Institute for Clinical and Economic Review Releases Revised Evidence Report on Dupilumab and Crisaborole for Treatment of Atopic Dermatitis

–Limitations noted on the evidence for crisaborole; analyses find stronger evidence for dupilumab and suggest its price has been set to align fairly with its added benefit for patients– 

Boston, Mass., May 12, 2017 – The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. This Evidence Report will be the subject of the upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) on May 25, 2017.

The report evaluates the evidence on dupilumab (Dupixent®, Sanofi-Regeneron), an injectable treatment for moderate-to-severe atopic dermatitis, and crisaborole (EucrisaTM, Pfizer), a topical treatment for mild-to-moderate atopic dermatitis, focusing on the clinical benefits, side effects, and value of these therapies compared to other treatment options available.

“Atopic dermatitis can have a substantial effect on quality of life,” stated ICER Chief Medical Officer David Rind, MD, MSc. “Our report noted limitations in the evidence on the comparative clinical effectiveness of crisaborole, but we found consistent evidence demonstrating clinical benefits for dupilumab among patients who have not seen adequate improvement with topical treatments. In addition, our analysis of long-term cost-effectiveness suggest that dupilumab is being introduced at a price that aligns fairly with the added benefit it brings to patients. We look forward to the public meeting, at which this evidence will be debated and a multi-stakeholder roundtable will discuss the implications for clinical practice, price negotiation, and insurance coverage.”

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report reflects changes made based on comments received from patient groups, clinicians, the manufacturers of the drugs, and other stakeholders.

Key Report Findings

ICER’s report found that for adults who have moderate-to-severe atopic dermatitis that is not adequately controlled with topical therapy, or for whom topical therapy is not appropriate, evidence for dupilumab provides high certainty of at least a small net health benefit. This is compared to usual care using emollients, with or without continued use of topical treatments that have not been effective. Compared to cyclosporine, an older systemic therapy, there is moderate certainty that dupilumab provides a comparable or better net health benefit.

ICER’s report includes cost-effectiveness calculations and value-based price benchmarks for dupilumab. In these calculations, based on information provided by the manufacturer, ICER used an estimated average net price of $31,000, rather than dupilumab’s wholesale acquisition cost (WAC) of $37,000. Using this net price, ICER’s analyses concluded that dupilumab’s cost fell within commonly cited thresholds for cost-effectiveness of $50,000-$150,000 per quality-adjusted life-year (QALY), at approximately $101,800/QALY. Similar cost-effectiveness calculations were not performed for crisaborole, given inadequate information on comparative effectiveness of crisaborole.

ICER’s analyses go on to calculate a value-based price benchmark, or the price at which the cost of a drug aligns with the benefit it provides to patients. For dupilumab, ICER calculated this range to be $30,516-$43,726; thus, dupilumab’s $37,000 WAC and $31,000 expected net price fall well within this range. At its current price, dupilumab represents a good value to patients based on the benefit it provides in relation to its cost.

ICER is committed to a transparent public engagement process to ensure that all stakeholders have the opportunity to provide input to the reports and public meetings. After ICER’s Draft Evidence Report was released on March 24th, stakeholders had four weeks to provide comments. ICER staff considered these comments and made revisions to the report before posting the revised Evidence Report. The Evidence Report, as well as the accompanying voting questions, public comments, and ICER’s written response to comments, are available on the ICER website.

The Evidence Report will be the subject of the May 25th public meeting of the Midwest CEPAC, during which the independent council will vote on key questions raised in the report, and a policy roundtable of experts will discuss recommendations to apply the evidence to policy and practice. During the meeting, a limited amount of time will be available for pre-registered stakeholders to provide a brief oral comment on the report and its findings. Requests to make an oral comment were accepted during the public comment period on the Draft Evidence Report.

Registration for the in-person meeting is open here. Registration for a live webcast of the meeting is open here.