GuselkumabTREMFYA
Treatment of adults with severe Crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Decisions on record
- Meeting Jul 2025 Recommended Severe Crohn disease
- Meeting May 2025 Recommended Severe chronic plaque psoriasis
- Meeting Jul 2023 Noted Chronic plaque psoriasis no PSD
- Meeting Mar 2021 Not recommended Severe chronic plaque psoriasis
- Meeting Nov 2020 Recommended Psoriatic arthritis (PsA)
- Meeting Jul 2020 Recommended Severe chronic plaque psoriasis
- Meeting Jul 2018 Recommended Severe chronic plaque psoriasis no PSD
- Meeting Mar 2018 Not recommended Severe chronic plaque psoriasis
Access path
- TGA registered · TREMFYA
TGA label narrower than the PBS population
- Mar 2018Recommended · restricted
vs ustekinumab (primary); adalimumab (supplementary)
- Jul 2020Recommended
Comparator changed: ustekinumab (primary); adalimumab (supplementary) → lowest cost…
- Nov 2020Recommended · restricted
Comparator changed: lowest cost biological agent available for severe chronic plaque…
- Mar 2021Not recommended
guselkumab PFP does not provide a substantial and clinically relevant improvement in efficacy or reduction of toxicity…
- ↻ resubmittedMay 2025Recommended · restricted
Comparator changed: lowest cost PBS-listed biological disease-modifying antirheumatic…
- Jul 2025Recommended · restricted
Comparator changed: guselkumab 100 mg pre-filled syringe (PFS) → adalimumab, infliximab…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100 (Highly Specialised Drugs Program) and General Schedule Authority Required (in writing) Pharmaceutical Benefits Scheme (PBS) listings of guselkumab (GUS) for the treatment of adults with severe Crohn’s disease (CD).PSD · Jul 2025
The PBAC noted the consumer comments regarding the significant quality of life impact severe CD has on patients and the importance of having additional treatment options available, particularly medicines with different mechanisms of action. 50 OFFICIALPSD · Jul 2025
The submission presented a cost-utility analysis comparing GUS (GUS 200 mg Q4W and GUS 100 mg Q8W separately) versus a weighted comparator of other b/tsDMARDs, informed by the direct and indirect evidence presented in the submission and parameters from the literature. The main treatment effect in the model was derived from the trial-design-adjusted Australian NMA for maintenance treatment.PSD · Jul 2025
Overall, the ESC considered the modelled economic evaluation presented in the submission was largely uninformative for decision-making, given that the trial-design- adjusted Australian NMA was considered unreliable and the other clinical evidence on balance indicated that GUS was comparable to other b/tsDMARDs in terms of effectiveness.PSD · Jul 2025
In patients with severe CD, the submission described GUS as superior compared to all currently PBS-listed b/tsDMARDs (ADA, IFX, UST, UPA and VDZ) in terms of effectiveness based on maintenance outcomes at Week 48-60. In terms of safety, the submission described GUS as superior compared to IFX and non-inferior compared to ADA, UST, UPA and VDZ.PSD · Jul 2025
The ESC considered the clinical claim of non-inferior efficacy and safety between the GUS IV and GUS SC induction dosing regimens was reasonably supported by the evidence presented in the submission.PSD · Jul 2025
The individual described the positive impacts of guselkumab treatment, including ability to enjoy life and return to work. The individual noted the inequitable opportunity for improved clinical and quality of life outcomes, due to current lack of access to guselkumab outside of clinical trials.PSD · Jul 2025
Input was received from GESA, Inflammatory Bowel Disease Sydney and Crohn’s & Colitis Australia (CCA). All organised emphasised the very significant impact CD has on patients and their families and the importance of having access to additional treatment options.PSD · Jul 2025
Cost-effectiveness
ICER values are redacted (marked as &&&&) in the publicly available document; commercial-in-confidence pricing and economic model details are not disclosed.
The PBAC considered that guselkumab PFP did not meet these criteria to be listed at a price higher than the lowest cost of PBS-listed bDMARDs for the treatment of severe CPP. PBAC · 2021
Decision context
PopulationAdults aged 18 years or older with severe Crohn's disease (CDAI ≥300 or CDAI ≥220 with extensive small intestine disease) who have failed prior systemic therapy (corticosteroids and at least 3 months of immunosuppressive therapy) and have evidence of intestinal inflammation or high faecal output or require surgery or total parenteral nutrition.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | adalimumab, infliximab, upadacitinib, ustekinumab, vedolizumab | — | RCT · Clinical response and clinical remission |
| May 2025 | Recommended · restricted | guselkumab 100 mg pre-filled syringe (PFS) | — | RCT · PASI 75, PASI 90 |
| Mar 2021 | Not recommended | lowest cost PBS-listed biological disease-modifying antirheumatic drugs (bDMARDs) for severe chronic plaque psoriasis | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | ustekinumab | — | RCT · ACR20 |
| Jul 2020 | Recommended | lowest cost biological agent available for severe chronic plaque psoriasis | — | Cost-minimisation · Cost-minimisation |
| Mar 2018 | Recommended · restricted | ustekinumab (primary); adalimumab (supplementary) | — | RCT · PASI-75 |
Clinical evidence
Consumer voice
Consumer input highlighted an unmet need for effective treatments for moderate to severe Crohn's disease, with comments emphasizing guselkumab's potential to help those who have exhausted other options, its favorable safety profile, and benefits including reduced treatment burden via subcutaneous administration and improved quality of life outcomes.
Input described an unmet need regarding effective and durable treatments for moderate to severe CD, with current treatment options noted as moderately effective with high rates of loss of response. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe disease (CDAI ≥300 or ≥220 with extensive small bowel disease) and requires documented prior systemic therapy failure, versus TGA's broader moderately to severely active label.