financial consequences for the makers of the multibillion-dollar anemia
drugs -- Johnson & Johnson and Amgen -- since Medicare is a major
purchaser of these medicines.
"We want the national coverage decision reopened because the available
evidence does not support what the Center for Medicare and Medicaid
Services has proposed," said Joseph Bailes, co- chairman of the
government rela tions council of the American Society of Clinical
Oncology, a leading organization of cancer doctors.
"It doesn't allow patients to get what physicians may feel is
appropriate treatment, and that may cause problems regarding the quality
of patient care," said the Texas oncologist.
This past summer, the Medicare agency barred reimbursement under certain
circumstances for J&J's Procrit and Amgen's Epogen and Aranesp,
injectible biologic medicines given to boost red blood cell counts to
prevent anemia and avoid the need for blood transfu sions.
Anemia is a common side effect of chemotherapy and cancer, caus ing
fatigue, shortness of breath and diminished activity. Blood transfu
sions are associated with risks of infections and other medical
problems.
The government said it would reimburse doctors who administer the drug
only to cancer patients whose hemoglobin levels fall below 10 grams per
deciliter, but not at higher levels, as doctors frequently prescribe.
Patients with about 14 grams of hemoglobin per deciliter of blood are
considered healthy, while those with less than 10 are considered
moderately or severely anemic.
Medicare pays 80 percent of the costs of the treatment, with patients or
their secondary insurers picking up the rest.
STUDIES TRIGGER SHIFT
The shift in policy follows several studies that suggested the use of
the anemia drugs can cause heart problems, blood clots and death in
patients undergoing chemotherapy.
In March, the Food and Drug Administration added new warnings to the
labels of the drugs, say ing they should be used at the smallest
possible doses needed to avoid blood transfusions. The label said
hemoglobin levels should not exceed 12 grams per deciliter.
In May, an expert panel advis ing the FDA called for restricting use of
the drugs by some cancer patients until more is known about safety. The
panel, whose recommendations are now under FDA review, also called for
additional studies, but did not recommend altering the current
hemoglobin levels that are suggested for usage.
Medicare, the government health insurance program for some 43 million
elderly and disabled Americans, said its payment decision for cancer
patients undergoing chemotherapy was "based on the best science to date
and (is) consistent with FDA labeling and warnings."
Yet after much protest, the Medicare agency last month gave critics of
the move until Oct. 24 to come up with new evidence to jus tify
reversing the decision -- a prospect that some observers think is
unlikely.
William Sargent Jr., a securities analyst for Banc of America Securi
ties, told investors in a recent research report, Medicare had set "a
high bar" for reconsideration, not ing new clinical trials may be needed
to provide the data necessary for any change of course.
A Medicare spokesman said the agency annually spends $5.4billion on the
three anemia drugs, including $1.6 billion for cancer patients and
$2.1billion for kidney patients, who are not affected by the cutback in
reimbursement. The drugs also are used for HIV patients and in some
surgeries to prevent ane mia.
Amgen's Aranesp and Epogen had combined sales of $6.6billion worldwide
last year, while Procrit's global sales were $3.1billion. Epo gen is
used for kidney dialysis patients while Aranesp and Procrit are used
primarily for cancer patients and those with kidney disease who are not
on dialysis.
A recent study by the Duke University Medical Center found the average
cost of the anemia drugs over 12 weeks for a cancer patient undergoing
chemotherapy was about $6,000, a figure some ex perts said is probably
higher outside the clinical trial setting.
The New York Times reported earlier this year that cancer doctors and
kidney dialysis centers profit handsomely from using the anemia
medicines, receiving hundreds of millions a year in rebates from Amgen
and J&J for prescribing and administering the drugs.
FIGHTING WORDS
Ortho Biotech, the Bridgewa ter-based subsidiary of J&J that markets
Procrit, said in a statement that the Medicare agency, often referred to
as CMS, is disre garding substantial scientific evi dence and setting "a
serious policy precedent for inferior coverage of cancer treatments for
Medicare beneficiaries."
"The company believes that the CMS decision significantly restricts the
ability of doctors to exercise good clinical decision-making in treating
their Medicare patients by denying coverage for uses of an FDA-approved
medication that has played an important role in supportive care of
cancer patients for nearly 15 years," said the company statement.
Amgen said in a statement the policy "undermines clinical judgment,"
could mean more blood transfusions and "effectively removes physicians'
ability to make decisions." The California company called the decision
both "unreasonable and impractical," and said there are "no studies we
are aware that have tested the new prescrib ing paradigm invented by
CMS."
J&J and Amgen both recently announced they are laying off employees,
citing the Medicare decision as one reason.
In addition to pressing Medicare, the drugmakers, aided by the
oncologists' society and other medical groups, have spent millions of
dollars on an intensive Capitol Hill lobbying campaign to influence the
prescribing policy.
This summer, Reps. Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) were
joined by more than 200 colleagues in a letter to Medicare questioning
the agency's decision
They have since introduced legislation to overturn the Medicare payment
policy, claiming it puts patients at risk. In addition, the Senate last
month passed a nonbinding resolution requesting Medicare reconsider its
decision.
J&J praised the Senate action, but William Vaughan, a senior health
policy analyst with Consumers Union, said the congressional efforts are
misguided.
"We think it is outrageous for Congress to be interfering in the FDA/CMS
decisions on a drug they can't even spell the name of, all on behalf of
people who make a fortune overdosing the product and thus endangering
people," Vaug han said.
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