Announcements

ICER Publishes Final Report and Policy Recommendations for Hemophilia A Therapies

-- Independent appraisal committee votes that evidence is adequate to demonstrate clinical superiority of emicizumab over factor VIII prophylaxis; emicizumab is also cost saving, but only because factor VIII prices remain so high --

-- Due to FDA’s Complete Response Letter requesting longer-term data for valoctocogene roxaparvovec, there was no vote on its clinical effectiveness or cost-effectiveness; ICER’s preliminary analyses using a placeholder price of $2.5 million suggested that it would also be cost saving when compared to the high costs of current factor VIII dosing levels; for one-time treatments such as gene therapies, alternative approaches to value-based pricing that share more of the long-term cost offsets with the health system should be considered by policymakers --

-- Experts on policy roundtable recommend that life sciences companies and payers work together to de-escalate prices for current and future hemophilia treatments, recognizing that the current pricing structure creates financial toxicity for patients and their families, financial toxicity for health systems, and builds a platform for pricing potential cures that will only exacerbate these problems --

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ICER Publishes Evidence Report Finding That Supervised Injection Facilities Save Lives and Money

-- For communities that experience high rates of overdose, ICER has judged the evidence adequate to demonstrate that supervised injection facilities prevent overdose deaths and reduce overall costs by preventing emergency room visits and hospitalization --

-- Evidence suggests that SIFs do not affect crime rates but may decrease public drug consumption --

-- At an upcoming December 3 virtual meeting, the New England Comparative Effectiveness Public Advisory Committee will review the evidence, hear further testimony from stakeholders, and deliberate over the comparative clinical effectiveness, other potential benefits, and long-term value for money of constructing and operating these facilities --

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ICER Provides Second Update to Pricing Models for Remdesivir as a Treatment for COVID-19

-- Based on an analysis of four studies evaluating remdesivir’s influence on mortality, ICER has concluded that the totality of evidence no longer supports an assumption of survival benefit from remdesivir; however, new data from the US-based ACTT-1 trial does support savings on insurer payment for hospital services --

-- Given these new data and remdesivir’s expanded label to include less severely ill patients, ICER now suggests a health benefit price benchmark of $2,470 for hospitalized patients with moderate-to-severe disease, and $70 for patients hospitalized with milder disease --

-- New results, along with scenario analyses retaining survival benefit assumptions, will be shared with international health technology assessment agencies using the ICER COVID model for policy making --

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ICER Publishes Evidence Report on Digital Therapeutics for Opioid Use Disorder

-- The available evidence on the benefits of reSET-O, Connections, and DynamiCare has substantial limitations and can provide no firm estimate of net health benefit for patients with opioid use disorder versus usual care for any of these interventions --

-- Cost-effectiveness could not be modeled except for that of reSET-O; even when assuming short-term improvements in retention in treatment, at its current net price this intervention only aligns with commonly cited cost-effectiveness thresholds when outcomes are assumed to persist beyond the time horizon of the clinical trial; more evidence is needed around the durability of benefit after individuals complete this program --

-- At an upcoming November 18 virtual meeting, the Midwest Comparative Effectiveness Public Advisory Committee will review the evidence, hear further testimony from stakeholders, and deliberate over the comparative clinical effectiveness, other potential benefits, and long-term value for money of these interventions --

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ICER Publishes Evidence Report on New Therapies for Bladder Cancer

-- The evidence has significant limitations, and no firm estimate of net health benefit versus best supportive care was able to be determined for either nadofaragene firadenovec or oportuzumab monatoxs; the evidence is also inadequate to enable a clear comparison of these treatments to each other or to other active treatments --

-- Based on the estimates derived from single-arm trials of patient benefits from delay of metastasis and need for cystectomy, ICER calculates an annual health benefit price benchmark of approximately $118,000 to $204,000 for both agents; the underlying limitations in the clinical evidence create substantial uncertainty in these price benchmarks --

-- At an upcoming November 20 virtual meeting, the Midwest Comparative Effectiveness Public Advisory Committee will review the evidence, hear further testimony from stakeholders, and deliberate over these treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money --

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