NICE rebuffs Vidaza, backs MabThera
The U.K.'s NICE issued two final appraisal determinations (FAD) on Thursday, including one against the use of Vidaza azacitidine from Celgene Corp. (NASDAQ:CELG) in its approved indication. Vidaza is not recommended for 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. While NICE said Vidaza met the criteria for an end-of-life treatment, the price of the hypomethylating agent is still too high even with the company's proposed patient access scheme to reduce the drug's acquisition cost by 7%. The committee estimated that the incremental cost-effective ratio (ICER) for Vidaza would be about L63,000 ($95,432) per quality-adjusted life-year (QALY) compared to best supportive care. The Myelodysplastic Syndromes (MDS) Foundation said in a statement that it plans to work with Celgene to appeal the FAD, which is in line with an August preliminary appraisal. Celgene was off $0.23 to $60.99 on Thursday. ...