Estimation of the Economic Burden and Labor Impact of Migraine in Spain: Results from the Spanish Atlas of Migraine Survey 2018

P170 Objectives: To estimate the average annual cost per patient and theimpact on work t of migraine in Spain. Material and Method: This is a prospective, online, anonymous, cross-sectional survey, conducted between June and September2017, promoted by the Spanish Association of Patients with Headache(AEPAC) within the framework of the Spanish Atlas of Migraine2018. People who completed the survey answered questions in relationto their migraine. A distinction was made between chronic migraine(CM) and episodic migraine (EM), considering the monthlyheadache days declared by patients. The economic burden of migrainewas evaluated: direct health costs (including visits to specialists, medical tests, emergency visits, hospital admissions andmedication), indirect costs (lost labor productivity), and those assumedby the migraineur. The labor consequences of migraine overthe last year were analyzed. Chi-square and Mann- Whitney testswere used as contrast tests. Ethics Approval: A central ethics reviewboard approved the study design. Results: 1, 281 people with migraine participated in the survey, 34.2%with CM, 88.2% women, with an average age of 37.3 (SD 11.5). Thedirect health costs for the last year were estimated at €3, 847.29 forCM and €964.19 for EM (p<0, 001). The costs assumed by the patientin the last year were €1, 609.89 for CM and €878.04 for EM (p<0.001).The indirect cost was estimated at €7, 464.83 for CM and €3, 199.15for EM (p <0.001). The total average cost per patient/year rised to€12, 922.01 for CM and €5, 041.41 for EM (p<0.001). Regarding the jobstatus: 62.2% with EM and 49.0% with CM were working, 2.6% withEM and 9.1% with CM were on sick leave and 12.2% with EM and16.8% with CM were unemployed (p <0.05). In the last year, becauseof migraine, 17.8% of patients with EM and 27.2% with CM (p<0.01)requested days of leave or leave of absence, and reduced their workinghours 8.5% with EM and 11.1% CM (p=0.270). Labor efficiencywas reduced in 61.1% of patients with EM and 65.7% with CM(p=0.257). Conclusion: Migraine represents an important economic burden inSpain, particularly in patients with CM. Migraine causes importantproductivity losses resulting from absenteeism, presentism, decreasingthe working hours and the probabilities to keep working, and itsimpact is significantly greater in CM

Burden of Migraine in Patients With Preventive Treatment Failure Attending European Headache Specialist Centers: Real-World Evidence From the BECOME Study

Migraña; Fracaso del tratamiento; Productividad laboralMigraine; Treatment failure; Work productivityMigranya; Fracàs del tractament; Productivitat laboralIntroduction Migraine is consistently ranked as one of the most disabling neurological conditions in the world, often causing a substantial impairment of daily activities and quality of life. It also carries a high economic burden of direct and indirect healthcare costs. Patients with difficult-to-treat migraine often cycle through different preventive therapies, but real-world prospective evidence describing the burden of migraine in patients with prior preventive treatment failure (PPTF) in Europe is limited. In BECOME, we aimed to characterize and assess the prevalence and burden of migraine in patients with PPTF attending specialist headache centers in Europe and Israel. Furthermore, we assessed this burden in pre-specified subgroups based on the frequency of monthly migraine days (MMD) and number of PPTFs. Methods BECOME was a prospective, non-interventional study conducted in two concurrent parts across 17 countries in Europe and Israel. In part 1, patients visiting the centers over a 3-month period were screened for frequency of PPTF, MMD, and other characteristics. In part 2, patients from part 1 with ≥ 1 PPTF and ≥ 4 MMD were enrolled, and impact of migraine on patient-reported outcomes, and healthcare resource utilization (HRU) were examined. Results In part 1 (n = 20,837), 62.2% of patients reported ≥ 1 PPTF. In part 2 (n = 2419), 15.3% of patients reported ≥ 4 PPTF. In part 2, the migraine burden measured by the EuroQoL 5 dimensions 5 level (EQ-5D-5L) questionnaire indicated an impact of at least moderate severity in performing usual activities in 26.5% of patients, pain/discomfort in 51.2%, and 26.1% reported being at least moderately anxious/depressed. Most patients reported a severe impact on daily activities and disability due to migraine. Abnormal Hospital Anxiety and Depression subscale scores of ≥ 11 were observed in 29% (anxiety) and 19.8% (depression) of the population. In part 2, analysis of HRU showed 21.2% patients visited an emergency department and 8.4% were hospitalized for headache/migraine in the past year. Conclusions This study provides real-world evidence of the high personal, social, and HRU burden of migraine in Europe and Israel.This study was funded by Novartis Pharma AG, Basel, Switzerland. The study sponsor participated in the study design, data collection, data review, data analysis and writing of the report. The Rapid Service Fee was funded by Novartis Pharma AG, Basel, Switzerland

Real-world preventative drug management of Chronic Migraine among Spanish Neurologists

O42 Background: In migraine, the therapeutic preventive drug arsenal is varied. Whenprescribing both Guidelines and patient characteristics are taken intoaccount. In Spain, the use of preventive therapies seems to beheterogeneous.The objective of this study was to evaluate real-life clinical prescribingpractice amongst neurologists in Spain Methods: Observational descriptive study done with a survey by Neurologistsof the Spanish Neurological Society (SEN). Neurologists who participatedwere divided into Headache Specialists or not. The followingdata was collected: socio-demographic data, ; preventive treatmentand choices different migraine sub-types, and their personal perceptionof efficacy and tolerability to different drugs. Results: We analyzed 152 surveys from neurologists around our country.From them: 43.4% were female, 53.3% <40 years, and 34.9% were interestedin headache .In regards to preventive treatment choice; in chronic migraine topiramate(57%) amytriptiline (17.9%) and beta-blockers (14.6%), whereasin episodic migraine the preferred drugs were beta-blockers (47.7%), topiramate (21.5%) and amytriptiline (13.4%).Regarding perceived efficacy, topiramate was considered the bestoption in chronic migraine (42.7%) followed by onabotulinumtoxinA(25.5%) and amitryptiline (22.4%). In episodic migraine, neurologistpreferred topiramate (43.7%) and beta-blockers (30.3%).Regarding the duration of preventive therapy when improvementwas achieved, when treating episodic migraine 43.5% of the surveyedneurologists recommended 3 months and 39.5% preferred 6months. When they treated chronic migraine, 20.4% of neurologistsrecommended 3 months, 42.1% 6 months, 12.5% 9 months and22.4% preferred to maintain treatment during 12 months.When considering onabotulinumtoxinA treatment, the number ofprior therapeutical failures was cero in 7.2% of surveyed, one in5.9%, two in 44.1%, three in 30.9%, and four or more in 11.9%. Theincrease of OnabotulinumtoxinA dose up to 195 UI was consideredby 51% of neurologists after a first ineffective procedure, by 42.2% after two injections, and by 83% after a third infiltration. Surveyedcolleagues admitted to take into account in their decisions mainlypatient comorbidities (70.2%) rather than guidelines (13.9%). Conclusions: Initial management of Migraine among Spanish Neurologists is madewith the preventative drugs which are considered as first choices inmost of the guidelines. Management of episodic migraine differedfrom chronic migraine, both in the order or drugs and the perceptionof the most effective therapy

Migraine-attributed burden, impact and disability, and migraine-impacted quality of life: Expert consensus on definitions from a Delphi process

Background Migraine-attributed burden, impact, disability and migraine-impacted quality of life are important concepts in clinical management, clinical and epidemiological research, and health policy, requiring clear and agreed definitions. We aimed to formulate concise and precise definitions of these concepts by expert consensus. Methods We searched the terms migraine-attributed burden, impact, disability and migraine-impacted quality of life in Embase and Medline from 1974 and 1946 respectively. We followed a Delphi process to reach consensus on definitions. Results We found widespread conflation of concepts and inconsistent terminology within publications. Following three Delphi rounds, we defined migraine-attributed burden as “the summation of all negative consequences of the disease or its diagnosis”; migraine-attributed impact as “the effect of the disease, or its diagnosis, on a specified aspect of life, health or wellbeing”; migraine-attributed disability as “physical, cognitive and mental incapacities imposed by the disease”; and migraine-impacted quality of life as “the subjective assessment by a person with the disease of their general wellbeing, position and prospects in life”. We complemented each definition with a detailed description. Conclusion These definitions and descriptions should foster consistency and encourage more appropriate use of currently available quantifying instruments and aid the future development of others

PrevenBox: Evaluation of concomitant use of preventive medications with OnabotulinumtoxinA in migraine

P114 Background: OnabotulinumtoxinA is an effective, tolerable and safepreventive treatment for chronic migraine (CM). Other than a reduc-tion in headache frequency or disability, in CM the withdrawal ofconcomitant preventive medication indicates treatment effectivenessand quality of life improvement. Objective: To characterize the change in the use of oral preventivemedication after treatment with OnabotulinumtoxinA in patientswith migraine. Methods: This is a multicentre study. We consecutively included pa-tients with migraine (ICHD-3) that were on preventive treatment withOnabotulinumtoxinA. We retrospectively collected demographic data, diagnosis of migraine, frequency and intensity changes, number ofcycle and OnabotulinumtoxinA dose. In addition, we listed the initialand current preventive treatment (number of drugs and group) andthe number and cycle of medications withdrawn. We performed aunivariate and logistic regression analysis. Results: We included 542 patients: 87.6% women, mean age 47.6 ±11.7 years. A 89.3% had chronic migraine and 10.8% had high fre-quency episodic migraine. The mean reduction in frequency aftertreatment was 13.4±8.2 headache days/month. At baseline, a 91.3%took other preventives and during treatment with Onabotulinumtox-inA a 58.6% withdrew at least one drug, 25.8% stopped completelyall oral preventive drugs. Factors associated with withdrawal were:being male, having >50% response in frequency and intensity, thenumber of infiltrations and a shorter chronification period until thefirst OnabotulinumtoxinA administration (p <0.05). The multivariateanalysis showed that a better response in intensity (OR:1.8 [1.4-2.2], p<0.001), a greater number of infiltrations (OR:1.1 [1.0-1.2], p<0.001)and a shorter chronification period (OR:0.994 [0.992-0.997], p<0.001)were predictors of withdrawal. The ROC curve, showed that 6 Onabo-tulinumtoxinA cycles was the cut-off point that better predicted oralpreventive medication withdrawal (p <0.001). Conclusions: Treatment with OnabotulinumtoxinA reduces the use ofother preventive medications for migraine. The highest probability ofwithdrawal occurs after 6 cycles of treatment

Cómo y cuándo derivar un paciente con cefalea secundaria y otros tipos de dolores craneofaciales desde Urgencias y Atención Primaria: recomendaciones del Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología

Introducción: Cuando se sospecha que estamos ante una cefalea secundaria y se deriva un paciente a Urgencias o a la consulta de Neurología es importante saber qué exploraciones complementarias son oportunas hacer en cada caso, además de saber posteriormente cuál es el circuito adecuado que ha de seguir el paciente. Por este motivo, el Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología (GECSEN) ha decidido crear unas recomendaciones consensuadas que establezcan un protocolo de derivación de pacientes con cefalea y/o neuralgias craneofaciales. Desarrollo: Se ha contactado con neurólogos jóvenes con interés y experiencia en cefalea y con la Junta Directiva del GECSEN han desarrollado este documento que, por razones prácticas, se ha dividido en 2 artículos. El primero centrado en las cefaleas primarias y neuralgias craneofaciales, y este centrado en las cefaleas secundarias y otros dolores craneofaciales. El enfoque es práctico, con tablas que resumen los criterios de derivación con exploraciones complementarias y otros especialistas a los que derivar, para que sea útil y facilite su uso en nuestra práctica asistencial diaria. Conclusiones: Esperamos ofrecer una guía y herramientas para mejorar la toma de decisiones ante un paciente con cefalea valorando exploraciones a priorizar y que circuitos seguir para así evitarla duplicación de consultas y retrasos en el diagnóstico y en el tratamiento

Headache: What to ask, how to examine, and which scales to use. Recommendationsof the Spanish Society of Neurology’s Headache Study Group

Introducción: La cefalea es el motivo de consulta neurológico más prevalente en los distintos niveles asistenciales, donde la anamnesis y exploración son primordiales para realizar un diagnóstico y tratamiento adecuados. Con la intención de unificar la atención de esta patología, el Grupo de Estudio de Cefalea de la Sociedad Española de Neurología (GECSEN) ha decidido elaborar unas recomendaciones consensuadas para mejorar y garantizar una adecuada asistencia en atención primaria, urgencias y neurología. Metodología: El documento es práctico, sigue el orden de la dinámica de actuación durante una consulta: anamnesis, escalas que cuantifican el impacto y la discapacidad y exploración. Además, finaliza con pautas para realizar un seguimiento adecuado y un manejo de las expectativas del paciente con el tratamiento pautado.Conclusiones: Esperamos ofrecer una herramienta que mejore la atención al paciente con cefalea para garantizar una asistencia adecuada y homogénea a nivel nacional.Introduction: Headache is the most common neurological complaint at the different levelsof the healthcare system, and clinical history and physical examination are essential in thediagnosis and treatment of these patients. With the objective of unifying the care given topatients with headache, the Spanish Society of Neurology’s Headache Study Group (GECSEN)has decided to establish a series of consensus recommendations to improve and guaranteeadequate care in primary care, emergency services, and neurology departments.Methods: With the aim of creating a practical document, the recommendations follow thedynamics of a medical consultation: clinical history, physical examination, and scales quantif-ying headache impact and disability. In addition, we provide recommendations for follow-upand managing patients’ expectations of the treatment.Conclusions: With this tool, we aim to improve the care given to patients with headache inorder to guarantee adequate, homogeneous care across Spain

Do novel European Headache Federation criteria identify differences in migraine burden?: baseline data of an international real-life study on resistant and refractory migraine (REFINE)

Question. We evaluated if EHF criteria for resistant (RES) and refractory (REF) migraine identify patients with more severe migraine burden. Methods. We performed an observational, multi center, international study to compare baseline characteristics, comorbidities, and PROMs of non-resistant and non-refractory (NRNR) migraine, RES and REF individuals in the REFINE study. Results. We included 175 individuals with NRNR migraine, 133 (39.7%) with RES and 27 (8.0%) with REF. Individuals with RES and REF migraine as compared to those with NRNR reported higher monthly migraine days (median=8, IQR=5-14 vs. median=13, IQR=10- 17 and median=15, IQR=10-20; p≤0.001), months of chronification (median=24, IQR=12-72 vs. median=40, IQR=12-108 and median=60, IQR=18-96; p=0.044), monthly days of symptomatic drugs assumption (median=8, IQR=5-15 vs. median=12, IQR=9-20 and median=15, IQR=10-20; p≤0.001), medication overuse (19.4% vs. 45.9% and 40.7%; p≤0.001). They also had more comorbidities such as depression (18.3% vs. 31.1% and 44.4%; p=0.002) and anxiety (13.7% vs. 21.1% and 37%; p=0.009). In these groups, PROMs also revealed a higher presence of anxiety (p≤0.001) and depression (p≤0.001) symptoms and poorer sleep quality (p=0.006). Regarding specific perceptions about migraine, RES and REF individuals reported higher impact of migraine on daily life (p≤0.001) and work, household work, and social life (p≤0.001), along with a lower perception of the effectiveness of their ongoing treatment for migraine (p≤0.001), when compared to NRNR subjects (Table 1). Conclusion. RES and REF migraine is associated with relevant migraine burden considering migraine features, comorbidities and scores at several scales; the severe burdensome condition of RES and REF is confirmed by the median number of monthly migraine days and PROMs.info:eu-repo/semantics/publishedVersio

Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

BackgroundAlthough the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine.MethodsAn international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine.ResultsKey terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.ConclusionsAdoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.Paroxysmal Cerebral Disorder

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

The identification of patients who can benefit the most from the available preventive treatments is important in chronic migraine. We explored the rate of excellent responders to onabotulinumtoxinA in a multicenter European study and explored the predictors of such response, according to different definitions. A pooled analysis on chronic migraineurs treated with onabotulinumtoxinA and followed-up for, at least, 9 months was performed. Excellent responders were defined either as patients with a ≥75% decrease in monthly headache days (percent-based excellent responders) or as patients with &lt;4 monthly headache days (frequency-based excellent responders). The characteristics of excellent responders at the baseline were compared with the ones of patients with a &lt;30% decrease in monthly headache days. Percent-based excellent responders represented about 10% of the sample, whilst frequency-based excellent responders were about 5% of the sample. Compared with non-responders, percent-based excellent responders had a higher prevalence of medication overuse and a higher excellent response rate even after the 1st and the 2nd injection. Females were less like to be frequency-based excellent responders. Chronic migraine sufferers without medication overuse and of female sex may find fewer benefits with onabotulinumtoxinA. Additionally, the excellent response status is identifiable after the first cycle