script.reportAU
Neurology

Diroximel fumarate

Brand: Vumerity®

PBAC's latest decision on Diroximel fumarate: Recommended with restriction (2022). Considered for Treatment of relapsing-remitting multiple sclerosis (RRMS) in patients diagnosed as clinically definite RRMS by MRI with at least two documented relapses within the preceding two years.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2022
Submissions
1
2022 → 2022

Eligible population

Adults with relapsing-remitting multiple sclerosis diagnosed as clinically definite by MRI of brain and/or spinal cord with at least 2 documented attacks of neurological dysfunction in the preceding 2 years; ambulatory without assistance or support; receiving DRF as sole PBS-subsidised disease modifying therapy.

Therapy area
Neurology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Gastrointestinal tolerability
Pivotal trial size
506 patients
Key trials
EVOLVE-MS-2, ALK8700-A103, ALK8700-A104, ALK8700-A109, EVOLVE-MS-1
Comparator
dimethyl fumarate (DMF)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated

Similar precedents

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