Yesterday, the Institute for Clinical and Economic Review (ICER) announced
the release of its Draft Evidence Report
assessing the comparative clinical effectiveness and value of bempedoic acid (NEXLETOL), bempedoic acid/ezetimibe (NEXLIZET), and inclisiran for the treatment of heterozygous familial hypercholesterolemia (HeFH) and for secondary prevention of atherosclerotic cardiovascular disease (ASCVD). NEXLIZET and NEXLETOL were approved by FDA in February 2020 and March 2020, respectively, and an FDA decision is expected for inclisiran by the end of 2020. ICER’s preliminary findings state bempedoic acid products would produce a modest improvement in outcomes but are unlikely to achieve the cost-effectiveness threshold of $150,000 per quality-adjusted life-year (QALY) at current prices. The draft report also states that the large reduction in LDL-C with inclisiran is projected to
substantially reduce major adverse cardiovascular events, and with a placeholder price of $5,644 per year, inclisiran approaches a cost-effectiveness threshold of $150,000 per QALY. The Draft Evidence Report is open to public comment until December 11, and the Midwest Comparative Effectiveness Public Advisory Committee (CEPAC) will deliberate and vote on the evidence presented in ICER's Final Evidence Report on February 5, 2021.
On Tuesday, ICER announced
the release of the second assessment update
to its pricing models for remdesivir (VEKLURY) as a treatment for COVID-19, which includes changes based on new data from ongoing trials, as well as public comments and interactions with the manufacturer. Although ICER did not update its cost-recovery model, ICER’s updated base-case cost-effectiveness analysis, which includes both patients with moderate to severe disease and patients with milder disease, found that the current US price for VEKLURY is too high to align with a key cost-effectiveness threshold of $50,000 per QALY and per equal value of life-year gained. These new findings are primarily a result of new data from a meta-analysis that included the
, which did not demonstrate a survival benefit nor an impact on time improvement or progression to higher levels of respiratory support for patients with moderate to severe illness. Additionally, VEKLURY’s expanded indication for patients with mild disease was an influential driver for these results, as the current price would meet the $50,000 cost-effectiveness threshold if VEKLURY was used only in patients hospitalized for moderate to severe disease. The models will continue to be updated as new data become available.
Last Friday, ICER announced
the release of its revised Evidence Report
evaluating nadofaragene firadenovec (ADSTILADRIN) and oportuzumab monatox (VICINEUM) for the treatment of non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guerin intravesical therapy. Both treatments, which have not yet been approved by the FDA, were considered to be at least comparable to best supportive care, but no firm estimate of net health benefit was determined due to significant limitations of the evidence. Additionally, ICER recommended that the health-benefit price benchmark (HBPB) ranges for VICINEUM and ADSTILADRIN should be $118,000 to $198,000 per year and $119,000 to $204,000 per year, respectively. The Midwest CEPAC will meet on November 20, and the Final Report will be posted on or around December 15.
Also last Friday, ICER announced
the release of its revised Evidence Report
for 3 digital health technologies developed to treat opioid use disorder, including reset-O, Connections, and DynamiCare. Although there were no randomized controlled trials demonstrating how well these interventions enhance abstinence or retention in medication-assisted treatment (MAT), ICER determined that the apps are unlikely to harm patients and are therefore at least comparable to MAT alone. ICER also recommended the HBPB range for reset-O should be between $1,100 and $1,400 based on the assumption that there would be a significant impact on MAT retention for 5 years beyond the 12-week program. Cost-effectiveness analyses were not conducted for the remaining interventions due to limitations of the evidence. The topic will be reviewed by the Midwest CEPAC during the virtual
public meeting scheduled for November 18, and the Final Report will be released on December 15.
If you need assistance with all things ICER or value-related, please contact Anne Loos