GolimumabSIMPONI
Treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation (elevated CRP and/or MRI evidence) who have had an inadequate response to or are intolerant to NSAIDs.
Decisions on record
- Meeting Jul 2018 Recommended Active non-radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Nov 2017 Recommended Moderate to severe ulcerative colitis
- Meeting Nov 2017 Not recommended Active non-radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Jul 2014 Deferred Indication not stated
- Meeting Mar 2010 Recommended Monoclonal antibody for use in ankylosing spondylitis and other chronic inflammatory diseases
- Meeting Mar 2010 Recommended Monoclonal antibody for use in psoriatic arthritis and other chronic inflammatory diseases
- Meeting Mar 2010 Recommended Monoclonal antibody for use in rheumatoid arthritis and other chronic inflammatory diseases
Access path
- TGA registered · SIMPONI
TGA label narrower than the PBS population
- Mar 2010Recommended · restricted
Comparator changed: etanercept → etanercept and adalimumab
- Mar 2010Recommended · restricted
Comparator changed: etanercept → etanercept and adalimumab
- Mar 2010Recommended · restricted
Comparator changed: etanercept → etanercept and adalimumab
- Mar 2010Recommended · restricted
Comparator changed: etanercept → etanercept and adalimumab
- Mar 2010Recommended · restricted
Comparator changed: etanercept → etanercept and adalimumab
- Nov 2017Not recommended
Comparator changed: etanercept and adalimumab → placebo in combination with background…
- ↻ resubmittedNov 2017Recommended · restricted
Comparator changed: etanercept and adalimumab → placebo in combination with background…
- Jul 2018Recommended · restricted
Comparator changed: adalimumab (main comparator for pricing); infliximab and vedolizumab…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended extending the PBS-listing of golimumab to include the treatment of patients with non-radiographic axial spondyloarthritis (nr-axSpA) as a Section 85 Authority Required (written) listing. The PBAC is satisfied that golimumab provides, for some patients, a significant improvement in efficacy over conventional care. The PBAC considered that the cost-effectiveness of golimumab was acceptable at the price applied in the economic model.PSD · Jul 2018
7.2 The PBAC reiterated there was a clinical need in certain patients with inflammatory back pain associated with nr-axSpA. However, PBAC remained concerned about the risk of over-treating patients with lower back pain (ie the inappropriate use in misdiagnosed patients).PSD · Jul 2018
6.26 As for the previous submission, the resubmission presented a stepped economic evaluation based on the 16 week direct randomised trial (GO-AHEAD) comparing golimumab 50 mg + conventional care (GLM+CC) versus placebo + conventional care (CC alone), and implemented a modelled economic evaluation based on the 52-week open-label extension of the GO-AHEAD trial.PSD · Jul 2018
6.27 The approach and structure of the model presented in the resubmission was unchanged from the previous submission, with trajectories of BASDAI/BASFI scores within health states representing transitions between different levels of health.PSD · Jul 2018
6.2 The PBAC noted and welcomed the input from individuals (4), health care professionals (5) and organisations (1) via the Consumer Comments facility on the PBS website. The comments outlined the impacts of nr-axSpA on patients’ ability to work, exercise, study, and maintain family life.PSD · Jul 2018
6.61 PBS utilisation was likely overestimated compared with the population intended by the PBAC in its November 2017 consideration (i.e. patients with the highest clinical need and those who would benefit the most) and if a stopping rule were applied. The ESC considered that neither the proposed restriction nor the RSA proposed in the PSCR had adequately addressed these issues.PSD · Jul 2018
6.62 The pre-PBAC response proposed an RSA based on: capping the number of golimumab scripts for nr-axSpA at '''''% of that predicted in the financial estimates (per Table 14) in Year 1 of PBS listing; with the cap (proportion of predicted) increasing by a ''''''% increment each year to '''''% in Year 5; and An '''''% rebate on Commonwealth expenditure for all scripts above the cap.PSD · Jul 2018
Cost-effectiveness
ICER value is redacted (commercially sensitive); document states the model exists but numeric values are redacted throughout
The submission presented a cost-minimisation analysis based on the claim of non-inferiority of golimumab to adalimumab and etanercept. PSD · 2010
Decision context
PopulationAdults over 18 years with non-radiographic axial spondyloarthritis (defined by ASAS criteria), chronic lower back pain for ≥3 months, BASDAI ≥4, elevated CRP, sacroiliitis on MRI, who have failed to achieve adequate response to ≥2 NSAIDs for ≥3 months and have additional clinical features (enthesitis, uveitis, dactylitis, psoriasis, IBD, or HLA-B27)
Risk sharingA revised Risk Sharing Arrangement (RSA) was proposed to address the risk of use outside the intended population and to account for uncertainty surrounding long-term cost-effectiveness; the exact terms are not detailed in this PSD
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | placebo in combination with conventional care (NSAID background treatment) | — | RCT · ASAS 20 |
| Nov 2017 | Not recommended | placebo in combination with background NSAID therapy | — | RCT · ASAS 20 (response rate at Week 16) |
| Nov 2017 | Recommended · restricted | adalimumab (main comparator for pricing); infliximab and vedolizumab (clinical comparators) | — | Meta-analysis · Remission, response, mucosal healing |
| Mar 2010 | Recommended · restricted | etanercept | — | RCT · ASAS20 response at Week 12, BASDAI improvement at Week 12/14, SF-36 change from baseline at Week 14 |
| Mar 2010 | Recommended · restricted | etanercept and adalimumab | — | RCT · ACR20 and ACR50 response, PASI 75 response |
| Mar 2010 | Recommended · restricted | etanercept and adalimumab | — | RCT | Other (indirect comparisons) · ACR20, ACR50 response |
| Mar 2010 | Recommended · restricted | etanercept and adalimumab | — | Meta-analysis · ACR20 |
| Mar 2010 | Recommended · restricted | etanercept and adalimumab | — | Meta-analysis · ACR20 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| GO-AHEAD | Ph 3 | 198 | Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Res… | completed |
Consumer voice
Consumer and healthcare professional input highlighted the significant impact of nr-axSpA on patients' work, exercise, study, and family life, with support for early biological treatment to reduce symptoms and disease progression, though healthcare professionals raised concerns about potential overtreatment without stricter diagnostic criteria.
The comments outlined the impacts of nr-axSpA on patients' ability to work, exercise, study, and maintain family life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults >18, BASDAI ≥4, elevated CRP, sacroiliitis on MRI, failure of ≥2 NSAIDs ≥3 months, and specific clinical features; TGA label lacks these specific thresholds.