Kidney Foundation lowers target hemoglobin rangeThu Apr 12, 3:46 PM ET
The National Kidney Foundation said on Thursday it plans to cut its recommended target for hemoglobin levels in kidney disease patients -- a move that could hurt sales of lucrative anemia drugs that boost hemoglobin but have come under scrutiny over safety concerns.
The foundation said its work group on kidney disease outcomes now believes hemoglobin levels should be kept in the range of 11 to 12 grams per decilitre (gm/dl), down from a previous 11 to 13 gm/dl.
The work group also recommended that, for chronic kidney disease patients, on or off dialysis, the hemoglobin levels should not exceed 13 gm/dl.
The changes could hurt sales of Amgen Inc.'s key anemia drugs Aranesp and Epogen, which brought in $6.6 billion in 2006, and Johnson & Johnson's Procrit, which saw $3.2 billion in sales, although some analysts say that drug has become a less-critical product for the company.
The injectable drugs -- man-made versions of a natural protein that boosts oxygen-carrying hemoglobin in red blood cells -- are approved for use against anemia in people with chronic kidney failure and in cancer patients receiving chemotherapy.
The U.S. Food and Drug Administration called last month for the drugs' labels to include a "black box warning" -- the strongest possible for prescription drugs -- after studies showed a higher risk of death, blood clots, strokes, and heart attacks in some patient groups.
The drugs' labels had already called for a top-end hemoglobin target of 12 gm/dl.
The Centers for Medicare and Medicaid Services, the nation's largest health-care payer, is reviewing its reimbursement of the drugs.
"If Medicare lowers the upper end of reimbursable hemoglobin levels from 13 to 12, our survey says volumes could fall at least 8 percent," Bear Stearns analyst Mark Schoenebaum said in a research note this week.
Bernstein Research said in a report on Wednesday that dose volume in renal disease patients could fall as much as 25 percent if clinicians adhered to the black box warning and insurers refused to pay for the drugs in patients with hemoglobin levels over 12 g/dl.
"We want all clinicians who treat patients with chronic kidney disease to have guidelines based on the most up-to-date and reliable science available," Dr. Michael Rocco, vice-chair of the work group, said in a statement.
The Kidney Foundation, a health organization that supports research and patient services, said the draft recommendations are being sent to foundation stakeholders for review and comment, prior to being finalized and published.
http://news.yahoo.com/s/nm/20070412/hl_nm/kidneyfoundation_hemoglobin_dc_3
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