ErenumabAimovig
Prophylaxis of chronic migraine in adults who have experienced an inadequate response, intolerance or a contraindication to at least 3 prophylactic migraine medications.
Decisions on record
- Meeting Nov 2024 Recommended Chronic migraine prophylaxis
- Meeting Mar 2019 Not recommended ERENUMAB is indicated for prophylaxis of migraine in adults.
- Meeting Mar 2019 Not recommended Indication not stated
- Meeting Jul 2018 Not recommended Chronic migraine
Access path
- TGA registered · Aimovig
TGA label narrower than the PBS population
- Jul 2018Not recommended
vs Botox (botulinum toxin type A)
- Mar 2019Not recommended
Comparator changed: Botox (botulinum toxin type A) → Botulinum toxin type A (Botox) and…
- ↻ resubmittedNov 2024Recommended
Comparator changed: Botulinum toxin type A (Botox) and best supportive care (BSC) →…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended erenumab for the prophylactic treatment of chronic migraine in adults who have experienced an inadequate response, intolerance or a contraindication to at least 3 prophylactic migraine medications.PSD · Nov 2024
7.2 The PBAC noted the substantial number of comments from individuals, a health professional and an organisation that supported the resubmission and highlighted the need for additional, effective treatment options for migraine.PSD · Nov 2024
6.53 The resubmission presented a cost-minimisation approach (CMA) comparing erenumab to galcanezumab and fremanezumab on the basis that erenumab was non- inferior to galcanezumab and fremanezumab in terms of effectiveness and safety.PSD · Nov 2024
6.54 The resubmission did not present a CMA compared to eptinezumab. 6.55 The equi-effective doses were estimated as: 29PSD · Nov 2024
6.49 The resubmission described erenumab as non-inferior in terms of effectiveness compared to galcanezumab, fremanezumab and eptinezumab. On balance, the evaluation considered that this claim, although uncertain, was reasonably supported by the clinical evidence. Several issues increased uncertainty in the results:PSD · Nov 2024
• No head-to-head clinical trials comparing erenumab to the comparators were presented.PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from individuals (51), health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The PBAC also recalled the large number of consumer comments provided in relation to the July 2018 and March 2019 erenumab submissions.PSD · Nov 2024
Individuals stated that erenumab was associated with reduced migraine days and sensitivities (e.g. to light and noise), increased clarity and significant improvements in quality of life. Individuals stated that they experienced minimal adverse events.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation approach; no ICER calculated. Document states erenumab was non-inferior in effectiveness and safety compared to comparators.
The PBAC did not consider a differential price for the two groups of patients (those treated with Botox versus those not treated with Botox) to be adequately justified. PBAC · 2019
Decision context
PopulationAdults with chronic migraine (≥15 headache days per month with ≥8 migraine days) who have experienced inadequate response, intolerance or contraindication to at least 3 prophylactic migraine medications.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended | galcanezumab, fremanezumab, eptinezumab | — | RCT · Reduction in monthly migraine days |
| Mar 2019 | Not recommended | Botulinum toxin type A (Botox) and best supportive care (BSC) | — | RCT · Change from baseline in monthly migraine days; proportion of responders (≥50% reduction) |
| Jul 2018 | Not recommended | Botox (botulinum toxin type A) | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DRAGON | Ph 3 | 557 | Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treat… | completed |
| NCT03303079 | Ph 2, PHASE3 | 571 | Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Le… | completed |
Consumer voice
Fifty-one individuals, one healthcare professional, and one organisation (Migraine Australia) provided input supporting erenumab. Current users reported superior efficacy, reduced migraine days and sensitivities, improved quality of life, and minimal adverse events. Those seeking access highlighted high private treatment costs and the need for additional effective migraine treatments.
Individuals stated that erenumab was associated with reduced migraine days and sensitivities (e.g. to light and noise), increased clarity and significant improvements in quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic migraine with ≥15 headache days/month and failure of ≥3 prior prophylactic medications; TGA label covers all migraine prophylaxis.