Sarilumab
Withdrawn RheumatologyAuthority RequiredFirst-line line
Severe active rheumatoid arthritis in adult patients who have had an inadequate response to conventional disease-modifying anti-rheumatic drugs (cDMARDs).
1
Submissions
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2021 Withdrawn Rheumatoid arthritis no PSD
- Meeting Nov 2018 Recommended Rheumatoid arthritis
Access path
- Nov 2018Recommended · restricted
vs tocilizumab subcutaneous formulation
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the authority required listing of sarilumab on a cost minimisation basis with the least costly biological disease modifying anti-rheumatic drug (bDMARD) for severe active rheumatoid arthritis (RA). In making this recommendation, the PBAC accepted any of the current PBS listed bDMARDs that include conditions for severe RA could be an alternative therapy to sarilumab.PSD · Nov 2018
7.2 The PBAC considered the equi-effective doses of the 200mg strength of sarilumab (at the recommended dose of 200mg every two weeks) and alternative bDMARDs could be derived from the product information and with reference to the previously recommended equi-effective doses collated in the PBS Therapeutic Relativity Sheets.PSD · Nov 2018
Economic analysis
6.23 The submission presented a cost-minimisation analysis between SAR 200mg and TCZ SC 162mg, based on the published ex-manufacturer price over 52 weeks. The equi-effective doses were based on the recommended doses (without dose reduction for adverse events): SAR 200mg q2w = TCZ SC 162mg qw.PSD · Nov 2018
6.24 The cost-minimisation analysis to TCZ did not take into account the differential dosing regimens recommended in the PI for management of adverse events for TCZ or SAR.PSD · Nov 2018
Clinical claim
6.19 The submission described SAR as non-inferior in terms of effectiveness and safety compared with TCZ. The ESC considered that the evidence presented in the submission reasonably supported the clinical claim. While the majority of the evidence presented in the submission compared ACR response between SAR 200mg q2w and TCZ IV 8mg/kg q4w, the PBAC has previously accepted that TCZ SC 162mg qw is equivalent to TCZ IV 8mg/kg q4w.PSD · Nov 2018
6.20 The submission did not present any data that indicated SAR could be considered superior in terms of efficacy or safety to any of the other bDMARDs available for the treatment of severe RA.PSD · Nov 2018
Consumer comments
6.2 The PBAC noted there were no consumer comments received for this item.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis performed; ICER not applicable by design.
Decision context
PopulationAdults with severe active rheumatoid arthritis and inadequate response to conventional disease-modifying anti-rheumatic drugs (cDMARDs), with no prior PBS-subsidised biologic DMARD treatment in the previous 12 months.
Why it was knocked back
- Pricing concerns regarding the 150mg formulation resulting in price advantage (double the cost) compared to tocilizumab at reduced dosages for adverse event management; streamlined authority listing deemed inappropriate; wording of restrictions required clarification regarding total treatment durations.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Recommended · restricted | tocilizumab subcutaneous formulation | — | RCT · ACR response (20%, 50%, 70%) at Week 12 and 24 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe RA with cDMARD inadequate response and no prior biologic use in 12 months; TGA permits moderate-to-severe with any DMARD type.