— Evidence demonstrates the JAK inhibitors abrocitinib and upadacitinib are effective treatments for atopic dermatitis, but safety concerns about drugs in this class remain; the JAK inhibitor baricitinib and the emerging IL-13 inhibitor tralokinumab appear unlikely to be more efficacious than dupilumab, a treatment which has demonstrated long-term safety —
— For treating atopic dermatitis, health-benefit price benchmarks for these therapies range from $21,400 to $41,800 per year; upadacitinib requires the steepest discount — 35-63% — off its list price to reach common thresholds for cost-effectiveness —
— At July 23 virtual meeting, the New England 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 —
BOSTON, July 9, 2021 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of the following therapies for atopic dermatitis:
- abrocitinib (Pfizer)
- tralokinumab (LEO Pharma)
- baricitinib (Olumiant®, Eli Lilly and Incyte)
- upadacitinib (Rinvoq®, AbbVie)
- ruxolitinib (Incyte)
- dupilumab (Dupixent®, Regeneron and Sanofi)
“Both with this review and our 2017 review, we heard from multiple stakeholders how disruptive severe atopic dermatitis can be for patients and their families, affecting work, school, sleep, mental health, and self-assurance, said David Rind, MD, ICER’s Chief Medical Officer. “For many people, atopic dermatitis is a relatively mild condition, but atopic dermatitis can be a severe, chronic disease with large effects on quality of life. Dupilumab was a major advance, but it does not work for all patients and new therapies are needed. JAK inhibitors, if they prove safe, are likely to benefit many patients, including some who did not get adequate relief with dupilumab.”
This Evidence Report will be reviewed at a virtual public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on July 23, 2021. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.
Key Clinical Findings
Balancing the short-term benefits demonstrated in the clinical trials with ongoing concerns about long-term safety, ICER determined that the current evidence is promising but inconclusive (“P/I”) to demonstrate that abrocitinib, tralokinumab, baricitinib, or upadacitinib provide a net health benefit over topical therapies alone. The evidence provides moderate certainty that baricitinib and tralokinumab are comparable or inferior (C-) to dupilumab, and the current evidence is insufficient (“I”) to compare either abrocitinib or upadacitinib to dupilumab. The evidence is also insufficient (“I”) to compare abrocitinib, tralokinumab, baricitinib, and upadacitinib to each other.
Key Cost-Effectiveness Findings
For the treatment of atopic dermatitis, ICER’s recommended health-benefit price benchmark (HBPB) ranges are as follows:
- For abrocitinib, $30,600-$41,800 per year
- For tralokinumab, $25,700-$35,000 per year
- For baricitinib, $24,400-$33,300 per year, aligning with the treatment’s current US list price of $29,000
- For upadacitinib, $30,400-$41,500 per year, which would require a 35-53% discount off the treatment’s current US list price of $64,300
- For dupilumab, $29,000-$39,500 per year, which would require a 6-31% discount off the treatment’s current US list price of $41,800
The HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.