Real-World Treatment Patterns among Patients with Alopecia Areata in the USA: A Retrospective Claims Analysis.

Alopecia areata is an autoimmune disorder characterized by hair loss, for which there are few treatment options. This claims-based study characterized recent real-world treatment patterns among patients in the USA with alopecia areata, including the subtypes alopecia totalis and alopecia universalis, in the first year after diagnosis of an episode of alopecia areata. Approximately 5% of all patients (adults (age ≥ 18 years), n = 7,703; adolescents (age 12-17 years), n = 595) had alopecia totalis or alopecia universalis. Corticosteroids were the most common first-line (1L) and second-line (2L) treatments. The mean time from diagnosis of alopecia areata to initiation of 1L treatment was 2.2 days for adults and 2.6 days for adolescents; mean 1L duration was 76.9 and 64.3 days, respectively. For adults (57.5%) and adolescents (59.7%) with 2L therapy, the mean time from 1L discontinuation to 2L initiation was 57.2 and 53.6 days, respectively; the mean duration of 2L treatment was 55.5 and 50.1 days, respectively. More patients with vs without alopecia totalis or alopecia universalis initiated 2L therapy (adults: 71.9% vs 56.8%; adolescents: 71.4% vs 58.9%). The proportion of days covered during the first year post-diagnosis was 36.7% (adults) and 34.1% (adolescents). These results highlight the substantial disease burden of alopecia areata and a need for more effective treatments.

Disease-free survival as a predictor of overall survival in localized renal cell carcinoma following initial nephrectomy: A retrospective analysis of Surveillance, Epidemiology and End Results-Medicare datac.

OBJECTIVES: This study aimed to assess whether disease-free survival (DFS) may serve as a predictor for long-term survival among patients with intermediate-high risk or high risk renal cell carcinoma (RCC) post-nephrectomy when overall survival (OS) is unavailable. METHODS: The Surveillance, Epidemiology and End Results-Medicare database (2007-2016) was used to identify patients with non-metastatic intermediate-high risk and high risk RCC post-nephrectomy. Landmark analysis and Kendall's τ were used to evaluate the correlation between DFS and OS. Multivariable regression models were used to quantify the incremental OS post-nephrectomy associated with increased time to recurrence among patients with recurrence, adjusting for baseline covariates. RESULTS: A total of 643 patients were analyzed; mean age of 75 years; >95% of patients had intermediate-high risk RCC at diagnosis; 269 patients had recurrence post-nephrectomy. For patients with versus without recurrence at the landmark points of 1, 3, and 5 years post-nephrectomy, the 5-year OS were 37.0% versus 70.1%, 42.3% versus 72.8%, and 53.2% versus 78.6%, respectively. The Kendall's τ between DFS and OS post-nephrectomy was 0.70 (95% CI: 0.65, 0.74; p < 0.001). After adjusting for baseline covariates, patients with one additional year of time to recurrence were associated with 0.73 years longer OS post-nephrectomy (95% CI: 0.40, 1.05; p < 0.001). CONCLUSION: The significant positive association of DFS and OS among patients with intermediate-high risk and high risk RCC post-nephrectomy from this study supports the use of DFS as a potential predictor of OS for these patients when OS data are immature.

Trends in Prevalence and Incidence of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Among Adults and Children in a US Employer-Sponsored Insured Population.

Importance: Alopecia areata (AA) is characterized by nonscarring hair loss of the scalp, face, and/or body. Alopecia totalis (AT) and alopecia universalis (AU) involve complete loss of the scalp and body hair, respectively. The epidemiology of AA in the US remains unclear, having previously been extrapolated from older studies that were limited to specific geographic areas or clinical settings, or from self-reported data. Objective: To estimate the annual prevalence and incidence of AA and AT and/or AU (AT/AU) in the US. Design, Setting, and Participants: This retrospective, population-based cohort study was conducted from January 2016 to December 2019 and included enrollees in the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental databases and their dependents, with plan enrollment during each study calendar year and the year prior. Exposures: Prevalent cases were identified by 1 or more claims for AA or AT/AU (International Statistical Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] codes L63.x, L63.0, L63.1) during each year of interest or the year prior. Incident cases were identified by 1 or more claims for AA or AT/AU during a specific year and no diagnosis the year prior. Main Outcomes and Measures: Annual incidence and prevalence rates were calculated and stratified by age, sex, and region. National employer-sponsored insurance population estimates were obtained using population-based weights. Results: Among eligible patients (2016: n = 18 368 [mean (SD) age, 40.6 (17.9) years; 12 295 women (66.9%)]; 2017: n = 14 372 [mean (SD) age, 39.6 (17.7) years; 9195 women (64.0%)]; 2018: n = 14 231 [mean (SD) age, 38.9 (17.3) years; 8998 women (63.2%)]; 2019: n = 13 455 [mean (SD) age, 39.1 (17.4) years; 8322 women (61.9%)]), AA prevalence increased from 0.199% (95% CI, 0.198%-0.200%) in 2016 to 0.222% (95% CI, 0.221%-0.223%) in 2019. Roughly 5% to 10% of prevalent and incident cases of AA were AT/AU. The prevalence of AT/AU increased from 0.012% (95% CI, 0.012%-0.013%) to 0.019% (95% CI, 0.018%-0.019%) from 2016 to 2019. Incidence of AA per 100 000 person-years ranged from 87.39 (95% CI, 86.84-87.96) in 2017 to 92.90 (95% CI, 92.35-93.45) in 2019. Incidence of AT/AU ranged from 7.09 (95% CI, 6.94-7.25) in 2017 to 8.92 (95% CI, 8.75-9.09) in 2016. Prevalence and incidence of AA and AT/AU were higher among female vs male individuals, adults vs children and adolescents, and in the Northeast vs other regions. Conclusions and Relevance: The results of this cohort study suggest that these recent AA prevalence and incidence estimates could help improve current understanding of the disease burden. Further research is warranted to elucidate subpopulation differences and trends in AA in the broader US population.

All-cause health care resource utilization and costs among adults with alopecia areata: A retrospective claims database study in the United States.

BACKGROUND: Alopecia areata (AA) is an autoimmune disorder characterized by hair loss. Patients may present with hair loss of the scalp, eyelashes, eyebrows, and/or body. Alopecia totalis (AT), total scalp hair loss, or alopecia universalis (AU), total body hair loss, are extensive forms. Although the impact of AA on quality of life is understood, evidence of its economic burden is limited. A better understanding of the all-cause health care costs for health plans and patients with AA is critical to comprehend disease burden. OBJECTIVE: To evaluate all-cause health care resource utilization and direct health care costs in US adults with AA with or without AT or AU, vs matched control subjects. METHODS: Patients (≥ 18 years) with AA with no less than 2 claims of AA at diagnosis (October 31, 2015, to March 3, 2018) were identified in the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental databases. Patients were enrolled no less than 12 months before and after first diagnosis (index). Patients were grouped according to AT or AU status (AT/AU group) or AA without AT/AU (non-AT/AU group) and matched 1:3 to control subjects without AA/AT/AU. Summary statistics were calculated for demographic and clinical characteristics at baseline and follow-up. RESULTS: At baseline, there were 14,972 adult patients with AA and 44,916 control subjects. Of patients with AA, 1,250 and 13,722 were in the AT/AU and non-AT/AU groups, respectively. A significantly greater proportion of patients with AA had atopic and autoimmune comorbidities vs control subjects. After index, patients with AA used significantly more corticosteroid treatments (injectable/oral/topical) than control subjects. A greater mean number of annual outpatient and dermatologist visits was observed for both AA groups vs control subjects (outpatient visits: AT/AU group: 17.8 vs 11.8; non-AT/AU group: 15.4 vs 11.2; dermatologist visits: AT/AU group: 3.4 vs 0.4; non-AT/AU group: 3.4 vs 0.4; P < 0.001 for all). Mean total all-cause medical and pharmacy costs (2018 US$) were higher in both AA groups vs control subjects (AT/AU group: $18,988 vs $11,030; non-AT/AU group: $13,686 vs $9,336; P < 0.001 for both). Patient out-of-pocket costs were higher for AA vs control subjects (AT/AU group: $2,685 vs $1,457; non-AT/AU group: $2,223 vs $1,341; P < 0.001 for both). CONCLUSIONS: Compared with control subjects, patients with AA are more likely to have atopic and autoimmune comorbidities, to use corticosteroids, and to make outpatient visits. Patients with AA have greater all-cause medical (including pharmacy) and out-of-pocket costs. The difference in total medical costs for patients with AT/AU vs control subjects is higher than the difference for patients with non-AT/AU vs control subjects. DISCLOSURES: This study was sponsored by Pfizer Inc. Pfizer Inc was involved in the study design; collection, analysis, and interpretation of data; writing of the report; and the decision to submit this report for publication. A. Mostaghimi reports consulting fees from Pfizer Inc, Concert, Lilly, AbbVie, hims, and Digital Diagnostics; reports equity from Lucid and hims; and is an associate editor at JAMA Dermatology. K. Gandhi, M. Ray, and V. Sikirica are former employees of Pfizer Inc and held stock and/or stock options with Pfizer Inc at the time of writing. N. Done, W. Gao, C. Carley, T. Wang, and E. Swallow are employees of Analysis Group, Inc, a consultancy that received payment from Pfizer Inc for participation in this analysis.

Healthcare Utilization and Costs Among US Adolescents With Alopecia Areata.

Background: Alopecia areata (AA) is an autoimmune disease of hair loss affecting people of all ages. Alopecia totalis (AT) and universalis (AU) involve scalp and total body hair loss, respectively. AA significantly affects quality of life, but evidence on the economic burden in adolescents is limited. Objectives: To assess healthcare resource utilization (HCRU) and all-cause direct healthcare costs, including out-of-pocket (OOP) costs, of US adolescents with AA. Methods: IBM MarketScan® Commercial and Medicare databases were used to identify patients aged 12-17 years with ≥2 claims with AA/AT/AU diagnosis (prevalent cases), from October 1, 2015, to March 31, 2018, enrolled for ≥12 months before and after the first AA diagnosis (index). Patients were matched 1:3 to non-AA controls on index year, demographics, plan type, and Charlson Comorbidity Index. Per patient per year HCRU and costs were compared post-index. Results: Patients comprised 130 AT/AU adolescents and 1105 non-AT/AU adolescents (53.8% female; mean age, 14.6 years). Post-index, AT/AU vs controls had more outpatient (14.5 vs 7.1) and dermatologist (3.6 vs 0.3) visits, higher mean plan costs ($9397 vs $2267), including medical ($7480 vs $1780) and pharmacy ($1918 vs $487) costs, and higher OOP costs ($2081 vs $751) (all P<.001). The non-AT/AU cohort vs controls had more outpatient (11.6 vs 8.0) and dermatologist (3.4 vs 0.4) visits, higher mean plan costs ($7587 vs $4496), and higher OOP costs ($1579 vs $805) (all P<.001). Discussion: This large-sample, real-world analysis found that adolescents with prevalent AA had significantly higher HCRU and all-cause costs than matched controls. The greater burden was driven by more frequent outpatient visits, and higher payer medical and pharmacy costs in comparison with controls. Oral corticosteroid use was higher among patients with AT/AU; topical and injectable corticosteroid use was higher for non-AT/AU. Although the data preclude the identification of AA-attributable costs, the matched-control design allows an estimation of incremental all-cause costs associated with AA. Conclusions: Adolescents with AA incurred substantial incremental healthcare costs, with greater costs incurred among those with AT/AU. Study findings suggest that AA incurs costs as a medical condition with a high burden on adolescent patients and health plans.

Clinical and economic burdens of recurrence following nephrectomy for intermediate high- or high-risk renal cell carcinoma: A retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data.

BACKGROUND: Renal cell carcinoma (RCC) is associated with a high risk of recurrence. Although RCC has been shown to impose a substantial burden on patients, little is known about the incremental clinical and economic burden attributable to disease recurrence. With recent advances in the RCC-therapeutic landscape, including adjuvant therapies, it is important to quantify the clinical and economic burden associated with RCC recurrence to better evaluate the potential impact of treatment in this patient population. OBJECTIVE: To quantify the incremental clinical and economic burden associated with disease recurrence among patients with intermediate high-risk and high-risk RCC postnephrectomy. METHODS: Data from the Surveillance, Epidemiology, and End Results-Medicare database (2007-2016) were used to identify patients with newly diagnosed, intermediate high-risk or high-risk RCC following nephrectomy. Patients with a diagnosis of metastatic disease or repeat nephrectomy or initiating a systemic treatment for advanced RCC were grouped as the recurrence cohort; patients without evidence of recurrence were grouped as the cohort without recurrence. Health care resource utilization (HRU), health care costs (2019 US dollars), and overall survival (OS) were compared between cohorts with and without recurrence, adjusting for demographic and clinical characteristics. RESULTS: A total of 269 patients with recurrence and 374 patients without recurrence were analyzed. Mean age was 75.2 and 75.7 years (P = 0.383), respectively, and 64.7% and 57.8% (P = 0.076) of patients were male, respectively. Median follow-up duration was 17 and 28 months, respectively. Patients with recurrence had a significantly shorter OS relative to patients without recurrence (adjusted hazard ratio = 6.00; 95% CI = 4.24-8.48; P < 0.001). Additionally, compared with patients without recurrence, patients with recurrence had significantly more inpatient admissions (0.16 vs 0.04 admissions per person-month [PM]; adjusted incidence rate ratio [aIRR] = 3.88; 95% CI = 3.12-4.81), outpatient visits (3.06 vs 1.77 visits per PM; aIRR = 1.68; 95% CI = 1.56-1.81), emergency department visits (0.10 vs 0.05 visits per PM; aIRR = 2.11; 95% CI = 1.66-2.68), and days hospitalized (1.40 vs 0.35 days per PM; aIRR = 6.73; 95% CI = 4.95-9.15) per patient per month (all P < 0.001). Adjusted mean monthly health care costs per patient were significantly higher among patients with recurrence vs patients without recurrence (differences of all-cause total costs, total medical costs, and pharmacy cost per month: $6,320, $4,924, and $1,387; all P < 0.001). CONCLUSIONS: RCC recurrence is associated with a significant increase in mortality, HRU, and health care costs, highlighting the substantial unmet need in patients with intermediate high-risk and high-risk RCC postnephrectomy when adjuvant therapies are not widely available. DISCLOSURES: Dr Sundaram is an employee of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., and holds stock in AbbVie, Abbott, Johnson & Johnson, Bristol Myers Squibb, and Merck & Co., Inc. Dr Bhattacharya is an employee of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., and holds stock in Merck & Co., Inc. Dr Adejoro and Dr Rogerio were employees of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. at the time of study conduct. Dr Adejoro holds stock in Johnson & Johnson. Dr Song, Dr Zhang, Mr Carley, and Dr Signorovitch are employees of Analysis Group, Inc., a consulting firm that received funding from Merck & Co., Inc. for the conduct of this research. Ms Zhu was an employee of Analysis Group, Inc. at the time of study conduct. Dr Haas is a Professor of Medicine at the Perelman School of Medicine, University of Pennsylvania and also serves on the advisory board for Aveo, Calithera and Exelixis, Co. Financial support for this study was provided by Merck & Co., Inc. The study sponsor was involved in the design and conduct of the study; collection, management, analysis, interpretation of data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Impact of Medication Adherence on Healthcare Resource Utilization, Work Loss, and Associated Costs in a Privately Insured Employed Population Treated With Adalimumab in the United States.

OBJECTIVE: The aim of this study was to evaluate the impact of adherence to adalimumab on all-cause work loss, healthcare resource utilization (HRU), and direct medical and indirect costs over 2 years using real-world data. METHODS: This was a retrospective cohort study using a large, United States administrative claims database. Adult patients treated with adalimumab were grouped into adherent and non-adherent cohorts and followed for up to 2 years. Outcomes were compared between cohorts. RESULTS: Over 2 years, adherent patients had $10,214 lower per patient medical and indirect costs compared to non-adherent patients, resulting from lower HRU, fewer days of absenteeism, and lower rates of work loss events. CONCLUSION: Patient and societal benefits of adherence to adalimumab are significant over 2 years. These findings highlight the importance of policies aimed at improving adherence to self-administrated medications.

Deterioration of Health-Related Quality of Life After Withdrawal of Risankizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: A Machine Learning Predictive Model.

INTRODUCTION: Risankizumab has demonstrated efficacy in treating moderate-to-severe psoriasis. The phase-3 IMMhance trial (NCT02672852) examined the effect of continuing versus withdrawing from risankizumab treatment on psoriasis severity, including the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA). However, the effect of withdrawal on health-related quality of life (HRQL) was not assessed. Therefore, this study was conducted to evaluate the impact of risankizumab withdrawal on HRQL measured by the Dermatology Life Quality Index (DLQI). Because DLQI was not measured beyond week 16 in IMMhance, a machine learning predictive model for DLQI was developed. METHODS: A machine learning model for DLQI was fitted using repeated measures data from three phase-3 trials (NCT02684370, NCT02684357, NCT02694523) (pooled N = 1602). An elastic-net algorithm performed automated variable selection among candidate predictors including concurrent PASI and sPGA, demographics, and interaction terms. The machine learning model was used to predict DLQI at weeks 28-104 of IMMhance among patients re-randomized to continue (N = 111) or withdraw from (N = 225) risankizumab after achieving response (sPGA = 0/1) at week 28. RESULTS: The machine learning predictive model demonstrated good statistical fit during tenfold cross-validation and external validation against observed DLQI at weeks 0-16 of IMMhance (N = 507). Predicted improvements in DLQI from baseline were lower in the withdrawal versus the continuation cohort (mean DLQI change at week 104, -5.9 versus -11.5, difference [95% CI] = 5.6 [4.1, 7.3]). Predicted DLQI deteriorated more extensively than PASI (49.7% versus 36.4%) after treatment withdrawal. CONCLUSIONS: The predicted DLQI score deteriorated more rapidly after risankizumab withdrawal than the PASI score, an objective measure of disease. These findings suggest that the deterioration in HRQL reflects more substantial impacts after risankizumab discontinuation than those measured by PASI only.

Measuring The Impact Of Air Pollution On Health Care Costs.

Air pollution contributes to the development of numerous adverse human health outcomes. The Environmental Protection Agency's Environmental Benefits Mapping and Analysis Program-Community Edition (BenMAP-CE) tool is widely used in estimating the health care costs of air pollution and in the development of federal and state regulations and policy. Its default features consider only the costs of hospital and emergency department admissions. A more complete accounting of the chain of costs would include ambulatory and other care. In this article we use employer health insurance claims data to infer additional costs that accompany hospitalizations but are not included in BenMAP-CE. Including additional categories increases BenMAP-CE health care cost estimates by approximately 40 percent for respiratory and cardiovascular patients. That is, for each dollar of health care costs captured by BenMAP-CE, a more complete accounting would include an additional 40 cents. These results suggest that because such air pollution costs are underestimated, the health care benefits associated with reducing air pollution may be much larger than previously estimated.

Patient characteristics associated with all-cause healthcare costs of alopecia areata in the United States.

Evidence on the factors of medical costs involved in the care of people with alopecia areata (AA) is limited, but mounting evidence points to significant variation in financial impact for patients with AA in the absence of effective treatments. This study explored drivers of medical costs among privately insured adults and adolescents with AA in the United States. The study found that patients of middle age (45­64 years), located in the Northeast region, with comprehensive health insurance, with greater extent of hair loss, or with other health disorders face greater all-cause medical costs. Adult females of young (18­44 years) and older (65+ years) age also faced greater costs on average. This research confirms high variability in the burden of AA, pointing to population subgroups that may be more affected by the disease and its commonly associated disorders.