RA-related Costs Research Articles

Effect of a Billing Code to Reimburse Nurse-Supported Rheumatology Care on Health Care Costs and Access: An Interrupted Time Series Analysis.

This study was undertaken to evaluate the impact of a Multidisciplinary Care Assessment (MCA) billing code on health system costs and access to care in British Columbia (BC). Data on all people treated by rheumatologists in BC were obtained from five linked health administrative databases held by Population Data BC from April 1, 2006, to March 31, 2020. Rheumatologists were allocated to either the intervention (ever-billers) or control groups (never-billers). For the intervention group, the index date was the month of the first MCA code billing. For the control group the index dates were imputed from intervention index dates. Our analysis focused on a 48-month period (24 months before and after the index date). We evaluated the impact on two cost (costs related to rheumatoid arthritis [RA]; total health care costs) and access outcomes (rheumatology-related visits per rheumatologist; days between rheumatology visits for patients with RA) using an interrupted time series analysis. A total of 46 rheumatologists (31 intervention and 15 control) met our inclusion criteria. Introduction of the MCA was associated with a small but significant increase in RA-related costs that, at 2 years, translates to a net absolute change of $9.66 per patient per month, but no statistically significant changes in total health care costs. There was no statistically significant change in the number of rheumatology-related visits, but at 2 years there was a net absolute reduction in the median days between rheumatologist visits for patients with RA (6.3 days). The introduction of the MCA code was associated with a negligible increase in the RA-related costs and an improvement in access to ongoing care for patients.

Healthcare resource utilisation andeconomic burden ofpatients with adequate andinadequate responses to biological andtargeted synthetic disease-modifying antirheumatic drugs forrheumatoid arthritis inJapan.

To compare healthcare resource utilisation (HCRU) and direct costs between responders versus non-responders to advanced therapies for rheumatoid arthritis (RA). Patients initiating ≥1 advanced therapy (October 2018 - September 2019) with ≥1 RA claim (6-month pre-index period), ≥2 RA claims (any period), and ≥12 months follow-up were identified from the Medical Data Vision claims database. HCRU and all-cause and RA-related costs [direct medical, emergency department (ED), laboratory, and pharmacy] were compared between responders and non-responders. Adjusted incidence rate ratios (IRRs) for HCRU or cost were calculated via multivariable analyses. Among 2446 patients [non-responders (n = 1817); responders (n = 629)], non-responders had significantly longer hospitalisation days [IRR: 1.8 (95% CI: 1.2 - 2.6)], and significantly more ED visits [2.5 (1.5 - 4.2)] and prescriptions [1.1 (1.1 - 1.2)]. Mean all-cause hospital/outpatient medical costs were significantly higher for non-responders [1.4 (1.3 - 1.6), ¥530,895 versus ¥357,009 ($3992 versus $2684) for responders; ¥173,886 ($1307) difference]; RA-related medical costs showed a similar trend [¥351,306 vs ¥253,030 ($2641 vs $1902); ¥98,276 ($739) difference]. No differences between responders and non-responders were observed in mean all-cause and RA-related pharmacy costs. Non-responders to advanced therapies had greater HCRU and all-cause/RA-related direct costs as compared with responders, suggesting a need for more effective RA therapies to reduce the economic burden associated with non-response.

Healthcare Costs of Not Achieving Remission in Patients with Rheumatoid Arthritis in the United States: A Retrospective Cohort Study.

IntroductionTo compare all-cause and rheumatoid arthritis (RA)-related healthcare costs and resource use in patients with RA who do not achieve remission versus those who achieve remission, using clinical practice data.MethodsData were derived from Optum electronic health records linked to claims from commercial and Medicare Advantage health plans. Two cohorts were created: remission and non-remission. Remission was defined as Disease Activity Score 28-joint count with the C-reactive protein level or erythrocyte sedimentation rate (DAS28-CRP/ESR) < 2.6 or Routine Assessment of Patient Index Data 3 (RAPID3 ≤ 3.0). Outcomes were all-cause and RA-related costs and resource use during a 1-year follow-up period. A weighted generalized linear regression and negative binomial regression were used to estimate adjusted annual costs and resource use, respectively, controlling for confounding factors, including patient and socio-demographic characteristics.ResultsData from 335 patients (remission: 125; non-remission: 210) were analyzed. Annual all-cause total costs were significantly less in the remission versus non-remission cohort ($30,427 vs. $38,645, respectively; cost ratio [CR] = 0.79; 95% CI 0.63, 0.99). All-cause resource use (mean number of visits) was less in the remission versus non-remission cohort: inpatient (0.23 vs. 0.63; visit ratio [VR] = 0.36; 95% CI 0.19, 0.70), emergency department (0.36 vs. 0.77; VR = 0.47; 95% CI 0.30, 0.74), and outpatient visits (20.7 vs. 28.5; VR = 0.73; 95% CI 0.62, 0.86). Annual RA-related total costs were similar in both cohorts; however, RA-related medical costs were numerically lower in the remission versus non-remission cohort ($8,594 vs. $10,002, respectively; CR = 0.86; 95% CI 0.59, 1.25). RA-related resource use was less in the remission versus non-remission cohort.ConclusionsSignificant economic burden was associated with patients who did not achieve remission compared with those who did achieve remission.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01730-w.

Effectiveness and Costs Among Rheumatoid Arthritis Patients Treated with Targeted Immunomodulators Using Real-World U.S. Data.

Targeted immunomodulators (TIMs) are used for the treatment of moderate to severe rheumatoid arthritis (RA) and include biologic and nonbiologic medications with different mechanisms of action. Data describing disease activity levels in RA are not directly available in claims databases but can be determined using a claims-based effectiveness algorithm. Rheumatology has benefited from the recent introduction of new drugs, many with new mechanisms of action. We provide an analysis of this broader range of medications. To (a) describe and summarize the effectiveness of available TIMs for the treatment of moderate to severe RA and (b) determine the RA-related health care costs per effectively treated patient, using recent data. This was a retrospective analysis using data from the IBM MarketScan Commercial Claims and Encounters Database from July 1, 2012, through December 31, 2016. Index date was the new prescription claim for a TIM (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, tocilizumab, or tofacitinib). A 6-month pre-index baseline period was used to determine demographic and clinical characteristics. Patients without a TIM claim during the baseline period were considered naive; patients with a TIM claim in the baseline period that was different than the index TIM were assessed as receiving second-line therapy. A claims-based algorithm was used to assess 12-month treatment effectiveness and total RA-related costs. Costs included RA-related pharmacy costs and medical costs. Data from 14,775 patients were analyzed, including patients prescribed abatacept (n = 1,250), adalimumab (n = 4,986), certolizumab pegol (n = 387), etanercept (n = 5,266), golimumab (n = 577), infliximab (n = 969), tocilizumab (n = 451), and tofacitinib (n = 889). Of these, 705 were receiving second-line therapy. TIM effectiveness by first-line and second-line therapy, respectively, were abatacept 27.1%, 18.1%; adalimumab 30.9%, 22.1%; certolizumab pegol 20.9%, 14.3%; etanercept 31.4%, 31.5%; golimumab 32.7%, 22.2%; infliximab 21.9%, 21.3%; tocilizumab 30.9%, 30.6%; and tofacitinib 26.0%, 21.6%. The main reason for failing effectiveness was not achieving an 80% medication possession ratio or being nonadherent. The 1-year total RA-related cost per effectively treated patient for first-line and second-line therapies, respectively, were abatacept $121,835, $174,090; adalimumab $112,708, $154,540; certolizumab pegol $149,946, $236,743; etanercept $102,058, $94,821; golimumab $108,802, $140,651; infliximab $155,123, $185,369; tocilizumab $93,333, $109,351; and tofacitinib $100,306, $130,501. The effectiveness of TIMs from this real-world experience showed that the range of patients who were effectively treated with first-line therapy was higher for certain tumor necrosis factor inhibitors and tocilizumab. The percentages of effectively treated patients were generally lower in second-line treatment compared with first-line except for etanercept, which had the same percentage between lines of therapy. Etanercept had the lowest RA-related cost per effectively treated patient among tumor necrosis factor inhibitors in first-line use and the lowest RA-related cost per effectively treated patient compared with all second-line treatments. This study was sponsored by Amgen. Amgen employees contributed to study design, analysis of the data, and the decision to publish the results. Maksabedian Hernandez and Stolshek are employees and shareholders of Amgen; Gharaibeh was employed by Amgen at the time of this study. Bonafede was employed by IBM Watson Health, at the time of this study, and McMorrow is employed by IBM Watson Health, which received funding from Amgen to conduct this study. Data from this study were presented at AMCP Nexus, October 22-25, 2018, in Orlando, FL.

Comparison of Healthcare Utilization and Costs Between RA Patients Receiving Biological and Conventional Synthetic DMARDs: A Nationwide Population-Based Cohort Study in Taiwan.

Background: The therapy with biological disease-modifying anti-rheumatic drugs (bDMARDs) has proven to rapidly reduce articular symptoms/signs, decrease morbidities, and improve health outcome in patients with rheumatoid arthritis (RA) and be cost-effective in Western countries. However, the difference in healthcare utilization and costs between conventional synthetic DMARDs (csDMARDs) and bDMARDs in the treatment of RA patients in Taiwan remains largely unexplored. Methods: Two cohorts of RA patients and their matched controls were identified from the National Health Insurance Research database (NHIRD). The csDMARD cohort comprised of patients who submitted claims during 1997–2003 for cyclosporine≥50 mg/day with concomitant use of ≥2 csDMARDs for ≥28 days (n=1,569), whilst the bDMARD cohort comprised of patients who had ≥1 claim during 2003–2011 for bDMARD (n = 1,530). The per-patient per-year healthcare utilization and costs were estimated by bootstrapping method, with a comparison being undertaken between csDMARD and bDMARD. Results: The incremental number of hospitalization days was reduced from 2.3 days for csDMARD to 0.58 day for bDMARD. When compared to csDMARD-treated patients, the incremental total costs and RA-related medication costs were significantly higher in bDMARD-treated patients (US$9,081 vs. US$2,481; US$8,992 vs. US$1,883). However, the combined incremental healthcare utilization costs and non-RA medication costs were significantly lower in bDMARDs-treated patients compared to csDMARD-treated patients (US$374.7 vs. US$1,156.2). Conclusion: Although total costs increased as a result of introducing biologics in RA treatment, biologics have undoubtedly given rise to the benefits of reduced healthcare utilization. The increase in medication costs from biologics was offset by the lower costs of healthcare utilization. Our findings suggest that the medication costs of biologics may be alleviated by an improvement in clinical outcomes.

The economic burden of switching targeted disease-modifying anti-rheumatic drugs among rheumatoid arthritis patients

Aims: To estimate real world healthcare costs and resource utilization of rheumatoid arthritis (RA) patients associated with targeted disease modifying anti-rheumatic drugs (tDMARD) switching in general and switching to abatacept specifically.Materials and methods: RA patients initiating a tDMARD were identified in IMS PharMetrics Plus health insurance claims data (2010–2016), and outcomes measured included monthly healthcare costs per patient (all-cause, RA-related) and resource utilization (inpatient stays, outpatient visits, emergency department [ED] visits). Generalized linear models were used to assess (i) average monthly costs per patient associated with tDMARD switching, and (ii) among switchers only, costs of switching to abatacept vs tumor necrosis factor inhibitors (TNFi) or other non-TNFi. Negative binomial regressions were used to determine incident rate ratios of resource utilization associated with switching to abatacept.Results: Among 11,856 RA patients who initiated a tDMARD, 2,708 switched tDMARDs once and 814 switched twice (to a third tDMARD). Adjusted average monthly costs were higher among patients who switched to a second tDMARD vs non-switchers (all-cause: $4,785 vs $3,491, p < .001; RA-related: $3,364 vs $2,297, p < .001). Monthly RA-related costs were higher for patients switching to a third tDMARD compared to non-switchers remaining on their second tDMARD ($3,835 vs $3,383, p < .001). Switchers to abatacept had significantly lower RA-related monthly costs vs switchers to TNFi ($3,129 vs $3,436, p = .021), and numerically lower all-cause costs ($4,444 vs $4,741, p = 0.188). Switchers to TNFi relative to abatacept had more frequent inpatient stays after switch (incidence rate ratio (IRR) = 1.85, p = .031), and numerically higher ED visits (IRR = 1.32, p = .093). Outpatient visits were less frequent for TNFi switchers (IRR = 0.83, p < .001) compared to switchers to abatacept.Limitations and conclusions: Switching to another tDMARD was associated with higher healthcare costs. Switching to abatacept, however, was associated with lower RA-related costs, fewer inpatient stays, but more frequent outpatient visits compared to switching to a TNFi.

The economic burden of depression among adults with rheumatoid arthritis in the United States

Aims: Depression is the most frequent comorbidity reported among patients with rheumatoid arthritis (RA). Comorbid depression negatively impacts RA patients’ health-related quality-of-life, physical function, mental function, mortality, and experience of pain and symptom severity. The objective of this study was to assess healthcare utilization, expenditures, and work productivity among patients with RA with or without depression.Materials and methods: Data from adult patients who had at least two visits each related to RA and depression over a 1-year period were extracted from the Truven Health MarketScan research databases. Outcomes comprised healthcare resource utilization, work productivity loss, and direct healthcare costs comparing patients with RA with depression (n = 3,478) vs patients with RA without depression (n = 43,222).Results: Patients with RA and depression had a significantly greater relative risk of hospitalization and number of all-cause and RA-related hospitalizations, utilization of emergency services, days spent in the hospital, physician visits, and RA-related surgeries compared with RA patients without depression. Patients with RA and depression had a higher risk of and experienced more events and days of short-term disability compared with patients without depression. The incremental adjusted annual all-cause and RA-related direct costs were $8,488 (95% CI = $6,793–$10,223) and $578 (95% CI = –$98–$1,243), respectively, when comparing patients with RA and depression vs RA only.Limitations: The current analysis is subject to the known limitations of retrospective studies based on administrative claims data.Conclusions: This study suggested increased healthcare utilization, work productivity loss, and economic burden among RA patients due to comorbid depression. These findings emphasize the importance of managing depression and including depression as a factor when devising treatment algorithms for patients with RA.

PMS28 - The Effect of Medication Choice After Tumor Necrosis Factor Inhibitor (TNFI) use on the Healthcare Costs for Patients with Rheumatoid Arthritis: An Instrumental Variables Approach

To measure differences in healthcare costs for patients with rheumatoid arthritis (RA) who initiated a targeted disease modifying anti-rheumatic drug (tDMARD), specifically tumor necrosis factor inhibitor (TNFi) therapy, and switched to another TNFi compared to a non-TNFi. Using 2010-2016 health insurance claims from IMS PharMetrics, RA patients who initiatied a TNFi were identified. We included patients who switched to another tDMARD and were located in a 2-digit ZIP code area with ≥10 patients in the data. The outcome of interest was post-switch monthly costs (total and RA-related) from inpatient, outpatient, and pharmacy claims. We first used an ordinary least squares (OLS) approach to determine costs associated with switching to a non-TNFi versus TNFi while adjusting for patient characteristics. To address the potential endogeneity of the switch-to medication selected, we applied an instrumental variable regression approach, which used variation by ZIP code in non-TNFi prescribing rates as an instrument for individual prescribing choice. Of the included 1,940 RA patients who initiated a TNFi therapy,1,467 (76%) switched to another TNFi and 473 (24%) switched to a non-TNFi. Across ZIP codes, the share of patients who switched from TNFi to non-TNFi ranged from 0 to 38.9%. Using OLS, switching to non-TNFi compared to TNFi resulted in lower total costs (-$426, p=0.035) and lower RA-related costs (-$475, p<0.001). Using the instrumental variables regression, the marginal effect of switching to non-TNFi reduced all-cause spending (-$2,532, p=0.047) and showed a larger, but not statistically significant decrease in RA-related cost (-$1,030, p=0.182). Estimates of the effect of medication choice after TNFi use on healthcare costs may be biased if providers prescribe selectively. Using an instrumental variables approach to control for this selection bias, we found that traditional methods may underestimate all-cause cost savings from switching to non-TNFi after use of a TNFi.

PRM28 - Comparison of Methods to Estimate Disease-Related Cost in the Truven Marketscan Adminstrative Claims Database

Compare four methods of calculating disease-related cost. This study utilized the Truven Marketscan® claims database and two disease cohorts, Rheumatoid Arthritis (RA) and Ulcerative Colitis (UC). Patients were age 18+, had two diagnoses for either RA or UC, no other autoimmune conditions and were continuously enrolled in 2015. Disease cohorts were matched to controls using age, gender, region and insurance type. In cost methods 1, 3, and 4, disease-related inpatient costs were attributed using the primary diagnosis field. In addition, method 1 included outpatient cost if the disease was on the claim and pharmacy cost using a pre-determined drug list. Method 2 included outpatient/pharmacy cost for procedures/medications occurring at increased frequency in the disease cohorts versus controls (1.5x and 3.5x were both tested). Method 3 used the difference in total cost between disease cohorts and matched controls. Method 4 (RA only) served as our internal standard method and utilized a separate stand-alone clinician review of codes received by the RA cohort. Outpatient/pharmacy claims flagged as RA-related were included in the Method 4 analysis. 24,373 RA patients and 9,665 UC patients were included. Average total cost was $28,750 per RA patient and $20,480 per UC patient. RA-related cost as a percent of total cost: method 1, 48%; method 2 (1.5x), 56%; method 2 (3.5x), 44%; method 3, 73%; method 4, 44%. UC-related cost as a percent of total cost: method 1, 50%; method 2 (1.5x), 50%; method 2 (3.5x), 42%; method 3, 70%. Percent disease-related cost attributed to each cost component (emergency room, inpatient, outpatient, pharmacy) tracked similarly comparing RA to UC within each method 1-3. In RA, our internal standard method 4 was closest in disease-related cost and cost component attribution to method 2 (3.5x). Method 2 (3.5x) is our proposed method for calculating disease-related cost.

Treatment Persistence and Healthcare Costs Among Patients with Rheumatoid Arthritis Changing Biologics in the USA.

IntroductionAfter a patient with rheumatoid arthritis (RA) fails tumor necrosis factor inhibitor (TNFi) treatment, clinical guidelines support either cycling to another TNFi or switching to a different mechanism of action (MOA), but payers often require TNFi cycling before they reimburse switching MOA. This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers.MethodsThis study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1 year. The index date was the date of the change in therapy. Treatment persistence was defined as no subsequent switch or 60-day gap in therapy for 1 year post-index. RA-related costs included plan-paid and patient-paid amounts for inpatient, outpatient, and pharmacy claims. Medication costs included index and post-index costs of TNFi and different MOA therapies.ResultsThere were 581 (38.3%) MOA switchers and 935 (61.7%) TNFi cyclers. The treatment persistence rate was significantly higher for MOA switchers versus TNFi cyclers (47.7% versus 40.2%, P = 0.004). Mean 1-year healthcare costs were significantly lower among MOA switchers versus TNFi cyclers for total RA-related costs ($37,804 versus $42,116; P < 0.001) and medication costs ($29,001 versus $34,917; P < 0.001). When costs were divided by treatment persistence, costs per persistent patient were lower among MOA switchers versus TNFi cyclers: $25,436 lower total RA-related cost and $25,999 lower medication costs.ConclusionMOA switching is associated with higher treatment persistence and lower healthcare costs than TNFi cycling. Reimbursement policies that require patients to cycle TNFi before switching MOA may result in suboptimal outcomes for both patients and payers.FundingSanofi and Regeneron Pharmaceuticals.

Costs associated with failure to respond to treatment among patients with rheumatoid arthritis initiating TNFi therapy: a retrospective claims analysis

BackgroundTumor necrosis factor inhibitors (TNFi) are common second-line treatments for rheumatoid arthritis (RA). This study was designed to compare the real-world clinical and economic outcomes between patients with RA who responded to TNFi therapy and those who did not.MethodsFor this retrospective cohort analysis we used medical and pharmacy claims from members of 14 large U.S. commercial health plans represented in the HealthCore Integrated Research Database. Adult patients (aged ≥18 years) diagnosed with RA and initiating TNFi therapy (index date) between 1 January 2007 and 30 April 2014 were included in the study. Treatment response was assessed using a previously developed and validated claims-based algorithm. Patients classified as treatment responders in the 12 months postindex were matched 1:1 to nonresponders on important baseline characteristics, including sex, age, index TNFi agent, and comorbidities. The matched cohorts were then compared on their all-cause and RA-related healthcare resource use, and costs were assessed from a payer perspective during the first, second, and third years postindex using parametric tests, regressions, and a nonparametric bootstrap.ResultsA total of 7797 patients met the study inclusion criteria, among whom 2337 (30%) were classified as treatment responders. The responders had significantly lower all-cause hospitalizations, emergency department visits, and physical/occupational therapy visits than matched nonresponders during the first-year postindex. Mean total all-cause medical costs were $5737 higher for matched nonresponders, largely driven by outpatient visits and hospitalizations. Mean all-cause pharmacy costs (excluding costs of biologics) were $354 higher for matched nonresponders. Mean RA-related pharmacy costs (conventional synthetic and biologic drugs), however, were $8579 higher in the responder cohort, driven by higher adherence to their index TNFi agent (p < 0.01 for all comparisons). A similar pattern of cost differentiation was observed over years 2 and 3 of follow-up.ConclusionsIn this real-world study we found that, compared with matched nonresponders, patients who responded to TNFi treatments had lower all-cause medical, pharmacy, and total costs (excluding biologics) up to 3 years from initiation of TNFi therapy. These cost differences between the two cohorts provide a considerable offset to the cost of RA medications and should encourage close monitoring of treatment response to minimize disease progression with appropriate therapy choices.

Geographic Variation in the Quality and Cost of Care for Patients with Rheumatoid Arthritis.

There is considerable push to improve value in health care by simultaneously increasing quality while lowering or containing costs. However, for diseases that are best treated with comparatively expensive treatments, such as rheumatoid arthritis (RA), there could be tension between these aims. In this study, we measured geographic variation in quality, access, and cost for patients with RA, a disease with effective but costly specialty treatments. To assess the geographic differences in the quality, access, and cost of care for patients with RA. Using large claims databases covering the period between 2008 and 2014, we measured quality of care metrics by metropolitan statistical areas (MSAs) for patients with RA. Quality measures included use of disease-modifying antirheumatic drugs (DMARDs) and tuberculosis (TB) screening before initiating biologic DMARD therapy. Access to care measures included measured detection and the share of patients with RA who visited a rheumatologist. Regression models were used to control for differences in patient demographics and health status across MSAs. For the 501,376 patients diagnosed with RA, in the average MSA 64.1% of RA patients received a DMARD, and 29.6% of RA patients initiating a biologic DMARD appropriately received a TB screening. Only 17% (73/430) of MSAs comprised the top 2 Medicare Advantage star ratings for DMARD use. Measured detection was 0.59% (IQR = 0.47%-0.71%; CV = 0.355) on average, and 57.6% (IQR = 48%-69%; CV = 0.341) of RA patients visited a rheumatologist. MSAs with the highest DMARD use spent $26,724 (in 2015 U.S. dollars) annually treating patients with RA, $5,428 more (P < 0.001) than low DMARD-use MSAs, largely because of higher pharmacy cost ($5,090 vs. $7,610, P < 0.001). However, MSAs with higher DMARD use had lower RA-related inpatient cost ($1,890 vs. $2,342, P = 0.024). There were significant geographic variations in the quality of care received by patients with RA, although quality was poor in most areas. Fewer than 1 in 5 MSAs could be considered high quality based on patient DMARD use. Access to specialist care may be an issue, since just over half of patients with RA visited a rheumatologist annually. Efforts to incentivize better quality of care holds promise in terms of unlocking value for patients, but for some diseases, this approach may result in higher costs. The research reported in this manuscript was supported by AbbVie through consulting fees paid to Precision Health Economics (PHE). AbbVie and PHE collaborated to develop the study design and protocol. AbbVie and PHE participated in the interpretation of data, review, and approval of the manuscript. Shafrin and Shim are employed by PHE. Ganguli and Sanchez Gonzalez are employed by AbbVie. Seabury reports consulting fees from PHE. The results from this study were presented in poster form at the Academy of Managed Care Pharmacy's 2015 Annual Meeting and Expo; April 7-10, 2015; San Diego, California, and at the Academy of Managed Care Pharmacy's 2016 Annual Meeting and Expo; April 19-22, 2016; San Francisco, California. Study concept and design were contributed primarily by Shafrin, along with Ganguli and Seabury. Shafrin and Shim took the lead in data collection, and data interpretation was performed by Ganguli, Sanchez Gonzalez, Seabury, and Shafrin. The manuscript was written primarily by Shafrin, along with Shim and Seabury, and revised primarily by Ganguli, along with Sanchez Gonzalez and Seabury.

Initial Experience With Tofacitinib in Clinical Practice: Treatment Patterns and Costs of Tofacitinib Administered as Monotherapy or in Combination With Conventional Synthetic DMARDs in 2 US Health Care Claims Databases

PurposeTofacitinib is an oral Janus kinase inhibitor indicated for the treatment of rheumatoid arthritis (RA). Tofacitinib can be administered as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs). This study describes RA patients’ characteristics, treatment patterns, and costs for those initiating tofacitinib treatment as monotherapy or combination therapy, using US claims data from clinical practice. MethodsA retrospective cohort analysis of patients aged ≥18 years with RA (International Classification of Diseases, Ninth Revision code 714.xx) and with ≥1 tofacitinib claim in the Truven Marketscan (TM) or the Optum Clinformatics (OC) database. Index was defined as the first tofacitinib fill date (November 2012–June 2014). Patients were continuously enrolled for ≥12 months before and after index. Adherence was assessed using the proportion of days covered (PDC) and medication possession ratio (MPR). Persistence was evaluated using a 1.5× days’ supply gap or switch. All-cause and RA-related costs in the 12-month pre- and post-index periods were evaluated. Unadjusted and adjusted analyses were conducted on data on treatment patterns and costs stratified by monotherapy status. FindingsA total of 337 (TM) and 118 (OC) tofacitinib patients met the selection criteria; 52.2% (TM) and 50.8% (OC) received monotherapy and 83.7% (TM) and 76.3% (OC) had pre-index biologic DMARD experience. Twelve-month mean PDC values were 0.56 (TM) and 0.53 (OC), and 12-month mean MPR was 0.84 (TM) and 0.80 (OC), with persistence of 140.0 (TM) and 124.6 (OC) days. Between 12-month pre- and post-index periods, mean (SD) 12-month RA-related medical costs decreased by $5784 ($31,832) in TM and $6103 ($25,897) in OC (both, P < 0.05), whereas total costs increased by $3996 ($30,397) in TM (P < 0.05) and $1390 ($26,603) in OC. There were no significant differences in adherence, persistence, or all-cause/RA-related costs between monotherapy and combination therapy in unadjusted/adjusted analyses. ImplicationsThis analysis adds to the existing tofacitinib knowledge base and will enable informed clinical and policy decision making based on valuable datasets independent of randomized controlled trials.

Economic Burden of Switching to a Non-Tumor Necrosis Factor Inhibitor Versus a Tumor Necrosis Factor Inhibitor Biologic Therapy among Patients with Rheumatoid Arthritis.

The objective of this study was to examine healthcare resource utilization (HRU) and costs associated with switching to another tumor necrosis factor alpha inhibitor (TNFi) therapy versus a non-TNFi therapy among patients with rheumatoid arthritis (RA) discontinuing use of an initial TNFi biologic therapy. Patients with ≥2 RA diagnoses who used ≥1 TNFi on or after their initial RA diagnosis were identified in a US employer-based insurance claims database. Patients were selected based on ≥1 claim of another TNFi or a non-TNFi biologic therapy (occurring after 2010, and within 30days before to 60days after discontinuation of the initial TNFi), and continuous insurance ≥6months before (baseline period) and ≥12months after the switch date (study period). Patient demographic and clinical characteristics were measured during the baseline period. All-cause and RA-related HRU and costs were analyzed during the 12-month study period using multivariable regression analysis controlling for baseline characteristics and selected comorbidities. Of the 1577 patients with RA that switched therapies, 1169 patients used another TNFi and 408 patients used a non-TNFi biologic. The most commonly used initial TNFi treatments were etanercept (50%) and adalimumab (34%) among the TNFi cohort, and infliximab (39%) and etanercept (28%) among the non-TNFi cohort. The TNFi cohort had significantly fewer outpatient visits [all-cause: 23.01 vs. 29.77visits/patient/year; adjusted incidence rate ratio (IRR)=0.78, P<0.001; RA-related: 7.42 vs. 13.58; adjusted IRR=0.58, P<0.001] and rheumatologist visits (all-cause: 4.01 vs. 6.81; adjusted IRR=0.66, P<0.001; RA-related: 3.23 vs. 6.40; adjusted IRR=0.58, P<0.001) than the non-TNFi cohort. All-cause total costs were significantly lower for patients who switched to another TNFi instead of a non-TNFi therapy ($36,932 vs. $44,566; adjusted difference=$7045, P<0.01), as were total RA-related costs ($26,973 vs. $31,735; adjusted difference=$4904, P<0.01). Adult patients with RA discontinuing TNFi therapy who switched to an alternative TNFi incurred lower healthcare costs than patients who switched to a non-TNFi biologic. AbbVie, Inc.

Rates, factors, reasons, and economic impact associated with switching in rheumatoid arthritis patients newly initiated on biologic disease modifying anti-rheumatic drugs in an integrated healthcare system

Objectives To identify how many RA patients newly-initiated on bDMARD therapy switch to another bDMARD during the first year of treatment; to evaluate the factors and reasons associated with bDMARD switching; and to compare the RA-related healthcare resource utilization (HCRU) and costs between switchers vs non-switchers during the post-index period.Methods A retrospective cohort study was conducted in RA patients using the Kaiser Permanente Southern California (KPSC) database with the study time period of January 1, 2007 to December 31, 2012. The index date was defined as the date of the first bDMARD prescription. Patients had to have continuous membership eligibility with drug benefit and no prior history of bDMARD during the 24 months prior to the index date. bDMARD switching was defined as a different bDMARD claim during post-index. A multivariable logistic regression model was used to evaluate factors associated with switchers vs non-switchers. Chart notes were reviewed to evaluate reasons for switching from index bDMARD. RA-related HCRU use and costs were evaluated using a generalized linear model (GLM) with gamma distribution and log link function.Results Two hundred and fifty-one patients (12%) switched from their index bDMARD to a different bDMARD during the post-index period. bDMARD switchers were more likely to be female, of Asian/Pacific race, younger than ≤65 years of age, overweight, CCI score ≤2, initiating etanercept or adalimumab, and have a commercial insurance plan compared to non-switchers. Reasons for switching were related mostly to lack or loss of efficacy (∼51%); bDMARD switchers had overall mean adjusted RA related total costs that were 25% higher (p = 0.04) compared to non-switchers.Conclusion It is important for RA patients to receive appropriate therapy and consider bDMARD with different mechanisms of action to decrease subsequent switching, and decrease overall RA related costs as shown in this study.

Real-world evaluation of TNF-inhibitor utilization in rheumatoid arthritis

Objectives:To evaluate 12-month treatment patterns, healthcare resource use (HCRU), and costs for patients with rheumatoid arthritis (RA), following initiation of index TNF inhibitors (TNFi) and subsequent biologic DMARDs (bDMARDs).Methods:This was a retrospective cohort analysis of adults with RA newly initiating TNFi in the Truven Marketscan Commercial Claims and Encounters and Medicare Supplemental Databases during 2010–2013. A sub-group of patients who switched to a bDMARD within 12 months post-index and within 180 days of last index TNFi were subsequently evaluated over 12 months. TNFi/bDMARD treatment patterns were characterized as: continuers, no gap >180 days in prescription/administration of index TNFi; discontinuers, gap >180 days; switchers, initiated new bDMARD. Concomitant conventional synthetic DMARD use, co-morbid chronic illnesses, and RA severity were assessed. All-cause/RA-related HCRU and costs were evaluated 12 months post-index.Results:Of 9567 identified patients, 67.2%, 17.3%, and 15.4% were continuers, discontinuers, and switchers, respectively. Switchers had the highest 12-month unadjusted mean all-cause costs of $34,585 vs $33,051 for continuers (p = 0.1158) and $24,915 for discontinuers (p < 0.0001; discontinuers vs continuers, p < 0.0001). RA-related costs comprised 82.8%, 31.4%, and 85.7% of total costs for continuers, discontinuers, and switchers, respectively. Of 764 switchers, 68.2% switched to alternative TNFi (cyclers), the rest to non-TNFi bDMARDs; 36.7% of patients who switched to TNFi switched again (to third-line bDMARD) vs 27.6% (p = 0.0313) of those who switched to non-TNFi bDMARDs. Switchers to non-TNFi bDMARDs had higher mean 12-month all-cause costs of $76,580 compared with $50,689 for switchers to alternative TNFi (p < 0.0001); biologic-administration visits comprised 78.8% of the greater total RA-related costs of switchers to non-TNFi bDMARDs.Conclusions:Real-world TNFi discontinuation/switching rates correspond to randomized controlled trial non-response rates. TNFi cycling is common and associated with an increased likelihood of switching to third-line bDMARD. Switching to non-TNFi bDMARDs was associated with higher costs, mostly attributed to in-office administrations.

Impact of Switching From an Initial Tumor Necrosis Factor Inhibitor on Health Care Resource Utilization and Costs Among Patients With Rheumatoid Arthritis

PurposeDespite improved clinical outcomes for the majority of patients, nearly 30% of patients with rheumatoid arthritis (RA) who initiate tumor necrosis factor antagonist (anti-TNF) biologic agents fail to respond to their first-line anti-TNF and switch to another anti-TNF or a non-TNF biologic. How this change affects health care costs and resource utilization is unknown. We therefore compared RA patients taking first-line anti-TNFs who switched to a second anti-TNF versus those patients who switched to an alternate biologic. MethodsHealth care claims data were obtained from a large US database for eligible adults with confirmed RA diagnoses who initiated anti-TNF treatment and switched to another biologic. Health care costs and utilization during the first 12 months’ postswitch were compared. Generalized linear models were used to adjust for differences in demographic and clinical characteristics before switching. FindingsPatients who switched to a second anti-TNF rather than a non-TNF biologic were generally younger (53.0 vs. 55.3 years; P < 0.0001) and less likely to be female (79.7% vs. 82.7%; P = 0.0490). Of the 3497 eligible patients who switched from first-line anti-TNFs, 2563 (73.3%) switched to another anti-TNF and 934 (26.7%) switched to a non-TNF. Adalimumab was the most frequently prescribed (43.4%) second-line anti-TNF, and abatacept was the most common non–anti-TNF (71.4%). Patients who switched to a second anti-TNF remained on their first medication for a significantly shorter period (342.5 vs 420.6 days; P < 0.0001) and had lower comorbidity indices and higher disease severity at baseline than those who switched to a non–anti-TNF. After adjusting for baseline differences, patients who switched to second anti-TNFs versus a non-TNF incurred lower RA-related costs ($20,938.9 vs $22,645.2; P = 0.0010) and total health care costs ($34,894.6 vs $38,437.2; P = 0.0010) 1 year postswitch. These differences were driven by increased physician office visit costs among the non-TNF group. ImplicationsAmong the anti-TNF initiators who switched therapy, more patients switched to a second anti-TNF than to a non-TNF. Switching to a second anti-TNF treatment was associated with lower all-cause and RA-related health care costs and resource utilization than switching to a non-TNF. Because switching therapy may be unavoidable, finding a treatment algorithm mitigating this increase to any extent should be considered. These data are limited by their retrospective design. Additional confounding variables that could not be controlled for may affect results.

Cost per patient-year in response using a claims-based algorithm for the 2 years following biologic initiation in patients with rheumatoid arthritis

Objective:To estimate cost per patient-year in response during 2 years following biologic initiation among patients with rheumatoid arthritis (RA).Methods:Adults newly initiating biologics for RA (etanercept, abatacept, adalimumab, certolizumab, golimumab, or infliximab) between January 2009 and July 2011 were identified in the MarketScan Commercial Database. Eligible patients were continuously enrolled 6 months before (pre-index) and 24 months after (post-index) their first (index) biologic claim. Biologic effectiveness was assessed using six criteria during 2-year follow-up: treatment adherence ≥80%, no biologic dose escalation, no biologic switch, no new disease-modifying anti-rheumatic drug, no new/increased glucocorticoid dose, and limited intra-articular joint injections (≤2). After a 90-day period of non-response for a treatment failure, effectiveness or failure of subsequent treatment was assessed again for the index biologic or new biologic (after switching). Post-index RA-related medical, pharmacy, and drug administration costs were attributed to the index biologic. Cost per patient-year in response was calculated as RA-related costs divided by duration of response.Results:Overall, 15.0% of patients (1229/8193) did not fail any criterion for 2 years and were effectively treated. Mean duration of response was highest for etanercept (538.3 days), followed by golimumab (537.0 days; p = 0.864), adalimumab (534.7 days; p = 0.301), certolizumab (524.0 days; p = 0.165), infliximab (480.0 days; p < 0.001), and abatacept (482.3 days; p < 0.001). Total disease-related cost per patient-year in response was lower for patients initiated on etanercept ($25,086) than for patients initiated on adalimumab ($25,960), certolizumab ($26,339), golimumab ($26,332), abatacept ($35,581), or infliximab ($36,107).Limitations:This study was limited to employer-paid commercial insurance. Database analyses cannot determine reasons for failing criteria. The algorithm was not designed and validated for 2 years of follow-up.Conclusions:An effectiveness algorithm estimated that initiating etanercept was the most effective treatment during 2 years of follow-up, with the lowest cost per patient-year in response.

SAT0595-HPR Real-World Risk of Fall-Related Injuries among Rheumatoid Arthritis (RA) Patients Treated with Tumor Necrosis Factor Inhibitors (ANTI-TNFS) or Methotrexate (MTX)

BackgroundStructural damage and disease activity in RA patients may increase the risk of fall-related injuries (FRIs) due to limited mobility, impaired balance and postural instability.ObjectivesTo compare risks for FRIs between...

AB1353 Comorbidity and cost burden of patients prior to use of second line biologic for rheumatoid arthritis

BackgroundPatients with rheumatoid arthritis (RA) often have significant comorbidity which, along with underlying RA severity, may impact both choice and response to treatment. We have previously shown that patients initiating...