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.
Pay for Performance
Insurers clamping down on what treatments they’ll pay for isn’t the only challenge facing oncologists these days. The community cancer center journal Oncology Issues recently published an article by Macdonald and a fellow Aptium colleague detailing the challenges their profession faces in dealing with the pay-for-performance movement.
In pay for performance, insurers tell doctors and health care facilities they’ll be paid more if they follow certain treatment protocols designed to raise the quality of care. Not coincidentally, these practices also tend to be more cost-efficient.
The process of establishing these protocols has been a prickly one for the medical profession, whose members may reach consensus within their professional groups, but are free to set their own course in personal practice.
Oncology, because of the wide variety of ways to treat a myriad of cancers, so far hasn’t been hit by pay for performance. Macdonald and Dr. Deane Wolcott, Aptium’s vice president for clinical care, argue their specialty must get ahead of the curve and develop their own standards before they are imposed on them.
Key in controlling the process will be getting payers to buy into the concept that they can save money in the long run by paying for what might be more expensive treatments up front. That’s particularly true with breast and colon cancer, where relapses can quickly degenerate into terminal cases.
“If you treat patients properly the first time, you can prevent a significant health care cost to society,” Macdonald said.
Staff reporter Deborah Crowe can be reached at (323) 549-5225, ext. 232, or at
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