Health Care Resource Utilization and Costs for Metastatic Breast Cancer Patients Newly Treated with Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Agents.

INTRODUCTION: HER2-positive metastatic breast cancer (mBC) is an incurable disease associated with years of chronic therapy and excess cost. HER2-targeted therapies have shown survival benefit for early-stage and mBC; however, the economic impact of these therapies has not been fully assessed. We evaluated health care resource use (HCRU) and costs of mBC patients treated with HER2-targeted therapy. METHODS: This was a retrospective cohort study using the IQVIA Real-World Data Adjudicated Claims Database (July 1, 2014 to July 31, 2019). Female patients aged ≥18 years with mBC who initiated HER2-targeted therapy in the prior year were identified. The index date was the initiation date of the HER2-targeted agent, after which patients were required to have ≥12 months of follow-up. Annual and cumulative all-cause and BC-related costs (2019 USD) and annual BC-related HCRU were computed in years 1, 2, and 3 following the index date. RESULTS: Following the initiation of HER2-targeted therapy, the mean annual total all-cause costs per patient in years 1 (n = 423), 2 (n = 357), and 3 (n = 166) were $320,892 (SD: $224,343), $235,159 (SD: $185,287), and $226,254 (SD: $197,901), respectively. The mean annual total BC-related costs were $240,048 (SD: $151,230), $175,631 (SD: $148,058), and $165,506 (SD: $159,374) in years 1, 2, and 3, respectively. A major portion of BC-related costs were costs associated with HER2-targeted treatment. The 3-year cumulative all-cause and BC-related total costs were $769,573 (SD: $456,920) and $624,455 (SD: $401,319), respectively. CONCLUSION: Treatment of HER2-positive mBC is a substantial economic burden. A potential approach to minimizing cost and HCRU is to prevent recurrence.

Correction to: Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

Changes within text are indicated in bold.

Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

BACKGROUND: Given the improved convenience of oral prostacyclins, there is a shift toward their use in treating pulmonary arterial hypertension (PAH). OBJECTIVES: Our objective was to compare patient characteristics, medication adherence, healthcare resource use (HCRU), and costs among patients receiving oral treprostinil or selexipag. METHODS: We used Truven Health MarketScan Commercial and Medicare databases to identify patients with PAH with a diagnosis code for pulmonary hypertension (PH) plus a prescription for oral treprostinil or selexipag from July 2013 to September 2017. Medication adherence, persistence, and all-cause and PAH-related HCRU and costs were compared between cohorts during the 6-month follow-up. Adjusted healthcare costs were obtained using recycled predictions and bootstrapped samples. RESULTS: A total of 256 (130 oral treprostinil, 126 selexipag) patients fulfilled the study criteria. The oral treprostinil cohort was more likely to be male, to have previously used parenteral prostacyclins, and to have higher outpatient costs at baseline than the selexipag cohort. During follow-up, both cohorts had similar proportions of patients who were adherent to and persistent with their respective therapies. All-cause and PAH-related medical utilization was generally similar between cohorts. The oral treprostinil cohort had 66.9% lower total PAH-related healthcare costs (mean difference - $75,183; 95% confidence interval [CI] - 102,584 to - 49,771) and 70.6% lower PAH-related pharmacy costs (mean difference - $76,439; 95% CI - 104,512 to - 51,458) than the selexipag cohort, with similar differences in all-cause healthcare and pharmacy costs. CONCLUSIONS: Lower all-cause and PAH-related total healthcare and pharmacy costs were observed in patients receiving oral treprostinil compared with those receiving selexipag. It will be important to study longer-term costs and clinical outcomes.

Identifying Patients with Pulmonary Arterial Hypertension Using Administrative Claims Algorithms.

Retrospective administrative claims database studies provide real-world evidence about treatment patterns, healthcare resource use, and costs for patients and are increasingly used to inform policy-making, drug formulary, and regulatory decisions. However, there is no standard methodology to identify patients with pulmonary arterial hypertension (PAH) from administrative claims data. Given the number of approved drugs now available for patients with PAH, the cost of PAH treatments, and the significant healthcare resource use associated with the care of patients with PAH, there is a considerable need to develop an evidence-based and systematic approach to accurately identify these patients in claims databases. A panel of pulmonary hypertension clinical experts and researchers experienced in retrospective claims database studies convened to review relevant literature and recommend best practices for developing algorithms to identify patients with PAH in administrative claims databases specific to a particular research hypothesis.

Cost differential of immuno-oncology therapy delivered at community versus hospital clinics.

OBJECTIVES: The site of cancer care delivery has been shown to be associated with the total cost of care. The magnitude of this effect in patients receiving expensive immuno-oncology (I-O) therapies has not been evaluated. We evaluated cost differentials between community-based and hospital-based outpatient clinics among patients receiving I-O therapies. STUDY DESIGN: This was a retrospective analysis utilizing Truven MarketScan Commercial and Supplemental Medicare claims databases. METHODS: Cost data for 3135 patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, bladder cancer, renal cell carcinoma, or melanoma who received pembrolizumab, nivolumab, and/or ipilimumab between January 1, 2015, and February 14, 2017, were analyzed as cost per patient per month (PPPM). Patients treated within a community setting were matched 2:1 with those treated at a hospital clinic based on cancer type, specific I-O therapy, receipt of radiation therapy, evidence of metastatic disease, gender, age, and evidence of surgery in the preindex period. RESULTS: Mean (SD) total (medical plus pharmacy) PPPM cost was significantly lower for patients treated in a community- versus hospital-based clinic ($22,685 [$16,205] vs $26,343 [$22,832]; P <.001). Lower PPPM medical cost in the community versus hospital setting ($21,382 [$15,667] vs $24,831 [$22,102]; P <.001) was the major driver of this cost differential. Lower total cost was seen regardless of cancer type or I-O therapy administered. CONCLUSIONS: Treatment with I-O therapies in community practice is associated with a lower total cost of care compared with that in hospital-based outpatient practices. With the expanding indications of these agents, future research is needed.

Cost Differences Associated With Oncology Care Delivered in a Community Setting Versus a Hospital Setting: A Matched-Claims Analysis of Patients With Breast, Colorectal, and Lung Cancers.

PURPOSE:: Access to high-quality cancer care remains a challenge for many patients. One such barrier is the increasing cost of treatment. With recent shifts in cancer care delivery from community-based to hospital-based clinics, we examined whether this shift could result in increased costs for patients with three common tumor types. METHODS:: Cost data for 6,675 patients with breast, lung, and colorectal cancer were extracted from the IMS LifeLink database and analyzed as cost per patient per month (PPPM). Patients treated within a community setting were matched (2 to 1) with those treated at a hospital clinic on the basis of cancer type, chemotherapy regimen, receipt of radiation therapy, presence of metastatic disease, sex, prior surgery, and geographic region. Approximately 84% of patients were younger than 65 years of age. RESULTS:: Mean total PPPM cost was significantly lower for patients treated in a community- versus hospital-based clinic ($12,548 [standard deviation {SD}, $10,507] v $20,060 [SD, $16,555]; P < .001). The PPPM chemotherapy cost was also significantly lower in the community setting ($4,933 [SD, $4,983] v $8,443 [SD, $10,391]; P < .001). The lower cost observed in community practice was irrespective of chemotherapy regimen and tumor type. CONCLUSION:: We observed significantly increased costs of care for our patient population treated at hospital-based clinics versus those treated at community-based clinics, largely driven by the increased cost of chemotherapy and provider visits in hospital-based clinics. If the site of cancer care delivery continues to shift toward hospital-based clinics, the increased health care spending for payers and patients should be better elucidated and addressed.

Retrospective assessment of patient characteristics and healthcare costs prior to a diagnosis of Alzheimer's disease in an administrative claims database.

BACKGROUND: The objective of this study was to examine patient characteristics and health care resource utilization (HCRU) in the 36 months prior to a confirmatory diagnosis of Alzheimer's disease (AD) compared to a matched cohort without dementia during the same time interval. METHODS: Patients newly diagnosed with AD (with ≥2 claims) were identified between January 1, 2013 to September 31, 2015, and the date of the second claim for AD was defined as the index date. Patients were enrolled for at least 36 months prior to index date. The AD cohort was matched to a cohort with no AD or dementia codes (1:3) on age, gender, race/ethnicity, and enrollment duration prior to the index date. Descriptive analyses were used to summarize patient characteristics, HCRU, and healthcare costs prior to the confirmatory AD diagnosis. The classification and regression tree analysis and logistic regression were used to identify factors associated with the AD diagnosis. RESULTS: The AD cohort (N = 16,494) had significantly higher comorbidity indices and greater odds of comorbid mental and behavioral diagnoses, including mild cognitive impairment, mood and anxiety disorders, behavioral disturbances, and cerebrovascular disease, heart disease, urinary tract infections, and pneumonia than the matched non-AD or dementia cohort (N = 49,482). During the six-month period before the confirmatory AD diagnosis, AD medication use and diagnosis of mild cognitive impairment, Parkinson's disease, or mood disorder were the strongest predictors of a subsequent confirmatory diagnosis of AD. Greater HCRU and healthcare costs were observed for the AD cohort primarily during the six-month period before the confirmatory AD diagnosis. CONCLUSION: The results of this study demonstrated a higher comorbidity burden and higher costs for patients prior to a diagnosis of AD in comparison to the matched cohort. Several comorbidities were associated with a subsequent diagnosis of AD.

Patient and Provider Characteristics Associated With Optimal Post-Fracture Osteoporosis Management.

Despite an estimated 2 million osteoporosis (OP)-related fractures annually, quality of care for post-fracture OP management remains low. This study aimed to identify patient and provider characteristics associated with achieving or not achieving optimal post-fracture OP management, as defined by the current HEDIS quality measure. The study included women 67 to 85 years of age, with ≥1 fracture, and continuous enrollment in a Humana insurance plan. The study identified a higher percentage of black women in the not achieved group (6.2% vs 5.4%; P < .0001) and Hispanic women in the achieved group (3.0% vs 1.3%; P < .0001). The not achieved group largely included patients residing in the South and urban and suburban areas. The majority of providers were primary care or OP-related specialty, and 66% did not achieve the 4-star OP rating. The study findings can guide development of predictive models to identify at-risk women to improve post-fracture OP management.

A Historical Retrospective Analysis of the Impact of Diabetes Quality Measure Attainment on Outcomes in Medicare Advantage Members.

The objective of this study was to assess achievement of 4 diabetes mellitus (DM)-related quality measures (QMs) and examine the relationship between QM attainment, concurrent health care costs, and DM complications over 1 year by conducting a retrospective analysis of claims data for Medicare Advantage Prescription Drug plan members with DM. Claims and member-level quality data were used to assess QM achievement, concurrent health care costs, and presence of new or worsening DM complications during the QM year. Multivariable regression models were used to examine the relationship between QM achievement and outcome measures controlling for potentially confounding baseline characteristics. QM attainment rates ranged from 54.2% for DM Treatment measure to 83.4% for Cholesterol Screening measure. Odds of new or worsening complications were greater for members who did not meet the Blood Sugar Controlled performance goal (odds ratio [OR]: 1.12, P < 0.001), DM Treatment goal (OR: 1.40, P < 0.001), or Cholesterol Screening goal (OR: 1.32, P < 0.001). Failure to attain the DM Medication Adherence goal was associated with lower odds of new or worsening complications (OR: 0.94, P < 0.001). In the regression models, all-cause health care costs were greater for members who achieved the Blood Sugar Controlled quality goal (P < 0.001), but lower for members who attained DM Treatment (P < 0.001) and low-density lipoprotein Cholesterol Screening goals (P < 0.001). There was no statistically significant relationship between attaining the DM Medication Adherence measure and all-cause costs. Achievement rates for individual QMs varied across the study population and relationships between QM attainment, health care costs, and DM complications during the QM measurement year were mixed.

Predictors of Change in Adherence Status from 1 Year to the Next Among Patients with Type 2 Diabetes Mellitus on Oral Antidiabetes Drugs.

BACKGROUND: Diabetes is a leading cause of morbidity, mortality, and medical resource utilization in the United States and worldwide. Treatment is aimed at keeping blood glucose levels close to normal and preventing or delaying medical complications. It has been estimated that only 50% of patients with diabetes in the United States achieve glycosylated hemoglobin A1c level < 7%. Nonadherence to antidiabetic medications has been identified as a major factor related to poor glycemic control. OBJECTIVES: To (a) assess adult patients with type 2 diabetes mellitus (T2DM) whose adherence status to oral antidiabetic drugs (OADs) changed from 1 year to the next and (b) identify predictors of change in adherence status. METHODS: This retrospective study of the Humana Medicare Advantage Database included patients with T2DM and continuous enrollment between 2010 and 2012. Proportion of days covered (PDC) by OADs was calculated for each of the 3 study years (2010, 2011, 2012). Patients were classified as adherent (PDC ≥ 80%) or nonadherent (PDC < 80%) during each year. Patient characteristics from the baseline period (2010) were used as covariates, and adherence status changes from baseline to follow-up year (2011) were used as response variables. Data from the subsequent study periods (2011 as baseline, 2012 as follow-up) were used to validate the model (final model). RESULTS: A total of 238,402 patients met inclusion criteria. Among them, 144,216 (60.5%) were adherent, and 94,186 (39.5%) were nonadherent during the baseline period. Change in adherence status from baseline to follow-up year was observed in 31,320 (21.7%) patients that were adherent and 39,284 (41.7%) patients that were nonadherent during the baseline year. The final model for baseline adherent patients had a receiver-operating characteristic (ROC) index of 73% and a misclassification rate of 39%. The predictors of highest importance were identified as total number of prescriptions filled with 90-day supply, diabetes-related pill burden, longest gap in OADs, total number of antidiabetic classes filled, and copay for the last OAD filled. The final model had a sensitivity value of 76.4%. The final model for baseline nonadherent patients had a ROC index of 68%, a misclassification rate of 36.4%, and sensitivity value of 52.9%. The predictors of highest importance were diabetes-related pill burden, longest gap in OADs, month-wise patient oscillation from adherent to nonadherent during baseline year, total number of prescriptions filled with a 90-day supply, and total pill burden during the baseline year. CONCLUSIONS: One third of the T2DM patients changed adherence status from 1 year to the next, and factors associated with adherence status changes were identified. Predictive models such as those used in this study can serve as useful and cost-effective tools for payers, helping to identify members that should be targeted for adherence enhancement programs and, ultimately, to improve patients' long-term outcomes. DISCLOSURES: Funding for this research was provided by Eli Lilly and Company. Comprehensive Health Insights, owned by Humana, completed this study. Peng, Fu, Ascher-Svanum, Ali, and Rodriguez are employees of Eli Lilly and Company. Saundankar and Louder are employed by Comprehensive Health Insights, and Slabaugh and Young are employed by Humana. Study concept and design were contributed by Peng, Ascher-Svanum, and Young. Saundankar and Louder took the lead in data collection, while Saundankar, Peng, Fu, and Louder interpreted the data. The manuscript was written by Saundankar, Peng, Fu, and Louder and revised by Saundankar, Rodriguez, Ali, and Louder.

Early treatment revisions by addition or switch for type 2 diabetes: impact on glycemic control, diabetic complications, and healthcare costs.

BACKGROUND: The study examined the prevalence of early treatment revisions after glycosylated hemoglobin (HbA1c) ≥9.0% (75 mmol/mol) and estimated the impact of early treatment revisions on glycemic control, diabetic complications, and costs. RESEARCH DESIGN AND METHODS: A retrospective cohort study of administrative claims data of plan members with type 2 diabetes and HbA1c ≥9.0% (75 mmol/mol) was completed. Treatment revision was identified as treatment addition or switch. Glycemic control was measured as HbA1c during 6-12 months following the first qualifying HbA1c ≥9.0% (75 mmol/mol) laboratory result. Complications severity (via Diabetes Complication Severity Index (DCSI)) and costs were measured after 12, 24, and 36 months. Unadjusted comparisons and multivariable models were used to examine the relationship between early treatment revision (within 90 days of HbA1c) and outcomes after controlling for potentially confounding factors measured during a 12-month baseline period. RESULTS: 8463 participants were included with a mean baseline HbA1c of 10.2% (75 mmol/mol). Early treatment revision was associated with greater reduction in HbA1c at 6-12 months (-2.10% vs -1.87%; p<0.001). No significant relationship was observed between early treatment revision and DCSI at 12, 24, or 36 months (p=0.931, p=0.332, and p=0.418). Total costs, medical costs, and pharmacy costs at 12, 24, or 36 months were greater for the early treatment revision group compared with the delayed treatment revision group (all p<0.05). CONCLUSIONS: The findings suggest that in patients with type 2 diabetes mellitus, treatment revision within 90 days of finding an HbA1c ≥9.0% is associated with a greater level of near-term glycemic control and higher cost. The impact on end points such as diabetic complications may not be realized over relatively short time frames.

Type 2 Diabetes Mellitus Patients' Healthcare Costs Related to Inpatient Hospitalizations: A Retrospective Administrative Claims Database Study.

INTRODUCTION: Diabetes-related healthcare costs are increasing in the United States, with inpatient hospitalization the largest component of medical expenditures. The aims of this study were to characterize hospitalized type 2 diabetes mellitus (T2DM) patients, understand the relationship between hospitalization and healthcare costs, and explore treatment modification after inpatient hospitalization. METHODS: A retrospective cohort analysis of Humana Medicare Advantage and commercial members with T2DM was conducted. T2DM members were identified and assigned to three groups: (1) inpatient hospitalization (IPH) without a 30-day readmit (IPH group); (2) IPH with a 30-day readmission (IPH readmission group); and, (3) matched non-IPH group. Demographics, clinical characteristics, comorbidities and healthcare costs were measured based on enrollment data and claims. Descriptive statistics were used and the relationship between IPH and costs was assessed using generalized linear models. RESULTS: A total of 15,555 IPH patients, 1757 IPH readmission patients, and 17,312 matched non-IPH patients were included in the study. The IPH readmission group had the highest adjusted mean all-cause total costs ($76,806), followed by the IPH group ($42,011), and the non-IPH group ($9624). A similar trend was observed for adjusted all-cause mean medical and pharmacy costs. DM-related total healthcare costs were highest for the IPH readmission group ($13,714), followed by the IPH group ($7477), and non-IPH group ($1620). While overall therapy modification (discontinuation, addition, switch) was low, T2DM patients with an IPH (with or without a readmission) had greater rates of therapy modification relative to the non-IPH patients. CONCLUSION: Adjusted all-cause and DM-related total costs were greatest for IPH readmission patients. Rates of treatment modification within 10 days of discharge after IPH were generally low. Identifying T2DM patients at high risk of readmission and employing methods to decrease that risk during the index hospitalization could have a significant impact on health system costs. FUNDING: Novo Nordisk.