ICER news: November 2020
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ICER news: November 2020 The US Institute for Clinical and Economic Review (ICER) has published Evidence Reports on the effectiveness and value of two new therapies for bladder cancer and three digital health technologies for opioid use disorder (OUD).1,2
Bladder cancer therapies ICER has released an Evidence Report assessing the comparative effectiveness and value of nadofaragene firadenovec [Adstiladrin; FKD Therapies Oy and FerGene] and oportuzumab monatox [Vicineum; Sesen Bio] for the treatment of non-muscle invasive bladder cancer that is unresponsive to BCG intravesical therapy. "While our review of the evidence suggests that both nadofaragene firadenovec and oportuzumab monatox may provide benefits for patients, more rigorous trials are needed. The lack of a placebo or active comparator in pivotal trials, though meeting FDA guidance, leaves clinicians, patients, and other stakeholders with significant uncertainty around comparative benefits and the magnitude of those benefits. Additionally, without longer-term data, it is impossible to know how often these therapies allow patients to progress past the point where removal of the bladder (cystectomy) is curative," said Dr David Rind, ICER’s Chief Medical Officer. Available evidence was inadequate to determine the net health benefit of either treatment compared with best supportive care, or to compare the two treatments with each other, or other active treatments (gemcitabine with or without docetaxel, and pembrolizumab). ICER calculated a health-benefit price benchmark (HBPB; the highest US price a manufacturer should charge) range of $118 000–$198 000 per year for nadofaragene firadenovec and $119 000–$204 000 per year for oportuzumab monatox, but limitations in the clinical evidence created uncertainty in the price benchmarks. The Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Comparative Effectiveness Public Advisory Council) on 20 November 2020.
Digital apps for OUD In November 2020, ICER also released an Evidence Report assessing of three digital technologies for OUD: • reSET-O [Pear Therapeutics], a 12-week prescription app used in conjunction with buprenorphine and small rewards, aimed at improving adherence to outpatient OUD treatment; • Connections [Chess Health], an app combining communication with addiction experts and support groups alongside a 7-session program teaching cognitive and behavioral skills, aimed at improving abstinence in patients with substance use disorders; and • DynamiCare [DynamiCare Health], an app that includes 36 classroom-based training modules, monitoring for substance abstinence, and debit card rewards for negative drug tests and appointment attendance. "While these new digital therapeutics incorporate cognitive and behavioral interventions that may provide benefits to patients, there are no randomized trials demonstrating that patients benefit from any of these specific apps compared to medication assisted treatment alone. More evidence is needed to fully understand these apps’ comp
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