Siponimod
Recommended NeurologyAuthority Required 💬 consumer voice
Treatment of adult patients with secondary progressive multiple sclerosis (SPMS), specifically for intermediate and extensive metabolisers requiring a 1 mg daily maintenance dose.
3
Submissions
2 resub
2019–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2024 Recommended Multiple sclerosis
- Meeting Jul 2020 Recommended Multiple sclerosis (MS)
- Meeting Nov 2019 Not recommended Secondary progressive multiple sclerosis (SPMS)
Access path
- Nov 2019Not recommended
vs placebo (untreated SPMS); interferon-beta, glatiramer…
- ↻ resubmittedJul 2020Recommended · restricted
Comparator changed: placebo (untreated SPMS); interferon-beta, glatiramer acetate…
- Mar 2024Recommended · restricted
Comparator changed: fingolimod → siponimod 0.25 mg tablet
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the General Schedule, Authority Required (STREAMLINED) listing of siponimod, tablet 1 mg, under the same circumstances as the PBS-listed siponimod 0.25 mg tablets. This recommendation was made on a cost-minimisation basis to siponimod 0.25 mg tablet.PSD · Mar 2024
6.2 The PBAC advised that the cost-minimisation should be to the nominated clinical comparator, siponimod 0.25 mg tablet and that the price of tablet 1 mg should not be any higher than the 0.25 mg tablet on a per day basis.PSD · Mar 2024
Economic analysis
5.4 The submission presented a cost-minimisation analysis (CMA) of siponimod 1 mg tablet compared with siponimod 2 mg tablet (Table 1), claiming that the rationale was that the PBAC did not differentiate between the standard maintenance dose (siponimod 2 or 1 mg tablets) following its July 2020 recommendation of siponimod 2 mg tablet.PSD · Mar 2024
0.25 mg tablets (120 unit pack) was the appropriate comparator.PSD · Mar 2024
Clinical claim
5.3 The submission did not make a specific clinical claim. However, the PBAC considered that a claim of non-inferior comparative effectiveness and safety to siponimod 4 x 0.25 mg tablets was adequately supported.PSD · Mar 2024
Consumer comments
The PBAC noted and welcomed the input from individuals (2), and the Australian and New Zealand Association of Neurologists (ANZAN) via the Consumer Comments facility on the PBS website. The comments from ANZAN supported the listing of siponimod for patients with relapsing forms of MS with an EDSS of up to 6.5.PSD · Jul 2020
Financial management – risk sharing
The resubmission proposed to share the risk of the overall budget impact of a PBS listing for siponimod through a subsidisation cap and rebate arrangement to give the PBAC confidence in the budget estimates.PSD · Jul 2020
The resubmission stated “as the PBS population to be treated with siponimod differs from the population eligible for the current DMTs (by including patients with the highest unmet need, EDSS 6.0/6.5), the subsidisation caps should be unique to siponimod and based on the agreed estimates”. Given the overlapping populations (e.g.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The PBAC considered that the proposed listing was likely to result in a minor cost to the PBS/RPBS due to the higher AEMP requested and the increased frequency of dispensing required compared to the existing 0.25 mg siponimod listing. PBAC · 2024
Indirect comparison
Decision context
PopulationAdult patients with secondary progressive multiple sclerosis (SPMS) determined to have CYP2C9*2*3 or *1*3 genotype (intermediate metabolisers, approximately 12% of population) requiring a 1 mg daily maintenance dose.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | siponimod 0.25 mg tablet | — | Cost-minimisation · Cost-minimisation |
| Jul 2020 | Recommended · restricted | fingolimod | — | RCT · Annualised relapse rate; proportion free from relapse; 3- and 6-month confirmed disability progression |
| Nov 2019 | Not recommended | placebo (untreated SPMS); interferon-beta, glatiramer acetate, natalizumab (treated SPMS) | — | RCT · Disability progression |
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 intermediate/extensive metabolisers with specific CYP2C9 genotypes requiring 1 mg daily dose; TGA label has no such pharmacogenomic restriction.