TildrakizumabILUMYA
Continuing treatment of adults with severe chronic plaque psoriasis who have achieved at least a PASI75 response with tildrakizumab 100 mg.
Decisions on record
- Meeting Mar 2026 Recommended Severe chronic plaque psoriasis
- Meeting Mar 2023 Not recommended Severe chronic plaque psoriasis (CPP)
- Meeting Jul 2018 Recommended Severe chronic plaque psoriasis
Access path
- TGA registered · ILUMYA
TGA label narrower than the PBS population
- Jul 2018Recommended · restricted
vs ustekinumab
- Mar 2023Not recommended
Evidence: RCT → Other
- ↻ resubmittedMar 2026Recommended
Evidence: Other → RCT
- PBS listing · Authority Required
From the public summary
5.1 The PBAC did not recommend adding a new grandfathering restriction to the existing PBS-listing for tildrakizumab injection 100 mg in 1 mL single dose pre-filled syringe (Ilumya) for the treatment of severe CPP for patients enrolled in two new clinical trials.PSD · Mar 2023
5.2 The PBAC noted that the clinical trials presented in both this submission and the July 2018 submission had an inclusion criterion of PASI score >12, however the current PBS clinical criteria for initial treatment with tildrakizumab states that the condition must have a PASI score >15.PSD · Mar 2023
4.5 No changes to the price of tildrakizumab were proposed. The submission stated that as tildrakizumab is currently listed on the PBS and the request was to reinstate the original grandfathering restriction, cost-effectiveness had already been established and no economic evaluation was presented.PSD · Mar 2023
4.6 The submission stated that the current special pricing arrangement (SPA) should still apply for the requested updated listing.PSD · Mar 2023
6.20 The submission described TIL as: non-inferior in terms of effectiveness and safety compared to UST superior in terms of effectiveness and safety compared to ETN; and non-inferior in terms of effectiveness and safety compared to ADA.PSD · Jul 2018
6.21 Based on the evidence presented in the submission, the claims appeared reasonable except for: The claim of non-inferior efficacy against UST. Results of indirect comparisons using PBO as common reference generally did not favour TIL for attainment of PASI75 response at Week 12.PSD · Jul 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdults with severe chronic plaque psoriasis who have achieved at least a PASI75 response to initiating treatment with tildrakizumab 100 mg.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended | tildrakizumab 100 mg | — | RCT · PASI75 |
| Mar 2023 | Not recommended | — | — | Other |
| Jul 2018 | Recommended · restricted | ustekinumab | — | RCT · PASI-75 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| reSURFACE 1 | Ph 3 | 772 | Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at … | completed |
| reSURFACE 2 | Ph 3 | 1,090 | Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Resp… | completed |
Consumer voice
The Australasian College of Dermatologists supported the grandfathering restriction, noting it would enable patients to continue with timely, affordable and quality treatment.
the addition of the grandfathering restriction would enable patients to continue with timely, affordable and quality treatment Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe psoriasis (PASI >15), ≥6 months duration, prior tildrakizumab use, and ≥75% PASI reduction—all absent from TGA label.