Association between nintedanib adherence trajectory and healthcare use among idiopathic pulmonary fibrosis patients.

BACKGROUND: Although inverse associations have been found between medication adherence and healthcare use and spending outcomes in many clinical settings, no studies to date have examined these relationships for patients with idiopathic pulmonary fibrosis (IPF) initiating nintedanib. We build on our prior study that used group-based trajectory modeling (GBTM) to compare inpatient hospitalization and medical care spending outcomes between groups of patients with different nintedanib adherence trajectories. METHODS: This analysis used 100% Medicare data and included beneficiaries with IPF who initiated nintedanib during 10/01/2014-12/31/2018. The sample consisted of community-dwelling older adults (≥ 66 years) with continuous coverage in Medicare Parts A (inpatient care), B (outpatient care) and D (prescription drugs) for one year before (baseline) and after (follow-up) initiating nintedanib. Patients were assigned to the GBTM-derived adherence trajectory group closest to their own nintedanib adherence experience. All-cause and IPF-related hospitalization events and total medical spending were measured during the follow-up period. Unadjusted and adjusted regression models were estimated to compare outcomes between patients in different nintedanib adherence trajectories. RESULTS: Among the 1,798 patients initiating nintedanib, the mean age was 75.4 years, 61.1% were male, and 91.1% were non-Hispanic white. The best-fitting GBTM had five adherence trajectories: high adherence, moderate adherence, high-then-poor adherence, delayed-poor adherence, and early-poor adherence. All-cause hospitalizations and total all-cause medical spending were higher among patients in the high-then-poor, delayed-poor and early-poor adherence trajectories than those in the high adherence trajectory. For example, adjusted total all-cause medical spending was $4,876 (95% CI: $1,470 to $8,282) higher in the high-then-poor adherence trajectory, $3,639 (95% CI: $1,322 to $5,955) higher in the delayed-poor adherence trajectory and $3,907 (95% CI: $1,658 to $6,156) higher in the early-poor adherence trajectory compared with the high adherence trajectory. IPF-related hospitalizations and medical care spending were higher among those in the high-then-poor adherence trajectory compared with those in the high adherence trajectory. CONCLUSIONS: Poor adherence to nintedanib was associated with all-cause hospitalizations and medical costs. Therefore, improved adherence programs, such as support programs, can be implemented to reduce economic burden.

Short report on navigating access to care for Medicaid-enrolled autistic youth and young adults: Examining accrual of intellectual disability diagnoses in adolescence.

LAY ABSTRACT: What is known? In most states, Medicaid waivers provide individuals with an intellectual disability diagnosis generous healthcare coverage throughout adulthood. By comparison, fewer Medicaid programs are available for autistic individuals, and they are more likely to experience disruptions, or gaps, in Medicaid coverage and subsequently not re-enroll.What this paper adds? One in five autistic individuals with Medicaid coverage between ages 8 and 25 accrued a new intellectual disability diagnosis. The probability of a new intellectual disability diagnosis was higher among those who had previous disruptions in Medicaid coverage.Implications for research and policy. Expanding Medicaid to cover autistic people of all ages could decrease the need for intellectual disability diagnosis accrual. Input from autistic individuals and their families regarding their health insurance access and healthcare experiences is critically important to understanding next steps for research.

Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population.

BACKGROUND: Real-world treatment patterns and survival in metastatic castration-resistant prostate cancer (mCRPC) have not been characterized for the full fee-for-service Medicare population. METHODS: Men newly diagnosed with mCRPC were identified in Medicare fee-for-service claims during 1/1/2014-6/30/2019. Men had evidence of mCRPC and continuous insurance coverage ≥1 year before and ≥6 months after diagnosis unless patients died. Treatment patterns after diagnosis were described. Survival from mCRPC diagnosis and from start of first-line (1 L) therapy was modeled using Kaplan-Meier analysis. RESULTS: Among 14,780 men with mCRPC, mean age was 76 and median follow-up after mCRPC was 17.0 months. 22% received no life-prolonging therapy after mCRPC, 78% received ≥1 line of therapy (LOT), 42% underwent ≥2 LOTs, and 20% had ≥3 LOTs. Median time from start of 1 L to next LOT or end of follow-up was 13.7 months, 10.9 months from 2 L start, and 8.9 months from 3 L start. The most common 1 L to 2 L treatment sequences among men with ≥2 lines were NHT followed by a different NHT (33%), chemotherapy followed by NHT (14%), and NHT followed by chemotherapy (13%). For those initiating 1 L treatment with NHTs, only 28% received subsequent treatment with a different class of therapy. Median survival was 25.6 months after mCRPC and 23.4 months following treatment initiation. CONCLUSIONS: More than 1 in 5 Medicare patients with mCRPC did not receive any life-prolonging therapy, and less than half received 2 L therapy. NHTs were the most common 1 L and 2 L therapies, with patients treated with NHT as 1 L followed by a different NHT for 2 L as the most common treatment sequence. Median survival from diagnosis for all patients was 25.6 months. These data highlight the dramatic undertreatment that occurs for mCRPC patients, particularly for therapies beyond NHTs as well as the common use of sequential NHTs in real-world data.

Healthcare Costs in Men with Metastatic Castration-Resistant Prostate Cancer: An Analysis of US Medicare Fee-For-Service Claims.

INTRODUCTION: To analyze healthcare resource utilization (HRU) and healthcare costs in men with metastatic castration-resistant prostate cancer (mCRPC) in the US Medicare population. METHODS: A published claims-based algorithm was used to identify men with mCRPC in the fee-for-service Medicare population between January 1, 2014, and December 31, 2019. Unadjusted all-cause HRU (days) and healthcare costs paid by Medicare (medical and pharmacy) per patient per year (PPPY) are described for the periods before mCRPC diagnosis, after diagnosis, and from the start of first-line (1L), second-line (2L), and third-line (3L) therapy with mCRPC life-prolonging treatments to the start of subsequent therapy or end of follow-up/death. RESULTS: A total of 14,780 men with mCRPC were identified. After mCRPC diagnosis, 11,528 men initiated 1L mCRPC therapy, 6275 initiated 2L, and 2945 initiated 3L. All-cause medical HRU (days PPPY) increased after mCRPC diagnosis and from 1L through 3L treatment, particularly for outpatient care (pre-diagnosis, 10.4; 1L, 16.2; 2L, 18.9; 3L, 22.0) and physician/other visits (pre-diagnosis, 30.1; 1L, 46.5; 2L, 50.2; 3L, 56.9). Similarly, mean all-cause healthcare costs PPPY were $27,468 in the year before mCRPC diagnosis and increased over four fold to $124,379 after mCRPC diagnosis and continued to rise from start of 1L ($148,325) to 2L ($160,118) to 3L ($165,186) therapy. CONCLUSION: HRU and healthcare costs increased substantially following mCRPC diagnosis, and continued to increase even further through progression from 1L through 3L mCRPC therapy. These findings help to quantify the economic burden of mCRPC and to contextualize the economic value of treatments that delay disease progression.

Association between vasomotor symptom frequency and weight gain in the Study of Women's Health Across the Nation.

OBJECTIVE: The menopause transition is associated with weight gain in women. We examined whether changes in vasomotor symptom (VMS) frequency precede weight changes. METHODS: This longitudinal retrospective analysis included data from the multisite, multiethnic Study of Women's Health Across the Nation. Women in premenopause or perimenopause aged 42 to 52 years at baseline self-reported VMS frequency (hot flashes/night sweats) and sleep problems at up to 10 annual visits. Menopause status, weight, body mass index, and waist circumference were compared across visits. The primary objective was to measure the association between VMS frequency and weight gain using a lagged approach with first-difference regression models. Secondary objectives were to statistically quantify mediation by sleep problems and moderation by menopause status and explore the association between cumulative, 10-year VMS exposure and long-term weight gain. RESULTS: The primary analysis sample included 2,361 participants (12,030 visits; 1995-2008). Increased VMS frequency across visits was associated with subsequently increased weight (0.24 kg), body mass index (0.08 kg/m 2 ), and waist circumference (0.20 cm). Cumulative exposure to a high frequency of VMS (≥6 d/2 wk) over 10 consecutive annual visits was associated with increases in weight measures, including a 3.0-cm increase in waist circumference. Contemporaneous sleep problems mediated no more than 27% of waist circumference increases. Menopause status was not a consistent moderator. CONCLUSIONS: This study demonstrates that increases in VMS, onset of a high frequency of VMS, and persistent VMS symptoms over time may precede weight gain in women.

Using group based trajectory modeling for assessing medication adherence to nintedanib among idiopathic pulmonary fibrosis patients.

BACKGROUND AND OBJECTIVE: Adherence to antifibrotic medications has been evaluated in a few studies using annual proportion of days covered (PDC), a common adherence metric. However, PDC alone cannot identify and distinguish between different patterns of adherence over time, which can be accomplished using group-based trajectory models (GBTM) of monthly PDC. The objective is to assess nintedanib adherence trajectories using GBTM and identify characteristics of patients within each trajectory group. METHODS: Individuals with idiopathic pulmonary fibrosis (IPF) who initiated nintedanib during 10/1/2014-12/31/2018 were identified in 100% Medicare claims and enrollment data. The sample consisted of community-dwelling older adults (≥ 66 years) with continuous coverage in Medicare Parts A, B and D for one year before (baseline) and after (follow-up) initiating nintedanib. A series of GBTMs of adherence was estimated to identify the best-fitting specification. Patients were then grouped based on their estimated adherence trajectories. Associations between baseline patient characteristics, including demographics, comorbidities, and health care use, and group membership probabilities were quantified as odds ratios using fractional multinomial logit modeling. RESULTS: Among the 1,798 patients initiating nintedanib, mean age was 75.4 years, 61.1% were male, and 91.1% were non-Hispanic white. The best-fitting GBTM had five adherence trajectory groups: high adherence (43.1%), moderate adherence (11.9%), high-then-poor adherence (10.4%), delayed-poor adherence (13.2%), and early-poor adherence (21.5%). The principal factors associated with higher odds of being in at least one of the poor-adherence groups were older age, female sex, race and ethnicity other than non-Hispanic white, and number of medications during baseline. CONCLUSIONS: GBTM identified distinct patterns of nintedanib adherence for the IPF patient cohort. Identifying adherence trajectory groups and understanding the characteristics of their members provide more actionable information to personalize interventions than conventional metrics of medication adherence.

Association Between Medicaid Waivers and Medicaid Disenrollment Among Autistic Adolescents During the Transition to Adulthood.

This cohort study examines whether Medicaid waivers were associated with a reduced risk of Medicaid disenrollment among autistic adolescents who are transitioning to adulthood.

Medicaid Disruption Among Transition-Age Youth on the Autism Spectrum.

Enrollment in Medicaid facilitates access to needed services among transition-age youth on the autism spectrum and youth with intellectual disability (ID). There are long-standing programs to ensure that individuals with ID remain enrolled as they age; similar programs for autistic youth are newer, not as widespread, and may not be as effective. We compared Medicaid disenrollment and re-enrollment between transition-age youth on the autism spectrum, youth with ID, and youth with both diagnoses using a national claims-based prospective cohort study from 2008 through 2012. Autistic youth were most likely to disenroll and least likely to re-enroll. Disenrollment peaked for all three groups at ages 19 and 21. Transition-age youth on the autism spectrum experience more disruptions in access to Medicaid-reimbursed services than youth with ID. More equitable Medicaid enrollment options for autistic individuals are needed to ensure their access to critical health care as they age.

A 12-Year Retrospective Study of the Prevalence of Anticholinergic Polypharmacy and Associated Outcomes Among Medicare Patients with Overactive Bladder in the USA.

BACKGROUND AND OBJECTIVE: Antimuscarinics, drugs with anticholinergic properties, are frequently prescribed for overactive bladder, and anticholinergic burden is associated with adverse events. The "Polypharmacy: Use of Multiple Anticholinergic Medications in Older Adults" (Poly-ACH) measure was developed by the Pharmacy Quality Alliance and is used by the Centers for Medicare and Medicaid Services. Using the Poly-ACH measure, we assessed the prevalence of anticholinergic polypharmacy among Medicare patients in the USA with overactive bladder and determined associations between polypharmacy and medical conditions, care, and spending. METHODS: This was a retrospective cohort study of Medicare beneficiaries with overactive bladder (coverage period: 2006-2017). Anticholinergic polypharmacy, measured by the Poly-ACH, was defined as concurrent use of two or more anticholinergics, each with two or more prescription claims on different dates of service for ≥ 30 cumulative days. Change in annual frequency of anticholinergic polypharmacy was assessed using logistic regression. Associations between anticholinergic polypharmacy over 3 years and falls, fractures, mental status, and medical care spending were assessed with longitudinal regression models. RESULTS: In total, 226,712 patients contributed 940,201 person-years of follow-up after overactive bladder diagnosis. The share of patients meeting the Poly-ACH definition was 3.3% in 2006 and 1.7% in 2017. Women and nursing home residents had higher risks of anticholinergic polypharmacy. Having 1 year or more of positive Poly-ACH status in the 3 years prior was associated with higher rates of all outcomes. CONCLUSIONS: Anticholinergic polypharmacy was uncommon among older adults with overactive bladder. Prevalence was higher among women and nursing home residents, and it was associated with negative outcomes, highlighting potential longitudinal implications of anticholinergic burden.

Impact of sleep disturbances on employment and work productivity among midlife women in the US SWAN database: a brief report.

OBJECTIVE: Menopause is associated with an increased prevalence of sleep difficulties. We evaluated the economic burden of sleep disturbances among working midlife women. METHODS: This retrospective, longitudinal cohort study collected data from the US Study of Women's Health Across the Nation (SWAN) database of women age 42-52 years at enrollment. We assessed the association between sleep disturbances (trouble falling asleep, waking early, or nocturnal awakenings) and workplace productivity (employment [yes/no] and work hours/wk) for women who were employed at the baseline visit and had ≥1 follow-up visit. We estimated overall economic burden by multiplying changes in productivity by median age-specific hourly US wages. Each woman's data were compared from visit to visit and were excluded after the first observed unemployment. Regression analysis was used to estimate associations between changes in sleep and changes in workplace productivity while controlling for relevant characteristics that varied over time. RESULTS: The analysis included 2,489 working women (19,707 visits); 31% became unemployed during follow-up. Risk of unemployment was 31% higher for women with versus without new-onset sleep disturbances (P  = 0.0474). Onset of sleep disturbances was associated with a 0.44-0.57 hours/wk reduction in work time (not significant). Using the more conservative reduction (0.44 h), sleep problems were associated with an annual loss of $517 to $524 per woman and $2.2 billion/yr in lost productivity among women age 42-64 nationwide. CONCLUSIONS: New-onset sleep problems in midlife women are associated with significant increases in risk of unemployment and ∼$2 billion/yr in lost productivity nationwide.

Video Summary : http://links.lww.com/MENO/A798 .

Estimating Progression Rates Across the Spectrum of Alzheimer's Disease for Amyloid-Positive Individuals Using National Alzheimer's Coordinating Center Data.

INTRODUCTION: Published estimates of Alzheimer's disease (AD) progression do not capture the full disease continuum. This study provides transition probabilities of individuals with amyloid-ß (Aß+) pathology across the disease continuum. METHODS: Patient-level longitudinal data from the National Alzheimer's Coordinating Center were used to estimate progression rates. Progression rates through five clinically defined AD stages-asymptomatic, mild cognitive impairment due to AD (MCI-AD), mild AD dementia, moderate AD dementia, severe AD dementia-and death were measured as transition probabilities. Rates were assessed in "incident" patients who recently entered the stage, controlling for covariates. Transition probabilities were generated from multinomial logit regression models that predicted an individual's health state as a function of health state at the previous visit and adjusted for time between initial and follow-up visits, age, sex, years of education, and concomitant symptomatic AD medications. RESULTS: Annual transition probabilities to more severe dementia stages for surviving incident Aß+ patients were as follows: asymptomatic to MCI-AD, 40.8%; MCI-AD to mild AD dementia or worse, 21.8%; mild AD dementia to moderate AD dementia or worse, 35.9%; moderate AD dementia to severe AD dementia, 28.6%. Transition probabilities to less severe dementia stages were: 5.3% annual reversion from MCI-AD to asymptomatic, 3.0% mild AD dementia to MCI-AD, 1.8% moderate AD dementia to mild AD dementia, and 1.3% for severe AD dementia to moderate AD dementia. CONCLUSIONS: These transition probabilities reflect the full continuum of AD progression in Aß+ individuals and can be used to assess the impact of treatment on expected transitions.

Comparative economic outcomes in patients with focal seizures initiating eslicarbazepine acetate versus brivaracetam as their first adjunctive ASD.

AIMS: To study the association between initiation of first adjunctive therapy with eslicarbazepine acetate (ESL) vs. brivaracetam (BRV) on healthcare resource utilization (HCRU) and charges among patients with treated focal seizures (FS). MATERIALS AND METHODS: Symphony Health's Integrated Dataverse (IDV) claims data (1 April 2015 to 30 June 2018) were used to identify two cohorts as first adjunctive therapy with ESL or BRV following a generic anti-seizure drug (ASD). The index date was the earliest claim for a new ESL or BRV prescription. Key inclusion criteria were only 1 generic ASD in the 12 months before the index date; ≥1 medical claim with an FS diagnosis. Unit of analysis was the 90-day person-time-block. Changes in HCRU and charges were assessed using a difference-in-differences framework. Both unadjusted and adjusted analyses were performed. The adjusted model utilized person-specific fixed effects and propensity score-based weighting to control for differences in baseline covariates. Bias-corrected bootstrap confidence intervals (CIs) were calculated for charge outcomes. RESULTS: 208 and 137 patients initiated first adjunctive therapy with ESL (43.7 years, 51.9% female) or BRV (39.3 years, 51.8% female). Patients in the ESL cohort had numerically larger reductions in all-cause and FS-related inpatient hospitalizations and outpatient visits and FS-related emergency department visits. Compared to patients initiating BRV, patients treated with ESL had significantly larger reductions in total charges (-$3,446, CI: -$13,716, -$425), all-cause (-$3,166, CI: -$13,991, -$323) and FS-related (-$2,969, CI: -$21,547, -$842) medical charges, all-cause (-$3,397, CI: -$15,676, -$818) and FS-related (-$2,863, CI: -$19,707, -$787) outpatient charges, and non-ASD-related prescription charges (-$420, CI: -$1,058, -$78). LIMITATIONS: Claims may be missing, or miscoded; outcomes may be influenced by variables not accounted for in the analysis; only information on submitted charges was included. CONCLUSIONS: Among patients with FS, initiation of first adjunctive therapy with ESL was associated with significantly larger reductions in medical and non-ASD-related prescriptions charges compared to BRV.

Comparative Economic Outcomes in Patients with Focal Seizure Initiating First-Line Eslicarbazepine Acetate Monotherapy versus Generic Antiseizure Drugs.

OBJECTIVE: To examine the association between initiating first-line (1L) monotherapy with eslicarbazepine acetate (ESL) vs a generic antiseizure drug (ASD) and healthcare resource utilization (HCRU) and charges in adults with treated focal seizures (FS). METHODS: This was a retrospective analysis of Symphony Health's Integrated Dataverse® open-source claims data. Two cohorts were identified as having initiated 1L monotherapy with ESL or literature-defined generic ASDs. Linear regression models with person fixed effects and inverse probability treatment weights assessed the relative additional changes in HCRU and charges among patients who received ESL compared to generic ASD. RESULTS: A total of 250 and 43,220 patients initiated ESL (48.3 years; 57.2% female) or a generic ASD (54.5 years; 58.1% female), respectively. Compared to patients initiating a generic ASD, patients treated with ESL had additional reductions of 11.8 percentage points in the likelihood of any all-cause outpatient visits (P<0.001), 7.4 percentage points in the likelihood of any emergency department (ED) visits (P=0.013), and 22.7 percentage points in the likelihood of any FS-related outpatient visits (P<0.001). Patients initiating ESL had greater reductions in mean charges for all-cause medical ($2620; P=0.002), outpatient ($1995; P=0.005), and non-FS-related medical ($2708; P<0.001) services. Patients initiating ESL had greater relative increases in mean total prescription ($1368; P<0.001) and ASD-related prescription ($1636; P<0.001) charges, but greater relative reductions in non-ASD prescription ($269; P=0.032) charges. The increases in prescription charges were of a lower magnitude than the decreases in medical charges. CONCLUSION: Initiation of ESL as 1L monotherapy was associated with statistically significantly greater reductions in any use of several all-cause and FS-related services, number of visits, and charges compared to initiation of a generic ASD as 1L monotherapy in patients with FS. Initiation of a generic ASD as 1L monotherapy was associated with significantly smaller increases in total prescription charges and ASD-related prescription charges.

Impact of Early Initiation of Eslicarbazepine Acetate on Economic Outcomes Among Patients with Focal Seizure: Results from Retrospective Database Analyses.

INTRODUCTION: This study assessed the association between early initiation of eslicarbazepine acetate (ESL) as first-line therapy (1L cohort) or as first adjunctive regimen to either levetiracetam (LEV) or lamotrigine (LTG) (add-on cohort), and healthcare resource utilization (HCRU) and charges among adults with treated focal seizures (FS). METHODS: This retrospective, longitudinal cohort analysis used Symphony Health's Integrated Dataverse (IDV®) claims data to identify patients aged ≥ 18 years with a diagnosis of FS who had a new prescription for ESL between April 2015 and June 2018. Baseline was the 90-day period immediately prior to the date of the first-dispensed claim for ESL (index date) with a follow-up of 1-4 consecutive 90-day periods. Linear regression models were estimated to assess changes in HCRU and charge outcomes. RESULTS: There were 274 and 153 patients who received ESL in the 1L cohort and add-on cohort, respectively. The 1L cohort experienced significant reductions from baseline during follow-up in all-cause inpatient (IP; P < 0.0001), emergency room (ER; P < 0.0001), and outpatient (OP; P < 0.0001) visits; FS-related IP (P = 0.006) and OP (P < 0.0001) visits; total, medical, all-cause ER and OP, and FS-related medical charges (P < 0.05); and significant increases in total prescription and anti-seizure drug (ASD)-related prescription (P < 0.001) charges. The add-on cohort experienced significant reductions in all-cause IP (P = 0.009) and all-cause and FS-related OP visits (P < 0.0001 for both) and significant increases in total prescription and ASD-related prescription (P < 0.001) charges during the follow-up period. In both cohorts, the increases in prescription charges were smaller than the reduction in total medical charges. CONCLUSION: Early initiation of ESL as 1L or add-on therapy was associated with statistically significant reductions in all-cause IP and all-cause and FS-related OP visits during follow-up compared to baseline. The 1L cohort also had statistically significant reductions in all-cause ER visits, FS-related IP visits, and total, medical, all-cause ER and OP, and FS-related medical charges. Knowledge of healthcare resource utilization (HCRU) and costs of care in patients taking anti-seizure drugs (ASDs) is required to inform prescribing and formulary decision-making. Levetiracetam (LEV) and lamotrigine (LTG) are the most widely used first-line (1L) ASDs in the USA. Eslicarbazepine acetate (ESL), a third-generation ASD with sodium channel-modulating activity, is typically used in later lines of therapy. Sodium channel-blocking anti-seizure drugs may represent an effective treatment option for patients with epilepsy in the 1L setting. This study assessed the association between early initiation of ESL as 1L therapy (1L cohort) or as first adjunctive therapy to either LEV or LTG (add-on cohort), and HCRU and charges among adults with treated focal seizures (FS). The results showed that following ESL initiation the 1L cohort experienced significant reductions in all-cause inpatient (IP), emergency room (ER), and outpatient (OP) visits; FS-related IP and OP visits; and total, medical, all-cause ER and OP, and FS-related medical charges, and significant increases in total prescription and ASD-related prescription charges. The add-on cohort showed significant reductions in all-cause IP and all-cause and FS-related OP visits and significant increases in total prescription and ASD-related prescription charges. In both cohorts, the increases in prescription charges were smaller than the reduction in total medical charges. These data imply that use of ESL as 1L therapy in adult patients with FS could help conserve scarce healthcare resources and reduce the burden on healthcare budgets. These findings may inform selection of ASD therapy in this patient population.

Healthcare Resource Utilization Pre- and Post-Initiation of Eslicarbazepine Acetate Among Pediatric Patients with Focal Seizure: Evidence from Routine Clinical Practice.

OBJECTIVE: To examine the impact of initiating treatment with eslicarbazepine acetate (ESL) on healthcare resource utilization (HCRU) among pediatric patients with focal seizures (FS). METHODS: This retrospective study used Symphony Health's Integrated Dataverse® claims data. Patients aged 4 to 17 years with a diagnosis of FS and a new prescription for ESL between April 2015 and June 2018 were included and defined as the overall patient population. Index date was the first dispensed claim for ESL. Baseline period was the 90-day block immediately prior to the index date. The follow-up period comprised up to 4 consecutive 90-day blocks immediately following the index date. Subgroups were defined based on the presence (DP+) or absence (DP-) of developmental and/or psychiatric disorders at baseline. All-cause and FS-related inpatient (IP), emergency room (ER), outpatient (OP) hospital, and office (OF) visits were measured during the follow-up period. Reduction in HCRU per block in the post-ESL period was assessed using fixed-effects linear regression models. RESULTS: A total of 234 patients were included in the overall study population, of whom 86 (36.8%) were DP+ and 148 (63.2%) were DP-. Relative to the baseline period, significant reductions were observed in the overall population for all-cause ER (P=0.001), OP (P<0.001), and OF (P<0.001) visits and FS-related IP (P=0.037) and OF (P<0.001) visits in the follow-up period. Among DP+ and DP- patients, significant reductions were observed for all-cause ER (DP+: P=0.024; DP-: P=0.017), OP (DP+: P<0.001; DP-: P=0.035), and OF (DP+: P=0.004; DP-: P=0.001) visits during the follow-up period. No significant differences were observed between DP+ and DP- patients in the change in all-cause or FS-related HCRU from baseline to the follow-up period. CONCLUSION: Pediatric patients with FS (DP+ and DP-) who initiated ESL had significant reductions in all-cause ER, OP, and OF visits and FS-related IP and OF visits.

Impact of Formulary Restrictions on Antiepileptic Drug Dispensation Outcomes.

INTRODUCTION: The aim of this analysis was to assess the relationship between formulary restrictions and antiepileptic drug (AED) dispensation in patients with focal seizure (FS). STUDY DESIGN: A retrospective cohort analysis was conducted using data from Symphony Health's Integrated Dataverse® (1 April 2015-30 June 2018). METHODS: This study included two patient populations: the overall patient population (N = 54,097) and a pediatric population (< 18 years) (N = 12,610). Cohorts were defined based on approval or rejection of the index AED claim. Study outcomes were prescription life cycle analysis, proportion of patients with dispensation, time to dispensation, and likelihood of successful dispensation. A multivariable Cox proportional hazards model was estimated to study the association between formulary restriction and likelihood of successful AED dispensation. RESULTS: Among patients in the overall population with a rejected claim (n = 9133), 8.0% did not receive any AED and 77.6% received approval for the index AED following an appeal. Among the pediatric patients with a rejected claim (n = 3081), 6.0% did not receive any AED and 81.7% received approval for the index AED after an appeal. In both populations, formulary restrictions were associated with significant delays in index AED dispensation (6.9 and 5.3 days, respectively; P < 0.0001 for each population), compared to approved AED claims. In the overall and pediatric populations, formulary-related rejections of AEDs were associated with a 35% (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.64-0.66; P < 0.0001) and 27% (HR 0.73; 95% CI 0.69-0.76; P < 0.0001) lower likelihood of successful dispensation of the index AED, respectively. CONCLUSIONS: Formulary restrictions of AEDs were associated with significant delays in treatment and significantly lower likelihood of successful AED dispensation in patients with FS.

Formulary restrictions on antiepileptic drugs (AEDs) are adopted by payers in the USA to guide the use of therapies and contain the costs of care. However, formulary restrictions on AEDs are inconsistent with the American Epilepsy Society position statement that indicates patients with epilepsy must have unrestricted access to all AEDs. This retrospective cohort analysis of open-source claims data assessed the effects of formulary restrictions on AED dispensation in patients with focal seizure (FS). Findings showed that formulary-related rejections of AED claims were associated with significant delays in treatment initiation and a significantly lower likelihood of successful AED dispensation. The treatment delays associated with formulary restrictions on AEDs may have a negative clinical and economic impact on patients with epilepsy and the healthcare system. Approximately 80% of rejected initial claims were reversed after an appeal. Claim denials and appeals represent an unnecessary administrative burden on physicians' practices. Further studies are required to identify the patient, physician, or payer factors that drive the delay in access to AEDs among patients with FS.

Federal Payments for Coronary Revascularization Procedures Among Dual Enrollees in Medicare Advantage and the Veterans Affairs Health Care System.

Importance: More than 1 million US veterans are dually enrolled in a Medicare Advantage (MA) plan and in the Veterans Affairs (VA) health care system. The federal government prepays private MA plans to cover veterans; if a dually enrolled veteran receives an MA-covered service at the VA, the government is making 2 payments for the same service. It is not clear what proportion of veterans dually enrolled in VA and MA are undergoing coronary revascularization at VA vs non-VA hospitals. Objective: To describe where veterans who are enrolled in both VA and MA undergo coronary revascularization and the associated costs. Design, Settings, and Participants: This is a cohort study consisting of US veterans dually enrolled in VA and MA from January 1, 2010, to December 31, 2013, who had at least 1 VA encounter and underwent coronary revascularization during the study period. Data were analyzed from April 2019 to September 2019. Main Outcomes and Measures: Number of coronary artery bypass graft (CABG) operations and percutaneous coronary interventions (PCIs) performed through the VA and through MA during years 2010 to 2013, and the associated VA costs of coronary revascularization. In addition, multivariable logistic regression was performed to assess patient factors associated with receiving care through the VA. Results: A total of 18 874 VA users with concurrent MA enrollment who underwent coronary revascularization during 2010 to 2013 were identified (mean [SD] age, 75.3 [8.8] years; 18 739 men [99.0%]). Enrollees were predominantly white (17 457 patients [92.0%]). Among patients, 4115 (22.0%) underwent either CABG or PCI through the VA only, 14 281 (75.0%) did so through MA only, and 478 (2.5%) underwent coronary revascularization procedures through both payers. From 2010 to 2013, these veterans underwent 4764 coronary revascularization procedures (721 CABGs and 3043 PCIs) that cost the VA $214.7 million ($115.8 million for CABGs and $99.0 million for PCIs). In multivariable analysis, nonwhite patients were more likely than white patients to undergo coronary revascularization through the VA (odds ratio, 1.73; 95% CI, 1.52-1.96; P < .001), and for each year of age, veterans were less likely to undergo coronary revascularization through the VA (odds ratio, 0.95; 95% CI, 0.94-0.95; P < .001). There was no statistically significant association between undergoing coronary vascularization through the VA and distance in miles to the nearest VA hospital (odds ratio, 1.00; 95% CI, 0.99-1.00; P = .30). Conclusions and Relevance: A substantial share of VA users concurrently enrolled in an MA plan underwent coronary revascularization procedures through the VA, incurring significant duplicative federal health care spending. Given the financial pressures facing both Medicare and the VA, government officials should consider policy solutions to mitigate redundant spending.

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.

Impact of a co-pay accumulator adjustment program on specialty drug adherence.

OBJECTIVES: To assess the impact of a co-pay accumulator adjustment program (CAAP) on usage patterns of autoimmune specialty drugs, comparing health savings account (HSA) or preferred provider organization (PPO) plan enrollees before and after implementation of the CAAP. STUDY DESIGN: Retrospective cohort analysis. METHODS: Data on HSA and PPO patients with autoimmune specialty drug use were drawn from the Conduent pharmacy benefit manager for January 2016 to October 2017 from 15 self-insured employers initiating a CAAP in January 2017. Outcomes included monthly mean fills per person, therapy discontinuation, and proportion of days covered (PDC). Linear regressions, Kaplan-Meier survival curves, and Cox proportional hazards models assessed differences while adjusting for patient characteristics. RESULTS: There were 365 HSA and 238 PPO patients. After the CAAP implementation, for HSA versus PPO patients, adjusted trends in monthly fills per person decreased more rapidly, the risk of treatment discontinuation was significantly higher, and PDC was significantly lower. Prior to the CAAP, these metrics were not statistically different between groups except in 1 case. To help place the post-CAAP adjusted differences in trends in context, by the end of October 2017, 10 months after the CAAP start, HSA patients had 233 fewer autoimmune drug fills per 1000 patients, 20 percentage points higher treatment discontinuation, and 12 percentage points lower PDC. CONCLUSIONS: After the CAAP, HSA patients on autoimmune drugs had significantly lower monthly fill rates, higher risk of discontinuation, and lower PDC than did PPO patients, suggesting that CAAPs have the potential to negatively affect specialty drug use.