Amgen executive angered over coverage restrictions: CMS won't pay for anemia treatment, which means fewer Aranesp sales.

AMGEN Inc.'s Roger Perlmutter's blood was boiling last week.

The executive vice president of global research and development was reacting to the decision of the Centers for Medicare and Medicaid Services to not pay for his company's anemia treatment if a cancer patient's hemoglobin level--a measure of red blood cells--is greater than 10 grams per deciliter of blood.

"The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," Perlmutter said in a release. "In our view, restricting coverage in this way is unreasonable, impractical and unworkable."

Normal hemoglobin levels range between 14 to 18 grams for men and 12 to 15 for women, which oncologists generally try to shoot for. Getting there can include use of Thousand Oaks-based Amgen's Aranesp or an older version called Procrit, which Amgen manufactures for Johnson & Johnson to sell.

The new CMS guidelines will mean a fewer Aranesp sales to elderly and poor patients, who can develop a low red blood cell count as a result of chemotherapy or cancer that's being treated in other ways. Safety concerns have already led Aranesp sales to fall 7 percent in the second quarter. Lazard Capital Markets analyst Joel Sendek, who has a "sell" recommendation on Amgen shares, expects that trend will accelerate if the CMS restrictions hold.

But as a physician, Perlmutter was even more concerned about the impact on a doctor's ability to effectively treat patients and keep them comfortable during the process.

That's because if hemoglobin levels dip much below 10 grams, a patient's anemia could quickly worsen to the extent that they might need a blood transfusion, which brings its own potential complications. Doctors will have to take blood samples a lot more often to closely monitor patients, and have fewer options when patients develop symptoms that sap their strength to endure the cancer treatment itself, say critics of the new limits.

Aranesp and other similar agents already are under more restrictive dosing guidelines since the U.S. Food and Drug Administration earlier this year acted on studies suggesting that the drugs can also stimulate tumor growth in certain instances. Perlmutter said those guidelines, plus the label warnings he now has to put on Aranesp, provide sufficient protections.

Perlmutter isn't alone in his concern. Local cancer doctors such as Dr. John Macdonald expect national physician groups, which mounted a significant protest when CMS originally proposed a 9 gram hemoglobin limit, will be unsatisfied with this compromise. That's because CMS guidelines could become a national norm if picked up by private insurers.

"The new policy is restrictive, and in some respects confusing to doctors," said Macdonald, chief medical officer for Los Angeles-based Aptium Oncology, which operates the outpatient cancer center at Cedars-Sinai Medical Center and similar facilities around the country. "These drugs can make people feel better, and doctors have gotten used to using them for a variety of anemia."

CMS pays $5.4 billion a year for Aranesp-style drugs, which are also used for kidney disease.

Staff reporter Deborah Crowe can be reached at [phone], ext. 232, or at [e-mail].