Treatment patterns and health care resource utilization among Japanese patients with ankylosing spondylitis: A hospital claims database analysis.

OBJECTIVES: To understand the current state of treatment patterns and health care resource utilization among patients in Japan with ankylosing spondylitis (AS) managed in the real-world setting. METHODS: Patient records from the Medical Data Vision database were analyzed to identify patients with ICD-10 AS from April 2009 through July 2017. Measures evaluated included demographic, clinical, and other characteristics at diagnosis; treatment patterns; health care resource utilization; and costs. RESULTS: Four hundred and seventeen patients met the study's inclusion criteria. Treatments observed during the first year after the initial AS diagnosis included nonsteroidal anti-inflammatory drugs (79.6%), corticosteroids (39.3%), methotrexate (22.3%), sulfasalazine (16.8%), adalimumab (14.2%), and infliximab (12.2%). At any time during the mean 33 months of study follow-up, biologic disease-modifying antirheumatic drugs (bDMARDs) were initiated by 115 patients. During the study follow-up, patients who initiated bDMARDs had higher median total per-patient annual health care costs ($26,937 vs $15,323), lower median per-patient hospitalization costs ($29,817 vs. $39,509), and fewer median hospital days per admission (7.0 vs. 11.0 days) compared with the overall group of patients diagnosed with AS. CONCLUSION: This database study provides knowledge of patient characteristics, treatment patterns, HCRU, and costs for patients with AS in Japan. The study outcomes demonstrate a need for increased awareness of proper AS management.

Cost-Effectiveness of Treatment Strategies with Biologics in Accordance with Treatment Guidelines for Ankylosing Spondylitis: A Patient-Level Model.

BACKGROUND: Ankylosing spondylitis (AS) is a form of rheumatic disease caused by chronic inflammation of the axial skeleton. Patients with AS experience significant functional limitations and reduced quality of life. Consequently, AS imposes a substantial economic burden on society due to productivity loss and work disability. Biologics, including tumor necrosis factor (TNF) inhibitors and human anti-interleukin-17A monoclonal antibody (IL-17A) agents, are effective treatment strategies in relieving symptoms and slowing down disease progression. Currently, 5 TNF inhibitors and 2 IL-17A antibody agents are approved by the FDA for the management of AS. Of these agents, there is no clear preferred agent in initial biologic therapy, although an IL-17A antibody agent or alternative TNF inhibitor agent is recommended after failure of the initial TNF inhibitor therapy. OBJECTIVE: To assess cost-effectiveness of treatment strategies with biologics, TNF inhibitor or IL-17A, in accordance with the treatment guidelines for patients with AS. METHODS: An economic patient-level simulation combining decision-tree and Markov models was constructed from the U.S. health care payer's perspective over a 10-year time horizon. The current model examined 5 treatment strategies: (1) conventional care treatment with nonsteroidal anti-inflammatory drugs, (2) 1 TNF inhibitor, (3) an IL-17A antibody agent, (4) sequential therapy with 2 TNF inhibitors, and (5) sequential therapy with a TNF inhibitor followed by an IL-17A antibody agent. Initially, treatment responses were determined after 12-week treatments. Patients who responded to treatment entered a "responders" Markov model. Patients entered a "nonresponders" Markov model if they inadequately responded to treatment. In sequential treatment strategies, patients who inadequately responded to treatment with the first TNF inhibitor received a second TNF inhibitor or an IL-17A antibody agent. Health utility was estimated based on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Functional Index (BASFI) scores. The models accounted for real-world adherence to TNF inhibitor treatment. Scenario and probabilistic sensitivity analyses were performed to test the robustness and uncertainty of the model results. RESULTS: Over a 10-year time horizon and 100,000 simulated patients for each treatment strategy, base-case results produced average total discounted per-patient costs of $19,765, $130,302, $159,934, $190,553, and $179,118 and quality-adjusted life-years (QALYs) of 4.675, 5.410, 5.499, 5.919, and 5.893 for conventional care, treatment strategies with 1 TNF inhibitor, an IL-17A, 2 TNF inhibitors, and a TNF inhibitor followed by an IL-17A, respectively. The optimal treatments at willingness-to-pay (WTP) thresholds ≤ $130,813 per QALY, between $130,813 per QALY and $442,728 per QALY, and > $442,728 per QALY were conventional care and sequential treatment strategies with 1 TNF inhibitor, followed by an IL-17A agent and 2 TNF inhibitors, respectively. CONCLUSIONS: Study findings suggested that all treatment strategies with biologics, TNF inhibitors or IL-17A antibody agents, in the treatment guidelines for AS were not cost-effective at the common WTP of $100,000 per QALY. However, the sequential treatment with 1 TNF inhibitor followed by an IL-17A antibody agent was considered cost-effective at a higher WTP of $150,000 per QALY. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Primary findings of this study were presented in part at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Baltimore, MD, May 2018.

Golimumab improves socio economic and health economic parameters in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

BACKGROUND: Golimumab (GLM) has shown its efficacy and safety in various clinical trials. We aimed to assess the effect of GLM on socio economic and health economic parameters in daily clinical practice. SETTING: Rheumatology offices in Germany. METHOD: Analysis of socio economic and health economic parameters of the non-interventional, multicentre, prospective study GO-NICE. Analyses were performed in an exploratory manner using descriptive statistical methods. Further, p-values on socio economic variables were calculated based on one-sample t-test on the differences between baseline and follow-up visits. RESULTS: A total of 1458 patients were evaluable, of whom a total of 664 patients completed the 24-month observation period. The proportions of hospitalizations decreased statistically significantly (p ≤ .05) from 10.4/7.6/14.0% at baseline (BL) to 1.7/2.2/0.8%, and the in-patient rehabilitations decreased from 3.3/3.7/7.5% at BL to 0.6/1.8/2.1% at month 24 in patients with RA, PsA, and AS. When considering a 30-day period, the mean number of sick leave days decreased statistically significantly (p ≤ .005) from 4.0 at BL to 0.9 at month 24 (greatest improvement in RA), and the mean number of days with impaired capability decreased statistically significantly (p ≤ .001) from 14.9 at BL to 4.5 at month 24 (greatest improvement in patients with AS). There was also a reduction in the number of consultations and remedies. CONCLUSION: This evaluation shows improvements in socio economic and health economic parameters on GLM treatment.

The costs associated with ankylosing spondylitis/axial spondyloarthritis in Aotearoa/New Zealand.

AIMS: To evaluate costs associated with a diagnosis of spondyloarthritis (SpA) in an Aotearoa/New Zealand cohort. METHODS: Patients with SpA attending specialist SpA clinics in Auckland and Hamilton completed a series of questionnaires on costs associated with ankylosing spondylitis, disease parameters (BASDAI), work productivity (WPAI, WLQ) and quality of life measures (EQ-5D, ASAS-HI). RESULTS: Eighty-one patients (median age 43 years) completed the study. All fulfilled the ASAS criteria for axial spondyloarthritis and 44 (58%) fulfilled the Modified New York Criteria for ankylosing spondylitis. The mean (SD) score on the EQ-VAS was 69mm (24.1). More than half reported difficulties with usual activities and more than 80% had moderate pain or discomfort despite current treatment. Sixty-six (82%) were in the workforce, and the mean work productivity loss was 4.8%. The mean (SD) annual cost was NZ$15,677 (NZ$11,269) with NZ$12,189 direct cost and NZ$3,488 productivity loss. The largest cost driver was use of biologic medications, which were used by 48% patients. CONCLUSIONS: This study has quantified the direct and indirect costs of spondyloarthritis (SpA) in Aotearoa/New Zealand, and demonstrates meaningful reduction in quality of life and work productivity in patients with SpA. The major driver of direct costs in SpA are biologic medications.

The costs associated with ankylosing spondylitis/axial spondyloarthritis in Aotearoa/New Zealand.

AIMS: To evaluate costs associated with a diagnosis of spondyloarthritis (SpA) in an Aotearoa/New Zealand cohort. METHODS: Patients with SpA attending specialist SpA clinics in Auckland and Hamilton completed a series of questionnaires on costs associated with ankylosing spondylitis, disease parameters (BASDAI), work productivity (WPAI, WLQ) and quality of life measures (EQ-5D, ASAS-HI). RESULTS: Eighty-one patients (median age 43 years) completed the study. All fulfilled the ASAS criteria for axial spondyloarthritis and 44 (58%) fulfilled the Modified New York Criteria for ankylosing spondylitis. The mean (SD) score on the EQ-VAS was 69mm (24.1). More than half reported difficulties with usual activities and more than 80% had moderate pain or discomfort despite current treatment. Sixty-six (82%) were in the workforce, and the mean work productivity loss was 4.8%. The mean (SD) annual cost was NZ$15,677 (NZ$11,269) with NZ$12,189 direct cost and NZ$3,488 productivity loss. The largest cost driver was use of biologic medications, which were used by 48% patients. CONCLUSIONS: This study has quantified the direct and indirect costs of spondyloarthritis (SpA) in Aotearoa/New Zealand, and demonstrates meaningful reduction in quality of life and work productivity in patients with SpA. The major driver of direct costs in SpA are biologic medications.

A cost per responder analysis of secukinumab vs adalimumab for the treatment of ankylosing spondylitis from the Korean perspective.

AIM: To compare the cost-effectiveness of secukinumab vs adalimumab at 1 and 2 years of treatment in patients with ankylosing spondylitis (AS) by analyzing the cost per responder reported in randomized controlled trials (RCTs) from the Korean perspective. METHOD: A systematic literature search was performed via PubMed for relevant RCTs for comparing the response rate in patients with AS. The response rates in anti-tumor necrosis factor-naive subjects were extracted from RCTs and cost per responder analyses were calculated in case of both with or without a loading dosage of secukinumab compared with adalimumab. RESULTS: The Assessment in AS International Working Group (ASAS) 20 and 40 response rates of secukinumab from the MEASURE 2 trial and those of adalimumab from the ATLAS trial were comparable. The cost per ASAS 20 responder was lower by 40% in secukinumab compared to adalimumab: USD9637 vs 16 129 at 52 weeks and USD20 051 vs 32 699 at 104 weeks for secukinumab (in maintenance dosing) vs adalimumab, respectively. The cost per ASAS 40 responder was also lower by 40% in secukinumab: USD12 179 vs 22 395 at 52 weeks and USD27 338 vs 41 655 at 104 weeks for secukinumab vs adalimumab, respectively. With a loading dosage of secukinumab at 52 and 104 weeks, secukinumab showed lower costs per responder by 25% compared to adalimumab. CONCLUSION: The costs per responder associated with ASAS 20 and 40 response rates were consistently lower for secukinumab compared with adalimumab. The treatment with secukinumab for patients with AS could be a cost-saving treatment option in South Korea.

Treatment with golimumab or infliximab reduces health resource utilization and increases work productivity in patients with ankylosing spondylitis in the QUO-VADIS study, a large, prospective real-life cohort.

AIM: We evaluated the effects of anti-tumor necrosis factor (TNF) agents on health economics in ankylosing spondylitis (AS) patients. METHODS: QUality of Life as Outcomes and its VAriation with DIsease States (QUO-VADIS) was a prospective observational study following bio-naïve AS patients (modified New York criteria) newly treated with golimumab (GLM) or infliximab (IFX; originator) in a clinical practice setting over 6 months. We evaluated use of concomitant medications, hospitalizations (in-patient care or acute care) and visits in day care and out-patient settings for the assessment of healthcare resource utilization (HCRU). Work productivity and activity impairment (WPAI) was assessed by the number of work days missed and quantifying absenteeism, presenteeism, work impairment, and activity using the WPAI instrument adapted to spondyloarthritis (WPAI-SpA). RESULTS: Nine hundred and sixty-three patients received ≥1 dose of medication (78%, n = 751 GLM; 22%, n = 221 IFX). Mean age was 42.7 years; 61.4% were male. At baseline, the percentage of patients who reported hospitalizations (in-patient care) was 13.6%, which decreased to 3.1% at 6 months, while out-patient care at baseline was reported by 39.4% of patients, which decreased to 19.0% at 6 months. The percentage of patients receiving acute emergency at baseline reduced from 1.6% to 0.3% at 6 months. The mean (SD) number of days of work missed due to AS, was reduced from 6.3 (31.1) days at baseline to 2.7 (12.3) days at 6 months. CONCLUSION: In patients with AS newly treated with GLM or IFX for 6 months, HCRU was reduced and work productivity and activity increased.

Cost evolution of biological agents for the treatment of spondyloarthritis in a tertiary hospital: influential factors in price.

Background Spending on biological agents has risen dramatically due to the high cost of the drugs and the increased prevalence of spondyloarthritis. Objective To evaluate the annual cost per patient and cost for each biological drug for treating patients with spondyloarthritis from 2009 to 2016, and to calculate factors that affect treatment cost, such as optimizing therapies by monitoring drug serum levels, the use of biosimilar-TNF inhibitors, and official discounts or negotiated rebates in biologicals acquired by the pharmacy department. Method Retrospective, observational study in a Spanish tertiary hospital. Main outcome Annual cost per patient and per drug. Factors that influenced the costs and socio-demographic parameters and disease activity. Results A total of 129, 215, and 224 patients were treated in 2009, 2013, and 2016, respectively. The annual cost per patient decreased: EUR11,604 in 2009, EUR8513 in 2013, and EUR7464 in 2016. The introduction of new drugs drives economic competition, leading to total savings per drug, with discounts reaching 5.8, 12.4, 16.7, 17.7, 13.7, and 24.8% for original infliximab, etanercept, adalimumab, ertolizumab, golimumab, and secukinumab, respectively, while rebates for biosimilar infliximab reached 31.90% in 2016. The number of patients with optimized therapies reached 47.5% in 2016, which led to cost savings of EUR798,614, in addition to savings from official discounts and rebates of EUR252,706 and savings from optimized therapies of EUR545,908 in 2016. Conclusion The cost of biological treatments declined after official discounts, negotiated rebates, and optimized therapies, leading to a significant decrease in the annual cost per patient. The greatest contribution to economic savings in biological therapy according to our study was biological therapy optimization.

Ankylosing spondylitis causes high burden to patients and the healthcare system: results from a German claims database analysis.

To compare healthcare resource utilization and costs between ankylosing spondylitis (AS) patients and a matched sample from the general population without AS covered by the German Statutory Health Insurance (SHI) system, a non-interventional retrospectively matched cohort analysis was conducted using anonymized SHI claims data. Data from January 1st, 2011 through December 31st, 2014 were analyzed. Individuals with a coded diagnosis of AS during the enrollment period comprising the full year of 2013 were directly matched (1:5) to individuals without AS diagnosis in the whole study period by age, gender, hospitalizations, and comorbidities. All-cause healthcare resource utilization and direct costs were analyzed for the year 2013. Statistical tests were applied to compare the differences between the two sampled populations. In 2013, 10,208 AS patients were identified and matched to a sample of 51,040 patients without AS from the general population. Healthcare resource utilization was significantly higher in all healthcare sectors (inpatient, outpatient, pharmaceuticals, remedies, devices and aids, and sick leave) in the AS cohort. Mean all-cause healthcare costs per patient were about €2475 higher in the AS cohort compared to the general population. Most important cost drivers were hospitalizations and pharmaceuticals in terms of bDMARDs prescribed in 10% of the patients. Real-world data from this German claims database analysis showed that AS is associated with a substantial incremental economic burden to the healthcare system.

Cost Effectiveness of Secukinumab for the Treatment of Active Ankylosing Spondylitis in the UK.

OBJECTIVE: To determine the cost effectiveness of secukinumab, a fully human interleukin-17A inhibitor, for adults in the UK with active ankylosing spondylitis (AS) who have not responded adequately to previous treatment with conventional care (CC; biologic-naïve population) or previous biologic therapy (biologic-experienced population). PERSPECTIVE AND SETTING: UK National Health Service (NHS). METHODS: The model was structured as a 3-month decision tree leading into a Markov model. Comparators were licensed tumour necrosis factor inhibitors (including available biosimilars) and CC in the biologic-naïve and biologic-experienced populations, respectively. Clinical parameters captured treatment response, short-term disease activity and patient functioning, as well as long-term structural disease progression. Utilities were derived from secukinumab trial data. List prices were used for all drugs. The cost year was 2017 and costs and outcomes were discounted at 3.5%. RESULTS: In the biologic-naïve population, secukinumab dominated adalimumab and certolizumab pegol. Incremental cost-effectiveness ratios (ICERs) versus other comparators were either below £10,000 per quality-adjusted life-year (QALY) gained or south-west ICERs that implied cost effectiveness of secukinumab. In biologic-experienced patients, the ICER for secukinumab versus CC was £4927 per QALY gained. Treatment response rates, short-term treatment effects, long-term radiographic progression and biologic acquisition costs were key model drivers. Scenario analysis found results to be robust to changes in model structural assumptions. Probabilistic analysis identified greater uncertainty in results in the biologic-naïve population. CONCLUSIONS: Even at list price, secukinumab appears to represent a cost-effective use of NHS resources for biologic-naïve and biologic-experienced patients with active AS. Further research on long-term radiographic progression outcomes would be valuable for future cost-effectiveness analyses in AS.

Trends in the prevalence and incidence of ankylosing spondylitis in South Korea, 2010-2015 and estimated differences according to income status.

The aim of this study is to determine the prevalence and incidence of ankylosing spondylitis (AS) in South Korea, 2010-2015. This study was conducted using the Health Insurance Review Agency (HIRA) database, which includes information on every patient diagnosed with AS. The incidence and prevalence of AS were evaluated by age, sex, and income status. The prevalence increased linearly by 7.7% annually, i.e., 31.62 in 2010 to 52.30 in 2015 (per 100,000 persons). During the study period, the incidence was 6.34 per 100,000 person-years. The prevalence peaked for both men and women in the age range 30-39 years. Incidence peaked for men in the age range 20-29 years, but peaked for women between ages 70 and 89. AS was 3.6 times more prevalent in men than in women, and the incidence in men was 2.1 times greater than in women. With respect to income status, the prevalence and incidence of AS were 3 times greater and 5 times greater, respectively, in medical aid recipients compared to individuals with other income levels. The trend of increasing AS prevalence and the observation that 14.3% of all patients newly diagnosed with AS are medical aid recipients have significant implications for healthcare planning.

The economic impacts of using adalimumab (Humira® ) for reducing pain in people with ankylosing spondylitis: A microsimulation study for Australia.

AIM: The onset and progression of ankylosing spondylitis (AS) usually occurs during the life stage when individuals are more likely to be working and receiving an income, but little is known about the effects of interventions that reduce pain and improve the economic circumstances of patients out of the labour force due to AS. This study evaluates the economic benefits of pain reduction among people aged 19-64 with AS using adalimumab (Humira® ) from the patient and governmental perspectives. METHODS: We estimated the benefits of adalimumab for reducing pain in people aged 19-64 with AS in terms of labor force participation and earnings, and to the Australian Government in terms of income tax revenue and welfare payments using economic simulation. The simulation model integrated data from the Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS), the Household Income and Labour Dynamics in Australia (HILDA) Survey - Wave 10, and Static Incomes Model (STINMOD). All benefits are expressed in 2014 real Australian dollars. RESULTS: We estimated an additional 131 people aged 19-64 with AS (111 males, 20 females) would be in the labour force after using adalimumab for 24 weeks. National benefits consisted of an increase in annual earnings of AU$7.4 million for patients through increased labour force participation, savings of $2 million in annual welfare payments, and an increase of $1.3 million in income tax revenue in 2014 (after 24 weeks). CONCLUSION: Adalimumab therapy generates substantial economic benefits in addition to health benefits for individuals, and savings for government.

Relationship between monocytes to lymphocytes ratio and axial spondyloarthritis.

BACKGROUND: Axial spondyloarthritis (axSpA) is a progressive, chronic, inflammatory skeletal disorder affecting the spine and sacroiliac joints. Many studies have shown that neutrophils, lymphocytes, monocytes, platelets, and red blood cells (RBCs) play important roles in the inflammatory process of axSpA. Neutrophils to lymphocytes ratio (NLR) and red blood cell distribution width (RDW) have been reported to be simple and inexpensive markers to indicate the disease activity of axSpA. However, the role of monocytes to lymphocytes ratio (MLR) and platelets to lymphocytes ratio (PLR) in axSpA was rarely mentioned. OBJECTIVE: The study's aim was to determine the role of MLR and PLR in axSpA patients and to investigate their relationships with disease severity. METHODS: AxSpA patients who fulfilled the Assessment in Ankylosing Spondylitis International Society classification criteria published in 2009 were enrolled in this study and divided into nonradiographic axial spondyloarthritis (nr-axSpA) group and ankylosing spondylitis (AS) group. Healthy age and gender-matched subjects were also enrolled as control group. MLR, PLR, NLR, RDW, C-reactive protein (CRP) level, and erythrocyte sedimentation rate (ESR) level were assessed. The correlation between the variables with finger-to-floor distance, Modified Schober test, and occiput-to-wall distance were tested with Pearson correlation. Furthermore, area under curve (AUC) value, sensitivity, specificity, and the optimal cutoff values were determined using receiver operating characteristic (ROC) curves. RESULTS: A total of 148 axSpA patients (67 nr-axSpA patients and 81 AS patients) and 58 healthy subjects were included in the study. The MLR, NLR, PLR, and RDW in axSpA group were higher than those in the control group (P < 0.05). Among them, MLR and RDW were highly increased in AS group compared with the nr-axSpA group (P < 0.05). MLR, NLR, PLR, and RDW were all positively correlated with ESR level and CRP level (P < 0.05). MLR and RDW were positively correlated with finger-to-floor distance and negatively correlated with Modified Schober test (P < 0.05). RDW was positively correlated with occiput-to-wall distance (P < 0.05). ROC curve results showed MLR yielded a higher AUC than NLR, PLR, and RDW (P < 0.05). In addition, the optimal cutoff value of MLR for axSpA was 0.22, with a specificity of 70.9% and sensitivity of 68.4%. CONCLUSIONS: MLR was elevated in AS patients compared to nr-axSpA patients and had a close relationship with CRP level, ESR level, and spine movements. MLR may be a reliable, cost-effective, and novel potential parameter to evaluate disease severity in axSpA.

Comorbidity, disability, and healthcare expenditure of ankylosing spondylitis in Korea: A population-based study.

BACKGROUND: Ankylosing spondylitis (AS) is an inflammatory rheumatic disease typically diagnosed in young age and follows a chronic progressive course. Its impact on the patient is life-long and the burden that AS exerts on society is increasing cumulatively every year. We aimed to quantify the burden of AS and to identify the factors associated with comorbidity, disability, and healthcare expenditure in Korean AS patients. METHODS: We conducted a nationwide, population-based study using health insurance data (2003-2013). The analysis included individuals with incident AS (1,111 patients) and controls (5,555 patients) matched by age, sex, income, and geographic region. The incidence rates of extra-articular manifestations (EAMs), comorbidities, mortality, and disability (type and severity) were compared between AS patients and controls. Annual health expenditure per patient was also analyzed. Associations were expressed as odds ratios (ORs) with 95% confidence intervals (95%CIs). RESULTS: During the follow-up, 28% of AS patients experienced at least one EAM. AS diagnosis was significantly associated with Charlson comorbidity index ≥3 (OR 2.18, 95% CI 1.91-2.48). Disability rate was higher in AS patients than in controls regardless of cause and severity (OR 2.94, 95% CI 2.48-3.48), but crude incidence rate ratios for mortality were not significantly higher. On multivariate analysis, male sex (OR 3.18, 95% CI 2.13-4.75), presence of an EAM (OR 1.63, 95% CI 1.15-2.32), and older age at diagnosis (OR 1.27, 95% CI 1.20-1.35) were evidently associated with increased disability in AS. Presence of an EAM was also associated with increased AS-unrelated expenditures in biologic-naïve patients (median, 1112 vs. 877 USD per person, P < 0.05). CONCLUSIONS: In patients with AS, demographic factors and systemic manifestations including EAMs and other comorbidities were associated with increased disability and healthcare expenditures.

Valuing Treatment With Infliximab for Ankylosing Spondylitis Using a Willingness-to-Pay Approach.

OBJECTIVE: To investigate willingness to pay (WTP) for treatment with infliximab by patients with ankylosing spondylitis (AS) and explore factors associated with WTP. METHODS: Data from 85 patients participating in the European AS Infliximab Cohort (EASIC) open-label extension of the AS Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) were used. WTP was included at baseline in EASIC and comprised a hypothetical scenario exploring whether the patient would be willing to pay for beneficial effects of infliximab and, if so, what amount they would be willing to pay per administration. Factors associated with WTP were explored using zero-inflated negative binomial (ZINB) regressions. RESULTS: Of the 85 patients, 63 (74.1%) were willing to pay, and among these, the mean amount they were willing to pay per administration was €275 (median €100 [interquartile range €50-200]). Multivariable ZINB analysis showed that Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response was associated with a 7-fold lower likelihood to pay 0 euros (odds ratio [OR] 0.14 [95% confidence interval (95% CI) 0.03-0.71]) and a 3-fold increase in the amount willing to pay (exp(ß) = 3.32 [95% CI 1.44-7.69]). In addition, the country of residence was associated with a lower likelihood to pay 0 euros (OR 0.07 [95% CI 0.02-0.36]), while increased age was associated with the amount willing to pay (exp(ß) = 1.05 [95% CI 1.01-1.09]). CONCLUSION: In a hypothetical scenario, three-quarters of patients with AS receiving long-term infliximab stated that they were willing to pay an out-of-pocket contribution for this treatment. Treatment response contributed to the willingness as well as to the amount patients were willing to pay.

The Duality of Economic Issues With Medication Non-adherence in Patients With Inflammatory Arthritis.

PURPOSE OF REVIEW: In this review, we synthesize current data on non-adherence across inflammatory arthritides and explore (1) the effects of economic factors on non-adherence and (2) the impacts of non-adherence on economic outcomes. RECENT FINDINGS: Recent evidence demonstrates medication non-adherence rates as high as 74% in ankylosing spondylitis (AS), 90% in gout, 50% in psoriatic arthritis (PsA), 75% in systemic lupus erythematosus (SLE), and 82% in rheumatoid arthritis (RA). The effects of socioeconomic factors have been studied most in RA and SLE but with inconsistent findings. Nonetheless, the evidence points to having prescription coverage and costs of treatment as important factors in RA and education as an important factor in SLE. Limited data in AS and gout, and no studies of the effects of socioeconomic factors in PsA, show knowledge gaps for future research. Finally, there is a dearth of data with respect to the impacts of non-adherence on economic outcomes.

Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis.

BACKGROUND: AbbVie provides a free-to-patient patient support program (PSP) to assist adalimumab-treated patients with medication costs, nurse support, injection training, pen disposal, and medication reminders. The impact of these services on patient adherence to adalimumab and direct medical costs associated with autoimmune disease has not been assessed. OBJECTIVE: To quantify the relationship between participation in a PSP and outcomes (adalimumab adherence, persistence, and direct medical costs) in patients initiating adalimumab treatment. METHODS: A longitudinal, retrospective, cohort study was conducted using patient-level data from the PSP combined with Symphony Health Solutions administrative claims data for patients initiating adalimumab between January 2008 and June 2014. The sample included patients aged ≥ 18 years with a diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis who were biologic-naïve before initiation of adalimumab. Patients who enrolled in the PSP (PSP cohort) were matched to those who did not enroll (non-PSP cohort) based on age, sex, year of treatment initiation, comorbidities, diagnosis, and initiation at a specialty pharmacy. For the PSP cohort, the index date was assigned as the earliest date of PSP enrollment, and time to enrollment following adalimumab initiation was used to assign index dates for the non-PSP cohort. All patients were required to have evidence of medical and pharmacy coverage for at least 6 months before and after their first adalimumab claim and at least 12 months after their index date. Adherence (proportion of days covered during the 12 months following PSP opt-in [index date]) was compared between cohorts using t-tests. Persistence was assessed using survival analysis of discontinuation rates. Medical costs for emergency department, inpatient, physician, and outpatient visits (all-cause and disease-related) and total costs (medical plus drug costs) were compared at 12 months following the index date using t-tests. RESULTS: A total of 2,386 patients were included in the study and were allocated to the PSP (n = 1,199) and non-PSP (n = 1,187) cohorts. Baseline characteristics were similar between cohorts. During the follow-up period, adalimumab adherence was 14% greater in the PSP cohort than for the non-PSP cohort (67.0% vs. 58.8%; P < 0.001). The discontinuation rate for adalimumab was 14% lower in the PSP cohort compared with the non-PSP cohort (39.7% vs. 46.2%; P = 0.001). Univariate analyses showed that PSP patients had 23% lower 12-month medical costs (excluding costs for biologic treatment) than did non-PSP patients ($18,322 vs. $23,679; P = 0.003). Disease-related medical costs were 22% lower for PSP than for non-PSP patients ($8,001 vs. $10,202; P = 0.045). Total costs were 10% lower for PSP than for non-PSP patients ($35,741 vs. $39,713; P = 0.030). CONCLUSIONS: Patient enrollment in the PSP was associated with greater adherence, improved persistence, and reduced medical (all-cause and disease-related) and total health care costs for patients receiving adalimumab therapy. DISCLOSURES: Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Rubin has received consulting fees or research support from AbbVie, Amgen, Emmi, Genentech, Ironwood, Janssen, Pfizer, Prometheus, Shire, and Takeda. Skup and Mittal are employees and stockholders of AbbVie. Chao was an employee of AbbVie at the time of the study and may hold AbbVie stock. Johnson and Davis are employees of Medicus Economics, which received payment from AbbVie to participate in this research. Study concept and design were contributed by Rubin, Mittal, Chao, and Skup, along with Davis and Johnson. Davis and Johnson took the lead in data collection, with assistance from the other authors, and data interpretation was performed by Rubin, Mittal, Chao, and Skup, with assistance from Davis and Johnson. All authors contributed to the writing and revision of the manuscript. The abstract for this study was published as Rubin DT, Skup M, Davis M, Johnson S, Chao J. Impact of AbbVie's patient support program on resource costs in Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. J Manag Care Spec Pharm. 2015;21(Suppl 4a):S74-75 (poster presentation at Academy of Managed Care, 27th Annual Meeting and Expo; April 7-10, 2015; San Diego, CA) and as abstract 2339 in Arthritis Rheumatol. 2015;67(Suppl 10; poster presentation at American College of Rheumatology 2015 ACR/AHRP Annual Meeting; November 7-11, 2015; San Francisco, CA).

TNFα blockers followed by continuation of sulfasalazine and methotrexate combination: a retrospective study on cost saving options of treatment in Spondyloarthritis.

High cost deters continuous use of tumor necrosis factor α blockers (TNFi) in developing countries. The objective of this study was to evaluate outcome and expenditure incurred in Spondyloarthritis (SpA) patients beyond a year of follow-up after receiving four doses of infliximab (IFX) over and above background therapy of methotrexate (MTX) and sulfasalazine (SSZ) combination. Electronic medical records were screened for patients with SpA satisfying the Assessment of Spondyloarthritis International Society (ASAS) criteria between 2008 and 2014. Patients who completed at least 1 year of follow-up after receiving four doses of IFX (5 mg/kg at 0, 2, 6, and 14 weeks) on a background therapy of MTX (10-25 mg/week) and SSZ (2-3 g/day) combination were enrolled after obtaining an informed consent. Primary outcome assessed was "time to disease flare". Changes in acute phase reactants, patient reported outcomes (BASDAI, BASFI), and cost were also assessed. Forty-five patients were enrolled. Mean (SD) duration of follow up after fourth IFX dose was 28.9 (18.7) months. Disease flare occurred in 33.3% (15/45) after a mean (SD) duration of 14.5 (10.8) months as compared to 4-6 months described in literature on discontinuing TNFi. Reduction in ESR, CRP, BASDAI and BASFI continued to be statistically significant at follow-up as compared to baseline. As compared to continuous IFX therapy, this treatment reduced cost by 57.1% for each patient-month of follow-up. Short course IFX dosing followed by continuation of MTX and SSZ combination can prolong time to disease flare and decrease requirement for additional IFX dose in SpA. This regimen could be a cost saving option for patients with SpA.

Geographic Variation in Diagnostic Ability and Quality of Care Metrics: A Case Study of Ankylosing Spondylitis and Low Back Pain.

Studies examining geographic variation in care for low back pain often focus on process and outcome measures conditional on patient diagnosis but generally do not take into account a physician's ability to diagnose the root cause of low back pain. In our case study, we used increased detection of ankylosing spondylitis-a relatively rare inflammatory back disease-as a proxy for diagnostic ability and measured the relationship between ankylosing spondylitis detection, potentially inappropriate low back pain care, and cost. Using 5 years of health insurance claims data, we found significant variation in ankylosing spondylitis detection across metropolitan statistical areas (MSAs), with 8.1% of the variation in detection explained by a region's racial composition. Furthermore, low back pain patients in MSAs with higher ankylosing spondylitis detection had 7.9% lower use of corticosteroids, 9.0% lower use of opioids, and 8.2% lower pharmacy cost, compared with patients living in low-detection MSAs.

Consensus development on eligibility of government subsidisation of biologic disease modifying anti-rheumatic agents for treatment of ankylosing spondylitis: The Singapore experience.

INTRODUCTION: The beneficial effects of biologic disease-modifying anti-rheumatic drugs (bDMARDs), such as tumour necrosis factor inhibitors (anti-TNF) in active ankylosing spondylitis (AS) are well established. The significant costs on patients in the absence of financial subsidization can limit their use. The objective was to describe a consensus development process on recommendations for government-assisted funding of biologic therapy for AS patients in Singapore. METHODS: Evidence synthesis followed by a modified RAND/UCLA Appropriateness Method (RAM) was used. Eleven rheumatologists rated indications for therapies for different proposed clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate 10 practice recommendations. RESULTS: It was agreed that a bDMARD (anti-TNF) is indicated if a patient has active AS with a Bath Ankylosing Spondylitis Activity Index (BASDAI) ≥ 4 and spinal pain of ≥ 4 cm on visual analogue scale (VAS) on two occasions at least 12 weeks apart, despite being on a minimum of two sequential non-steroidal anti-inflammatory drugs at maximal tolerated dose for at least 4 weeks, in addition to adherence to an appropriate physiotherapy program for at least 3 months. To qualify for continued biologic therapy, a patient must have documentation of response every 3 months and at least 50% improvement in BASDAI and reduction of spinal pain VAS ≥ 2 cm. CONCLUSION: A validated and feasible consensus process can enable pragmatic standardized recommendations to be developed for bDMARD subsidization for AS patients in a local Asian context.