TacrolimusAZEMATOP 0.1%
Treatment of moderate to severe atopic dermatitis in patients aged 16 years and older who have failed to achieve satisfactory disease control with topical corticosteroids or are unsuitable/contraindicated for topical corticosteroids.
Decisions on record
- Meeting Mar 2026 Recommended Atopic dermatitis no PSD
- Meeting Jul 2025 Recommended Moderate to severe atopic dermatitis affecting body, face and eyelids
- Meeting Nov 2019 Recommended Prevention of transplant rejection
- Meeting Mar 2016 Recommended Liver, kidney, lung or heart allograft transplantation in adults and children
- Meeting Jul 2010 Recommended Immunosuppressant no PSD
- Meeting Nov 2008 Recommended Immunosuppressant no PSD
- Meeting Mar 2008 Recommended Prevent lung transplant rejection
- Meeting Nov 2007 Recommended Heart transplant rejection
1 earlier decision
- Jun 2001 Recommended For prevention of rejection no PSD
Access path
- TGA registered · AZEMATOP 0.1%
TGA label narrower than the PBS population
- Nov 2007Recommended · restricted
vs cyclosporin
- Nov 2007Recommended · restricted
- Mar 2008Recommended · restricted
- Mar 2016Recommended
Evidence: RCT → Cost-minimisation
- Nov 2019Recommended · restricted
Listing: Restricted → Unrestricted
- Jul 2025Recommended · restricted
Comparator changed: tacrolimus 1 mg once daily prolonged release capsules (3 x 1 mg doses…
- Jul 2025Recommended · restricted
Comparator changed: tacrolimus 1 mg once daily prolonged release capsules (3 x 1 mg doses…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended 0.1% tacrolimus (TAC) ointment be listed on the PBS as a General Schedule Authority Required (Streamlined) listing for the treatment of moderate to severe atopic dermatitis (AD) affecting the body, face and eyelids.PSD · Jul 2025
OFFICIAL Public Summary Document - July 2025 PBAC Meeting a cost minimisation approach versus TCS would be appropriate.PSD · Jul 2025
6.58 The submission presented a trial-based economic evaluation based on (i) a 3-week, randomised study24 for primary treatment (Ruzicka 1997), (ii) CONTROL25, a direct randomised trial, that compared the effectiveness of 0.1% TAC versus VO for the treatment of mild to severe AD (Wollenberg 2008), and (iii) a post hoc subgroup analysis of patients with moderate to severe AD from the adult CONTROL study (Reitamo 2010)26.PSD · Jul 2025
6.59 The key components of the economic evaluation are summarised in Table 8.PSD · Jul 2025
6.52 The submission presented two clinical claims: i. The submission described 0.1% TAC ointment as superior in terms of efficacy and non-inferior in terms of safety compared with VO in the treatment of patients with moderate to severe AD affecting any part of the body. ii.PSD · Jul 2025
6.53 Based on the evidence provided in the submission, the ESC considered that 0.1% TAC demonstrated superior efficacy and non-inferior safety versus VO for the treatment of flares, and as maintenance treatment in adults ≥16 years with moderate to severe AD. Thus, in patients who were contraindicated to TCS, the ESC considered that 0.1% TAC was superior to VO.PSD · Jul 2025
6.3 The PBAC noted the advice received from the Australasian College of Dermatologists which supported the submission, stating that there was strong evidence for the safety and efficacy of 0.1% TAC over long-term TCSs. The College also noted that the currently available compounded products are available at significant cost to patients and are associated with drug stability issues and secondary bacterial infections.PSD · Jul 2025
6.4 Eczema Support Australia expressed their strong support for the submission, noting the high cost, limited shelf life and access issues with the currently available compounded products. Eczema Support Australia also noted the need for non- steroidal anti-inflammatory options for patients who are unable to use TCSs.PSD · Jul 2025
Cost-effectiveness
ICER values not stated in the public summary document.
The PBAC noted that while the new strength is priced at the same cost per mg, there may be a small cost to the PBS due to decreased patient co-payments. PBAC · 2019
Decision context
PopulationAdults aged 16 years and older with moderate to severe atopic dermatitis affecting any part of the body, including face and eyelids, who have failed to achieve satisfactory disease control with intermittent (moderate or potent) topical corticosteroid therapy despite appropriate dose, duration and adherence, or who are unsuitable/contraindicated for topical corticosteroids.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | Vehicle ointment (VO) and 1% pimecrolimus (PIM) | — | RCT · Disease severity (EASI score, physician and patient rating of overall clinical response, %BSA affected) |
| Jul 2025 | Recommended · restricted | vehicle ointment (VO) and 1% pimecrolimus (PIM) | — | RCT · EASI |
| Nov 2019 | Recommended · restricted | tacrolimus 1 mg once daily prolonged release capsules (3 x 1 mg doses replaced by single 3 mg dose) | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Recommended | — | — | Cost-minimisation |
| Mar 2008 | Recommended · restricted | cyclosporin | — | RCT · Freedom from acute rejection; bronchiolitis obliterans syndrome incidence |
| Nov 2007 | Recommended · restricted | cyclosporin | — | RCT · OS, PFS |
| Nov 2007 | Recommended · restricted | cyclosporin | — | RCT |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EAILTx (2007) | Ph 3 | 274 | Incidence of bronchiolitis obliterans syndrome | completed |
Consumer voice
Health professionals and patient/clinical organisations supported PBS listing of 0.1% TAC ointment, citing access equity issues with current compounded products, their high cost, limited shelf life, and the need for non-steroidal alternatives to topical corticosteroids.
compounded TAC ointments, which are generally accessed through the public hospital setting, are recommended to be discarded 30 days after first use, which may result in access and equity issues. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed topical corticosteroids or are unsuitable/contraindicated; TGA label permits any moderate-to-severe cases.