Dimethyl FumarateAKM Dimethyl Fumarate
Treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
Decisions on record
- Meeting Nov 2019 Recommended Relapsing-remitting multiple sclerosis (RRMS)
- Meeting Jul 2016 Recommended Relapsing-remitting multiple sclerosis
- Meeting Jul 2013 Recommended Multiple sclerosis
Access path
- TGA registered · AKM Dimethyl Fumarate
TGA label equal than the PBS population
- Jul 2013Recommended
vs ABCR therapies (intramuscular interferon beta-1a…
- Jul 2016Recommended
Evidence: RCT → Cost-minimisation
- Nov 2019Recommended · restricted
Listing: Restricted → Authority Required
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended amending the listing of dimethyl fumarate to Authority Required (STREAMLINED) for the treatment of relapsing remitting multiple sclerosis (RRMS).PSD · Nov 2019
5.2 The PBAC also recommended amending the listings of fingolimod, teriflunomide and cladribine to Authority Required (STREAMLINED) for the treatment of RRMS.PSD · Nov 2019
4.4 The PBAC noted and welcomed the health care professional (1) input via the Consumer Comments facility on the PBS website. The comment supported making increased maximum quantities available for the dose titration period.PSD · Jul 2016
Cost-effectiveness
Minor submission; no new economic evaluation performed. Originally listed on cost-minimisation basis in July 2013.
The PBAC considered that increasing the maximum quantity of 120 mg DMF may simplify dose titration for both patients and medical practitioners. PBAC · 2016
Decision context
PopulationAdults with relapsing-remitting multiple sclerosis (RRMS).
Risk sharingRisk sharing arrangement (RSA) with a cap on expenditure for the 120 mg form, with rebates for any expenditure over the cap, and a special price arrangement (SPA). Original Deed replaced on 1 April 2019 with a new Deed.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2016 | Recommended | — | — | Cost-minimisation |
| Jul 2013 | Recommended | ABCR therapies (intramuscular interferon beta-1a, subcutaneous interferon beta-1a, interferon beta-1b and glatiramer ace | — | RCT · Annualised relapse rate |
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 equal than PBS population — Both TGA label and PBAC recommendation specify treatment of adults with relapsing-remitting multiple sclerosis without additional restrictions.