PBAC's latest decision on Fremanezumab: Recommended with restriction (2022). Considered for Prevention of high frequency episodic migraine (8–14 migraine headache days per month) in patients with inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
5
first 2019
Submissions
5
2019 → 2022
Eligible population
Adults aged ≥18 years with high frequency episodic migraine (8–14 migraine headache days per month) who have had inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications (propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate, or topiramate), not concurrently receiving botulinum toxin type A or another CGRP monoclonal antibody, and appropriately managed for medication overuse headache.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
171 patients
Key trials
FOCUS, CONQUER
Comparator
galcanezumab
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis (CMA) versus galcanezumab; no ICER calculated by design.
Submission history
Nov 2019: Recommended with restriction · Restricted
Mar 2020: Recommended with restriction · Authority Required
Mar 2022: Recommended · Authority Required
Mar 2022: Recommended with restriction · Restricted
Nov 2022: Recommended with restriction · Authority Required