Spectrum gets CMS nod for radiotherapeutic non-Hodgkin's lymphoma drug

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The Centers for Medicare & Medicaid Services (CMS) has allowed reimbursement for Spectrum Pharmaceuticals radiotherapeutic antibody, Zevalin (ibritumomab tiuxetan) for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma (NHL).

The company said the drug is indicated for those who achieve a partial or complete response to first-line chemotherapy and also for patients with relapsed or refractory, low-grade or follicular B-cell NHL.

The reimbursement methodology for Zevalin, a CD20-directed radiotherapeutic antibody will go into effect in Jan. 1, 2010, in the Hospital Outpatient Prospective Payment System (HOPPS), based on the average sales price methodology applicable to other injectable drugs and biologicals, according to the Irvine, Calif.-based Spectrum.

The antibody will be administered as part of the Zevalin therapeutic regimen which consists of three components: rituximab, Indium-111 (In-111) radiolabeled Zevalin for imaging, and Yttrium-90 (Y-90) radiolabeled Zevalin for therapy, according to Spectrum.

In September, the FDA approved Zevalin's expanded label for the treatment of patients with previously untreated follicular NHL, who achieve a partial or complete response to first-line chemotherapy.