DupilumabDupixent
Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation (defined by blood eosinophil count ≥300 cells/µL) despite stable triple inhaled therapy.
Decisions on record
- Meeting Mar 2026 Recommended Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
- Meeting Mar 2025 Recommended Severe atopic dermatitis (age <12 years) and uncontrolled severe asthma (age 6-11 years)
- Meeting Nov 2024 Noted Chronic severe atopic dermatitis; uncontrolled severe asthma no PSD
- Meeting Jul 2024 Noted Severe atopic dermatitis in patients aged 12 years and older
- Meeting Mar 2024 Recommended Uncontrolled severe asthma in children aged 6 to 11 years
- Meeting Nov 2023 Noted Severe atopic dermatitis (adults and adolescents)
- Meeting Jul 2023 Noted Chronic severe atopic dermatitis (AD)
- Meeting Nov 2022 Recommended Chronic severe atopic dermatitis; uncontrolled severe asthma
7 earlier decisions
- Jul 2022 Not recommended Chronic severe atopic dermatitis
- Mar 2022 Recommended Atopic dermatitis
- Nov 2020 Recommended Asthma
- Nov 2020 Noted Atopic dermatitis
- Mar 2020 Recommended Atopic dermatitis
- Jul 2019 Not recommended The treatment of moderate to severe atopic dermatitis (AD) in adult patients who are candidates for chronic
- Jul 2018 Not recommended Severe atopic dermatitis
Access path
- TGA registered · Dupixent
TGA label narrower than the PBS population
- Jul 2018Not recommended
vs placebo (concomitant topical corticosteroid, topical…
- Jul 2019Not recommended
Comparator changed: placebo (concomitant topical corticosteroid, topical calcineurin…
- ↻ resubmittedMar 2020Recommended · restricted
Comparator changed: standard of care (placebo) and ciclosporin A → placebo representing…
- Nov 2020Recommended · restricted
Comparator changed: placebo representing standard of care → benralizumab, mepolizumab…
- Nov 2020Noted
Comparator changed: placebo representing standard of care → benralizumab, mepolizumab…
- Mar 2022Recommended
Comparator changed: standard of care (topical corticosteroids and phototherapy) → placebo…
- Jul 2022Noted
Evidence: RCT → Other
- Nov 2022Recommended
Evidence: Other → Single-arm
- Jul 2023Noted
Comparator changed: dupilumab 200 mg in 1.14 mL and 300 mg in 2 mL pre-filled syringe →…
- Nov 2023Noted
Comparator changed: Not applicable → upadacitinib
- Mar 2024Recommended · restricted
Comparator changed: upadacitinib → omalizumab (Subgroup A); standard of care/placebo…
- Jul 2024Not recommended
Sponsor requested delist; not a PBAC rejection. However, the underlying issues include: sponsor's proposed price…
- ↻ resubmittedMar 2025Recommended · restricted
Comparator changed: standard of care → dupilumab pre-filled syringe (PFS) 200 mg in 1.14…
- Mar 2026Recommended · restricted
Comparator changed: dupilumab pre-filled syringe (PFS) 200 mg in 1.14 mL and 300 mg in 2…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the General Schedule Authority Required listing of two new forms of dupilumab, 200 mg in 1.14 mL and 300 mg in 2 mL single dose pre-filled pen (PFP) for the treatment of severe atopic dermatitis (AD) in patients aged less than 12 years on a cost minimisation basis to dupilumab PFS. The PBAC further recommended the Section 100 (Highly Specialised Drugs Program) Authority Required 8PSD · Mar 2025
6.2 The PBAC considered the following equi-effective doses to be appropriate: 200 Dupilumab PFP = 200 Dupilumab PFS 300 Dupilumab PFP = 300 Dupilumab PFSPSD · Mar 2025
5.14 The submission presented a cost-minimisation approach of dupilumab PFP compared with dupilumab PFS assuming there will be no material differences in administration complexity or completeness, setting of care, treatment uptake, compliance or adherence, or use of other healthcare resources arising following the listing of dupilumab PFP.PSD · Mar 2025
5.15 The submission estimated the equi-effective doses to be: Dupilumab PFP 200 mg in 1.14 mL once every 2 weeks (Q2W) = Dupilumab PFS 200 mg in 1.14 mL Q2W Dupilumab PFP 300 mg in 2.0 mL Q2W = Dupilumab PFS 300 mg in 2.0 mL Q2W 6PSD · Mar 2025
5.12 The submission claimed non-inferior comparative effectiveness and safety of dupilumab PFP compared with dupilumab PFS.PSD · Mar 2025
5.13 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable.PSD · Mar 2025
5.2 The PBAC noted and welcomed the input from medical organisations (2) and Consumer group/organisation (2) via the Consumer Comments facility on the PBS website. The comments from Australasian Society of Clinical Immunology and Allergy (ASCIA) expressed its support for this submission, highlighting that dupilumab significantly improves the health and quality of life for patients with chronic severe atopic dermatitis (eczema) and/or uncontrolled severe …PSD · Mar 2025
5.3 The PBAC noted input received from the National Paediatric Medicines Forum (NPMF) in support for the PBS listing of dupilumab PFP. The input outlined the effectiveness of dupilumab in treating severe uncontrolled asthma and atopic dermatitis in paediatric patients, reducing the need for excessive corticosteroids, often associated with negative long-term- adverse effects.PSD · Mar 2025
Cost-effectiveness
ICER value(s) not stated in the public text; the economic model exists but the numeric ICER appears to be redacted or not published in this PSD.
The submission estimated the requested listing of dupilumab PFP to be cost neutral to the PBS/RPBS. PSD · 2025
Decision context
PopulationAdults with uncontrolled COPD with type 2 inflammation (blood eosinophil count ≥300 cells/µL) despite at least 3 months of stable triple therapy (LAMA + LABA + ICS), with at least one severe exacerbation requiring hospitalisation or two or more moderate exacerbations (at least one requiring systemic corticosteroids) in the previous 12 months.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | triple inhaled therapy (LABA + LAMA + ICS) alone | — | RCT · ARR |
| Mar 2025 | Recommended · restricted | dupilumab pre-filled syringe (PFS) 200 mg in 1.14 mL and 300 mg in 2 mL | — | Single-arm · Surrogate |
| Jul 2024 | Not recommended | standard of care | $15k–25k | Other · Cost-effectiveness |
| Mar 2024 | Recommended · restricted | omalizumab (Subgroup A); standard of care/placebo (Subgroup B) | — | RCT · Annualised rate of severe asthma exacerbations |
| Nov 2023 | Noted | upadacitinib | $25k–35k | RCT · QALY |
| Jul 2023 | Noted | Not applicable | — | Registry |
| Nov 2022 | Recommended | dupilumab 200 mg in 1.14 mL and 300 mg in 2 mL pre-filled syringe | — | Single-arm · Other |
| Jul 2022 | Noted | — | — | Other |
| Mar 2022 | Recommended | placebo (standard of care) | — | RCT · EASI-75 |
| Nov 2020 | Recommended · restricted | benralizumab, mepolizumab, omalizumab | — | RCT · Asthma exacerbation rate |
| Nov 2020 | Noted | standard of care (topical corticosteroids and phototherapy) | $45k–55k | RCT · QoL |
| Mar 2020 | Recommended · restricted | placebo representing standard of care | — | RCT · EASI-75 |
| Jul 2019 | Not recommended | standard of care (placebo) and ciclosporin A | — | RCT · EASI-75 |
| Jul 2018 | Not recommended | placebo (concomitant topical corticosteroid, topical calcineurin inhibitor and emollient use alone) | — | RCT · EASI-75 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CHRONOS | Ph 3 | 740 | Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1"… | completed |
| VENTURE | Ph 3 | 210 | Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Mai… | completed |
| R668-AD-1607 (NCT03050151) | Ph 1 | 176 | Number of validated AI device-associated product technical failures (PTFs) during the trea… | completed |
| R668-AD-1434 (NCT02612454) | Ph 3 | 880 | Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline throu… | active not recruiting |
Consumer voice
Six medical and consumer organisations supported PBS listing of dupilumab, highlighting improved quality of life, effectiveness in severe atopic dermatitis and uncontrolled asthma in paediatric patients, reduced corticosteroid use, simplified dosing, and improved treatment adherence, while noting potential adverse effects and need for proper training.
dupilumab significantly improves the health and quality of life for patients with chronic severe atopic dermatitis (eczema) and/or uncontrolled severe asthma. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to paediatric patients aged <12 years with severe AD and aged 6-11 years with uncontrolled severe asthma; TGA label includes broader age ranges and severity criteria.