TofacitinibXeljanz, Xeljanz XR
Noted RheumatologyAuthority Required 💬 consumer voice
Severe active rheumatoid arthritis (initial treatment, first continuing treatment, and subsequent continuing treatment) and severe psoriatic arthritis (initial treatment and continuing treatment).
8
Submissions
3 resub
2015–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2026 Noted Rheumatoid arthritis, psoriatic arthritis no PSD
- Meeting Mar 2024 Recommended Rheumatoid arthritis (RA) and Psoriatic arthritis (PsA)
- Meeting Mar 2023 Recommended Ankylosing spondylitis (AS)
- Meeting Mar 2023 Recommended Juvenile idiopathic arthritis (JIA); severe active juvenile idiopathic arthritis
- Meeting Nov 2020 Recommended Ulcerative colitis and other listed indications
- Meeting Nov 2020 Noted Chronic plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis"
- Meeting Mar 2020 Deferred Chronic plaque psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis
- Meeting Mar 2019 Recommended Ulcerative Colitis (UC)
2 earlier decisions
- Nov 2018 Recommended Psoriatic arthritis
- Mar 2015 Recommended Severe active rheumatoid arthritis
Access path
- TGA registered · Xeljanz, Xeljanz XR
TGA label narrower than the PBS population
- Mar 2015Recommended · restricted
vs adalimumab
- Nov 2018Recommended · restricted
- Mar 2019Recommended · restricted
Comparator changed: adalimumab → infliximab
- Mar 2020Deferred
Evidence: Meta-analysis → Other
- Nov 2020Recommended · restricted
Evidence: Other → Meta-analysis
- Mar 2023Recommended
Comparator changed: weighted comparator of infliximab, vedolizumab, golimumab, and…
- Mar 2023Recommended · restricted
Comparator changed: weighted comparator of infliximab, vedolizumab, golimumab, and…
- Mar 2024Recommended · restricted
Comparator changed: adalimumab → tofacitinib 5 mg tablets (immediate release)
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of a new form and strength of tofacitinib (tofacitinib tablet (modified release) 11 mg (Xeljanz® XR)) under the same circumstances as the current Pharmaceutical Benefits Scheme (PBS) listings for tofacitinib 5 mg tablets for the treatment of severe active rheumatoid arthritis (RA) and severe psoriatic arthritis (PsA).PSD · Mar 2024
6.2 The PBAC, considering Xeljanz XR as an appropriate comparator, acknowledged that a proportion of patients who would use Xeljanz XR would either switch from the currently PBS-listed tofacitinib 5 mg tablets or commence treatment with Xeljanz XR instead of choosing tofacitinib 5 mg tablets.PSD · Mar 2024
Economic analysis
5.9 The submission presented a cost-minimisation analysis of tofacitinib XR 11 mg tablets compared with tofacitinib 5 mg tablets. The equi-effective doses were estimated as tofacitinib XR 11 mg one tablet daily and tofacitinib 5 mg one tablet twice a day. It was assumed there would be no differences in treatment duration and monitoring requirements between the two forms of tofacitinib. 7PSD · Mar 2024
5.10 The submission noted a Special Pricing Arrangement (SPA) applies to the listing of tofacitinib 5 mg tablets and requested this also apply to the requested listing for tofacitinib XR 11 mg tablets.PSD · Mar 2024
Clinical claim
5.6 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Xeljanz XR compared with tofacitinib 5 mg tablets. The PBAC considered that the claim of non-inferior comparative effectiveness and non-inferior comparative safety was reasonable.PSD · Mar 2024
5.7 Tofacitinib XR 11 mg once daily did not meet all the TGA criteria to demonstrate bioequivalence to tofacitinib 5 mg twice daily. The TGA Delegate’s Overview concluded that the application provided evidence to support a conclusion that the efficacy and safety of tofacitinib XR 11 mg once daily and tofacitinib 5 mg twice daily was similar when used for RA and PsA (Delegate’s Overview).PSD · Mar 2024
Consumer comments
5.2 The PBAC noted and welcomed the input from CreakyJoints Australia on behalf of itself and its parent organisation Global Healthy Living Foundation Australia via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with Xeljanz XR, including easier and less time-consuming administration with oral tablets compared to medicines requiring subcutaneous injection or infusion.PSD · Mar 2024
Financial management – risk sharing
A Special Pricing Arrangement was requested. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
As a Category 4 submission, the economic analysis has not been independently evaluated. PBAC · 2024
Cost-effectiveness accepted ×2
Decision context
PopulationAdults with severe active rheumatoid arthritis or severe psoriatic arthritis, receiving tofacitinib 11 mg modified-release tablet once daily.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | tofacitinib 5 mg tablets (immediate release) | — | RCT · Non-inferiority |
| Mar 2023 | Recommended | adalimumab | — | Meta-analysis · ASAS20 |
| Mar 2023 | Recommended · restricted | adalimumab | — | RCT · Surrogate |
| Nov 2020 | Recommended · restricted | weighted comparator of infliximab, vedolizumab, golimumab, and adalimumab | — | Meta-analysis · Clinical response and clinical remission |
| Mar 2020 | Deferred | — | — | Other |
| Mar 2019 | Recommended · restricted | infliximab | — | Meta-analysis · Clinical remission |
| Nov 2018 | Recommended · restricted | adalimumab | — | RCT · ACR20 |
| Mar 2015 | Recommended · restricted | adalimumab | — | RCT · ACR20 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study A3921120 (NCT03502616) | Ph 3 | 270 | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society… | completed |
| Study A3921119 (NCT01786668) | Ph 2 | 208 | Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloA… | completed |
| PROPEL | Ph 3 | 225 | Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric R… | completed |
| OCTAVE 1 | Ph 3 | 547 | Percentage of Participants With Remission at Week 8 | completed |
| NCT02281552 (Tanaka et al., 2019) | Ph 3 | 209 | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C… | completed |
| NCT04018001 (Cohen et al., 2021a) | — | 1,057 | Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Ind… | completed |
| NCT04267380 | — | 298 | Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvem… | completed |
| NCT02831855 (Cohen et al., 2021b ORAL Shift) | Ph 4 | 694 | Double Blind Phase: Change From Randomization in Disease Activity Score in 28 Joints Using… | completed |
Consumer voice
CreakyJoints Australia provided input highlighting benefits of Xeljanz XR including easier oral administration compared to injections, improved treatment adherence, effectiveness for severe RA and PsA, more stable drug concentration with once-daily formulation, and environmental benefits from reduced tablet burden.
The comments described a range of benefits of treatment with Xeljanz XR, including easier and less time-consuming administration with oral tablets compared to medicines requiring subcutaneous injection or infusion. Consumer comments · PSD
treatment burdenadministration route preferencetreatment adherenceefficacyneedle aversionenvironmental impact
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe disease only, whereas TGA label includes moderate to severe RA and active PsA without severity requirement.