NICE now backs Revlimid for MDS

The U.K.'s NICE issued a Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) to treat patients with transfusion-dependent anemia with low- or intermediate-1-risk myelodysplastic syndromes (MDS) with a 5q chromosomal deletion when other therapeutics are insufficient or inadequate -- one of its approved EU indications. The recommendation is contingent on a patient access scheme (PAS) in which Celgene will provide Revlimid free of charge to all patients who receive more than 26 monthly cycles.

The FAD reverses draft guidance issued in May, in which NICE recommended against the use of Revlimid for the indication and concluded that because the proportion of patients surviving more than 26 cycles in clinical practice was uncertain, so were the potential cost-savings from the PAS. In the FAD, NICE reiterated that the incremental cost-effectiveness ratio (ICER) was uncertain because of the PAS, but accepted that a commitment from Celgene to publish data on the proportion of people on treatment beyond 26 cycles would "provide reassurance." The cost of a 28-day cycle of treatment with 10 mg of Revlimid (excluding VAT) is £3,780 ($6,325). ...