Guidelines On Anemia Drugs Undermine Doctors' Ability To Treat Patients, Say Doctors

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Main Category: Cancer / Oncology
Also Included In: Blood / Hematology;  Medicare / Medicaid / SCHIP
Article Date: 09 Sep 2007 - 0:00 PDT

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New guidelines regarding anemia drugs are not good for patients, says the American Society of Clinical Oncology (ASCO) - the guidelines indicate the drugs have some potentially deadly adverse effects.

According to ASCO, the new Medicare Program guidelines undermine a doctor's treatment options for patients with anemia. Medicare says it will only reimburse physicians who use low levels of the drugs - saying the risk of death will be less this way. After federal health regulators added warnings to the labels of these drugs, explaining that overuse can raise the risk of blood clots, heart attack and death, Medicare changed the drugs' reimbursement guidelines.

The problem for doctors is that they are having deal with patients who were receiving treatments before the guidelines came out, but cannot any more. ASCO is asking the Centers for Medicare and Medicaid Services (CMS) to abandon their reimbursement policy.

Beforehand, doctors would get reimbursed if they raised their patients' hemoglobin levels to a maximum of 12 grams per deciliter - now the limit is 10 grams per deciliter. ASCO is asking CMS to wait till the FDA finishes its review of drug labeling for these drugs before making its guidelines permanent.

Aranesp, an Amgen drug for treating anemia, has seen its sales fall sharply recently. The company says it is planning to lay thousands of workers off. Last year Aranesp constituted about 30% of the company's income. Procrit, a Johnson & Johnson drug, which is also used for treating anemia, has dropped in sales.

ASCO argues there is no scientific proof showing that the reduced dosing is safer for patients. FDA approved labeling indicates the dosages are safe up to 12 grams per deciliter. The FDA is having another look at the labeling policy. However, a panel of advisers has told the FDA the labeling should not be altered. The FDA is under no legal obligation to do what the panel advises, but history has shown that the agency usually complies with the panel's recommendations.

-- Letter from ASCO to the Centers for Medicare & Medicaid Services (PDF)
-- Senate Passes Resolution Urging CMS to Reconsider ESA Policy
-- Aranesp(R) Study Showing No Negative Impact on Survival in SCLC Presented at World Conference on Lung Cancer

Written by: Christian Nordqvist
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