Before delving into the news, TrialSite News introduces The Institute for Clinical and Economic Review. Founded in 2005 by physician-researcher Steven D. Pearson, MD, MSc, FRCP. For its initial years the staff concentrated on assessing health care costs (rather than evaluating drugs). It has come under criticism from the drug industry. Since 2014, it has issued a number of drug evaluation. The institution is funded by the Laura and John Arnold Foundation, drug makers, insurers and government grants.
As reported in the Pharma Letter, 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.
An “Open Input” period has begun and comments on the topic will be accepted from all interested stakeholders until August 17, 2018 at 5 PM ET. The Open Input period is intended to allow stakeholders to share key information relevant to the development of the evidence report. During this time, ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of these treatments.