Medicare proposes no changes for anemia drugs

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LOS ANGELES | Wed Mar 16, 2011 5:34pm EDT

LOS ANGELES (Reuters) - Medicare officials do not plan at this time to change payment terms for anemia drugs used in kidney patients who are undergoing dialysis.

The agency, which is slated to issue a final decision on the matter in June, also said it has found no clear proof that the drugs provide clinical benefits other than increasing hemoglobin.

Endorsement of current reimbursement guidelines would benefit shares of Amgen Inc, which rakes in billions from sales of its flagship Epogen anemia drug for treatment of kidney dialysis patients.

Under a draft decision announced on Wednesday, the U.S. Centers for Medicare and Medicaid Services said it would not issue a national coverage determination at this time.

The agency said it would seek comments on the announcement, and would respond in a final decision memorandum in June.

Wall Street analysts say the government healthcare plan might lower the threshold for target hemoglobin rates in dialysis patients, thereby reducing usage of Epogen, which is approved for usage in kidney patients undergoing dialysis.

A second-generation Amgen drug, Aranesp, as well as Procrit, which is sold by Johnson & Johnson, are used to treat anemia in kidney patients who are not yet sick enough to need dialysis.

Known as erythropoiesis stimulating agents, or ESAs, the anemia medicines are used by patients with chronic kidney disease at various stages to help reduce fatigue caused by the disease or blood transfusions.

Sales of the drugs have declined steeply in recent years amid safety concerns, but Amgen's Aranesp and Epogen along with J&J's Procrit are still expected to generate $7 billion in 2011 revenue, according to data from Thomson Reuters.

(Reporting by Susan Heavey and Deena Beasley; Editing by Steve Orlofsky)

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Comments (2)
DTR61 wrote:
Further limiting the use of Epogen or other ESAs in renal failure would be a mistake. Current CMS guidelines already limit hemoglobin levels to 12 gm/dL…that is below normal for women (who have naturally lower levels) and is MUCH lower than the 13.8-17 gm/dL normal for men. For the percentage-based hematocrit, the restriction is 36%. That is well below the normal 38-42% for women and again much below the 42-54% normal for men. CMS already forces dialysis patients into sub-par health. It shouldn’t be forced lower due to other low probability risks.

Mar 17, 2011 9:09am EDT  --  Report as abuse
DrMoskowitz wrote:
Another example of brain-dead leadership from Medicare. In 2002, I published how to prevent 90% of dialysis. The media required an endorsement from somebody in the renal community. Not surprisingly for a $50 billion a year industry, nobody came forward. So I visited Medicare myself in 2004 to explain how they could save 10% of their budget along with 90,000 American lives yearly. Medicare had zero interest. Again, zero interest this past fall from Medicare. (Too many of their own salaries at stake). Details are at http://www.genomed.com/images/guyot_dec09nl.pdf

Mar 18, 2011 1:12pm EDT  --  Report as abuse
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