TeriflunomideAPO-TERIFLUNOMIDE
Treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
Decisions on record
- Meeting Nov 2016 Not recommended Relapsing-remitting multiple sclerosis (RRMS)
- Meeting Jul 2013 Recommended Multiple sclerosis
- Meeting Nov 2012 Not recommended Multiple sclerosis
Access path
- TGA registered · APO-TERIFLUNOMIDE
TGA label narrower than the PBS population
- 2012Recommended
vs interferon beta-1a and interferon beta-1b
- Nov 2012Not recommended
insufficient evidence of non-inferiority in comparative effectiveness, increased relapse rate in teriflunomide group vs…
- ↻ resubmittedJul 2013Recommended · restricted
- Nov 2016Not recommended
market for oral therapies for RRMS had not yet stabilised; utilisation of other oral therapies (fingolimod and DMF) was…
From the public summary
6.1 The PBAC decided not to recommend amending the listing of teriflunomide to Authority Required (STREAMLINED), as it considered that the market for oral therapies for RRMS had not yet stabilised.PSD · Nov 2016
6.2 The PBAC noted the input from the DUSC secretariat with regards to the utilisation of all RRMS therapies, and noted that the utilisation of the other oral therapies, 4PSD · Nov 2016
Cost-effectiveness
Cost-minimisation basis; no ICER calculated.
The PBAC has previously accepted IFN β-1a and IFN β-1b as appropriate comparators. PBAC · 2016
Decision context
PopulationPatients with relapsing-remitting multiple sclerosis (RRMS).
Risk sharingRisk Share Arrangement (RSA) with annual Commonwealth expenditure cap in place for teriflunomide.
Why it was knocked back
- market for oral therapies for RRMS had not yet stabilised; utilisation of other oral therapies (fingolimod and DMF) was higher and the market for oral treatments was still growing
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Not recommended | interferon β-1a and interferon β-1b | — | Cost-minimisation · Cost-minimisation |
| Jul 2013 | Recommended · restricted | interferon beta-1a and interferon beta-1b | — | RCT · ARR |
| Nov 2012 | Not recommended | interferon beta-1a and interferon beta-1b | — | RCT · ARR |
| 2012 | Recommended | interferon beta-1a and interferon beta-1b | — | RCT, indirect comparison · OS, PFS, DFS, ORR, QoL, Surrogate |
Clinical evidence
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 restricted subsidy to RRMS only, excluding progressive relapsing forms covered by the broader TGA label.