ARTICLE | Clinical News

Vidaza azacitidine regulatory update

November 8, 2010 8:00 AM UTC

The U.K.'s NICE issued a new preliminary appraisal for Vidaza azacitidine from Celgene that reiterates the agency's previous negative recommendations despite a reappraisal of the cancer drug with additional information from the company. In July, a NICE appeals panel said the agency should reappraise the hypomethylating agent because its original appraisal against NHS use only included one of two possible comparators. The agency 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 (see BioCentury, Aug. 2).

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 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 £58,900 ($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%. ...