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The US Centers for Medicare and Medicaid Services has issued a proposal to limit Medicare payments for anaemia drugs used to treat patients with cancer.
The proposal came on the heels of new warnings from the oncology drugs committee of the US Food and Drug Administration that the drugs, known as erythropoiesis stimulating agents (ESAs) are overused and could shorten patients' lives.
The committee unanimously recommended new clinical trials of the drugs, including Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), made by Amgen, and Procrit (epoetin alfa), made by Johnson and Johnson (BMJ 2007;334:1022, 19 May doi: 10.1136/bmj.39216.489780.DB).
The FDA issued updated public health advise on 14 May, warning that patients treated with the drugs have a higher risk of “serious and life-threatening side effects and [a] greater number of deaths” among several groups of patient, including patients in whom anaemia was not caused by chemotherapy, and patients with chronic renal failure or head and neck or breast cancer whose haemoglobin concentrations were greater than 12 g/dl.
The centres have said that they will not reimburse the use of the drugs in 13 conditions in which the drugs are considered either unsafe or unwarranted, including anaemia caused by radiation therapy; myelodysplasia or myeloid cancers; prophylaxis of anaemia; patients receiving certain drugs, such as bevacizumab (Avastin, Genentech); or monoclonal or polyclonal antibody treatment for epidermal growth factor.
The proposal is followed by 30 days for public commentary, ending on 13 June. The funding agency must issue its final decision by 14 September.
The centres responded to criticism that its proposal was based on financial rather than safety considerations, saying that it based its recommendations on the FDA decision in March to place “black box” warnings on the drugs.
Leslie Norwalk, the centres' acting administrator, said, “We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount. We have carefully examined the evidence surrounding these labelling changes and have issued this proposed decision to protect our beneficiaries.”
Reimbursement will be limited to treatment that starts when the patient's haemoglobin concentration or hematocrit is less than 9 g/dl or 27% in patients without known cardiovascular disease or less than 10 g/dl or 30% in patients with documented symptomatic ischaemic disease that cannot be treated with blood transfusion. Additional proposed limits are based on length of treatment and patients' response to treatment (www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=203).
The updated FDA advise and centres' recommendations follow a scandal over charges that doctors reaped substantial profits for prescribing one of the drugs, epoetin alfa (BMJ 2007;334:1022, 19 May). The centres estimate that it spent more than $4.4bn (£2.2bn; €3.3bn) for the drugs in 2006, excluding inpatient treatment, more than on any other class of drugs.
The agency was unable to state how many patients would be affected by its proposed changes. However, according to statistics compiled by the agency, it spent roughly $2.02bn in 2006 to treat patients with cancer, other anaemias, and haematological diseases—conditions that could be affected by the proposal.
Although all the current restrictions are directed at the treatment of patients with cancer, the agency is also opening an assessment of its reimbursement practices for patients with anaemia caused by renal failure.