NemolizumabNemluvio
Treatment of patients aged 12 years or older with chronic severe atopic dermatitis affecting the whole body, face, and/or hands who are inadequately controlled on topical therapies.
Decisions on record
- Meeting Mar 2026 Recommended Atopic dermatitis
- Meeting Jul 2025 Not recommended Severe atopic dermatitis affecting whole body, face, and/or hands
Access path
- TGA registered · Nemluvio
TGA label narrower than the PBS population
- Jul 2025Not recommended
vs dupilumab
- ↻ resubmittedMar 2026Recommended · restricted
Evidence: Indirect treatment comparison (ITC) → RCT
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not recommend the General Schedule, Authority Required (Telephone/Online) listing of nemolizumab (NEMO) for the treatment of patients with severe atopic dermatitis (AD) affecting the whole body, face, and/or hands.PSD · Jul 2025
7.2 The primary reason for this outcome was due to the comparative clinical evidence.PSD · Jul 2025
6.49 The submission presented a CMA comparing NEMO with DUPI for the treatment of chronic severe AD based on a claim of non-inferior effectiveness and safety compared to DUPI, but with fewer injection site reactions and incidences of conjunctivitis. The CMA relies on the claim of non-inferior efficacy of NEMO compared to DUPI. The ESC considered that NEMO was likely inferior compared to DUPI.PSD · Jul 2025
Table 18: Key components and assumptions of the CMA Component Claim or assumption Based on evidence presented in the submission, effectiveness is assumed to be Therapeutic claim: effectiveness non-inferior. The ESC considered that NEMO was inferior to DUPI in terms of effectiveness.PSD · Jul 2025
6.40 The submission described NEMO as non-inferior in terms of effectiveness compared with DUPI and non-inferior in terms of safety compared to DUPI for the treatment of chronic severe AD in patients who are inadequately controlled on topical therapies. In addition, the submission claimed that NEMO offers the benefits of fewer injections and reduced rate of conjunctivitis, compared to DUPI.PSD · Jul 2025
6.41 The ESC considered that the claim of non-inferior efficacy was not supported by the evidence presented in the submission and the PSCR. Further, the ESC noted that no comparative data between NEMO and its main comparator, DUPI, was presented in the proposed PBS target population of patients with severe AD.PSD · Jul 2025
6.3 The PBAC noted and welcomed the input from health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The PBAC noted inputs received from the Australasian College of Dermatologists (ACD), Eczema Support Australia and a joint submission between Allergy & Anaphylaxis Australia, Australasian Society of Clinical Immunology and Allergy (ASCIA) and the National Allergy Council, which were all in support of …PSD · Jul 2025
6.4 All inputs stated that atopic dermatitis can impact an individual’s ability to participate in social, work, and educational activities. Itch is often cited as a major debilitating component of atopic dermatitis, resulting in broken painful skin and an increased risk of infection often results in social isolation with poor sleep and low self-esteem contributing to a poor quality of life.PSD · Jul 2025
Cost-effectiveness
Cost minimisation analysis; no ICER calculated by design
The submission presented a CMA comparing NEMO with DUPI for the treatment of chronic severe AD based on a claim of non-inferior effectiveness and safety compared to DUPI, but with fewer injection site reactions and incidences of conjunctivitis. PSD · 2025
Decision context
PopulationPatients aged 12 years or older with chronic severe atopic dermatitis affecting the whole body, face, and/or hands who are inadequately controlled on topical therapies (corticosteroid of medium to high potency or calcineurin inhibitor for at least 28 days).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | dupilumab | — | RCT · EASI-75 |
| Jul 2025 | Not recommended | dupilumab | — | Indirect treatment comparison (ITC) · EASI-75 and IGA 0/1 at Week 16 |
Consumer voice
Four health care professional and consumer organisations submitted input supporting nemolizumab listing. They emphasised that atopic dermatitis significantly impacts quality of life through severe itch, broken skin, infection risk, and mental health issues, and highlighted the need for alternative treatments with different mechanisms of action for patients who don't respond adequately to current t
Itch is often cited as a major debilitating component of atopic dermatitis, resulting in broken painful skin and an increased risk of infection often results in social isolation with poor sleep and low self-esteem contributing to a poor quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic severe atopic dermatitis with specific body site involvement and quantified severity thresholds despite prior topical therapy.