FremanezumabAjovy
Prevention of high frequency episodic migraine (8–14 migraine headache days per month) in patients with inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications.
Decisions on record
- Meeting Nov 2022 Recommended High frequency episodic migraine in treatment-resistant patients
- Meeting Mar 2022 Recommended Chronic migraine
- Meeting Mar 2022 Recommended Chronic migraine
- Meeting Mar 2020 Recommended Chronic migraine
- Meeting Nov 2019 Deferred Chronic migraine
Access path
- TGA registered · Ajovy
TGA label narrower than the PBS population
- Nov 2019Deferred
vs botulinum toxin type A; best supportive care
- Mar 2020Recommended · restricted
Comparator changed: botulinum toxin type A; best supportive care → botulinum toxin type A…
- Mar 2022Recommended · restricted
Comparator changed: botulinum toxin type A (Botox) → fremanezumab pre-filled syringe (PFS)
- Mar 2022Recommended
Comparator changed: botulinum toxin type A (Botox) → fremanezumab pre-filled syringe (PFS)
- Nov 2022Recommended · restricted
Comparator changed: fremanezumab 225 mg monthly dosing → galcanezumab
- PBS listing · Authority Required
From the public summary
The PBAC recommended amending the current listing of fremanezumab for chronic migraine to include the treatment of patients with treatment-resistant high frequency episodic migraine (HFEM). Consistent with its March 2022 recommendation for galcanezumab in this population, the PBAC considered fremanezumab would be cost- effective for the HFEM population at a price no higher than the effective price for fremanezumab for patients with chronic migraine.PSD · Nov 2022
The PBAC considered that galcanezumab was the appropriate comparator for treatment-resistant HFEM, although noted it was not currently PBS listed for this population.PSD · Nov 2022
The submission presented a cost-minimisation approach. The key assumptions and components are summarised in Table 8. The cost-minimisation approach was consistent with the clinical claim of non-inferiority.PSD · Nov 2022
Table 8: Key components and assumptions of the cost-minimisation approach Component Claim or assumption Based on the evidence presented, the effectiveness of fremanezumab is assumed to Therapeutic claim: effectiveness be non-inferior to galcanezumab in patients with HFEM.PSD · Nov 2022
The submission described fremanezumab as non-inferior in terms of effectiveness and safety compared with galcanezumab for treating patients with HFEM (8 to 14 monthly migraine days) who have an inadequate response, intolerance, or a contraindication to at least three prior prophylactic migraine medications.PSD · Nov 2022
The submission proposed an MCID of two days for the key primary outcome of change in monthly migraine days, and this was also nominated as the non-inferiority margin.PSD · Nov 2022
5.2 The PBAC noted and welcomed the input from individuals (18), a health care professional and an organisation via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with fremanezumab AI including the improved ability to self-administer.PSD · Mar 2022
5.3 The PBAC noted the comments from Migraine Australia indicating its full support of an AI presentation to allow more autonomy for patients and ease of use during cognitive difficulties.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis (CMA) versus galcanezumab; no ICER calculated by design.
The PBAC considered the cost-minimisation analysis of fremanezumab quarterly dosing compared with fremanezumab monthly dosing to be acceptable. PBAC · 2022
Decision context
PopulationAdults aged ≥18 years with high frequency episodic migraine (8–14 migraine headache days per month) who have had inadequate response, intolerance, or contraindication to at least three prophylactic migraine medications (propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate, or topiramate), not concurrently receiving botulinum toxin type A or another CGRP monoclonal antibody, and appropriately managed for medication overuse headache.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2022 | Recommended · restricted | galcanezumab | — | RCT · PFS |
| Mar 2022 | Recommended · restricted | fremanezumab pre-filled syringe (PFS) | — | Single-arm · Bioequivalence |
| Mar 2022 | Recommended | fremanezumab 225 mg monthly dosing | — | RCT · Non-inferiority in comparative effectiveness and safety |
| Mar 2020 | Recommended · restricted | botulinum toxin type A (Botox) | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Deferred | botulinum toxin type A; best supportive care | — | RCT · Reduction in monthly migraine days; reduction in monthly headache days; proportion of patients achieving ≥50% reduction from baseline in monthly migraine days |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT03308968 (FOCUS) | Ph 3 | 838 | DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-W… | completed |
Consumer voice
No consumer comments were received for this item, though the PBAC recalled previous comments regarding this population from the March 2022 PBAC meeting on Galcanezumab.
The PBAC noted that no consumer comments were received for this item but recalled the comments received previously regarding this population (para 7.2, Galcanezumab PSD, March 2022 PBAC meeting). Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to high-frequency episodic migraine (8–14 days/month) with prior failure of three specific prophylactic medications.