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PREVIEW-More U.S. hurdles ahead for anemia drugs
January 13, 2011 / 3:42 PM / 7 years ago

PREVIEW-More U.S. hurdles ahead for anemia drugs

* Medicare advisers meet Jan 19 on transplant issues

* Looking at whether anemia drugs help kidney transplants

* Affects Amgen’s Epogen and Aranesp, J&J’s Procrit

* Amgen, J&J drugs expected to see $7 bln in 2011 sales

By Susan Heavey

WASHINGTON, Jan 13 (Reuters) - Controversial anemia drugs used by kidney disease patients face another test from the U.S. government next week when Medicare’s outside advisers weigh their use in transplant patients.

The widely-used drugs, made by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N), have already faced a barrage of scrutiny in recent years over safety concerns and payment restrictions. Such issues have tempered sales, although they still are expected to generate $7 billion in 2011 revenue.

On Jan. 19, a Medicare advisory panel will take up the issue of whether using the drugs, also known as erythropoiesis stimulating agents (ESAs), help patients with chronic kidney disease better survive kidney transplantation.

“Some parties claim that prior ESA use may predict the long term success of subsequent renal transplantation in patients with (chronic kidney disease),” the U.S. Centers for Medicare and Medicaid Services (CMS), which oversees the federal insurance program, said in announcing the meeting.

The advisers will provide input that CMS could use in deciding how to cover the drugs in kidney disease patients on dialysis as well as those not yet ill enough for dialysis.

CMS, which began closely looking at kidney patients’ use of ESAs last year and spends billions of dollars each year on the drugs, is weighing potential dangers such as increased heart problems and death, versus benefits such as more energy.

More successful transplants rates could also be a plus.

The meeting comes as controversial “bundled” Medicare payments start. The new reimbursements lump payments for drugs with other aspects of kidney patient care such as dialysis, a change aimed at curbing unsafe overuse of the drugs.

So far, Medicare does not have a standardized national policy for covering the drugs in treating anemia in kidney patients, although it still generally pays for them. A final coverage decision is due in March.

TRANSPLANT QUESTION

By law, although Medicare insures elderly and disabled Americans, all end-stage kidney disease patients on dialysis are covered under the program.

At issue next week is whether using ESAs helps kidney patients have a more successful organ transplant by preventing rejection and other problems that may arise from blood transfusions.

Amgen has defended ESAs, saying they can substantially reduce risky transfusions and that those not on dialysis who are at risk for transfusions may also benefit.

ESAs are genetically engineered versions of a protein that boosts production of oxygen-carrying red blood cells, aiming to treat anemia that can plague people with kidney disease as well as cancer patients.

But safety issues and criticism that providers have overused the drugs to earn bigger government payments have drawn closer scrutiny. Recent studies have shown high doses could cause heart complications or even death.

Capitol Street analyst Ipsita Smolinski has said the agency’s proposed questions to next week’s panel bode well for a favorable nationwide payment decision overall.

There is little doubt among doctors that transfusions can increase antibodies that make transplantation more difficult, she said in a recent research note. “The only question now ... is whether ESAs truly decrease transfusion requirements.”

Other governmental hurdles also linger as the Food and Drug Administration weighs whether to curb approved dosing in kidney patients, having already set new guidelines for cancer use. [ID:nN16220120]

In October, an FDA advisory panel recommended against limited dosing for kidney patients, although the agency will make the final decision. [ID:nN18269114]

“FDA is still working on this,” said agency spokeswoman Karen Riley. (Reporting by Susan Heavey; Editing by Tim Dobbyn)

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