[Real-world analysis of obstructive respiratory tract disorders: characterization, health care and costs.] / Analisi real-world dei disturbi ostruttivi delle vie respiratorie: caratterizzazione, assistenza sanitaria e costi.

INTRODUCTION: This analysis has described the burden of patients with asthma, chronic obstructive pulmonary disease (COPD), asthma/COPD mixed conditions or undefined obstructive diseases (UODs), from the Italian National Health System point of view. METHODS: In the accrual period (2015), starting from the ReS database, a record linkage among demographic, pharmaceuticals, hospitalizations and outpatient specialist services databases has identified patients affected by only asthma, only COPD, asthma/COPD and UODs. From the less recent date of identification, each patient was analyzed in one previous year and in two years of follow-up (at most up to 12/31/2017). In the accrual period, in the previous one and in 2-year follow-up sinus polyps was researched. One-year free filled respiratory (ATC code R03) and concomitant prescriptions, outpatient specialist services, hospitalizations were described. Two-year costs were assessed annually. RESULTS: In 2015, 110,453 subjects with asthma (16.6 x1000 ≥12 years old), 229,747 with COPD, 8828 with asthma/COPD (55.5 x1000 and 2.1 x1000 ≥40 years, respectively) and 75,072 with UODs (27.2 x1000 subjects aged 40 to 65) were selected. Sinus polyps was found in 753 patients with asthma, 181 with COPD and 122 with asthma/COPD. A very high use of inhaled corticosteroids - ICS (R03AB) as monotherapy and as fixed association ICS/LABA and of cardiovascular drugs was highlighted among patients with COPD and asthma/COPD. The spirometry test was used in 21.4% patients with asthma/COPD, in 9.2% with asthma, in 8.6% with COPD and in 5.8% with UODs. Subjects with COPD and asthma/COPD were the most frequently hospitalized, mainly due to respiratory and cardiovascular causes, and those with the longest in-hospital stay. On average, the mean overall one-year expenditure per COPD or asthma/COPD patient was three times higher than per asthma or UOD one (€3508/€3613 vs €942/€1394, respectively). CONCLUSIONS: Concomitant drugs and hospitalizations due to other causes than respiratory ones accounted for the highest expenses. In general, comorbidities and cardiopulmonary complications played a key role in obstructive airway disease managing and controlling, by determining unsustainable socio-economic impacts.

Effect of compliance with GOLD treatment recommendations on COPD health care resource utilization, cost, and exacerbations among patients with COPD on maintenance therapy.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

Muscle loss contributes to higher morbidity and mortality in COPD: An analysis of national trends.

BACKGROUND AND OBJECTIVE: COPD is the third most common cause of death worldwide and fourth most common in the United States. In hospitalized patients with COPD, mortality, morbidity and healthcare resource utilization are high. Skeletal muscle loss is frequent in patients with COPD. However, the impact of muscle loss on adverse outcomes has not been systematically evaluated. We tested the hypothesis that patients hospitalized for COPD exacerbation with, compared to those without, a secondary diagnosis of muscle loss phenotype (all ICD-9 codes associated with muscle loss including cachexia) will have higher mortality and cost of care. METHODS: The NIS database of hospitalized patients in 2011 (1 January-31 December) in the United States was used. The impact of a muscle loss phenotype on in-hospital mortality, LOS and cost of care for each of the 174 808 hospitalizations for COPD exacerbations was analysed. RESULTS: Of the subjects admitted for a COPD exacerbation, 12 977 (7.4%) had a secondary diagnosis of muscle loss phenotype. A diagnosis of muscle loss phenotype was associated with significantly higher in-hospital mortality (14.6% vs 5.7%, P < 0.001), LOS (13.3 + 17.1 vs 5.7 + 7.6, P < 0.001) and median hospital charge per patient ($13 947 vs $6610, P < 0.001). Multivariate regression analysis showed that muscle loss phenotype increased mortality by 111% (95% CI: 2.0-2.2, P < 0.001), LOS by 68.4% (P < 0.001) and the direct cost of care by 83.7% (P < 0.001) compared to those without muscle loss. CONCLUSION: In-hospital mortality, LOS and healthcare costs are higher in patients with COPD exacerbations and a muscle loss phenotype.

Projecting Long-term Health and Economic Burden of COPD in the United States.

BACKGROUND: In the United States, COPD is a leading cause of mortality, with a substantial societal health and economic burden. With anticipated population growth, it is important for various stakeholders to have an estimate for the projected burden of disease. RESEARCH QUESTION: The goal of this study was to model the 20-year health and economic burden of COPD, from 2019 to 2038, in the United States. STUDY DESIGN AND METHODS: Using country-specific data from published literature and publicly available datasets, a dynamic open cohort Markov model was developed in a probabilistic Monte Carlo simulation. Population growth was modeled across different subgroups of age, sex, and smoking. The COPD prevalence rates were calibrated for different subgroups, and distributions of severity grades were modeled based on smoking status. Direct costs, indirect absenteeism costs, losses of quality-adjusted life years (QALYs), and number of exacerbations and deaths associated with COPD were projected. RESULTS: The 20-year discounted direct medical costs attributable to COPD were estimated to be $800.90 billion (95% credible interval [CrI], 565.29 billion-1,081.29 billion), with an expected $337.13 billion in male subjects and $463.77 billion in female subjects. The 20-year discounted indirect absenteeism costs were projected to be $101.30 billion (70.82 billion-137.41 billion). The 20-year losses of QALYs, number of exacerbations, and number of deaths associated with COPD were 45.38 million (8.63 million-112.07 million), 315.08 million (228.59 million-425.33 million), and 9.42 million (8.93 million-9.93 million), respectively. The proportion of disease burden attributable to continued smoking was 34% in direct medical costs, 35% in indirect absenteeism costs, and 37% in losses of QALYs over 20 years. INTERPRETATION: This study projects the substantial burden of COPD that the American society is expected to incur with current patterns for treatments and smoking rates. Mitigating such burden requires targeted budget appropriations and cost-effective interventions.

Association Between Financial Incentives in Medicare's Hospital Readmissions Reduction Program and Hospital Readmission Performance.

Importance: The strongest evidence for the effectiveness of Medicare's Hospital Readmissions Reduction Program (HRRP) involves greater reductions in readmissions for hospitals receiving penalties compared with those not receiving penalties. However, the HRRP penalty is an imperfect measure of hospitals' marginal incentive to avoid a readmission for HRRP-targeted diagnoses. Objectives: To assess the association between hospitals' condition-specific incentives and readmission performance and to examine the responsiveness of hospitals to condition-specific incentives compared with aggregate penalty amounts. Design, Setting, and Participants: This retrospective cohort analysis used Medicare readmissions data from 2823 US short-term acute care hospitals participating in HRRP to compare 3-year (fiscal years 2016-2019) follow-up readmission performance according to tertiles of hospitals' baseline (2016) marginal incentives for each of 5 HRRP-targeted conditions (acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, pneumonia, and hip and/or knee surgery). Main Outcomes and Measures: Linear regression models were used to estimate mean change in follow-up readmission performance, measured using the excess readmissions ratio, with baseline condition-specific incentives and aggregate penalty amounts. Results: Of 2823 hospitals that participated in the HRRP from baseline to follow-up, 2280 (81%) had more than 1 excess readmission for 1 or more applicable condition and 543 (19%) did not have any excess readmissions. The mean (SD) financial incentive to reduce readmissions for incentivized hospitals ranged from $8762 ($3699) to $58 158 ($26 198) per 1 avoided readmission. Hospitals with greater incentives for readmission avoidance had greater decreases in readmissions compared with hospitals with smaller incentives (45% greater for pneumonia, 172% greater for acute myocardial infarction, 40% greater for hip and/or knee surgery, 32% greater for chronic obstructive pulmonary disease, and 13% greater for heart failure), whereas hospitals with no incentives had increases in excess readmissions of 4% to 7% (median, 4% [percentage change for nonincentivized hospitals was 3.7% for pneumonia, 4.2% for acute myocardial infarction, 7.1% for hip and/or knee surgery, 3.7% for chronic obstructive pulmonary disease, and 3.7% for heart failure]; P < .001). During the study period, each additional $5000 in the incentive amount was associated with a 0.6- to 1.3-percentage point decrease, or up to a 26% decrease, in excess readmissions (P < .001). Regression to the mean explained approximately one-third of the results depending on the condition examined. Conclusions and Relevance: The findings suggest that improvements in readmission avoidance are more strongly associated with incentives from the HRRP than with aggregate penalty amounts, suggesting that the program has elicited sizeable changes. Worsened performance among hospitals with small or no incentives may indicate the need for reconsideration of the program's lack of financial rewards for high-performing hospitals.

Earlier palliative home care is associated with patient-centred medical resource utilisation and lower costs in the last 30†days before death in COPD: a population-level decedent cohort study.

COPD patients often use many medical resources, such as hospital admissions and medical imaging, inappropriately close to death. Palliative home care (PHC) could beneficially affect this. The aim was to study the effect of use and timing of PHC on medical resource use and costs in the last 30 days before death (DBD) for COPD.We performed a retrospective study of all Belgian decedents in 2010-2015 with COPD and a primary cause of death being COPD or cardiovascular diseases. Odds ratios for medical resources were calculated between using and four PHC timing categories (>360, 360-181, 180-91 and 90-31 DBD) versus not using. Confounders were socio-demographic, care intensity and disease severity variables.Of the 58 527 decedents with COPD, 644 (1.1%) patients received PHC earlier than 30 DBD. Using PHC (versus not using) decreased the odds ratio for hospitalisation (0.35), intensive care unit admission (0.16), specialist contacts (0.58), invasive ventilation (0.13), medical imaging including chest radiograph (0.34), sedatives (0.48) and hospital death (0.14). It increased the odds ratio for home care (3.27), general practitioner contact (4.65), palliative care unit admission (2.61), noninvasive ventilation (2.65), gastric tube (2.15), oxygen (2.22) and opioids (4.04) (p<0.001). Mean total healthcare costs were €1569 lower for using PHC. All PHC timing categories showed a benefit in medical resource use and costs. However, we observed the largest benefit in the category PHC 90-31 DBD.Health policy and services should focus on increasing PHC access, while research should further explore early PHC initiation for COPD.

Chronic obstructive pulmonary disease (COPD) in Spain and the different aspects of its social impact: a multidisciplinary opinion document.

Chronic obstructive pulmonary disease (COPD) is one of the most prevalent diseases in the World, and one of the most important causes of mortality and morbidity. In adults 40 years and older, it affects more than 10% of the population and has enormous personal, family and social burden. Tobacco smoking is its main cause, but not the only one, and there is probably a genetic predisposition that increases the risk in some patients. The paradigm of this disease is changing in Spain, with an increase of women that has occurred in recent years. Many of the physio pathological mechanisms of this condition are well known, but the psychological alterations to which it leads, the impact of COPD on relatives and caregivers, the limitation of daily life observed in these patients, and the economic and societal burden that they represent for the health system, are not so well-known. A major problem is the high under-diagnosis, mainly due to difficulties for obtaining, in a systematic way, spirometries in hospitals and health-care centers. For this reason, the Fundación de Ciencias de la Salud and the Spanish National Network Center for Research in Respiratory Diseases (CIBERES) have brought together experts in COPD, patients and their organizations, clinical psychologists, experts in health economics, nurses and journalists to obtain their opinion about COPD in Spain. They also discussed the scientific bibliometrics on COPD that is being carried out from the CIBERES and speculated on the future of this condition. The format of the meeting consisted in the discussion of a series of questions that were addressed by different speakers and discussed until a consensus conclusion was reached.

Legal demands of the tiotropium bromide for treatment of chronic obstructive pulmonary disease and their financial impact for the State of Paraná, Brazil.

OBJECTIVE: To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. METHODS: We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. RESULTS: Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. CONCLUSION: Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.

Impact of COPD on outcomes in hospitalized patients treated with transcatheter aortic valve implantation or surgical aortic valve replacement in Spain.

OBJECTIVES: To describe the use of transcatheter aortic valve implantation (TAVI) and conventional surgery (SAVR) among hospitalized patients with and without COPD, to compare the in-hospital mortality (IHM), length of hospital stay (LOHS) and cost between patients with COPD undergoing TAVI and SAVR and to identify factors associated to IHM among these patients. BACKGROUND: TAVI would be expected to be less invasive and safer than SAVR among COPD patients. METHODS: We analyzed patients whose medical procedures included TAVI and SAVR included in the Spanish National Hospital Discharge Database, 2014-2015. We stratified analysis by COPD status. Propensity score matching (1:2) was performed to assess the outcomes of TAVI vs. SAVR among COPD patients. RESULTS: We identified 2,141 and 16,013 patients who underwent TAVI (27.60% with COPD) and SAVR (19.31% with COPD) respectively. For TAVI, we found no differences in IHM according to COPD status. Patients undergoing SAVR and suffering COPD had higher IHM than patients without COPD (adj.OR 1.32; 95%CI 1.10-1.58). After propensity score matching, IHM (8.35% vs. 5.83%, p = .040) and LOHS (18.62 days vs. 13.62; p < .001) were higher in COPD patients who underwent SAVR than those who underwent TAVI. CONCLUSIONS: COPD patients undergoing TAVI did not have a worse prognosis compared to non-COPD patients during hospitalization. However, for SAVR, patients with COPD had significantly higher mortality than patients without this condition. COPD patients who underwent SAVR had higher IHM and LOHS than propensity score matched TAVI patients.

Legal demands of the tiotropium bromide for treatment of chronic obstructive pulmonary disease and their financial impact for the State of Paraná, Brazil / Demandas judiciais do uso de brometo tiotrópio para o tratamento da doença pulmonar obstrutiva crônica e o impacto financeiro para o Estado do Paraná, Brasil

ABSTRACT Objective To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. Methods We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. Results Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. Conclusion Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.

RESUMO Objetivo Analisar as demandas judiciais do brometo de tiotrópio para tratar a doença pulmonar obstrutiva crônica. Métodos Foram considerados dados secundários dos sistemas gerenciais de assistência farmacêutica, disponibilizados pelo Centro de Medicamentos do Paraná. Resultados Ações civis públicas e ações ordinárias, de procedimento comum, entre outras, foram as mais praticadas pelos pacientes para obter o medicamento. Duas Regionais de Saúde do Paraná (Londrina e Umuarama) concentraram mais de 50% das ações. Quanto à especialidade dos médicos prescritores, 33,8% eram pneumologistas. Verificou-se discreto impacto financeiro do brometo de tiotrópio nos gastos gerais com medicamentos pelo Centro de Medicamentos do Paraná. Entretanto, também houve relevante impacto financeiro individual, pois uma unidade do medicamento consome 38% do salário mínimo. Conclusão O estudo aponta para a necessidade de incorporação deste medicamento da classe broncodilatadores anticolinérgicos de longa duração, no Sistema Único de Saúde.

Metabolic Syndrome in Early Chronic Obstructive Pulmonary Disease: Gender Differences and Impact on Exacerbation and Medical Costs.

Background: Metabolic syndrome (MetS) is a well-known comorbidity of chronic obstructive pulmonary disease (COPD). However, their interrelationship, particularly in early COPD, remains unclear. Therefore, we aimed to assess the prevalence and clinical characteristics of MetS in patients with early COPD, and to explore the impact of MetS on the frequency of COPD exacerbations and associated medical costs. Patients and methods: We retrospectively enrolled 43,874 subjects from the KNHANES, including 2164 patients with early COPD (≥40 years old), recorded smoking history, and Global Initiative for Chronic Obstructive Lung Disease spirometric grade I or II, with data linked to the NHI database. We extracted and analyzed data regarding health-care utilization and medical costs for 5 years (2007 to 2012). Results: Among 2164 patients with early COPD, the prevalence of MetS was 31.2%, and it was higher in women than in men (35.1% vs. 26.6%; P<0.001). Patients with MetS were older and had lower pulmonary function and greater number of comorbidities. The frequency of moderate-to-severe COPD exacerbations for 5 years was significantly higher in women with MetS than in those without MetS (5.8/year vs. 4.9/year; P=0.02). After adjusting for confounding factors, the risk for moderate-to-severe exacerbation was significantly greater in women with MetS (IRR, 1.17; 95% CI, 1.01 to 1.36; P=0.03). COPD exacerbations leading to hospitalization and medical expenses were also higher in women with MetS than in those without MetS. Conclusion: MetS is more prevalent in women with early COPD. MetS increased the frequency of exacerbations and the medical costs in women with early COPD.

Direct and indirect costs of COPD progression and its comorbidities in a structured disease management program: results from the LQ-DMP study.

BACKGROUND: Evidence on the economic impact of chronic obstructive pulmonary disease (COPD) for third-party payers and society based on large real world datasets are still scarce. Therefore, the aim of this study was to estimate the economic impact of COPD severity and its comorbidities, stratified by GOLD grade, on direct and indirect costs for an unselected population enrolled in the structured German Disease Management Program (DMP) for COPD. METHODS: All individuals enrolled in the DMP COPD were included in the analysis. Patients were only excluded if they were not insured or not enrolled in the DMP COPD the complete year before the last DMP documentation (at physician visit), had a missing forced expiratory volume in 1 s (FEV1) measurement or other missing values in covariates. The final dataset included 39,307 patients in GOLD grade 1 to 4. We used multiple generalized linear models to analyze the association of COPD severity with direct and indirect costs, while adjusting for sex, age, income, smoking status, body mass index, and comorbidities. RESULTS: More severe COPD was significantly associated with higher healthcare utilization, work absence, and premature retirement. Adjusted annual costs for GOLD grade 1 to 4 amounted to €3809 [€3691-€3935], €4284 [€4176-€4394], €5548 [€5328-€5774], and €8309 [€7583-9065] for direct costs, and €11,784 [€11,257-€12,318], €12,985 [€12,531-13,443], €15,805 [€15,034-€16,584], and €19,402 [€17,853-€21,017] for indirect costs. Comorbidities had significant additional effects on direct and indirect costs with factors ranging from 1.19 (arthritis) to 1.51 (myocardial infarction) in direct and from 1.16 (myocardial infarction) to 1.27 (cancer) in indirect costs. CONCLUSION: The findings indicate that more severe GOLD grades in an unselected COPD population enrolled in a structured DMP are associated with tremendous additional direct and indirect costs, with comorbidities significantly increase costs. In direct cost category hospitalization and in indirect cost category premature retirement were the main cost driver. From a societal perspective prevention and interventions focusing on disease control, and slowing down disease progression and strengthening the ability to work would be beneficial in order to realize cost savings in COPD.

End-of-life care in individuals with respiratory diseases: a population study comparing the dying experience between those with chronic obstructive pulmonary disease and lung cancer.

Purpose: Among individuals with COPD and/or lung cancer, to describe end-of-life health service utilization, costs, and place of death; to identify predictors of home palliative care use, and to assess benefits associated with palliative care use. Patients and methods: We conducted a retrospective population-based study using provincial linked health administrative data (Ontario, Canada) between 2010 and 2015. We examined health care use in the last 90 days of life in adults 35 years and older with physician-diagnosed COPD and/or lung cancer identified using a validated algorithm and the Ontario Cancer Registry, respectively. Four mutually exclusive groups were considered: (i) COPD only, (ii) lung cancer only, (iii) COPD and lung cancer, and (iv) neither COPD nor lung cancer. Multivariable generalized linear models were employed. Results: Of 445,488 eligible deaths, 34% had COPD only, 4% had lung cancer only, 5% had both and 57% had neither. Individuals with COPD only received less palliative care (20% vs 57%) than those with lung cancer only. After adjustment, people with lung cancer only were far more likely to receive palliative care (OR=4.22, 4.08-4.37) compared to those with neither diagnosis, while individuals with COPD only were less likely to receive palliative care (OR=0.82, 0.81-0.84). Home palliative care use was associated with reduced death and fewer days in acute care, and less cost, regardless of the diagnosis. Conclusion: Although individuals with lung cancer were much more likely to receive palliative care than those with COPD, both populations were underserviced. Results suggest greater involvement of palliative care may improve the dying experience of these populations and reduce costs.

Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol.

Introduction: Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits. U.S. health care payment reforms create financial opportunities to offer HBPC. Consequently, more HBPC programs are emerging, heightening the need to evaluate their effectiveness. Methods: This randomized, controlled trial is comparing the effectiveness of an evidence-based model of HBPC and enhanced usual primary care for participants who receive primary care from medical groups and clinics organized under an accountable care organization or Medicare Advantage plan. Palliative care services are reimbursed by our partnering health plan provider. The five-year trial will enroll 1155 seriously ill participants (and ∼884 of their caregivers) with heart failure, chronic obstructive pulmonary disease, or advanced cancer. We are collecting data via telephone surveys with participants at baseline and one and two months postenrollment and with caregivers at baseline, one and two months postenrollments, and following the death of a loved one. We are collecting participant-reported outcome measures of pain, symptoms, anxiety, depression, participant-provider communication, and hope. Caregiver outcome measures include caregiver burden, communication with providers, anxiety, and depression. Additional outcomes are participant survival time and participants' emergency department visits and hospitalizations. Study Implementation: Challenges and Contributions: Our research team has encountered several significant challenges in early study implementation. These include engaging primary care providers in the study and coordinating logistics with a health plan. Both challenges have contributed to a lag in participant enrollment. Despite these challenges, our study holds tremendous promise to accelerate adoption and spread of an evidence-based HBPC model across the country.

Determinants of healthcare utilization and costs in COPD patients: first longitudinal results from the German COPD cohort COSYCONET.

Background: In light of overall increasing healthcare expenditures, it is mandatory to study determinants of future costs in chronic diseases. This study reports the first longitudinal results on healthcare utilization and associated costs from the German chronic obstructive pulmonary disease (COPD) cohort COSYCONET. Material and methods: Based on self-reported data of 1904 patients with COPD who attended the baseline and 18-month follow-up visits, direct costs were calculated for the 12 months preceding both examinations. Direct costs at follow-up were regressed on baseline disease severity and other co-variables to identify determinants of future costs. Change score models were developed to identify predictors of cost increases over 18 months. As possible predictors, models included GOLD grade, age, sex, education, smoking status, body mass index, comorbidity, years since COPD diagnosis, presence of symptoms, and exacerbation history. Results: Inflation-adjusted mean annual direct costs increased by 5% (n.s., €6,739 to €7,091) between the two visits. Annual future costs were significantly higher in baseline GOLD grades 2, 3, and 4 (factors 1.24, 95%-confidence interval [1.07-1.43], 1.27 [1.09-1.48], 1.57 [1.27-1.93]). A history of moderate or severe exacerbations within 12 months, a comorbidity count >3, and the presence of dyspnea and underweight were significant predictors of cost increase (estimates ranging between + €887 and + €3,679, all p<0.05). Conclusions: Higher GOLD grade, comorbidity burden, dyspnea and moderate or severe exacerbations were determinants of elevated future costs and cost increases in COPD. In addition we identified underweight as independent risk factor for an increase in direct healthcare costs over time.

Model-based evaluation of the long-term cost-effectiveness of systematic case-finding for COPD in primary care.

INTRODUCTION: 'One-off' systematic case-finding for COPD using a respiratory screening questionnaire is more effective and cost-effective than routine care at identifying new cases. However, it is not known whether early diagnosis and treatment is beneficial in the longer term. We estimated the long-term cost-effectiveness of a regular case-finding programme in primary care. METHODS: A Markov decision analytic model was developed to compare the cost-effectiveness of a 3-yearly systematic case-finding programme targeted to ever smokers aged ≥50 years with the current routine diagnostic process in UK primary care. Patient-level data on case-finding pathways was obtained from a large randomised controlled trial. Information on the natural history of COPD and treatment effects was obtained from a linked COPD cohort, UK primary care database and published literature. The discounted lifetime cost per quality-adjusted life-year (QALY) gained was calculated from a health service perspective. RESULTS: The incremental cost-effectiveness ratio of systematic case-finding versus current care was £16 596 per additional QALY gained, with a 78% probability of cost-effectiveness at a £20 000 per QALY willingness-to-pay threshold. The base case result was robust to multiple one-way sensitivity analyses. The main drivers were response rate to the initial screening questionnaire and attendance rate for the confirmatory spirometry test. DISCUSSION: Regular systematic case-finding for COPD using a screening questionnaire in primary care is likely to be cost-effective in the long-term despite uncertainties in treatment effectiveness. Further knowledge of the natural history of case-found patients and the effectiveness of their management will improve confidence to implement such an approach.

Comparative analysis of medical expenditure with nebulized budesonide versus systemic corticosteroids in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease in China.

Purpose: Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and is a leading cause of disability in China. Acute exacerbations of COPD (AECOPD) are a leading cause of hospitalizations, and account for a substantial proportion of medical expenditure. Corticosteroids are commonly used to manage AECOPD in hospitalized patients, so our objective was to analyze the total medical expenditure associated with nebulized budesonide (nBUD) vs. systemic corticosteroids (SCS) in this population. Patients and methods: A post-hoc analysis was carried out in 1,577 and 973 patients diagnosed with COPD who had received "any" nBUD or SCS regimen for AECOPD during hospitalization, respectively. Regimens included monotherapy, sequential therapy, and sequential-combination therapy. Comparative total medical expenditure was analyzed using a generalized linear model controlling for age, gender, comorbidities, smoking history, and respiratory failure or pneumonia on admission. Results: The total medical expenditure per capita with any nBUD or SCS regimen was CN¥11,814 (US$1,922) and CN¥12,153 (US$1,977), respectively. Any nBUD regimen was associated with a significant saving of 5.1% in expenditure compared with any SCS regimen (P=0.0341). Comorbidities, Type II respiratory failure, or pneumonia were patient factors associated with higher total medical expenditure (P<0.0001). In a subgroup analysis of the patients who received monotherapy, total medical expenditure was CN¥10,900 (US$1,773) for nBUD and CN¥11,581 (US$1,884) for SCS; nBUD was associated with a significant saving of 8.7% in expenditure compared with SCS (P=0.0013). Similarly, in patients with respiratory failure, treatment with any nBUD regimen was associated with a 10.6% saving in expenditure over any SCS regimen (P=0.0239); however, the same comparison was not significant in patients without respiratory failure (3.4%; P=0.2299). Conclusion: AECOPD is a leading cause of hospitalization in China, which places substantial burden on the healthcare system. This post-hoc analysis suggests that nBUD regimens are associated with lower medical expenditure than SCS regimens in hospitalized patients with AECOPD, and may reduce the financial burden of COPD. However, prospective studies evaluating the effectiveness of nBUD therapies are warranted.

Economic burden of incident interstitial lung disease (ILD) and the impact of comorbidity on costs of care.

INTRODUCTION: Evidence about the economic burden related to interstitial lung diseases (ILDs) and the cost-driving factors is sparse. In the knowledge that distinct comorbidities affect the clinical course of ILDs, our study investigates their impact on costs of care within first year after diagnosis. METHODS: Using claims data of individuals diagnosed with Idiopathic Interstitial Pneumonia (IIP) (n = 14 453) or sarcoidosis (n = 9106) between 2010 and 2013, we calculated total and ILD-associated mean annual per capita costs adjusted by age, sex and comorbidity burden via Generalized Linear Gamma models. Then, we assessed the cost impact of chronic obstructive pulmonary disease (COPD), diabetes, coronary artery disease, depression, gastro-esophageal reflux disease, pulmonary hypertension (PH), obstructive sleep apnoea syndrome (OSAS) and lung cancer using the model-based parameter estimates. RESULTS: Total mean annual per capita costs were €11 131 in the pooled cohort, €12 111 in IIP and €8793 in sarcoidosis, each with a 1/3 share of ILD-associated cost. Most comorbidities had a significant cost-driving effect, which was most pronounced for lung cancer in total (1.989 pooled, 2.491 sarcoidosis, 1.696 IIP) and for PH in ILD-associated costs (2.606 pooled, 2.347 IIP, 3.648 sarcoidosis). The lung-associated comorbidities COPD, PH, OSAS more strongly affected ILD-associated than total costs. CONCLUSION: Comorbidities increase the already substantial costs of care in ILDs. To support patient-centred ILD care, not only highly cost-driving conditions that are inherent with high mortality themselves require systematic management. Moreover, conditions that are more rather restricting the patient's activities of daily living should be addressed - despite a low-cost impact.

Health Plan Enrollment and Disenrollment of Individuals With and Without Established Chronic Disease in a U.S. Commercially Insured and Medicare Advantage Population.

BACKGROUND: Chronic disease is associated with increased health care resource utilization and costs. Effective development and implementation of health care management and clinical intervention programs require an understanding of health plan member enrollment and disenrollment behavior. OBJECTIVE: To examine the health plan enrollment and disenrollment behavior of commercially insured and Medicare Advantage members with established chronic disease compared with matched members without the disease of interest, using data from a large national health insurer in the United States. METHODS: This retrospective matched cohort study used administrative claims data from the HealthCore Integrated Research Database from January 1, 2006, to November 30, 2015, to identify adults with chronic disease (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], rheumatoid arthritis [RA], and breast cancer [BC]). Members with no established chronic disease (controls) were directly matched to members with established chronic disease (cases) on demographic characteristics. The earliest date on which members met the criteria for a given disease was defined as the index date. Controls had the same index date as the matched cases. All members had ≥ 12 months of continuous health plan enrollment before the index date. Outcomes included health plan member disenrollment and enrollment duration. Incidence rates per 1,000 member-years for member disenrollment were evaluated along with incidence rate ratios (relative risk) using a Poisson model. Time to disenrollment was analyzed by Cox proportional hazard models and Kaplan-Meier survival curves. Sensitivity analyses were conducted where death was included as a disenrollment event. RESULTS: 70,907 health plan members with BC (99.7% female, mean age 60.5 years); 28,883 members with COPD (52.3% female, mean age 66.7); 835,358 members with CVD (50.5% female, mean age 62.7 years); 210,936 members with T2DM (45.2% female, mean age 53.6 years); and 31,954 members with RA (72.0% female, mean age 55.5 years) were matched to controls and met the study criteria. The incidence rates of health plan disenrollment ranged from 155 to 192 members per 1,000 members per year. Compared with controls, members with chronic disease were 30%-40% less likely to disenroll from a health plan (P < 0.001 for all comparisons). Among those who disenrolled, enrollment duration ranged from 2.3 to 2.7 years among cases and 1.5 to 1.8 years among matched controls (P ≤ 0.001 for all comparisons). CONCLUSIONS: This real-world study demonstrated that members with chronic disease had a significantly lower rate of disenrollment and a longer duration of enrollment compared with matched controls and were continuously enrolled for almost a year longer than members without a diagnosed chronic disease. Understanding health plan enrollment and disenrollment behavior may provide a valuable context for determining the time frame for the effect of health care programs and initiatives. DISCLOSURES: Funding for this study was provided by HealthCore, a wholly owned subsidiary of Anthem. Chung, Deshpande, Zolotarjova, Quimbo, and Willey are employees of HealthCore. Kern and Cochetti are former employees of HealthCore. Quimbo, Cochetti, and Willey are shareholders of Anthem. HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work. The preliminary results of this study were presented at AMCP Nexus 2015; March 26-29, 2015; Orlando, FL, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Conference; May 20-24, 2017; Boston, MA.