Medicare officials signaled Wednesday that they will not change a payment policy for biotech drugs made by Amgen and Johnson & Johnson when they are used to treat anemia in kidney disease patients, despite data suggesting heart risks for those patients.
The Centers for Medicare and Medicaid posted a memo online saying it will not issue a national rule on how doctors should use the drugs when treating patients in the government's Medicare plan, which covers 47 million seniors. The agency said it will take comments on this proposal before finalizing it by June 17.
A rule specifying lower doses of the drugs would have cut into sales of the injectable medications, which are multibillion-dollar sellers.
The agency began its review after a study suggested higher doses of anemia drugs can increase the risk of stroke and heart attack in patients with failing kidneys. Medicare said there was not enough evidence to issue strict guidelines on how and when it would pay for the drugs _ indicating doctors will continue to be paid for treating patients however they choose.
"The current published studies are insufficient to delineate the risk-benefit for the various patient populations, particularly the Medicare population," the agency states.
The medicines _ Procrit, Aranesp and Epogen _ are multibillion-dollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers.
The FDA is now reviewing the drug's potential risks for kidney disease patients, many of whom are on dialysis.
Doctors adjust their patients' drug doses to maintain healthy levels of hemoglobin, a component of blood that carries oxygen and keeps anemia patients active. Anemia causes weakness and shortness of breath and is a side effect of chemotherapy and kidney failure.
Current labeling on the drugs recommends keeping patients' hemoglobin levels between 10 grams and 12 grams per deciliter, though levels often exceed that range. Investors and analysts have been anticipating Medicare's ruling for months, on speculation that it might reduce dosing of the drugs.
While the agency appears to have decided against that course, it noted in the review that the drugs showed no medical benefit beyond raising hemoglobin levels.
"We view this language as very cautious. In addition, the document indicates there is evidence of harm," stated Deutsche Bank analyst Robyn Karnauskas, in a note to investors.
Amgen Inc., based in Thousand Oaks, Calif., makes all three drugs. Procrit is sold by Johnson & Johnson's Centocor Ortho Biotech division, under a long-standing agreement between the companies.
The drugs _ known as erythropoiesis stimulating agents _ had combined sales of $6.3 billion in 2009, according to health data firm IMS Health.
Amgen shares rose 46 cents to $53.15 in after-hours trading following the Medicare decision. In the regular session, the stock fell 31 cents to $52.69.
Johnson & Johnson, based in New Brunswick, N.J., lost a penny after hours, following a loss of 82 cents to a close of $57.66 in the regular session.