Benlysta belimumab regulatory update

The U.K.'s NICE issued draft guidance recommending against Benlysta belimumab from Human Genome and partner GlaxoSmithKline to treat patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

The committee said that compared with standard of care, Benlysta would have an incremental cost effectiveness ratio (ICER) at high end of the range of £64,410-£71,000 ($99,400-$109,600) per quality-adjusted life year (QALY), even with an undisclosed discount under a patient access scheme. The committee usually considers products with ICERs less than or equal to £20,000-£30,000 per QALY to be cost-effective. ...