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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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