Medicare imposes limits on anemia drugs

Washington -- Medicare officials last month decided not to go as far in limiting coverage of a key anemia drug for cancer patients as they initially said they would. But physicians still are worried that the new policy will hamstring them and keep some patients from getting their needed treatments.

The Centers for Medicare & Medicaid Services released July 30 a final national coverage determination on Medicare coverage of erythropoiesis-stimulating agents, known generically as darbepoetin and epoetin, in patients with certain types of cancer. The drugs, which are designed to raise hematocrit levels, are manufactured respectively by Amgen as Aranesp for cancer patients and by Johnson & Johnson under the name Procrit. Amgen also produces Epogen for patients with kidney disease.

In May the agency released a proposed coverage determination that would have limited more strictly the conditions under which Medicare would pay for the drugs for cancer patients. For beneficiaries with certain types of the disease, the coverage would have disappeared altogether.

The proposal came after the Food and Drug Administration issued a series of warnings and recommendations for epoetin agents because of the potential for strokes and hearts attacks if the drugs were used too readily.

But the uproar that ensued from physicians and from patient advocates, who sent more than 2,600 comments to CMS, caused the agency to back off its original stance and soften the proposed limits. Instead of ruling out coverage altogether for patients with certain cancer types or who are undergoing certain other treatments, it is keeping the coverage open for beneficiaries whose anemia is caused by their chemotherapy -- regardless of tumor type or secondary treatment. For myelodysplastic syndrome, a condition for which coverage would have been prohibited under the original proposal, CMS now is leaving the coverage decision up to individual local Medicare carriers.

Medicare also no longer will differentiate between patients based on whether their tumors have epoetin receptors, which some experts fear could lead to the cancer worsening when stimulated by the drugs.

"Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries in light of the FDA boxed warnings," said CMS Acting Deputy Administrator Herb Kuhn. "This final [decision] is based on the best science to date and consistent with FDA labeling and warnings."

But many physicians disagree with this assessment. While the more liberal policy finalized by CMS is an improvement over the earlier proposal, a number of its elements still clash with the clinical evidence, they said.

Chief among the disagreements are the approved starting and ending points for anemia treatment. Medicare will cover the drugs for chemotherapy patients only if their hemoglobin levels are less than 10 g/dL before treatment and will stop the coverage if it exceeds that level after four weeks of treatment.

The final policy ties physicians' hands because it does not allow them to continue using epoetin to maintain patients' hemoglobin levels at a healthy range between 10 g/dL and 12 g/dL, said Samuel M. Silver, MD, PhD, a hematologist/oncologist at the University of Michigan in Ann Arbor and member of the American Society of Hematology Executive Committee. Instead, a doctor will need to wait until his or her patient drops back under the safe level before renewing treatment, potentially sending the patient's hemoglobin levels on a roller coaster ride that is difficult to stop.

"That leaves you very little wiggle room," he said. "It will require very intensive monitoring that wasn't required before."

A representative for one of the companies that manufactures epoetin warned that the consequences of the CMS decision could be severe.

"The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, MD, PhD, executive vice president of global research and development at Amgen. "We are concerned that inappropriately limiting coverage for erythropoiesis-stimulating agents at hemoglobin levels less than 10 g/dL will both increase blood transfusions and severely compromise the high quality of cancer care that is delivered by American physicians."

Revisiting the issue

Oncologists, hematologists and other physicians are clamoring for CMS to revisit the decision, which went into effect at the end of last month.

CMS on Aug. 10 held a hastily scheduled meeting in Baltimore with stakeholders, including cancer researchers and drug manufacturers, to discuss complaints about the new limits. Dr. Silver, who attended the meeting for the hematology society, said agency officials expressed a willingness to give serious consideration to the organizations' concerns.

But until the agency decides whether to reopen the decision, doctors are stuck with the limits as currently written. The significant expense of the drugs and the vague nature of some of the restrictions means that some doctors will decide not to give them to certain patients if there is a possibility that they will not receive payment from Medicare under the new policy, said Deborah Kamin, PhD, senior director of cancer policy and clinical affairs for the American Society of Clinical Oncology.

"There's just enough confusion. It may be that physicians will not use it at all and find alternative ways of dealing with the symptoms, even though they may not be ideal," she said.

Dr. Silver said his society already had seen signs that wary physicians were greatly dialing back their epoetin use in response to the recent FDA and CMS activity on the issue. If CMS does not change its final policy, use of the drugs could potentially drop by as much as half, he said.