Posted by Michael Wonder on 01 Aug 2018
Institute for Clinical and Economic Review to evaluate comparative clinical effectiveness and value of AVXS-101 and nusinersen for spinal muscular atrophy
31 July 2018 - Open input period now open until 17 August.
The ICER will develop a report assessing the comparative clinical effectiveness and value of AVXS-101 (Novartis) and nusinersen (Spinraza, Biogen) for treatment of spinal muscular atrophy (SMA). 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. AVXS-101 is a gene therapy currently being studied for use in infants with SMA, and many analysts expect FDA 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.
