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To analyze secondary objectives of the REGAIN study related to acute headache medication use and healthcare resource utilization (HCRU) in patients with chronic migraine treated with galcanezumab, a monoclonal antibody to calcitonin gene-related peptide.Adults with chronic migraine (At baseline, 63-64% of patients met criteria for acute headache medication overuse. At Month 3, incidence of headache medication overuse in the galcanezumab groups (33% and 33%) was significantly lower than in the placebo group (46%, bothOnly 3 months of double-blind, placebo-controlled data, a longer HCRU recall period for baseline than postbaseline, and patients receiving care in the clinical trial itself, may limit generalizability.Treatment with galcanezumab resulted in significant reductions in headache medication overuse and migraine headache days requiring acute medication use, with notable reductions in migraine-specific HCRU.

Objective To evaluate the measurement properties of all three domains of the Migraine‐Specific Quality of Life questionnaire version 2.1 (MSQ v2.1) electronic patient‐reported outcome (ePRO) to assess the functional impact of migraine in patients with episodic or chronic migraine (CM); and identify meaningful within‐patient change thresholds for the Role Function‐Restrictive (RFR), Role Function‐Preventive (RFP), and Emotional Function (EF) domains. Methods Data were drawn from three double‐blind, placebo‐controlled, and randomized Phase 3 clinical studies (episodic migraine [EM]: EVOLVE‐1 and EVOLVE‐2; CM: REGAIN). The psychometric properties of the MSQ v2.1 ePRO domains were demonstrated by evaluating reliability (internal consistency and test–retest), construct validity (convergent and known groups), and responsiveness. Meaningful within‐patient change thresholds for domains were estimated using anchor‐based approaches, supplemented by empirical cumulative distribution function curves and probability density function plots to enable interpretation of meaningful change over 3 months. The Patient Global Impression of Severity (PGI‐S) and Patient Global Impression of Improvement served as anchors. Results A total of 2,850 patients with either EM (EVOLVE‐1: 851; EVOLVE‐2: 909) or CM (REGAIN: 1,090) were included. The Cronbach's alpha estimates of internal consistency exceeded the recommended threshold of ≥0.70 for all domains from the three studies, indicating adequate internal consistency. Test–retest reliability intraclass correlation coefficients were ≥0.80 for all domains across all three studies, demonstrating almost perfect agreement. Convergent validity was supported by moderate‐to‐strong correlation (r ≥ 0.30) between all domains of MSQ v2.1 ePRO and studied anchors (Migraine Disability Assessment Score and PGI‐S scores) across all three studies. Known group validity was established between all domains and subgroups of patients stratified by baseline PGI‐S scores and baseline number of monthly migraine headache days for all three studies. The 3‐month meaningful within‐patient change thresholds were the same for EM and CM for RFP: 20.00 and EF: 26.67; and for RFR: 25.71. Conclusions These findings demonstrate that all three domains of the MSQ v2.1 ePRO have sufficient reliability, validity, responsiveness, and appropriate interpretation standards. Our results suggest that MSQ v2.1 ePRO is a well‐defined and reliable patient‐reported outcome instrument that is suitable for use in clinical studies for evaluating the impact of migraine on patient functioning in episodic and CM.

Objective This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient‐reported outcomes of health‐related quality of life (HRQoL) and disability categories. Background Migraine causes considerable disease‐related disability and negatively impacts HRQoL of patients. Calcitonin gene‐related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients. Methods Analyses used data from 3 double‐blind, placebo (PBO)‐controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE‐1: N = 858 and EVOLVE‐2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE‐1 and ‐2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response‐level groups based on percent change from baseline (

Purpose Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. Methods CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. Results A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p Conclusion Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

Purpose To evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine. Methods Patients randomly received galcanezumab (120 mg n = 278, 240 mg n = 277) or placebo (n = 558) during 3 months of double-blind treatment, followed by a 9-month open-label extension. The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance. Results Total MSQ score at baseline was 44.88 ± 18.02 (mean ± SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change ± SE in total MSQ for galcanezumab-treated patients were 20.51 ± 1.49 (120 mg) and 20.49 ± 1.49 (240 mg), both statistically significantly greater vs placebo-treated patients (14.55 ± 1.21; both P P P Conclusions Galcanezumab-treated patients with chronic migraine reported statistically significant improvements in functioning and disability, representing a clinically significant change. Trial registration ClinicalTrials.gov registry: NCT02614261. Registered 25 November 2015.

This post-hoc analysis estimated annual indirect cost savings with galcanezumab (GMB) treatment in patients with episodic migraine (EM) or chronic migraine (CM). Data from 4 randomized, Phase 3, double-blind (DB), placebo (PBO)-controlled studies of GMB were analyzed: EVOLVE-1 and EVOLVE-2 (EM, 6-months DB), REGAIN (CM, 3-months DB), and CONQUER (previous failure of 2–4 migraine preventive medication categories, 3-months DB). Indirect costs were calculated at baseline and Month 3 using the first 2 items in Migraine Disability Assessment (MIDAS): (A + B)/60*country specific annual wage (A = days of missed work/school; B = days of reduced productivity at work/school; assuming 60 working days in 3 months). All costs were annualized and expressed in international dollars (Int$) in 2018. ANCOVA models estimated the indirect cost savings as a change from baseline. Secondary analyses determined cost savings by employment and responder status. Patients (>80% females) from EVOLVE-1 and −2 (n = 1,201; mean age 41.9 years), REGAIN (n = 759; mean age 41.3 years), and CONQUER (n = 453; mean age ∼46.0 years) were analyzed. GMB showed significant indirect cost savings for EM (Int$6256, p p = .0002), with substantial savings for patients with previous failure of 2–4 migraine preventive medication categories (EM: Int$5664, p = .0030; CM: Int$5181, p = .1300). Compared with PBO, GMB showed significantly greater indirect cost savings for EM (p = .0156) and patients with previous failure of 2–4 migraine preventive medication categories (p = .0340). Employed patients with CM (p = .0018) and with previous failure of 2–4 migraine preventive medication categories (p GMB treatment resulted in annual indirect cost savings in patients with EM, CM, and with previous failure of 2–4 migraine preventive medication categories, with similar observations in the sensitivity analyses.

IntroductionMigraine, the second leading cause of disability worldwide, remains underdiagnosed and undertreated. Considering the high burden of migraine, we analyzed the strengths and limitations of existing migraine management guidelines.MethodsA targeted literature review was conducted using MEDLINE on 24 March 2021 to identify current migraine management guidelines (including policies and position statements) published in the English language from France, Germany, Italy, Spain, the United Kingdom, and the USA. This was supplemented by a gray literature search. Disease state or pharmacological management guidelines for adults with migraine comprising any of the following perspectives were included: health economics; payer; health technology assessment; treatment access; and impact of guideline implementation on economic or disease burden. Guidelines were analyzed using the Centers for Disease Control and Prevention (CDC) policy analytical framework, which comprises three domains: problem identification, policy analysis, and strategy or policy development, with ranking criteria for each.ResultsOf 39 selected guidelines, 25 adequately identified problems related to migraine, 35 sufficiently reviewed the literature on migraine treatment, three failed to cite literature, and one lacked sufficient content. Twenty-three guidelines targeted healthcare professionals. Almost all guidelines lacked a stepwise migraine treatment approach; only the American Academy of Family Physicians guideline offered first- and second-line treatment options. Four guidelines mentioned current political forces, and coverage of economic or budgetary impact aspects was limited. Numerous guidelines described the substantial economic burden of migraine and were categorized as ‘high’ for benefits. Public health impact was categorized as ‘high’ for 28 guidelines and budgetary impact was rated as ‘more favorable’ for 27 guidelines. Thirteen guidelines defined a strategy for the intended purpose. Only the United States Department of Health and Human Services pain management guideline met all of the CDC criteria.ConclusionsFuture policies on migraine management may benefit from the inclusion of information on economic data, political feasibility, and public health impact. Furthermore, migraine management guidelines could potentially be improved by considering a comprehensive treatment approach and guideline implementation, as well as addressing knowledge gaps in disease state, public health, and economic aspects.

Background Although several self-injectable preventive treatments for migraine have become available, they are not yet widely used. Thus, understanding patients’ perceptions towards them is limited. Objective This study aimed to inform the design of a preference-elicitation instrument, which is being developed to quantify preventive treatment preferences of people with migraine. Methods We conducted a qualitative study involving nine in-person focus groups (three per country) in the United States, the United Kingdom, and Germany. Participants were adults (n = 47) with episodic or chronic migraine who were currently using or had used a prescription preventive treatment for migraine within the previous 5 years. During the focus groups, participants described their experiences of migraine and preventive treatments; handled and simulated self-injection using five different unbranded, fired demonstration auto-injectors and prefilled syringes; and ranked different aspects of preventive treatments by importance. Focus groups were analyzed with a focus on themes that would be feasible or meaningful to include in a subsequent preference-elicitation instrument. Results Reducing the frequency and severity of migraine attacks was consistently ranked as the most important aspect of preventive treatment. Participants expressed dissatisfaction with available daily oral preventive treatments for migraine they had previously used because they were ineffective or caused intolerable adverse events. Many participants were willing to self-inject a treatment that was effective and tolerable. When presented with devices for self-injecting a preventive treatment for migraine, participants generally preferred autoinjectors over prefilled syringes. Participants especially valued safety features such as the unlocking step and automated needle insertion, and audible and visual dose confirmation increased confidence in autoinjector use. Autoinjector needle protection mechanisms were also appreciated, especially by participants averse to needles, as the needles are not visible. Conclusions This study highlights the fact that many people with migraine still lack access to a preventive treatment that is effective and tolerable. In addition to efficacy and safety considerations, treatment decisions may be guided by the mode of administration. In the case of self-injectable preventive treatments, key device characteristics affecting these decisions may be ease of use, comfort, and confidence in self-injection. Insights gained from this study were used to help develop a preliminary set of attributes and levels for a preference-elicitation instrument. Supplementary Information The online version contains supplementary material available at 10.1007/s40271-021-00525-z.

Patients with migraine and prior preventive treatment failures have a significant burden on quality of life and disability. The CONQUER study evaluated the effects of galcanezumab on patient functioning, disability, and health status in episodic or chronic migraine with a previous failure of two to four migraine preventive medication categories.Patients with two to four preventive migraine treatment category failures received galcanezumab 120 mg/month (240-mg loading dose) or placebo subcutaneously, for 3 months (double-blind period). In the 3-month open-label period, all patients received galcanezumab irrespective of the treatment received in the double-blind period. Changes in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ), Migraine Disability Assessment (MIDAS), and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) scores were assessed.A total of 462 patients were randomized to receive galcanezumab (N = 232) or placebo (N = 230). At month 3, improvement in the MSQ Role-Function-Restrictive score from baseline was significantly greater for galcanezumab (23.19 ± 1.34) vs placebo (10.66 ± 1.33) [p ≤ 0.0001]. Significant improvements in remaining MSQ domains and total MSQ scores were observed (p0.0001) during the double-blind period. MIDAS total scores were significantly (p ≤ 0.0001) reduced with galcanezumab (- 21.10 + 3.32) vs placebo (- 3.30 + 3.28). EQ-5D-5L visual analog scale scores improved for galcanezumab (3.40 + 1.31) vs placebo (- 0.09 + 1.29; p = 0.028). During the open-label period, quality of life continued to improve for galcanezumab, with patients previously assigned to placebo reaching similar results. During both study periods, similar findings were reported in subpopulations with episodic migraine and chronic migraine.Galcanezumab significantly improved functioning and reduced disability in patients with episodic migraine and chronic migraine and two to four migraine preventive treatment category failures.NCT03559257, registration date: 6 June, 2018.

ObjectiveTo evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo.MethodsPatients with episodic migraine (4–14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]–1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only).ResultsDifferences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4–6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = −6.3 (p < 0.001) and −5.2 (p = 0.002); EVOLVE-2 = −9.2 and −8.2 (both p < 0.001).ConclusionsPatients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo.Classification of evidenceThis study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

This study compared all-cause direct cost and healthcare resource utilization (HCRU) among preventive migraine medication (PMM)-naïve patients and patients with up to 3 PMM category switches before initiating calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). This was a retrospective analysis of the IBM Marketscan database. Patients who initiated injectable CGRP mAbs between May 2018 and December 2019 (index period) were included in 4 groups based on the number of prior non-CGRP PMM classes used during the 24-month pre-index period: P0 = none; P1 = one; P2 = two; P3 ≥ three. All-cause direct cost and HCRU for groups were compared without adjustment and after generalized propensity score (GPS) matching. Of the 23,288 patients included (mean age ± standard deviation [SD] 45.4 ± 12.0 years), 85.6% were females, and the mean Charlson Comorbidity Index was 0.69 ± 1.2. P3 group had the highest average annual unadjusted total healthcare costs per patient ($50,274±$76,629); the highest costs attributed to procedure/imaging-related expenses ($20,105±$36,401) and pharmacy ($11,633±$29,763). P0 group had the lowest cost ($25,288±$41,427). Pairwise comparison of GPS matched costs showed significantly greater average annual direct costs per patient in the P3 group vs. P0 (p = .003), P1 (p = .014), and P2 (p = .021) groups. GPS matched HCRU also increased with the number of prior PMM classes used. Anti-epileptics (48.9%) were the most commonly used PMM class, with triptans (75.2%) being the most common acute medication class. Total direct healthcare cost and HCRU increased significantly with increasing use of PMM classes with the greatest cost difference existing between the P0 and the P3 groups. Medications used for the prevention of migraine (PMM) are underused as they might cause adverse effects, intolerance, or may lack efficacy. This leads to the discontinuation of the current treatment and switching to other treatments. Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) are a new class of drugs for the prevention of migraine. Since 2018, four CGRP mAbs have been approved for use in the prevention of migraine. It is known that patients who use more preventive migraine treatments incur greater total direct (caused by a number of medical visits or increased healthcare resource utilization, surgery, drugs, equipment, etc.) annual healthcare costs and healthcare resource utilization (HCRU) in patients with migraine. In the current study, the annual average direct cost and HCRU were compared between patients who had not used preventive medicine and patients who had used 1, 2, or ≥3 preventive medicines for migraine before starting CGRP mAbs. We observed that the healthcare costs and HCRU increased with the use of a higher number of preventive medicines for migraine. Patients who started using injectable CGRP mAbs after at least 3 preventive medicines had the highest healthcare costs and HCRU compared with other groups.

IntroductionAcute headache medication use (AHM) and health care resource utilization (HCRU) in patients with protocol-defined treatment-resistant migraine treated with galcanezumab (GMB).Material and methodsIn the 3-month double-blind (DB) study phase, patients with episodic or chronic migraine and 2-4 migraine preventive category failures due to lack of effectiveness or safety/tolerability, received GMB 120 mg/month (following initial 240 mg loading dose) or placebo (PBO); an optional 3-month open-label (OL) GMB treatment followed. AHM was self-reported daily with eDiary and paper-forms. HCRU was reported at baseline (retrospectively for previous 6 months) and at monthly visits.ResultsOf the 462 patients (GMB n=232, PBO n=230), baseline mean (±SD) days/month of AHM was 12.3 (±6.0); 44.8% had AHM overuse. The percentage of patients reporting migraine-specific HCRU at baseline in the GMB and PBO groups were respectively: 40% and 50% healthcare-professional visits (HCP), 6% and 5% emergency-room (ER) visits, and in each, 2% hospitalizations. LS mean reductions from baseline in the mean number of days/month with AHM in the DB was greater for the GMB group (3.9 to 4.5 days) compared to PBO (0.4 to 1.0 days) in each of the first 3 months; change difference, -3.1 to -3.5, p

Background Migraine has a severe impact on health-related quality of life (HRQoL) affecting physical, emotional, and social aspects of daily living of an individual. Preventive treatment has been demonstrated to improve HRQoL by reducing the frequency of migraine headache days. Methods The study used data from 2017 Adelphi Migraine Disease Specific Program, which is a cross-sectional survey of physicians and their consulting patients with migraine in the United States (US) and five European countries (EU [Germany, France, UK, Italy and Spain]). Objectives were to evaluate patient-reported outcome (PRO) measures in the following two subgroups and by region (US and EU): (i) patients who are eligible for migraine preventive treatment (≥4 migraine headache days/month), and (ii) patients who are non-eligible for preventive treatment (

Objectives To assess the measurement properties of the Migraine‐Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient‐reported outcome (ePRO) Role Function‐Restrictive (RFR) domain to evaluate the functional impact of migraine in patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials. Methods The 7‐item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n = 851] and CGAH [n = 909]) and 1 CM (CGAI [n = 1090]) Phase 3 galcanezumab clinical trials. Anchor‐ and distribution‐based analyses were utilized to derive a responder threshold for clinical interpretation of change over time. The Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI‐S), Patient Global Impression of Improvement (PGI‐I), and migraine headache days (MHD) served as anchors. Responsiveness and responder threshold analyses were completed from baseline to the average of months 4‐6 for EM studies, and from baseline to month 3 for the CM study; timeframes selected were based on the primary endpoints in these studies. Results Cronbach’s alpha values for internal consistency reliability were 0.93, 0.92, and 0.92, for CGAG, CGAH, and CGAI, respectively. Test–retest reliability intra‐class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients. Convergent validity was supported by moderate to strong correlations (≥0.30) between the RFR and both MIDAS and PGI‐S. Known‐groups validity was established between subgroups stratified by baseline PGI‐S and MHD (P

Migraine is a common and disabling neurological disease associated with substantial economic burden. Among patients with migraine, it is unknown if cost differences exist when preventive migraine medication (PMM) switches occur.To understand the cost burden and health care resource utilization of patients who discontinue or cycle through 1 (PMM1), 2 (PMM2), or ≥ 3 (PMM3) unique PMM drug classes over a 12-month period versus patients who adhere persistently to their initial PMM class.This retrospective observational study used the Truven Health Analytics MarketScan databases to identify adult patients with migraine initiating their first PMM class (antidepressants, antiepileptics, beta blockers, or neurotoxins) from 2011-2013 (index date = first PMM claim). Patients were required to have ≥ 2 outpatient (1 if inpatient) migraine diagnosis codes (ICD-9-CM 346.xx) from 1 year pre-index to 1 year post-index with ≥ 1 code occurring pre-index. Inclusion criteria also required 12 months of pre- and post-index continuous medical and prescription enrollment. All-cause and migraine-specific total direct costs (outpatient, inpatient, emergency department, and prescriptions), based on the 2014 Consumer Price Index, were estimated for each PMM versus a persistent subgroup during the 12-month post-index period. Propensity score bin bootstrapping, controlling for patient baseline characteristics, was used to adjust separate cost comparisons between each PMM subgroup and the persistent subgroup; bootstrap simulations yielded propensity score-adjusted P values.The study population included 55,402 patients who received a PMM. The study population was mainly female (85%) with a mean age of 39.2 years and mean Charlson Comorbidity Index of 0.31. Antiepileptics were the most common drug class chosen at index across all subgroups; however, lower use of antiepileptics was observed in PMM2 and PMM3 subgroups, which were more likely to be prescribed either antidepressants or beta blockers at index. Mean all-cause total direct costs, including prescription costs, were significantly higher in PMM2 ($13,429) and PMM3 ($18,394) subgroups versus the persistent subgroup ($11,941; each adjusted pairwise comparison, P0.001). Mean migraine-specific total direct costs were significantly lower for the persistent subgroup ($2,420) versus PMM2 and PMM3 subgroups and escalated with increasing numbers of drug class discontinuations or switches, from a mean of $2,997 to $5,004 (both adjusted pairwise comparisons, P0.001). Subgroup differences in all-cause and migraine-specific direct costs were primarily due to variations in outpatient and emergency department services.All-cause total direct costs rose with increasing number of PMM switches over the 12-month post-index period, and were significantly higher than in the persistent subgroup, with the exception of PMM1. Additional analyses indicated that the lack of increase between PMM-persistent and PMM1 costs was due to higher pharmacy costs that were likely related to continuous use of medication in the PMM-persistent subgroup. These data suggest an increased cost burden among patients with migraine who cycle through ≥ 2 PMMs versus those who continue to receive their initial medication class.Eli Lilly and Company was the sole sponsor and funder for this study and was responsible for the study design, data collection, data analysis, interpretation of data, and decision to publish the findings. All authors are employees and minor stockholders of Eli Lilly and Company. Nyhuis was employed by Eli Lilly and Company at the time of this study. The findings of this study were presented in part at the 18th Congress of the International Headache Society; September 7-10, 2017; Vancouver, Canada.

Cluster headache (CH) is a rare trigeminal cephalalgia that is associated with extremely painful unilateral headache attacks and autonomic symptoms. Attacks may be episodic or chronic and associated with substantial suffering due to excruciating pain and limited treatment options. Frequent cluster headaches cause substantial burden for patients, resulting in reduced productivity caused by disability, as well as direct costs in some European countries. Less is known, however, about direct costs of recurring health care resource utilization (HCRU) in the United States.To characterize HCRU and direct costs associated with CH in the United States from a third-party payer perspective.This retrospective observational study analyzed claims data from the Truven Health Analytics MarketScan Research Databases from 2009-2014. Two cohorts were compared: CH (2 diagnostic CH claims) and controls (nonheadache patients). All patients were enrolled continuously for ± 12 months from date of first CH claim. HCRU and direct costs were examined during 12 months post-index as all-cause and CH-specific. Cost and HCRU differences were compared using propensity score-adjusted bin bootstrapping.CH and control cohorts comprised 6,562 and 143,761 patients (aged ≥ 18 years), respectively. Post-index, 36.9% of CH patients versus 16.2% of controls were admitted to the emergency department (ED), and 14.8% versus 6.1% were hospitalized for any reason, respectively (each P0.001). CH patients had a 2- to 3-fold significantly greater number of all-cause mean claims for outpatient visits (26.5 vs. 12.4 visits), hospital visits (0.2 vs. 0.1 visits), and ED visits (1.0 vs. 0.3 visits) versus controls (all P0.001). The mean number of all-cause visits with reported radiology and laboratory claims was 1.5- to 2.0-fold greater in CH patients versus controls (each P0.001). Mean total direct costs for all-cause claims were more than 2-fold greater in post-index ($16,530) for CH patients versus controls ($7,197, P0.0001). Similarly, mean direct all-cause costs attributable to outpatient, inpatient, and pharmacy claims were significantly (2-fold) greater; radiology and ED claims were 3- to 4-fold greater among CH patients versus controls (all P0.001). However, CH was cited infrequently as a reason for HCRU, indicating that comorbid conditions may substantially increase HCRU in CH patients. The most common reasons for ED admission in CH patients were gastric ulcer with hemorrhage, sub-arachnoid hemorrhage, and headache symptoms. The most common hospital discharge diagnoses for CH patients not observed in top 10 reasons in controls included cerebral artery occlusion/unspecified with cerebral infarction, headache symptoms, syncope/collapse, and diverticulitis.These findings suggest that, from a payer perspective, CH patients incur significantly higher health care costs versus controls. However, these high costs were not exclusively headache-related. Extrapolating our cost findings to estimated U.S. prevalence rates, approximate total direct cost for CH is greater than $2.8 billion/year.Eli Lilly and Company was the sole sponsor and funder for this study and was responsible for the study design, data collection, data analysis, interpretation of data, and decision to publish the findings. All authors are employees and minor stockholders of Eli Lilly and Company.

Background Cluster headache (CH) is a primary headache disorder associated with low levels of diagnosis and high unmet medical need. The pain attacks, associated anxiety, and fear in anticipation of the attacks are extremely debilitating to a patient with CH. For acute therapy, treatment guidelines recommend inhalation of high flow oxygen during the period of an attack. However, the use of oxygen for treatment of CH remains largely underutilized. Objectives The objectives of the study, which covered each of the US states, were to map the current market landscape of medical grade oxygen for use in CH and to develop a cost simulator based on a patient's needs and geography. Methods Desk research was undertaken to obtain price lists and product catalogs from wholesale and retail suppliers of medical grade oxygen across all US states. Base case scenarios for chronic and episodic forms of CH were assumed. A cost simulator was used to calculate the cost of oxygen use using inputs including the state in USA, tank size and price, exacerbations per year, duration of exacerbation, attacks per day, flow rate and duration of flow. Information was also collected to determine if healthcare insurers covered the costs of home oxygen use for CH. Results Out of the 42 US states where pricing information of medical grade oxygen was available from suppliers, in 38 states the annual cost of high-flow oxygen for a patient with episodic CH was estimated to be

Objective To characterize demographics, clinical characteristics, and treatment patterns of patients with cluster headache (CH). Background CH is an uncommon trigeminal autonomic cephalalgia with limited evidence‐based treatment options. Patients suffer from extremely painful unilateral headache attacks and autonomic symptoms with episodic and chronic cycles. Design/Methods This retrospective analysis used insurance claims from Truven Health Analytics MarketScan® research databases from 2009 to 2014. Two cohorts were compared: CH patients (with ≥2 CH claims) were propensity score matched with 4 non‐headache controls, all with continuous enrollment for 12 months before and after the date of first CH claim or matched period among controls. Results CH patients (N = 7589) were mainly male (57.4%) and 35‐64 years old (73.2%), with significantly more claims for comorbid conditions vs controls (N = 30,341), including depressive disorders (19.8% vs 10.0%), sleep disturbances (19.7% vs 9.1%), anxiety disorders (19.2% vs 8.7%), and tobacco use disorders (12.8% vs 5.3%), with 2.5 times greater odds of suicidal ideation (all P 12 unique prescription drug claims. Most commonly prescribed drug classes for CH patients included: opiate agonists (41%), corticosteroids (34%), 5HT‐1 agonists (32%), antidepressants (31%), NSAIDs (29%), anticonvulsants (28%), calcium antagonists (27%), and benzodiazepines (22%). Only 30.4% of CH patients received recognized CH treatments without opioids during the 12‐month post‐index period. These patients were less likely to visit emergency departments or need hospitalizations (26.8%) as compared to CH patients with no pharmacy claims for recognized CH treatments or opioids (33.6%; P

In the original publication, Figure 3 showed an upward directed arrow for improvement in the monthly migraine headache days. However, the direction of the arrow has been corrected to downward direction, to present the improvement in monthly migraine headache days.

Background and purpose The efficacy of galcanezumab, a monoclonal antibody for migraine prevention, has been demonstrated in two pivotal trials in patients with episodic migraine. Methods EVOLVE‐1 and EVOLVE‐2 were identical phase 3, randomized, double‐blind, placebo‐controlled studies in patients with episodic migraine. Mean migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120 mg/240 mg during the 6‐month double‐blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure). Results In an integrated analysis of EVOLVE studies, galcanezumab 120 mg/240 mg versus placebo led to larger overall mean (SE) reductions in monthly migraine headache days across 6 months in patients with prior preventive failures (P

Purpose A concept elicitation, cognitive debriefing, and usability study was undertaken to: 1) ascertain the migraine experience with a particular focus on the impact on roles and daily functioning; 2) determine the comprehensiveness and comprehensibility of the Migraine-Specific Quality of Life Questionnaire version 2.1 electronic patient-reported outcome Role Function-Restrictive (MSQ v2.1 ePRO RFR) domain items, and the appropriateness and understanding of the recall period, response options, and instructions; and 3) assess the usability on an electronic tablet device. Methods Eleven US English-speaking people with episodic or chronic migraine were recruited to participate in one-on-one interviews, encompassing methods appropriate for concept elicitation, cognitive debriefing, and usability testing. Interviews were audio-recorded, transcribed, and analyzed following the constant comparative method. Results Participants (seven episodic and four chronic) had a mean age of 34.8 years, and nine were female. Through spontaneous mention or probing, the concepts of the MSQ v2.1 ePRO RFR domain items were described and endorsed by all participants as day-to-day functioning restrictions; except for item 5 (ability to concentrate), which was endorsed by 10 of 11 participants. Cognitive interviewing confirmed the MSQ v2.1 ePRO instructions were clear, meaningful, and important to assess as daily functioning impacts experienced as a result of migraine. Overall impressions of the ePRO device were favorable, and no participants reported any difficulties with use. Conclusions The MSQ v2.1 ePRO RFR domain is content-valid and appropriate for inclusion in future studies designed to measure the functional impact of episodic or chronic migraine on the performance of day-to-day activities.

BackgroundEfficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed.Study design/methodsREGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score.ResultsTreatment with galcanezumab versus placebo resulted in significant improvements ( p ConclusionGalcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome.Clinicaltrials.gov identifier numberNCT02614261.

Aim: Within a treated migraine population, to evaluate if the sub-group meeting criteria for high disease-specific total costs is significantly different to the sub-group with medium and/or...

Introduction Les personnes souffrant de migraine episodique (ME) ou chronique (MC) signalent une baisse de leur productivite au travail et de leur activite, tant pendant qu’entre les crises de migraine. Objectifs Evaluer l’evolution depuis l’inclusion de la baisse de productivite au travail/activite et de l’impact entre les crises chez des patients souffrant de migraine difficile a traiter recevant du galcanezumab (GMB) ou un placebo (PBO). Patients et methodes Dans l’etude CONQUER, les patients avec ME/MC difficile a traiter ont ete randomises dans un groupe GMB (dose initiale 240 mg, puis 120 mg/mois) (n = 232) ou PBO (n = 230) pendant 3 mois. Les scores d’absenteisme, de presenteisme, et de baisse de productivite au travail/activite du Work Productivity and Activity Impairment Questionnaire (WPAI) ont ete calcules comme pourcentage d’invalidite. L’echelle Migraine Interictal Burden Scale (MIBS) a evalue l’impact entre les crises pendant les 4 dernieres semaines. Resultats La diminution moyenne des moindres carres (LS) des scores WPAI depuis l’inclusion etait significativement superieure pour GMB vs PBO : baisse d’activite −20,7 % vs −8,6 %, presenteisme −12,5 % vs −2,6 % et invalidite globale liee au travail −14,3 % vs −3,5 %, respectivement (p ≤ 0,0004), sans difference significative pour l’absenteisme. L’evolution moyenne des LS du MIBS depuis l’inclusion (5,5) etait superieure pour le GMB (−1,8) vs PBO (−0,8 ; p Discussion Dans l’etude CONQUER, les patients traites par GMB ont montre vs PBO des reductions significatives depuis l’inclusion des scores WPAI en ce qui concerne la baisse d’activite, le presenteisme et l’invalidite globale liee au travail ainsi que sur le score MIBS. Conclusion Dans l’etude CONQUER, la baisse de productivite au travail/activite et l’impact des migraines entre les crises etaient significativement reduits chez les patients traites par galcanezumab vs PBO.

Introduction L’etude CONQUER de phase 3 randomisee, en double aveugle, controlee vs placebo a evalue l’efficacite/la tolerance de GMB chez des patients atteints de migraine difficile a traiter. Objectifs Evaluer l’efficacite du GMB sur la qualite de vie de patients atteints de migraine episodique (ME) ou chronique (MC) participant a l’etude CONQUER sur une periode de 3 mois. Patients et methodes Les patients ont ete randomises 1 :1 recevant soit 120 mg de GMB/mois (dose initiale 240 mg), soit un placebo (PBO) par voie sous-cutanee. Les scores MIDAS et EQ-5D-5L ont ete evalues a l’inclusion et au mois 3. Le score MSQ a ete evalue a l’inclusion et a tous les mois. Les comparaisons de traitements au mois 3 utilisaient des mesures repetees avec modele mixte et l’analyse de modeles de covariance (mesure unique apres l’inclusion). Resultats Dans la population en intention de traiter (ITT) (n = 462) et dans les sous-populations atteintes de ME (n = 269) et MC (n = 193), les ameliorations moyennes depuis l’inclusion etaient significatives pour GMB vs PBO pour le score MIDAS total (p Discussion Dans l’etude CONQUER, le GMB a ameliore significativement la qualite de vie par rapport au PBO chez les patients souffrant de ME/MC difficile a traiter (echec anterieur de 2 a 4 categories de traitements prophylactiques standards de la migraine au cours des 10 dernieres annees en raison d’une efficacite et/ou d’une intolerance). Conclusion Les patients souffrant de migraine difficile a traiter sous GMB ont eu une amelioration de leur fonctionnement quotidien et dans leur perception de leur qualite de vie, ainsi qu’une diminution de leur invalidite vs PBO.

Objective: Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication. Methods: The Truven Health Analytics MarketScan1 U.S. Commercial and Medicare Supplemental claims database (2011-2013) was used to identify adults newly diagnosed with migraine. Patients were divided into 2 subgroups: initiated a preventive migraine medication (antidepressants, anti-epileptics, beta-blockers, or neurotoxins) within 1 year of migraine diagnosis and did not initiate a preventive migraine medication. Logistic regression models were constructed to identify factors associated with preventive migraine medication initiation. Results: Study population included 147,923 patients: 43,660 preventive migraine medication initiators and 104,263 non-preventive migraine medication patients. Best-fit model for predicting preventive migraine medication initiation included: female gender (odds ratio = 1.181 [95% CI = 1.144,1.218]; measured at date of first migraine diagnosis); headache diagnosis prior to migraine diagnosis (odds ratio = 1.538 [95% CI = 1.498,1.579]; measured 1-year before first migraine diagnosis); and sleep disorder (odds ratio = 1.206 [95% CI = 1.161,1.252]), headache/migraine-specific Emergency Department (ED) visit (odds ratio = 1.224 [95% CI = 1.168,1.283]), neurologist visit (odds ratio = 1.502 [95% CI = 1.459,1.547]), and acute medication refills with Conclusions: In addition to consistent acute medication refills, specific comorbidity diagnoses, headache/migraine-specific ED utilization, and neurologist care are predictive of preventive migraine medication initiation in the 1-year post-incident migraine diagnosis.

Janet H Ford,1 Shonda A Foster,1 Virginia L Stauffer,1 Dustin D Ruff,1 Sheena K Aurora,1 Jan Versijpt2 1Eli Lilly and Company, Indianapolis, IN 46225, USA; 2Department of Neurology – Headache and Facial Pain Clinic, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), 1090 Brussels, Belgium Background: Effects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.Methods: Patients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient’s last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period.Results: At Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: -5.1 for galcanezumab 120 mg/240 mg; p

The objective of this article is to identify prevalence changes in depressed mood/suicidal behaviors among female high school students reporting physical fighting. This research analyzed the national combined data set of the Youth Risk Behavior Surveillance (YRBS) cross-sectional surveys from 2001 to 2015. Logistic regression analyzed the time trends. Two multiple logistic regression models were built. A quadratic trend was present with an initial decrease followed by an increase 2009 to 2015 ( p < .001). The odds and severity of depressed mood/suicidal behaviors were greater among female youths with four or more fights and for other violent events, which were even greater when accounting for electronic bullying. The odds of depressed mood/suicidal behaviors among female adolescents engaged in physical fighting has been increasing with electronic bullying contributing to polyvictimization.

Objective - To evaluate 12-week changes from baseline of 2 disease-specific patient-reported outcome (PRO) measures in adults with migraine treated with galcanezumab, an investigational humanized antibody binding calcitonin gene-related peptide (CGRP), or placebo. Background - Preventing headache-related functional impairment is an important goal of migraine preventive treatment and a measurement target for PROs. Understanding which drugs have the potential to improve patient functioning in addition to preventing migraine headaches is vital to lessening patient burden. Design/Methods - This Phase 2b double-blind, randomized, placebo-controlled study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 weeks. Post hoc secondary analyses were conducted for those who completed 12 weeks of treatment on 2 PROs: The Migraine-Specific Quality of Life Questionnaire (MSQ) v2.1 and the Headache Impact Test™ (HIT-6). Results - Analysis of covariance revealed significant differences in least square mean changes from baseline between galcanezumab and placebo for all MSQ domains including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 2.449, 15.008; P-value of .0067); Role Function-Restrictive mean change placebo of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P-value of .0071); Role Function-Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 0.476, 12.185; P-value of .0342); and Emotional Function mean change placebo of 16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P-value of .0063). At baseline, mean number of migraine headache days (MHDs) did not correlate with MSQ total scores or HIT-6. At 12 weeks post-treatment, MHD correlated with MSQ and HIT-6 scores (all P < .0001). Change in MHD was associated with change in MSQ domains and change in HIT-6 scores (all P < .0001). Conclusions - In comparison with placebo, treatment with galcanezumab was associated with significant functional improvements as reflected by changes in MSQ scores. Change in MHD was associated with improvements in MSQ and reductions in HIT-6 scores, indicating the clinical importance of these changes in relation to PROs that measure function.

To estimate direct and indirect costs in patients with a diagnosis of cluster headache in the US.Adult patients (18-64 years of age) enrolled in the Marketscan Commercial and Medicare Databases with ≥2 non-diagnostic outpatient (≥30 days apart between the two outpatient claims) or ≥1 inpatient diagnoses of cluster headache (ICD-9-CM code 339.00, 339.01, or 339.02) between January 1, 2009 and June 30, 2014, were included in the analyses. Patients had ≥6 months of continuous enrollment with medical and pharmacy coverage before and after the index date (first cluster headache diagnosis). Three outcomes were evaluated: (1) healthcare resource utilization, (2) direct healthcare costs, and (3) indirect costs associated with work days lost due to absenteeism and short-term disability. Direct costs included costs of all-cause and cluster headache-related outpatient, inpatient hospitalization, surgery, and pharmacy claims. Indirect costs were based on an average daily wage, which was estimated from the 2014 US Bureau of Labor Statistics and inflated to 2015 dollars.There were 9,328 patients with cluster headache claims included in the analysis. Cluster headache-related total direct costs (mean [standard deviation]) were $3,132 [$13,396] per patient per year (PPPY), accounting for 17.8% of the all-cause total direct cost. Cluster headache-related inpatient hospitalizations ($1,604) and pharmacy ($809) together ($2,413) contributed over 75% of the cluster headache-related direct healthcare cost. There were three sub-groups of patients with claims associated with indirect costs that included absenteeism, short-term disability, and absenteeism + short-term disability. Indirect costs PPPY were $4,928 [$4,860] for absenteeism, $803 [$2,621] for short-term disability, and $3,374 [$3,198] for absenteeism + disability.Patients with cluster headache have high healthcare costs that are associated with inpatient admissions and pharmacy fulfillments, and high indirect costs associated with absenteeism and short-term disability.

Objective The purpose of this cross-sectional study was to assess the sociodemographics, disease burden, and treatment patterns of patients with episodic and chronic migraine in the United States. Background Migraine is a disabling neurological disease that places an enormous burden on patients. Methods Data were drawn from the Adelphi Migraine United States Disease Specific Programme (index period: January to March 2014). Physicians (N = 150) completed a patient report form on 10 consulting patients with migraine. Episodic migraineurs had ≤14 headache days per month (HDM) and those with chronic migraine had ≥15. Headache-related disability was assessed with the Migraine Disability Assessment (MIDAS) questionnaire. Disability was also compared across subgroups based on the number of HDM (≤3, 4-7, 8-14, and ≥15). Results A total of 1487 patient report forms were completed. Over 70% of the patients were female, 90.8% (n = 1350) were episodic migraineurs, and 9.2% (n = 137) were chronic migraineurs. Acute treatment was prescribed for >90% of the patients, and >50% had a current prescription for preventive treatment. Despite taking acute and/or preventive treatment, 29.2% of episodic migraineurs (including some patients with ≤3 headache days/month) and 73.2% of chronic migraineurs had moderate-to-severe headache-related disability (MIDAS total score ≥11). Preventive treatment was discontinued/switched at least once by 26.4% of episodic migraineurs and by 53.3% of chronic migraineurs. Of those patients (n = 382) who gave collective reasons for discontinuation/switching preventive treatment, over 70% selected lack of efficacy and tolerability/safety. Conclusions This real-world analysis provides additional support for the unmet medical need for efficacious therapies that reduce migraine frequency and severity, headache-related disability, and have better tolerability for patients with migraine. In addition, further research is needed to better understand the burden of illness among patients with lower migraine frequency, and to implement treatment strategies to prevent progression of the disease.