ICER Publishes Final Evidence Report and Policy Recommendations on Therapies for Atopic Dermatitis

— Given uncertainty about safety data on oral JAK inhibitors for other indications, a narrow majority of the independent appraisal committee voted that the current evidence is adequate to demonstrate that abrocitinib, baricitinib, and upadacitinib provide a net health benefit —

— Committee found the evidence is adequate to demonstrate that systemic tralokinumab and topical ruxolitinib both provide a net health benefit —

— Policy recommendations highlight rationale for formulary inclusion of at least one biologic and one JAK inhibitor should JAK inhibitors receive marketing approval; importance of diversity of patients in framing options for step therapy; and the shared responsibility to price and cover new therapies in a way that reduces health inequities —

BOSTON, August 17, 2021 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of the following therapies for atopic dermatitis:

abrocitinib (Cibinqo®, Pfizer)
tralokinumab (Adtralza®, LEO Pharma)
baricitinib (Olumiant®, Eli Lilly, Incyte Corporation)
upadacitinib (Rinvoq®, AbbVie)
ruxolitinib (Opzelura™, Incyte Corporation)

ICER’s report on these therapies was reviewed at the July 2021 public meeting of the New England CEPAC (New England CEPAC), one of ICER’s three independent evidence appraisal committees.

Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations

“Both in this review and in 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 significant effects on quality of life. Dupilumab was a major advance, but it does not work for all patients, and new therapies are needed. If they prove safe, JAK inhibitors are likely to benefit many patients, including some who did not get adequate relief with dupilumab. At our public meeting, the New England CEPAC discussed the importance of ensuring these new therapies for atopic dermatitis improve the health of patients and families and do not aggravate existing health inequities. Clinical experts and patients highlighted that the high cost of new therapies might worsen disparities in accessing care.”

Voting on Clinical Effectiveness and Contextual Considerations

For adults with moderate-to-severe atopic dermatitis, the New England CEPAC voted:

8-5 that the evidence was adequate to demonstrate that abrocitinib plus usual care provides a net health benefit when compared to usual care alone;
7-6 that the evidence was adequate to demonstrate that baricitinib added to usual care provides a net health benefit when compared to usual care alone;
9-4 that the evidence was adequate to demonstrate that upadacitinib added to usual care provides a net health benefit when compared to usual care alone; and
11-2 that the evidence was adequate to demonstrate that tralokinumab added to usual care provides a net health benefit when compared to usual care alone.

For adolescents and adults with mild-to-moderate atopic dermatitis, the New England CEPAC voted:

12-1 that the evidence was adequate to demonstrate that ruxolitinib provides a net health benefit when compared to topical emollients alone.

During their deliberations, panel members also weighed the therapies’ other potential benefits, disadvantages, and contextual considerations. The voting highlighted the following aspects as particularly important for payers and other policymakers to note:

The acuity of need for treatment based on the severity of atopic dermatitis;
The magnitude of the lifetime impact on individual patients of atopic dermatitis;
Patients’ ability to achieve major life goals related to education, work, or family life; and
Caregivers’ quality of life and/or ability to achieve major life goals related to education, work, or family life.

Voting on Long-Term Value for Money

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; and
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 and which is in line with the therapy’s estimated net price of $31,000.

In the prior ICER review of new treatments for atopic dermatitis, dupilumab was found to be priced at a cost-effective level, and the appraisal committee voted that it represented “high” long-term value for money. At this current meeting, a majority of panelists found that baricitinib, at its current pricing, represents “intermediate” long-term value for money. They also found that upadacitinib represents “low” long-term value for money. The New England CEPAC did not vote on the long-term value of abrocitinib and tralokinumab because those therapies do not yet have a US price.

ICER’s HBPBs are price ranges 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.

Key Policy Recommendations  

Following the voting session, a policy roundtable of experts — including clinical experts, patient advocates, and representatives from US payers and the relevant pharmaceutical companies — convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include:

If multiple agents for severe atopic dermatitis are approved, payers should make available at least one biologic (dupilumab and/or tralokinumab) and at least one JAK-1 inhibitor given how different these classes are in their onset of action and their risk profile.
Payers establishing step therapy with less expensive systemic agents and/or phototherapy should allow patients and clinicians to choose from multiple options rather than require patients to try all options. 
All stakeholders have a responsibility and an important role to play in ensuring that effective new treatment options for patients with atopic dermatitis are introduced in a way that will help reduce health inequities.

ICER’s detailed set of policy recommendations, including considerations for establishing prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

About ICER

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.