GalcanezumabEmgality
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.
Decisions on record
- Meeting Jul 2025 Noted Treatment-resistant high frequency episodic migraine no PSD
- Meeting Mar 2022 Recommended Migraine
- Meeting Nov 2020 Not recommended Episodic migraine
- Meeting Nov 2020 Noted Chronic migraine
- Meeting Jul 2019 Recommended Chronic migraine
Access path
- TGA registered · Emgality
TGA label narrower than the PBS population
- Jul 2019Recommended · restricted
vs botulinum toxin type A (Botox)
- Nov 2020Recommended · restricted
Comparator changed: botulinum toxin type A (Botox) → botulinum toxin (Botox)
- Nov 2020Not recommended
Comparator changed: botulinum toxin type A (Botox) → botulinum toxin (Botox)
- ↻ resubmittedMar 2022Recommended · restricted
Listing: Authority Required → Restricted
- PBS listing · Restricted
From the public summary
The PBAC recommended amending the current PBS listing of galcanezumab for chronic migraine to include the treatment of patients with high frequency episodic migraine by removing the criteria for patients to have an average of 15 or more headache days per month.PSD · Mar 2022
The PBAC noted the consumer comments and acknowledged there was a clinical need for broader access to CGRP inhibitors to increase the treatment options for people with treatment-resistant high frequency episodic migraine.PSD · Mar 2022
The resubmission presented a stepped economic evaluation of galcanezumab compared to placebo (as a proxy for best supportive care), in patients with high frequency episodic migraine who have an inadequate response, intolerance or a contraindication to at least three prior prophylactic migraine medications.PSD · Mar 2022
A summary of the model structure and key inputs is presented in the table below. The model structure was unchanged from the November 2020 submission. 14PSD · Mar 2022
best supportive care in terms of efficacy and similar in terms of safety. Source: Table 1.2.1, p29 of the resubmission.PSD · Mar 2022
Underlined text indicates key changes from the November 2020 submission.PSD · Mar 2022
The PBAC noted and welcomed the input from individuals (30) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the benefit of treatment with galcanezumab including reduction in number and severity of migraines, reduced use of acute medications, improvement in quality of life and the 6PSD · Mar 2022
The PBAC noted the advice received from Migraine & Headache Australia that the disease burden for patients with high frequency episodic migraine is very similar to that of patients with chronic migraine. The advice noted the devastating impacts on quality of life, ability to work and livelihood for people living with migraine and the significant benefits of treatment with the CGRP antibodies.PSD · Mar 2022
Cost-effectiveness
ICER values are redacted (commercial-in-confidence) in the public summary document.
Decision context
PopulationAdult 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.
Risk sharingRisk-sharing arrangement (RSA) with combined caps for chronic migraine and high frequency episodic migraine proposed.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | best supportive care | — | RCT · Reduction in migraine headache days |
| Nov 2020 | Recommended · restricted | botulinum toxin (Botox) | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Not recommended | best supportive care | — | RCT · ≥50% responder rate |
| Jul 2019 | Recommended · restricted | botulinum toxin type A (Botox) | — | RCT · Other |
Clinical evidence
Consumer voice
Consumers and patient organisations reported that galcanezumab treatment reduced migraine frequency and severity, improved quality of life, and enabled self-administration. They requested GP prescribing access to overcome neurologist appointment challenges and noted the severe disease burden and quality-of-life impacts of migraine.
The comments described the benefit of treatment with galcanezumab including reduction in number and severity of migraines, reduced use of acute medications, improvement in quality of life and the ability to self-administer. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-resistant high frequency episodic migraine (8–<15 days/month) with failure of ≥3 prior prophylactic medications; TGA label covers all migraine prophylaxis in adults.