A 3-year follow-up study of outcomes associated with patterns of traditional acute and preventive migraine treatment: An administrative claims-based cohort study in the United States.

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.

Clinical Outcomes and Healthcare Resource Utilization for Gastrointestinal Acute Graft-versus-Host Disease after Allogeneic Transplantation for Hematologic Malignancy: A Retrospective US Administrative Claims Database Analysis.

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.

Prevalence of comorbid conditions among adult patients diagnosed with phenylketonuria.

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.

Patients' Experiences During the Long Journey Before Initiating Migraine Prevention with a Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody (mAb).

INTRODUCTION: Migraine is under-diagnosed and under-treated. Many people with migraine do not seek medical care, and those who do may initially receive a different diagnosis and/or be dissatisfied with provided care on their journey before treatment with a CGRP-mAb (calcitonin-gene-related-peptide monoclonal antibody). METHODS: This is a cross-sectional, self-reported, online survey of subjects in Lilly's Emgality® Patient Support Program in 2022. Questionnaires collected insights into subjects' prior experiences with migraine and interactions with healthcare professionals before receiving CGRP-mAbs. RESULTS: Of the 250 participants with episodic and 250 with chronic migraine, 90% were female and white with a mean age of 26.2 years (± 11.9) at diagnosis and 40.6 (± 12.0) years at survey enrollment. Many participants (71%) suspected they had migraine before diagnosis, with 31% reluctant to seek help. Of these, approximately one-third were unaware of treatment, did not think that a physician could do anything more for migraine, would not take them seriously, or were reluctant due to a previous unhelpful experience. Participants mainly received information from friends/family (47%) or the internet (28%). Participants initially sought treatment due to an increase in migraine frequency (77%), attacks interfering with work or school (75%), or increased pain intensity (74%). Subjects saw a mean of 4.1 (± 4.3) healthcare providers before migraine diagnosis, and 20% of participants previously received a different diagnosis. Participants reported migraine causes included stress/anxiety/depression (42%), hormonal changes (30%), nutrition (20%), and weather (16%). Acute treatment of migraine included prescription (82%) and over-the-counter (50%) medications, changes in nutrition (62%), adjusting fluid intake (56%), and relaxation techniques (55%). Preventive medications included anticonvulsants (61%), antidepressants (44%), blood pressure-lowering medications (43%), and botulinum toxin A injections (17%). Most discontinuations were due to lack of efficacy or side effects. CONCLUSION: People with migraine describe reluctance in seeking health care, and misunderstandings seem common especially in the beginning of their migraine journey. Graphical abstract available for this article.

Health care resource utilization and direct costs incurred over 24 months after initiating galcanezumab or standard-of-care preventive migraine treatments in the United States.

BACKGROUND: Health care resource utilization (HCRU) and direct costs incurred over 12 months following initiation of galcanezumab (GMB) or standard-of-care (SOC) preventive migraine treatments have been evaluated. However, a gap in knowledge exists in understanding longer-term HCRU and direct costs. OBJECTIVE: To compare all-cause and migraine-related HCRU and direct costs in patients with migraine initiating GMB or SOC preventive migraine treatments over a 24-month follow-up. METHODS: This retrospective study used Optum deidentified Market Clarity Data. The study included adults diagnosed with migraine, with at least 1 claim for GMB or SOC preventive migraine therapy (September 2018 to March 2020), with continuous enrollment for 12 months before and 24 months after (follow-up) the index date (date of first GMB or SOC claim). Propensity score (PS) matching (1:1) was used to balance cohorts. All-cause and migraine-related HCRU and direct costs for GMB vs SOC cohorts were reported as mean (SD) per patient per year (PPPY) over a 24-month follow-up and compared using a Z-test. Costs were inflated to 2022 US$. RESULTS: After PS matching, 2,307 patient pairs (mean age: 44.4 years; female sex: 87.3%) were identified. Compared with the SOC cohort, the GMB cohort had lower mean (SD) PPPY all-cause office visits (17.9 [17.7] vs 19.1 [18.7]; P = 0.023) and migraine-related office visits (2.6 [3.3] vs 3.0 [4.7]; P = 0.002) at follow-up. No significant differences were observed between cohorts in other all-cause and migraine-related events assessed including outpatient visits, emergency department (ED) visits, inpatient stays, and other medical visits. The mean (SD) costs PPPY were lower in the GMB cohort compared with the SOC cohort for all-cause office visits ($4,321 [7,518] vs $5,033 [7,211]; P < 0.001) at follow-up. However, the GMB cohort had higher mean (SD) PPPY all-cause total costs ($24,704 [30,705] vs $21,902 [28,213]; P = 0.001) and pharmacy costs ($9,507 [12,659] vs $5,623 [12,605]; P < 0.001) compared with the SOC cohort. Mean (SD) costs PPPY were lower in the GMB cohort for migraine-related office visits ($806 [1,690] vs $1,353 [2,805]; P < 0.001) compared with the SOC cohort. However, the GMB cohort had higher mean (SD) PPPY migraine-related total costs ($8,248 [11,486] vs $5,047 [9,749]; P < 0.001) and migraine-related pharmacy costs ($5,394 [3,986] vs $1,761 [4,133]; P < 0.001) compared with the SOC cohort. There were no significant differences between cohorts in all-cause and migraine-related costs for outpatient visits, ED visits, inpatient stays, and other medical visits. CONCLUSIONS: Although total costs were greater for GMB vs SOC following initiation, changes in a few categories of all-cause and migraine-related HCRU and direct costs were lower for GMB over a 24-month follow-up. Additional analysis evaluating indirect health care costs may offer insights into further cost savings incurred with preventive migraine treatment.

Treatment patterns of galcanezumab versus standard of care preventive migraine medications over 24 months: a US retrospective claims study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Availability of tobacco and alcohol products in Los Angeles community pharmacies.

The availability of tobacco and alcohol products in community pharmacies contradicts the pharmacists' Code of Ethics and presents challenges for a profession that is overwhelmingly not in favor of the sale of these products in its practice settings. The primary aim of this study was to estimate the proportion of pharmacies that sell tobacco products and/or alcoholic beverages and to characterize promotion of these products. The proportion of pharmacies that sell non-prescription nicotine replacement therapy (NRT) products as aids to smoking cessation also was estimated. Among 250 randomly-selected community pharmacies in Los Angeles, 32.8% sold cigarettes, and 26.0% sold alcohol products. Cigarettes were more likely to be available in traditional chain pharmacies and grocery stores than in independently-owned pharmacies (100% versus 10.8%; P < 0.001), and traditional chain drug stores and grocery stores were more likely to sell alcoholic beverages than were independently-owned pharmacies (87.5% vs. 5.4%; P < 0.001). Thirty-four (41.5%) of the 82 pharmacies that sold cigarettes and 47 (72.3%) of the 65 pharmacies that sold alcohol also displayed promotional materials for these products. NRT products were merchandised by 58% of pharmacies. Results of this study suggest that when given a choice, pharmacists choose not to sell tobacco or alcohol products.

A Real-world Claims Data Analysis of Meningococcal Serogroup B Vaccine Series Completion and Potential Missed Opportunities in the United States.

BACKGROUND: In the United States, meningococcal serogroup B (MenB) vaccination is recommended for 16-23-year-olds based on shared clinical decision-making. We estimated series completion among individuals initiating MenB vaccination for the 2 available vaccines: MenB 4-component (MenB-4C, doses at 0 and ≥1 month) and MenB factor H binding protein (MenB-FHbp, doses at 0 and 6 months). METHODS: This retrospective health insurance claims data analysis included 16-23-year-olds who initiated MenB vaccination (index date) during January 2017 to November 2018 (MarketScan Commercial Claims and Encounters Database) or January 2017 to September 2018 (MarketScan Multi-State Medicaid Database) and had continuous enrollment for ≥6 months before and ≥15 months after index. The main outcome was MenB vaccine series completion within 15 months. Among noncompleters, preventive care/well-child and vaccine administrative office visits were identified as potential missed opportunities for series completion. Robust Poisson regression models identified independent predictors of series completion. RESULTS: In the Commercial (n = 156,080) and Medicaid (n = 57,082) populations, series completion was 56.7% and 44.7%, respectively, and was higher among those who initiated MenB-4C versus MenB-FHbp (61.1% versus 49.8% and 47.8% versus 33.9%, respectively; both P < 0.001). Among noncompleters, 40.2% and 34.7% of the Commercial and Medicaid populations, respectively, had ≥1 missed opportunity for series completion. Receipt of MenB-4C and younger age were independently associated with a higher probability of series completion. CONCLUSIONS: Series completion rates were suboptimal but were higher among those who initiated MenB-4C. To maximize the benefits of MenB vaccination, interventions to improve completion and reduce missed opportunities should be implemented.

Diagnostic Testing of Vaginitis: Improving the Value of Care.

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.

Productivity Loss and Associated Costs Among Employed Patients Receiving Disease-Modifying Treatment for Multiple Sclerosis.

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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Higher Incidence Rates of Comorbidities in Patients with Psoriatic Arthritis Compared with the General Population Using U.S. Administrative Claims Data.

BACKGROUND: Psoriatic arthritis (PsA) is associated with multiple comorbid conditions, including cardiovascular (CV) comorbidities that impose a considerable burden on patients. Effective management of PsA requires an understanding of comorbidity profiles. OBJECTIVE: To compare the frequency and incidence rates of comorbidities and hospitalizations among newly diagnosed PsA patients and a matched general population without PsA, using large national claims databases in the United States. METHODS: This retrospective observational study used MarketScan databases from January 1, 2008, to September 30, 2015, to identify adult patients with newly diagnosed PsA (i.e., no PsA diagnosis during the 1 year before the first observed PsA diagnosis). The earliest date of PsA diagnosis was defined as the index date. Patients with no PsA diagnosis any time during the study period (controls) were directly matched to PsA patients with demographic characteristics. All patients had ≥ 2 years of medical and pharmacy coverage before the index date and ≥ 1 year of follow-up. Incident rates per 100 person-years for comorbidities of interest were evaluated. The hazard ratios of having various comorbid conditions for PsA patients were estimated by Cox proportional hazards models. All-cause and CV-related hospitalizations during the follow-up period were evaluated. RESULTS: A total of 14,898 PsA patients and 35,037 matched controls met the study criteria. Compared with controls, PsA patients had a higher risk of CV disorders (incidence rate = 6.5 vs. 5.8; HR = 1.46; 95% CI = 1.37-1.56) and a higher risk of the majority of the specific CV disorders (hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, peripheral vascular disease). PsA patients also had a higher risk for any autoimmune disease (incidence rate = 8.4 vs. 1.6; HR = 18.26; 95% CI = 17.18-19.40) and most autoimmune categories (psoriasis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, and other autoimmune disorders). Rates of other PsA-related comorbidities (diabetes, anxiety, fatigue, smoking, alcohol use, obesity or overweight, depression, osteoporosis, uveitis, eczema, and gout) were also significantly higher for PsA patients. The all-cause hospitalization rate was higher among PsA patients than controls (24.9% vs. 16.2%; P < 0.001). The CV-related hospitalization rate varied depending on whether the CV condition was the primary discharge diagnosis only or was any diagnosis on the inpatient claims. The rates of coronary artery disease hospitalizations were significantly higher in PsA patients than in controls with both methods of analysis (primary diagnosis: 0.8% vs. 0.5%; P < 0.001; nonprimary diagnosis: 3.2% vs. 2.2%; P < 0.001). CONCLUSIONS: This retrospective U.S.-based claims study found that PsA patients had a high comorbidity burden. Compared with the non-PsA population, PsA patients were associated with a higher incidence of CV comorbidities, autoimmune diseases, and other PsA-related comorbidities and a higher rate of all-cause and CV-related hospitalizations. Understanding these comorbidity profiles may provide insight on the effect of comorbid conditions on disease management and health care utilization associated with PsA. DISCLOSURES: This study was funded by Novartis. Kaine is a paid consultant for Novatis. Hur and Palmer are Novartis employees and stockowners. Song and Kim work for Truven Health Analytics, which received funding from Novartis to conduct this study.

Evaluation of the comorbidity burden in patients with ankylosing spondylitis using a large US administrative claims data set.

Comorbidities among US patients with ankylosing spondylitis (AS) are inadequately understood. This study compared the prevalence and incidence of comorbidities between patients with AS and matched controls using national claims databases. Adults enrolled in the MarketScan Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2012 and December 31, 2014 were included. Patients had to have ≥ 1 AS diagnosis in 2013; the first AS diagnosis in 2013 was assigned as the index date. Control patients without AS were matched to AS patients on age, geographic region, index calendar year, and sex. Comorbidities were evaluated in AS patients and matched controls during the baseline and follow-up periods (before and after the index date, respectively). Hazard ratios of developing new comorbidities were estimated using Cox proportional hazard models adjusted for patients' characteristics. A total of 6679 patients with AS were matched to 19,951 control patients. In addition to extra-articular manifestations of AS (inflammatory bowel disease [IBD], psoriasis, uveitis), a higher proportion of AS patients had asthma, cardiovascular disease, depression, dyslipidemia, gastrointestinal ulcers, malignancies, multiple sclerosis, osteoporosis, sleep apnea, and spinal fractures during the baseline period than matched controls. After AS diagnosis, a higher proportion of patients developed newly diagnosed cases of cardiovascular diseases, depression, osteoporosis, spinal fracture, IBD, psoriasis, and uveitis than matched controls. In this real-world, US claims-based study, patients with AS were shown to have significantly more comorbidities than matched controls.

Absenteeism and Indirect Economic Burden Associated With Primary and Secondary Hypogonadism: A Retrospective Matched Cohort Analysis of Employed, Commercially Insured Patients in the U.S.

OBJECTIVE: The aim of this study was to evaluate the indirect economic burden incurred by patients with primary and secondary hypogonadism (HG) compared with non-HG controls using real-world data. METHODS: In this retrospective cohort study using a large US administrative claims database, adult males with primary or secondary HG were selected from 2010 to 2014. Non-HG controls had no evidence of HG from 2009 to 2014 and were matched on age, insurance type, and geographic region to HG patients. Outcomes included absenteeism and associated costs. RESULTS: HG (vs non-HG) patients had a significant 15% increase in nonrecreational absenteeism hours (adjusted odds ratio 1.15, P = 0.002) and associated costs ($2152 vs $1172, P < 0.001) post-index after adjusting for pre-period differences. CONCLUSION: The indirect economic burden of HG is significant. Further research is needed to test whether treatment with testosterone can help alleviate the indirect burden associated with HG.

Healthcare Utilization and Direct Costs in Patients with Ankylosing Spondylitis Using a Large US Administrative Claims Database.

INTRODUCTION: In addition to the considerable patient and societal burdens, the financial burdens of ankylosing spondylitis (AS) are substantial. Understanding both all-cause and AS-specific direct costs in patients with AS is important if we are to understand the financial impact on patients with AS and payers in the United States. This study assessed both all-cause and AS-specific healthcare utilization and direct costs in US patients with AS using administrative claims data. METHODS: Adults aged ≥ 18 years enrolled in the MarketScan® Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2013, and December 31, 2013, were included. Patients had continuous enrollment with medical and pharmacy benefits for ≥ 12 months before and after the index date (first diagnosis). Non-AS controls were matched up to 5:1 to patients with AS on age, geographic region, index calendar year, and sex. All-cause and AS-specific healthcare utilization and direct costs were measured during the follow-up period and reported as per patient per year. RESULTS: Patients with AS (N = 6679) had significantly higher rates of total all-cause inpatient admission (12% vs 6%), emergency department visits (23% vs 15%), nonhospital-based outpatient visits (100% vs 84%), hospital-based outpatient visits (68% vs 46%), other outpatient services (97% vs 81%), and medication use (97% vs 82%) compared with matched controls (N = 19,951). Patients with AS had approximately tenfold higher median total healthcare costs than matched controls ($24,978 vs $2139 per patient per year), largely driven by increased outpatient and pharmacy costs; P < 0.05 for all comparisons. The median (IQR) total AS-specific healthcare costs were $10,250 ($774, $28,824). CONCLUSION: In this analysis of claims data, increased outpatient and pharmacy costs were key contributors to higher all-cause total healthcare costs in US patients with AS. FUNDING: Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Evaluation of the comorbidity burden in patients with ankylosing spondylitis treated with tumour necrosis factor inhibitors using a large administrative claims data set.

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.

Costs of Disease Relapses Among Individuals with Granulomatosis, with Polyangiitis, or Microscopic Polyangiitis in the United States.

INTRODUCTION: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are two related forms of systemic vasculitis. Patients with these conditions often experience relapses affecting various body systems. Here we describe rates of relapse and review healthcare costs resulting from relapse among patients with GPA/MPA. METHODS: Two groups of patients with GPA and MPA were selected from the MarketScan claims databases between 2011 and 2013 based on diagnosis codes. Patients were followed for 12 months to identify relapses based on an algorithm of diagnoses in medical and medication claims. Relapses were categorized into one of the following groups: renal relapse, pulmonary relapse, other relapse-associated condition relapse, GPA or MPA utilization relapse, and mixed relapse. RESULTS: The final sample of patients with GPA and MPA consisted of 2707 and 740 patients, respectively. In both groups, approximately one-quarter of patients experienced relapse during the 12-month follow-up period. The mean all-cause healthcare costs in the 4-month period after relapse were $38,313 (SD, $54,120) for patients with GPA and $35,947 (SD, $48,065) for patients with MPA. In both groups, renal relapses were the costliest. Costs during the 4 months immediately following relapses were substantially higher than what could be expected over a 4-month follow-up among patients who did not experience relapse based on 12-month all-cause costs (GPA, $32,005 [SD, $64,570]; MPA, $61,044 [SD, $125,093]). CONCLUSIONS: Relapses are common among patients with GPA and MPA, and treatment of relapses can be costly. More effective therapies are needed to prevent relapses. FUNDING: Genentech, Inc.

Societal burden of cluster headache in the United States: a descriptive economic analysis.

AIM: To estimate direct and indirect costs in patients with a diagnosis of cluster headache in the US. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Factors Associated with Direct Health Care Costs Among Patients with Migraine.

BACKGROUND: Migraine imposes substantial economic burden on patients and the health care system. Approximately 18% of women and 6% of men suffer from migraine in the United States. This is a heterogeneous group, and little data are available to evaluate factors associated with migraine costs. OBJECTIVE: To evaluate characteristics associated with high costs among commercially insured patients with migraine. METHODS: This retrospective analysis identified patients with migraine in the Truven Health MarketScan Research Databases between January 2008 and June 2013. Patients were required to have 12 months continuous enrollment before and after migraine diagnoses and/or migraine-specific medications (index date). Patients with costs greater than the top 25th percentile of all-cause costs during the 12-month post-index period were classified into the upper quartile (UQ) cohort. Multiple logistic regression was used to evaluate demographic and clinical factors associated with being in the UQ cohort, and generalized linear models were used to estimate the incremental costs by select factors after controlling for other covariates. RESULTS: In the total population, 857,073 patients (mean [SD] age: 43.2 [12.5] years), were included, with 83.2% females. Average post-index annual all-cause costs were $13,045 (SD = $25,328) with the top 25th percentile of costs at $14,120. Overall, 44.4% and 54.8% of patients had ≥ 1 pre-index claim for opioids and triptans, respectively. Patients with ≥ 2 migraine-related emergency room visits were twice as likely to be in the UQ cohort (OR = 2.13, 95% CI = 2.02-2.25; P < 0.05) and incurred $3,125 incremental all-cause costs compared with those with < 2 visits. Patients who visited a neurologist were 33.0% more likely to be in the UQ cohort and had significantly higher adjusted all-cause costs ($11,794 vs. $9,868, P < 0.05). Opioid users had a 1.5-3 times increased likelihood of being in the UQ cohort (P < 0.05); adjusted all-cause annual costs ranged from $8,888 (95% CI = $8,862-$8,914) for nonusers to $15,210 (95% CI = $15,113-$15,307) for high users (7+ claims). Patients having 7+ triptan claims were 1.2 times as likely to be in the UQ cohort compared with nonusers, with estimated costs of $11,517 (95% CI = $11,438-$11,596) for high users and $10,753 (95% CI = $10,717-$10,790) for nonusers. CONCLUSIONS: Results suggest that certain modifiable factors, such as increased acute medication use (opioids and triptans) and more migraine-related emergency room visits are associated with higher all-cause health care costs for patients with migraine. These findings could be used to identify patients who require early intervention, enhanced symptoms monitoring, and appropriate disease management. Future studies could examine the effect of disease severity on health resource utilization and costs using survey or medical record data. DISCLOSURES: This study was funded by Amgen and conducted by Truven Health Analytics. Bonafede, Cappell, and Kim are employees of Truven Health Analytics, which received compensation from Amgen for the overall conduct of the study and preparation of the manuscript. Cai was an employee of Truven Health Analytics at the time of this study. Sapra, Shah, and Desai are employees of Amgen. Katherine Widnell was an employee of Amgen when the manuscript draft was developed. Winner reports receiving research support from Allergan, Amgen, A-Z, Teva, Pfizer, Novartis, and Lilly. Study concept and design were contributed by Bonafede, Sapra, Shah, and Desai, along with Widnell and Winner. Kim and Cai took the lead in data collection, assisted by Bonafede and Cappell. Data interpretation was performed by Widnell and Winter, along with the other authors. All authors contributed to the writing and revision of the manuscript.

Examining Time to Initiation of Biologic Disease-modifying Antirheumatic Drugs and Medication Adherence and Persistence Among Texas Medicaid Recipients With Rheumatoid Arthritis.

PURPOSE: Little is known about the transition from nonbiologic disease-modifying antirheumatic drugs (DMARDs) to biologic DMARDs or about individual nonbiologic DMARD use patterns among patients with rheumatoid arthritis (RA). This study examined time to initiation of biologic DMARDs and nonbiologic DMARD medication adherence and persistence among Texas Medicaid recipients with RA taking nonbiologic DMARDs. METHODS: In this retrospective study (July 1, 2003-December 31, 2010) of the Texas Medicaid database, patients were aged 18 to 62 years at index, were diagnosed with RA (International Classification of Diseases, Ninth Revision, Clinical Modification, code 714.xx), had no claims for nonbiologic or biologic DMARDs in the preindex period, and had a minimum of 2 prescription claims for the same nonbiologic DMARD in the postindex period. Kaplan-Meier survival analysis and log-rank tests were used to compare time to initiation of biologic DMARDs according to nonbiologic DMARD type and therapy. Adherence and persistence were examined according to nonbiologic type and therapy by using ANOVA models and χ(2), Duncan, and t tests. FINDINGS: On average, patients were 47.9 (± 10.4) years of age, mostly female (89.1%) and Hispanic (55.2%). Methotrexate (MTX) and leflunomide (LEF) users took the shortest time to initiate biologic DMARDs (207 [190] days and 188 [205] days, respectively). LEF users had the highest mean adherence of 37.5% (27.5%), which was similar to MTX users (35.7% [26.9%]), whereas dual-therapy users had the lowest mean adherence at 17.1% (14.4%). Sulfasalazine users (108 [121] days) had the lowest persistence, whereas LEF (227 [231] days) and MTX (211 [222] days) users had the longest persistence. Nonbiologic DMARD monotherapy users were more adherent than dual-therapy users (32.6% [25.8%] vs 17.1% [14.4%]). IMPLICATIONS: These results should be interpreted in light of some study limitations, such as using proportion of days covered as a proxy for adherence, not having clinical data to control for RA severity, and lack of generalizability to all US populations. Given the study findings, both clinicians and other decision makers may want to investigate the potential driving factors of initiation of biologic DMARDs to provide effective RA management and consider patient education programs to enhance medication adherence and persistence to RA medications.

Clinical and Economic Burden of Antineutrophil Cytoplasmic Antibody-associated Vasculitis in the United States.

OBJECTIVE: To describe the prevalence of major relapse and healthcare costs among patients with granulomatosis with polyangiitis (GPA); to find patients with microscopic polyangiitis (MPA) in administrative databases, because no MPA diagnosis code exists; and to describe the clinical and economic burden associated with MPA. METHODS: Adults (≥ 18 yrs) with ≥ 2 diagnoses of GPA [International Classification of Diseases-9-Clinical Modification (ICD-9-CM 446.4)] during 2009-2013 were extracted from the Truven Health MarketScan Commercial and Medicare Supplemental databases. Evidence of major relapse (based on the Birmingham Vasculitis Activity Score) and healthcare costs were collected during 12-month and 24-month followup periods. Adults with ≥ 2 diagnoses of unspecified arteritis (ICD-9-CM 447.6) were found as potential patients with MPA and additional criteria based on clinical input were applied to refine the sample. Major relapse-associated conditions and healthcare costs in the 6 months pre- and post-diagnosis were measured. Costs were inflated to 2013 US$. RESULTS: A total of 2784 patients with GPA were found and 18.7% experienced a major relapse in the 12-month followup period. The patients with a major relapse incurred higher average all-cause (12-month: $88,065 vs $30,682; p < 0.0001) and GPA-related costs (12-month: $61,636 vs $15,748; p < 0.0001) than patients without a relapse. Trends were consistent over the 24-month followup period. There were 612 incident patients with MPA. Following MPA diagnosis, healthcare costs nearly doubled ($30,166 vs $56,642; p < 0.0001). CONCLUSION: In a real-world setting, patients with GPA who experience major relapse have higher economic burden, compared to patients without a relapse. MPA diagnosis was associated with nearly a 2-fold increase in healthcare costs.