Hospital Prices for Physician-Administered Drugs for Patients with Private Insurance.

BACKGROUND: Hospitals can leverage their position between the ultimate buyers and sellers of drugs to retain a substantial share of insurer pharmaceutical expenditures. METHODS: In this study, we used 2020-2021 national Blue Cross Blue Shield claims data regarding patients in the United States who had drug-infusion visits for oncologic conditions, inflammatory conditions, or blood-cell deficiency disorders. Markups of the reimbursement prices were measured in terms of amounts paid by Blue Cross Blue Shield plans to hospitals and physician practices relative to the amounts paid by these providers to drug manufacturers. Acquisition-price reductions in hospital payments to drug manufacturers were measured in terms of discounts under the federal 340B Drug Pricing Program. We estimated the percentage of Blue Cross Blue Shield drug spending that was received by drug manufacturers and the percentage retained by provider organizations. RESULTS: The study included 404,443 patients in the United States who had 4,727,189 drug-infusion visits. The median price markup (defined as the ratio of the reimbursement price to the acquisition price) for hospitals eligible for 340B discounts was 3.08 (interquartile range, 1.87 to 6.38). After adjustment for drug, patient, and geographic factors, price markups at hospitals eligible for 340B discounts were 6.59 times (95% confidence interval [CI], 6.02 to 7.16) as high as those in independent physician practices, and price markups at noneligible hospitals were 4.34 times (95% CI, 3.77 to 4.90) as high as those in physician practices. Hospitals eligible for 340B discounts retained 64.3% of insurer drug expenditures, whereas hospitals not eligible for 340B discounts retained 44.8% and independent physician practices retained 19.1%. CONCLUSIONS: This study showed that hospitals imposed large price markups and retained a substantial share of total insurer spending on physician-administered drugs for patients with private insurance. The effects were especially large for hospitals eligible for discounts under the federal 340B Drug Pricing Program on acquisition costs paid to manufacturers. (Funded by Arnold Ventures and the National Institute for Health Care Management.).

Greater cost without greater benefit: The need to refine transfer criteria for patients with severe acute pancreatitis.

BACKGROUND: Appropriate and timely care is essential in the management of severe acute pancreatitis (SAP). We hypothesized that transferred patients with SAP undergoing procedural intervention would have higher mortality compared to those managed directly at academic centers. METHODS: This was a retrospective analysis of Maryland's statewide claims database from 2009 to 2022 of adult patients admitted with a primary diagnosis of SAP (acute pancreatitis with organ failure). Patients were divided into three groups: those admitted directly from the emergency room to academic facilities (AD), non-academic facilities (NA), or transferred to academic facilities (TR). Procedural intervention included endoscopic, percutaneous image-guided, or surgical. The primary outcome was in-hospital mortality. Secondary outcomes were admission costs, length of stay (LOS), and intensive care unit (ICU) admission. RESULTS: There were 7,648 (48.9%) in the NA group, 6,682 (42.7%) in the AD group and 1,316 (8.4%) in the TR group. On regression analysis, odds of death were 0.57x lower in the NA group and 0.67x lower in the AD group compared to transfers (<0.001). Procedural intervention was not associated with increased mortality. Transferred patients had longer median LOS (11 vs NA = 5, AD = 6, p < 0.001), increased median cost of admission ($41k vs NA = $12k, AD = $17k, p < 0.001) and greater ICU admission (45.6% vs NA = 20.6%, AD = 23.9%, p < 0.001). CONCLUSION: Transferred patients have greater burden of illness and cost of care without evidence of improved outcomes in the management of SAP regardless of procedural intervention. Transfer criteria for patients with SAP must be further refined to reduce unnecessary transfers.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Medical Care and Long-Term Care Expenditures Attributable to Alzheimer's Disease Onset: Results from the LIFE Study.

BACKGROUND: Alzheimer's disease (AD) can increase both medical care and long-term care (LTC) costs, but the latter are frequently neglected in estimates of AD's economic burden. OBJECTIVE: To elucidate the economic burden of new AD cases in Japan by estimating patient-level medical care and LTC expenditures over 3 years using a longitudinal database. METHODS: The study was performed using monthly claims data from residents of 6 municipalities in Japan. We identified patients with new AD diagnoses between April 2015 and March 2016 with 3 years of follow-up data. Medical care and LTC expenditures were estimated from 1 year before onset until 3 years after onset. To quantify the additional AD-attributable expenditures, AD patients were matched with non-AD controls using propensity scores, and their differences in expenditures were calculated. RESULTS: After propensity score matching, the AD group and non-AD group each comprised 1748 individuals for analysis (AD group: mean age±standard deviation, 81.9±7.6 years; women, 66.0%). The total additional expenditures peaked at $1398 in the first month, followed by $1192 and $1031 in the second and third months, respectively. The additional LTC expenditures increased substantially 3 months after AD onset ($227), and gradually increased thereafter. These additional LTC expenditures eventually exceeded the additional medical care expenditures in the second year after AD onset. CONCLUSION: Although total AD-attributable expenditures peaked just after disease onset, the impact of LTC on these expenditures rose over time. Failure to include LTC expenditures would severely underestimate the economic burden of AD.

Budget Impact of Tyrosine Kinase Inhibitor Discontinuation in Chronic Myeloid Leukemia With Sustained Deep Molecular Response.

OBJECTIVES: Tyrosine kinase inhibitors (TKIs) account for the vast majority of healthcare expenditure on patients with chronic myeloid leukemia (CML), and it has been demonstrated that TKI discontinuation in patients in long-term deep molecular remission (DMR) is safe and improves quality of life. Our objective was to estimate the budget impact of TKI discontinuation in CML patients in long-term DMR from the perspective of the French healthcare system. METHODS: This analysis was conducted over a 5-year time horizon using a Markov model with cycles of 6 months. Transition probabilities were estimated through systematic reviews and meta-analyses. Costs were estimated from the French National Claims Database. Monte Carlo simulations were performed to take into account the uncertainty surrounding model parameters. Sensitivity analyses were carried out by varying the size of the target population and the cost of TKIs. RESULTS: Over a 5-year period and for a target population of 100 patients each year eligible and agreeing to stop TKI, the TKI discontinuation strategy would save €25.5 million (95% confidence interval -39.3 to 70.0). In this model, the probability that TKI discontinuation would be more expensive than TKI continuation was 12.0%. In sensitivity analyses, mean savings ranged from €14.9 million to €62.9 million. CONCLUSIONS: This study provides transparent, reproducible, and interpretable results for healthcare professionals and policy makers. Our results clearly show that innovative healthcare strategies can benefit both the healthcare system and patients. Savings from generalizing TKI discontinuation in CML patients in sustained DMR should yield health gains for other patients.

Incidence and Direct Medical Cost of Acute Stress Disorder and Post-traumatic Stress Disorder in Korea: Based on National Health Insurance Service Claims Data from 2011 to 2017.

BACKGROUND: We aimed to investigate the annual incidence of trauma and stress-related mental disorder including acute stress disorder (ASD) and post-traumatic stress disorder (PTSD) using the National Health Insurance Service Database. In addition, we estimated direct medical cost of ASD and PTSD in Korea. METHODS: To examine the incidence, we selected patients who had at least one medical claim containing a 10th revision of the International Statistical Classification of Diseases and Related Health Problems code for ASD (F43.0) and PTSD (F43.1) and had not been diagnosed in the previous 360 days, from 2010 to 2017. We estimated annual incidence and the number of newly diagnosed patients of ASD and PTSD. Annual prevalence and direct medical cost of ASD and PTSD were also estimated. RESULTS: The number of newly diagnosed cases of ASD and PTSD from 2011 to 2017 totaled 38,298 and 21,402, respectively. The mean annual incidence of ASD ranged from 8.4 to 13.7 per 100,000 population and that of PTSD ranged from 4.2 to 8.3 per 100,000 population, respectively. The incidence of ASD was found more in females and was highest among the 70-79 years of age group and the self-employed individuals group. The incidence of PTSD was also more common in the female group. However, the incidence of PTSD was highest in the 60-69 years of age group and in the medical aid beneficiaries group. The annual estimated medical cost per person of ASD ranged from 104 to 149 US dollars (USD). In addition, that of PTSD ranged from 310 to 426 USD. CONCLUSION: From 2011 to 2017, the annual incidence and direct medical cost of ASD and PTSD in Korea were increased. Proper information on ASD and PTSD will not only allows us to accumulate more knowledge about these disorders themselves but also lead to more appropriate therapeutic interventions by improving the ability to cope with these trauma related psychiatric sequelae.

Is Hospital Nurse Staffing Legislation in the Public's Interest?: An Observational Study in New York State.

BACKGROUND: The Safe Staffing for Quality Care Act under consideration in the New York (NY) state assembly would require hospitals to staff enough nurses to safely care for patients. The impact of regulated minimum patient-to-nurse staffing ratios in acute care hospitals in NY is unknown. OBJECTIVES: To examine variation in patient-to-nurse staffing in NY hospitals and its association with adverse outcomes (ie, mortality and avoidable costs). RESEARCH DESIGN: Cross-sectional data on nurse staffing in 116 acute care general hospitals in NY are linked with Medicare claims data. SUBJECTS: A total of 417,861 Medicare medical and surgical patients. MEASURES: Patient-to-nurse staffing is the primary predictor variable. Outcomes include in-hospital mortality, length of stay, 30-day readmission, and estimated costs using Medicare-specific cost-to-charge ratios. RESULTS: Hospital staffing ranged from 4.3 to 10.5 patients per nurse (P/N), and averaged 6.3 P/N. After adjusting for potential confounders each additional patient per nurse, for surgical and medical patients, respectively, was associated with higher odds of in-hospital mortality [odds ratio (OR)=1.13, P=0.0262; OR=1.13, P=0.0019], longer lengths of stay (incidence rate ratio=1.09, P=0.0008; incidence rate ratio=1.05, P=0.0023), and higher odds of 30-day readmission (OR=1.08, P=0.0002; OR=1.06, P=0.0003). Were hospitals staffed at the 4:1 P/N ratio proposed in the legislation, we conservatively estimated 4370 lives saved and $720 million saved over the 2-year study period in shorter lengths of stay and avoided readmissions. CONCLUSIONS: Patient-to-nurse staffing varies substantially across NY hospitals and higher ratios adversely affect patients. Our estimates of potential lives and costs saved substantially underestimate potential benefits of improved hospital nurse staffing.

Patient cost sharing during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment in ovarian cancer.

BACKGROUND: More patients with ovarian cancer are being treated with poly(adenosine diphosphate-ribose) polymerase inhibitors because regulatory agencies have granted these drugs new approvals for a variety of treatment indications. However, poly(adenosine diphosphate-ribose) polymerase inhibitors are expensive. When administered as a maintenance therapy, these drugs may be administered for months or years. How much of this cost patients experience as out-of-pocket spending is unknown. OBJECTIVE: This study aimed to estimate the out-of-pocket spending that patients experience during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment and to characterize which healthcare services account for that spending. STUDY DESIGN: A retrospective cohort study was performed with a sample of patients with ovarian cancer treated between 2014 and 2017 with olaparib, niraparib, or rucaparib. Patients were identified using MarketScan, a health insurance claims database. All insurance claims during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment were collected. The primary outcome variable was the patients' out-of-pocket spending (copayment, coinsurance, and deductibles) during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment for the medication itself. Other outcomes of interest included out-of-pocket spending for other healthcare services, the types and frequency of other healthcare services used, health plan spending, the estimated proportion of patients' household income used each month for healthcare, and patients' out-of-pocket spending immediately before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment. RESULTS: We identified 503 patients with ovarian cancer with a median age of 55 years (interquartile range, 50-62 years); 83% of those had out-of-pocket spendings during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment. The median treatment duration was 124 days (interquartile range, 66-240 days). The mean out-of-pocket spending for poly(adenosine diphosphate-ribose) polymerase inhibitors was $305 (standard deviation, $2275) per month. On average, this accounted for 44.8% (standard deviation, 34.8%) of the patients' overall monthly out-of-pocket spending. The mean out-of-pocket spending for other healthcare services was $165 (standard deviation, $769) per month. Health plans spent, on average, $12,661 (standard deviation, $15,668) per month for poly(adenosine diphosphate-ribose) polymerase inhibitors and $7108 (standard deviation, $15,254) per month for all other healthcare services. The cost sharing for office visits, laboratory tests, and imaging studies represented the majority of non-poly(adenosine diphosphate-ribose) polymerase inhibitor treatment out-of-pocket spending. The average amount patients paid for all healthcare services per month during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $470 (standard deviation, $2407), which was estimated to be 8.7% of the patients' monthly household income. The mean out-of-pocket spending in the 12 months before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $3110 (standard deviation, $6987). CONCLUSION: Patients can face high out-of-pocket costs for poly(adenosine diphosphate-ribose) polymerase inhibitors, although the sum of cost sharing for other healthcare services used during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment is often higher. The spending on healthcare costs consumes a large proportion of these patients' household income. Patients with ovarian cancer experience high out-of-pocket costs for healthcare, both before and during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment.

Economic impact of dry eye disease in Spain: A multicentre retrospective insurance claims database analysis.

PURPOSE: To analyse the occurrence and cost of dry eye disease in Spain in the recent years. METHODS: A cross-sectional analysis based on anonymised data from an insurance claims database that includes data from 1997 to 2015 from public and private hospitals and healthcare centres; 36,081 patients were eligible for the study after duplicate elimination. Five ICD9 codes associated with dry eye were used for patient selection, including vitamin A deficiency with xerophthalmic scars of cornea, xerophthalmia due to vitamin A deficiency, keratoconjunctivitis sicca not specified as Sjögren's, dry eye syndrome and keratoconjunctivitis sicca Sjögren's disease. RESULTS: Over 88% of the patients were female, and the mean age was 66 years. Patients with keratoconjunctivitis sicca Sjögren's disease represented more than 89% of all patients and had the highest percentage of women. Both the annual number of patients and the number of admissions have increased exponentially since 1997 raising from 1079 to 3097 and from 1344 to 5938, respectively. The in-hospital length of stay was 9.6 (standard deviation = 11.6) days where more than 65% of the admissions were due to emergencies. Total costs were found to increase from €4.9 to €30.3 million during the study period; in parallel, there was an increase in the mean annual cost per patient, which was on average €7379. CONCLUSION: Disease incidence is likely to increase due to the influence of modern-day workplace, and it is important to take into account the high economic burden and the large decrease in quality of life in regards to Spanish society and health policies.

Drivers of variation in 90-day episode payments after mechanical thrombectomy for acute ischemic stroke.

BACKGROUND: Although mechanical thrombectomy for acute ischemic stroke from a large vessel occlusion is now the standard of care, little is known about cost variations in stroke patients following thrombectomy and factors that influence these variations. METHODS: We evaluated claims data for 2016 to 2018 for thrombectomy-performing hospitals within Michigan through a registry that includes detailed episode payment information for both Medicare and privately insured patients. We aimed to analyze price-standardized and risk-adjusted 90-day episode payments in patients who underwent thrombectomy. Hospitals were grouped into three payment terciles for comparison. Statistical analysis was carried out using unpaired t-test, Chi-square, and ANOVA tests. RESULTS: 1076 thrombectomy cases treated at 16 centers were analyzed. The average 90-day episode payment by hospital ranged from $53 046 to $81,767, with a mean of $65 357. A $20 467 difference (35.1%) existed between the high and low payment hospital terciles (P<0.0001), highlighting a significant payment variation across hospital terciles. The primary drivers of payment variation were related to post-discharge care which accounted for 38% of the payment variation (P=0.0058, inter-tercile range $11,977-$19,703) and readmissions accounting for 26% (P=0.016, inter-tercile range $3,315-$7,992). This was followed by professional payments representing 20% of the variation (P<0.0001, inter-tercile range $7525-$9,922), while index hospitalization payment was responsible for only 16% of the 90-day episode payment variation (P=0.10, inter-tercile range $35,432-$41,099). CONCLUSIONS: There is a wide variation in 90-day episode payments for patients undergoing mechanical thrombectomy across centers. The main drivers of payment variation are related to differences in post-discharge care and readmissions.

Adverse Events and Bundled Costs after Cranial Neurosurgical Procedures: Validation of the LACE Index Across 40,431 Admissions and Development of the LACE-Cranial Index.

OBJECTIVE: Anticipating postdischarge complications after neurosurgery remains difficult. The LACE index, based on 4 hospitalization descriptors, stratifies patients by risk of 30-day postdischarge adverse events but has not been validated in a procedure-specific manner in neurosurgery. Our study sought to explore the usefulness of the LACE index in a population undergoing cranial neurosurgery and to develop an enhanced model, LACE-Cranial. METHODS: The OptumClinformatics Database was used to identify cranial neurosurgery admissions (2004-2017). Procedures were grouped as trauma/hematoma/intracranial pressure, open vascular, functional/pain, skull base, tumor, or endovascular. Adverse events were defined as postdischarge death/readmission. LACE-Cranial was developed using a logistic regression framework incorporating an expanded feature set in addition to the original LACE components. RESULTS: A total of 40,431 admissions were included. Predictions of 30-day readmissions was best for skull base (area under the curve [AUC], 0.636) and tumor (AUC, 0.63) admissions but was generally poor. Predictive ability of 30-day mortality was best for functional/pain admissions (AUC, 0.957) and poorest for trauma/hematoma/intracranial pressure admissions (AUC, 0.613). Across procedure types except for functional/pain, a high-risk LACE score was associated with higher postdischarge bundled payment costs. Incorporating features identified to contribute independent predictive value, the LACE-Cranial model achieved procedure-specific 30-day mortality AUCs ranging from 0.904 to 0.98. Prediction of 30-day and 90-day readmissions was also improved, with tumor and skull base cases achieving 90-day readmission AUCs of 0.718 and 0.717, respectively. CONCLUSIONS: Although the unmodified LACE index shows inconsistent classification performance, the enhanced LACE-Cranial model offers excellent prediction of short-term postdischarge mortality across procedure groups and significantly improved anticipation of short-term postdischarge readmissions.

Calculating physician supply using a service day method and the income percentiles method: a descriptive analysis.

BACKGROUND: It is important to have an accurate count of physicians and a measurable understanding of their service provision for physician resource planning. Our objective was to compare 2 methods (income percentiles [IP] and service day activities [SVD]) for calculating the supply of full-time (FT) and part-time (PT) primary care physicians (PCPs) as measures of both physician supply counts and level of provider continuity. METHODS: Using an observational study design, we compared 2 methods of calculating the supply of PT and FT PCPs for 2011-2015. For the IP approach, the Canadian Institute for Health Information's method was applied to Alberta Health billing data. The SVD method calculated annual service days for fee-for-service PCPs. A simple descriptive analysis was conducted of the supply of PT and FT PCPs. RESULTS: The 2 methods agreed on the FT versus PT status of 85.2% of PCPs in 2015 but disagreed on the status of 490 PCPs. A total of 239 PCPs were classified as working FT by the IP method but PT by the SVD method. Two hundred and fifty-one PCPs were classified as working PT according by the IP method but FT by the SVD method. The former group of 239 PCPs worked fewer days per week (3.22 v. 4.1) and fewer weekend days per year (8.6 v. 24.1), billed more per year ($300 327 v. $201 834) and saw more patients per day (26.8 v. 17.8) with less continuity of care (38.0% v. 72.0%) than the latter group of 251 PCPs. INTERPRETATION: The SVD method provides a valid alternative to calculating GP supply that distinguishes groups of physicians that the standard IP methodology does not. Those groups provide very different service; policy-makers may benefit from distinguishing them.

Predictors of Insurance Claim Rejection in Hand and Upper Extremity Surgery.

INTRODUCTION: Insurance claim rejections represent a challenge for healthcare providers because of the potential for lost revenue and administrative costs of reworking claims. METHODS: The billing records of five hand and upper extremity surgeons at a tertiary academic center were queried for all patient billing activity over a 1-year period yielding a total of 14,421 unique patient encounters. RESULTS: A total of 11,839 unique patient encounters were included, and the overall claim rejection rate was 19.3%. Claim rejection rate varied significantly by payer (P < 0.0001) and was lowest in private insurance (14.0%) and highest in Medicare (31.2%). The use of multiple Current Procedure Terminology codes for an encounter was independently associated with an increased risk of claim rejection for both office (25.6%, relative risk [RR] 1.27, 95% confidence interval [CI] 1.03 to 1.49, P = 0.0032) and surgical (25.6%, RR 1.67, 95% CI 1.28 to 2.18, P = 0.0002) settings. After multivariate regression adjustment, modifier 25 was associated with a decreased risk of claim rejection (23.3%, RR 0.72, 95% CI 0.61 to 0.85, P < 0.0001). DISCUSSION: Insurance claim rejection occurs frequently (19.3%) in hand/upper extremity surgery and varies by insurance type, with the highest rejection rate occurring in Medicare (31.2%). For a given encounter, the use of multiple Current Procedure Terminology codes and specific modifiers are predictive of rejection risk. LEVEL OF EVIDENCE: Level III, prognostic.

Buying Time: Comptroller Delays Medical Billing Tax Until October 2021.

Comptroller delays medical billing tax until October 2021, giving TMA a chance to work out a legislative fix.

Regional differences in healthcare costs at the end of life: an observational study using Swiss insurance claims data.

OBJECTIVES: We evaluated healthcare cost differences at the end of life (EOL) between language regions in Switzerland, accounting for a comprehensive set of variables, including treatment intensity. METHODS: We evaluated 9716 elderly who died in 2014 and were insured at Helsana Group, with data on final cause of death provided by the Swiss Federal Statistical Office. EOL healthcare costs and utilization, ≥ 1 ICU admission and 10 life-sustaining interventions (cardiac catheterization, cardiac assistance device implantation, pulmonary artery wedge monitoring, cardiopulmonary resuscitation, gastrostomy, blood transfusion, dialysis, mechanical ventilation, intravenous antibiotics, cancer chemotherapies) reimbursed by compulsory insurance were examined. RESULTS: Taking into consideration numerous variables, relative cost differences decreased from 1.27 (95% CI 1.19-1.34) to 1.06 (CI 1.02-1.11) between the French- and German-speaking regions, and from 1.12 (CI 1.03-1.22) to 1.08 (CI 1.02-1.14) between the Italian- and German-speaking regions, but standardized costs still differed. Contrary to individual factors, density of home-care nurses, treatment intensity, and length of inpatient stay explain a substantial part of these differences. CONCLUSIONS: Both supply factors and health-service provision at the EOL vary between Swiss language regions and explain a substantial proportion of cost differences.

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

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

Economic Burden of Treatment-Resistant Depression in Privately Insured U.S. Patients with Physical Conditions.

BACKGROUND: Little is known about the economic burden of treatment-resistant depression (TRD) in patients with physical conditions. OBJECTIVE: To assess health care resource utilization (HRU) and costs, work loss days, and related costs in patients with TRD and physical conditions versus patients with the same conditions and non-TRD major depressive disorder (MDD) or without MDD. METHODS: Adults aged < 65 years with MDD treated with antidepressants were identified in the OptumHealth Care Solutions database (July 2009-March 2017). Patients who received a diagnosis of MDD and initiated a third antidepressant regimen (index date) after 2 regimens of adequate dose and duration were defined as having TRD. Patients with non-TRD MDD and without MDD were assigned a random index date. Patients with < 6 months of continuous health plan eligibility pre- or post-index; a diagnosis of psychosis, schizophrenia, bipolar disorder/mania, dementia, and developmental disorders; and/or no baseline physical conditions (cardiovascular, metabolic, and respiratory disease or cancer) were excluded. Patients with TRD were matched 1:1 to each of the non-TRD MDD and non-MDD cohorts based on propensity scores. Per patient per year HRU, costs, and work loss outcomes were compared up to 24 months post-index date using negative binominal and ordinary least square regressions. RESULTS: A total of 2,317 patients with TRD (mean age, 47.6 years; 63.1%, female; mean follow-up, 19.7 months) had ≥ 1 co-occurring key physical condition (cardiovascular, 52.5%; metabolic, 48.2%; respiratory, 16.4%; and cancer, 9.5%). Relative to non-TRD MDD and non-MDD cohorts, respectively, patients with TRD had 46% and 235% more inpatient admissions, 28% and 128% more emergency department visits, and 53% and 155% more outpatient visits (all P < 0.05). Health care costs were $22,541 in the TRD cohort, $17,450 in the non-TRD MDD cohort, and $10,047 in the non-MDD cohort, yielding cost differences of $5,091 (vs. non-TRD MDD) and $12,494 (vs. non-MDD; all P < 0.01). In patients with work loss data available (n = 278/cohort), those with TRD had 2.0 and 2.9 times more work loss as well as $8,676 and $10,323 higher work loss costs relative to those with non-TRD MDD and without MDD, respectively (all P < 0.001). CONCLUSIONS: In patients with physical conditions, those with TRD had higher HRU and health care costs, work loss days, and associated costs compared with non-TRD MDD and non-MDD cohorts. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs (JSA), which was involved in all aspects of the research, including the design of the study; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Joshi and Daly are employed by JSA. Zhdanava, Pilon, Rossi, Morrison, and Lefebvre are employees of Analysis Group, which received funding from JSA for conducting this study and has received consulting fees from Novartis Pharmaceuticals and GSK, unrelated to this study. Kuvadia is employed by Integrated Resources, which has provided research services to JSA unrelated to this study; Joshi reports past employment by and stock ownership in Johnson & Johnson; Nelson reports advisory board, data and safety monitoring board, and consulting fees from Assurex, Eisai, FSV-7, JSA, Lundbeck, Otsuka, and Sunovion and royalties from UpToDate, unrelated to this study. This work was presented at AMCP Nexus 2019, held in National Harbor, MD, from October 29 to November 1, 2019.

Compensation claims after knee cartilage surgery is rare. A registry-based study from Scandinavia from 2010 to 2015.

BACKGROUND: Focal cartilage defects (FCDs) in the knee joint has a high prevalence. A broad range of treatment options exists for symptomatic patients. Knowledge of patient compensation claims following surgical treatment of FCDs is missing. The purpose of this study is to evaluate compensation claims filed to the Scandinavian registries for patient compensation following treatment of FCDs in the knee joint from 2010 to 2015 and identify possible areas of improvement. METHODS: A cross-sectional study design was used to obtain all complaints following surgical treatment of FCDs from the Scandinavian registries from 2010 to 2015. Data such as age, gender, type of treatment, type of complaint, reason of verdict and amount of compensation were collected and systematically analyzed. RESULTS: 103 patients filed a compensation claim. 43 had received debridement (41.7%), 54 microfracture (MF) (52.4%), 3 mosaicplasty (2.9%) and 3 autologous chondrocyte implantation (ACI) (2.9%). Of the 103 claims, 36 were granted (35%). 21 following debridement (58.3%), 13 after MF (36.1%), 1 following mosaicplasty (2.8%) and 1 after ACI (2.8%). The most common reason for complaint was infection (22.1%), of which 89% were granted. The average compensation was €24.457 (range €209 - €458.943). CONCLUSION: Compensation claims following surgical treatment of knee cartilage injuries in Scandinavia are rare. Establishing nationwide cartilage registries can add further knowledge on this troublesome disease.

Assessment of HF Outcomes Using a Claims-Based Frailty Index.

OBJECTIVES: This study used a claims-based frailty index to investigate outcomes of frail patients with heart failure (HF). BACKGROUND: Medicare value-based payment programs financially reward and penalize hospitals based on HF patients' outcomes. Although programs adjust risks for comorbidities, they do not adjust for frailty. Hospitals caring for high proportions of frail patients may be unfairly penalized. Understanding frail HF patients' outcomes may allow improved risk adjustment and more equitable assessment of health care systems. METHODS: Adapting a claims-based frailty index, the study assigned a frailty score to each adult in the National in-patient Sample (NIS) from 2012 through September 2015 with a primary diagnosis of HF and dichotomized frailty by using a cutoff value established in the general NIS population. Multivariate regression models were estimated, controlling for comorbidities and hospital characteristics, to investigate relationships between frailty and outcomes. RESULTS: Of 732,932 patients, 369,298 were frail. Frail patients were more likely than nonfrail patients to die during hospital stay (3.57% vs. 2.37%, respectively; adjusted odds ratio [aOR]: 1.67; 95% confidence interval [CI]: 1.61 to 1.72; p < 0.001); were less likely to be discharged to home (66.5% vs. 79.3%, respectively; aOR: 0.58; 95% CI: 0.57 to 0.58; p < 0.001); were hospitalized for more days (5.89 vs. 4.63 days, respectively; adjusted coefficient: 0.21 days; 95% CI: 0.21 to 0.22; p < 0.001); and incurred higher charges ($47,651 vs. $40,173, respectively; adjusted difference = $9,006; 95% CI: $8,596 to $9,416; p < 0.001). CONCLUSIONS: Frail patients with HF had significantly poorer outcomes than nonfrail patients after accounting for comorbidities. Clinicians should screen for frailty to identify high-risk patients who could benefit from targeted intervention. Policymakers should perform risk adjustments for frailty for more equitable quality measurement and financial incentive allocation.

Comparative Clinical and Economic Outcomes Associated with Warfarin Versus Apixaban in the Treatment of Patients with Venous Thromboembolism in a Large U.S. Commercial Claims Database.

BACKGROUND: Venous thromboembolism (VTE), constituting deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common cause of vascular-related morbidity and mortality, resulting in a significant clinical and economic burden in the United States each year. Clinical guidelines recommend that patients with DVT and PE without cancer should be initiated on anticoagulation therapy with a direct oral anticoagulant over a vitamin K antagonist. Yet there is limited real-world evidence comparing the economic burden of warfarin and apixaban in treating VTE patients in a large commercially insured population. OBJECTIVE: To compare safety and effectiveness of warfarin and apixaban and evaluate associated economic burden in treating VTE patients in a large U.S. commercial health care claims database. METHODS: The PharMetrics Plus database was used to identify oral anticoagulant (OAC)-naive patients aged ≥ 18 years who initiated apixaban or warfarin within 30 days of a qualifying VTE encounter and had continuous health plan enrollment with medical and pharmacy benefits for 6 months before treatment initiation. Apixaban initiators and warfarin initiators were matched using the propensity score matching (PSM) technique. Cox proportional hazard models were used to assess and compare the risk of major bleeding (MB), clinically relevant nonmajor (CRNM) bleeding, and recurrent VTE. Generalized linear models were used to assess and compare the all-cause health care costs. A 2-part model with bootstrapping was used to evaluate MB- and recurrent VTE-related medical costs. RESULTS: Among 25,193 prematched patients, 13,421 (53.3%) were prescribed warfarin and 11,772 (46.7%) were prescribed apixaban. After 1:1 PSM, 8,858 matched warfarin-apixaban pairs were selected with a mean follow-up of 109 days and 103 days, respectively. Warfarin was associated with a significantly higher risk of MB (HR = 1.52, 95% CI = 1.14-2.04), CRNM bleeding (HR = 1.27, 95% CI = 1017.15-1.40), and recurrent VTE (HR = 1.50, 95% CI = 1.24-1.82) compared with apixaban. Warfarin patients had significantly higher all-cause medical costs per patient per month (PPPM; $2,333 vs. $1,992; P = 0.001), MB-related costs PPPM ($112 vs. $65; P = 0.020), and recurrent VTE-related costs PPPM ($287 vs. $206; P = 0.014) compared with apixaban patients. Warfarin patients had similar all-cause total health care costs PPPM ($2,630 vs. $2,420; P = 0.051) compared with apixaban patients. CONCLUSIONS: Warfarin use was associated with a higher risk of MB, CRNM bleeding, and recurrent VTE compared with apixaban. Warfarin use was also associated with higher all-cause medical costs, MB-related medical costs, and recurrent VTE-related costs PPPM compared with apixaban. DISCLOSURES: This study was funded by Bristol Myers Squibb and Pfizer, which were also involved in the study design, as well as writing and revising of the manuscript. Guo, Rajpura, Okano, and Rosenblatt are employees of Bristol Myers Squibb. Hlavacek, Mardekian, and Russ are employees of Pfizer. Keshishian, Sah, Delinger, and Mu are employees of SIMR, LLC, which received funding from the study sponsors to conduct this study.