RimegepantNurtec ODT
Acute treatment of migraine attacks in adult patients who have not responded adequately, are intolerant or contraindicated to analgesics and at least two selective 5-hydroxytryptamine receptor agonists (triptans).
Decisions on record
- Meeting Mar 2024 Not recommended Acute migraine attacks
- Meeting Jul 2023 Not recommended Acute migraine attacks no PSD
Access path
- TGA registered · Nurtec ODT
TGA label narrower than the PBS population
- Mar 2024Not recommended
vs placebo (as a proxy for best supportive care)
From the public summary
5.1 The PBAC did not recommend rimegepant for the acute treatment of migraine in adults who have not responded adequately, are intolerant or contraindicated to analgesics and at least two selective 5-hydroxytryptamine receptor agonists (triptans).PSD · Mar 2024
The PBAC acknowledged that there was a clinical need for new, oral treatments for the acute treatment of migraine and considered that rimegepant provided a benefit over best supportive care (BSC) in terms of efficacy. However, the PBAC considered that the resubmission did not appropriately address the issues raised in July 2023 relating to the economic evaluation and the financial impact estimates.PSD · Mar 2024
4.9 In July 2023, the PBAC considered that the base case incremental cost-effectiveness ratio (ICER) presented in the submission ($15,000 to < $25,000 per QALY) was 5PSD · Mar 2024
• The efficacy inputs were based on the post hoc, pooled subgroup analysis of the secondary outcome, pain relief at two hours. The PBAC considered that the use of the post hoc, pooled subgroup analyses was not adequately justified and data from the mITT analysis should be used.PSD · Mar 2024
4.4 The July 2023 submission described rimegepant as superior in terms of effectiveness and non-inferior in terms of safety compared to placebo in adults with moderate to severe migraine attacks who inadequately responded to at least two triptans or who are intolerant or contraindicated to triptans.PSD · Mar 2024
4.5 Based on the results of the analyses presented in the submission, in July 2023 the PBAC considered that a single dose of rimegepant was superior compared to BSC in terms of treating an acute migraine. The PBAC, noting that no longer term efficacy data were presented in the submission, considered that the long-term treatment effect of rimegepant was uncertain (paragraph 7.8, rimegepant public summary document (PSD), July 2023).PSD · Mar 2024
4.3 The PBAC recalled the advice received from Migraine Australia which provided a detailed description of the impact of migraine and the current available therapies. The advice also highlighted the importance of the availability of alternate options for the treatment of acute migraine prophylaxis and clarifying the likely use of rimegepant in clinical practice.PSD · Mar 2024
4.21 In July 2023, the PBAC advised that an RSA would be required to manage the uncertainties in rimegepant eligibility, uptake and use (paragraph 7.12, rimegepant PSD, July 2023).PSD · Mar 2024
Cost-effectiveness
Decision context
PopulationAdults with moderate to severe acute migraine attacks who have inadequately responded to at least 2 triptans or who are intolerant or contraindicated to triptans, who require treatment for not more than 8 acute migraine attacks of moderate to severe intensity per month, and who have also failed analgesics.
Risk sharingA three-tier risk sharing arrangement was proposed in the resubmission to manage uncertainties in rimegepant eligibility, uptake and use.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Not recommended | placebo (as a proxy for best supportive care) | $25k–35k | RCT · Pain relief |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| BHV3000-301 | Ph 3 | 1,485 | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | completed |
| BHV3000-302 | Ph 3 | 1,499 | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | completed |
| BHV3000-303 | Ph 3 | 1,811 | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | completed |
Consumer voice
Consumer input from 9 individuals and 3 organisations (Migraine & Headache Australia, Australian and New Zealand Headache Society, Pain Australia) strongly supported the submission, describing the need for new migraine treatments and the debilitating effects of migraines on quality of life, work, study and socialising. Input also highlighted the importance of alternate treatment options and potent
They described the need for new, effective and safe treatments for acute migraine, the potential benefits of rimegepant in relieving acute migraine pain and frequency. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed ≥2 triptans and analgesics; TGA label includes all acute migraine without prior treatment requirement.