← The record

TildrakizumabILUMYA

Recommended DermatologyAuthority Required 💬 consumer voice

Continuing treatment of adults with severe chronic plaque psoriasis who have achieved at least a PASI75 response with tildrakizumab 100 mg.

3
Submissions
2 resub
2018–26
On the record
—
ICER range
Cost-min
Cost basis

Decisions on record

3 decisions
  • 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

3 submissions · public record
  1. TGA registered · ILUMYA

    TGA label narrower than the PBS population

  2. Jul 2018
    Recommended · restricted

    vs ustekinumab

  3. Mar 2023
    Not recommended

    Evidence: RCT → Other

  4. ↻ resubmitted
    Mar 2026
    Recommended

    Evidence: Other → RCT

  5. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
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
Economic analysis
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
Clinical claim
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

3 entries
DecidedOutcomeComparatorICEREvidence
Mar 2026 Recommended tildrakizumab 100 mg — RCT · PASI75
Mar 2023 Not recommended — — Other
Jul 2018 Recommended · restricted ustekinumab — RCT · PASI-75

Clinical evidence

Trials cited in the PSDs · ClinicalTrials.gov
TrialPhaseNPrimary outcomeStatus
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

Mar 2023

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
access to treatmentaffordabilitytreatment qualitytimeliness of care

Similar precedents

By decision profile

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

Federal Register of Legislation

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.

DeterminationMadeStatus
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 ↗