MepolizumabNucala
Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype (blood eosinophil count ≥300 cells/µL) on stable triple inhaled therapy (ICS/LABA/LAMA).
Decisions on record
- Meeting Mar 2026 Recommended Chronic obstructive pulmonary disease (COPD) with eosinophilic phenotype
- Meeting Mar 2024 Recommended Uncontrolled severe asthma
- Meeting Nov 2022 Recommended Chronic rhinosinusitis with nasal polyps
- Meeting Mar 2022 Withdrawn Severe asthma no PSD
- Meeting Nov 2021 Not recommended Chronic rhinosinusitis with nasal polyps
- Meeting Mar 2020 Recommended Eosinophilic asthma
- Meeting Mar 2018 Deferred Severe eosinophilic asthma
- Meeting Nov 2017 Recommended Uncontrolled severe eosinophilic asthma
2 earlier decisions
- Jul 2016 Recommended Severe eosinophilic asthma
- Mar 2016 Not recommended Severe eosinophilic asthma
Access path
- TGA registered · Nucala
TGA label narrower than the PBS population
- Mar 2016Not recommended
vs standard of care (placebo) and omalizumab
- ↻ resubmittedJul 2016Recommended · restricted
Comparator changed: standard of care (placebo) and omalizumab → omalizumab
- Nov 2017Recommended
- Mar 2018Deferred
- Mar 2020Recommended · restricted
Evidence: Other → RCT
- Nov 2021Not recommended
Comparator changed: mepolizumab powder for injection (Nucala Vial) → standard of care…
- ↻ resubmittedNov 2022Recommended · restricted
Comparator changed: standard of care (intranasal corticosteroids, saline rinses, and…
- Mar 2024Recommended · restricted
Comparator changed: standard of care (including intranasal corticosteroids, saline…
- Mar 2026Recommended · restricted
Comparator changed: omalizumab → triple inhaled therapy (LABA + LAMA + ICS) alone
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of mepolizumab as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation (defined by the submission as blood eosinophil count (BEC) ≥ 300 cells/µL). The PBAC was satisfied that mepolizumab provides, for some patients, a significant improvement in efficacy over triple inhaled therapy alone.PSD · Mar 2026
7.2 The PBAC noted comments from individuals who would like access to mepolizumab, health care professionals and organisations which expressed support for the proposed PBS listing of mepolizumab. The comments highlighted that patients with COPD who continue to exacerbate despite optimised triple inhaled therapy represent a group with a persisting unmet clinical need, as ongoing exacerbations are strongly associated with accelerated disease progression.PSD · Mar 2026
6.40 The submission presented a modelled cost-utility analysis comparing mepolizumab plus triple inhaled therapy with triple inhaled therapy alone utilising inputs from thePSD · Mar 2026
7 Note that these results are derived from post-hoc analyses conducted by the applicant specifically for the purposes of informing the PBAC consideration. Interpretation of the results and their application should therefore be limited to seeking to understand the basis for the PBAC outcome and should not be used for any other purpose. 23PSD · Mar 2026
6.34 The submission described mepolizumab plus triple inhaled therapy as superior in terms of effectiveness compared to triple inhaled therapy alone, in patients with uncontrolled COPD with an eosinophilic phenotype.PSD · Mar 2026
6.35 The Sub-Committees noted that the PSCR disagreed that the treatment effect was sensitive to outlier patients with ≥ 9 exacerbations and noted that there was a balanced distribution of treatment effect modifiers across both arms. The PSCR noted 22PSD · Mar 2026
4.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (4) and organisations (6) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of the proposed amendments to mepolizumab for uncontrolled severe asthma, including reduced administrative burden and complexity for prescribers.PSD · Mar 2024
4.3 The input was also supportive of the removal of the OCS requirement from the clinical criteria. It stated that in order to enable access to mepolizumab, the current threshold may result in unintended exposure to higher doses of corticosteroids beyond what is clinically reasonable. This may lead to long term OCS-related side effects and reduced quality of life.PSD · Mar 2024
Cost-effectiveness
ICER values redacted in the public summary document; commercial-in-confidence pricing arrangement
At its July 2016 meeting, the PBAC recommended the listing of mepolizumab for SEA on a cost-minimisation basis with omalizumab. PBAC · 2024
Decision context
PopulationAdults aged 18 years or older with uncontrolled COPD (≥2 moderate or ≥1 severe exacerbation in last 12 months despite optimised triple therapy) and blood eosinophil count ≥300 cells/µL in the last 12 months, on stable ICS/LABA/LAMA therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | triple inhaled therapy (LABA + LAMA + ICS) alone | — | RCT · ARR |
| Mar 2024 | Recommended · restricted | omalizumab | — | Cost-minimisation · Cost-minimisation |
| Nov 2022 | Recommended · restricted | standard of care (including intranasal corticosteroids, saline rinses, short courses of oral corticosteroids) | — | RCT · Other |
| Nov 2021 | Not recommended | standard of care (intranasal corticosteroids, saline rinses, and short courses of oral corticosteroids) | $55k–75k | RCT · Total endoscopic nasal polyp score and nasal obstruction visual analogue scale score |
| Mar 2020 | Recommended · restricted | mepolizumab powder for injection (Nucala Vial) | — | RCT · Pharmacokinetic parameters (bioequivalence) |
| Mar 2018 | Deferred | — | — | Other |
| Nov 2017 | Recommended | omalizumab | — | — |
| Jul 2016 | Recommended · restricted | omalizumab | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Not recommended | standard of care (placebo) and omalizumab | — | RCT · exacerbation rate |
Consumer voice
Consumer input from individuals, healthcare professionals, and organisations supported amendments to mepolizumab for uncontrolled severe asthma, highlighting reduced administrative burden for prescribers and improved disease control through streamlined processes and removal of OCS requirements from clinical criteria to prevent unnecessary corticosteroid exposure.
The comments described a range of benefits of the proposed amendments to mepolizumab for uncontrolled severe asthma, including reduced administrative burden and complexity for prescribers. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to uncontrolled severe asthma on optimised therapy (high-dose ICS+LABA ≥12 months); TGA label includes add-on treatment without prior therapy requirement.
Listed in law
PBS listings commencing 1 Jun 2020 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 42 of 2020 | 29 May 2020 | Repealed | PDF ↗ |
| PB 43 of 2020 | 29 May 2020 | Repealed | PDF ↗ |
| PB 51 of 2020 | 29 May 2020 | Repealed | PDF ↗ |