Insurer costs of COVID-19 by disease severity and duration.

OBJECTIVES: To analyze US commercial insurance payments associated with COVID-19 as a function of severity and duration of disease. STUDY DESIGN: Retrospective database analysis. METHODS: Patients with COVID-19 between April 1, 2020, and June 30, 2021, in the Merative MarketScan Commercial database were identified and stratified as having asymptomatic, mild, moderate (with and without lower respiratory disease), or severe/critical (S/C) disease based on the severity of the acute COVID-19 infection. Duration of disease (DOD) was estimated for all patients. Patients with DOD longer than 12 weeks were defined as having post-COVID-19 condition (PCC). Outcomes were all-cause payments (ACP) and disease-specific payments (DSP) for the entire DOD. Variables included demographic and comorbidities at the time of acute disease. Adjusted payments by disease severity were estimated using generalized linear models (γ distribution with log link). RESULTS: A total of 738,339 patients were included (374,401 asymptomatic, 156,220 mild, 180,213 moderate, and 27,505 S/C cases). DSP increased from $217 (95% CI, $214-221) for asymptomatic cases to $2744 (95% CI, $2678-$2811) for moderate cases with lower respiratory disease and $28,250 (95% CI, $26,963-$29,538) for S/C cases. ACP increased from $505 (95% CI, $497-$512) for asymptomatic cases to $46,538 (95% CI, $44,096-$48,979) for S/C cases. The DSP and ACP further increased by $50,736 (95% CI, $45,337-$56,136) and $94,839 (95% CI, $88,029-$101,649), respectively, in S/C cases with PCC vs a DOD of fewer than 4 weeks. CONCLUSIONS: COVID-19 payments for S/C cases were more than 10-fold greater than those of moderate cases and further increased by nearly $95,000 in S/C cases with PCC vs a DOD of fewer than 4 weeks.

Health care costs of COVID-19 vs influenza and pneumonia.

OBJECTIVES: To estimate payments for the treatment of COVID-19 compared with that of influenza or viral pneumonia (IP), from the perspective of the US payer. STUDY DESIGN: Retrospective cohort analysis. METHODS: Patients with COVID-19 during the period from October 1, 2020, to February 1, 2021, or IP during the period from October 1, 2018, to February 1, 2019, in the IBM MarketScan databases were identified. The index was defined as the date of the first COVID-19 or IP diagnosis. Patients with COVID-19 were stratified by severity. Variables for all patients included demographics and comorbidities at the time of index and duration of disease. IP and COVID-19 cohorts were matched using propensity scores, and inflation-adjusted all-cause payments (ACP), and disease-specific payments (DSP) for IP vs COVID-19 were estimated using generalized linear models. RESULTS: Matched cohorts included 6332 Medicare (female, 58.5%; mean [SD] age, 75.3 [7.6] years), and 397,532 commercially insured patients (female, 57.6%; mean [SD] age, 34.7 [16.7] years). ACP and DSP were significantly higher in the COVID-19 cohort vs IP cohort. Payments for severe/critical COVID-19 were significantly greater than those for IP, with adjusted marginal incremental DSP and ACP of $24,852 (95% CI, $21,573-$28,132) and $50,325 (95% CI, $43,932-$56,718), respectively. IP was significantly less expensive than moderate COVID-19 for commercial payers but not Medicare. IP was more expensive than mild COVID-19 for all payers. CONCLUSIONS: Payments associated with severe/critical COVID-19 significantly exceeded those associated with IP. For Medicare, IP was more expensive than mild or moderate COVID-19. For commercial payers, IP was less expensive than moderate COVID-19 but more expensive than mild COVID-19.

Economic burden of invasive Escherichia coli disease among older adult patients treated in hospitals in the United States.

BACKGROUND: Although invasive Escherichia coli disease (IED) can lead to severe clinical outcomes, little is known about the associated medical resource use and cost burden of IED in US hospitals. OBJECTIVE: To comprehensively describe medical resource use and costs associated with IED during the initial IED event and over the subsequent 12 months. METHODS: Patients aged 60 years or older with 1 or more IED encounters were identified from the PINC AI Healthcare US hospital database (October 1, 2015, to March 31, 2020). The index encounter was defined as the first encounter with a positive E coli culture in a normally sterile site (group 1 IED) or positive E coli culture in urine with signs of sepsis (group 2 IED). Encounters with a positive culture from other bacteria or fungal pathogens were excluded. Outcomes were descriptively reported between admission and discharge for the index encounter and more than 1 - year post-index discharge. Medical resource use and costs included inpatient admissions and outpatient hospital services; costs were reported from a hospital's perspective (ie, charged amount) in 2021 USD. RESULTS: A total of 19,773 patients were identified (group 1 IED = 51.8%; group 2 IED = 48.2%). Mean age was 76.8 years, 67.4% were female, and 82.1% were White. Most index encounters were community-onset (94.3%) and led to hospitalization (96.5%) (mean inpatient days = 6.9 days). During the 1 - year post-index, 36.8% of patients had 1 or more all-cause hospitalizations. Mean [median] total all-cause hospital costs (as captured through the PINC AI Healthcare database) amounted to $16,760 [$11,340] during the index encounter and $10,942 [$804] during the 1 - year post-index; these costs were higher in the presence of sepsis and multidrug resistance and among hospital-onset IED. CONCLUSIONS: IED is associated with a substantial medical resource use and economic burden both during the initial encounter and over the following year in older adults. This highlights the critical need and potential benefits of preventive measures that may reduce the incidence of IED and associated economic burden. DISCLOSURES: This study was funded by Janssen Global Services, LLC. Dr Hernandez-Pastor is an employee of Janssen Pharmaceutica NV. Dr Geurtsen is an employee of Janssen Vaccines & Prevention BV. Dr Baugh is an employee of Janssen Research & Development, LLC. Dr El Khoury is an employee of Janssen Global Services, LLC. Dr Kalu and Dr Krishnarajah are employees of Janssen Scientific Affairs, LLC. Dr Gauthier-Loiselle, Ms Bungay, and Mr Cloutier are employees of Analysis Group, Inc., a consulting company that provided paid consulting services to Janssen Global Services, LLC. Dr Saade received consultation and speaker fees from Janssen.

Economic Burden of COVID-19: A Systematic Review.

Objective: To review and qualitatively synthesize the evidence related to the economic burden of COVID-19, including healthcare resource utilization and costs. Methods: A systematic review of studies that assessed the economic burden [eg, direct costs, productivity, macroeconomic impact due to non-pharmaceutical interventions (NPIs) and equity] of COVID-19 was conducted by searches in EMBASE, MEDLINE, MEDLINE-IN-PROCESS, and The Cochrane Library, as well as manual searches of unpublished research for the period between January 2020 to February 2021. Single reviewer data extraction was confirmed independently by a second reviewer. Results: The screening process resulted in a total of 27 studies: 25 individual publications, and 2 systematic literature reviews, of narrower scopes, that fulfilled the inclusion criteria. The patients diagnosed with more severe COVID-19 were associated with higher costs. The main drivers for higher costs were consistent across countries and included ICU admission, in-hospital resource use such as mechanical ventilation, which lead to increase costs of $2082.65 ± 345.04 to $2990.76 ± 545.98. The most frequently reported indirect costs were due to productivity losses. On average, older COVID-19 patients incurred higher costs when compared to younger age groups. An estimation of a 20% COVID-19 infection rate based on a Monte Carlo simulation in the United States led to a total direct medical cost of $163.4 billion over the course of the pandemic. Conclusion: The COVID-19 pandemic has generated a considerable economic burden on patients and the general population. Preventative measures such as NPIs only have partial success in lowering the economic costs of the pandemic. Implementing additional preventative measures such as large-scale vaccination is vital in reducing direct and indirect medical costs, decreased productivity, and GDP losses.

Projecting the Long-Term Economic Impact of Once-Monthly Paliperidone Palmitate Versus Oral Atypical Antipsychotics in Medicaid Patients with Schizophrenia.

BACKGROUND: Recent evidence has demonstrated that, over 12 months, pharmacy costs associated with switching nonadherent recently relapsed patients from oral atypical antipsychotics (OAAs) to once-monthly paliperidone palmitate (PP1M) were offset by reduced relapse rates and schizophrenia-related health care costs. In addition, earlier use of PP1M may generate greater cost savings. OBJECTIVE: To project the long-term economic impact when a proportion of nonadherent patients with a recent relapse switch from OAAs to PP1M. METHODS: A 36-month decision-tree model with twelve 3-month cycles was developed from a Medicaid payer's perspective. The target population was nonadherent, recently relapsed OAA patients. At equal adherence, probability of relapse was equal between PP1M and OAAs, and OAA patients were nonadherent until treatment switch. Event rates (adherence, relapse, and switch) and cost inputs (pharmacy and relapse) were based on the literature, and rates remained constant. Outcomes included number of relapses, pharmacy costs, and relapse costs (2017 U.S. dollars) at years 1, 2, and 3. One-way sensitivity (OSA) and probabilistic sensitivity analyses (PSA) evaluated the effect of varying model inputs on health plan and per-patient level costs. RESULTS: Based on a hypothetical health plan of 1 million members, 3,037 OAA patients were recently relapsed and nonadherent. Compared with continuing OAAs, switching 5% of patients (n = 152) to PP1M resulted in net cost savings of $674,975, $723,298, and $562,310 at the plan level; $4,445, $4,764, and $3,703 per patient switched per year; and $0.0562, $0.0603, and $0.0469 per member per month in years 1, 2, and 3, respectively, resulting in total plan-level savings of > $1.9 million over 3 years. A total of 221 relapses were avoided (year 1: 92; year 2: 72; and year 3: 57). In years 1, 2, and 3, respectively, total annual plan-level schizophrenia-related costs were $114.1 million, $107.2 million, and $105.8 million when all patients switched to PP1M before any subsequent relapse (n = 3,037); $123.4 million, $109.6 million, and $106.7 million when patients switched to PP1M after a first subsequent relapse (n = 2,631); and $127.6 million, $121.6 million, and $117.0 million when all patients remained on OAAs. The cost per patient switched to PP1M was lower when all patients received PP1M before a subsequent relapse versus after their first subsequent relapse at all years (year 1: $37,559 vs. $45,089; year 2: $35,288 vs. $36,321; and year 3: $34,826 vs. $35,155). OSA demonstrated consistent net cost savings per patient switched, ranging from $640 to $10,484 (year 1); $1,774 to $9,245 (year 2); and $1,354 to $7,026 (year 3). PSA demonstrated 96.3%, 99.7%, and 99.7% of iterations were cost saving in years 1, 2 and 3, respectively. CONCLUSIONS: Pharmacy costs associated with switching nonadherent OAA patients with a recent relapse to PP1M were offset by reduced relapse rates and health care costs at years 1, 2, and 3, with earlier use of PP1M resulting in increased cost savings at all years. DISCLOSURES: This research was funded by Janssen Scientific Affairs. Pilon, Morrison, Lefebvre, and Shak are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs to conduct this study. El Khoury and Kim are employees of Janssen Scientific Affairs. At the time this study was conducted, Llaneza was an employee of HireGenics, which provided services to Janssen Scientific Affairs for the study. Part of the material in this manuscript was presented at the Academy of Managed Care Pharmacy 2019 Annual Meeting; March 25-29, 2019; San Diego, CA.

Are Medicaid Coverage Gaps Associated with Higher Health Care Resource Utilization and Costs in Patients with Schizophrenia?

The objective was to assess the association of Medicaid coverage gaps with health care resource utilization (HRU) and costs of patients with schizophrenia. Patients with schizophrenia were identified from the Medicaid database. The beginning of the first eligible gap was defined as the index date. Per-patient per-month (PPPM) HRU and costs before versus after a gap were assessed, and the association between gap duration and PPPM HRU and costs was examined up to 12 months post index. Together with 95% confidence intervals, HRU differences were reported in rate ratios (RRs), and cost differences were reported in 2016 US dollars. A subgroup of males with substance use disorder (SUD; risk factors for incarceration) also was analyzed. Total PPPM health care costs increased significantly by $711.04 following a coverage gap (P < 0.001). Gaps of 180-365 days were associated with a significant increase in inpatient visits (RR = 1.27; P < 0.001) relative to gaps of <90 days. Gaps of 90-179 days were associated with significantly more PPPM inpatient visits (RR = 1.14; P = 0.024) relative to a gap of <90 days. Inpatient costs were particularly increased for gaps of 180-365 days versus those of <90 days (cost difference = $101.81 PPPM; P = 0.0008). Similar results were found in male patients with SUD, in whom HRU and cost differences appeared larger. In patients with schizophrenia, longer Medicaid coverage gaps were associated with increases in inpatient admissions, emergency room visits, and inpatient costs, particularly among patients with risk factors for incarceration. These results support policies that aim to facilitate Medicaid reinstatement for patients with schizophrenia.

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization.

Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.Methods: VHA patients with schizophrenia (aged ≥18 years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015-March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12 months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar's test, as appropriate.Results: The study included 319 patients (mean [SD] age = 51.6 [4.2] years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered [PDC] ≥ 80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p < .0001) and shorter inpatient length of stay (43.4 vs 18.3 days, p < .0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p < .0001), total medical costs ($87,917 vs $56,947, p < .0001), and total costs ($91,181 vs $69,106, p < .0001). A similar trend was observed for mental health and schizophrenia-related costs.Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.

Treatment discontinuation of long-acting injectables or oral atypical antipsychotics among Medicaid recipients with schizophrenia.

Aims: Among patients with schizophrenia, poor adherence and persistence with oral atypical antipsychotics (OAA) often results in relapse and hospitalization. Second-generation antipsychotic long-acting injectables (SGA LAI) have demonstrated higher adherence than first-generation antipsychotic LAI and OAA therapies. This study aimed to determine whether SGA LAIs are associated with better persistency compared to OAA among Medicaid recipients with schizophrenia. Materials and methods: From the MarketScan Medicaid Database (January 1, 2010-June 30, 2016), patients aged ≥18 years with schizophrenia and ≥2 pharmacy claims more than 90 days apart for the same SGA LAI or OAA were selected. New users of the specific antipsychotic agent were classified, based on their index agent, as: OAA, paliperidone palmitate LAI (PPLAI), aripiprazole LAI (ALAI), and risperidone LAI (RLAI). Discontinuation during 1 year of follow-up was defined as a ≥ 60-day gap in the index OAA or SGA LAI medication past the exhaustion of the previous claim's supply. Inverse probability of treatment weights (IPTW) balanced the cohort characteristics, and weight outliers (<0.1 or >0.9) were excluded. IPTW-weighted Cox proportional hazards regression estimated hazard ratios for discontinuation. Results: Cohorts included 7,029 OAA, 4,302 PPLAI, 586 ALAI, and 1,456 RLAI patients. Mean age was 38.0-41.0 years and 44.0-46.6% were female. Persistence was significantly longer in the SGA LAI cohorts than in the OAA cohort. Adjusted hazard ratios (95% confidence intervals) for discontinuation were 0.60 (0.56-0.64) for PPLAI, 0.69 (0.60-0.79) for ALAI, and 0.70 (0.64-0.77) for RLAI vs OAA. Limitations: Results may not be generalizable to patients covered by commercial or Medicare insurance, and limitations inherent to any claims-based retrospective analysis apply. Conclusions: SGA LAI may be a valuable option for treating schizophrenia given the improvement in persistence.

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study.

INTRODUCTION: Factors underlying the selection of antipsychotics for patients with schizophrenia are poorly understood. This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia. METHODS: Adults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12 months of continuous health plan enrollment prior to index date were included in the analysis. Multivariable logistic regression was performed to determine the factors associated with the initiation of LAI-PP versus LAI-AP. RESULTS: Of included patients, 5501 initiated LAI-PP and 1449 initiated LAI-AP. Patients more likely to initiate LAI-PP versus LAI-AP were older, male, or African American (all p < 0.01). Patients with obesity (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.71, 0.98), post-traumatic stress disorder (OR 0.76; 95% CI 0.63, 0.92), or prior oral antipsychotic use (OR 0.66; 95% CI 0.55, 0.79) were less likely to initiate LAI-PP; whereas, patients with nonorganic psychoses (OR 1.35; 95% CI 1.18, 1.55) or prior use of other injectable antipsychotics (OR 1.26; 95% CI 1.09, 1.47) were more likely to initiate LAI-PP versus LAI-AP. Patients with at least two all-cause hospitalizations were 1.37 times more likely to initiate LAI-PP vs LAI-AP (OR 1.37; 95% CI 1.18, 1.60). CONCLUSION: Factors associated with initiating LAI-PP and LAI-AP differed. Notably, patients who initiated LAI-PP had greater prior use of medical services than LAI-AP patients. Understanding prescribing practices may help optimize treatment strategies and improve disease management. FUNDING: Janssen Scientific Affairs, LLC.

The prospective economic impact of once monthly paliperidone palmitate versus oral atypical antipsychotics in Medicaid patients with schizophrenia.

OBJECTIVES: Multiple real-world studies have reported potential cost savings associated with second-generation antipsychotic long-acting injectable therapies (SGA-LAIs), including once monthly paliperidone palmitate (PP1M). Yet, only about 12% of Medicaid patients with schizophrenia initiate SGA-LAIs, with poor adherence contributing to frequent relapse among patients on oral atypical antipsychotics (OAAs). The objective of this study was to project the economic impact when an incremental proportion of non-adherent patients with a recent relapse switched from OAAs to PP1M. METHODS: A 12 month decision-tree model was developed from a Medicaid payers' perspective. The target population was non-adherent OAA patients with a recent relapse. At equal adherence, risk of relapse was equal between PP1M and OAAs, and OAA patients remained non-adherent until treatment switch. Outcomes included number of relapses, relapse costs and pharmacy costs. RESULTS: Based on a hypothetical health plan of 1 million members, 3037 schizophrenia patients were non-adherent on OAAs with a recent relapse. Compared to continuing OAAs, switching 5% of patients (n = 152) to PP1M resulted in net schizophrenia-related cost savings of $674,975 at a plan level, $4445 per patient switched per year and $0.0562 per member per month, with a total of 92 avoided relapses over 12 months. Total annual plan level schizophrenia-related costs were $114.1 M when all patients switched to PP1M before any subsequent relapse (n = 3037), $123.4 M when patients switched to PP1M after a first subsequent relapse (n = 2631), and $127.6 M when all patients continued OAAs. Switching all patients to PP1M before any subsequent relapse averted 917 relapses, at a lower cost per patient switched ($37,559) compared to switching after a first subsequent relapse ($45,089) or continuing OAAs ($42,005). CONCLUSION: Over 12 months, pharmacy costs associated with switching patients from OAAs to PP1M were offset by reduced relapse rates and schizophrenia-related healthcare expenditures, with earlier use of PP1M projected to generate greater cost savings.

A comparison of treatment patterns, healthcare resource utilization, and costs among young adult Medicaid beneficiaries with schizophrenia treated with paliperidone palmitate or oral atypical antipsychotics in the US.

BACKGROUND: Much of the burden associated with schizophrenia is attributed to its early onset and chronic nature. Treatment with once monthly paliperidone palmitate (PP1M) is associated with lower healthcare utilization and better adherence as compared to oral atypical antipsychotics (OAAs). This study aimed to evaluate real-world effectiveness of PP1M and OAA therapies among US-based adult Medicaid patients with schizophrenia, overall and among young adults aged 18-35 years. METHODS: Adult patients with a diagnosis of schizophrenia and at least two claims for PP1M or OAA between January 1, 2010 and December 31, 2014 were selected from the IBM Watson Health MarketScan Medicaid Database. Treatment patterns and healthcare resource utilization and costs were compared between PP1M and OAA treatment groups following inverse probability of treatment (IPT) weighting to adjust for potential differences. Utilization and cost outcomes were estimated using OLS and weighted Poisson regression models. RESULTS: After IPT weighting, the young adult PP1M and OAA cohorts were comprised of 3,095 and 3,155 patients, respectively. PP1M patients had a higher duration of continuous treatment exposure (168.2 vs 132.5 days, p = .004) and better adherence on the index medication (proportion of days covered ≥80%: 19.0% vs 17.1%, p < .049). Young adults treated with PP1M were 37% less likely to have an all-cause inpatient admission (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.53-0.74) and 33% less likely to have an ER visit (OR = 0.67, 95% CI = 0.55-0.81) compared to OAA young adult patients, but 27% more likely to have an all-cause outpatient office visit (OR = 1.27, 95% CI = 1.02-1.56). PP1M patients incurred significantly lower medical costs as compared to OAA patients. CONCLUSIONS: Medicaid patients with schizophrenia treated with PP1M have higher medication adherence and have fewer hospitalizations as compared to patients treated with OAAs. PP1M may lead to reduced healthcare utilization and improved clinical outcomes.

Health Care Resource Utilization and Costs Associated with Transitioning to 3-month Paliperidone Palmitate Among US Veterans.

PURPOSE: The aim of this article was to describe and compare treatment patterns, health care resource utilization (HRU), and health care costs before and after transition in veterans with schizophrenia who were transitioned from paliperidone palmitate given once monthly (PP1M) to paliperidone palmitate given every 3 months (PP3M) according to prescribing-information guidelines. METHODS: This retrospective, longitudinal study was conducted using electronic health records data from the Veterans Health Administration (VHA). Veterans were eligible for inclusion if they were aged 18years or older, had ≥1 dispensation of PP3M, were enrolled with VHA benefits for ≥24 months prior to transition to PP3M, had ≥1 schizophrenia diagnosis, were transitioned to PP3M according to prescribing-information guidelines (operationalized as no gap in PP1M treatment of >45days during the 4 months prior to PP3M transition, with the same dosage in the last 2 PP1M dispensations), and had appropriate dose conversion. Treatment patterns, HRU, and costs 6 months pre and post PP3M transition were described and compared using the McNemar test and the Wilcoxon signed rank test. FINDINGS: Of the 277 veterans identified, the majority were men (92.8%); the median age was 56.5years. Among 197 veterans who had at least 6 months of follow-up pre and post PP3M transition, oral antipsychotic use was significantly decreased (from 49.7% to 43.1%; P = 0.0326). Additionally, the mean number of days spent in an inpatient setting (41.4vs 21.6; P = 0.0164), the mean number of outpatient visits per patient (31.0vs 25.6; P < 0.0001), and the mean total health care costs ($27,745vs $23,772; P = 0.0050) were significantly decreased. IMPLICATIONS: After transitioning to PP3M treatment, veterans had significantly reduced use of oral antipsychotics, HRU, and costs. Although generalizability may be limited due to the veteran population and to those who transitioned according to PP3M prescribing guidelines, future studies in other patient populations may be used to extend these conclusions.

Economic evaluation of paliperidone palmitate once monthly for treating chronic schizophrenia patients in the United Arab Emirates.

OBJECTIVE: Schizophrenia is one of the most debilitating diseases in the United Arab Emirates. Oral antipsychotics (OA) are commonly used in terms of pharmacotherapy; however, these treatments can be rendered ineffective by poor patient adherence. Paliperidone palmitate once monthly (PP1M) is a long acting antipsychotic which can offer an adherence advantage when compared to oral treatments. The study objective is to estimate the cost effectiveness of PP1M in the UAE setting. RESEARCH DESIGN AND METHODS: A 1-year validated decision-tree model was adapted to the UAE setting using published literature and expert opinion. Patients on PP1M were compared with or without oral supplementation to patients on any oral antipsychotic. Patient outcomes studied were incremental cost per quality adjusted life years gained, incremental cost per hospitalizations, relapses, and emergency room visits averted. RESULTS: After 1 year, patients on PP1M monotherapy when compared to oral antipsychotics had better outcomes (0.840 vs 0.811 QALYs; 31 relapse days averted as well as 9 and 24 percentage points of ER and hospitalizations averted, respectively), and better healthcare savings (AED 1405). PP1M economically dominated oral antipsychotics. The results were stable across a broad range of deterministic and probabilistic sensitivity analyses. PP1M plus oral antipsychotics could not be evaluated due to the absence of clinical data that would provide insight into the clinical value of combination therapy. CONCLUSION: PP1M is estimated to save the UAE healthcare system money, while at the same time improving patient outcomes.

Evaluating the costs of glycemic response with canagliflozin versus dapagliflozin and empagliflozin as add-on to metformin in patients with type 2 diabetes mellitus in the United Arab Emirates.

OBJECTIVE: This study evaluates the cost of achieving glycemic control with three sodium glucose co-transporter 2 (SGLT2) inhibitors, canagliflozin, dapagliflozin, and empagliflozin, in patients with type 2 diabetes mellitus (T2DM) from the payer perspective in the United Arab Emirates (UAE). METHODS: A systematic literature review identified randomized controlled trials of antihyperglycemic agents as add-on to metformin in patients with T2DM of 26 ± 4 weeks in duration, published by 10 September 2014. A Bayesian network-meta analysis (NMA) compared HbA1c changes with canagliflozin 100 and 300 mg versus dapagliflozin 10 mg and empagliflozin 10 and 25 mg. The cost associated with a 1% placebo-adjusted HbA1c reduction with each SGLT2 inhibitor as add-on to metformin was calculated based on NMA results and UAE drug costs. RESULTS: In the NMA, canagliflozin 100 and 300 mg were associated with HbA1c reductions (-0.67% and -0.79%) compared with dapagliflozin 10 mg (-0.41%) and empagliflozin 10 and 25 mg (-0.57% and -0.64%). Probabilities of canagliflozin 100 mg performing better were 79%, 60%, and 53% versus dapagliflozin 10 mg and empagliflozin 10 and 25 mg, respectively; probabilities for canagliflozin 300 mg performing better were 88%, 72%, and 65%, respectively. The cost per 1%-point reduction in HbA1c was projected to be lower with canagliflozin 100 and 300 mg ($448 and $422) compared with dapagliflozin 10 mg ($785) and empagliflozin 10 and 25 mg ($527 and $563). CONCLUSIONS: Canagliflozin may provide a greater glycemic response at a lower effective cost than dapagliflozin or empagliflozin for patients with T2DM inadequately controlled with metformin from the payer perspective in the UAE.

Health outcomes of bedaquiline in the treatment of multidrug-resistant tuberculosis in selected high burden countries.

BACKGROUND: Less than one-third of patients who are estimated to be infected with multidrug-resistant tuberculosis (MDR-TB) receive MDR-TB treatment regimens, and only 48% of those who received treatment have successful outcomes. Despite current regimens, newer, more effective and cost-effective approaches to treatment are needed. The aim of the study was to project health outcomes and impact on healthcare resources of adding bedaquiline to the treatment regimen of MDR-TB in selected high burden countries: Estonia, Russia, South Africa, Peru, China, the Philippines, and India. METHODS: This study adapted an existing Markov model to estimate the health outcomes and impact on total healthcare costs of adding bedaquiline to current MDR-TB treatment regimens. A price threshold analysis was conducted to determine the price range at which bedaquiline would be cost-effective. RESULTS: Adding bedaquiline to the background regimen (BR) resulted in increased disability-adjusted life years (DALYs) averted, and reduced total healthcare costs (excluding treatment acquisition costs) compared with BR alone in all countries analyzed. Addition of bedaquiline to BR resulted in savings to healthcare costs compared with BR alone in all countries analyzed, with the highest impact expected in Russia (US$194 million) and South Africa (US$43 million). The price per regimen at which bedaquiline would be cost-effective ranged between US$23,904-US$203,492 in Estonia, Russia, Peru, South Africa, and China (high and upper middle-income countries) and between US$6,996-US$20,323 in the Philippines and India (lower middle-income countries); however, these cost-effective prices do not necessarily address concerns about affordability. CONCLUSIONS: Adding bedaquiline to BR provides improvements in health outcomes and reductions in healthcare costs in high MDR-TB burden countries. The range of prices per regimen for which bedaquiline would be cost-effective varied between countries.

Health-related quality of life in patients with hepatitis C virus infection in Brazil.

OBJECTIVE: To quantify the health-related quality of life (HRQoL) burden of hepatitis C virus (HCV) infection among a broad sample of adults in Brazil, particularly among those 40 years of age and older. METHODS: This was a retrospective observational study of data from the 2011 Brazil National Health and Wellness Survey, a large (n = 12 000) cross-sectional survey that includes information on medical conditions and health outcomes, including the Medical Outcomes Study Short-form 12 health questionnaire, version 2 (SF-12v2). Respondents who reported a physician diagnosis of HCV infection were compared with those who reported never experiencing HCV on the Mental (MCS) and Physical (PCS) Component Summary scores and SF-6D health utility scores. Unadjusted comparisons were conducted with chi-square tests for categorical variables and t-tests for continuous variables. Regression was used to adjust outcomes for potential confounds. Subgroup analyses were conducted on those 40 years of age and older. RESULTS: Unadjusted comparisons between respondents infected with HCV (n = 100) and controls (n = 11 694) revealed similar MCS and PCS scores, but HCV patients had lower SF-6D utility scores (0.70 vs. 0.73, P < 0.05). Regressions adjusting for demographic and health characteristics provided similar results to unadjusted comparisons. Subgroup analyses of respondents 40 years of age and older revealed decrements in both MCS (45.95 vs. 49.72, P < 0.05) and SF-6D (0.71 vs. 0.76, P < 0.05). PCS scores were comparable in HCV patients and controls. CONCLUSIONS: HCV infection in Brazil causes significant HRQoL burden, especially among the older population. Prevention measures to curtail the spread of the virus in Brazil should provide societal benefits in terms of quality of life, in addition to preventing morbidity and mortality from chronic infection.

Health-related quality of life in patients with hepatitis C virus infection in Brazil / Calidad de vida relacionada con la salud en pacientes infectados por el virus de la hepatitis C en el Brasil

OBJECTIVE: To quantify the health-related quality of life (HRQoL) burden of hepatitis C virus (HCV) infection among a broad sample of adults in Brazil, particularly among those 40 years of age and older. METHODS: This was a retrospective observational study of data from the 2011 Brazil National Health and Wellness Survey, a large (n = 12 000) cross-sectional survey that includes information on medical conditions and health outcomes, including the Medical Outcomes Study Short-form 12 health questionnaire, version 2 (SF-12v2). Respondents who reported a physician diagnosis of HCV infection were compared with those who reported never experiencing HCV on the Mental (MCS) and Physical (PCS) Component Summary scores and SF-6D health utility scores. Unadjusted comparisons were conducted with chi-square tests for categorical variables and t-tests for continuous variables. Regression was used to adjust outcomes for potential confounds. Subgroup analyses were conducted on those 40 years of age and older. RESULTS: Unadjusted comparisons between respondents infected with HCV (n = 100) and controls (n = 11 694) revealed similar MCS and PCS scores, but HCV patients had lower SF-6D utility scores (0.70 vs. 0.73, P < 0.05). Regressions adjusting for demographic and health characteristics provided similar results to unadjusted comparisons. Subgroup analyses of respondents 40 years of age and older revealed decrements in both MCS (45.95 vs. 49.72, P < 0.05) and SF-6D (0.71 vs. 0.76, P < 0.05). PCS scores were comparable in HCV patients and controls. CONCLUSIONS: HCV infection in Brazil causes significant HRQoL burden, especially among the older population. Prevention measures to curtail the spread of the virus in Brazil should provide societal benefits in terms of quality of life, in addition to preventing morbidity and mortality from chronic infection.

OBJETIVO: Cuantificar la carga de la infección por el virus de la hepatitis C (VHC) en cuanto a calidad de vida relacionada con la salud (CVRS) en una amplia muestra de adultos del Brasil, particularmente en los de 40 años de edad o mayores. MÉTODOS: Se llevó a cabo un estudio retrospectivo y de observación de los datos de la Encuesta Nacional de Salud y Bienestar del Brasil del 2011, una amplia encuesta transversal (n = 12 000) que aporta información sobre trastornos médicos y resultados en materia de salud, e incluye el cuestionario de salud denominado Estudio de los Resultados Médicos, en la versión 2 de su forma abreviada de 12 ítems (SF-12v2). Los entrevistados que notificaron un diagnóstico médico de infección por el VHC se compararon con los que afirmaron que nunca habían padecido esta infección en cuanto a las puntuaciones resumen de las componentes mental (MCS) y física (PCS) y las puntuaciones de utilidad en salud del SF-6D. Se llevaron a cabo comparaciones no ajustadas mediante pruebas de ji al cuadrado para las variables categóricas y pruebas t para las variables continuas. Se empleó un modelo de regresión para ajustar los resultados en cuanto a confusiones potenciales. Se realizaron análisis del subgrupo de adultos de 40 años de edad o mayores. RESULTADOS: Las comparaciones no ajustadas entre los entrevistados infectados por el VHC (n = 100) y los controles (n = 11 694) mostraron puntuaciones de MCS y PCS similares, pero los pacientes infectados por el VHC obtuvieron puntuaciones de utilidad del SF-6D inferiores (0,70 frente a 0,73, P < 0.05). Las regresiones de ajuste de las características demográficas y de salud proporcionaron resultados similares a los de las comparaciones no ajustadas. Los análisis del subgrupo de entrevistados de 40 años de edad o mayores mostraron disminuciones tanto en la MCS (45,95 frente a 49,72, P < 0.05) como en el SF-6D (0,71 frente a 0,76, P < 0.05). Las puntuaciones de la PCS fueron comparables en los pacientes infectados por el VHC y los controles. CONCLUSIONES: La infección por el VHC en el Brasil causa una carga significativa en cuanto a CVRS, especialmente en la población de mayor edad. Las medidas preventivas para reducir la propagación del virus en el Brasil deben proporcionar beneficios sociales en cuanto a calidad de vida, además de prevenir la morbilidad y la mortalidad causadas por la infección crónica.

Cost-effectiveness of boceprevir in patients previously treated for chronic hepatitis C genotype 1 infection in the United States.

OBJECTIVES: The phase 3 trial, Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol-2 (RESPOND-2), demonstrated that the addition of boceprevir (BOC) to peginterferon-ribavirin (PR) resulted in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection as compared with PR alone. We evaluated the cost-effectiveness of treatment with BOC in previously treated patients with chronic hepatitis C in the United States using treatment-related data from RESPOND-2 and PROVIDE studies. METHODS: We developed a Markov cohort model to project the burden of HCV disease, lifetime costs, and quality-adjusted life-years associated with PR and two BOC-based therapies-response-guided therapy (BOC/RGT) and fixed-duration therapy for 48 weeks (BOC/PR48). We estimated treatment-related inputs (efficacy, adverse events, and discontinuations) from clinical trials and obtained disease progression rates, costs, and quality-of-life data from published studies. We estimated the incremental cost-effectiveness ratio (ICER) for BOC-based regimens as studied in RESPOND-2, as well as by patient's prior response to treatment and the IL-28B genotype. RESULTS: BOC-based regimens were projected to reduce the lifetime incidence of liver-related complications by 43% to 53% in comparison with treatment with PR. The ICER of BOC/RGT in comparison with that of PR was $30,200, and the ICER of BOC/PR48 in comparison with that of BOC/RGT was $91,500. At a willingness-to-pay threshold of $50,000, the probabilities of BOC/RGT and BOC/PR48 being the preferred option were 0.74 and 0.25, respectively. CONCLUSIONS: In patients previously treated for chronic HCV genotype-1 infection, BOC was projected to increase quality-adjusted life-years and reduce the lifetime incidence of liver complications. In addition, BOC-based therapies were projected to be cost-effective in comparison with PR alone at commonly used willingness-to-pay thresholds.

Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study.

BACKGROUND: SPRINT-2 demonstrated that boceprevir (BOC), an oral hepatitis C virus (HCV) nonstructural 3 (NS3) protease inhibitor, added to peginterferon alfa-2b (P) and ribavirin (R) significantly increased sustained virologic response rates over PR alone in previously untreated adult patients with chronic HCV genotype 1. We estimated the long-term impact of triple therapy vs. dual therapy on the clinical burden of HCV and performed a cost-effectiveness evaluation. METHODS: A Markov model was used to estimate the incidence of liver complications, discounted costs (2010 US$), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) of three treatment strategies for treatment-naïve patients with chronic HCV genotype 1. The model simulates the treatment regimens studied in SPRINT-2 in which PR was administered for 4 weeks followed by: 1) placebo plus PR for 44 weeks (PR48); 2) BOC plus PR using response guided therapy (BOC/RGT); and 3) BOC plus PR for 44 weeks (BOC/PR48) and makes projections within and beyond the trial. HCV-related state-transition probabilities, costs, and utilities were obtained from previously published studies. All costs and QALYs were discounted at 3%. RESULTS: The model projected approximately 38% and 43% relative reductions in the lifetime incidence of liver complications in the BOC/RGT and BOC/PR48 regimens compared with PR48, respectively. Treatment with BOC/RGT is associated with an incremental cost of $10,348 and an increase of 0.62 QALYs compared to treatment with PR48. Treatment with BOC/PR48 is associated with an incremental cost of $35,727 and an increase of 0.65 QALYs compared to treatment with PR48. The ICERs were $16,792/QALY and $55,162/QALY for the boceprevir-based treatment groups compared with PR48, respectively. The ICER for BOC/PR48 compared with BOC/RGT was $807,804. CONCLUSION: The boceprevir-based regimens used in the SPRINT-2 trial were projected to substantially reduce the lifetime incidence of liver complications and increase the QALYs in treatment-naive patients with hepatitis C genotype 1. It was also demonstrated that boceprevir-based regimens offer patients the possibility of experiencing great clinical benefit with a shorter duration of therapy. Both boceprevir-based treatment strategies were projected to be cost-effective at a reasonable threshold in the US when compared to treatment with PR48.

The burden of hepatitis C in Europe from the patients' perspective: a survey in 5 countries.

BACKGROUND: Few studies have examined the impact of Hepatitis C virus (HCV) infection on patient reported outcomes in Europe. This study was conducted to assess the burden of HCV infection in terms of work productivity loss, activity impairment, health-related quality of life, healthcare resource utilization, and associated costs. METHODS: The 2010 European National Health and Wellness Survey (n = 57,805) provided data. Patients reporting HCV infection in France, Germany, the UK, Italy, and Spain were matched to respondents without HCV using propensity scores. Outcome measures included the Work Productivity and Activity Impairment (WPAI) questionnaire and the Medical Outcomes Study Short Form-12 (SF-12v2) questionnaire. Subgroup analyses focused on treatment-naïve patients. RESULTS: HCV Patients (n = 286) had more work impairment (30% vs. 18%, p < .001), more impairment in non-work activities (34% vs. 28%, p < .05), and more annual physician visits per patient (19.8 vs. 13.3, p < .001). Estimated indirect and direct costs were €2,956 (p < .01) and €495 (p < .001) higher than in matched controls, respectively. Health-related quality of life was also lower among HCV patients. Treatment-naïve HCV patients (n = 139) also reported higher work impairment (29% vs. 15%, p < .01), as well as more frequent physician visits (19.5 vs. 12.1, p < .01) than matched controls. Each treatment-naïve HCV infected patient incurred €934 in direct costs vs. €508 (p < .01 in matched controls. Employed treatment-naïve patients reported higher productivity loss per year compared to matched controls (€6,414 vs. €3,642, p < .05). CONCLUSION: HCV infection in Europe is associated with considerable economic and humanistic burden. This is also true of diagnosed patients who have never been treated for HCV.