Upadacitinib
Recommended GastroenterologyRestricted 💬 consumer voice
Complex refractory fistulising Crohn's disease with externally draining enterocutaneous or rectovaginal fistula.
11
Submissions
3 resub
2019–26
On the record
$75k–95k
ICER range
1 sourced ICER · 2021
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2026 Recommended Fistulising Crohn's disease (FCD)
- Meeting Dec 2023 Recommended Severe active rheumatoid arthritis (RA)
- Meeting Nov 2023 Noted Severe atopic dermatitis (adults and adolescents) no PSD
- Meeting Jul 2023 Recommended Crohn disease (CD)
- Meeting Mar 2023 Recommended Non-radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Mar 2023 Noted Crohn disease; severe Crohn disease
- Meeting Nov 2022 Not recommended Severe active rheumatoid arthritis no PSD
- Meeting Nov 2022 Recommended Moderate to severe ulcerative colitis no PSD
7 earlier decisions
- Nov 2022 Deferred Non-radiographic axial spondyloarthritis no PSD
- Jul 2022 Deferred Ulcerative colitis, moderate to severe in patients contraindicated or not responsive to conventional therapies
- Jul 2021 Deferred Severe atopic dermatitis
- Mar 2021 Recommended Ankylosing spondylitis
- Mar 2021 Recommended Severe psoriatic arthritis
- Nov 2020 Noted Severe rheumatoid arthritis (RA)
- Nov 2019 Recommended Rheumatoid arthritis (RA)
Access path
- Nov 2019Recommended · restricted
Comparator changed: baricitinib 4 mg (primary); adalimumab 40 mg (secondary) →…
- Nov 2019Recommended
Comparator changed: baricitinib 4 mg (primary); adalimumab 40 mg (secondary) →…
- Nov 2020Noted
Comparator changed: Baricitinib 4 mg (primary); Adalimumab 40 mg SC injection (secondary)…
- Mar 2021Recommended · restricted
- Mar 2021Recommended · restricted
- Jul 2021Recommended
Comparator changed: tofacitinib → dupilumab
- Jul 2022Recommended · restricted
Comparator changed: dupilumab → tofacitinib (main); infliximab, adalimumab, vedolizumab…
- Mar 2023Recommended · restricted
Comparator changed: tofacitinib (main); infliximab, adalimumab, vedolizumab, golimumab…
- Jul 2023Recommended · restricted
Comparator changed: golimumab → adalimumab
- Dec 2023Recommended · restricted
Evidence: RCT → Other
- Mar 2026Recommended · restricted
Evidence: Other → Meta-analysis
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended an amendment to the Authority Required (Written) listing for continuing treatment of PBS-listed upadacitinib 15 mg modified release tablet (Rinvoq) for the treatment of severe active rheumatoid arthritis (RA) to:PSD · Dec 2023
• Authority Required (Written) for first continuing treatment.PSD · Dec 2023
Economic analysis
The submission presented a cost-minimisation approach comparing upadacitinib with adalimumab. The key components and assumptions are summarised in Table 10. The evaluation considered the claim of non-inferior effectiveness and safety of upadacitinib compared with adalimumab may not be adequately supported by the clinical evidence presented in the submission. Therefore, the cost-minimisation approach is only appropriate if the clinical claims are accepted.PSD · Jul 2023
The submission stated that adalimumab was an appropriate comparator due to its high market share and that it is exclusively used in the community setting, where upadacitinib was also anticipated to be used. 29PSD · Jul 2023
Clinical claim
The submission claimed that upadacitinib is non-inferior in terms of effectiveness and safety compared with adalimumab, risankizumab, infliximab, ustekinumab and vedolizumab.PSD · Jul 2023
The evaluation considered the non-inferior effectiveness claim may not be adequately supported due to the following concerns:PSD · Jul 2023
Consumer comments
The PBAC noted and welcomed the input from one organisation via the Consumer Comments facility on the PBS website. The comments from consumer organisation Crohn’s and Colitis Australia described the additional flexibility for patients an oral treatment for MSUC offers for patients, particularly those in rural and remote areas who may otherwise need to travel substantial distances for infusible therapies.PSD · Jul 2022
Financial management – risk sharing
The submission did not identify any risk of usage beyond the restriction, and no risk- sharing arrangements were proposed. There are no risk-sharing arrangements in place for the comparator treatments for severe CD.PSD · Jul 2023
Cost-effectiveness
Cost-minimisation approach used; no ICER calculated by design.
The submission proposed a cost-minimisation approach (CMA) comparing upadacitinib with infliximab, ustekinumab and adalimumab for the treatment of FCD, on the basis of non-inferior comparative effectiveness and safety. PSD · 2026
Economic model disputedPrice cut / RSA neededSurrogate endpointCost-effectiveness accepted
Decision context
PopulationAdults aged 18 years or older with complex refractory fistulising Crohn's disease with externally draining enterocutaneous or rectovaginal fistula.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | infliximab (main); adalimumab and ustekinumab (additional) | — | Meta-analysis |
| Dec 2023 | Recommended · restricted | — | — | Other |
| Jul 2023 | Recommended · restricted | adalimumab | — | RCT · Clinical remission |
| Mar 2023 | Recommended · restricted | golimumab | — | RCT · ASAS40 |
| Jul 2022 | Recommended · restricted | tofacitinib (main); infliximab, adalimumab, vedolizumab, golimumab (supplementary); ozanimod (near-market) | — | RCT · Clinical remission, clinical response, mucosal healing / endoscopic improvement |
| Jul 2021 | Recommended | dupilumab | $75k–95k | RCT · EASI-75 |
| Mar 2021 | Recommended · restricted | adalimumab | — | RCT · ASAS20 |
| Mar 2021 | Recommended · restricted | tofacitinib | — | RCT · ACR20 |
| Nov 2020 | Noted | adalimumab | — | RCT · ACR50 |
| Nov 2019 | Recommended · restricted | baricitinib 4 mg (primary); adalimumab 40 mg (secondary) | — | RCT · ACR20/ACR50/ACR70; DAS28(CRP) |
| Nov 2019 | Recommended | Baricitinib 4 mg (primary); Adalimumab 40 mg SC injection (secondary) | — | RCT · ACR20 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SELECT-AXIS 1 | Ph 2 | 187 | Percentage of Participants With Assessment of SpondyloArthritis International Society (ASA… | completed |
| SELECT-PsA 2 | Ph 3 | 642 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response a… | completed |
Consumer voice
Crohn's and Colitis Australia highlighted the value of a first oral therapy for severe Crohn's disease treatment and the importance of additional patient choice.
the value of a first oral therapy for the treatment of severe Crohn's disease and additional choice for patients Consumer comments · PSD
unmet needtreatment optionspatient choiceaccess to therapy
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with adequate response to prior PBS-subsidised biological therapy; TGA label appears unrestricted by prior treatment.