LebrikizumabEbglyss
Treatment of severe atopic dermatitis (affecting the whole body or the face and/or hands) in patients aged 12 years or older who are inadequately controlled on topical therapies.
Decisions on record
- Meeting Mar 2026 Noted Atopic dermatitis no PSD
- Meeting Mar 2024 Recommended Severe atopic dermatitis (AD)
Access path
- TGA registered · Ebglyss
TGA label narrower than the PBS population
- Mar 2024Recommended · restricted
vs dupilumab
- PBS listing · Restricted
From the public summary
The PBAC recommended the listing of lebrikizumab (LEB) for adult and adolescent patients (12 years of age and older) with severe atopic dermatitis. The PBAC acknowledged the clinical need for additional systemic treatments for severe AD and considered that LEB provides an overall clinical benefit similar to the primary comparator dupilumab (DUPI) and the additional comparator upadacitinib (UPA).PSD · Mar 2024
The PBAC considered that inclusion of an extended induction period, as proposed for the LEB restrictions, was reasonable, but the additional doses for a proportion of ‘slow responders’ would need to be accounted for in the calculation of equi-effective doses applied in the cost-minimisation approach. The PBAC considered the equi-effective doses, assuming equivalent drug costs over a two-year period are: For adults and adolescents ≥ 60 kg:PSD · Mar 2024
The submission presented a CMA which compared LEB 250 mg for adult and adolescent patients aged 12 years and over, with DUPI 300 mg for adult patients and DUPI 200 mg for adolescent patients weighing <60 kg, over a two-year time horizon, including a 16 week induction period.PSD · Mar 2024
The equi-effective doses of LEB and DUPI estimated by the submission were:PSD · Mar 2024
The submission described LEB 250 mg Q2W as non-inferior compared with DUPI 300 mg Q2W in terms of effectiveness. Although the results of the indirect treatment comparison between LEB and DUPI in the severe AD subgroup were not statistically significant (RR=0.99, 95%CI: 0.50, 1.96; RD=-0.03, 95%CI: -0.16, 0.09), the evaluation considered the therapeutic conclusion presented in the submission may not be adequately supported by the evidence presented by the …PSD · Mar 2024
• The submission’s non-inferiority claim was based on an absence of a statistically significant difference in the indirect treatment comparisons. However, the 95% CI for RR was wide and the absence of a statistically significant difference based on an indirect comparison may be insufficient to support a claim of non-inferiority.PSD · Mar 2024
The PBAC noted and welcomed the input from individuals (5), health care professionals (4) and organisations (4) via the Consumer Comments facility on the PBS website. The comments described the unmet need for individuals with AD who do not respond to current available treatment options, are contraindicated to, or experience side effects from available treatments.PSD · Mar 2024
The PBAC noted the advice received from The Australasian College of Dermatologists in support of the LEB submission, noting that having an alternative treatment option is important for patients who have not achieved and maintained meaningful responses with DUPI or UPA or have experienced adverse events leading to discontinuation.PSD · Mar 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a CMA which compared LEB 250 mg for adult and adolescent patients aged 12 years and over, with DUPI 300 mg for adult patients and DUPI 200 mg for adolescent patients weighing <60 kg, over a two-year time horizon, including a 16 week induction period. PSD · 2024
Decision context
PopulationAdults and adolescents aged 12 years or older with severe atopic dermatitis (EASI ≥20 and PGA=4 for whole body; or 2 × EASI severe symptom sub-scores or ≥30% surface area for face/hands) affecting the whole body or face and/or hands, inadequately controlled on topical corticosteroids or calcineurin inhibitors for at least 28 days.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | dupilumab | — | RCT · EASI-75 |
Consumer voice
Consumer input from 5 individuals, 4 healthcare professionals, and 4 organisations described unmet need for atopic dermatitis patients who do not respond to or cannot tolerate current treatments, and noted that lebrikizumab may offer advantages including fewer ocular side effects and more convenient monthly dosing compared to dupilumab.
The comments described the unmet need for individuals with AD who do not respond to current available treatment options, are contraindicated to, or experience side effects from available treatments. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe AD with defined EASI/PGA thresholds and prior topical therapy failure; TGA label includes moderate-to-severe without these constraints.