Health Plan Claims Data Research Articles

Comparison of Real-World On-Label Treatment Persistence in Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Tumor Necrosis Factor Inhibitors.

Treatment persistence among patients with psoriatic arthritis (PsA) is essential for achieving optimal treatment outcomes. Guselkumab, a fully human interleukin-23p19-subunit inhibitor, was approved by the United States (US) Food and Drug Administration for the treatment of active PsA in July 2020, with a dosing regimen of 100 mg at week 0, week 4, then every 8 weeks. In the Phase 3 DISCOVER-1 and DISCOVER-2 studies of patients with active PsA, 94% of guselkumab-randomized patients completed treatment through 1 year and 90% did so through 2 years (DISCOVER-2). Real-world evidence is needed to compare treatment persistence while following US prescribing guidelines (i.e., on-label persistence) for guselkumab versus subcutaneous (SC) tumor necrosis factor inhibitors (TNFis). Adults with PsA receiving guselkumab or their first SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, or golimumab) between 14 July 2020 and 31 March 2022 were identified inthe IQVIA PharMetrics® Plus database (first claim defined the treatment start date [index date]). Baseline characteristics and biologic use (biologic-naïve/biologic-experienced) were assessed during the 12-month period preceding the index date. Baseline characteristics were balanced between cohorts using propensity-score weighting based on the standardized mortality ratio approach. The follow-up period spanned from the index date until the earlier of the end of continuous insurance eligibility or end of data availability. On-label persistence, defined as the absence of treatment discontinuation (based on a gap of 112 days for guselkumab or 56 days for SC TNFi) or any dose escalation/reduction during follow-up, was assessed in the weighted treatment cohorts using Kaplan-Meier (KM) curves. A Cox proportional hazards model, further adjusted for baseline biologic use, was used to compare on-label persistence between the weighted cohorts. The guselkumab cohort included 526 patients (mean age 49.8 years; 61.2% female) and the SC TNFi cohort included 1953 patients (mean age: 48.5 years; 60.2% female). After weighting, baseline characteristics were well balanced with a mean follow-up of 12.3-12.4 months across cohorts; 51.5% of patients in the guselkumab cohort and 16.7% in the SC TNFi cohort received biologics in the 12-month baseline period. Respective rates of treatment persistence at 3, 6, 9, and 12 months were 91.2%, 84.1%, 75.9%, and 71.5% for the guselkumab cohort versus 77.3%, 61.6%, 50.0%, and 43.7% for the SC TNFi cohort (all log-rank p<0.001). At 12 months, patients in the guselkumab cohort were 3.0 times more likely than patients in the SC TNFi cohort to remain persistent on treatment (p<0.001). Median time to discontinuation was not reached for the guselkumab cohort and was 8.9 months for the SC TNFi cohort. This real-world study employing US commercial health-plan claims data to assess on-label treatment persistence in PsA demonstrated that, at 12 months, guselkumab was associated with a 3 times greater likelihood of persistence compared with SC TNFi.

Treatment approaches and costs associated with diabetes clinical metrics as measured by Healthcare Effectiveness Data and Information Set (HEDIS)

BackgroundThe clinical outcomes of diabetes can be influenced by primary care providers’ (PCP) treatment approaches. This study explores the association between PCP approaches to management and performance measured by established diabetes metrics and related costs.MethodsIn phase one, Electronic Medical Records were used to extract diabetes related metrics using Healthcare Effectiveness Data and Information Set (HEDIS), for patients with diabetes who had office visits to 44 PCP practices from April 2019 to March 2020. Using those metrics and scoring system, PCP practices were ranked and then categorized into high- and low-performing groups (top and bottom 25%, n = 11 each), with a total of 19,059 clinic visits by patients with a diagnosis of diabetes. Then extensive analysis was performed to evaluate a correlation between treatment approaches and diabetes outcomes across the top and bottom performing practices. In phase 2, patients with diabetes who were attributed to the aforementioned PCP practices were identified in a local health plan claims data base (a total of 3,221 patients), and the allowed amounts from their claims were used to evaluate differences in total and diabetes-related healthcare costs by providers’ performance.ResultsComparing 10,834 visits in high-performing practices to 8,235 visits in low-performing practices, referrals to certified diabetes care and education specialists and provider-to-provider electronic consults (e-consults) were higher in high-performing practices (Z = 6.06, p < .0001), while traditional referrals were higher in low-performing practices (Z = -6.94, p < .0001). The patient-to-provider ratio was higher in the low-performing group (M = 235.23) than in the high-performing group (M = 153.26) (Z = -2.82, p = .0048). Claims data analysis included 1,825 and 1,396 patients from high- and low-performing providers, respectively. The patient-to-provider ratio was again higher in the low-performing group (p = .009, V = 0.62). Patients receiving care from lower-performing practices were more likely to have had a diabetes-related hospital observation (5.7% vs. 3.9%, p = .02; V = 0.04) and higher diabetes-related care costs (p = .002; d = − 0.07); these differences by performance status persisted when controlling for differences in patient and physician characteristics. Patients seeing low-performing providers had higher Charlson Comorbidity Index scores (Mdn = 3) than those seeing high-performing providers (Mdn = 2).ConclusionsReferrals to the CDCES and e-Consult were associated with better measured diabetes outcomes, as were certain aspects of cost and types of hospital utilization. Higher patients to providers ratio and patients with more comorbidities were observed in low performing group.

Incremental Burden Associated with Dose Escalation in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Complement Inhibitors

Introduction: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder characterized by complement-mediated hemolytic anemia. Terminal complement component C5 inhibitors eculizumab (ECU) and ravulizumab (RAVU) inhibit the formation of membrane attack complex, and thereby ameliorates intravascular hemolysis in PNH. Some patients exhibit breakthrough intravascular hemolysis near the end of 14-day treatment cycle for ECU or 8-week treatment cycle for RAVU. To manage breakthrough hemolysis, different treatment strategies may be attempted in the clinical practice, including shortening the dosing interval and/or increasing the dose of ECU and RAVU. This study aimed to estimate the incremental costs associated with dose escalation in patients with PNH treated with ECU or RAVU in the US. Methods: Adult (age ≥18 years) patients with PNH (ICD-10-CM code D59.5) treated with ECU or RAVU from health plan claims data (01/01/2011 to 09/30/2022) with ≥3 months of continuous health plan coverage following the first claim for ECU or RAVU were included in this retrospective cohort study. Dosing patterns were investigated during the maintenance phase. Consistent with label-recommended dosing schedule, the maintenance phase started from day 29 and day 15 post-first claim for ECU and RAVU, respectively, until the earliest of treatment discontinuation/loss to follow-up/end of data. Dose escalation for ECU was defined as 1) an increased dose (i.e., 1,200 or 1,500 mg) and/or 2) an increased infusion frequency (i.e., ≥2 infusions within 12 days). Patient-weight information was not available; dose escalation for RAVU was defined as an increased infusion frequency (i.e., ≥2 infusions within 49 days). All-cause and PNH-related direct healthcare costs measured during maintenance phase for the overall cohort and subgroup of patients with dose escalation were assessed for ECU and RAVU separately. Incremental costs associated with dose escalation in the pre vs. post dose escalation period were assessed for ECU and RAVU separately; p-values from Wilcoxon signed-rank tests were reported. Results: A total of 278 patients treated with ECU (mean± SD age, 42±13 years; 60% female) were included in the overall cohort and a subgroup of 151 patients were observed with a dose escalation (mean±SD age, 41±13 years; 58% female). For the overall ECU cohort (N=278), during a mean follow-up of 23 months, total all-cause and PNH-related costs (mean±SD) were $67,650±$32,518 and $65,751±$31,379 per patient per month (PPPM), respectively. In the subgroup of patients with dose escalation (N=151), over a mean follow-up of 30 months, total all-cause and PNH-related costs (mean±SD) were $71,466±$33,452 and $69,471±$31,595 PPPM, respectively. In the overall cohort and subgroup of patients with dose escalation, PNH-related treatment costs represented 90% and 92% of total all-cause costs respectively. A total of 171 patients treated with RAVU (mean± SD age, 39±12 years; 43% female) were included in the overall cohort and a subgroup of 26 patients were observed with a dose escalation (i.e., increased infusion frequency only) (mean± SD age, 37±11 years; 54% female). For the overall RAVU cohort (N=171), during a mean follow-up of 17 months, total all-cause and PNH-related costs (mean±SD) were $50,779±$26,258 and $49,213±$25,751 PPPM, respectively. In the subgroup of patients with dose escalation (N=26), over a mean follow-up of 20 months, total all-cause and PNH-related costs (mean±SD) were $52,819±$20,965 and $50,740±$20,837 PPPM, respectively. In the overall cohort and subgroup of patients with dose escalation, PNH-related treatment costs represented 93% and 91% of total all-cause costs, respectively. Incremental costs (mean cost differences) associated with dose escalation for ECU were of $16,861 (p&amp;lt;0.01) and $15,956 (p&amp;lt;0.01) PPPM for all-cause and PNH-related total costs, respectively; and for RAVU were of $4,950 (p&amp;lt;0.05) and $3,738 (p=0.06) PPPM for all-cause and PNH-related total costs, respectively (Figures 1A and 1B). Conclusions: In this study of PNH patients treated with C5 inhibitors, dose escalation was associated with significant incremental costs for both ECU and RAVU. Further research is warranted to clarify the reasons for dose escalation, which may potentially indicate an unmet clinical need for more efficacious treatment options to help prevent breakthrough symptoms and reduce the burden of PNH.

Correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) measures with unplanned healthcare resources utilization (HRU) among patients with epilepsy (PWE): a retrospective cohort study (P6-1.001)

<h3>Objective:</h3> To evaluate whether PROMIS scores correlate with unplanned HRU among PWE. <h3>Background:</h3> Mental, physical, and social health determinants have a significant effect on quality of life with sparse data on their effect on unplanned HRU. <h3>Design/Methods:</h3> We utilized the PROMIS-16 questionnaire to assess patients’ mental, physical, and social health. Patients completed the questionnaire as part of routine medical care at outpatient neurology clinic visits. We performed a retrospective analysis of the PROMIS measures completed between June 2018, and August 2022. PROMIS data was combined with Health Plan claims data on utilization at 7, 30 and 90-day from the index clinic visit and analyzed using a logit model. A pathologic score in each of the 8 PROMIS measures (Anxiety&gt;62, Depression&gt;60, Fatigue &gt;65, Pain&gt;65, Sleep Disturbance&gt;65, Cognition&lt;35, Physical function&lt;35, Social scores&lt;35) was analyzed as an independent predictor of unplanned HRU in each of 4 domains (Mortality all causes, Hospitalization all causes, ED treat and release all causes and Urgent care all causes). <h3>Results:</h3> The cohort included 6485 unique PWE (13159 encounters; 53.1% females, 10.1% black, median age 46.4-years). The following statistically significant correlations emerged: 1) pathological Physical Function and Social Scores were associated with 90-day mortality; 2) pathological Fatigue, Pain, Sleep Disturbance, Physical Function, and Social Scores were associated with 7-day Hospitalization, 3) Pathological Anxiety, Depression, Fatigue, Pain, Physical Function, and Social Scores were associated with 7-day ED visits, 4) Pathological scores on each of the 8 measures correlated with 90-day Hospitalization (7 measures with a 30-day) and ED visits (5 measures with a 30-day), and 5) Pathological Fatigue scores correlated with 90-day urgent care utilization. <h3>Conclusions:</h3> PROMIS scores are associated with unplanned HRU at short index times from outpatient neurology clinic visits among PWE. This prognostic utility supports the routine collection of patient-reported health measures in clinical practice along with developing timely interventions. <b>Disclosure:</b> Dr. Urban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuropace. The institution of Dr. Kirkpatrick has received research support from American Academy of Neurology. The institution of Dr. Kirkpatrick has received research support from Academic Pediatric Association. The institution of Dr. Kirkpatrick has received research support from American Academy of Pediatrics. The institution of Dr. Kirkpatrick has received research support from Society of Family Planning. The institution of Dr. Kirkpatrick has received research support from North American Society for Pediatric and Adolescent Gynecology. Dr. Rajasekaran has a non-compensated relationship as a PI with UCB Drug study that is relevant to AAN interests or activities. Dr. Rajasekaran has a non-compensated relationship as a PI with Engrail Drug study that is relevant to AAN interests or activities. Dr. Fong has nothing to disclose. Dr. Hanmer has nothing to disclose. Dr. Bagic has nothing to disclose. The institution of Dr. Thirumala has received research support from University of Pittsburgh.

Identification of inadequate responders to advanced therapy among commercially-insured adult patients with Crohn’s disease and ulcerative colitis in the United States

BackgroundThe purpose of this analysis was to assess the frequency of inadequate response over 1 year from advanced therapy initiation among patients with Crohn’s disease (CD) or ulcerative colitis (UC) in the United States using a claims-based algorithm. Factors associated with inadequate response were also analyzed.MethodsThis study utilized claims data of adult patients from the HealthCore Integrated Research Database (HIRD®) from January 01, 2016 to August 31, 2019. Advanced therapies used in this study were tumor necrosis factor inhibitors (TNFi) and non-TNFi biologics. Inadequate response to an advanced therapy was identified using a claims-based algorithm. The inadequate response criteria included adherence, switching to/added a new treatment, addition of a new conventional synthetic immunomodulator or conventional disease-modifying drugs, increase in dose/frequency of advanced therapy initiation, and use of a new pain medication, or surgery. Factors influencing inadequate responders were assessed using multivariable logistic regression.ResultsA total of 2437 patients with CD and 1692 patients with UC were included in this analysis. In patients with CD (mean age: 41 years; female: 53%), 81% had initiated TNFi, and 62% had inadequate response. In patients with UC (mean age: 42 years; female: 48%), 78% had initiated a TNFi, and 63% had an inadequate response. In both patients with CD and UC, inadequate response was associated with low adherence (CD: 41%; UC: 42%). Inadequate responders were more likely to be prescribed a TNFi (for CD: odds ratio [OR] = 1.94; p < 0.001; for UC: OR = 2.76; p < 0.0001).ConclusionMore than 60% of patients with CD or UC had an inadequate response to their index advanced therapy within 1 year after initiation, mostly driven by low adherence. This modified claims-based algorithm for CD and UC appears useful to classify inadequate responders in health plan claims data.

Real-World Effectiveness of Newly Initiated Systemic Therapy for Atopic Dermatitis in the United States: A Claims Database Analysis

IntroductionAtopic dermatitis (AD) is associated with significant quality-of-life and economic burdens. Real-world evidence is needed to identify optimal treatment pathways for AD. Here we evaluate real-world effectiveness of systemic therapies for moderate-to-severe AD in the USA.MethodsData (September 2016 to December 2019) were from the IQVIA Health Plan Claims data set (IQVIA, Danbury, CT) from patients aged 12 years or older with AD (ICD-9/10-CM, 691.8/L20.x) initiating a systemic immunosuppressive (SIS) agent (methotrexate, cyclosporine, mycophenolate, or azathioprine) or dupilumab and continuously enrolled for at least 6 months before and after the index date. Indicators of non-response (i.e., adding on/switching systemic therapy, AD-related inpatient/emergency room visits, or incident staphylococcal/streptococcal skin infection) and predictors of non-response were evaluated. Descriptive statistics and Kaplan–Meier rates and times were obtained; Cox regression models were used.ResultsIn 3249 patients, 45.4% exhibited at least one indicator of non-response, with median time to non-response being longer for dupilumab than for any SIS therapy (27.0 vs 4.0–7.7 months, respectively). Key non-response predictors were age, geographic region, and baseline number of annual AD-related medical visits.ConclusionNon-response was common in patients with AD who required systemic treatment, and non-response indicators occurred significantly more frequently with SIS treatment than with dupilumab treatment.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02197-z.

MSR53 Is Some Anticoagulant Prescription Data Missing in Your Atrial Fibrillation Population? An Approach to Attaching Prescription Data Omitted from Health Plan Claims

Anticoagulants are critical in managing atrial fibrillation (AFib) patients, and health plan claims data are used to assess patient utilization and outcomes associated with anticoagulant use. Prescription claims (Rx) may be missing in these data as patients use discount cards, cash, Medicaid or Medicare PartD which are not captured by the health plan. This study identifies missing anticoagulant Rx information in AFib patients and augments the data with pharmacy point-of-sale (POS) data to generate more complete Rx information.

MSR39 An Approach to Quantifying and Appending Missing Prescription Utilization for Asthma Patients in Health Plan Claims Data Utilizing Point-of-Sale Data

Health plan claims databases are used extensively for health outcomes research, with prescription claims used as a proxy for drug utilization. Prescription claims may be missing in payer-sourced data due to the use of alternative forms of payment not captured in the database including discount cards, cash, Medicaid and Medicare PartD. This study quantifies the extent of missing prescription claims information for asthma patients when using payer-sourced claims alone and shows how appending with point-of-sale data (POS) may provide a more accurate proxy for utilization.

Identifying inadequate response among patients with ankylosing spondylitis and psoriatic arthritis prescribed advanced therapy in a real-world, commercially insured adult population in the USA.

This study aimed to assess treatment patterns and frequency of inadequate response associated with advanced therapy initiation among patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in the USA. Adult patients with AS or PsA who initiated advanced therapy were identified from the HealthCore Integrated Research Database®. Inadequate response to advanced therapies (tumour necrosis factor inhibitors [TNFi] and non-TNFi biologics) was identified using a claims-based algorithm. Factors influencing inadequate response were assessed using multivariable logistic regression. In total, 646 patients with AS, and 1433 patients with PsA were evaluated. Among patients with AS (mean age, 43years; male, 58%), 93% patients initiated TNFi, and 69% of patients had inadequate response. In patients with PsA (mean age, 49years; male, 47%), 67% initiated TNFi, and 77% had inadequate response. Low adherence was the main predictor of inadequate response in patients with AS (56%) and PsA (63%). Inadequate responders were more likely to be female (odds ratio [OR] 2.05 for AS and 1.37 for PsA). Prior exposure to TNFi was associated with 3.89- and 2.14-fold greater odds of inadequate response in both AS and PsA patients, respectively, while patients using methotrexate were less likely to have inadequate response (OR 0.48 for AS and 0.72 for PsA; all p < 0.05). Over 69% of patients with AS and 77% of patients with PsA had inadequate response to their index advanced therapy during 1year after initiation. Health plan claims data appear useful to classify inadequate responders in AS and PsA. Key Points • Estimating inadequate response to advanced therapies and identifying factors associated with this outcome using claims data could improve treatment outcomes in AS and PsA. • In a sample of commercially insured US patients, over 69% of patients with AS and 77% of patients with PsA had inadequate response to their index advanced therapy during 1year after initiation. Patient characteristics such as sex and prior therapy use were predictive of inadequate response to advanced therapies. • Health plan claims data appear useful to classify inadequate responders in AS and PsA and identify factors associated with this outcome.

COVID-19 mRNA vaccination and myocarditis or pericarditis

COVID-19 mRNA vaccination and myocarditis or pericarditis

Racial disparities in stage 3 lung cancer treatment.

e18574 Background: In the 1990s, it was demonstrated that Black patients were less likely to receive timely treatment for Stage 3 lung cancer than White patients. While contemporary work has found racial disparities in accessing insurance, diagnostics, and treatments, we wished to explore whether patients faced disparities once in treatment. To do this, we examined whether racial disparities were observable in a 2019 cohort of Medicare Advantage beneficiaries receiving treatment for lung cancer. Methods: This retrospective, observational study used health plan claims data to identify Black and White patients aged 18 to 89 years with a Medicare Advantage health plan in calendar year 2019 who received diagnostic imaging (computed tomography or positron emission tomography) followed by lung cancer treatment (radiation therapy [RT] or surgery claims mentioning a diagnosis of lung cancer) within 90 days. Only patients treated in 2019 were considered so that the findings would reflect the state of care immediately preceding the COVID-19 pandemic. Patients were excluded if they had a history of RT or lung surgery in the year prior to the diagnostic imaging date. Other databases were used to determine cancer stage, patient demographics, comorbidities, the urbanicity and median income of patients’ home ZIP code, and whether treatment was ordered by a hospital-based physician. A multivariate logistic model was used to examine the association between race and surgery, and a multivariate negative binomial model was used to examine the association between race and days to treatment (surgery or RT). Results: We identified 823 patients, 83.8% White (690), and 16.2% (133) Black. Surgery was received by 3.1% [4/133] of Black patients and 9.7% [61/690]) of White patients. Black patients received treatment on average 36.9 days after diagnosis, versus 35.1 days for White patients. Adjusted analysis did not find a significant association between race and receipt of surgery (P = 0.07) or race and days to treatment (P = 0.77). No covariate was significantly associated with receipt of surgery. Residence in a state with a higher obesity rate was associated with fewer days to treatment (P = 0.02). Conclusions: In a uniformly insured population that successfully received treatment, adjusted analysis found no evidence of a Black / White racial disparity in use of lung surgery for Stage 3 lung cancer or in timeliness of treatment. Given the directionality of the findings, they could potentially have been significant if the sample size had been increased by extending the enrollment period. The implication of these findings is that it may be most fruitful to address racial disparities at the frontend of the care process; working to ensure that patients have access to insurance, diagnostics, and treatments, as disparities were not observed in a population that had accessed treatment. Further research is needed to assess whether racial disparities in lung cancer treatment have dissipated over time.

The Association Between Use of Hypofractionated Radiation Therapy for the Treatment of Prostate Cancer and Treatment Completion

While hypofractionated (HF) radiation therapy (RT) is recognized as a suitable treatment for low and intermediate risk prostate cancer, it is not yet the standard of care. As HF RT requires the patient to attend fewer appointments, it is potentially easier for patients to complete than conventional fractionation (CF) RT. Since noncompletion of RT has been shown to lead to inferior outcomes, use of HF RT may be a way to increase treatment adherence. This study examines whether there is a difference in treatment completion rates for HF RT versus CF RT in the context of prostate cancer.Radiation therapy order data from a prior authorization program and health plan claims data were extracted. The data related to patients belonging to commercial and Medicare Advantage health plans from a national organization. The patients included had early-stage prostate cancer, had not had prostatectomy, were not receiving palliative care, had no prior prostate cancer RT orders, and received their order for RT between July 1st, 2016 and September 30th, 2019. Orders were categorized as HF if they were authorized for 5 to 28 fractions of RT, and CF if they were authorized for 29 to 48 fractions. Each RT order was assigned a target date for completion, and completion was assessed on the basis of whether the patient had received the number of fractions authorized by that date. Patients with orders for 5 fractions were considered to have completed treatment if they received 3+ fractions, as these were stereotactic body RT regimens that are adjusted based upon treatment response. A Chi-square test was used to evaluate the association between the authorized regimen and completion. A multivariate logistic regression was used to assess the same, after controlling for age, urbanicity, the median income of the patient's home ZIP code, if the order was placed at a hospital, and if the ordering facility's name suggested an academic affiliation. Finally, a multivariate logistic regression was used to assess whether any of the control variables were associated with the authorization of a HF regimen.Of the 936 orders included, 309 (33.0%) were for HF and 627 (67.0%) were for CF. The completion rate significantly (P < 0.01) differed between the groups; 64.7% (200/309) for HF orders and 55.8% (350/627) for CF orders. Multivariate analysis found HF orders were significantly associated with treatment completion, relative to CF orders; 1.49 (95% CI: 1.12-1.99) adjusted odds. None of the other covariates were significantly associated with completion. Patients had significantly higher odds of having an order for HF if they came from a < $40,000 median income ZIP code (OR: 1.40; 95% CI: 1.01-1.93), or if the site of service at which the order was placed was a hospital (OR: 1.75; 95% CI: 1.26-2.42).Patients with orders for HF regimens completed their RT more frequently than patients with orders for CF regimens. The potential for greater treatment adherence should be considered as a possible benefit of HF.

Opioid and benzodiazepine dispensing and co-dispensing patterns among commercially insured pregnant women in the United States, 2007\u20132015

BackgroundLittle is known about benzodiazepine and opioid-benzodiazepine co-dispensing patterns among pregnant women. Understanding these patterns is necessary to mitigate high-risk medication use during pregnancy. Our objective in this analysis was to evaluate opioid and benzodiazepine dispensing and co-dispensing patterns among commercially insured pregnant women in the United States.Methods This retrospective study used a 10% random sample of commercially insured enrollees from the IQVIA™ Adjudicated Health Plan Claims Data from 2007 to 2015. The study included women (12–55 years of age) with completed pregnancies who had continuous medical and prescription drug coverage from 3 months prior to the date of conception through 3 months post-delivery. We estimated the prevalence of opioid and benzodiazepine dispensing and co-dispensing before, during, and after pregnancy, and evaluated trends in dispensing patterns across the study period (2007–2015) using Cochrane-Armitage tests. Chi-square tests were used to examine differences in demographic and clinical characteristics by dispensing and co-dispensing patterns. Among women that received an opioid or benzodiazepine during pregnancy, logistic regression models were used to quantify the association between sample characteristics and dispensing patterns (co-dispensing vs single dispensing).ResultsOf 168,025 pregnant women that met our inclusion criteria, 10.1% received at least one opioid and 2.0% received at least one benzodiazepine during pregnancy, while 0.5% were co-dispensed these drugs. During the study period (2007 vs 2015), prevalence of opioid dispensing during pregnancy decreased from 11.2 to 8.6% (p < 0.01); while benzodiazepine dispensing increased from 1.3 to 2.9% (p < 0.01), and the prevalence of co-dispensing, while low and stable, increased slightly from 0.39 to 0.44% (p < 0.01). Older age, a higher comorbidity burden, pain diagnosis, anxiety diagnosis, and alcohol, tobacco, and drug use disorders, were all associated with an increased odds of co-dispensing during pregnancy.ConclusionsThis study provides evidence that while opioid dispensing during pregnancy has decreased in the past decade, benzodiazepine dispensing has increased. The prevalence of opioid-benzodiazepine co-dispensing was rare and remained fairly stable during our study period. Those co-dispensed both drugs had a higher prevalence of adverse birth outcomes. Further research to establish the potentially causal relationship between opioid and benzodiazepine co-dispensing and adverse birth outcomes should be undertaken.

IDENTIFYING INADEQUATE RESPONSE AMONG CROHN’S DISEASE PATIENTS ON A BIOLOGIC IN A REAL-WORLD ADMINISTRATIVE CLAIMS DATABASE

Abstract Objectives The purpose of this analysis was to assess the frequency of inadequate response (IR) over 1 year from biologic initiation among Crohn’s disease (CD) patients in the United States using a claims-based algorithm. Baseline factors associated with IR to a biologic were also analyzed. Methods This was a retrospective cohort study using claims data from the HealthCore Integrated Research Database. Adult patients with CD who initiated a biologic (TNFi: adalimumab, certolizumab, infliximab; non-TNFi: natalizumab, ustekinumab, and vedolizumab) from 7/1/2016 to 8/31/2018 and had continuous enrollment ≥6 months before and ≥12 months after index date (date of first biologic claim) were included. The index biologic was defined as the first biologic prescribed during the study time period. The claims-based algorithm used in this study to identify IR was originally developed and validated in rheumatoid arthritis and was modified for CD patients. Patients were identified as having IR to their index biologic if during the 12 months after index date they had one or more of the following: low adherence (defined as proportion of days covered (PDC)&amp;lt;80%), switched/added new biologic, added a new conventional therapy, increased dose/frequency of biologic, addition or dose increase of oral glucocorticoids, used a new pain medication, or had surgery for CD. Baseline patient characteristics were compared between responders and IRs using Chi-square tests for categorical variables and t-tests for continuous variables. A multivariable logistic regression model was constructed to identify baseline characteristics associated with IR to the index biologic. Results A total of 2,437 CD patients were included in this analysis. Mean age was 41 years, 53% were female, 81% initiated a TNFi, and 19% initiated a non-TNFi as their index biologic (Table 1). Over the 1-year follow-up period, 62% of CD patients had an IR to their biologic: 41% of patients had low adherence, 14% switched/added a new biologic, 13% added a new conventional therapy, 12% had a dose/frequency increase of their index biologic, 12% had an addition/dose increase of oral glucocorticoids, 8% used a new pain medication, and 5% had surgery. Inadequate responders were more likely to be female (odds ratio (OR)=1.36; p&amp;lt;0.001), have historical use of TNFi (OR=1.94; p&amp;lt;0.001), and be on a consumer-driven health plan (OR=1.28; p&amp;lt;0.001); while patients with baseline use of conventional therapy were more likely to be responders (OR=0.72; p&amp;lt;0.001) (Table 2). Conclusion Over 62% of CD patients had an inadequate response to their index biologic within 1 year after initiation, mostly driven by low adherence. This modified claims-based algorithm for CD appears useful to classify inadequate responders in health plan claims data. Additional research is needed to further validate this algorithm in a clinical setting.

Identifying disability level in multiple sclerosis patients in a U.S.-based health plan claims database

Aims In clinical trials, disability progression in multiple sclerosis (MS) is measured by the Kurtzke expanded disability status scale (EDSS), which is not captured in routine clinical care in the U.S. This study developed a claims-based disability score (CDS) based on the EDSS for assigning MS disability level in a U.S. claims database. Methods This retrospective cohort study of patients with MS in the U.S., utilized adjudicated health plan claims data linked to electronic medical records (EMRs) data. Patients were identified between 1 January 2012 and 31 December 2016 and indexed on the first date of MS diagnosis. The CDS was developed to assign disability level at baseline using claims and ambulatory EMR records observed over the 1-year baseline period. All-cause healthcare costs were assessed by baseline disability level to validate the CDS. Results In total, 45,687 patients were identified in claims (full sample) and 1,599 linked to EMR (core sample). Over half of patients in both samples were classified with mild disability at baseline. Adjusted healthcare costs in patients with moderate and severe disability were 15% (p<.0001) and 20% higher, respectively, than in patients with mild disability at baseline in the full sample. Disease-modifying therapy (DMT) costs accounted for 89%, 82%, and 78% of outpatient pharmacy costs in patients with mild, moderate, and severe disability, respectively. Conclusions The CDS is the first claims-based measure of MS disability utilizing data from EMR. This novel measure advances the opportunity to examine outcomes by disability accumulation in the absence of standard markers of disease progression. Although formal validation of the CDS was not possible due to lack of available EDSS in the EMR, the economic burden results align with prior publications and show that healthcare costs increase with increasing disability. Future validation studies of the CDS are warranted.

Costs and Adverse Events Associated with Ibrutinib or Ruxolitinib in Chronic Graft-Versus-Host Disease

Background: Chronic Graft-Versus-Host Disease (cGVHD) is a common and potentially fatal complication after allogeneic hematopoietic stem cell transplantation. Beyond corticosteroids, there are multiple potential treatment options, including ibrutinib and ruxolitinib (off-label). Both ibrutinib and ruxolitinib are associated with adverse events (AEs) that may limit adherence or lead to treatment discontinuation. This retrospective analysis of United States administrative claims data examined ibrutinib and ruxolitinib use in cGVHD patients, including persistence on treatment, cost of care, and healthcare resource utilization (HCRU). Methods: Adult (≥18 years old) patients were identified in IQVIA™ Health Plan Claims Data (1/2014-9/2019) by ≥1 diagnosis claim for cGVHD by ICD-9 (279.51) and ICD-10 (D89.811) codes. The ibrutinib and ruxolitinib cohorts required ≥1 prescription claim (with the first claim as a proxy for treatment initiation = index) for the drug of interest, and no claims for the other drug (i.e., ruxolitinib or ibrutinib) within 12 months post index. Control cohorts required ≥1 prescription or treatment claim (index) for calcineurin inhibitors, mTOR inhibitors, mycophenolate mofetil, imatinib, methotrexate, etanercept, rituximab, or extracorporeal photopheresis, and no ibrutinib or ruxolitinib claim within 12 months post index. Propensity score matching (PSM) analyses required medical and drug benefit continuous enrollment for ≥6 months prior to index and ≥12 months after. Treatment persistence was assessed by Kaplan-Meier methodology, with a 30-day permissible gap between treatments, and AEs reported within 30 days of discontinuation were reported. In addition to individual AEs, composite measures of infections and lung AEs were assembled from ICD diagnosis codes. PSM of the ibrutinib and ruxolitinib cohorts to controls used age, sex, baseline cost, region, comorbidities, and lung involvement. PSM ensured patients will share similar characteristics, and outcome comparisons between these matched cohorts will not be confounded by the covariates used in the matching process. Costs and HCRU were assessed in the 12-month post index period. Results: In discontinuation analyses, 117 ibrutinib and 266 ruxolitinib patients were identified. In the year after index, 58/117 (50%) of ibrutinib and 109/266 (41%) of ruxolitinib patients discontinued (Figure 1). Within 30 days of discontinuation, AEs reported in the ibrutinib cohort in ≥10% of patients included (in decreasing order) the infection composite AE (36%), the lung composite AE (34%), dyspnea (28%), kidney failure (24%), edema (16%), atrial fibrillation (12%), thrombocytopenia (12%), and neutropenia (10%). In the ruxolitinib cohort, AEs reported within 30 days of discontinuation and occurring in ≥10% of patients included (in decreasing order) the infection composite AE (45%), the lung composite AE (37%), dyspnea (34%), thrombocytopenia (31%), edema (27%), kidney failure (27%), hypokalemia (15%), neutropenia (14%), thrombosis (13%), and hemorrhage (11%). In analyses of PSM cohorts, 39 ibrutinib patients matched to 110 control patients, and 81 ruxolitinib patients matched to 187 control patients. Annualized costs for the ibrutinib (median $263,658) and ruxolitinib (median $223,564) cohorts were significantly greater than control cohorts (p&amp;lt;0.001). Costs excluding the treatment of interest were greater for ibrutinib (median $82,989 vs. $64,546; p=0.25) and ruxolitinib (median $66,824 vs. $48,673; p=0.033). Ibrutinib patients showed a greater hospitalization rate versus control patients (24/39, 62% vs. 49/110, 45%; p=0.093). Ruxolitinib patients showed increased mean healthcare visits versus control patients (65.6 vs. 52.6; p=0.034). Conclusions: In this analysis, ibrutinib and ruxolitinib discontinuation and AEs previously reported to be associated with either ibrutinib or ruxolitinib utilization occurred in a similar temporal window. Ibrutinib and ruxolitinib patients also demonstrated higher treatment costs and increased healthcare visits versus control cGVHD patients. Further research is required to better understand the cost of cGVHD treatment with these medications. Sponsorship: Kadmon Corporation, LLC Disclosures Bachier: Sanofi: Speakers Bureau; AlloVir: Honoraria; CRISPR: Honoraria; Juno Therapeutics, a Bristol-Myers Squibb Company: Honoraria. Eiznhamer:Kadmon Corporation, LLC: Current Employment, Current equity holder in publicly-traded company. Milgroom:Trinity Life Sciences: Current Employment. Lenco:Trinity Life Sciences: Current Employment. Patel:Trinity Life Sciences: Current Employment. Skaar:Trinity Life Sciences: Current Employment. OffLabel Disclosure: ruxolitinib for chronic graft versus host disease

COVERAGE, ACCESS, AND MEDICAID

In June 2019, New Hampshire began requiring beneficiaries to report work and community engagement hours as a condition of eligibility for its Medicaid expansion program, Granite Advantage, becoming the second state to do so following Arkansas’s program implemented a year earlier. State officials set out to design and implement a program that would avoid the problems in Arkansas that resulted in over 18,000 Medicaid adults being disenrolled in the first six months of Arkansas Works. But after just one month, New Hampshire officials realized they had not succeeded in reaching and informing the target population, and 17,000 Granite Advantage enrollees were scheduled to receive letters saying they were out of compliance with Medicaid work rules and faced the prospect of losing coverage. However, state officials suspended the program before this occurred, and federal courts subsequently halted the program indefinitely. We studied New Hampshire’s Medicaid work requirement program to understand how it was implemented and why, like Arkansas, it apparently failed to promote work and threatened coverage.Building on a similar case study of Arkansas Works conducted earlier in 2019, we visited New Hampshire for three days in October 2019, conducting seven interviews with 13 stakeholders and two focus groups with 11 Medicaid enrollees to learn about the state’s program and its effects on beneficiaries. Nineteen additional interviews were conducted by telephone.Medicaid beneficiaries enrolled in Granite Advantage, New Hampshire’s Medicaid expansion program.Regarding outreach, New Hampshire allowed insufficient time and funding to publicize and educate beneficiaries about new work rules and relied too heavily on mail‐ and telephone‐based methods that failed to connect with a hard‐to‐reach population. In attempting to promote work, the state’s Granite Workforce pilot was crippled by very limiting eligibility requirements and a short, six‐month implementation period that helped just 120 enrollees while spending less than 13% of its budget allocation. Like Arkansas, New Hampshire tried to proactively exempt many members from work requirements (eg, those already working 100 hours/month, satisfying SNAP work requirements, who are disabled, pregnant, or caring for children under six). But also, like Arkansas, the state failed to use health plan claims data to identify “medically frail” individuals who experienced difficulties applying for exemptions. New Hampshire designed a “no wrong door” approach for reporting work and community engagement that, unlike Arkansas’s primarily online system, allowed people to report hours online, by mail, over the phone, or in‐person. However, the system was fraught with problems and only a fraction of beneficiaries was able to successfully report hours.Despite intentional efforts to design a “better” program than Arkansas’s, New Hampshire’s Medicaid work requirements produced nearly the same result in a fraction of the time, facing the disenrollment of a large share—67 percent—of persons subject to the requirement.Based on the experiences of the first two states to implement Medicaid work requirements—states that adopted considerably different approaches under different circumstances—evidence suggests that such programs cause significant harm to Medicaid beneficiaries while not appreciably supporting their ability to work.The Robert Wood Johnson Foundation.

Economic outcomes of insurer-led care management for high-cost Medicaid patients.

To evaluate the impact of the Community-Based Care Management (CBCM) program on total costs of care and utilization among adult high-need, high-cost patients enrolled in a Medicaid managed care organization (MCO). CBCM was a Medicaid insurer-led care coordination and disease management program staffed by nurse care managers paired with community health workers. Retrospective cohort analysis. We obtained deidentified health plan claims data, enrollment information, and the MCO's monthly registry of the top 10% of costliest patients. The analysis included 896 patients enrolled in CBCM over the course of 2 years (January 2016 to December 2017) and a propensity score-matched cohort of high-cost patients (n = 2152) who received primary care at sites that did not participate in CBCM during the same time period. The primary outcomes were total costs of care and utilization in the 12-month period after enrollment. Secondary outcomes included utilization by care setting: outpatient, inpatient, emergency department, pharmacy, postacute care, and all other remaining sites. We used zero-inflated gamma and Poisson regression models to estimate average differences in postperiod costs and utilization between CBCM enrollees versus non-CBCM enrollees. We did not observe meaningful differences in total costs or visit frequency among CBCM enrollees relative to non-CBCM enrollees. Although our study found no association between the CBCM program and subsequent cost or utilization outcomes, understanding why these outcomes were not achieved will inform how future Medicaid programs are designed to achieve better patient outcomes and lower costs.

Costs and Treatment Patterns Among Patients with Atopic Dermatitis Using Advanced Therapies in the United States: Analysis of a Retrospective Claims Database.

IntroductionFor many, atopic dermatitis (AD) is not adequately controlled with topical regimens. This analysis examined treatment using advanced therapies and associated costs.MethodsThe IQVIA Health Plan Claims data set was analyzed. Patients aged ≥ 12 years with AD who newly initiated advanced therapy after the availability of dupilumab (March 28, 2017) and had ≥ 6 months continuous enrollment before and after their first advanced therapy claim (index date) were included. Advanced therapies included dupilumab, systemic corticosteroids (SCSs), systemic immunosuppressants (SISs), and phototherapy. A multivariate regression model was used to predict annualized follow-up healthcare costs.ResultsIn total, 1980 patients were included (61.1% female; mean age, 41.2 years [SD, 17.4]; 11.3% < 18 years). Pre-index date, 65.2% of patients used topical corticosteroids (TCSs; 40.7% and 32.1% used medium and high potency, respectively). The most common advanced therapy was SCSs (N = 1453 [73.4%]; 69.2% prednisone) followed by dupilumab (N = 265 [13.4%]), SISs (N = 99 [5.0%]; 47.5% methotrexate), and phototherapy (N = 163 [8.2%]). Of patients treated with dupilumab, SISs, and phototherapy, 17.4%, 26.3%, and 14.1%, respectively, were prescribed SCSs post-index date. Overall, 62.6% of patients initiating SCSs, 49.1% initiating dupilumab, 64.6% initiating SISs, and 36.2% initiating phototherapy were prescribed TCSs post-index date. Mean annualized total costs (SD) post-index date were $20,722 ($47,014): $11,196 ($41,549) in medical costs ($7973 [$35,133] in outpatient visit costs) and $9526 ($21,612) in pharmacy costs. Mean annualized total cost (SD) varied significantly (P < 0.05) by index treatment: dupilumab, $36,505 ($14,028); SCSs, $17,924 ($49,019); SISs, $24,762 ($47,583); phototherapy, and $17,549 ($57,238).ConclusionsSwitching to combination therapy with SCSs and TCSs was common within 6 months of initiating advanced therapy in patients with AD. Patients also incurred significant pharmacy and outpatient costs. These results highlight the difficulty of managing AD with these existing treatment options.

Burden of relapsed/refractory (RR) acute myeloid leukemia.

e19509 Background: To examine treatment patterns and health care costs of RRAML in the US. Methods: We identified adults with ≥ 2 outpatient or ≥ 1 inpatient claim with a diagnosis of AML from 1/1/2011 to 12/31/2017 (first AML claim = index date) using IQVIA’s fully-adjudicated Health Plan Claims Data. Continuous health plan enrolment for ≥ 12 months prior to the index date and ≥ 1-month post-index, a RRAML diagnosis on or prior to the index date, or with hematopoietic stem cell transplantation (HSCT) or chemotherapy pre-index were required. Patients were grouped by post-index treatment (high- or low-intensity chemotherapy [HIC, LIC] with and with no HSCT, HSCT only, best supportive care [BSC], or no treatment within 90 days of index [NoTx]). Costs were evaluated for 12 months following index. Results: The final sample of patients with RRAML (n = 804) were grouped by age:18-59 (n = 411; 51.2%), 60-74 (n = 318; 39.5%), and ≥75 years (n = 75; 9.3%). Treatment within the three age cohorts was: HIC (13%, 11%, 1%); LIC (27%, 38%, 52%); HIC+HSCT (14%, 7%, 0%); LIC+HSCT (2%, 3%, 0%); HSCT (9%, 9%, 0%); BSC (21%, 21%, 31%); NoTx (13%, 12%, 16%), respectively. Mean monthly costs were lowest for BSC and highest for HSCT or HIC containing treatments, irrespective of age (Table). Inpatient costs were 50 to 100% of total costs. Monthly costs across treatment/age groups were higher earlier in treatment [month 1 range: $28,627 (BSC) to $180,867 (HIC)] and declined over time [month 12 range: $2,853 (BSC) to $53,003 (HIC+HSCT)]. Conclusions: Nearly half of all patients age ≥75 years and 33% of patients &lt; 75 years received BSC or NoTx, which highlights a significant unmet need for new treatment options. Average costs per patient, especially early in treatment are high and driven by hospital service utilization. [Table: see text]