Post-index Continuous Enrollment Research Articles

P-473. Health Care Resource Use Burden Among People With HIV (PWH) and Concurrent Mental Health Disorders (MHDs): Claims Analysis of Treatment-Naïve Medicaid Population Initiating Multi-Tablet Regimens (MTRs) vs. Single-Table Regimens (STRs)

Abstract Background Multi-tablet antiretroviral (ART) regimens (MTRs) have been largely replaced by single-tablet ART regimens (STRs) for treating people with HIV(PWH). STRs provide lower pill burden, increased patient adherence, and lower health care resource utilization (HCRU) among PWH. However, their effects among vulnerable sub-populations of PWH with coexisting mental health disorders (PWH/MHDs) in real-world settings are not well understood. This analysis examined the characteristics and HCRU patterns among PWH/MHDs who initiated MTRs vs STRs in a US Medicaid population. Methods A retrospective analysis of treatment-naïve Medicaid PWH/MHDs (based on claims for MHD-related diagnosis or treatments) using Anlitiks All Payor Claims database from 01/01/16-06/30/23 was conducted. The study included MTR or STR initiators (i.e., MTR/STR initiation date=index date) with ≥12-months pre- and post-index continuous enrollment. Baseline characteristics and post-index all-cause HCRU outcomes (PWH/MHD with ≥1 inpatient (IP) hospitalization, outpatient (OP) visits, emergency department (ED) visits, office visits, and other visits) were described using Chi-square, t-tests and Wilcoxon rank-sum tests as appropriate. HCRU outcomes were assessed using multivariate logistic regression models and reported as adjusted odds ratios (aOR) and 95% confidence intervals (CI). Results Among PWH/MHDs, MTR initiators (n=7,874) vs. STR initiators (n=46,024) were younger (43.6 vs. 47.2 years; p< 0.05), more likely to be female (64.3% vs. 53.6%; p< 0.05), and more likely to use substances (32.1% vs 29.4%; p< 0.05). MTR initiators had significantly higher aOR for: IP hospitalizations (1.49; CI:1.41-1.56), ER visits (1.38; CI: 1.31-1.44), OP visits (1.19; 1.44-1.26), and other visits (1.19; 1.44-1.26) compared to STR initiators. However, MTR initiators had significantly lower aOR (0.94; 0.89-0.99) for office visits compared to STR initiators. Conclusion This analysis indicates that PWH with MHDs in the Medicaid population are more likely to have higher HCRU while taking MTR compared to STR. The analysis also highlights that PWH with MHDs may be the underserved population who may benefit from receiving more tailored and simplified ART regimens. Disclosures Megan Chen, MSPH, Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Mary J. Christoph, PhD, MPH, AstraZeneca: Advisor/Consultant|AstraZeneca: Former employee|AstraZeneca: Stocks/Bonds (Private Company)|Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Seojin Park, PharmD, MS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Woodie Zachry, RPh, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Amy Weinberg, DNP, MS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Cassidy Trom, PharmD, AAHIVE, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Joshua Gruber, PhD MPH, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Krithika Rajagopalan, PhD, Gilead Sciences, Inc.: Advisor/Consultant

Healthcare resource utilization and costs among treatment-naïve people with HIV in state Medicaids: analysis of multi-tablet vs. single-tablet antiretroviral regimen initiators with and without concurrent mental health disorders

Background Research is needed to understand the impact of mental health disorders (MHD) on healthcare resource utilization (HCRU) and costs among people with human immunodeficiency virus (PWH). Objectives Examine the HCRU and cost burden among treatment-naïve PWH with and without MHD initiating single tablet antiretroviral regimens (STRs) and multi-tablet regimens (MTRs). Methods A retrospective database analysis of the US Medicaid population from Anlitiks’ All Payor Claims database between 1 January 2016 and 30 June 2023 was conducted. Treatment-naïve MTR-initiators vs STR-initiators (the index was the first prescription fill claim date) with ≥ 12-months pre- and post-index continuous enrollment and no pre-index HIV-2 diagnosis among PWH/MHD and PWH/no-MHD during 1 January 2017–30 June 2022 were selected. Demographics, clinical characteristics, HCRU and costs between MTR-initiators vs STR-initiators among PWH/MHD and PWH/no-MHD were described using Chi-square tests and Wilcoxon rank-sum or t-tests for categorical and continuous variables, as appropriate. HCRU and costs were examined using multivariable logistic and gamma-log link regression models, controlling for potential confounders. Results MTR-initiators (PWH/MHD: n = 7,874, PWH/no-MHD: n = 3,612) vs. STR-initiators (PWH/MHD: 46,024, PWH/no-MHD: 23,452) were significantly younger (PWH/MHD: 43.6 vs. 47.2 years; PWH/no-MHD: 39.2 vs. 43.3 years) and more likely to be female (PWH/MHD: 46.4% vs. 35.7%; PWH/no-MHD: 42.3% vs 29.7%) in both groups (all p-values < 0.05). MTR-initiators vs. STR-initiators had significantly higher rates of inpatient (IP) hospitalizations (PWH/MHD: 28.9% vs. 27.1%; PWH/no-MHD:13.9% vs. 11.9%) and emergency department (ED) visits (PWH/MHD: 53.3% vs. 49.2%; PWH/no-MHD: 35.2% vs. 31.8%) among both those with and without MHD (all p-values < 0.05). MTR-initiators vs. STR-initiators also had significantly higher adjusted all-cause medical costs (PWH/MHD: $60,228 vs $40,634; PWH/no-MHD: $33,623 vs. $17,996) (all p-values < 0.05). Conclusions Among PWH/MHD and PWH/no-MHD, MTR-initiators experienced significantly higher HCRU, and 1.5 times greater costs compared to STR-initiators. In both MTR and STR-initiator groups, the PWH/MHD cohort consistently demonstrated a greater HCRU and cost burden than the PWH/no-MHD.

Abstract 4137810: Association of Sociodemographic Characteristics on Costs of Care in Patients with Obstructive Hypertrophic Cardiomyopathy

Introduction: No evidence exists on the impact of sociodemographic characteristics on costs of care for obstructive hypertrophic cardiomyopathy (oHCM). Therefore, we evaluated 5-year cumulative costs by age, sex, and race/ethnicity. Methods: Retrospective cohort study of adults diagnosed with oHCM (January 2013 to December 2021) using Optum claims and electronic medical record data. Patients with ≥2 claims for HCM (ICD-9 and-10) at least 30 days apart (index date = earliest oHCM claim) with ≥1 additional oHCM claim or septal reduction therapy, 6-months pre-index and 5-year post-index continuous enrollment were included. HCM-related cumulative costs (2022 CPI adjusted) were reported for medical (ambulatory [AB]: office [OV] visits, outpatient [OP] visits); emergency room [ER] visits; inpatient admissions (IP); and pharmacy (Rx). Results: Among 5,129 patients with oHCM, 52% were female (mean age 63.9 ± 14.3 years; 77.6% non-Hispanic White; 40% Medicare). Compared to females (Table), male patients had greater costs including total ($71,581 vs $63,710, p= 0.014), medical ($70,395 vs $62,455, p= 0.013), ambulatory ($16,024 vs $10,776, p&lt;0.001), OV ($1,906 vs $1,573, p&lt;0.001), and OP ($14,118 vs $9,202, p&lt;0.001). Compared with White patients, Black patients had significantly greater IP costs ($54,572 vs $42,686, p= 0.01), Hispanic patients had greater ER costs ($1,724 vs $791, p&lt;0.001), and Asian patients had greater OV costs ($2,094 vs $1,800, p&lt;0.001). Patients aged 18-39 years had greater costs across all categories (p&lt;0.001; IP=NS), except Rx. Patients aged 40-54 years had the highest Rx costs ($1,557, p&lt;0.001), followed by 18-39, 55-64, 65-74, 75+ years ($1,528; $1,329; $1,197; $867), respectively. Conclusions: For oHCM patients , being male and age 18-39 years was associated with increased HCM-related healthcare costs. Differences in cost across race/ethnicity exist, including greater IP and ER costs for Black and Hispanic patients, respectively. Future research is required to understand the source of these differences among oHCM patients.

Real-World Analysis of Healthcare Resource Utilization and Costs Among Patients Diagnosed with Von Willebrand Disease and Angiodysplasia

Background: Von Willebrand disease (VWD), an autosomal inherited bleeding disorder, is characterized by deficiency or dysfunction of von Willebrand factor (VWF). Patients with VWD may suffer from recurrent bleeding in the gastrointestinal (GI) tract associated with angiodysplasia (AGD). Recurrent hospitalizations due to bleeding are common in patients with VWD and AGD, causing significant financial burden and poor quality of life. There are limited data on the economic and clinical burden of patients with VWD and AGD. This study aims to understand the healthcare resource utilization (HCRU) and economic burden among patients with VWD related AGD from patient and payer perspectives. Objectives: To describe the sociodemographic & clinical characteristics, HCRU & all-cause costs (ACC), treatment and procedure patterns for patients with VWD of any type and AGD. Methods: This retrospective, observational cohort study used the IBM MarketScan® database (2011-2020), containing healthcare data from the United States (US). Selected patients had ≥1 medical claim for VWD or low VWF, ≥1 medical claim for AGD, and ≥3 GI-related bleed episodes within a year identified using International Classification of Diseases (ICD-9/10) codes. The index date was defined as the date of the first GI bleed-related medical claim before or within 30 days of the first AGD claim. Otherwise, it was defined as the date of the first AGD-related medical claim. Patients were excluded if they did not have 6 months pre- and 12 months post-index continuous enrollment and if they had ≥2 medical claims of hemophilia A (HA), hemophilia B, acquired HA, ulcerative colitis, Crohn's disease, acquired VWD, or other bleeding disorders atleast 30 days apart. HCRU and ACC were compared with a VWD (only) cohort (i.e., continuously enrolled VWD patients without AGD) and a general cohort (i.e., continuously enrolled patients without VWD or AGD) to improve the strength of the evidence via reducing the risk of bias and generating statistical inferences. For comparison of the cohorts, 1:4 exact matching was performed using age, gender, index year, and Charlson Comorbidity Index (CCI) score (relaxing age and index year by ± 5 years). Statistical comparisons were made using ANOVA tests for continuous and Chi-square tests for categorical variables. The ACC were inflated to 2021 US dollars using the annual medical care component of the consumer price index. In addition to the HCRU and ACC comparisons, clinical characteristics of the VWD and AGD cohort were reported along with 2 other cohorts that met 2 of the 3 inclusion criteria to allow for a more relevant description of diagnostics, procedures, and bleed rates. Results: After exact matching, 34 patients were selected from the VWD & AGD cohort with 136 patients each from VWD (only) and general population. Mean (SD) HCRU were significantly higher for the VWD & AGD cohort than the VWD (only) and general cohorts: {2.2 (2.2), 0.6 (1.3), and 0.3 (0.6)} inpatient visits, {17.6 (36.4), 3.4 (10.9), and 2.0 (7.1)} inpatient hospital days, {2.2 (2.6), 0.8 (2.1), and 0.7 (1.5)} emergency visits, and {28.8 (19.4), 18.8 (16.0), and 17.3 (19.6)} outpatient visits, respectively. Mean (SD) total ACC were significantly higher for the VWD & AGD cohort than the VWD (only) and general cohorts {$150,101 ($305,052), $48,249 ($97,689), and $31,029 ($45,512), respectively} (Table 1). Sociodemographic and clinical characteristics (e.g. diagnosis related procedures, bleed rates) of the VWD cohort along with the 2 cohorts that met 2 of 3 inclusion criteria are reported in Table 2. Conclusions: This study found that patients with VWD and AGD were predominantly female with high HCRU and clinical burden due to recurrent bleeding episodes. The data demonstrated a substantial economic burden, primarily driven by hospitalizations. The diagnostic journey for patients and HCRU is highly variable and may benefit from a more structured and empiric understanding of how VWD and AGD patients are diagnosed and treated. Additionally, costs and burden of VWD & AGD could be mitigated by greater outpatient management to prevent recurrent GI bleeds (i.e. VWF prophylaxis). More research is needed to better understand disease management and healthcare outcomes of patients with VWD and AGD. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Healthcare Resource Utilization and Costs Associated with Obinutuzumab Plus Bendamustine Versus Rituximab Plus Bendamustine for First-Line Treatment of Follicular Lymphoma

Background: Obinutuzumab (G) is an anti-CD20 monoclonal antibody approved in the US for the first-line (1L) treatment of follicular lymphoma (FL), relapsed or refractory FL, and 1L chronic lymphocytic leukemia. G plus chemotherapy (G-chemo) demonstrated superior progression-free survival versus (vs) rituximab (R) plus chemotherapy (R-chemo) in patients with previously untreated FL in the Phase III, randomized GALLIUM study (NCT01332968; Marcus et al. N Engl J Med 2017). R-bendamustine (R-benda) and G-bendamustine (G-benda) are among the most commonly used chemoimmunotherapy (CIT) regimens for FL (Ta et al. J Clin Oncol 2021), and information on comparative healthcare resource use (HRU) and real-world costs associated with G-chemo vs R-chemo in previously untreated FL patients is limited. The aim of this study was to compare HRU and costs for G-benda and R-benda for the 1L treatment of FL using US claims databases.Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics® Plus and IBM® MarketScan Commercial and Medicare Supplemental databases. We identified patients aged ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims with a diagnosis of FL from February 1, 2015 to September 30, 2020, and received 1L R-benda or G-benda between February 1, 2016 and March 31, 2020. The first claim for FL treatment was the index date. All patients had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Patients with other primary cancers, FL treatment, diffuse large B-cell lymphoma (DLBCL), or stem cell transplant during the pre-index period, or clinical trial participation or end-stage renal disease during the study period were excluded. Patients initiating 1L G-benda were propensity score matched 1:2 with patients initiating 1L R-benda based on age, sex, Charlson Comorbidity Index (CCI), region, and insurance type. All-cause and FL-related (i.e. claim with a FL diagnosis in any position) HRU and costs (2020 USD) per patient per month (PPPM) during the follow-up period were reported. Patients were followed until the earliest of initiation of second-line therapy, end of continuous follow-up, or end of data availability.Results: Overall, 270 patients were included; of these, 90 (33.3%) patients receiving G-benda were matched to 180 (66.7%) patients receiving R-benda for 1L treatment of FL. 45.2% were male, and the mean (standard deviation [SD]) age and CCI at index date were 59.1 (9.9) years and 1.7 (1.1), respectively. Median follow-up was 7.4 months. After matching, baseline characteristics were well-balanced between R-benda and G-benda patients (standardized mean difference [SMD] <0.1). Both all-cause and FL-related HRU were similar between R-benda and G-benda treated patients across all service categories (Figure 1). Total all-cause mean [SD] PPPM costs were also similar in G-benda vs R-benda patients ($21,378 [$15,242] vs $21,352 [$14,145]; p=0.77) (Figure 2). The majority of the total costs were FL-related and comparable across both patient groups: $17,353 ($11,370) for G-benda vs $17,724 ($13,530) for R-benda (p=0.71). Specifically, FL-treatment related costs PPPM were $17,070 ($14,064) for G-benda; this is comparable to $16,138 ($11,828) PPPM for R-benda (p=0.39).Conclusions: Our study found similar total costs of care and HRU among patients receiving 1L G-benda versus those receiving R-benda, providing real-world economic evidence that complements clinical trial data supporting the use of G-chemo for 1L treatment of FL. [Display omitted] DisclosuresTo: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Ta: Genentech, Inc.: Current Employment. Seetasith: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Wang: The SPHERE Institute: Ended employment in the past 24 months; Aurinia Pharmaceuticals Inc.: Current equity holder in publicly-traded company; Novavax, Inc.: Current equity holder in publicly-traded company; Oragenics, Inc.: Current equity holder in publicly-traded company; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment; TG Therapeutics, Inc.: Current equity holder in publicly-traded company. Lai: Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company; AbbVie: Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months, Ended employment in the past 24 months; Bristol-Myers Squibb: Current equity holder in publicly-traded company. Shapouri: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company.

Healthcare Resource Utilization and Costs of Patients with Relapsed/Refractory Follicular Lymphoma Receiving 3 or More Lines of Therapy

Healthcare Resource Utilization and Costs of Patients with Relapsed/Refractory Follicular Lymphoma Receiving 3 or More Lines of Therapy

Suboptimal adherence to daily growth hormone in a US real-world study: an unmet need in the treatment of pediatric growth hormone deficiency

Objective To evaluate adherence to, and discontinuation of, somatropin treatment over 4 years in a US population-based study of children with pediatric growth hormone deficiency (pGHD). Methods A retrospective cohort analysis of commercially insured patients ≥3 and <16 years, diagnosed with pGHD, newly treated with somatropin was conducted using Optum De-identified Clinformatics Data Mart. Index date was defined as the first prescription for somatropin between 01 July 2002 and 30 September 2019. Five non-exclusive patient cohorts were identified (>3, 12, 24, 36, and 48 months of post-index continuous enrollment). Suboptimal adherence was defined as medication possession ratio <80%. Discontinuation was defined as the date at which a gap of >60 days between somatropin fills first occurred. Cox proportional hazards regression was used to evaluate time to discontinuation. Results In the 12-month cohort (n = 3091), mean age was 11.3 ± 2.9 years, 75.9% were male, 70.9% white, 9.4% Hispanic, 3.6% Asian, and 3.1% black. The proportion with suboptimal adherence at months 12 and 48 was 19.6% and 35.9%, respectively. Discontinuation occurred in 42.2% of patients. The rate of discontinuation (HR [95% CI]) was higher for age ≥10 (1.74 [1.53–1.98]), females (1.35 [1.21–1.50]), black and Hispanic race/ethnicity (1.50 [1.18–1.90] and 1.27 [1.09–1.49] compared to White) and obesity (1.69 [1.19–2.40]). Conclusion Suboptimal adherence increases with treatment duration, and risk of discontinuation is associated with age, female gender, black or Hispanic race/ethnicity, and obesity. Strategies that facilitate adherence among children at risk of discontinuation may improve clinical outcomes.

Real-world burden of illness and unmet need in locally advanced or metastatic urothelial carcinoma following discontinuation of PD-1/L1 inhibitor therapy: A Medicare claims database analysis

BackgroundSeveral programmed death-1 or death-ligand 1 (PD-1/L1) inhibitors are approved first- or second-line therapies for locally advanced or metastatic urothelial carcinoma (la/mUC); however, clinical trials show that only ∼20% of patients respond and all ultimately progress. This study elucidated real-world treatment patterns, healthcare resource utilization (HRU), and economic burden among Medicare beneficiaries with la/mUC who discontinue PD-1/L1 inhibitor therapies. MethodsWe conducted a retrospective claims analysis of patients aged ≥65 years diagnosed with la/mUC (2015−2017) who initiated and subsequently discontinued PD-1/L1 inhibitor therapy (index=date of last administration) using Medicare Fee-for-Service Research Identifiable Files. Included patients had ≥12 months pre- and ≥3 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or data cutoff. ResultsAmong 28,063 patients, 17% (n=4652) received ≥1 PD-1/L1 inhibitor following la/mUC diagnosis. Of these, 791 discontinued PD-1/L1 inhibitor therapy and met inclusion criteria (study cohort); 73% male, median age 76 years. Post-discontinuation, 3% received a different PD-1/L1 inhibitor, 46% chemotherapy, and 51% no further systemic treatment. HRU was high during follow-up: 97% had ≥1 outpatient visit and 52% ≥1 hospitalization. Healthcare costs per-patient-per-month were $7153 pre- and $7745 (adjusted) post-index; systemic therapy costs were higher pre- vs. post-index ($2978 vs. $1195) but other costs were higher post-index: hospitalization ($1120 vs. $2200), outpatient ($1437 vs. $2064), hospice ($3 vs. $536), skilled nursing facility ($106 vs. $384). ConclusionsOver half of Medicare beneficiaries with la/mUC received no disease-directed therapy post-PD-1/L1 inhibitor treatment. Patients who discontinued PD-1/L1 inhibitor therapy had intensive HRU unrelated to therapy costs, highlighting the significant burden of la/mUC and need for treatments that extend survival.

Real World Clinical and Economic Burden of Patients with Hodgkin Lymphoma (HL) Who Fail Frontline (FL) Therapy in the US

Introduction: Hodgkin lymphoma (HL) is a hematologic malignancy for which frontline treatment options and outcomes have remained unchanged for several decades. HL is considered to have a favorable prognosis although failure rates after FL therapy range from 10% to 30% depending on stage. Patients who fail go on to bear the burden of additional therapy after FL. Little real-world evidence exists on the burden of disease for patients who fail FL (FLF) therapy for healthcare providers to contextualize the value of novel therapies. This study aimed to identify FLF patients and compare healthcare costs between HL patients with and without FLF.Methods: This retrospective analysis used the MarketScan Commercial and Medicare Supplemental administrative claims databases to select adults aged >18 years with ≥ 1 inpatient or 2 outpatient claims with a HL diagnosis (ICD-9 201.xx excluding Hodgkin paragranuloma, Hodgkin sarcoma and lymphocytic-histiocytic predominance) from 1/1/2010 to 9/30/2015. Eligible patients were required to have continuous plan enrollment for > 6 months prior to the diagnosis, no prior cancer, and initiate a multi-agent regimen indicative of curative intent.Patients were in the FLF cohort if they had one of the following failure events: initiate a new chemotherapy after discontinuing FL (gap >60 days with no chemotherapy), switch to a new treatment, or having a stem cell transplant (SCT). Patients were in FLF+XRT cohort if they also received radiation after completing FL chemotherapy. Index dates for the FLF and FLF+XRT cohorts were the earliest date of the failure events, and were randomly assigned for non-FLF patients based on distribution of intervals between FL start date and index date for the FLF cohort. They had to have > 30-day post-index continuous enrollment and followed until date of disenrollment, death, or end of the study period.Annual healthcare costs were measured at 12-month post-index periods among patients with > 12-months post-index continuous enrollment. Costs were measured during FL and the entire follow-up period (reported as per patient per month [PPPM]).Results: 795 patients met the selection criterion (mean age 38.5 years, 47.5% female). 67.8% of patients 18-44 years old, 26.4% 45-64 years old, and 5.8% ≥65 years old. Most resided in urban areas (81.9%), and the mean pre-index Charlson Comorbidity Index score of study patients was 2.9±1.9. The two most frequent coded comorbidities during FL were symptoms involving the respiratory system (41.3%) and cardiovascular (22.9%) in both cohorts. Of the patients in the FL+XRT cohort, 60.1% received XRT after FL discontinuation, 21.8% discontinued and restarted therapy, 10.4% switched to a new therapy, and 7.8% went on to a SCT directly after FL.The PPPM costs for FLF cohort during the follow up was $12,494 (N=77, Table 1) and the annual all-cause cost of failure was $160,839 (N=33, Table 2) higher than patients who did not fail FL. The PPPM costs in FLF+XRT cohort (N=193) was $11,918 (vs $7,772) (Table 1). The annual all-cause cost in was $68,431 (N=94) higher than patients in non-FLF cohort (Table 2). PPPM costs during FL in FLF+XRT was $21,676 (vs $16,396) (Table 1) driven by outpatient services (50.5%) and inpatient admissions (48.6%). The FLF+XRT (vs non-FLF) cohort had a significantly shorter duration of FL therapy (average of 112 vs 131 days, p<0.05).The economic burden of failure varied by type (Table 3). The annual costs of failure due to restarting, switching, SCT, or radiation were $269,189, $46,951, $231,824, and $55,989, respectively. Similar trends in cost were observed among patients with ≥24 months post-index enrollment (n=200).Conclusions: HL patients who fail FL represent a substantially higher economic burden compared to those without FLF, not accounting for stage at diagnosis. We did not assess the indirect costs or societal impact of FLF for the population and therefore this is an underestimate of the overall burden. More research is needed to determine optimal treatment that could reduce the risk of progression, the need for treatment after completion of FL and enhance long-term clinical and economic outcomes. [Display omitted] DisclosuresStraus:Received consulting fee from Seattle Genetics for involvement in the research: Consultancy. Bonafede:Employee of Truven Health Analytics, an IBM Company, that received a research contract to conduct this study with and on behalf of Seattle Genetics, Inc: Employment. Feliciano:Seattle Genetics: Employment, Equity Ownership. Cai:Truven Health Analytics: Employment, Other: I am an employee of Truven Health Analytics, an IBM company which received funding from Seattle Genetics to conduct this study. Noxon:Truven Health Analytics, an IBM company which received project funding from Global Blood Therapeutics: Employment. Princic:Truven Health Analytics, IBM Company: Employment. Josephson:Seattle Genetics: Employment, Equity Ownership. Richhariya:Seattle Genetics: Employment, Equity Ownership.

PSY23 Persistence and Adherence Among Patients with Psoriatic Arthritis Treated with Targeted Immune Modulators

To compare treatment adherence and persistence among PsA patients initiating TNFi, IL-12/23i, IL-17i or tsDMARDs. Adults with ≥1 medical or pharmacy claim for a TNFi, IL-12/23i, IL-17i or tsDMARD during 10/1/2013–10/31/2018 were selected from IBM MarketScan® Commercial and Medicare Supplemental Databases. Date of first claim was the index date. Patients were required to have ≥12 months pre-index and ≥12 months post-index continuous enrollment, ≥2 PsA diagnoses ≥30 days apart during this 24-month period, and a PsA diagnosis on/ prior to index date. Patients with ≥2 study medications on the same day, other biologic-indicated autoimmune conditions, contraindications, or any study medication prior to the index date were excluded. Pairwise propensity score matching was performed. Proportion of Days Covered (PDC), duration of persistence, and number of patients discontinuing index biologic (i.e., gap between fills >1.5 times maintenance days’ supply) were compared between matched cohorts. Of 7,205 patients meeting identification criteria, there were 238 matched patient pairs for TNFi vs. IL-12/23i; 238 pairs for tsDMARDs vs. IL-12/23i; and 189 pairs for IL-17i vs. IL-12/23i. Patient characteristics were similar between cohorts. Duration of persistence was higher for the IL-12/23i cohort than for TNFi (269 vs 215 days, p<0.01) or tsDMARDs (269 vs 214 days, p<0.01), but comparable with IL-17i. The IL-12/23i cohort had fewer index treatment discontinuations than the TNFi (53.4% vs 73.9%, p<0.01) or tsDMARDs (53.4% vs 71.8%, p<0.01) cohorts, but no significant difference with IL-17i. During the 12-month follow-up period, patients initiating IL-12/23i had higher mean PDC than those on TNFi (0.64 vs 0.56, p<0.01) or tsDMARDs (0.64 vs 0.58, p=0.03), but similar to those on IL-17i. In this real-world study of PsA therapies with differing mechanisms of action, IL-12/23i demonstrated higher treatment adherence and longer persistence versus both TNFi and tsDMARDs, and comparability to IL-17i.

Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

Sub-Optimal Adherence With Daily Growth Hormones Increases With Each Year of Treatment in a US Commercial Claims Database

Introduction and Objective: Pediatric growth hormone deficiency (pGHD) occurs in approximately 1 in 4,000 children. The main manifestation is short stature managed with daily injections of somatropin, a recombinant human growth hormone (r-hGH). Prior research has shown that children with good adherence with r-hGH have significantly greater linear growth compared to those with sub-optimal adherence. While previous studies have found sub-optimal adherence with daily r-hGH injectables among children with pGHD, to date, r-hGH adherence has not been studied among large, usual-care populations using validated measurements of adherence. We describe adherence to somatropin treatment over 4 years in a population-based study. Materials and Methods: A retrospective cohort analysis of commercially insured patients ≥3 and <16 years, diagnosed with pGHD, newly treated with somatropin from 01 January 2002 through 31 December 2019 (study time period) was conducted using Optum De-identified Clinformatics Data Mart database. Index date was defined as the first prescription for somatropin between 01 July 2002 to 30 September 2019. Four patient cohorts were identified (12, 24, 36, and 48 months of post-index continuous enrollment). The demographic and clinical profiles of children with pGHD treated with daily injections of somatropin who have good adherence and those with sub-optimal adherence were characterized. Good adherence was defined as medication possession ratio (MPR) of ≥ 80%, sub-optimal adherence as MPR <80%. Logistic regression models will evaluate the relationship between demographic characteristics (age, gender, race/ethnicity) and adherence (good vs. sub-optimal). Results: Patient characteristics were similar across each cohort; in the 12-month cohort (n=3091), mean age was 11.34 ±2.89 years, 75.9% were male, 70.9% white, 9.4% Hispanic, 3.6% Asian, and 3.1% black. At 48 months, 1193 (38.6%) of the 12-month cohort remained for follow-up. At 12 months, 80.1% had good adherence and mean (95% CI) MPR was 0.89 (0.88-0.89) while mean (95% CI) MPR at 48 months was 0.82 (0.81-0.83). The proportion with good adherence at months 24, 36, and 48 were 70.2%, 65.6%, and 64.0%, respectively. Adherence was not associated with age or gender. Blacks and Hispanics consistently exhibited lower adherence. At 12 months, good adherence was observed among 85.7% of Asians, 80.0% of whites, 77.2% of Hispanics, and 76.0% of blacks; at 48 months, good adherence was observed among 73.9% of Asians, 65.4% of whites, 56.8% of blacks, and 55.2% of Hispanics. Logistic regression model results will be provided. Conclusion: Although the majority of children with pGHD demonstrated good adherence with a daily r-hGH regimen, sub-optimal adherence increases with treatment duration and is higher among black and Hispanic children. Strategies that facilitate good adherence to r-hGH may support improved clinical outcomes.

Contemporary treatment utilization among women diagnosed with symptomatic uterine fibroids in the United States

BackgroundThis study evaluated treatment patterns among women diagnosed with symptomatic uterine fibroids (UF) in the United States. Data were retrospectively extracted from the IBM Watson Health MarketScan® Commercial Claims and Encounters and Medicaid Multi-State databases.MethodsWomen aged 18–64 years with ≥1 medical claim with a UF diagnosis (primary position, or secondary position plus ≥1 associated symptom) from January 2010 to June 2015 (Commercial) and January 2009 to December 2014 (Medicaid) were eligible; the first UF claim during these time periods was designated the index date. Data collected 12 months pre- and 12 and 60 months post-diagnosis included clinical/demographic characteristics, pharmacologic/surgical treatments, and surgical complications. Prevalence (2015) and cumulative incidence (Commercial, 2010–2015; Medicaid, 2009–2015) of symptomatic UF were estimated.Results225,737 (Commercial) and 19,062 (Medicaid) women had a minimum of 12 months post-index continuous enrollment and were eligible for study. Symptomatic UF prevalence and cumulative incidence were: 0.57, 1.23% (Commercial) and 0.46, 0.64% (Medicaid). Initial treatments within 12 months post-diagnosis were surgical (Commercial, 36.7%; Medicaid, 28.7%), pharmacologic (31.7%; 53.0%), or none (31.6%; 18.3%). Pharmacologic treatments were most commonly non-steroidal anti-inflammatory drugs and oral contraceptives; hysterectomy was the most common surgical treatment. Of procedures of abdominal hysterectomy, abdominal myomectomy, uterine artery embolization, and ablation in the first 12 months post-index, 14.9% (Commercial) and 24.9% (Medicaid) resulted in a treatment-associated complication. Abdominal hysterectomy had the highest complication rates (Commercial, 18.5%; Medicaid, 31.0%).ConclusionsOff-label use of pharmacologic therapies and hysterectomy for treatment of symptomatic UF suggests a need for indicated non-invasive treatments for symptomatic UF.

Real-world cost of treatment for multiple sclerosis patients initiating and receiving infused disease-modifying therapies per recommended label in the United States

Aims: The study evaluated the real-world cost of treatment in multiple sclerosis (MS) patients initiating infused disease-modifying-therapies (DMT) in the United States.Materials and Methods: This retrospective cohort study using administrative claims data included adult patients with MS initiating index infusion DMT (ocrelizumab (OCR), natalizumab (NTZ) or alemtuzumab (ATZ)) from April 2017–September 2018 with 6-months pre/12-months post-index continuous enrollment. The primary cohort included patients who had prescribed annual dosing visits indicated by the approved product label (PL): 3 OCR, 5 ATZ, and 12–13 NTZ infusion visits within the first year of initiation. Annual treatment cost was the sum of all costs on index DMT infusion visit dates. Costs were summarized for a primary and secondary cohort of patients receiving additional doses than prescribed in PL (>3 OCR, >5 ATZ, and >13 NTZ infusion visits); and an overall cohort of patients who met minimum required annual dose (≥3 OCR, ≥5 ATZ, and ≥12 NTZ), further stratified by insurance type.Results: For patients in the primary cohort (123 OCR, 18 ATZ, and 48 NTZ), mean (standard-deviation) annual cost of treatment with OCR, ATZ, and NTZ cohorts was $72,066 ($34,480), $121,053 ($51,097) and $93,777 ($38,815), respectively. Among patients initiating OCR and NTZ, 15 and 6% respectively, had additional infusion visits leading to greater costs. Mean annual costs of index infusion DMT treatment in the overall cohort (162 patients treated with OCR, 18 with ATZ, 56 with NTZ) were $80,582, $121,053, and $93,807, respectively. The mean costs for commercial enrollees were higher than those for MAPD enrollees.Limitations: Small sample size, limited population generalizability, and cost-reduction for ATZ beyond the second year need to be accounted for.Conclusions: Real-world infusion DMT treatment costs for commercially insured patients were higher than perceived expenditures based on wholesale acquisition cost and administration costs via a physician-fee schedule. Consideration of real-world costs in cost-effectiveness and treatment/coverage decisions is needed.

Real-World Treatment Patterns, Adverse Events, Resource Use, and Costs Among Commercially Insured, Younger Patients with Chronic Lymphocytic Leukemia in the USA: A Retrospective Cohort Study.

Amidst a changing treatment landscape, real-world evidence on the burden of chronic lymphocytic leukemia (CLL) is limited. The purpose of this study was to describe treatment patterns, adverse events (AEs), and economic burden among treated patients with CLL. A retrospective cohort study was conducted with IQVIA PharMetrics® Plus. Patients at least 18years old with CLL treatment between November 1, 2013 and May 31, 2018 were identified; index date was first observed CLL treatment. Patients had at least one CLL diagnosis pre-index and a second diagnosis anytime during the study period, at least 1-year pre- and at least 30-day post-index continuous enrollment and no pre-index CLL treatment. Analyses focused on patients receiving one of the four most common regimens observed. Outcomes included treatment patterns, frequency of incident AEs, and healthcare resource use and costs. Multivariable logistic regression and generalized linear modelling were used to evaluate risk of hospitalization and all-cause costs per patient per month (PPPM). A total of 1706 patients were included in the study (median [interquartile range] age 58 [55-62]years, 66% male, median Charlson Comorbidity Index 2 [2-3], median follow-up 16 [8-28]months). Common regimens, irrespective of treatment line, were bendamustine-rituximab (B-R, 27%), ibrutinib monotherapy (I, 27%), rituximab monotherapy (R, 19%), and fludarabine combined with cyclophosphamide and rituximab (FCR, 16%); 59% had at least one incident AE (B-R, 62%; I, 60%; R, 25%; FCR, 79%). Mean total all-cause healthcare cost over follow-up was $13,858 ± 14,626PPPM. Increased number of AEs was associated with increased odds of hospitalization (odds ratio = 2.9; 95% confidence interval [CI] 2.5-3.4) and increased mean cost PPPM (cost ratio = 1.2; 95% CI 1.1-1.2). This study highlights the treatment toxicity and associated economic burden among patients with CLL in the USA. As novel therapies are increasingly used, further research examining outcomes will inform the risks, benefits, and value of novel agents to prescribers and patients.

PCN138 HEALTHCARE RESOURCE UTILIZATION AND TOTAL DIRECT COSTS OF CARE AMONG PATIENTS WITH WALDENSTRÖM MACROGLOBULINEMIA (WM) INITIATING IBRUTINIB IN FIRST LINE VS LATER LINES

Ibrutinib is an all-oral, once-daily regimen approved in the US for WM patients across all lines of treatment. Real-world evidence quantifying the benefits of initiating ibrutinib early in patients’ treatment journeys is lacking. This study compared healthcare-resource-utilization (HRU) and total-direct-costs-of-care (TDC; pharmacy+medical) in adults initiating ibrutinib as first-line (1L) vs later-line (2L+) treatment for WM. This retrospective study evaluated ibrutinib patients from the HealthCore Integrated Research Database between 12/01/2013 and 02/28/2019; index date was first claim of ibrutinib. Adults diagnosed with WM with ≥12-month prior (baseline) and ≥1-month post-index continuous enrollment (CE) were included. Patients were followed until earliest of treatment change, discontinuation, CE, or study end date (03/31/2019). Cohort assignments were based on baseline WM treatment. Inverse-probability-of-treatment-weighing (IPTW) was used to account for differences in baseline characteristics. IPTW-adjusted all-cause and WM-related HRU, and TDC mean differences were reported on a per-patient-per-month (PPPM) basis. Among 140 eligible patients, 87 and 53 started ibrutinib as 1L and 2L+ treatment with mean 636 and 714 days of CE follow-up, respectively. Patient characteristics were balanced between 1L (n=138) and 2L+ (n=141) after IPTW-adjustment. Adjusted all-cause HRU findings indicated that 1L patients used significantly fewer outpatient services compared to 2L+ patients (1.1; P<0.001). 1L patients also incurred significantly lower TDC than 2L+ patients ($2,307; P=0.042). This was largely driven by lower medical costs ($1,928; P=0.005) from fewer inpatient ($975; P=0.049), ER ($96; P<0.001), physician ($52; P=0.026), and other outpatient services ($804; P=0.045) costs. WM-related HRU and cost were directionally consistent with all-cause outcomes. Ibrutinib use among WM 1L patients was associated with significantly lower outpatient service use and TDC compared with patients who used ibrutinib in later lines. These data support the value of reduced health-system burden and economic benefits of using ibrutinib early in patients’ treatment journeys.

Initiation of triple therapy maintenance treatment among patients with COPD.

Triple therapy is indicated for patients with very severe chronic obstructive pulmonary disease (COPD). Use of this treatment in the appropriate patient population is important to ensure optimal outcomes. This study quantified the use of triple therapy and assessed concordance with 2013-2016 Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations within a national health plan. Retrospective cohort study using data from a large national health plan. To estimate the prevalence of triple therapy using claims data, patients in the first of 2 cohorts were indexed on their first diagnosis of COPD between January 1, 2012, and December 31, 2014, and required to have 24 months postindex continuous enrollment. To assess concordance with GOLD recommendations, a second cohort was created and indexed on the date of triple therapy initiation between January 1, 2013, and November 30, 2016, and required to have 12 months preindex and 1 month postindex continuous enrollment. For both cohorts, patients were aged 40 years or older, with no International Classification of Diseases code for asthma, cystic fibrosis, or lung cancer during the study period. In the first cohort of 92,248 patients with COPD receiving any COPD maintenance medication, 17% were prescribed triple therapy. In the second cohort (n = 19,645), the majority (60%) of patients on triple therapy were classified as GOLD group A or B (ie, no evidence of any exacerbation or only 1 exacerbation not resulting in hospitalization at baseline). Results showed that triple therapy was often prescribed among patients classified as GOLD group A or B. Additional research is required, however, to further assess whether these patients may have had an exacerbation that was not evident in claims data. Treatment of COPD should be individualized to optimize outcomes and reduce adverse events.

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma

Background: Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of lymphoid malignancies characterized by a clinically aggressive course with poor prognosis. A majority of PTCL patients are ≥60 years of age and typically present with advanced stage disease and multiple comorbidities. There remains no consensus standard of care for patients with most PTCL subtypes. Multi-agent chemotherapy, consisting of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP with etoposide (CHOEP), are guideline recommended options for nodal subtypes. Limited contemporary real-world data exist on the treatment patterns and overall survival (OS) of PTCL patients treated with CHOP or non-CHOP regimens in the United States before the FDA approval of brentuximab vedotin in combination with chemotherapy in November 2018 based on the ECHELON-2 trial. Objective: To evaluate treatment patterns and OS prior to the approval of brentuximab vedotin among Medicare Fee-for-Service (FFS) beneficiaries newly diagnosed with PTCL. Methods: The 100% sample of Medicare FFS claims (Parts A/B/D) was used to identify patients aged ≥65 years with ≥1 inpatient or ≥2 distinct outpatient diagnosis claims for PTCL (index event) from January 2011 to December 2017. Patients were required to have a least 6 months prior and 12 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or the end of the study period, whichever occurred first. OS, defined as the time from initial episode or treatment start date to the validated date of death, was measured using the Kaplan-Meier method; patients without a death date were assumed to be alive at the time of analysis and were censored. Results: A total of 2551 Medicare FFS beneficiaries with a PTCL diagnosis met study criteria and were included for analysis. The majority of patients were white (86.9%), over half were male (52.9%), and mean age was 75 years. Patients had multiple comorbidities at diagnosis (Charlson Comorbidity Index (CCI) score 4.47), including hypertension (77.3%), diabetes (32.9%), and chronic obstructive pulmonary disease (28.1%). Among the 2551 patients in the study cohort, 62.4% (n=1593 of 2551) received at least one identifiable drug regimen; 25.5% of treated patients received CHOP (n=407), 3.1% CHOEP (n=50) and 71.2% (n=1134) other regimens. Of patients treated with other regimens, 37.7% (n=427) received steroids only, 22.4% (n=254) steroids with unidentifiable chemotherapy, 6.9% (n=78) cyclophosphamide, 6.2% (n=70) methotrexate, 4.6% (n=52) brentuximab vedotin, 3.6% (n=41) bendamustine, 3.5% (n=40) romidepsin, and 15.2% (n=172) other therapy combinations. Among patients who were treated with CHOP, 16.6% (n=66) received an identifiable second line of therapy (LoT), 48.7% (n=194) an unidentifiable second LoT, and the remainder (34.7%, n=138) had no evidence of further anti-cancer treatment. The median time from CHOP initiation to a subsequent LoT was 5.6 months. The mean baseline CCI score for patients treated with CHOP was 4.33 (±2.93) compared with 4.76 (±2.97) for patients treated with other therapies (p=0.0118). In patients receiving an identifiable first LoT, median OS among CHOP and non-CHOP recipients was 4.8 years (95% CI 3.0-6.1) and 4.4 years (95% CI 3.0-4.9), respectively (Table). The 5-year OS estimate was 49% in patients receiving CHOP compared with 46% for non-CHOP recipients. Conclusions: Fewer than 30% of Medicare beneficiaries newly diagnosed with PTCL were treated with intensive chemotherapy as first LoT. Acknowledging a possible selection bias for more fit PTCL patients receiving CHOP, this group had increased OS compared with patients receiving non-CHOP therapy. However, the 5-year OS across all cohorts was less than 50%. New therapies such as brentuximab vedotin may fill the need for PTCL Medicare beneficiaries who may not be able to tolerate CHOP or CHOP-based regimens. Disclosures Shah: Avalere Health, An Inovalon Company: Employment. Petrilla:Avalere Health, An Inovalon Company: Employment. Rebeira:Seattle Genetics: Employment. Feliciano:Seattle Genetics: Employment, Equity Ownership. LeBlanc:Astra Zeneca: Consultancy, Research Funding; Duke University: Research Funding; Jazz Pharmaceuticals: Research Funding; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; NINR/NIH: Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Research Funding; CareVive: Consultancy; Celgene: Honoraria; Flatiron: Consultancy; American Cancer Society: Research Funding; Heron: Membership on an entity's Board of Directors or advisory committees; Medtronic: Membership on an entity's Board of Directors or advisory committees; Pfizer Inc: Consultancy. Lisano:Seattle Genetics, Inc.: Employment, Equity Ownership.

PND1 RELAPSE-RELATED OUTCOMES IN PATIENTS WITH MULTIPLE SCLEROSIS TREATED WITH FIRST-LINE DISEASE-MODIFYING THERAPIES

This study compared the annualized relapse rates (ARRs) and risk of relapse in patients with multiple sclerosis (MS) on first-line (F-L) oral vs platform disease-modifying therapies (DMTs). Adult patients with MS who newly initiated platform therapies (interferon or glatiramer acetate) and oral therapies (dimethyl fumarate or fingolimod) from January 2011 to December 2017 were identified using IBM MarketScan research databases. The index date was the first DMT claim date. Patients had ≥1-year pre-index and post-index continuous enrollment and ≥1 MS diagnosis prior to or within 30 days post-index. Relapse rates (ARRs) were annualized for the first 3 years post-index. Generalized linear models were used to compare ARRs, and Cox regression was used to estimate the risk of relapse after adjusting for age, gender, index year, Charlson Comorbidity Index score, baseline relapse, and time from earliest MS diagnosis to F-L DMT. A total of 9,375 MS patients met the study selection criteria; 3,060 patients were treated with F-L oral DMTs and 6,315 were treated with F-L platform DMTs. Patients treated with oral DMTs had significantly lower ARRs than those treated with platform DMTs (year 1 post-index: 0.226 vs 0.185, P<0.0001; years 1-2: 0.208 vs 0.175, P<0.0001; years 1-3: 0.201 vs 0.172, P<0.0001). Similar results were obtained after controlling for covariates (year 1 post-index: 0.217 vs 0.168, P<0.0001; years 1-2: 0.201 vs 0.156, P<0.0001; years 1-3: 0.197 vs 0.149, P<0.0001). F-L oral DMT patients had a reduced risk of experiencing relapse compared with F-L platform patients (year 1: HR=0.822, P<0.0001; years 1-2: HR=0.848, P<0.0001; years 1-3: HR=0.841, P<0.0001). These findings suggest that patients newly treated with oral DMTs had lower relapse rates and reduced risk of relapse compared with those treated with platform therapies over the first 3 years of treatment.

PSS15 REAL-WORLD COSTS IN BIOLOGIC NAIVE PSORIATIC ARTHRITIS PATIENTS INITIATING APREMILAST OR BIOLOGICS IN A US HEALTHCARE CLAIMS DATABASE

Psoriatic arthritis (PsA) is a chronic inflammatory disorder. Information on real-world healthcare costs associated with apremilast and biologic therapy in PsA is limited. This study examined healthcare costs among biologic-naive PsA patients who initiated treatment with apremilast or a biologic. Adult patients with PsA were identified if they initiated treatment with either apremilast, a tumor necrosis factor (TNF) inhibitor (adalimumab, certolizumab, etanercept, golimumab, infliximab) or an interleukin (IL) inhibitor (ixekizumab, secukinumab, ustekinumab) between January 1, 2015, and December 31, 2016, and had a minimum of 12 months pre-index and post-index continuous enrollment in the Truven Health (now IBM Watson Health) MarketScan® Commercial and Medicare Supplemental Database. The study used 1:2 propensity score matching between apremilast and biologic patients based on available demographics and clinical characteristics. Total healthcare costs were measured by type of service (inpatient, outpatient and outpatient pharmacy) and were based on paid amounts of adjudicated claims. Costs were reported at 6, 12 and 18 months post-index. T-test, Wilcoxon rank-sum test and chi-squared test were used to evaluate differences between the apremilast and biologic cohorts for continuous and categorical variables, as appropriate. In all, 1,471 biologic-naive PsA patients initiating apremilast were matched to 890 biologic-naive PsA patients initiating biologics (TNF: n=804; IL: n=86). Patient characteristics were similar between the 3 cohorts (mean age: 50 years; Charlson Comorbidity Index score: 0.58 [apremilast], 0.55 [TNF], 0.56 [IL]). Twelve-month total costs were significantly lower among apremilast initiators vs TNF and IL initiators ($39,854 vs $57,243 and $65,867; both P<0.0001). Outpatient pharmacy costs were significantly lower for apremilast patients vs TNF and IL patients ($29,130 vs $48,540 and $57,038; P<0.0001). Similar results were seen at 6 and 18 months post-index. Biologic-naive PsA patients initiating apremilast had significantly lower healthcare costs than patients initiating biologics in a US claims database.