DelgocitinibAnzupgo
Treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
Decision on record
- Meeting Nov 2025 Recommended Moderate to severe chronic hand eczema where topical corticosteroids failed or are medically inappropriate
Access path
- TGA registered · Anzupgo
TGA label narrower than the PBS population
- Nov 2025Recommended · restricted
vs Standard of care (non-medicated emollient use alone…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the General Schedule, Authority Required (telephone/electronic) listing of delgocitinib cream formulation for the treatment of moderate to severe chronic hand eczema (CHE), in patients who have previously not adequately responded to ongoing treatment with medium to high potency topical corticosteroids (TCS), or where eczema has repeatedly recurred, or for patients who are contraindicated to TCS.PSD · Nov 2025
OFFICIAL Public Summary Document – November 2025 PBAC Meeting delgocitinib should be available for prescribing by medical practitioners, with flexibility to allow for clinical decision-making in terms of patient age and potential combination therapy with other treatments, but with limits on the quantity of delgocitinib to be dispensed to ensure use is limited to CHE and not eczema on other body areas.PSD · Nov 2025
6.48 The submission presented a cost-utility analysis between delgocitinib and SoC and a cost-minimisation approach vs dupilumab. Cost-utility analysisPSD · Nov 2025
6.49 Key components of the economic evaluation are given in Table 9.PSD · Nov 2025
Delgocitinib 20 mg/g cream is non-inferior to dupilumab in terms of efficacy.PSD · Nov 2025
No safety claims were made for delgocitinib 20 mg/g vs dupilumab. Source: Table 1, p21 of the submission.PSD · Nov 2025
Cost-effectiveness
ICER value not stated in the public summary document provided. The economic evaluation section appears to be incomplete in the extracted text.
Decision context
PopulationAdults (aged ≥18 years) with moderate to severe chronic hand eczema who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | Standard of care (non-medicated emollient use alone; avoidance of known irritants and allergens) | — | RCT · IGA-CHE TS at Week 16 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DELTA 2 | Ph 3 | 473 | Number of Participants With IGA-CHE TS at Week 16 | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use after inadequate response to topical corticosteroids; TGA label includes primary use when TCS inadequate or inappropriate.