Economic Burden among Patients with Vitiligo in the United States: A Retrospective Database Claims Study.

Patients with vitiligo incur direct and indirect costs associated with their condition; however, data regarding the economic burden of vitiligo are scarce and outdated. In this retrospective cohort analysis of the Merative MarketScan Commercial Database, healthcare costs and healthcare resource utilization (HCRU) were evaluated among United States patients with vitiligo. Patients with vitiligo were matched (1:2) with individuals without vitiligo (controls) between January 2007 and December 2021. Outcomes included all-cause and vitiligo-related costs (2021 dollars) and all-cause HCRU, including mental health-related HCRU, during a 1-year postindex period. Subgroup analyses were completed for patients on vitiligo treatments with systemic effects (such as phototherapy and oral steroids) or a new mental health diagnosis. The analysis was focused solely on direct costs. Baseline demographics were well-balanced between matched vitiligo (49,512) and control (99,024) cohorts. Patients with vitiligo incurred significantly higher all-cause ($15,551 vs $7735) and vitiligo-related ($3490 vs $54) costs than controls (P < .0001). All-cause and mental health-related HCRU were also significantly higher among patients with vitiligo (P < .0001). Differences in all-cause and vitiligo-related healthcare costs remained significantly higher in patients on treatments with systemic effects/mental health diagnoses than in controls (P < .0001). Taken together, healthcare costs and HCRU were significantly higher among patients with vitiligo than among controls.

A Novel Low-Cost Technique to Allow for Jet Ventilation.

BACKGROUND/OBJECTIVE: Traditional jet ventilation requires the use of a catheter that is inserted either through an endotracheal tube or laryngoscope. Specially designed laryngoscopes with a built-in luer lock adapter to which the high-pressure tubing may be attached exist but are not always available. We present our experience with an adapter which allows connection of the high-pressure tubing to the suction side port of suitable laryngoscopes that is easily assembled using readily available materials in the operating room. METHOD: We designed a jet ventilator adapter using a high-pressure jet ventilation tubing assembly and a 3-way stopcock extension set which we have used for the past 13 years. A retrospective case series of all adult patients who underwent direct laryngoscopy and/or bronchoscopy using this jet ventilation adapter between January 2017 and August 2021 was performed. RESULT: A total of 100 consecutive patients underwent laryngoscopy and bronchoscopy using jet ventilation between January 2017 and August 2021 was identified. The mean age was 56.3 years, and the mean BMI was 31.2. The most common diagnoses were idiopathic subglottic/tracheal stenosis (46.4%), acquired tracheal stenosis (34.1%), and acquired subglottic stenosis (14.8%). The median duration of the surgical procedure was 53 minutes with an interquartile range of 23. The CO2 laser was used in all cases. There was no disconnection of the adapter, episodes of postoperative respiratory compromise, or extraluminal air on chest radiography for any of our cases. Oxygen saturations remained above 90% intraoperatively for all cases. CONCLUSION: Our simple jet ventilator adapter connects the jet ventilator to the suction side port of suitable laryngoscopes and eliminates the need for a jet ventilation catheter or specialized laryngoscope at a minimal cost.

COVID-19 telehealth preparedness: a cross-sectional assessment of cardiology practices in the USA.

Aim: The COVID-19 pandemic forced medical practices to augment healthcare delivery to remote and virtual services. We describe the results of a nationwide survey of cardiovascular professionals regarding telehealth perspectives. Materials & methods: A 31-question survey was sent early in the pandemic to assess the impact of COVID-19 on telehealth adoption & reimbursement. Results: A total of 342 clinicians across 42 states participated. 77% were using telehealth, with the majority initiating usage 2 months after the COVID-19 shutdown. A variety of video-based systems were used. Telehealth integration requirements differed, with electronic medical record integration being mandated in more urban than rural practices (70 vs 59%; p < 0.005). Many implementation barriers surfaced, with over 75% of respondents emphasizing reimbursement uncertainty and concerns for telehealth generalizability given the complexity of cardiovascular diseases. Conclusion: Substantial variation exists in telehealth practices. Further studies and legislation are needed to improve access, reimbursement and the quality of telehealth-based cardiovascular care.

As the COVID-19 pandemic was just beginning, the American College of Cardiology administered a survey to cardiology professionals across the USA regarding their preparedness for telehealth and video-visits. The results demonstrated rapid adoption of video based telehealth services, however revealed uncertainty for how to best use these services in different practice settings. Many providers expressed concerns about how these visits will be compensated, but fortunately federal agencies have dramatically changed the way telehealth is reimbursed as the pandemic has progressed. Further studies are needed to explore the impact of telehealth on healthcare inequality, however we hope that rather it serves to increase healthcare access to all.

Validation of the Physician's Global Assessment of Fingernail Psoriasis by Rheumatologists Treating Psoriatic Arthritis.

OBJECTIVES: This study aimed to assess the content validity and reliability of the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) by rheumatologists treating patients with psoriatic arthritis. METHODS: There were 3 stages of analyses with 3 clinician cohort groups. Stage 1 (concept confirmation) included rheumatologist qualitative data (cohort 1) to establish content validity, acceptability, utility, and feasibility of the PGA-F in assessing nail severity. Quantitative information regarding the response category utilization in nail abnormalities was assessed by photographs. Stage 2 (inter-rater reliability) involved quantitative analysis of PGA-F data from study investigators, including rheumatologists, involved in a phase III clinical study (cohort 2) and a cohort of newly recruited rheumatologists (cohort 3). Stage 3 included known-groups validity. RESULTS: Qualitative analyses identified consensus that the PGA-F severity levels are comprehensive of real-world patient symptoms and the instrument is simple to use and understand. Psychometric analyses support the PGA-F as a clinical outcome assessment tool. Inter-rater reliability showed rheumatologist agreement across the fingernail psoriasis severity spectrum. They were monotonically ordered by the hypothesized severity structure with excellent fit to the clinicians who evaluated them. Agreement on the rank order of the severity of the photographs in this target rheumatologist population was consistent with previous reports by dermatologists. CONCLUSIONS: The PGA-F was shown to be usable by rheumatologists to measure patients along the full range of the fingernail psoriasis severity spectrum, have a strong relationship with a conceptually similar reference measure, differentiate among patients based on fingernail psoriasis severity, and detect category severity change over a 24-week period.

Impact of PASI response on work productivity and the effect of risankizumab on indirect costs using machine learning in patients with moderate-to-severe psoriasis.

OBJECTIVES: To compare the impact of Psoriasis Area and Severity Index (PASI) response on total work productivity impairment (TWPI) in patients with moderate-to-severe psoriasis; to compare TWPI and associated indirect costs among patients treated with risankizumab, adalimumab, ustekinumab, and placebo. METHODS: Data from REVEAL (adalimumab phase III trial) were used to assess differences in trial-observed TWPI across PASI response cohorts. A machine learning model used REVEAL data to predict TWPI for patients in the risankizumab trials. These values were used to estimate work loss hours and work impairment-related indirect costs for each treatment cohort. RESULTS: Among REVEAL patients (N = 741), TWPI in the PASI 100, 90-99, 75-89 cohorts was lower than the PASI <75 cohort (p < .05); mean TWPI was lowest with PASI 100 (1.7%) vs. 90-99 (2.5%) vs. 75-89 (4.8%) vs. <75 (14.3%). There was a significant (p < .0001) monotonic relationship between higher PASI response and lower TWPI. In the risankizumab trials (N = 2046), incremental TWPI relative to risankizumab was 3.4%/week for ustekinumab/adalimumab, and 17.1%/week for placebo; incremental indirect cost savings for risankizumab were $2179/year vs. adalimumab, $2321/year vs. ustekinumab, and $11,284/year vs. placebo. CONCLUSIONS: Higher PASI responses were associated with reduced TWPI. Risankizumab was associated with less work impairment/indirect costs vs. ustekinumab/adalimumab/placebo.

Impact of Endometriosis on Fatigue and Productivity Impairment in a Cross-Sectional Survey of Canadian Women.

OBJECTIVE: To evaluate fatigue burden and productivity impairments in Canadian women with a self-reported diagnosis of endometriosis (DxE). METHODS: From December 2018 to January 2019, Canadian women aged 18-49 years completed an online survey assessing fatigue via the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 6a questionnaire. Fatigue T-scores were compared between women with and without a DxE, by age and endometriosis symptom severity, using t tests. Women with a DxE completed the Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) questionnaire. The effects of age and hallmark endometriosis symptoms on productivity impairments were assessed via analysis of variance. RESULTS: Survey data included 2004 women with and 26 528 women without a DxE. Mean fatigue T-scores were 58.5 ± 10.1 in women with a DxE and 59.2 ± 10.1 in women with hallmark endometriosis symptoms (i.e., menstrual or non-menstrual pelvic pain/cramping, dyspareunia) versus 55.2 ± 9.4 in women without a DxE (both P < 0.001). Women with moderate or severe endometriosis symptoms had a mean T-score of 61.2 ± 9.4 versus 55.9 ± 10.1 for women with mild symptoms (P < 0.001). Women with moderate or severe hallmark endometriosis symptoms had mean T-scores of 59.6-62.9 versus 57.0-58.2 for women with mild or no symptoms (all comparisons P < 0.01). Women with a DxE reported 17.1% of work time missed, 41.8% impaired work ability, 46.5% overall work impairment, and 41.4% activity impairment per the WPAI-SHP. Women with a DxE aged 30-34 and 35-39 years consistently experienced the greatest effects of fatigue and productivity impairments. CONCLUSIONS: Canadian women with a DxE experience a substantial fatigue burden and significant productivity impairments.

Short-acting and Long-acting Opioids Utilization among Women Diagnosed with Endometriosis in the United States: A Population-based Claims Study.

STUDY OBJECTIVE: To determine the prevalence and pattern of opioid use in endometriosis and the characteristics of patients prescribed an opioid using medical insurance claims data. DESIGN: We performed a retrospective cohort analysis of data from the Truven MarketScan Commercial database for the period of January 1, 2011 to December 31, 2016. SETTING: The Truven database includes inpatient, outpatient, and prescription claims covering more than 115 million unique individuals and over 36 million inpatient hospital discharges across multiple payer types and all 50 states. PATIENTS: Women with endometriosis were defined as those with 1 inpatient or 2 outpatient codes for endometriosis. INTERVENTIONS: No interventions were assigned. Women who filled an opioid prescription within 12 months of diagnosis were placed in the opioid cohort and women who did not fill an opioid prescription were placed in the nonopioid cohort. MEASUREMENTS AND MAIN RESULTS: Baseline characteristics were evaluated 12 months preindex (date of the first diagnosis) and opioid use was assessed for 12 months after the index date. The dataset included 58 472 women with endometriosis. Of these, 61.7% filled an opioid prescription during the study period. More than 95% filled prescriptions for short-acting opioids (SAOs) only, 4.1% filled prescriptions for both SAOs and extended-release/long-acting opioids (LAOs), and 0.6% filled prescriptions for LAOs only. Patients who filled an opioid prescription had higher baseline comorbidities (especially gynecologic and chronic pain comorbidities) and endometriosis-related medication use compared with patients who did not fill an opioid prescription during the study period. Patients who filled both LAO and SAO prescriptions had the highest total days' supply of opioids, the proportion of days covered by prescriptions, and morphine equivalent daily dose. These patients also had the highest proportions of opioid switching and dose augmentation. Statistical trends in data were not substantially altered when analyses excluded patients with chronic pain comorbidities or surgical opioid prescriptions. CONCLUSION: Although opioids are not a recommended treatment for endometriosis, more than half of our cohort filled an opioid prescription within 1 year after a first recorded diagnosis of endometriosis. Patients who filled an opioid prescription tended to use more endometriosis-related medications and have a higher comorbidity burden. Additional research is necessary to better understand the reasons and outcomes associated with opioid utilization in endometriosis and to determine if there is a more effective pain management treatment plan for patients taking opioids.

The impact of high-risk and chronic opioid use among commercially insured endometriosis patients on health care resource utilization and costs in the United States.

OBJECTIVES: Evaluate all-cause and endometriosis-related health care resource utilization and costs among newly diagnosed endometriosis patients with high-risk versus low-risk opioid use or patients with chronic versus non-chronic opioid use. METHODS: A retrospective analysis of IBM MarketScan® Commercial Claims data from 2009 to 2018 was performed for females aged 18 to 49 with newly diagnosed endometriosis (International Classification of Diseases, Ninth Edition code: 617.xx; International Classification of Diseases, Tenth Edition code: N80.xx). Two sub-cohorts were identified: high-risk (⩾1 day with ⩾90 morphine milligram equivalents per day or ⩾1-day concomitant benzodiazepine use) or chronic opioid utilization (⩾90-day supply prescribed or ⩾10 opioid prescriptions). High-risk or chronic utilization was evaluated during the 12-month assessment period after the index date. Index date was the first opioid prescription within 12 months following endometriosis diagnosis. All outcomes were assessed over 12-month post-assessment period while adjusting for demographic and clinical characteristics. RESULTS: Out of 61,019 patients identified, 18,239 had high-risk opioid use and 5001 chronic opioid use. Health care resource utilization drivers were outpatient visits and pharmacy fills, which were higher among high-risk versus low-risk patients (outpatient visits: 17.49 vs 15.51; pharmacy fills: 19.58 vs 16.88, p < 0.0001). Chronic opioid users had a higher number of outpatient visits (19.53 vs 15.00, p < 0.0001) and pharmacy fills (23.18 vs 16.43, p < 0.0001) compared to non-chronic opioid users. High-risk opioid users had significantly higher all-cause health care costs compared to low-risk opioid users (US$16,377 vs US$13,153; p < 0.0001). Chronic opioid users also had significantly higher all-cause health care costs compared to non-chronic opioid users (US$20,930 vs US$12,272; p < 0.0001). Similar patterns were observed among endometriosis-related HCRU, except pharmacy fills among high-risk and chronic sub-cohorts. CONCLUSION: This analysis demonstrates significantly higher all-cause and endometriosis-related health care resource utilization and total costs for high-risk opioid users compared to low-risk opioid users among newly diagnosed endometriosis patients over 1 year. Similar trends were observed for comparing chronic opioid users with non-chronic opioid users, except for endometriosis-related pharmacy fills and associated costs.

Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.

BACKGROUND: Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials. OBJECTIVES: The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain. METHODS: In a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18-49 years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150 mg once daily, elagolix 200 mg twice daily, or placebo for 6 months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated. RESULTS: The analysis included 871 women, mean age 31.5 years. Internal consistency supported a single concept (Cronbach's alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p = 0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p < 0.0001). CONCLUSIONS: PROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.

Healthcare Resource Use and Costs Associated with Opioid Initiation Among Patients with Newly Diagnosed Endometriosis with Commercial Insurance in the USA.

INTRODUCTION: To compare all-cause and endometriosis-related healthcare resource utilization (HCRU) and healthcare costs by service categories (outpatient, inpatient, emergency room [ER], pharmacy) among patients with newly diagnosed endometriosis using opioids compared to patients with endometriosis not using opioids. METHODS: A retrospective analysis of IBM® MarketScan® Commercial Claims data from 2009 to 2018 was performed for women aged 18-49 with newly diagnosed endometriosis (International Classification of Diseases (ICD)-9 code 617.xx; ICD-10 code N80.xx) over 24 months follow-up. Patients were stratified on the basis of opioid use within 12 months post first endometriosis diagnosis date. Patients with opioid use were 1:1 matched to patients without opioid use using propensity score matching. RESULTS: A total of 85,329 female patients with a new endometriosis diagnosis were identified and 48,470 patients (24,235 opioid and 24,235 non-opioid users) remained after inclusion-exclusion criteria and matching. Opioid patients had an estimated mean 30.33 outpatient visits, 29.59 pharmacy fills, 0.28 inpatient visits, 0.65 ER visits, and total length of stay (LOS) was 1.01 days. Non-opioid patients had an estimated mean 27.94 outpatient visits, 22.06 pharmacy fills, 0.23 inpatient visits, 0.42 ER visits, and total LOS was 0.82 days. On average, opioid patients had significantly greater all-cause HCRU compared to non-opioid patients (all p < 0.0001). Among endometriosis-related healthcare utilization, there were similar ER visits, but lower outpatient visits, inpatient visits, and total LOS and higher pharmacy fills among opioid and non-opioid patients. Estimated mean all-cause costs were higher among opioid ($26,755) vs. non-opioid ($19,302) users (p < 0.0001). A similar trend was observed for estimated mean endometriosis-related costs. CONCLUSION: This analysis observed significantly higher all-cause HCRU and costs for opioid users compared to non-opioid users among patients with newly diagnosed endometriosis. While observed endometriosis-related costs were significantly higher in opioid users compared to non-opioid users during a 24-month follow-up period, endometriosis-related HCRU varied by service categories for these two populations over this time period.

A Longitudinal Assessment of the Impact of Endometriosis on Patients' Salary Growth and Risk of Leaving the Workforce.

INTRODUCTION: This retrospective cohort study evaluated the impact of endometriosis on the risks of work loss events and salary/growth over a 5-year period. METHODS: Women aged 18-49 years with ≥ 1 endometriosis diagnosis were identified in a claims database and matched 1:1 to women without endometriosis (controls). The index date was the first endometriosis diagnosis date (endometriosis cohort) or a random date during the period of continuous eligibility (controls). Baseline characteristics were compared between cohorts descriptively. Average annual salaries were compared over the 5 years post-index using generalized estimating equations accounting for matching. Time-to-event analyses assessed risk of short-term disability, long-term disability, leave of absence, early retirement, and any event of leaving the workforce (Kaplan-Meier curves with log-rank tests). RESULTS: A total of 6851 matched pairs (mean age at index date: 38.7 years) were included in the salary growth analysis, with a subset of 1981 pairs in the risk of leaving the workforce analysis. In year 1, the endometriosis cohort had a lower average annual salary ($61,322) than controls ($64,720); salaries were lower in years 2-5 by $3697-$6600 (all p < 0.01). The endometriosis cohort experienced smaller salary growth than controls in all years, ranging from $438 vs. $1058 in year 1 to $4906 vs. $7074 in year 5 (all p < 0.05). In the Kaplan-Meier analyses, patients with endometriosis were significantly more likely than controls to leave the workforce for any reason, take a leave of absence, and use short-term disability (all log-rank tests p < 0.001). Additionally, the median number of years to each of these events was lower for the endometriosis cohort relative to the matched controls. Sensitivity analyses among patients with moderate-to-severe endometriosis and by salary brackets confirmed the primary analyses. CONCLUSIONS: Patients with endometriosis experienced lower annual salary and salary growth, as well as higher risks of work loss events, compared with matched controls.

Impact of Endometriosis Diagnostic Delays on Healthcare Resource Utilization and Costs.

INTRODUCTION: Endometriosis symptoms are nonspecific and overlap with other gynecologic and gastrointestinal diseases, leading to long diagnostic delays. The burden of endometriosis has been documented; however, little is known about the impact of diagnostic delays on healthcare costs leading up to diagnoses. The purpose of this study was to examine the economic impact of diagnostic delays on pre-diagnosis healthcare utilization and costs among patients with endometriosis. METHODS: This was a retrospective database study of adult patients with a diagnosis of endometriosis from 1 January 2004 to 31 July 2016. Patients had continuous health plan enrollment 60 months prior to and 12 months following the earliest endometriosis diagnosis and ≥ 1 pre-diagnosis endometriosis symptom (dyspareunia, generalized pelvic pain, abdominal pain, dysmenorrhea, or infertility). Patients were assigned to short (≤ 1 year), intermediate (1-3 years), or long (3-5 years) delay cohorts based on the length of their diagnostic delay (time from first symptom to diagnosis). Healthcare resource utilization and costs were calculated and compared by cohort in the 60-month pre-diagnosis period. RESULTS: A total of 11,793 patients were included in the study, of which 37.7% (4446/11,793), 27.0% (3179/11,793), and 35.3% (4168/11,793) had short, intermediate, and long delays, respectively. Patients with intermediate or long diagnostic delays had consistently more all-cause and endometriosis-related emergency visits and inpatient hospitalizations in the pre-diagnosis period than patients with short delays. Pre-diagnosis all-cause healthcare costs were significantly higher among patients with longer diagnostic delays, averaging $21,489, $30,030, and $34,460 among patients with a short, intermediate, and long delay, respectively (p < 0.001 for all pairwise comparisons). Endometriosis-related costs accounted for 12.5% ($3553/$28,376) of all-cause costs and followed a similar pattern. CONCLUSION: Patients with endometriosis who had longer diagnostic delays had more pre-diagnosis endometriosis-related symptoms and higher pre-diagnosis healthcare utilization and costs compared with patients who were diagnosed earlier after symptom onset, providing evidence in support of earlier diagnosis.

Psychometric assessment of the health-related productivity questionnaire (HRPQ) among women with endometriosis.

Objective: Endometriosis impacts health-related quality of life. The objective was to assess the validity and responsiveness of the Health-Related Productivity Questionnaire, version 2 (HRPQ). Methods: Outcome measures (Endometriosis Health Profile-30; pain scales; and global assessment) from Elaris Endometriosis I and II clinical trials (EM-I, EM-II) were used. Validity testing using Cohen's conventions was assessed. Known-groups validity was evaluated using generalized linear models comparing clinical responders, assessment of change, and the endometriosis impact. The effect size (ES) and standard error of means were calculated to evaluate responsiveness. Results: 871 and 815 women participated in the EM-I and EM-II trials. The total hours of lost work among employed women were 16.5 (±11.4) hours per week for EM-I and 15.2 (±11.3) for EM-II. The total hours of lost work among the household group were 8.3 (±8.7) hours for EM-I and 8.4 (±9.0) hours for EM-II. HRPQ discriminated between all known group assessments tested. Correlations for the HRPQ compared to other measures were small to moderate. Moderate to large ES was observed and the ability of the HRPQ to detect change was strong using patient-reported impressions. Conclusion: The HRPQ is a valid and responsive tool for evaluating patient-reported productivity at work and at home among women with endometriosis.

A survey of care pathway and health-related quality of life impact for children with central precocious puberty.

Objective: To describe the timeline to diagnosis for children with central precocious puberty (CPP) and evaluate their psychosocial and health-related quality of life (HRQoL).Methods: A cross-sectional survey was used to prospectively collect data from caregivers, recruited via the MAGIC Foundation, of children with CPP. The control (non-CPP) group was recruited from a national panel of parents/caregivers. After completing a screening survey, respondents completed a burden of illness survey. Respondents in both groups completed the Pediatric Quality of Life Inventory (PedsQL) and Patient-Reported Outcomes Measurement Information System (PROMIS) peer relationship instruments.Results: Responses from 142 caregivers of children with and 300 without CPP were assessed. Mean time to treatment after a child's visit to the pediatric endocrinologist was 220 days and time from onset of symptoms to initiating treatment was approximately 2 years. Responses to HRQoL inventories were all lower in children with CPP versus non-CPP. Adjusted mean (± standard error) PedsQL total (65.3 ± 1.8 versus 75.7 ± 1.2), Psychosocial Health Summary (62.4 ± 1.8 versus 73.4 ± 1.2), and Physical Health Summary (70.7 ± 2.2 versus 79.9 ± 1.5) scores were significantly lower (p < .01) in CPP versus non-CPP group. PROMIS peer relationship T score (± standard error) was numerically lower for the CPP versus non-CPP group (45.4 ± 1.0 versus 47.4 ± 0.7, p = .11).Conclusions: In clinical practice, there is a longer than expected delay between CPP symptom onset and referral to an endocrinologist and ultimate treatment. Children with CPP experience a substantial disease burden with a significant impact on emotional, social, and physical functioning compared with children without CPP.

Treatment patterns, health resource utilization and costs among central precocious puberty patients treated with leuprolide or histrelin: an examination of the commercial and Medicaid populations.

Aims: To compare treatment duration, healthcare resource utilization (HRU), and direct healthcare costs between patients with central precocious puberty (CPP) treated with leuprolide or histrelin, and between patients with Medicaid or commercial insurance. This information is important as it affects treatment choice and outcomes.Materials and methods: This retrospective cohort study identified commercial and Medicaid-insured CPP patients ≤12-years-old who were diagnosed between 1 January 2010 and 30 September 2014 and had ≥1 prescription for leuprolide or histrelin (first prescription = index date). Treatment patterns were measured for the duration of available data; whereas, all-cause and disease-monitoring HRU and all-cause costs were compared between treatment groups for the year following treatment initiation. Multivariable analysis was used to adjust healthcare costs for differences in baseline patient characteristics.Results: A total of 1,177 commercially-insured (907 leuprolide and 270 histrelin) and 658 Medicaid-insured (613 leuprolide and 45 histrelin) patients were identified. Mean age at treatment initiation ranged from 7.5-8.5-years-old, 11.1-20.5% of patients were male, and the mean treatment duration was over one year. Commercially-insured patients treated with histrelin used more services in general than those treated with leuprolide but had fewer office visits. Healthcare service utilization was similar between Medicaid-insured treatment groups. In both payer populations, costs were similar.Limitations: The number of Medicaid-insured patients who received a histrelin implant was low, and this may make the findings more sensitive to influence by outliers.Conclusions: Mean overall healthcare costs were similar between CPP patients treated with leuprolide and those treated with histrelin. Medicaid patients generally received less testing and were less likely to receive specialist care. Patients treated with histrelin had fewer office visits but also had a shorter overall treatment.

National Patterns of Emergency Department Use for Women with Endometriosis, 2006-2015.

Introduction: Endometriosis is a burdensome chronic condition for which conservative management is often recommended when indicated. Nonetheless, some women seek care for endometriosis in the emergency department (ED). We evaluated trends in ED visits for endometriosis from 2006 to 2015. Materials and Methods: Nationally representative estimates of ED visits for endometriosis by women aged 18-49 were extracted from the Health Care Utilization Project Nationwide Emergency Department Sample into three cohorts by calendar years 2006-2007, 2010-2011, and 2014-Q3 2015. Visits with a principal diagnosis code of endometriosis (International Classification of Disease, 9th Edition, Clinical Modification, code 617.x) were included. Patient and hospital characteristics were compared across cohorts using analysis of variance. Trends in the proportion of ED visits ending in inpatient admission and in mean charges (2015 USD) were assessed using generalized linear models controlling for patient and hospital characteristics. Results: The annual number of ED visits nationally was stable at ∼15,000 visits per year during 2006-2015. From 2006-2007 to 2014-2015, the composition of ED visits shifted away from private pay (42.0% vs. 35.3%) and uninsured (23.6% vs. 16.6%) to Medicaid (26.7% vs. 40.1%) and became more concentrated in metro-teaching hospitals (33.9% vs. 51.9%) (p < 0.001 for all). Inpatient admission rates declined from 20.1% to 9.2% (p < 0.001). Mean ED charges increased from $2458 to $4953 (p < 0.001). Conclusion: During 2006-2015, the number of ED visits for endometriosis remained stable, the inpatient admission/transfer rate declined by half, and mean charges per visit doubled.

National trends in inpatient endometriosis admissions: Patients, procedures and outcomes, 2006-2015.

INTRODUCTION: Despite guidance towards minimally invasive, outpatient procedures for endometriosis, many patients nonetheless receive inpatient care. Our objective was to assess trends in patient and hospital characteristics, surgical complications and hospital charges for women with an endometriosis-related inpatient admission in the United States. METHODS: We conducted a pooled cross-sectional analysis of Healthcare Cost and Utilization Project Nationwide Inpatient Sample data. Visits were stratified into three time-period-defined cohorts (2006-2007, 2010-2011, and 2014 through the first three quarters of 2015). Visits were included if the patient was aged 18-49 years and the primary diagnosis code was for endometriosis (International Classification of Diseases, 9th Revision code 617.xx). We evaluated counts of inpatient admissions and rates of patient and hospital characteristics. RESULTS: The number of inpatient admissions with a primary diagnosis code for endometriosis decreased by 72.8% from 2006 to 2015. At the same time, among those admitted for inpatient care for endometriosis, the proportions who had Medicaid insurance and multiple documented comorbidities increased. From 2006 to 2015, mean total hospital charges increased by 75% to $39,662 in 2015 US dollars, although average length of stay increased by <1 day. CONCLUSIONS: The number of inpatient admissions with a primary diagnosis of endometriosis decreased over the past decade, while surgical complications and associated hospital charges increased. The share of patients with multiple comorbidities increased and an increasing proportion of inpatient endometriosis admissions were covered by Medicaid and occurred at urban teaching hospitals. These findings suggest a demographic shift in patients receiving inpatient care for endometriosis towards more complex, vulnerable patients.

Health Care Utilization and Economic Burden in Patients with Central Precocious Puberty: An Assessment of the Commercially Insured and Medicaid Populations.

BACKGROUND: Central precocious puberty (CPP), early onset of puberty caused by the premature activation of the hypothalamic-pituitary-gonadal axis, is a rare disease affecting children of both sexes. There is limited evidence that quantifies the economic burden of CPP. OBJECTIVE: To characterize the health care resource utilization (HRU) and costs among patients with CPP who were treated with gonadotropinreleasing hormone (GnRH) agonists, for those insured commercially and with Medicaid. METHODS: Eligible CPP patients for this retrospective cohort analysis were aged ≤ 12 years; were diagnosed between January 1, 2010, and September 30, 2014; and had at least 1 prescription for an FDA-approved GnRH agonist: leuprolide or histrelin (first prescription = index date). CPP patients had to be continuously enrolled in the MarketScan Commercial or Medicaid Database for at least 12 months before and after the index date. Control patients were randomly selected from all eligible non-CPP patients and N:1 matched on demographic characteristics with up to 20 controls per case. Clinical comorbidities, HRU, and costs were compared between study cohorts. Health care costs were examined via multivariable analysis to adjust for baseline differences between patients and controls. Treatment patterns among CPP patients were also characterized. RESULTS: There were 1,236 CPP patients and 24,206 controls with commercial insurance and 673 CPP patients and 11,965 controls with Medicaid insurance who met the inclusion criteria. Across payers, the mean age of CPP patients ranged from 7.6 years (Medicaid) to 8.5 (commercial), and 80%-87% were female. The mean observed duration (SD) of treatment with any approved GnRH agonist was 1.51 (0.98) years for commercial patients and 1.22 (1.04) for Medicaid patients. The mean age of discontinuation among patients who ceased GnRH agonist treatment ranged from 8.7 to 9.6 years. In the first year post-index, CPP patients had a greater number of unique diagnosis codes, unique medications, and comorbid conditions than controls. They also had significantly higher all-cause and diseasemonitoring related HRU. After adjusting for baseline characteristics, CPP patients with Medicaid insurance spent 6.42 times more ($16,768 [$31,460] vs. $2,610 [$4,897]), and patients with commercial insurance spent 12.25 times more ($19,940 [$20,132] vs. $1,628 [$1,645]) on health care in the year following treatment initiation than matched controls. CONCLUSIONS: Patients with CPP have substantially more comorbidities and greater HRU and costs than their non-CPP peers. DISCLOSURES: All funding for this study was provided by AbbVie, which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Soliman and Grubb are employed by AbbVie and hold stock in AbbVie. Bonafede and Nelson are employed by IBM Watson Health, which received funding from AbbVie to conduct this study. Klein is a paid consultant of AbbVie but was not compensated for any work on development of this manuscript for publication. Portions of this work were presented at Pediatric Academic Societies (PAS) 2018 Meeting, May 5-8, 2018, in Toronto, Canada, as a poster presentation titled "Examination of Economic Burden Among Commercially Insured Patients with Central Precocious Puberty (CPP)."

Health Care Utilization and Costs Associated with Endometriosis Among Women with Medicaid Insurance.

BACKGROUND: Endometriosis is a painful chronic inflammatory disease caused by endometrial tissue implanting and growing outside the uterus, resulting in pelvic pain symptoms and subfertility. Treatment imposes a substantial economic burden on the patient and health care system. OBJECTIVE: To evaluate direct health care utilization and costs among women newly diagnosed with endometriosis compared with age-matched controls in a U.S. Medicaid population. METHODS: This retrospective cohort study used deidentified health care claims from the 2007-2015 MarketScan Multi-State Medicaid Database. Women (aged 18-49 years) newly diagnosed with endometriosis (ICD-9-CM 617.xx) during January 2008 through September 2014 were identified (date of first diagnosis = index date). Age-matched women without endometriosis (controls) were selected from the database and assigned index dates matching the distribution for endometriosis patients. Direct health care resource utilization (HCRU) and costs (medical and pharmacy) over the 12-month post-index period (2015 U.S. dollars) were computed by service category (hospitalization, emergency room visits, outpatient services, and prescriptions) and compared between study cohorts using the chi-square test for proportions and t-test for continuous variables. RESULTS: The final sample included 15,615 endometriosis patients and 86,829 matched controls. HCRU during the 12-month post-index follow-up period was significantly higher for endometriosis cases compared with controls in all measured categories. Hospital admissions occurred among 33.1% of cases and 7.2% of controls, and 65.8% of endometriosis patients were admitted for endometriosis-related surgery. Emergency room visits occurred in 71.5% of cases, and 42.2% of controls. Mean (SD) office visits were 10.4 (8.5) for endometriosis patients and 5.1 (6.9) for controls. Endometriosis patients had significantly more prescription claims than controls, 45.9 (42.0) versus 25.1 (39.1). Mean total direct health care costs were $13,670 ($29,843) for cases versus $5,779 ($23,614) for controls. All differences between cases and controls were significant at P < 0.001. CONCLUSIONS: Health care costs and resource utilization in all measured categories were higher among endometriosis cases than controls. The economic burden of endometriosis among patients with Medicaid insurance is substantial, underscoring the unmet medical need for earlier diagnosis and cost-effective treatments. DISCLOSURES: This study was funded by AbbVie and conducted by Truven Health Analytics, an IBM Company. AbbVie participated in developing the study design, data analysis and interpretation, manuscript writing and revisions, and approval for publication. Soliman and Vora are employees of AbbVie and may own AbbVie stock/stock options. Surrey has served in a consulting role on research to AbbVie and is on the speaker bureau for Ferring Laboratories. Bonafede and Nelson are employees of Truven Health Analytics, an IBM Company, which received compensation from AbbVie for the overall conduct of the study and preparation of the manuscript. Agarwal has served in a consulting role on research to AbbVie. Preliminary results of this study were previously presented in a podium session at the 2017 American Society for Reproductive Medicine Scientific Congress and Expo; October 28-November 1, 2017; San Antonio, TX.

Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA.

AIM: To assess the cost-effectiveness of elagolix versus leuprolide acetate in women with moderate to severe endometriosis pain. METHODS: A Markov model was developed. The efficacy of leuprolide acetate was derived from statistical prediction models using elagolix trial data. Model inputs were extracted from Phase III clinical trials and published literature. RESULTS: Compared with leuprolide acetate, elagolix generated positive net monetary benefit (NMB) assuming a payer's willingness-to-pay threshold of US$100,000 per quality-adjusted life year over a 1-year time horizon: US$5660 for elagolix 150 mg and US$6443 for elagolix 200 mg. The 2-year NMBs were also positive. CONCLUSION: Elagolix was cost effective versus leuprolide acetate in the management of moderate to severe endometriosis pain over 1- and 2-year time horizons. Results were robust in sensitivity analyses.