- April 14, 2018
- Posted by: PharmaScroll
- Category:
Institute for Clinical and Economic Review (ICER), an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs, recently released a draft report which assessed both the comparative clinical effectiveness and economic impacts of CGRP inhibitors for patients with chronic or episodic migraine.
The assessment in the report was aimed at systematically evaluating the existing evidence, taking uncertainty and patient-centered considerations into account. To that aim, the assessment was informed by two research components (a systematic review of the existing evidence and an economic evaluation) developed with input from a diverse group of stakeholders, including patients and their families, clinicians, researchers, representatives from pain and migraine foundations, and manufacturers of the agents of focus in this review.
Research Questions:
The following research questions were developed with input from clinical experts, patients, and
patient groups:
- In patients with chronic migraine eligible for preventive therapy, what is the comparative efficacy, safety, effectiveness, and economic impacts of CGRP inhibitors (erenumab, fremanezumab, and galcanezumab) versus each other and commonly-used oral migraine preventive therapies (topiramate, propranolol, and amitriptyline), and onabotulinum toxin A?
- In patients with chronic migraine for whom other preventive therapies have failed, what is the comparative efficacy, safety, effectiveness, and clinical impacts of CGRP inhibitors (erenumab, fremanezumab, and galcanezumab) versus each other, onabotulinum toxin A, and no preventive therapy?
- In patients with episodic migraine eligible for preventive therapy, what is the comparative efficacy, safety, effectiveness, and economic impacts of CGRP inhibitors (erenumab, fremanezumab, and galcanezumab) versus each other and commonly-used oral migraine preventive therapies (topiramate, propranolol, and amitriptyline)?
- In patients with episodic migraine for whom other preventive therapies have failed, what is the comparative efficacy, safety, effectiveness, and economic impacts of CGRP inhibitors (erenumab, fremanezumab, and galcanezumab) versus each other and no preventive therapy?
Results and Outcomes:
Clinical Attributes:
Erenumab
- Efficacy: Results suggest a modest reduction 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% (OR 1.9-2.3) with erenumab compared with placebo.
- Safety: Erenumab was generally well tolerated during the 12-week or 26-week trials, with fewer proportions of patients discontinuing for any cause than with placebo, and small proportions discontinuing due to adverse events or experiencing a SAE. The most commonly-reported AEs pertained to injection-site pain or reactions. Nasopharyngitis and upper respiratory tract infections were also reported by < 10% of patients in the randomized trials, which were also reported during the one-year open-label extension of one trial.
Fremanezumab
- Efficacy: Results suggest a modest reduction in monthly migraine days (1.3-1.9 fewer migraine days) and modest reduction in days using acute medications (1.4-2.3 fewer days). Results also suggest a greater proportion of patients experiencing a reduction in migraine days by at least 50% versus placebo (OR 2-2.4 in episodic migraine) or a reduction in moderate-to-severe headache days by at least 50% versus placebo (OR 2.4 in chronic migraine).
- Safety: Fremanezumab was generally well tolerated during the 12-week trials, with small proportions of patients discontinuing for any cause, discontinuing due to AEs, or experiencing a SAE. The most commonly-reported AEs pertained to injection-site pain or reactions. Sinusitis and upper respiratory tract infections were also reported by ≤ 5% of patients.
Galcanezumab
- Efficacy: Results from one trial in episodic migraine 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% versus placebo (OR 2.0).
- Safety: Galcanezumab was generally well tolerated during the 12-week trials, with small proportions of patients discontinuing for any cause, discontinuing due to AEs, or experiencing a SAE. The most commonly-reported AEs pertained to injection-site pain or reactions. In addition, nasopharyngitis was reported by <10% of patients and upper respiratory tract infections were reported by <20% of patients.
Long term Cost Effectiveness:
CGRP inhibitors are predicted to positively impact the health of patients with both chronic or episodic migraine for whom prior preventive therapy had failed relative to no treatment. In the base-case analyses, which used a placeholder price of $8,500 per year, the incremental cost effectiveness ratio of erenumab was under the $150,000 per QALY gained threshold compared to no treatment and compared to onabotulinum toxin A. At the placeholder price, fremanezumab was above the threshold of $150,000 per QALY gained in patients with chronic migraine compared to no treatment and onabotulinum toxin A. However, the analyses were sensitive to a number of parameters including the costs of the medication, and in scenarios that took a societal perspective.
In conclusion, CGRP inhibitors are projected to have positive impact on migraine days and associated QALYs for episodic and chronic migraine patients. For patients with chronic migraine for whom other preventive treatments have failed, CGRP inhibitors may meet the upper bound of common WTP thresholds. In patients with episodic migraine and patients with chronic migraine who have other treatment options available to them, it is likely that CGRP inhibitors will exceed commonly-cited WTP thresholds using the placeholder price.
Potential Budget Impact:
The study found that the annual budget impact of using erenumab (using the placeholder price) in the eligible migraine population relative to no preventive therapy resulted in an additional $6,000 in costs per patient to the health system. At this price, only 16% of the eligible migraine population could be treated before total costs exceed the ICER potential budget impact threshold. The annual budget impact of using fremanezumab (again using the placeholder price) in the eligible migraine population relative to no preventive therapy resulted in an additional $3,600 in costs per patient to the health system. At this price, only 27% of the eligible migraine population could be treated with fremanezumab before total costs exceed the ICER potential budget impact threshold.
The detailed study results can be read at https://icer-review.org/wp-content/uploads/2017/11/ICER_Migraine_Draft_Report_041118.pdf
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