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
7.1 The PBAC recommended the listing of tildrakizumab (TIL) 200 mg (100 mg/mL injection, 2 x 1 mL syringe) for the treatment of severe chronic plaque psoriasis for continuing treatment only. The PBAC considered that TIL 200 mg was non-inferior compared to TIL 100 mg in terms of efficacy and safety.PSD · Mar 2026
7.2 The PBAC considered that the nominated comparator, TIL 100 mg, was reasonable.PSD · Mar 2026
6.26 The submission presented a cost minimisation approach to the economic evaluation, calculated over a 2-year time horizon. The only costs included in the evaluation were the drug costs. The assumptions and components of the evaluation are shown in Table 11. 10 OFFICIALPSD · Mar 2026
OFFICIAL Public Summary Document - March 2026 PBAC Meeting Table 11: Key assumptions and components of the economic evaluation Component Claim or assumption Therapeutic claim: effectiveness The clinical evaluation showed that TIL 200 mg Q12W is non-inferior to TIL 100 mg Q12W in terms of efficacy.PSD · Mar 2026
6.22 The submission described TIL 200 mg as non-inferior in terms of effectiveness compared to TIL 100 mg. No evidence was presented that demonstrated that an increase of the continuing treatment dose from TIL 100 mg to TIL 200 mg is associated with improved outcomes.PSD · Mar 2026
6.23 The submission described TIL 200 mg as non-inferior in terms of safety compared to TIL 100 mg.PSD · Mar 2026
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.
Listed in law
PBS listings commencing 1 Aug 2026 were made by these 4 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 87 of 2026 | 30 Jul 2026 | In force | PDF ↗ |
| PB 88 of 2026 | 30 Jul 2026 | In force | PDF ↗ |
| PB 89 of 2026 | 30 Jul 2026 | In force | PDF ↗ |
| PB 89 of 2026 | 30 Jul 2026 | In force | PDF ↗ |