The International Headache Society (IHS) has published the first guidelines recommending global standards for the collection and analysis of evidence associated with new technologies used to treat migraine. This position statement was published in Cephalalgia.
Standards and Real-World Data
The Clinical Trials Subcommittee of the IHS penned this statement in order to facilitate the development of an evidence base for migraine treatment technologies. Previously, there was no standardization for the use of health technology assessments to evaluate new medications and devices for migraine treatment.
“The approach to [health technology assessments] for migraine should be evidence-based, systematic, reproducible, transparent to stakeholders, and comprehensive,” the authors wrote. “While randomized controlled trials create high-grade, robust evidence, [health technology assessments] should also consider relevant real-world data, which can provide answers to questions that cannot be addressed in clinical trials.”
People of Interest
The target population for both established and new technologies includes people who have migraine with and without aura, chronic migraine, and those who experience probable migraine. In particular, patients with prior treatment failure or with intolerance to prior treatment, contraindication to treatment, or who cannot take oral medications “merit special consideration” in the assessment of new technologies.
When conducting health technology assessments, migraine frequency is an important classification tool. The guideline authors recommend that these assessments examine migraine frequency by counting days with migraine or headache per month; the unit of measure should be monthly migraine days and monthly headache days.
Comparators and Confounders
New technologies should be compared with established treatments in specific patient populations of interest. Indirect or mixed-treatment comparisons are acceptable if head-to-head trials are not available at the time of the assessment. When possible or required, statistical adjustments for potential confounders should be included.
Appropriate comparators for acute migraine treatment include oral tablet formulations of sumatriptan 50 and 100 mg, rizatriptan 10 mg, or eletriptan 40 and 80 mg. For patients who do not respond to or cannot tolerate triptans, comparators include different medication classes, usual care, or placebo.
Appropriate comparators for preventive treatment include propranolol 80 to 160 mg, flunarizine 5 to 10 mg/day, amitriptyline 25 to 50 mg, and monthly erenumab, fremanezumab, or galcanezumab or quarterly eptinezumab.
All comparisons should take into consideration multiple domains, including clinical, patient-reported, and economic, but should especially incorporate both individual and societal needs.
Primary and Secondary Endpoints
Although pain is one of the most disabling migraine symptoms, some patients are more affected by nausea, vomiting, and photophobia. For acute treatment health technology assessments, the primary endpoint should be pain freedom at 2 hours post-treatment or freedom or relief from the most bothersome symptom in the same timeframe.
For preventive treatments, the primary endpoint should be the reduction in monthly migraine days compared with baseline over a 3- to 6-month period.
Secondary endpoints can include migraine-specific instruments used to gather patient-reported outcomes, including the Headache Impact Test, the Migraine-Specific Quality of Life questionnaire, and the Migraine Disability Assessment questionnaire.
Tolerability and Side Effects
Health technology assessments should evaluate tolerability and safety through the collection of data on all-cause discontinuations, discontinuations due to adverse events, serious adverse events, and any adverse event reported by at least 5% of the treated population.
Assessing health technology usage in people with migraine can be challenging. These guidelines recommend that health technology assessments for migraine technologies should consider both the direct and indirect costs of care, including trial results, characteristics of enrolled patients, and technology timing and dose.
Many health technology assessment bodies focus on a healthcare payer perspective associated with direct costs, but migraine creates a “considerable burden” for patients, families, and health systems. The overall objective of an economic evaluation should be to raise awareness of the economic implications of various treatment options.
Public Health Impact
It is essential that health technology assessments include data about the public health impact of technologies used to treat people with migraine. Assessments should share the potential effect of these treatments in specific healthcare settings and geographic locations, in addition to, on a smaller scale, the families, partners, and caregivers of those affected.
“This position statement extends beyond the already available guidelines on randomized controlled trials for migraine to incorporate real-world evidence and a synthetic approach for considering multiple data sources and modeling methods when assessing the value of migraine treatments,” the researchers concluded.
Disclosure: Several position statement authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Diener HC, Ashina M, Durand-Zaleski I, et al. Health technology assessment for the acute and preventive treatment of migraine: a position statement of the International Headache Society. Published online January 20, 2021. Cephalalgia. doi:10.1177/0333102421989247