PBAC's latest decision on Dimethyl fumarate: Recommended with restriction (2019). Considered for Treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2013
Submissions
3
2013 → 2019
Eligible population
Adults with relapsing-remitting multiple sclerosis (RRMS).
Therapy area
Neurology
Line of therapy
Any
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Economic model
Cost-minimisation
ICER note
Minor submission; no new economic evaluation performed. Originally listed on cost-minimisation basis in July 2013.
Risk sharing
Risk-sharing arrangement in place — Risk 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
Jul 2013: Recommended · Authority Required
Jul 2016: Recommended with restriction · Restricted
Nov 2019: Recommended with restriction · Authority Required