The Economic Benefit of Remission for Patients with Rheumatoid Arthritis.

INTRODUCTION: In patients with rheumatoid arthritis (RA), attaining remission or low disease activity (LDA), as recommended by the treat-to-target approach, has shown to yield improvement in symptoms and quality of life. However, limited evidence from real-world settings is available to support the premise that better disease control is associated with lower healthcare costs. This study fills in evidence gaps regarding the cost of care by RA disease activity (DA) states and by therapy. METHODS: This retrospective cohort study linked medical and prescription claims from Optum Clinformatics Data Mart to electronic health record data from Illumination Health over 1/1/2010-3/31/2020. Mean annual costs for payers and patients were examined, stratifying on DA state and baseline use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologics, and targeted synthetic (ts)DMARDs. Subgroup analysis examining within-person change in costs pre- and post-initiation of new therapy was also performed. Descriptive statistics, means, and boot-strapped confidence intervals were analyzed by DA state and by RA therapy. Furthermore, multivariate negative binomial regression analysis adjusting for key baseline characteristics was conducted. RESULTS: Of 2339 eligible patients, 19% were in remission, 40% in LDA, 29% in moderate DA (MDA), and 12% in high DA (HDA) at baseline. Mean annual costs during follow-up were substantially less for patients in remission ($40,072) versus those in MDA ($56,536) and HDA ($59,217). For patients in remission, csDMARD use was associated with the lowest mean annual cost ($25,575), tsDMARD was highest ($75,512), and tumor necrosis factor inhibitor (TNFi) ($69,846) and non-TNFi ($57,507) were intermediate. Among new TNFi (n = 137) and non-TNFi initiators (n = 107), 31% and 26% attained LDA/remission, respectively, and the time to achieve remission/LDA was numerically shorter in TNFi vs. non-TNFi initiators. For those on biologics, mean annual within-person medical and inpatient costs were lower after achieving LDA/remission, although pharmacy costs were higher. CONCLUSIONS: Cost of care increased with increasing DA state, with patients in remission having the lowest costs. Optimizing DA has the potential for substantial savings in healthcare costs, although may be partially offset by the high cost of targeted RA therapies.

Treatment Patterns and Costs in Biologic DMARD-Naive Patients with Rheumatoid Arthritis Initiating Etanercept or Adalimumab with or Without Methotrexate.

BACKGROUND: Etanercept (ETN) and adalimumab (ADA) are tumor necrosis factor inhibitors indicated for treatment of moderate to severe rheumatoid arthritis (RA) and are used as monotherapy or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX). Data on treatment patterns and costs of ETN and ADA as monotherapies or in combination therapy with MTX are lacking in biologic DMARD (bDMARD)-naive patients with RA. OBJECTIVE: To evaluate treatment patterns and costs of ETN and ADA monotherapy and combination therapy in bDMARD-naive patients with RA. METHODS: Data from adult bDMARD-naive patients with RA were evaluated according to index therapy (ADA or ETN as monotherapy or combination therapy with MTX) in a retrospective cohort study using the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases from January 1, 2010, to June 30, 2017. Participants were bDMARD-naive for ≥ 12 months before initial ETN or ADA pharmacy claim (index date) and had continuous enrollment for ≥ 12 months pre-index and 24 months post-index. Combination therapy cohorts had an MTX claim within 30 days of the index date. Outcomes included persistence (no treatment changes or gap [≥ 60 days]); modifications to index therapy (discontinuation or switching without prior gap, restarting as switch or restart after gap, or MTX initiation/discontinuation); and mean total bDMARD costs for 2 years post-index. RESULTS: Patients on ETN monotherapy (n = 2,064) had higher persistence (26.8% vs. 21.1%, respectively; P < 0.001) on index treatment and received treatment for a longer duration (mean 375.9 days vs. 339.7 days, respectively; P < 0.001) than those on ADA monotherapy (n = 1,528). Regimen changes were more common in patients on ADA monotherapy than patients on ETN monotherapy (38.0% vs. 33.4%, respectively; P = 0.004). More patients on ADA monotherapy added MTX than those on ETN (17.5% vs. 12.6%, respectively; P < 0.001). Overall, 790 patients receiving index monotherapy had a regimen change following a gap (≥ 60 days), with a similar proportion between cohorts. Among these patients, 13.8% restarted index therapy, and 7.9% switched from index therapy. Significantly more patients receiving ETN monotherapy restarted their index regimen after a gap than those receiving ADA monotherapy (14.9% vs. 12.2%, respectively; P = 0.023). The proportion of patients persistent on combination therapy was similar between the ETN and ADA combination therapy cohorts (21.9% vs. 22.2%, respectively; P = 0.818). Treatment pattern rates were similar regardless of index combination therapy. Overall, costs for ADA were consistently higher within the index regimen throughout the follow-up period irrespective of MTX. CONCLUSIONS: ETN monotherapy as first-line treatment was associated with higher persistence, lower rate of MTX supplementation, and lower bDMARD costs than ADA monotherapy. ETN monotherapy may represent a less costly option for achieving treatment targets in bDMARD-naive patients with RA. DISCLOSURES: This study was sponsored by Amgen. Tkacz, Henderson DeYoung, and Wilson are employees of IBM Watson Health, which received funding from Amgen for this study. Collier and Oko-osi are employees and shareholders of Amgen. Gharaibeh was an employee of Amgen at the time of study execution and manuscript drafting. Data pertaining to this study were presented in a poster at AMCP Nexus 2018; October 25-28, 2018; Orlando, FL.

Assessing the Association of Formulary Copayment Changes with Real-World Treatment Patterns in Patients with Rheumatoid Arthritis on Etanercept.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic disease that requires long-term treatment to improve or maintain stable disease activity. Tumor necrosis factor inhibitors (TNFi), a class of biologic disease-modifying antirheumatic drugs (bDMARD), are effective at treating symptoms and inhibiting joint progression. Although treatment changes are not recommended in patients with stable disease, health plans have recently enacted formulary changes with higher copayments that could disrupt patient access to TNFis. OBJECTIVE: To assess the association of formulary copayment changes with real-world treatment patterns, treatment effectiveness, and health care costs among bDMARD-naive patients with RA receiving the TNFi etanercept. METHODS: This retrospective observational cohort analysis used the IBM Watson Health MarketScan Commercial Claims and Encounters Database. Adult patients with RA with 6 months of stable etanercept use (no refill gap ≥ 45 days) from January 1, 2013, through December 31, 2015, were selected and the index date was set to the first fill date after the stable-use period. Average etanercept copayment was calculated at the drug-plan level. Copayment change was defined as a monthly increase of at least $40 to account for copayment changes attributable to etanercept wholesale acquisition costs between 2014 and 2015. This amount also corresponded to the 90th percentile of average plan-level changes in etanercept copayments in the database, representing an average change in copayment by a payer. Patients were followed ≥ 12 months before and after the index date to track etanercept treatment changes and ≥ 12 months after a treatment change to track costs after etanercept copayment changes. Etanercept persistence, bDMARD switching, refill gaps, and treatment effectiveness (using a validated effectiveness algorithm) were described for patients with or without copayment change during the 12 months post-index or postchange. We also assessed the mean total of all-cause and RA-related expenditure during the 12-month post-index (or postchange) period. RESULTS: 1,970 stable patients met study inclusion criteria (mean [standard deviation] age: 50.3 [9.5] years; 77.8% female) and were evaluated. Of these, 133 (6.8%) patients had a copayment change ≥$40 during follow-up. Overall, most patients (60.3%) persisted on etanercept for the 12-month follow-up period, while 13.0% switched from etanercept, and 8.1% discontinued (refill gap of ≥ 45 days). Nearly half (48.0%) of all patients were considered effectively treated according to a validated algorithm. Compared with patients without a copayment change, those with a copayment change were more likely to switch biologics (19.5% vs. 12.6%; P = 0.021). Although statistical significance was not reached, patients with a copayment change were less likely to be persistent (54.1% vs. 60.7%; P = 0.135), and less likely to be effectively treated (42.1% vs. 48.4%; P = 0.161) than patients without a copayment change. All-cause and RA-related expenditures at baseline and post-copayment change were similar between patients with and without a copayment change. CONCLUSIONS: Changing formulary copayment of etanercept was associated with higher switching without difference in costs or health care utilization between copayment and no copayment change groups. DISCLOSURES: This study was sponsored by Amgen. Bonafede, Manjelievskaia, and Lopez-Gonzalez are employees of IBM Watson Health, which received funding from Amgen to conduct this study. Oko-osi, Collier, and Stolshek are employees and shareholders of Amgen. Gharaibeh was an employee of Amgen at the time of study execution and manuscript drafting. The authors have no other relationships that present a potential conflict of interest. Data pertaining to this study were presented in a poster at the 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL.