IxekizumabTaltz
Treatment of patients with non-radiographic ankylosing spondyloarthritis (nr-AxSpA) with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have responded inadequately to, or are intolerant to, nonsteroidal anti-inflammatory drugs.
Decisions on record
- Meeting Mar 2025 Noted Non-radiographic axial spondyloarthritis no PSD
- Meeting Jul 2023 Not recommended Non-radiographic axial spondyloarthritis (nr-AxSpA)
- Meeting Nov 2021 Recommended Non radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Jul 2020 Recommended Ankylosing spondylitis
- Meeting Jul 2018 Recommended Severe active psoriatic arthritis
- Meeting Jul 2016 Recommended Plaque psoriasis
Access path
- TGA registered · Taltz
TGA label equal than the PBS population
- Jul 2016Recommended · restricted
vs secukinumab
- Jul 2018Recommended · restricted
Evidence: Meta-analysis → RCT
- Jul 2020Recommended
Comparator changed: secukinumab → adalimumab
- Nov 2021Recommended · restricted
Comparator changed: adalimumab → golimumab
- Jul 2023Not recommended
Comparator changed: golimumab → secukinumab, golimumab, certolizumab pegol
From the public summary
6.1 The PBAC did not recommend revising its November 2021 recommendation to list IXE for the treatment of patients with nr-AxSpA to increase the maximum quantity (units) from one to two. The PBAC’s decision to not recommend was based on, among other matters, consistent and fair application of the PBAC Guidelines that drugs listed on the General Schedule are to have a maximum quantity per prescription that provides supply sufficient for one months’ …PSD · Jul 2023
6.2 The PBAC noted that the standing recommendation not implemented from November 2021 will be due for review in November 2023.PSD · Jul 2023
5.17 As a Category 4 submission, the economic analysis has not been independently evaluated.PSD · Jul 2023
5.18 The PBAC had previously accepted that it would be reasonable to list IXE for this indication based on a cost-minimisation analysis compared with the “least costly alternative bDMARD over 2 years” (paragraph 7.8 IXE PSD, November 2021 PBAC Meeting).PSD · Jul 2023
5.16 At its November 2021 meeting, the PBAC considered the claim that IXE had non- inferior efficacy and safety compared to GLM and SEC was reasonable.PSD · Jul 2023
• The sponsor conducted an internal analysis that presents “many complications associated with of the introduction of a 1-pen pack” including: o “International price referencing concerns”, which “presents a risk to continuity of supply as our organisation may apply pressure to withdraw, in order to 3PSD · Jul 2023
• The sponsor has not seen specific requests from clinicians and patients for a 1- pen pack since the 2-pen pack was listed in 2017 for other conditions.PSD · Jul 2023
The submission did not propose any risk-sharing agreement. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Economic analysis was not independently evaluated as this was a Category 4 submission.
The PBAC noted the submission did not present any evidence that IXE provided a significant improvement in efficacy and/or reduction in toxicity compared to any alternative, and therefore there was no basis for IXE to have a price advantage over any relevant alternative for an equivalent treatment period. PBAC · 2021
Decision context
PopulationAdult patients with active non-radiographic ankylosing spondyloarthritis with objective signs of inflammation (elevated CRP and/or MRI evidence) who have responded inadequately to or are intolerant to NSAIDs.
Risk sharingIXE was recommended to be included within the current risk sharing arrangements (RSA) for GLM, CZP and SEC with no increase to the expenditure cap levels.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Not recommended | secukinumab, golimumab, certolizumab pegol | — | Cost-minimisation · Cost-minimisation |
| Nov 2021 | Recommended · restricted | golimumab | — | RCT · ASAS20, ASAS40, BASDAI50 |
| Jul 2020 | Recommended | adalimumab | — | RCT · ASAS40 |
| Jul 2018 | Recommended · restricted | secukinumab | — | RCT · ACR20 |
| Jul 2016 | Recommended · restricted | secukinumab | — | Meta-analysis · PASI 75 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| UNCOVER-1 | Ph 3 | 1,296 | Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Effic… | completed |
| UNCOVER-2 | Ph 3 | 1,224 | Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Effi… | completed |
| UNCOVER-3 | Ph 3 | 1,346 | Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Ef… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify adult patients with nr-AxSpA, objective inflammation markers, and inadequate response/intolerance to NSAIDs.