TezepelumabTezspire
Add-on maintenance treatment in patients aged 12 years and older with severe uncontrolled asthma (both eosinophilic/allergic and non-eosinophilic/non-allergic phenotypes) who are inadequately controlled despite optimal therapy including medium or high-dose inhaled corticosteroids plus another non-steroidal medicinal product for maintenance treatment.
Decisions on record
- Meeting Nov 2025 Recommended Severe uncontrolled asthma in patients aged 12+ years (non-eosinophilic/non-allergic and eosinophilic/allergic phenotypes)
- Meeting Jul 2022 Withdrawn Asthma, severe uncontrolled allergic and/or eosinophilic no PSD
Access path
- TGA registered · Tezspire
TGA label narrower than the PBS population
- Nov 2025Recommended · restricted
vs Standard of care for non-eosinophilic/non-allergic SUA…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Section 100 (Highly Specialised Drugs Program [HSD]) listing of tezepelumab for the treatment of patients aged 12 years and older with severe uncontrolled asthma (SUA) that is non-eosinophilic and non-allergic. The PBAC was satisfied that tezepelumab provides, for some patients, a significant improvement in efficacy over standard of care (SoC).PSD · Nov 2025
7.2 The PBAC recommended the Section 100 (HSD) listing of tezepelumab for the treatment of patients aged 12 years and older with SUA that is eosinophilic or allergic.PSD · Nov 2025
6.45 The submission presented a stepped economic evaluation of tezepelumab compared to SoC in patients with non-eosinophilic and non-allergic SUA who require high-dose ICS.PSD · Nov 2025
6.46 The type of economic evaluation presented was a cost-utility analysis and cost- effectiveness approach. The cost-utility analysis was consistent with the clinical claim of superior effectiveness and non-inferior safety of tezepelumab compared to SoC for the population.PSD · Nov 2025
6.36 For the non-eosinophilic and non-allergic SUA population, the submission described tezepelumab as superior in terms of effectiveness compared to placebo. The ESC noted the following uncertainties regarding the data presented in the submission:PSD · Nov 2025
4 Results from the SUA subgroup of patients with non-EOSic (<300cells/µl) + non-allergic (perennial specific IgE status negative) + high ICSPSD · Nov 2025
6.2 The PBAC noted and welcomed input from health care professionals (2), a medical organisation (1) and a consumer group/organisation (1) via the Office of Health Technology Assessment Consultation Hub. Health care professional input emphasised that there is a clinical need for patients with T2-low biomarkers (non-eosinophilic and non-allergic) as they are ineligible, and not suitable, for biologics currently subsidised through the PBS.PSD · Nov 2025
6.96 The submission did not propose a risk-sharing arrangement, stating that it was consistent with the arrangements for the current asthma biologics. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2025
Cost-effectiveness
ICER values redacted (commercially sensitive) for non-eosinophilic/non-allergic population; cost-minimisation approach used for eosinophilic/allergic population versus dupilumab.
Decision context
PopulationPatients aged 12 years and older with severe uncontrolled asthma (non-eosinophilic/non-allergic or eosinophilic/allergic phenotypes) inadequately controlled despite optimised high-dose inhaled corticosteroid plus long-acting beta-2 agonist therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | Standard of care for non-eosinophilic/non-allergic SUA; dupilumab for eosinophilic/allergic SUA | — | RCT · AAER |
Consumer voice
Healthcare professionals and consumer organisations expressed support for PBS listing of tezepelumab, highlighting unmet clinical need for T2-low asthma patients ineligible for current biologics, favourable side effect profile compared to long-term oral corticosteroids, and the importance of equitable access to treatment and quality of life improvements.
Health care professional input emphasised that there is a clinical need for patients with T2-low biomarkers (non-eosinophilic and non-allergic) as they are ineligible, and not suitable, for biologics currently subsidised through the PBS. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe uncontrolled asthma with specified phenotypes and includes later-line positioning; TGA label is broader.