Atogepant
Prophylaxis of chronic migraine and high-frequency episodic migraine in adults who have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications.
Decision on record
- Meeting Jul 2023 Not recommended Prophylaxis of high frequency episodic and chronic migraine
From the public summary
The PBAC did not recommend atogepant for use as prophylaxis in adult patients with chronic migraine (CM) or high frequency episodic migraine (HFEM) who have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications.PSD · Jul 2023
The key reason for this outcome was due to the comparative clinical evidence.PSD · Jul 2023
The submission presented a CMA based on the claim of non-inferior effectiveness and safety for atogepant compared to galcanezumab. As noted in paragraph 5.3, fremanezumab may be considered an alternative therapy.PSD · Jul 2023
Table 15 presents the elements used to calculate equi-effective doses.PSD · Jul 2023
Chronic migraine The submission described atogepant as non-inferior in terms of effectiveness and safety compared with galcanezumab and fremanezumab in patients with chronic migraine who meet the PBS criteria.PSD · Jul 2023
The ESC considered that the claim of non-inferior effectiveness was uncertain because:PSD · Jul 2023
The PBAC noted and welcomed the input from individuals (43), health care professionals and organisations (3) via the Consumer Comments facility on the PBS website. The comments from individuals and the consumer organisations, Migraine & Headache Australia and the Australian and New Zealand Headache Society, strongly supported the submission.PSD · Jul 2023
The PBAC noted the advice received from Migraine Australia which provided a detailed description of the impact of migraine and the available therapies. The advice also highlighted the importance of the availability of alternate and oral options for migraine prophylaxis and clarified the likely use of atogepant in clinical practice. The PBAC specifically noted the advice that the use of atogepant may improve the quality of life of migraine sufferers.PSD · Jul 2023
Cost-effectiveness
Cost-minimisation approach; ICER not calculated. Effective price to be determined via Special Pricing Agreement using comparator's confidential price.
Decision context
PopulationAdults with chronic migraine or high-frequency episodic migraine (≥8 migraine days per month over ≥6 months) who have experienced an inadequate response, intolerance or contraindication to at least three prophylactic migraine medications.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Not recommended | galcanezumab and fremanezumab | — | RCT · Reduction in monthly migraine headache days; ≥50% reduction in monthly migraine headache days |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT03303079 | Ph 2, PHASE3 | 571 | Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Le… | completed |
| NCT02848326 | Ph 2, PHASE3 | 834 | Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Da… | completed |
| NCT02959177 | Ph 2 | 459 | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) | completed |
| NCT03303092 | Ph 2, PHASE3 | 357 | Mean Change From Baseline in the Monthly (28 Days) Average Number of Migraine Days During … | completed |
Consumer voice
Consumer input from 43 individuals and 3 organisations (Migraine & Headache Australia, Australian and New Zealand Headache Society, and Migraine Australia) strongly supported the submission, highlighting the need for new oral migraine treatments, the benefits of atogepant in preventing migraine pain and frequency, and the significant impact of migraines on quality of life and ability to work, stud
They described the need for new and effective oral migraine treatments, the potential benefits of atogepant in preventing migraine pain and frequency and the decreased likelihood of side effects. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ≥8 migraine days/month with prior failure of ≥3 prophylactic drugs; TGA label includes all ≥4 migraine days/month regardless of prior treatment.