WASHINGTON (AP) -- Cancer doctors seek to loosen
federal restrictions on anemia drugs that carry potentially deadly side effects,
saying the tight payment guidelines for treatments made by Amgen and Johnson and
Johnson are ultimately bad for patients.
The American Society of Clinical Oncology says guidelines issued last month by
the Medicare program interfere with physicians' ability to treat patients with
the blood disorder anemia, which causes weakness and shortness of breath.
The rules state that doctors will only be reimbursed if they use low levels of
the drugs, which the government believes could reduce the risks of death and
heart trauma that emerged earlier this year.
Physicians use Amgen's Aranesp and Johnson and Johnson's Procrit to raise
patients' red blood cell levels.
"Some of our members are being forced to turn away patients who received these
drugs under the old rules, but can't under the new rules," said Dr. Joseph
Bailes, the group's chief of government relations.
The society sent a letter to the Centers for Medicare and Medicaid Services
Thursday, asking them to suspend the payment policy. The agency, which provides
health care to 80 million Americans, reimburses doctors for administering anemia
drugs, which are usually injected at doctors' offices.
Safety concerns about anemia treatments have pummeled Amgen's stock price this
year, contributing to a 24 percent decline since March. Earlier this month the
Thousand Oaks-based, Calif. company said it would lay off 2,600 employees to
offset weak sales of Aranesp, which fell 10 percent in the last quarter.
Aranesp was the company's best-selling drug last year with $4.1 billion in
sales, or nearly a third of total revenue.
Johnson & Johnson recorded $3.2 billion in Procrit sales last year, though the
company is less dependent on the drug because of its size and diversification.
Medicare changed the drugs' reimbursement guidelines after federal health
regulators added warnings to their labels in March, cautioning that using too
much can increase risk of blood clots, heart attack and death.
Doctors can only be reimbursed under the new policy if they keep a patient's
hemoglobin level, a measure of red blood cells, at or below 10 grams per
deciliter. Under the old policy doctors could raise hemoglobin levels up to 12
grams per deciliter.
In its letter to the government, the society argues there is no scientific
evidence that the reduced dosing policy is safer for patients. The group also
points out that the current labeling approved by the Food and Drug
Administration says the drugs are safe up to the higher 12 gram per deciliter
threshold.
While FDA is considering revising that labeling, a panel of outside advisers in
May recommended against lowering the drugs' dosing regimens. FDA does not have
to follow the panel's advise, though it usually does.
The society, which represents about 25,000 physicians, argues CMS should wait
until FDA wraps up its review before making new guidelines permanent.
Medicare officials did not immediately return calls seeking comment for this
story. The agency generally does not revise rules after they are put in place,
though it continues to take public comments.
The American Society of Hematology, which represents blood disease specialists,
said Friday it would submit a similar request to Medicare next week.
Shares of Amgen Inc. fell 8 cents to $50 Friday. Johnson & Johnson shares rose
19 cents to $61.79.
Source : The Associated Press.
