AbataceptOrencia
Treatment of severe active psoriatic arthritis (PsA) in adults who have failed to achieve an adequate response to conventional non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Decisions on record
- Meeting Mar 2018 Not recommended Psoriatic arthritis (PsA)
- Meeting Nov 2015 Recommended Rheumatoid arthritis
- Meeting Jul 2011 Recommended Rheumatoid arthritis
- Meeting Jul 2011 Deferred Juvenile arthritis
- Meeting Nov 2007 Recommended Rheumatoid arthritis
Access path
- TGA registered · Orencia
TGA label narrower than the PBS population
- Nov 2007Recommended
vs infliximab
- Jul 2011Deferred
Comparator changed: infliximab → etanercept
- Nov 2015Recommended · restricted
Evidence: RCT → Cost-minimisation
- Mar 2018Not recommended
Evidence: Cost-minimisation → RCT
From the public summary
7.1 The PBAC did not recommend abatacept for the treatment of adult patients with severe active psoriatic arthritis (PsA) due to the low clinical need given the clinical evidence did not support the claim of non-inferior efficacy to the nominated comparators (certolizumab, ustekinumab and secukinumab).PSD · Mar 2018
7.2 The PBAC accepted that abatacept provides an alternative mode of action to the currently PBS listed bDMARDs and that the drug would most likely be prescribed as a third line agent after a tumour necrosis factor alfa inhibitor (TNF α inhibitor) and secukinumab; or as second-line therapy in patients with comorbidities precluding therapy with sekukinumab.PSD · Mar 2018
6.24 A cost-minimisation analysis against certolizumab, ustekinumab and secukinumab was presented.PSD · Mar 2018
6.25 The equi-effective doses were estimated based on the indirect comparisons of ACR50 and ACR20 presented above, summarised in Table 7. The PBAC has previously accepted the nominated doses of certolizumab, ustekinumab and secukinumab were equi-effective.PSD · Mar 2018
6.21 The submission described abatacept as non-inferior in terms of effectiveness and non-inferior in terms of safety compared with certolizumab, ustekinumab and secukinumab. The basis for this claim was unclear. The submission acknowledged abatacept to be numerically worse than the nominated comparators in terms of key patient relevant outcomes ACR50 and ACR20, as well as PASI75.PSD · Mar 2018
Based on the evidence, abatacept appeared to be inferior to certolizumab, ustekinumab and secukinumab for effectiveness: the results of the indirect comparisons (at either the Week 12/24 or Week 24 only) showed that abatacept was numerically and statistically significantly inferior to all of the nominated comparators in terms of the patient relevant outcomes ACR50 and ACR20 (ITT population); when the non-inferiority margins were applied to the RR …PSD · Mar 2018
6.2 The PBAC noted and welcomed the input from two organisations, ‘CreakyJoints Australia’ and ‘Psoriasis Australia’, health Professionals (5), and individuals (11) via the Consumer Comments facility on the PBS website. The comments noted support for the availability of a drug with a new mode of action, for patients who have trialled and failed other bDMARDs and for patients who are intolerant to the currently available bDMARDs.PSD · Mar 2018
Cost-effectiveness
Cost-minimisation analysis conducted; no numeric ICER calculated or stated.
The PBAC recommended the listing of abatacept on the PBS for the treatment, in combination with methotrexate, of adults with severe active rheumatoid arthritis (RA) who have failed prior DMARD therapy on a cost-minimisation basis compared with infliximab in the treatment of rheumatoid arthritis. PBAC · 2007
Decision context
PopulationAdults with severe active psoriatic arthritis who have failed to achieve an adequate response to methotrexate (at least 20 mg weekly for minimum 3 months) and sulfasalazine (at least 2 g daily for minimum 3 months) or leflunomide (up to 20 mg daily for minimum 3 months), and who have received no prior PBS-subsidised biologic agent or none for at least 5 years.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Not recommended | certolizumab pegol, ustekinumab, secukinumab | — | RCT · ACR20 |
| Nov 2015 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2011 | Deferred | etanercept | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Nov 2007 | Recommended | infliximab | — | RCT · DAS28 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Mease 2017 (ASTRAEA) | Ph 3 | 489 | Proportion of ACR 20 Responders at Day 169 | completed |
Consumer voice
Consumer input from two organisations, five health professionals, and eleven individuals expressed support for abatacept as a new mode of action for patients who have failed or are intolerant to other bDMARDs, citing potential benefits including return to work, fewer side effects, and improved quality of life.
support for the availability of a drug with a new mode of action, for patients who have trialled and failed other bDMARDs and for patients who are intolerant to the currently available bDMARDs Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe PsA with prior DMARD failure and biologic-naïve or 5-year washout requirement; TGA label has no such restrictions.