Sakai, Fumihiko

Migraine is one of the most disabling diseases worldwide, especially when it transforms into chronic migraine, which is often associated with medication overuse and can become resistant or even refractory to treatments. Molecular, neuroimaging and neurophysiological changes have been described in chronic migraine, some of which might not be fully reversible with preventive treatment. For these reasons, we should aim to prevent this transition, and initiate preventive treatment before disease becomes refractory and burden increases. Preventive migraine treatments are often delayed because of access to care, stigma leading to undertreatment and patients’ reluctance as a result of fear of side effects and, in some cases, fear of being labeled as chronically ill. With the availability of effective and well-tolerated preventive treatments, we must shift our mindset and take advantage of new opportunities to initiate preventive treatment earlier. In this International Headache Society position statement, we propose a migraine preventive strategy under the idea of shifting from reactive treatment once disability is established (prevention of attacks), to proactive, individualized prevention initiated early with safe, effective and tolerable therapies (prevention of disease progression). This approach is based on 1) promoting the early initiation of effective and tolerable preventive therapies, starting from two to four monthly migraine days in line with the majority of current guidelines and recommendations and 2) fostering longitudinal studies to gather more evidence on the potential benefit of early prevention, with the final goal of improving patient outcomes, promoting excellent migraine care, enhancing individual and social well-being, and, ultimately, preventing migraine progression and preserving brain health.

Migraine is one of the most prevalent and disabling neurological diseases, significantly affecting quality of life and productivity, as well as contributing to substantial societal costs. Recent innovations, including calcitonin gene-related peptide (CGRP) pathway inhibitors and onabotulinumtoxinA, have transformed migraine prevention by offering high efficacy and excellent tolerability, thus improving adherence. Clinical trials and real-world studies show that significant reductions in migraine frequency and, in some cases, complete migraine freedom is achievable. In this Position Statement, we advocate for raising the standards of migraine prevention by setting ambitious treatment goals aimed at optimal outcomes, such as migraine freedom or very low number of days with migraine or moderate/severe headache. We emphasize the importance of addressing residual migraine burden, highlighting that achieving a ≥50% reduction in monthly migraine days, although often considered a successful response, may not fully restore quality of life. Relying solely on percentage-based improvements can obscure the persisting impact of residual burden. This Position Statement does not want to change the standards for clinical trials but aims primarily at real-world clinical practice and proposes a shift from percentage-based measures of success to absolute goals while on treatment. We outline a framework that categorizes outcomes into four tiers: migraine freedom (no days with migraine or moderate-to-severe headache), optimal control (less than four days with migraine or moderate-to-severe headache), modest control (four to six days with migraine or moderate-to-severe headache) and insufficient control (more than days with migraine or moderate-to-severe headache). Focusing on residual burden while on treatment aims to further improve patient quality of life and drive innovation in preventive therapies and non-pharmacological approaches. By advocating for higher standards, this Position Statement, is not aimed primarily to drive reimbursement policies for migraine preventive treatments, but seeks to inspire clinicians, researchers and policymakers to prioritize ambitious goals in migraine prevention, ultimately enhancing patient outcomes and reducing the broader societal and economic impact of this debilitating condition.

Background Migraine is a highly prevalent, disabling, misunderstood, underdiagnosed, and undertreated neurological disease. It is a leading cause of productivity loss in the workplace. Methods This is the first large-scale company-wide headache education and evaluation program in the workplace. Results 73,432 (90.5%) Fujitsu employees participated. The prevalence of migraine was 16.7%, tension-type headache 40.7%, and cluster headache 0.5%. After completing the training, 82.9% of participants without headache said they would change their attitude towards colleagues with headache disorders and 72.5% of total participants said their understanding of headache changed. The proportion of employees who thought that headache had a significant impact on people’s lives increased from 46.8% to 70.6%; 2971 (4.1%) of all participants were interested in a virtual consultation with a headache specialist as part of the program, more than half of whom had not previously consulted for headache. Approximately 14.7 days per year of full productivity per employee with headache were gained resulting in an annual productivity saving per employee of US$4531. Conclusion This unique headache workplace program was associated with a high level of participation, an improvement in the understanding of migraine and attitude towards colleagues with migraine, reduction in disability and increased employee productivity, and decreased costs of lost productivity due to migraine. Workplace programs for migraine should be considered for all industry sectors.

In 2017, the International Headache Society convened a Global Patient Advocacy Summit (GPAS-1) to begin a collaborative effort involving patients, patient advocates, patient advocacy organizations, healthcare professionals, scientists, professional pain, neurology, and headache societies, pharmaceutical manufacturers, and regulatory agencies to advance issues of importance to patients affected by headache worldwide. In September 2019, the second Global Patient Advocacy Summit (GPAS-2) was convened to revisit issues from the inaugural meeting, assess the progress of the International Headache Society Global Patient Advocacy Coalition (IHS-GPAC) in meeting the goals set forth therein, and discuss strategies for achieving established goals and supporting future development. Short- and long-term mandates from the first Summit were realized, including publishing the Vancouver Declaration on Global Headache Patient Advocacy 2018, determining the governing and operational structures of the IHS-GPAC, and helping to facilitate the first World Federation of Neurology World Brain Day dedicated to migraine. Another short-term mandate, creating a unified advocacy strategy, was fulfilled by the Coalition’s decision to focus on encouraging support from employers and implementing employee support programs for people with migraine. To help execute the strategy, the Coalition is developing an employer engagement toolkit that will educate employers and employees about the impact of migraine in the workplace, reduce stigma directed toward employees with migraine, and facilitate the care of employees with migraine to reduce the burden of illness and improve workplace productivity. Coalition members will disseminate the toolkit and encourage the adoption of migraine workplace programs by employers worldwide. The Coalition has established an alliance with two global, multinational employers to expand migraine awareness and support among policy makers and other stakeholders around the world. The IHS-GPAC met many of the goals established at GPAS-1, and it has initiated a global strategy focused on the psychosocial and economic toll of headache disorders, especially migraine, in the workplace. Ongoing and future activities will explore a range of opportunities with employers and across the full spectrum of advocacy goals.

Background Headache disorders comprise the three most prevalent medical disorders globally and contribute almost 20% to the total burden of neurologic illness. Although the experience of a recurrent headache disorder tends to be highly individualized, patient preferences tend to be a low priority in guidelines for the management of patients with headache. Methods In September 2017, the first Global Patient Advocacy Summit was convened, bringing together patients, patient advocates, patient advocacy organizations, healthcare professionals, pharmaceutical manufacturers, scientists, and regulatory agencies to advance issues of importance to patients affected by headache worldwide. Results Presentations and discussion covered multiple issues, such as improving access to appropriate medical care; incorporating the insights of independent patient advocates and advocacy organizations; leveraging the insights, experience and influence of leading health and neurological organizations; and raising awareness of the role of regulatory agencies in disease advocacy. Attendees agreed that it is important to understand and promote the global, regional, and local interests of people with headache disorders, as well as challenge the pervasive stigma associated with headache. They also agreed that those with severe, recurrent, or disabling headache disorders should have reliable access to competent medical care; healthcare professionals should have access to adequate training in Headache Medicine; global benchmarks should be established for accurate diagnosis and the use of evidence-based treatments in patients with headache; and that information is needed about consultation, diagnosis, and treatment of headache, particularly in regard to patient preferences. Conclusion Based on the group’s consensus around these issues, a series of statements was developed, and they are collectively presented herein as the Vancouver Declaration on Global Headache Patient Advocacy 2018.