ICER to evaluate comparative effectiveness of Biogen and Novartis SMA drugs

The US Institute for Clinical and Economic Review (ICER) has announced plans to develop a report assessing the comparative clinical effectiveness and value of Novartis’ (NOVN: VX) AVXS-101 and Biogen’s (Nasdaq: BIIB) Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA).

The ICER’s report is set to be reviewed during a March 2019 meeting of the New England Comparative Effectiveness Public Advisory Council ( New England CEPAC), one of ICER’s three independent evidence appraisal committees.

Nusinersen was approved in 2016 for treatment of SMA in both children and adults, and in the second quarter of 2018 notched up sales of $423 million globally. AVXS-101 is a gene therapy currently being studied for use in infants with SMA, and many analysts expect US Food and Drug Administration approval of this treatment to occur in the first quarter of 2019. The formal scope of ICER’s review – including the drugs reviewed, special subpopulations of interest, and basic approach to economic modeling – will be finalized with the benefit of input from all stakeholders, including clinical experts and patients.