EptinezumabVyepti
Preventive treatment of chronic migraine in patients with inadequate response, intolerance or contraindication to at least three prior prophylactic migraine therapies.
Decision on record
- Meeting Jul 2022 Recommended Chronic migraine in patients with inadequate response, intolerance or contraindication to at least three prophylactic migraine medications
Access path
- TGA registered · Vyepti
TGA label narrower than the PBS population
- Jul 2022Recommended · restricted
vs galcanezumab and fremanezumab
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (Streamlined) listing of eptinezumab for the treatment of chronic migraine in patients who have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications.PSD · Jul 2022
The PBAC noted galcanezumab and fremanezumab were alternative therapies to eptinezumab and the equi-effective doses were: eptinezumab 100 mg every 12 weeks = galcanezumab 240 mg initially then 120 mg every month = fremanezumab 225 mg every month.PSD · Jul 2022
The submission presented the results of a cost minimisation approach (CMA) of eptinezumab vs. galcanezumab over a three-year time horizon. The CM approach presented by the submission was consistent with that for galcanezumab versus botox (paragraph 4.4 and 5.2, galcanezumab PSD, November 2020). The key components of the CMA are presented in Table 9. 18PSD · Jul 2022
DELIVER; PROMISE-2; Study-005 (eptinezumab versus placebo); REGAIN (galcanezumab versus placebo).PSD · Jul 2022
The submission described eptinezumab 100 mg q12w as non-inferior in terms of effectiveness and safety compared with galcanezumab 120 mg monthly and fremanezumab 225 mg monthly.PSD · Jul 2022
The evaluation considered the claim for efficacy was not adequately supported by the evidence presented in the submission for the following reasons: 17PSD · Jul 2022
The PBAC noted and welcomed the input from individuals (85), health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The comments described the benefit of having additional options available to treat chronic migraine and the need for better treatment options due to the debilitating nature of the condition.PSD · Jul 2022
The submission requested that eptinezumab be included in the risk sharing arrangement (RSA) for the existing CGRP inhibitors. The submission acknowledged the uncertainty related to the sequential use of GCRP inhibitors as no evidence demonstrating the clinical and cost-effectiveness of sequential use for eptinezumab was presented.PSD · Jul 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission presented cost-minimisation approach against galcanezumab.
Decision context
PopulationAdults aged 18 years or older with chronic migraine (≥15 headache days per month with ≥8 migraine days per month for ≥6 months) who have experienced inadequate response, intolerance or contraindication to at least three prophylactic migraine medications.
Risk sharingSpecial pricing arrangement requested, with effective price to be determined based on cost-minimisation to the effective price of galcanezumab or fremanezumab.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Recommended · restricted | galcanezumab and fremanezumab | — | Meta-analysis · Reduction in monthly migraine headache days and 50% response rate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DELIVER | Ph 3 | 892 | Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 t… | completed |
Consumer voice
Consumer input highlighted the need for additional treatment options for chronic migraine due to the condition's debilitating nature, with mixed perspectives on IV infusion administration and clinic-based treatment every 3 months. Professional organisations emphasised the importance of treatment variety and noted potential benefits of eptinezumab's mode of administration and efficacy in medication
The comments described the benefit of having additional options available to treat chronic migraine and the need for better treatment options due to the debilitating nature of the condition. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic migraine with ≥15 headache days/month and prior failure of ≥3 prophylactic therapies; TGA label permits any migraine preventive in adults.