PBAC's latest decision on Daclizumab: Recommended with restriction (2016). Considered for Treatment of relapsing-remitting multiple sclerosis (RRMS). The submission sought a General Schedule Authority Required listing, with treatment restricted to patients with clinically definite RRMS diagnosed by MRI, at least 2 documented attacks in the preceding 2 years, ambulatory status, and monotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2016
Submissions
2
2016 → 2016
Eligible population
Adults with clinically definite relapsing-remitting multiple sclerosis (RRMS) diagnosed by MRI of the brain and/or spinal cord, with at least 2 documented attacks of neurological dysfunction in the preceding 2 years, who are ambulatory without assistance or support, and receiving daclizumab as monotherapy. Treatment must be initiated and managed by a neurologist.
Therapy area
Neurology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
1,841 patients
Key trials
SELECT, DECIDE, FREEDOMS, FREEDOMS II, TRANSFORMS
Comparator
fingolimod (primary); dimethyl fumarate and ABCR therapies (interferon beta-1a, interferon beta-1b, glatiramer acetate) also considered
Economic model
Not modelled
ICER note
No ICER stated; this was a minor submission with no new economic evaluation presented.
Submission history
Jul 2016: Deferred · Authority Required
Nov 2016: Recommended with restriction · Authority Required