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 recommended the listing of nemolizumab (NEMO) for the treatment of patients with severe atopic dermatitis (AD) affecting the whole body, face, and/or hands. The PBAC, noting the additional data presented in the resubmission that included treatment with an extended NEMO induction period, considered the submission’s clinical claim of non-inferior effectiveness of NEMO to dupilumab (DUPI) was adequately supported.PSD · Mar 2026
7.2 The PBAC noted the sponsor hearing which highlighted safety benefits associated with NEMO, and the inputs received again from the Australasian College of Dermatologists (ACD), the Australasian Society of Clinical Immunology and Allergy (ASCIA) and a joint submission between Allergy & Anaphylaxis Australia, and the National Allergy Council, all of which supported the listing of NEMO on the PBS for AD.PSD · Mar 2026
6.31 The resubmission presented a CMA comparing NEMO with DUPI for the treatment of patients aged 12 years or older with chronic severe AD.PSD · Mar 2026
6.32 The key components of the CMA are summarised in Table 12.PSD · Mar 2026
6.27 The resubmission described NEMO as non-inferior in terms of effectiveness compared to DUPI. In the previous submission, the ITCs used to support the claim of non-inferior efficacy had several transitivity issues and indicated that NEMO may have inferior efficacy when compared to DUPI.PSD · Mar 2026
The data included from the ARCADIA LTE was single arm, open-label, and based on a subgroup determined post-hoc to consist of patients who did not respond at Week 16.PSD · Mar 2026
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.