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US Medicare imposes reimbursement restricions for anaemia drugs

The US government Medicare programme has partially overturned its reimbursement restrictions for the use of anti-anaemia drugs by cancer patients due to safety concerns

The US government's Medicare programme has partially back-tracked on its proposed reimbursement restrictions for the use of anti-anaemia drugs by cancer patients due to safety concerns.

The FDA had strengthened its safety warning for Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and J&J's Procrit (epoetin alfa), saying studies had linked erythropoiesis-stimulating agents to higher risk of death and tumour growth in certain cancer patients.

In Q1 2007, an FDA regulatory panel demanded warning labels to be upgraded on all marketed anaemia drugs. As a result, US sales of J&Jís anaemia drug Procrit dropped 14 per cent to rest at USD 449m in Q2 FY07. Aranesp's Q2 FY07 sales were USD 949m, down 10 per cent on the equivalent quarter of 2006 for the same reason.

The Centres for Medicare and Medicaid Services (CMS) stated on 30 July that it had changed its mind after receiving more than 2,600 public comments. A number of cancer doctors had argued that the CMS proposal was excessive and would increase the number of blood transfusions in anaemia. The drugs are approved to reduce the need for transfusions.

CMS said it will no longer distinguish between cancers which have certain tumour receptors and those without the receptors. The previous proposal had suggested only paying for drugs in specific tumour types (myelodysplasia) containing the receptors. The CMS said it had made no coverage determination on this use and had proposed that regional Medicare contractors decide whether to pay under these circumstances.

The final Medicare policy covers, with restrictions, treatment of anaemia associated with certain chemotherapy regimens in certain cancer conditions, such as solid tumours, multiple myeloma, lymphoma and lymphocytic leukaemia.

While the FDA loosened some proposed restrictions, it surprised analysts by ruling the drugs were unnecessary for patients with less severe anaemia.

CMSí acting deputy administrator Herb Kuhn said in a press release: "Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries in light of the FDA boxed warnings. We look forward to further reports from FDA and are prepared to make additional modifications to our policies to ensure that Medicare patients receive the best and most effective treatments."

Epogen racked up sales of USD 2.5bn in FY06, while Medicare, which pays for most dialysis treatments, spends more than USD 2bn a year on the drug.

31st July 2007

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