PBAC's latest decision on Galcanezumab: Recommended with restriction (2022). Considered for Treatment-resistant high frequency episodic migraine (8 to <15 migraine headache days per month) in adults who have inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2019
Submissions
4
2019 → 2022
Eligible population
Adult patients with high frequency episodic migraine (8 to <15 migraine headache days per month with <15 total headache days per month) who have inadequate response, intolerance, or contraindication to at least three prior prophylactic migraine medications.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Reduction in migraine headache days
Key trials
CONQUER
Comparator
best supportive care
Economic model
CUA
ICER note
ICER values are redacted (commercial-in-confidence) in the public summary document.
Risk sharing
Risk-sharing arrangement in place — Risk-sharing arrangement (RSA) with combined caps for chronic migraine and high frequency episodic migraine proposed.
Submission history
Jul 2019: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Authority Required
Nov 2020: Deferred · Authority Required
Mar 2022: Recommended with restriction · Restricted