Not enough data on anemia drugs, transplants: panel

There is not enough data to prove widely used anemia drugs made by Amgen Inc and Johnson & Johnson improve outcomes for kidney patients who undergo organ transplantation, a U.S. Medicare advisory panel said on Wednesday.

Advisors to the agency that oversees the nation’s health insurance program for the elderly and disabled overwhelmingly said there are not enough available studies to show using the drugs to boost patients’ hemoglobin levels to more than 10 grams per deciliter can help patients have a more successful kidney transplant.

The panel’s vote comes as the U.S. Centers for Medicare and Medicaid Services (CMS) wrestles with how to cover the drugs, which have drawn concerns amid safety issues such as heart risks that stem from possible overuse.

Sales have slipped in recent years amid the 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.

“The connection is just not there,” said panel vice chairman Saty Satya-Murti, a physician and health policy consultant.

CMS will consider the panel’s votes in making its larger decision on how to cover the anemia drugs for use in kidney disease patients overall. A draft decision is expected by March 16, with a final decision by June 16.

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

Potomac Research Group analyst Dave Blaszczak said the meeting pointed to CMS’ larger questions about the controversial drugs.

“They are being very critical of the evidence for ESAs,” he told Reuters. “There is a lack of evidence out there on ESAs, and they’re trying to decide what that means.”

But other analysts said they expected little fallout.

J.P. Morgan analysts, in a note, echoed others in saying they expected no impact from the CMS meeting and that Amgen’s shares still hold potential, especially given the biotech’s bone drugs Prolia and Xgeva.

Amgen, which makes Aranesp and Epogen and licenses the medicine for J&J to sell as Procrit, told the panel ESAs are critical for kidney disease patients to avoid risky blood transfusions that can make them less eligible for a donor kidney.

But CMS officials said there was limited data backing the notion that use of the drugs could curb blood transfusions or had a clear impact on transplantation.

“The data is generally weak and the strength of the evidence is low to insufficient,” C. Michael White, a pharmacy professor at the University of Connecticut who presented a review of available studies on the issue to the panel on behalf of CMS.

Amgen’s Reshma Kewalramani, who oversees kidney therapies for the biotech, rejected White’s review, saying many critical studies were excluded. She added CMS was not taking into account other factors such as the time patients had to wait for a transplant because of complications from blood transfusions.

“The data are there and the evidence are very clear in this regard,” she said, referring to patient sensitivity from transfusions and their “negative impact on graft access and transplant survival.”

Doctor and patient groups at the meeting urged CMS not to restrict ESAs in setting its coverage policy because flexibility is needed to treat various individuals.

The U.S. Food and Drug Administration is also weighing whether to change approved use of ESAs, but its own panel of outside advisers in October urged no action.

Both CMS and FDA have already taken steps to address use of the drugs in cancer patients, who can experience anemia alongside chemotherapy.

Shares of Amgen closed down 0.5 percent to $56.98 on the Nasdaq while shares of J&J ended up 0.7 percent at $62.56.

(Reporting by Susan Heavey; Editing by Carol Bishopric)

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By Susan Heavey

BALTIMORE, Maryland