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Objective: To describe treatment patterns and direct healthcare costs over 3 years following initiation of standard of care acute and preventive migraine medications in patients with migraine in the United States. Background: There are limited data on long‐term (>1 year) migraine treatments patterns and associated outcomes. Methods: This was a retrospective, observational cohort study using US claims data from the IBM® MarketScan® Research Database (January 2010–December 2017). Adults were included if they had a prescription claim for acute migraine treatments (AMT) or preventive migraine treatments (PMT) in the index period (January 2011–December 2014). The AMT cohort was categorized as persistent, cycled, or added‐on subgroups; the PMT cohort was categorized PMT‐persistent, switched without gaps, or cycled with gaps. Migraine‐specific annual direct costs (2017 US$) across AMT and PMT cohort subgroups were summarized at baseline through 3 years from index (follow‐up). Results: During the index period, 20,778 and 42,259 patients initiated an AMT and a PMT, respectively. At the 3‐year follow‐up, migraine‐specific direct costs were lower in the persistent subgroup relative to the non‐persistent subgroups in both AMT (mean [SD]: $789 [$1741] vs. $2847 [$8149] in the added‐on subgroup and $862 [$5426] for the cycled subgroup) and PMT cohorts (mean [SD]: $1817 [$5892] in the persistent subgroup vs. $4257 [$11,392] in the switched without gaps subgroup and $3269 [$18,540] in the cycled with gaps subgroup). Acute medication overuse was lower in the persistent subgroup (1025/6504 [27.2%]) vs. non‐persistent subgroups (11,236/58,863 [32.2%] in cycled with gaps subgroup and 1431/6504 [39.4%] in the switched without gaps subgroup). Most patients used multiple acute (19,717/20,778 [94.9%]) or preventive (38,494/42,259 [91.1%]) pharmacological therapies over 3 years following treatment initiation. Gaps in preventive therapy were common; an average gap ranged from 85 to 211 days (~3–7 months). Conclusion: Migraine‐specific annual healthcare costs and acute migraine medication overuse remained lowest among patients with persistent AMT and PMT versus non‐persistent treatment. Study findings are limited to the US population. Future studies should compare costs and associated outcomes between newer preventive migraine medications in patients with migraine. Plain Language Summary: Little is known about how patients use medications to acutely treat or prevent migraine over longer periods of time and their associated costs. This study used information from medical and pharmacy claims to understand costs over time for three groups of patients with migraine: (1) those who remained on the same medication for 3 years, (2) those who changed medications, or (3) those who stopped treatment and then changed medications. Results showed that fewer than one in 10 patients stayed on the same medication to treat or prevent migraine over 3 years, but migraine costs and acute migraine medication overuse were lowest in these patients. [ABSTRACT FROM AUTHOR]

To describe long-term (24-month) treatment patterns of patients initiating galcanezumab versus standard of care (SOC) preventive migraine treatments including anticonvulsants, beta-blockers, antidepressants, and onabotulinumtoxinA using administrative claims data. This retrospective cohort study, which used Optum de-identified Market Clarity data, included adults with migraine with ≥1 claim for galcanezumab or SOC preventive migraine therapy (September 1, 2018 − March 31, 2020) and continuous database enrollment for 12 months before (baseline) and 24 months after (follow-up) the index date (date of first claim). Baseline patient demographics, clinical characteristics, and treatment patterns were analyzed after 24-month follow-up, including adherence (measured as the proportion of days covered [PDC]), persistence, discontinuation (≥60-day gap), restart, and treatment switch. Propensity score matching (1:1) was used to balance the galcanezumab and SOC cohorts. The study included 2307 matched patient pairs with 24-month follow-up. The mean age across cohorts was 44.5 years (females: ∼87%). Patients in the galcanezumab versus SOC cohort demonstrated greater treatment adherence (PDC: 48% vs. 38%), with more patients considered adherent (PDC ≥80%: 26.6% vs. 20.7%) and persistent (322.1 vs. 236.4 d) (all p <.001). After 24-month follow-up, fewer galcanezumab-treated patients had discontinued compared with SOC-treated patients (80.1% vs. 84.7%; p <.001), of which 41.3% and 39.6% switched to a non-index medication, respectively. The most prevalent medication patients switched to in both cohorts was erenumab. Significantly greater proportions of patients who initiated galcanezumab versus SOC medications switched to fremanezumab (p <.001) and onabotulinumtoxinA (p =.016). Patients who initiated galcanezumab for migraine prevention had higher treatment adherence and persistence compared with those who initiated SOC medications after 24-month follow-up. Only few patients (3 − 13%) with migraine, who qualify for preventive treatment, are using them. Conventional preventive treatments have not been developed specifically for migraine treatment, and more than half of the patients stop using them prematurely. Calcitonin gene-related peptide monoclonal antibodies such as galcanezumab, fremanezumab, and erenumab are newer treatments that provide migraine-specific preventive treatment. Prior studies have compared 6- to 12-month migraine medication use by patients starting galcanezumab versus those starting traditional standard of care (SOC) migraine preventive medications. We compared long-term (24-month) migraine medication use in patients starting galcanezumab versus those starting SOC migraine preventive medications to confirm if the results are sustained over a longer period. Over 24 months, patients who used galcanezumab followed the prescribed treatment regimen to a greater extent compared with those who used SOC medications (48% vs. 38%, respectively). Additionally, patients using galcanezumab continued treatment for a longer time compared with those using SOC. Over 24 months, about 85% of patients stopped taking SOC medications, while around 80% of patients stopped taking galcanezumab. Our findings indicate that patients with migraine are more likely to continue using galcanezumab as a preventive treatment for a longer period compared with SOC medications. This study helps identify gaps in the preventive treatment of migraine and provides insights on how they are not being used enough. [ABSTRACT FROM AUTHOR]

Vaginitis is one of the most common reasons women access health care in the United States. Despite its prevalence and disruptive impact, it is frequently misdiagnosed and untreated, resulting in unnecessary patient discomfort, follow-up visits, and health care costs. This study presents a costs analysis of diagnostic testing technologies to demonstrate the potential of molecular tests to improve the value of care for women with vaginitis. This study tracks health care spending among women diagnosed with vaginitis and finds that nucleic acid amplification tests (NAATs) are cost-effective for the diagnosis of vaginal symptoms. Women who receive a NAAT on the day of their diagnosis have significantly lower 12-month follow-up costs compared to women who receive a direct probe test or those women who are clinically evaluated without the use of a molecular test. However, despite Food and Drug Administration approval, widely available molecular diagnostics have not been incorporated into clinical guidelines, and many payer policies fail to cover these tests. Greater utilization of NAAT for the diagnosis of vaginitis has the potential to improve the care of women seeking treatment for this prevalent condition and facilitate sexually transmitted infection testing without additional visits. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Comorbidity incidence rates among US patients with ankylosing spondylitis (AS) treated with tumour necrosis factor inhibitors (TNFis) are inadequately understood. This study compared the relative occurrence of comorbidities between patients with AS treated with TNFis and those not treated with TNFis. Methods: Adults aged ≥18 years enrolled in the MarketScan Commercial and Medicare Supplemental databases with a diagnosis of AS between 1 January 2008 and 30 June 2015 were eligible. Patients were divided into two groups, those treated with TNFis (TNFi users) and those not treated with TNFis (TNFi nonusers) during the 12 months after the index date, defined as the date of first TNFi treatment or a randomly assigned date for TNFi nonusers. Patients had to have continuous enrolment for 24 months with no AS diagnosis or TNFi therapy pre‐index and a follow‐up period of ≥12 months postindex. The incidence of new comorbidities was evaluated in patients and adjusted for baseline characteristics. Key findings: A total of 3077 TNFi users and 3830 TNFi nonusers were included. A higher proportion of TNFi users had a new diagnosis of inflammatory bowel disease (hazard ratio [HR], 2.00), including Crohn's disease (HR, 2.45) and ulcerative colitis (HR, 1.65), as well as uveitis (HR, 1.68) and sleep apnoea (HR, 1.21) after initiation of TNFi therapy than TNFi nonusers. Conclusions: Patients with AS treated with TNFis had higher incidence rates of IBD, uveitis and sleep apnoea after initiation of TNFi therapy than patients not treated with TNFi therapy. [ABSTRACT FROM AUTHOR]

Objective: To examine recent studies on the effect of mobile and electronic (ME)-health technology on adherence to acne treatment. Background: With emerging use of ME-health technology, there is a growing interest in evaluating the effectiveness of the tools on medication adherence. Examples of ME-health technology-based tools include text message-based pill reminders and Web-based patient education. Methods: MEDLINE, Cochrane Library, and Web of Science were searched for articles on adherence to acne treatment published through November 2013. A combination of search terms such as "acne" and "adherence" or "compliance" were used. Results: Adherence to oral acne medication was higher than for topical acne medication. The frequency of office visits was also an influencing factor for acne treatment adherence. The telephone-based reminders on a daily basis did not improve acne patients' medication adherence, whereas the Web-based educational tools on a weekly basis had a positive effect on medication adherence in acne treatment. Conclusion: In using ME-health interventions, factors such as medication dosage forms, frequency of intervention, and patients' preferences should be taken into consideration. Developing disease-specific text message reminders may be helpful to increase adherence rates. In addition, a combination of text message reminders with another type of intervention may improve medication adherence. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusion\nPLAIN LANGUAGE SUMMARYTo evaluate quality of life, migraine disability, and work productivity and activity impairment in patients with migraine who received preventive treatment by comparing standard of care preventive medications and calcitonin gene-related monoclonal antibodies (CGRP mAbs), including galcanezumab alone.This cross-sectional study conducted across the United States (US) and Europe used data from the Adelphi Migraine Disease Specific Programme. Physicians completed record forms for consecutive patients, who then completed self-report forms assessing patient-reported outcomes (PROs) such as quality of life, migraine disability, and work productivity and activity impairment. T-tests, Fisher’s exact test, and Mann–Whitney U test were used for analysis.From May 2022 to June 2023, 557 physicians submitted data for 6723 patients. A total of 4036 patients (US 956; Europe 3080) with a history of preventive treatment were included (>60% female, >80% White, mean [standard deviation] age range, 38.7 [12.8] to 46.3 [12.1]). Patients who received 3+ lines of preventive therapy and were receiving CGRP mAbs (including galcanezumab alone) had enhanced health-related quality of life (HRQoL) compared to those who received standard of care. Similar findings were observed across Europe; however, in the US, there was no significant difference in any PROs.Patients with migraine in the overall population and Europe who received 3+ lines of preventive migraine therapy and were receiving CGRP mAbs/galcanezumab demonstrated enhanced HRQoL compared to those who received standard of care.This study evaluated quality of life, migraine disability, and work productivity in patients with migraine who were treated with standard of care preventive medications or calcitonin gene-related monoclonal antibodies (CGRP mAbs), including galcanezumab alone. The study was conducted across the United States and Europe and included data from 557 physicians and 6723 patients. Results showed that patients with migraine who received 3+ lines of preventive therapy and were receiving CGRP mAbs in overall population and Europe demonstrated enhanced health-related quality of life (HRQoL) compared with those who received standard of care. However, in the US, there was no significant difference in HRQoL and migraine disability. The study concludes that CGRP mAb treatments, especially in patients requiring multiple lines of preventive therapy, are a viable approach for optimal migraine management. [ABSTRACT FROM AUTHOR]

Highlights • Development of acute gastrointestinal (GI) graft-versus-host disease (GVHD) increases hospital costs post-allogeneic hematopoietic cell transplantation (HCT). • There was no improvement in 1-year survival in allogeneic-HCT recipients with acute GI GVHD from 2009 to 2015. • Acute GI GVHD remains a barrier to the successful implementation of allogeneic-HCT. ABSTRACT Graft-versus-host disease (GVHD) is the leading cause of nonrelapse mortality among patients who receive allogeneic hematopoietic cell transplantation (allo-HCT). In its acute form (aGVHD), GVHD involves the skin, liver, and gastrointestinal (GI) tract, with GI involvement most strongly associated with poor prognosis. This retrospective cohort study used US healthcare claims data for 2008 to 2015 to identify patients who developed GI aGVHD after allo-HCT performed as curative treatment for hematologic malignancy and compared them with patients who did not develop aGVHD in terms of outcomes related to survival, infections, healthcare resource utilization (HRU), and costs. Whereas the patients without aGVHD saw a 66% improvement in 1-year survival between 2009 and 2015, this effect was not observed in patients with GI aGVHD. Compared with patients without evidence of aGVHD, patients with GI aGVHD were 3.9-fold more likely to develop an infection in the year after allo-HCT. Similarly, patients who developed GI aGVHD were 4.3-fold more likely to have an inpatient admission after allo-HCT discharge, and such an admission cost on average 47% more than an admission for patients without aGVHD. Our findings confirm that GI involvement in aGVHD is associated with higher mortality, risk of infection, HRU, and cost compared with absence of aGVHD. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US.DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls.A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001).Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed.Methods: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US.DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls.A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001).Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed.Results: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US.DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls.A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001).Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed.Conclusions: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US.DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls.A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001).Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed. [ABSTRACT FROM AUTHOR]

Abstract Background Phenylalanine hydroxylase (PAH) deficiency, otherwise known as phenylketonuria (PKU), is an inborn error of metabolism that requires treatment to be initiated in the newborn period and continued throughout life. Due to the challenges of treatment adherence and the resulting cumulative effects of high and labile blood phenylalanine, PKU exerts a significant burden of disease. Retrospective studies using large databases allow for unique perspectives on comorbidities associated with rare diseases. An evaluation of comorbidities across various organ systems is warranted to understand the disease burden in adult patients. Objectives The aim of this insurance claim-based observational study was to assess the prevalence of comorbid conditions across various organ systems (e.g. dermatological, renal, respiratory, gastrointestinal, hematological, and others) among adult PKU patients compared with matched controls from the general population. Methods This retrospective, case-controlled study selected patients from United States insurance claims databases from 1998 to 2014 using International Classification of Diseases, Ninth Revision (ICD-9) codes for diagnosis of PKU. The date of first diagnosis during the study period was index date and this was not necessarily the first time the patient was diagnosed with PKU. Cases were matched with a 1:5 ratio with general population (non-PKU controls) on age, sex, race, geographic location, duration of time in the database and insurance type. Prevalence and prevalence ratio (PR) calculations for comorbidities across various organ systems among adults (≥20 years old) with PKU were compared with the general population (non-PKU controls). The conditions were selected based on complications associated with PKU and feedback from clinicians treating PKU patients. Results A total of 3691 PKU patients and 18,455 matched, non-PKU controls were selected, with an average age of 35 years. The mean healthcare costs incurred by the PKU patients during baseline, were approximately 4 times that of the controls ($4141 vs $1283; p <.0001). The prevalence rates of comorbidities across various organ systems during the follow-up period were significantly higher for those with PKU than in the control group. After adjusting for baseline characteristics, the adjusted prevalence ratios (PR) of 15 conditions studied (asthma, alopecia, urticaria, gallbladder disease, rhinitis, esophageal disorders, anemia, overweight, GERD, eczema, renal insufficiency, osteoporosis, gastritis/esophagitis and kidney calculus) were all above PR = 1.24 and significantly higher for the PKU cohort (p ≤.001). The highest adjusted PR were for renal insufficiency with hypertension (PR [95% CI]: 2.20 [1.60–3.00]; p <.0001) and overweight (PR [95%CI]: 2.06 [1.85–2.30]; p <.0001). Conclusions The prevalence of selected comorbidities across several organ systems is significantly higher among PKU patients than for general population controls. Regular screening for common co-morbidities may be warranted as part of PKU management. [ABSTRACT FROM AUTHOR]