The first assessment of health technology for the acute treatment and prevention of migraine attacks was published in Cephalalgia by the International Headache Society’s Subcommittee on Clinical Studies.
Migraines are one of the leading causes of disability worldwide. Over 1 billion people, mostly women, live with it. It is defined as moderate to severe headache between 4 and 72 hours and can include nausea, photophobia, and phonophobia. Access to care varies widely and many people go undetected or receive below average treatment.
Therapeutics currently available to treat migraines include established technologies such as analgesics, nonsteroidal anti-inflammatory drugs, serotonin agonists, ergot and beta blockers, as well as newer technologies such as small molecules, monoclonal antibodies and neuromodulatory devices.
The Subcommittee on Clinical Trials recommends that studies of new technologies for acute migraine relief should target populations identified in the most recent international classification of headache disorders, particularly those with prior treatment failure, intolerance, contraindications, or those who do not have oral therapeutics can take. It is important that these patients are divided into distinct populations, randomly assigned to treatment and control cohorts, and compared with their counterparts in order to accurately evaluate therapies for the specific needs of these populations.
Studies on migraine prevention were particularly lacking in pregnant or breastfeeding women, children, adolescents and men. The Clinical Trials Subcommittee recommends weighting the scores to account for such evidence gaps. In addition, randomized controlled trials should recruit more participants from these underrepresented populations.
For studies that stratify patients by migraine frequency, the Subcommittee on Clinical Trials states that trials should evaluate monthly headache days (MHDs) or monthly migraine days (MMDs) based on study motivation. Studies in patients with chronic migraines should use MHDs versus MMDs because these phenotypes can change over time and not all headaches meet the diagnostic criteria for migraines. Preventive migraine treatment studies should use MMDs versus MHDs as they no longer consider the need to consider pain disorders due to sleep or acute medication use.
In order to assess the effectiveness of new technologies, a traditional placebo should not be given to patients, since placebos are not given in clinical practice. Instead, the Subcommittee on Clinical Trials recommends using the current standard of care as a comparison. Suitable comparator preparations for acute treatment include, for example, 50 or 100 mg sumatriptan, 40 or 80 mg eletriptan or 10 mg rizatriptan.
The endpoints given for migraine studies can be difficult to design because they are subjective and vary between affected parties (i.e. patients, clinicians, caregivers, health systems, and employers). In general, all areas of the core model of the European Network for the Assessment of Health Technologies should be considered in the design of the study endpoints. In addition, data collection should only be performed when adequate performance has been determined, taking into account primary outcomes, secondary outcomes, and expected patient dropout.
For studies of health technologies with acute migraine, the Subcommittee on Clinical Trials recommends that the primary result is pain relief or freedom after 2 hours, while when evaluating migraine prevention, MMD reduction should be measured over a period of 3 to 6 months.
The Subcommittee on Clinical Trials recommends the use of generic tools to assess secondary endpoints, including the Headache Impact Test, the Migraine-Specific Quality of Life Questionnaire, the Migraine Disability Assessment Scale, the Migraine Function Impact Questionnaire, and the Impact Diary Migraine body function.
Given the complexity of evaluating health technologies in patients with this chronic, intermittent disease, both direct and indirect costs should be assessed. Direct costs can include treatment costs, adverse event management, and doctor visits. Indirect costs can be more nuanced and should span at least three areas; For example, monetizing lost time at work or school, inability to complete household chores, and missed social or leisure activities.
The Clinical Trials Subcommittee concluded that the overall goal of health technology assessment is to determine whether people with migraines have improved symptoms from novel technologies. It also aims to provide policy makers with comprehensive, evidence-based research on the technology in question. The authors stated that “additional elements of HTAs [health technology assessments] should study the impact of migraines on health systems and communities and consider the potential benefits of professional training and increased access to care for people in high-risk populations. ”
Disclosure: Several authors have stated that they are part of the pharmaceutical industry. For a full list of details, see the original article.
Diener HC, Ashina M., Durand-Zaleski I. et al. Evaluation of Health Technology for the Acute and Preventive Treatment of Migraines: An Opinion from the International Headache Society. Cephalalgia. Published online January 20, 2021. doi: 10.1177 / 0333102421989247