The U.S. Food and Drug Administration approved Regeneron/Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis (PN). Dupixent is the first medication approved for PN, a rare inflammatory skin condition that can cause severe itching and have a significant negative impact on sleep and quality of life.

• Dupixent is an anti–interleukin (IL)-4 and anti–IL-13 biologic that was first approved to treat moderate to severe atopic dermatitis in 2017 and has since gained additional indications to treat several other type 2 inflammatory-driven conditions, such as asthma.

• In the Phase 3 PRIME and PRIME2 clinical trials, patients receiving Dupixent experienced superior itch reduction and achieved higher rates of clear or almost clear skin at 24 weeks compared with patients receiving placebo.

• IPD Analytics recommends prior authorization (PA) for Dupixent in the treatment of PN with a step through at least one medium- to super high-potency topical corticosteroid (TCS). Additionally, the PA criteria should match the labeled age and indication for PN. IPD also recommends including certain inclusion criteria from the PRIME and PRIME2 trials in the PA criteria.

• Utilization management of Dupixent should be high on payers’ radar, as utilization of the drug is expected to continue to grow for at least the next 5 years and biosimilar competition likely will not reach the market until 2031.