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NICE rebuffs Vidaza again

November 5, 2010 11:19 PM UTC

The U.K.'s NICE issued a new preliminary appraisal for Vidaza azacitidine from Celgene Corp. (NASDAQ:CELG) that reiterates the agency's previous negative recommendations for the cancer drug. In July, a NICE appeals panel said the agency should reappraise the hypomethylating agent because its original appraisal against NHS use included only one of two possible comparators. The agency again recommended against Vidaza in its approved indications of intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation.

Celgene submitted additional cost-effectiveness analyses that compared Vidaza separately with each conventional care regimen specified by the appeal panel, and compared Vidaza with a weighted average of all the conventional care regimens. NICE said in its new appraisal that because hematologists have not agreed on characteristics defining the eligibility of patients to receive chemotherapy, the agency could not make recommendations based on any of the separate conventional care regimen groups. NICE said the incremental cost effectiveness ratio (ICER) of L58,900 ($94,434) per quality adjusted life year (QALY) gained for Vidaza compared with a weighted average of the conventional care regimens was too high, even taking into account end of life considerations and a patient access scheme that would reduce Vidaza's acquisition cost by 7%. ...