Nplate romiplostim regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Amgen's Nplate romiplostim to treat chronic idiopathic thrombocytopenic purpura. In its appraisal, the agency said evidence for Nplate's relative effectiveness compared with other active treatments is lacking. NICE also noted that certain assumptions in Amgen's base cost resulted in underestimated cost per quality-adjusted life year (QALY) gained for use of Nplate. The agency calculated that the incremental cost-effectiveness ratio (ICER) for splenectomised patients charged from £29,800 ($48,821) to £110,000 ($180,213) per QALY gained and from £21,700 ($35,551) to £28,600 ($46,855) per QALY gained for non-splenectomised patients. It is generally accepted that a technology must have an incremental cost less than or equal to £20,000-£30,000 per QALY for the agency to consider it cost-effective. Standard of care in the indication includes IV immunoglobulin, anti-D or IV corticosteroids. ...