AbrocitinibCibinqo
Treatment of adult patients with chronic severe atopic dermatitis who are unable to achieve disease control with daily use of topical treatments for at least 28 days.
Decisions on record
- Meeting Nov 2024 Recommended Severe atopic dermatitis
- Meeting Nov 2021 Deferred Severe atopic dermatitis no PSD
Access path
- TGA registered · Cibinqo
TGA label narrower than the PBS population
- Nov 2024Recommended · restricted
vs dupilumab
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the General Schedule Authority Required listing of abrocitinib (ABRO) 200 mg, 100 mg and 50 mg tablets for the treatment of adult patients with chronic severe atopic dermatitis (AD). The PBAC recommended the listings (doses) on the basis of the following cost-effectiveness considerations:PSD · Nov 2024
- ABRO 200 mg was recommended on the basis of a cost-minimisation approach (CMA) compared to dupilumab (DUPI). The PBAC considered the evidence presented in the submission demonstrated that ABRO 200 mg has non-inferior efficacy compared to DUPI. The Committee considered the equi-effective doses 41PSD · Nov 2024
6.50 Based on the clinical claim of non-inferiority of ABRO 200 mg QD vs DUPI 300 mg Q2W, the submission presented a cost-minimisation approach (CMA). In addition, the submission made a claim of inferior efficacy and non-inferior safety of ABRO 100 mg vs DUPI 300 mg Q2W and presented a stepped cost-utility analysis (CUA) in which the model reported on a cost saving per responder missed, and per quality adjusted life year (QALY) forgone.PSD · Nov 2024
6.51 The ESC considered the approach taken was consistent with the clinical claims for ABRO. However, the ESC considered that an alternative approach would be to present a combined model for the 100 mg, 200 mg and 50 mg doses, and transitions between them.PSD · Nov 2024
6.44 The efficacy clinical claims were based on post hoc analyses of subgroups with severe AD (defined as IGA=4), with or without prior systemic treatment for AD, for a composite endpoint EASI50+DLQI≥4. The clinical claim in the submission was that:PSD · Nov 2024
• ABRO 200 mg is non-inferior in terms of efficacy and non-inferior in terms of safety compared to DUPI 300 mg.PSD · Nov 2024
6.3 The PBAC noted the advice received from Eczema Support Australia and the Australasian College of Dermatologists. Eczema Support Australia noted that a small number of patients have reported very positive outcomes with ABRO, and that it may meet the needs of patients who have not gained adequate control through other JAK inhibitors or biologics.PSD · Nov 2024
6.4 Consumers noted the impact of AD on their quality of life. One consumer reported having inadequate response to DUPI and that their condition improved after starting treatment with ABRO, in particular noting that pruritis stopped, pain when showering stopped and sleep improved.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation analysis for ABRO 200 mg versus dupilumab; cost-effectiveness analysis for ABRO 100 mg versus dupilumab. No numeric ICER stated in public text.
Decision context
PopulationAdults aged 18 years or older with chronic severe atopic dermatitis affecting the whole body or face/hands, with PGA score ≥4 and EASI score ≥20 despite daily topical therapy (corticosteroid of medium to high potency or calcineurin inhibitor) for at least 28 days.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | dupilumab | — | RCT · Other |
Consumer voice
Consumer input highlighted the significant impact of atopic dermatitis on quality of life, with one individual reporting inadequate response to dupilumab but substantial improvement after starting abrocitinib, particularly regarding itch, pain, and sleep. Organisations including Eczema Support Australia and the Australasian College of Dermatologists supported the treatment, noting positive outcome
One consumer reported having inadequate response to DUPI and that their condition improved after starting treatment with ABRO, in particular noting that pruritis stopped, pain when showering stopped and sleep improved. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe AD with objective disease severity criteria (PGA ≥4, EASI ≥20) and documented topical treatment failure for ≥28 days.