Certolizumab PegolCimzia
Noted RheumatologyAuthority RequiredSecond-line line 💬 consumer voice
Treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation (elevated C-reactive protein and MRI evidence) who have had inadequate response to or are intolerant to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).
9
Submissions
1 resub
2010–19
On the record
—
ICER range
Cost-min
Cost basis
risk sharing
Decisions on record
- Meeting Jul 2023 Noted Severe chronic plaque psoriasis no PSD
- Meeting Nov 2021 Noted Severe chronic plaque psoriasis no PSD
- Meeting Nov 2019 Recommended Non-radiographic axial spondyloarthritis (nr-axSpA)
- Meeting Nov 2019 Not recommended Chronic plaque psoriasis (CPP)
- Meeting Mar 2019 Recommended Severe chronic plaque psoriasis
- Meeting Mar 2016 Recommended Moderate to severe active rheumatoid arthritis, ankylosing spondylitis and severe psoriatic arthritis
- Meeting Nov 2014 Recommended 200 mg/ml injection, 2 x 1 ml syringes Cimzia® UCB Australia Pty Ltd Change to listing (Major submission) Psoriatic arthritis Authority Required listing for the treatment of patients with severe active psoriatic arthritis who meet certain criteria.
- Meeting Mar 2014 Recommended Cimzia® UCB Australia Pty Ltd Ankylosing Spondylitis To request Authority Required General Schedule listing for the treatment of adults with active ankylosing spondylitis (AS) who meet certain criteria. Adalimumab was the primary comparator for the cost-minimisation analysis. Etanercept, infliximab
1 earlier decision
- Mar 2010 Recommended Monoclonal antibody for use in rheumatoid arthritis and other chronic inflammatory diseases.
Access path
- TGA registered · Cimzia
TGA label narrower than the PBS population
- Mar 2010Recommended
vs adalimumab
- Mar 2010Recommended · restricted
- Mar 2014Recommended · restricted
Evidence: RCT → Meta-analysis
- Nov 2014Recommended · restricted
Evidence: Meta-analysis → RCT
- Mar 2016Recommended · restricted
Evidence: RCT → Cost-minimisation
- Mar 2017Recommended · restricted
Listing: Restricted → Authority Required
- Mar 2019Recommended · restricted
Evidence: Cost-minimisation → RCT
- Nov 2019Not recommended
Comparator changed: ustekinumab and adalimumab → adalimumab, ustekinumab, and other…
- ↻ resubmittedNov 2019Recommended · restricted
Comparator changed: ustekinumab and adalimumab → adalimumab, ustekinumab, and other…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC did not advise that a change should be made to its previous recommendation for certolizumab pegol (CZP) for the treatment of chronic plaque psoriasis (CPP). The PBAC reaffirmed its March 2019 recommendation that CZP 400 mg should be listed on a cost minimisation basis with the least costly alternative biologic for this indication and that it would be appropriate to price CZP 200 mg on the same per mg basis as CZP 400 mg.PSD · Nov 2019
6.2 The PBAC noted the submission argued that most patients would be treated with CZP 200 mg, and CZP 400 mg would only be used by patients who: (1) weigh ≥ 90 kg, and (2) do not achieve an adequate response to treatment with CZP 200 mg.PSD · Nov 2019
Economic analysis
5.9 The resubmission requested the same price as the March 2019 submission, i.e. the listed price of CZP for other listed indications. A comparison of the cost of CZP 200 mg, ADA and UST (both using the published price) over 2 years was presented, with the resubmission noting that based on this analysis it could claim a higher price than requested.PSD · Nov 2019
5.10 The resubmission argued the equi-effective doses should be 200 mg or 400 mg every two weeks compared with alternative therapies, with pricing based on a 200 mg every two weeks dosage regimen.PSD · Nov 2019
Clinical claim
5.5 The PBAC previously considered the claim of non-inferior effectiveness and safety of both CZP 200 mg and CZP 400 mg was supported versus UST and ADA (paragraph 7.6, CZP PSD, March 2019). The PBAC considered that while the clinical need for an additional treatment with a mechanism of action the same as several other listed biologics (tumour necrosis factor-alfa inhibitor) was low, the PBAC noted there may be advantages for patients who are either …PSD · Nov 2019
5.6 The resubmission argued the equi-effective doses should be 200 mg or 400 mg every two weeks as this reflects the dose regimen for CPP in the TGA approved Product Information (PI).PSD · Nov 2019
Financial management – risk sharing
5.20 The resubmission proposed a RSA to rebate the Commonwealth the cost of the additional 200 mg dose for all patients who use CZP 400 mg after the loading dose, with the intention of there being no additional cost to the PBS for any patients who use the higher dose regimen compared to CZP 200 mg.PSD · Nov 2019
5.21 The resubmission proposed separate listings for CZP 400 mg to facilitate management of the proposed RSA.PSD · Nov 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered that if CZP (at a dose of 400 mg every 2 weeks) was listed on the PBS on the basis of cost-minimisation to the lowest cost alternative biologic the listing would be cost-neutral to the PBS. PBAC · 2019
Cost-effectiveness accepted ×3
Decision context
PopulationAdults aged 18 years or older with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (elevated CRP and MRI evidence of sacroiliitis with bone marrow oedema), who have failed at least 2 NSAIDs for 3 months, have BASDAI ≥4 and CRP >10 mg/L, and meet ASAS classification criteria.
Risk sharingPBS listing of the comparator golimumab is currently subject to a Risk Sharing Arrangement (RSA).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Not recommended | adalimumab, ustekinumab, and other PBS-listed biologics for chronic plaque psoriasis | — | Meta-analysis · PASI 75 response |
| Nov 2019 | Recommended · restricted | golimumab | — | RCT · ASDAS-MI and ASAS40 |
| Mar 2019 | Recommended · restricted | ustekinumab and adalimumab | — | RCT · PASI 75 |
| Mar 2017 | Recommended · restricted | — | — | Cost-minimisation |
| Mar 2016 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | adalimumab | — | RCT · ACR20 |
| Mar 2014 | Recommended · restricted | adalimumab | — | Meta-analysis · ASAS20 |
| Mar 2010 | Recommended | adalimumab | — | RCT · ACR20/50/70 responses at 12, 14/16 and 24/26 weeks |
| Mar 2010 | Recommended · restricted | adalimumab | — | RCT · ACR20 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CIMPASI-1 | Ph 3 | 234 | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Respon… | completed |
| CIMPASI-2 | Ph 3 | 227 | Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Re… | completed |
| CIMPACT | Ph 3 | 559 | Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Respon… | 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 narrower than PBS population — PBAC restricts to failure of ≥2 NSAIDs, higher CRP threshold (>10 mg/L), BASDAI ≥4, and specific MRI criteria; TGA requires only inadequate response to NSAIDs without these quantified thresholds.