BimekizumabBimzelx
Treatment of severe chronic plaque psoriasis in adult patients as a single 320 mg injection administered subcutaneously at weeks 0, 4, 8, 12, 16 and every 8 weeks thereafter.
Decisions on record
- Meeting Nov 2025 Recommended Severe chronic plaque psoriasis
- Meeting May 2025 Recommended Moderate to severe hidradenitis suppurativa
- Meeting Mar 2024 Recommended Psoriatic arthritis (PsA)
- Meeting Mar 2024 Recommended Ankylosing spondylitis (AS)
- Meeting Mar 2024 Recommended Non-radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Mar 2023 Recommended Chronic plaque psoriasis (CPP)
- Meeting Mar 2022 Recommended Severe chronic plaque psoriasis
Access path
- TGA registered · Bimzelx
TGA label narrower than the PBS population
- Mar 2022Recommended · restricted
vs All currently PBS-listed biologic disease-modifying…
- Mar 2023Recommended · restricted
Comparator changed: All currently PBS-listed biologic disease-modifying anti-rheumatic…
- Mar 2024Recommended · restricted
Comparator changed: all PBS-listed biologic disease-modifying anti-rheumatic drugs…
- Mar 2024Recommended · restricted
Comparator changed: all PBS-listed biologic disease-modifying anti-rheumatic drugs…
- Mar 2024Recommended · restricted
Comparator changed: all PBS-listed biologic disease-modifying anti-rheumatic drugs…
- May 2025Recommended · restricted
Comparator changed: ixekizumab → secukinumab (primary); adalimumab (secondary)
- Nov 2025Recommended
Comparator changed: secukinumab (primary); adalimumab (secondary) → bimekizumab 160 mg in…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of bimekizumab 320 mg in 2 mL single use prefilled pen for the treatment of severe CPP under the same circumstances as bimekizumab 160 mg in 1 mL single use prefilled pen.PSD · Nov 2025
6.2 The PBAC accepted the proposed cost-minimisation approach with the equi-effective doses being bimekizumab 320 mg and 2 x bimekizumab 160 mg.PSD · Nov 2025
5.15 As a Category 4 submission, the economic analysis was not independently evaluated.PSD · Nov 2025
5.16 The submission presented a cost-minimisation approach of bimekizumab 320 mg/2 mL prefilled pen compared with two bimekizumab 160 mg/1 mL prefilled pens.PSD · Nov 2025
5.12 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of one bimekizumab 320 mg/2 mL prefilled pen compared with two bimekizumab 160 mg/1 pre-filled pens.PSD · Nov 2025
5.13 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Nov 2025
6.3 The PBAC welcomed the input from individuals that describe hidradenitis suppurativa as ‘hell on earth’, restricting the ability of those living with the condition to sit, walk, talk or move comfortably, and highlighted the limitations of current treatment options, which are painful, can cause fatigue, and require refrigeration.PSD · May 2025
6.5 The PBAC also welcomed the input from consumer organisations Hidradenitis Suppurativa Australia and the Global Healthy Living Foundation Australia, both also supporting the listing of bimekizumab. The Committee noted the input from Hidradenitis Suppurativa Australia discussed the debilitating symptoms and emphasised that the condition is often misunderstood and misdiagnosed, highlighting the need for greater awareness, education, early intervention …PSD · May 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC accepted the proposed cost-minimisation approach with the equi-effective doses being bimekizumab 320 mg and 2 x bimekizumab 160 mg. PBAC · 2025
Decision context
PopulationAdults with severe chronic plaque psoriasis requiring a 320 mg dose, currently treated with bimekizumab 160 mg in 1 mL pre-filled pen (two injections).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | bimekizumab 160 mg in 1 mL single use pre-filled pen (two injections) | — | Single-arm · Surrogate |
| May 2025 | Recommended · restricted | secukinumab (primary); adalimumab (secondary) | — | RCT · HiSCR50, HiSCR75, HiSCR90 |
| Mar 2024 | Recommended · restricted | secukinumab | — | RCT · ASAS20, ASAS40, BASDAI50 |
| Mar 2024 | Recommended · restricted | secukinumab | — | RCT · ASAS40 |
| Mar 2024 | Recommended · restricted | ixekizumab | — | RCT · Other |
| Mar 2023 | Recommended · restricted | all PBS-listed biologic disease-modifying anti-rheumatic drugs (adalimumab, guselkumab, ixekizumab, risankizumab, secuki | — | RCT · PASI 90 |
| Mar 2022 | Recommended · restricted | All currently PBS-listed biologic disease-modifying anti-rheumatic drugs (adalimumab, guselkumab, ixekizumab, risankizum | — | RCT · PASI 90 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| BE MOBILE 2 | Ph 3 | 332 | Percentage of Participants With Assessment of SpondyloArthritis International Society 40% … | completed |
| BE MOBILE 1 (NCT03928704) | Ph 3 | 274 | Percentage of Participants With Assessment of SpondyloArthritis International Society 40% … | completed |
| PREVENT (NCT02696031) | Ph 3 | 555 | The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo… | completed |
Consumer voice
The Australasian College of Dermatologists provided advice supporting the use of bimekizumab 320 mg/2 mL, noting that a single injection would improve adherence, safety, and reduce needle anxiety compared to two injections.
the use of bimekizumab 320 mg/2 mL injection will enable patients to have a single injection as opposed to two, improving adherence, safety and reducing needle anxiety Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe psoriasis requiring 320 mg dosing; TGA label includes moderate-to-severe candidates for systemic therapy or phototherapy.