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.).

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.

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.

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.

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.

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.

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.

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.

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.

Economic and Clinical Burden of Acute Myeloid Leukemia Episodes of Care in the United States: A Retrospective Analysis of a Commercial Payer Database.

BACKGROUND: In the United States, the incidence of acute myeloid leukemia (AML) has steadily increased over the last decade; in 2019, it was estimated that AML would affect 21,450 new patients and lead to 10,920 deaths. Detailed real-world cost estimates and comparisons of key AML treatment episodes, such as in high-intensity chemotherapy (HIC), low-intensity chemotherapy (LIC), hematopoietic stem cell transplantation (HSCT), and relapsed/refractory (R/R), are scarce in the commercially insured U.S. OBJECTIVE: To examine health resource utilization (HRU), clinical burden, and direct health care costs across various AML treatment episodes in a large sample of commercially insured U.S. METHODS: A retrospective cohort analysis was conducted. Patients with newly diagnosed AML were followed to identify the key active treatment episodes across the course of their disease. Data were obtained from 2 sources: IQVIA's Real-World Data (RWD) Adjudicated Claims Database - U.S. (formerly known as PharMetrics Plus), which comprises adjudicated claims for more than 150 million unique enrollees across the United States, and IQVIA Charge Detail Master Hospital Database, which has detailed data regarding services received in an inpatient setting. Calculation of all-cause HRU was based on physician office visits, nonphysician office visits, emergency department visits, inpatient visits, and outpatient pharmacy utilization. Calculation of all-cause health care costs was based on total allowed costs and reported by the following cost components: physician office visits, nonphysician office visits, emergency department visits, inpatient visits, and outpatient pharmacy utilization. Symptom and toxicity events were estimated via proxies such as diagnosis codes, procedures, and treatments administered. RESULTS: The final study sample consisted of 1,542 HIC-induction (HIC-I), 591 HIC-consolidation (HIC-C), 628 LIC, 1,000 patients with HSCT, and 707 patients with R/R AML. Total mean episode costs were highest in R/R episodes ($439,104), followed by HSCT ($329,621), HIC-I ($198,657), HIC-C ($73,428), and LIC ($53,081) episodes. Across all treatment episodes, hospitalization was the largest contributor to cost with mean hospitalization costs ranging from $308,978 in the R/R setting to $49,580 for patients receiving LIC; of these, costs related to intensive care unit admission were a noteworthy contributor. In patients with R/R AML and HSCT, expenditures related to pharmacy utilization averaged $24,640 and $12,203, respectively, and expenditures related to physician office visits averaged $10,926 and $6,090, respectively; these expenditures were much lower across other episodes. Across all categories of symptom and toxicity events, cardiovascular events was the only category of event that was a significant predictor of higher cost across all episodes. Symptom and toxicity events commonly associated with AML were associated with significantly increased costs, especially in R/R episodes. CONCLUSIONS: This resource utilization and direct health care cost analysis highlights the substantial economic burden associated with key AML treatment episodes in the United States, specifically during HIC-I, HSCT, and R/R episodes. DISCLOSURES: This study was funded by Astellas Pharma. Astellas employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit the manuscript for publication. Pandya and Wilson are employees of Astellas Pharma U.S. Walsh was an employee of Astellas Pharma U.S. while the study was conducted. Chen, McGuiness, and Wade are employees of IQVIA, which received funding from Astellas Pharma U.S. Madeiros was employed at Stanford University while this study was conducted and received a consulting fee from Astellas for work on this study. Data discussed in this study were previously presented at the 59th Annual American Society for Hematology Meeting & Exposition, 2017; December 9-12, 2017; Atlanta, GA.

Health Care Resource Utilization and Costs Associated with Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis.

BACKGROUND: Corticosteroids are used in the management of castration-resistant prostate cancer (CRPC) to reduce tumor-related symptoms because of CRPC therapies. Since corticosteroids have been associated with a range of toxicities, their use may increase the economic burden sustained by patients with CRPC. However, the economic impact of using corticosteroids in patients with CRPC has not been well characterized. OBJECTIVE: To assess the effect of previous corticosteroid use on health care resource utilization (HRU) and health care costs among men with CRPC. METHODS: Using administrative claims data (2007-2016), adult chemotherapy-naive patients who initiated CRPC treatment following surgical or medical castration were identified. Based on the cumulative corticosteroid dose during the 12 months before CRPC treatment initiation, patients were grouped into 4 cohorts: no corticosteroid (0 gm), low corticosteroid (< 0.5 gm), medium corticosteroid (0.5-2.0 gm), and high corticosteroid (> 2.0 gm). All-cause HRU and costs (2017 U.S. dollars) were compared between cohorts during the 1-year study period following CRPC treatment initiation using the no corticosteroid cohort as reference. Multivariable regression models were used to adjust for baseline covariates, including age, region, index year, Charlson Comorbidity Index score, presence of bone metastases, baseline all-cause HRU, and corticosteroid-related clinical events during baseline. RESULTS: 9,425 patients were included (no corticosteroid = 6,765, low corticosteroid = 1,660, medium corticosteroid = 655, and high corticosteroid = 345). On average, patients in the no corticosteroid cohort were older and had a lower baseline HRU and comorbidity burden than patients in the other 3 cohorts. During the study period, patients with corticosteroid exposure (across all corticosteroid cohorts) had significantly more inpatient admissions (high corticosteroid vs. no corticosteroid adjusted incidence rate ratio [IRR] = 1.56; P < 0.001), emergency department visits (high corticosteroid vs. no corticosteroid adjusted IRR = 1.30; P = 0.001), and outpatient visits (high corticosteroid vs. no corticosteroid adjusted IRR = 1.11; P < 0.001). In addition, compared with the no corticosteroid cohort, patients with corticosteroid exposure had significantly higher monthly total costs (high corticosteroid vs. no corticosteroid adjusted difference = $2,600; P < 0.001), including medical service costs (high corticosteroid vs. no corticosteroid adjusted difference = $1,564; P < 0.001) and pharmacy costs (high corticosteroid vs. no corticosteroid adjusted difference = $825; P < 0.001). CONCLUSIONS: Cumulative corticosteroid exposure before CRPC treatment initiation was associated with significantly higher HRU and costs. This increase in economic burden was more prominent among patients with annual cumulative corticosteroid doses of more than 2.0 gm. These results suggest that previous corticosteroid use may result in a higher economic burden among patients with CRPC. DISCLOSURES: This study was funded by Astellas Pharma (Northbrook, IL) and Medivation, a Pfizer Company (San Francisco, CA), the codevelopers of enzalutamide. The study sponsor was involved in the study design, data interpretation, and review. All authors contributed to the development of the manuscript and maintained control over the final content. Schultz and Wilson are employed by Astellas Pharma. Schultz owns stock in Gilead Sciences and Shire. Song and Yang are employed by Analysis Group, which received consultancy fees from Astellas Pharma. Ramaswamy is employed by Pfizer, and Lowentritt is employed by Chesapeake Urology and has served as a speaker and consultant for Astellas Pharma, Pfizer, Bayer, Dendreon, and Janssen. A synopsis of the current research was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019, which took place in San Diego, CA, on March 25-28, 2019.

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.

Perianal fistulas in adult patients with Crohn's disease in Germany - a retrospective cross-sectional analysis of claims data from German sickness funds.

INTRODUCTION: Perianal fistulas (PF) are presumably a frequent extraintestinal manifestation of Crohn's disease (CD), causing significant functional impairment. This study aims to gain representative data on the prevalence, characteristics, and treatment of CD patients suffering from PF in Germany. MATERIALS AND METHODS: A retrospective cross-sectional analysis of claims data from several German company health insurance funds included adult patients with CD and PF in 2015. The dataset comprised in- and outpatient services with diagnoses, drug prescriptions, and other patient data. It is representative for age, gender, and region and allows extrapolation to the total German statutory health insurance (SHI) population. A systematic literature review was conducted to discuss these results in the international context. RESULTS: A CD prevalence of 299 per 100 000 and a PF prevalence in CD patients of 3.4 % was observed in this cross-sectional study. PF are most prevalent in young age groups (< 24 to 39). One-third of patients with PF received biologics and surgery. Surgical procedures were performed in 31.3 % of PF patients in the inpatient setting and in 4.4 % of PF patients in the outpatient setting. All complicated perianal fistula patients received at least 1 inpatient surgery and 44.8 % received biologic therapy. DISCUSSION: This claims data analysis in German patients estimates a CD prevalence in the SHI population that corresponds well to previously reported data. The prevalence rate for PF in CD patients is comparable with a previous cross-sectional German claims data analysis but is markedly lower than cumulative risks reported in longitudinal cohort studies. PF patients are young and treatment intensive with one-third requiring biologic treatment or inpatient surgery.

Reoperations in intramedullary fixation of pertrochanteric hip fractures.

Objective: This study evaluated the frequency of reoperation within 1 year of initial intramedullary fixation for patients with pertrochanteric hip fracture and compared 1-year healthcare resource utilization and cost burden for patients with and without reoperation. Methods: This is a retrospective evaluation of medical claims from the US Centers for Medicare and Medicaid Standard Analytic File. Patients aged ≥65 years who underwent fixation with an intramedullary implant for a pertrochanteric fracture between 2013 and 2015 were included. Healthcare resources that were evaluated included skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), readmissions, and outpatient hospital visits. All-cause payments for these services comprised overall cost burden. Generalized Linear Models were used to evaluate healthcare resources and cost burden over 1-year post-surgery and to adjust for confounding between patients with and without a reoperation. Results: A total of 6,423 Medicare patients were included in the analysis. Mean (SD) age was 82.4 (7.8) years, 76.0% were female, and 93.3% were white. A second hip surgery within 1 year after the index fixation procedure was performed in 414 patients (6.4%): 121 (29.2%) contralateral, 115 (27.8%) ipsilateral, and 178 (43.0%) without specified laterality. After adjusting for confounding factors, Medicare patients with ipsilateral reoperations had statistically significantly higher readmissions (100% vs 32.5%, p < 0.0001), outpatient hospital visits (96.4% vs 88.8%, p = 0.018), admissions to a SNF (88.5% vs 80.4%, p = 0.024), and admissions to an IRF (38.8% vs 22.0%, p < 0.0001) compared to patients without reoperations. The adjusted mean total all-cause payments ($90,162 vs $55,131, p < 0.0001) during the 1-year follow-up were statistically significantly higher among patients with reoperations as compared to patients without reoperations. Conclusions: Patients who require a second hip surgery after initial fixation with an intramedullary implant for pertrochanteric hip fractures have significantly higher 1-year healthcare resource utilization and 63.5% higher costs than patients without reoperation.

Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis.

At the time of this study, prior to the introduction of biologics in the US, systemic therapies used for the treatment of moderate-to-severe atopic dermatitis included off-label immunosuppressants and corticosteroids. Immunosuppressant therapy is associated with a substantial risk of side-effects, therefore needing clinical monitoring, and is likely to incur a significant healthcare burden for patients and payers. This retrospective cohort study based on claims data measured immunosuppressant use and its associated burden among US adult patients with atopic dermatitis covered under commercial or Medicare Supplemental insurance from January 01, 2010, to September 30, 2015. Overall, based on age, gender, region, and index year, 4201 control patients with atopic dermatitis without immunosuppressant use were matched with 4204 patients treated with immunosuppressants. The majority (68.5%) of patients using immunosuppressants were non-persistent with immunosuppressant treatment during the 12-month follow-up period after a mean (standard deviation) of 88.1 (70.7) days of immunosuppressant use; 72.3% required systemic steroid rescue treatment. Immunosuppressant users had higher incidence of immunosuppressant-related clinical events than controls; in addition, a larger proportion of immunosuppressant users versus controls developed cancer (0.28% vs 0.14%, respectively; P < 0.0001). Healthcare utilization and costs associated with clinical events and monitoring were also higher for immunosuppressant users compared with controls (total costs, $9516 vs $1630, respectively; P < 0.0001; monitoring costs, $363 vs $54, respectively; P < 0.0001). This study revealed that patients treated with systemic immunosuppressants often require systemic steroids or changes to treatment. The increase in immunosuppressant-related clinical events, including the need for increased monitoring with immunosuppressant treatment, compared with controls demonstrates a substantial treatment burden and highlights the unmet need for more effective long-term therapies for atopic dermatitis with improved safety profiles and reduced monitoring requirements.

[Medico-legal risk in urology: Analysis of a portfolio of insured persons by a French insurance company between 2009 and 2018]. / Risque médico-légal en urologie : analyse d'un portefeuille d'assurés auprès d'une compagnie d'assurances française entre 2009 et 2018.

OBJECTIVE: Presentation of data collected on urology claims from the register of a French insurance company. MATERIAL AND METHOD: Compensation claims involving urologists covering the period 2009-2018 were identified and analyzed. RESULTS: A total of 37 files were found. Oncological and functional surgical interventions accounts for 78% of repair claims. Postoperative complications represent 76% of the cases. The most represented acts are total prostatectomy (5) and promonto-fixation (4). The average time of complaint is 28.6 months [1-144 months], the average duration of a procedure (opening-closing) is 32.8 months [12-72 months]. The Conciliation and Compensation Commissions (CCC) and the High Court Courts (HCC) were solicited respectively in 51% and 33% of the proceedings. An amicable agreement is found in 16% of cases. There was no criminal or disciplinary proceedings. The average cost of a closed urology file is 7836 € [0-31,120 €]. In total, 64.8% of the expertises confirm practices in the respect of the rules of the art. CONCLUSION: This series presents the first forensic analysis of a portfolio of urologists on a period of 9 years in French urology. There is a rate of responsibility retained against the practitioner in only 27% of cases. The low rate of faulty files, the absence of a conviction for breach of the duty to provide information and in connection with antibiotic prophylaxis seem to confirm that the practice of urology in France is of good quality, a further study on a longer period of time and on a larger cohort of urologists would allow a finer medico-legal approach. LEVEL OF EVIDENCE: 3.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.