The Institute for Clinical and Economic Review (ICER) has released a draft evidence report
assessing the clinical effectiveness and economic value of calcitonin gene-related peptide (CGRP) inhibitors for the treatment of chronic or episodic migraines.
The institute reviewed Amgen and Novartis’ erenumab, Teva’s fremanezumab, an Eli Lilly’s galcenezumab for outcomes including: frequency, intensity, and duration of migraine events; pain; cognitive functioning/impairment; disability; health-related quality of life; use of rescue therapies; tolerability; and adverse events.
ICER identified and examined existing evidence of the treatments from clinical studies of adult patients aged 18 and older with chronic or episodic migraines who were eligible for preventive migraine therapy.
For erenumab, 1 trial for chronic migraine and 3 trials for episodic migraine were included. All trials were placebo controlled. Results yielded modest reductions in monthly migraine days (1.3-2.4 fewer migraine days per month), a modest reduction in days using acute medications (0.9-2.5 fewer days per month), and a greater proportion of patients experiencing a reduction in migraine days by at least 50% (odds ratio [OR], 1.9-2.3) with erenumab compared to placebo.
One trial for the treatment of chronic migraines with fremanezumab and 1 trial for the treatment of episodic migraines with fremanezumab were included. Both trials were placebo-controlled. Results showed a modest reduction in monthly migraine days (1.3-1.9 fewer migraine days) and a modest reduction in days using acute medications (1.4-2.3 fewer days). Results also showed a greater proportion of patients experiencing a reduction in migraine days by at least 50% compared to placebo (OR, 2-2.24 in episodic migraine) and a reduction in moderate-to-severe headache days by at least 50% compared to placebo (OR, 2.4 in chronic migraine).
There were no published trials assessing galcanezumab in the chronic migraine population. Two trials assessing different regimens for the treatment of episodic migraines were included. Results from 1 trial suggest a modest reduction in monthly migraine days (0.9 fewer days per month) and a greater proportion of patients experiencing a reduction in migraine days by at least 50% compared to placebo (OR, 2.0).
Using a placeholder price of $8500 per year, base case incremental cost-effectiveness ratios for erenumab in chronic migraine for patients who have previously been treated with preventive therapy fell under the $150,000 cost effectiveness ratio threshold, with approximately $135,000 per quality-adjusted life year (QALY) when compared to no treatment, and approximately $147,000 per QALY gained when compared to current preventive treatment onabotulinum toxin A. However, results for fremanezumab in chronic migraine showed $184,000 per QALY gained compared to no treatment and approximately $315,000 per QALY gained when compared to onabotulinum toxin A. For patients with episodic migraine previously treated with preventive therapy, results showed more than $225,000 per QALY gained compared to no treatment.
Looking at the potential budget impact, using erenumab would result in an additional $6000 in costs per patient to the healthcare system. At this price, only 16% of the eligible migraine population could be treated before costs exceed the ICER potential budget impact threshold. The impact of used fremanezumab would result in an additional $3600 in costs per patient to the health system and only 27% of the eligible migraine population could be treated before exceed the ICER threshold.
While CGRP inhibitors are projected to have a positive impact on the health of patients with chronic or episodic migraines for whom preventive therapy had failed relative to no treatment, it is likely that the inhibitors will exceed commonly-cited willingness-to-pay thresholds, concluded the institute report.
The report is open for public comment until May 8.
In a response to the report
, Amgen and Novartis gave 5 recommendations:
- Employ a patient-centered approach. The base-case should be the patient and employer perspective that factors in the missed work days and reduced productivity of migraine patients, as opposed to a payer perspective.
- Assess erenumab only in treatment-experienced patients–those who have tried and failed topiramate or propranolol as opposed to treatment naïve patients.
- Factor in treatment discontinuation rates with currently available preventives in the analysis and in the impact on efficiency.
- Incorporate responder rates.
- Apply full continuous modeling techniques rather than a fixed health state model to more accurately capture the complexities of migraine burden and treatment benefit.
The response concluded by saying that the migraine prevention space has had no real innovation in 2 decades and patients are in need of new treatment options.