Development of a claims-based flare algorithm for systemic lupus erythematosus.

OBJECTIVE: To develop a claims-based algorithm identifying systemic lupus erythematosus (SLE) flares using a linked claims-electronic medical record (EMR) dataset. METHODS: This study was a retrospective analysis of linked administrative claims and EMR data spanning 1 January 2003 to 31 March 2019. Included were adult SLE patients with at least 12 months of continuous enrollment in claims data, 12 months of clinical activity in EMR, and an absence of malignancies excluding basal and squamous cell carcinoma. Patient follow-up was divided into 30-day windows, and a proxy SLEDAI-2K score based on the EMR data was calculated for each 30-day period. A flare was defined as an increase of at least 4 from the baseline score. A series of potential flare predictor variables identified in claims were based on a combination of established variables from a previous algorithm, with the addition of other SLE-related indicators based on clinical input. Logistic regression models were built to predict monthly SLE flares. RESULTS: Inclusion criteria identified 2427 patients. Results from a logistic model with forward selection capping the number of variables at 10 performed well with a c-statistic of 0.76 and a Brier score of 0.07. The top five predictors were any inpatient admission (OR = 4.76), outpatient office visit (OR = 3.04), MRI (OR = 2.26), ER visit (OR = 2.25), and number of rheumatology visits (OR = 1.75); p < .01 for all. CONCLUSIONS: The final algorithm shows promise in providing an alternative and more streamlined way for identifying likely flares in administrative claims data that will advance the study of SLE within the context of flares.

Clinical and economic burden of intravenous paclitaxel or nab-paclitaxel for metastatic breast cancer.

BACKGROUND: Intravenous (IV) taxane therapy for metastatic breast cancer (mBC) has been associated with toxicities and demanding dosing schedules, which can limit treatment effectiveness. OBJECTIVES: To assess treatment patterns, toxicities, and costs in women with mBC initiating IV paclitaxel or IV nab-paclitaxel. METHODS: Adult women diagnosed with BC from January 1, 2014, to September 30, 2018, were identified in the MarketScan Commercial and MarketScan Medicare Supplemental databases. Women had a metastatic disease diagnosis and newly initiated treatment with IV paclitaxel/nab-paclitaxel (first administration date was considered the index date), and continuous enrollment for at least 12 months prior to and at least 3 months following the index date. Treatment discontinuation, dose reductions, toxicities, and health care utilization and costs per patient per month (PPPM) were assessed over the full follow-up and the index line of IV paclitaxel/nab-paclitaxel therapy (Index LOT). RESULTS: The sample included 8890 women aged 54.6 (±10.9) years, followed for 18.9 (±13.5) months. Most (82.0%) initiated IV paclitaxel/nab-paclitaxel monotherapy; 83.1% had early discontinuation (<18 weeks of treatment) of the Index LOT. Among the 6943 women eligible for the dose-change analysis, 42.4% evidenced an IV paclitaxel/nab-paclitaxel dose reduction ≥10% during the Index LOT. The most common toxicities during the Index LOT were gastrointestinal upset (30.5%), myelotoxicity (27.0%), infection (26.2%), general symptoms (25.9%), and chemotherapy-induced peripheral neuropathy (22.7%). Over follow-up, 39.7% of women had an inpatient admission and 43.0% had an emergency department visit. The mean of all-cause total costs was $11,991 PPPM, while BC-related total costs were $5320 PPPM. CONCLUSIONS: Many mBC patients initiating IV paclitaxel/nab-paclitaxel experienced dose reductions, toxicities, and/or early discontinuation of the Index LOT, which may limit treatment effectiveness. More tolerable treatments with reduced dosing complexity could improve mBC treatment and help contain costs.

Chemotherapy-induced peripheral neuropathy in metastatic breast cancer patients initiating intravenous paclitaxel/nab-paclitaxel.

BACKGROUND: Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes. OBJECTIVE: To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel. METHODS: Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score-matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up. RESULTS: Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC-related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01). CONCLUSIONS: CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

The Economic Burden of End-Organ Damage Among Medicaid Patients with Sickle Cell Disease in the United States: A Population-Based Longitudinal Claims Study.

BACKGROUND: The management of sickle cell disease (SCD), an inherited, chronic, and multifaceted condition, is associated with considerable health care resource utilization (HRU) and costs, especially for Medicaid. Anemia affects most patients with SCD and correlates with end-organ damage (EOD), such as stroke, chronic kidney disease (CKD), end-stage renal disease (ESRD), and pulmonary hypertension (PH). Limited research has been conducted to quantify the economic burden of EOD among patients with SCD. OBJECTIVE: To estimate the effect of EOD on HRU and direct costs and productivity loss incurred by patients with SCD on Medicaid. METHODS: Patients with ≥ 3 nondiagnostic SCD ICD-9-CM/ICD-10-CM codes in ≤ 5 years (January 1, 2013-December 31, 2017) were identified in the MarketScan Medicaid claims database. The earliest SCD diagnosis date was the index date. Continuous enrollment at least 3 months before and 1 month after the index date were required. Patients' post-index periods were divided into 3-month intervals (referred to as "intervals"). History of stroke, CKD, ESRD, and PH were identified in patients' claims histories from January 1, 2008. Intervals within 1 year and more than 1 year after an acute stroke event were also defined. All-cause HRU, direct costs, and productivity losses were summed across intervals and stratified by EOD type. Multivariate regression models were used to estimate the effect of stroke, CKD, ESRD, and PH on annual total cost, inpatient days, and number of emergency department visits by controlling for patients' demographic characteristics and other SCD complications. RESULTS: In total, 10,784 Medicaid patients with SCD (average age: 18.5 years; female: 54.5%) contributed to 152,455 intervals. Approximately 12% of the intervals had EOD. Patients with EOD had higher all-cause health care costs and more inpatient days, emergency department visits, outpatient visits, laboratory tests, and outpatient pharmacy claims than patients without EOD. After controlling for patient characteristics, among Medicaid patients with SCD annual costs within 1 year after stroke were 4.68-fold versus patients with no EOD (more than 1 year after stroke: 2.08-fold; CKD: 2.19-fold; ESRD: 3.40-fold; PH: 2.32-fold). Adjusted mean annual costs for adult patients with SCD on Medicaid were $285,816 and $127,393 within 1 year and more than 1 year after stroke and $135,493, $209,172, and $148,174 for CKD, ESRD, and PH, respectively. Patients with multiple SCD complications had even higher costs. The mean annual time patients with SCD spent receiving health care services ranged from 56 to 62 days for those with EOD versus 21 to 25 days among those without EOD, which created additional economic burden. CONCLUSIONS: When Medicaid patients with SCD experience EOD, the economic burden is significantly increased through direct costs to the health care system and indirect costs from productivity loss to society. SCD management strategies that potentially reduce the risk of EOD offer clinical and economic value to patients and society. DISCLOSURES: Funding for this study was provided by Global Blood Therapeutics (GBT). Campbell is a consultant for GBT, Bluebird Bio, and Cyclerion and receives research funding from Novartis, GBT, and Cyclerion. Cong and Agodoa are employees of and have equity ownership in GBT. Song, Martinez, Black, Lew, Varker, and Chan are employees of IBM Watson Health, which received research funding from GBT for this study. Lanzkron receives research funding from GBT, Pfizer, Ironwood, HRSA, and NIH. A poster based on this study was presented at the 61st ASH Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL.

Real-World Injection Frequency and Cost of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

BACKGROUND: Ranibizumab and aflibercept are FDA-approved treatments for patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Although these agents differ in cost and labeled dosing, it is unclear whether these differences are reflected in clinical practice. OBJECTIVE: To compare the real-world frequency and cost of ranibizumab and aflibercept injections among treatment-naive and previously treated patients with nAMD and DME. METHODS: Claims data from MarketScan Research Databases were retrospectively reviewed to identify treatment-naive patients with nAMD who initiated intravitreal ranibizumab or aflibercept between January 1, 2014, and January 1, 2016, and treatment-naive patients with DME who initiated intravitreal ranibizumab or aflibercept between July 29, 2014, and July 1, 2016. Patients who switched to subsequent-line aflibercept or ranibizumab during the study period were eligible to enter previously treated subgroups. Multivariable regression models were derived to compare the per-patient frequency and cost of injections between ranibizumab- and aflibercept-treated patients with nAMD over 12 months (treatment-naive: n = 1,087 and n = 1,578; previously treated: n = 221 and n = 751) and 24 months (treatment-naive: n = 454 and n = 568; previously treated: n = 93 and n = 284) and in patients with DME over 6 months (treatment-naive: n = 507 and n = 681; previously treated: n = 53 and n = 223) and 12 months (treatment-naive: n = 326 and n = 382; previously treated: n = 24 and n = 122). RESULTS: After adjusting for patient demographics and clinical characteristics, per-patient injection frequency and cost were not significantly different between treatment-naive patients with nAMD who received ranibizumab versus aflibercept over 12 months (5.62 vs. 5.54; P = 0.52, and $11,351 vs. $10,702; P = 0.06, respectively) and 24 months (7.86 vs. 8.37; P = 0.16, and $16,286 vs. $16,666; P = 0.69, respectively). In previously treated patients with nAMD, injection frequency was significantly lower among ranibizumab- versus aflibercept-treated patients over 24 months (7.98 vs. 9.63; P = 0.03), whereas treatment costs were comparable over 12 months ($11,512 vs. $12,050; P = 0.44) and 24 months ($16,303 vs. $19,361; P = 0.13). In treatment-naive patients with DME, ranibizumab was associated with significantly fewer injections and lower costs than aflibercept over 6 months (2.60 vs. 2.92 and $3,379 vs. $5,925, respectively; both P < 0.001) and 12 months (3.33 vs. 3.87 and $4,136 vs. $7,656, respectively; both P < 0.001). Similar cost savings were observed among previously treated patients with DME who received ranibizumab over 6 months ($3,834 vs. $6,775 for aflibercept; P = 0.0001) and 12 months ($4,606 vs. $9,190; P = 0.02), despite nonsignificant differences in injection frequency during follow-up. CONCLUSIONS: Although the frequency and cost of ranibizumab and aflibercept injections were generally comparable among patients treated for nAMD, ranibizumab was associated with estimated per-patient-per-year cost savings of $3,500-$4,500 in those treated for DME. Most patients received fewer injections than any FDA-indicated dosing schedule, suggesting potential undertreatment that may result in suboptimal vision outcomes. DISCLOSURES: Study funding was provided by Genentech, a member of the Roche Group. The sponsor participated in the design of the study; collection, analysis, and interpretation of the data; preparation of the manuscript; and the decision to submit the article for publication. Kiss has been a consultant for and received honoraria from Alcon, Alimera, Allergan, BioMarin, Novartis, and Spark; has been on the advisory board for, a consultant for, received honoraria from, and held stock options in Adverum and Regenxbio; has been a consultant for, received honoraria from, and held stock/stock options in Fortress; has been on the advisory board for, a consultant and investigator for, and received grants and honoraria from Genentech and Regeneron; and has been on the advisory board for, a consultant for, and received grants and honoraria from Optos. Malangone-Monaco, Wilson, Varker, Stetsovsky, and Smith are employees of IBM Watson Health, which received funding from Genentech to undertake this study. Garmo is an employee of Genentech. Data reported in this manuscript were presented in part at the Academy of Managed Care Pharmacy (AMCP) Managed Care and Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Comparative analysis of US real-world dosing patterns and direct infusion-related costs for matched cohorts of rheumatoid arthritis patients treated with infliximab or intravenous golimumab.

PURPOSE: The objectives of this study were to evaluate and compare treatment patterns and infusion-related health care resource expenditures for rheumatoid arthritis (RA) patients initiating golimumab for intravenous use (GLM-IV) and infliximab (IFX) therapy and to assess cost implications from the commercial perspective. METHODS: Adult RA patients with a new episode of GLM-IV or IFX treatment between Janu-ary 1, 2014 and March 31, 2016 were identified from MarketScan databases and evaluated for maintenance infusion intervals and related costs of treatment. IFX and GLM-IV patients were matched 1:1 on index medication treatment duration, gender, payer type, prior biologic use, and post-index methotrexate use. Paid amounts for drugs and associated administration costs were applied to treatment group dosing patterns. RESULTS: Final matched treatment groups included 547 GLM-IV and 547 IFX patients (mean age = 55-56 years). Mean (SD) follow-up was 609 (161) days for GLM-IV and 613 (163) days for IFX. Treatment duration was 396 (240) days for GLM-IV and 397 (239) days for IFX. Overall, 80% of GLM-IV and 39% of IFX maintenance infusions were given approximately every 8 weeks; and 6% of GLM-IV and 53% of IFX maintenance infusions occurred more frequently than every 8 weeks (P<0.001). When weighting of the maintenance infusion interval was applied, the mean number of induction plus maintenance infusions during the first year of treatment was estimated at 7.03 for GLM-IV and 9.48 for IFX. From the commercial perspective, drug plus administration costs per infusion were $5,846 for GLM-IV and $5,444 for IFX with total annual cost of therapy for GLM-IV patients costing $10,507 less than that for IFX patients in the first year and $6,774 less than that for IFX patients in subsequent years. CONCLUSION: Annual GLM-IV drug plus administration costs for commercial health plans were significantly less than IFX in RA patients due to differences in real-world dosing and administration.

Treatment patterns and medication adherence among patients diagnosed with multiple myeloma and treated with panobinostat.

AIM: To examine real-world treatment patterns in multiple myeloma (MM) patients treated with panobinostat. MATERIALS & METHODS: Using a US claims database, MM patients treated with panobinostat during 02/01/2015-01/31/2017 were evaluated. Lines of therapy, combination regimens, dosing and duration were measured. RESULTS: Ninety-five patients were included (mean age: 61.4 years). Patients were heavily pretreated, with 88.4% exposed to both a proteasome inhibitor and an immunomodulatory agent. A panobinostat containing regimen was started in the fourth or more (86%) lines of therapy within a median of 3.77 years from initial treatment. The most common treatment combination was bortezomib/dexamethasone/panobinostat (31.6%) with 69.5% receiving the recommended dose (20 mg). Mean duration was 98.8 days. CONCLUSION: Patients received the recommended dose, most commonly with bortezomib and dexamethasone. Panobinostat was used in heavily pretreated patients within 4 years post-diagnosis, reflecting an advanced MM population.

Real-world Direct Health Care Costs for Metastatic Colorectal Cancer Patients Treated With Cetuximab or Bevacizumab-containing Regimens in First-line or First-line Through Second-line Therapy.

BACKGROUND: The present study examined real-world direct health care costs for metastatic colorectal cancer (mCRC) patients initiating first-line (1L) bevacizumab (BEV)- or cetuximab (CET)-containing regimen in 1L or 1L-through-second-line (1L-2L) therapy. PATIENTS AND METHODS: Using a large US insurance claims database, patients with mCRC initiating 1L BEV- or 1L CET-containing regimen from January 1, 2008 to September 30, 2014 were identified. The per-patient per-month (PPPM) all-cause health care costs (2014 US dollars) were measured during 1L therapy and, for patients continuing to a 2L biologic-containing regimen, 1L-2L therapy. Multivariable regression analyses were used to compare PPPM total health care costs between patients initiating a 1L BEV- versus 1L CET-containing regimen. RESULTS: A total of 6095 patients initiating a 1L BEV- and 453 initiating a 1L CET-containing regimen were evaluated for 1L costs; 2218 patients initiating a 1L BEV- and 134 initiating a 1L CET-containing regimen were evaluated for 1L-2L costs. In 1L therapy, 1L CET had adjusted PPPM costs that were $3135 (95% confidence interval [CI], $1174-$5040; P < .001) greater on average than 1L BEV. In 1L-2L therapy, 1L BEV-2L CET had adjusted PPPM costs that were $1402 (95% CI, $1365-$1442; P = .010) greater than those for 1L BEV-2L BEV, and 1L CET-2L BEV had adjusted PPPM costs that were $4279 (95% CI, $4167-$4400; P = .001) greater on average than those for 1L BEV-2L BEV. The adjusted PPPM cost differences for 1L BEV-2L other biologic or 1L CET-2L other biologic agent were numerically greater but statistically insignificant. CONCLUSION: PPPM total health care costs for 1L and 2L therapy tended to be greater for patients treated with 1L CET-containing regimens than for 1L BEV-containing regimens. Also, continuing treatment with BEV-containing regimens 1L-2L was less costly than switching between BEV and CET. The cost differences between BEV and CET hold important implications for treatment decisions of mCRC patients in real-world clinical practice.

Prescribing Patterns of Oral Antineoplastic Therapies Observed in the Treatment of Patients With Advanced Prostate Cancer Between 2012 and 2014: Results of an Oncology EMR Analysis.

PURPOSE: The purpose of this study was to examine, using a US electronic medical records (EMR) database, the clinical characteristics and real-world treatment sequences in men with advanced prostate cancer who initiated treatment with abiraterone acetate or enzalutamide. METHODS: This retrospective, observational study evaluated adult male patients with a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision, Clinical Modification code 185) in the EMR database between July 1, 2011, and March 31, 2014, who had initiated first-line treatment with abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014. The first record for a patient initiating abiraterone acetate or enzalutamide was the index date. Patients had 6 months of pre-index medical record history and a variable length follow-up period, extending from the index date to the end of medical record data availability or date of the end of the study (March 31, 2014). The sequence of first- and second-line therapies for advanced prostate cancer therapy was reported. FINDINGS: A total of 809 patients met study inclusion and exclusion criteria. This study found that the majority of patients who initiated treatment with either abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014, received a single line of therapy (72%); abiraterone acetate was the most common first-line treatment (74% of first-line patients). A subset of patients treated first-line with either abiraterone acetate or enzalutamide were transitioned to an oral second-line agent (17% of first-line abiraterone acetate-treated patients transitioned to second-line enzalutamide, and 16% of first-line enzalutamide-treated patients transitioned to second-line abiraterone acetate). Chemotherapy with docetaxel was also a commonly observed second-line treatment selection, occurring in 8% of first-line abiraterone acetate-treated patients and in 7% of first-line enzalutamide-treated patients. IMPLICATIONS: This EMR study is among the first to present evidence of US physician practice prescribing patterns regarding initiation of oral antineoplastic agents and use of subsequent therapies in patients with advanced prostate cancer.

Red blood cell (RBC) transfusion rates among US chronic dialysis patients during changes to Medicare end-stage renal disease (ESRD) reimbursement systems and erythropoiesis stimulating agent (ESA) labels.

BACKGROUND: Several major ESRD-related regulatory and reimbursement changes were introduced in the United States in 2011. In several large, national datasets, these changes have been associated with decreases in erythropoiesis stimulating agent (ESA) utilization and hemoglobin concentrations in the ESRD population, as well as an increase in the use of red blood cell (RBC) transfusions in this population. Our objective was to examine the use of RBC transfusion before and after the regulatory and reimbursement changes implemented in 2011 in a prevalent population of chronic dialysis patients in a large national claims database. METHODS: Patients in the Truven Health MarketScan Commercial and Medicare Databases with evidence of chronic dialysis were selected for the study. The proportion of chronic dialysis patients who received any RBC transfusion and RBC transfusion event rates per 100 patient-months were calculated in each month from January 1, 2007 to March 31, 2012. The results were analyzed overall and stratified by primary health insurance payer (commercial payer or Medicare). RESULTS: Overall, the percent of chronic dialysis patients with RBC transfusion and RBC transfusion event rates per 100 patient-months increased between January 2007 and March 2012. When stratified by primary health insurance payer, it appears that the increase was driven by the primary Medicare insurance population. While the percent of patients with RBC transfusion and RBC transfusion event rates did not increase in the commercially insured population between 2007 and 2012 they did increase in the primary Medicare insurance population; the majority of the increase occurred in 2011 during the same time frame as the ESRD-related regulatory and reimbursement changes. CONCLUSIONS: The regulatory and reimbursement changes implemented in 2011 may have contributed to an increase in the use of RBC transfusions in chronic dialysis patients in the MarketScan dataset who were covered by Medicare plus Medicare supplemental insurance.

Retrospective analysis of first-line anti-vascular endothelial growth factor treatment patterns in wet age-related macular degeneration.

INTRODUCTION: This study compared the number of, and expenditures on, first-line intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections between patients who were treated with aflibercept or ranibizumab for wet age-related macular degeneration (AMD). METHODS: This was a retrospective cohort study based on U.S. administrative claims data. Selected patients had initiated first-line intravitreal anti-VEGF treatment with ranibizumab or aflibercept (index date) between November 18, 2011 and April 30, 2013, were aged ≥ 18 years on the index date, had 12 months of continuous insurance enrollment prior to the index date (baseline period), were diagnosed with wet AMD during the baseline period or on the index date, and had at least 6 or 12 months of follow-up enrollment after the index date without switching to a different anti-VEGF agent (follow-up periods). Outcomes measured within the 6 and 12 month follow-up periods included the number of, and healthcare expenditures on, intravitreal anti-VEGF injections. Multivariable regressions compared the outcomes between aflibercept and ranibizumab. RESULTS: The 6 months analyses included 319 aflibercept patients and 1,054 ranibizumab patients (12 month analyses: 57 and 374, respectively). Over the first 6 months after the index date, neither the number of injections (aflibercept mean = 3.8 ± 1.6; ranibizumab mean = 3.9 ± 1.9) nor the expenditures on injections (aflibercept mean = $7,468 ± $4,211; ranibizumab mean = $7,816 ± $4,834) differed significantly between aflibercept patients and ranibizumab patients (in multivariable regression treating ranibizumab as reference: incidence rate ratio = 0.97, 95% confidence interval [CI] 0.91-1.03, P = 0.277; cost ratio = 0.96, 95% CI 0.89-1.04, P = 0.338). Differences were also insignificant in the 12 month analyses. The overall mean days between injections differed by only 1.8 (95% CI 1.3-2.3) days between the aflibercept patients and ranibizumab patients (42.4 and 40.6, respectively). CONCLUSION: Aflibercept and ranibizumab were used at a similar frequency resulting in similar intravitreal anti-VEGF injection healthcare expenditures among wet AMD patients initiating first-line intravitreal anti-VEGF treatment.

Outpatient red blood cell transfusion payments among patients on chronic dialysis.

BACKGROUND: Payments for red blood cell (RBC) transfusions are separate from US Medicare bundled payments for dialysis-related services and medications. Our objective was to examine the economic burden for payers when chronic dialysis patients receive outpatient RBC transfusions. METHODS: Using Truven Health MarketScan® data (1/1/02-10/31/10) in this retrospective micro-costing economic analysis, we analyzed data from chronic dialysis patients who underwent at least 1 outpatient RBC transfusion who had at least 6 months of continuous enrollment prior to initial dialysis claim and at least 30 days post-transfusion follow-up. A conceptual model of transfusion-associated resource use based on current literature was employed to estimate outpatient RBC transfusion payments. Total payments per RBC transfusion episode included screening/monitoring (within 3 days), blood acquisition/administration (within 2 days), and associated complications (within 3 days for acute events; up to 45 days for chronic events). RESULTS: A total of 3283 patient transfusion episodes were included; 56.4% were men and 40.9% had Medicare supplemental insurance. Mean (standard deviation [SD]) age was 60.9 (15.0) years, and mean Charlson comorbidity index was 4.3 (2.5). During a mean (SD) follow-up of 495 (474) days, patients had a mean of 2.2 (3.8) outpatient RBC transfusion episodes. Mean/median (SD) total payment per RBC transfusion episode was $854/$427 ($2,060) with 72.1% attributable to blood acquisition and administration payments. Complication payments ranged from mean (SD) $213 ($168) for delayed hemolytic transfusion reaction to $19,466 ($15,424) for congestive heart failure. CONCLUSIONS: Payments for outpatient RBC transfusion episodes were driven by blood acquisition and administration payments. While infrequent, transfusion complications increased payments substantially when they occurred.

Patterns and predictors of use of warfarin and other common long-term medications in patients with atrial fibrillation.

BACKGROUND AND OBJECTIVE: No study has been published that compared persistence and discontinuation of warfarin with other long-term medications in patients with atrial fibrillation (AF). The objective of this study was to evaluate persistence and discontinuation patterns in AF patients taking warfarin and other common long-term medications and identify predictors of persistence and discontinuation in this population. METHODS: Patients with warfarin prescription within 3 months after AF hospitalization discharge and 12-month data before and after the first prescription were evaluated using administrative claims data (1 January 2005 - 31 December 2007). For comparison, persistence patterns for other long-term medications for treatment of hypertension, hyperglycemia, heart disease, and dyslipidemia, including once- (od) and twice- (bid) daily medications, were evaluated. Non-persistence was defined as the presence of a ≥60-day gap in medication use. Permanent discontinuation was defined as no use of the medication for ≥90 days until the end of the follow-up period. Multivariate analysis was conducted to identify predictors of warfarin non-persistence and discontinuation. RESULTS: 28 384 patients with AF were identified; 16 036 (56.5%) had a warfarin prescription following AF hospitalization. 53.5% of warfarin users were persistent for at least 1 year, similar to other long-term medications commonly prescribed to the AF population (ranging between 45.2% and 61.3%). 42.6% of warfarin users permanently discontinued warfarin within 1 year, also consistent with the discontinuation rate of 32.9-52.0% of other long-term medications. Residence in the South and West regions of the US, history of cardiac dysrhythmias, and warfarin cost-sharing significantly decreased the likelihood of warfarin persistence and increased the likelihood of discontinuation, while older age, history of ischemic stroke, and warfarin use before hospitalization significantly increased warfarin persistence and decreased the likelihood of discontinuation. Adherence of od and bid medications was similar. CONCLUSION: Persistence and discontinuation with warfarin in patients with AF is consistent with other long-term medications. Identifying factors associated with non-persistence and discontinuation with long-term medications can help in developing targeted adherence programs.

Impact of atrial fibrillation and oral anticoagulation on hospital costs and length of stay.

PURPOSE: The results of a study assessing hospital length of stay (LOS) and inpatient costs associated with nonvalvular atrial fibrillation (AF) and AF-related warfarin use during hospitalization are presented. METHODS: Managed care administrative claims data were used to construct cohorts of patients hospitalized with AF as a primary (n = 1,868) or secondary (n = 11,200) discharge diagnosis and control groups of patients with similar demographics and clinical characteristics who were hospitalized during the same period (2002-07). Multivariate regression analyses were performed to estimate the incremental impact of AF on hospital LOS and costs per admission, as well as the incremental impact of in hospital warfarin use on the evaluated LOS and cost outcomes. RESULTS: The cohort of patients with AF as a secondary discharge diagnosis had a mean LOS 1.84 days greater (p < 0.001) and a mean hospital costs $3,146 higher (p < 0.001) than the control cohort; in hospital warfarin use in those patients was associated with a mean increase in LOS of 1.45 days (p < 0.001) and a mean increase in hospital costs of $1,761 per admission (p < 0.001). In the cohort of patients with AF as a primary discharge diagnosis, inpatient warfarin therapy was also associated with longer hospital stays (mean increase, 1.26 days; p < 0.001) and higher hospital costs (mean increase, $678; p = 0.031). CONCLUSION: Hospitalizations of patients with a secondary diagnosis of AF are significantly longer and more costly than those of patients without a secondary diagnosis of AF, especially when warfarin is used during the hospital stay. Among patients with a primary diagnosis of AF, warfarin therapy during hospitalization is associated with significant increases in mean LOS and hospital costs.

Duration of venous thromboembolism risk across a continuum in medically ill hospitalized patients.

BACKGROUND: Patients hospitalized for medical illness are at increased risk of venous thromboembolism (VTE), but the duration of risk is not well understood. OBJECTIVE: To assess incidence and time course of symptomatic VTE following hospitalization for medical illness in a large, real-world patient population. DESIGN: Data were extracted from the Thomson Reuters MarketScan(®) Inpatient Drug Link File. PATIENTS: Those hospitalized with cancer, heart failure, severe lung disease, or infectious disease from 2005 to 2008. MEASUREMENTS: The cumulative VTE risk over 180 days after admission was calculated using Kaplan-Meier analysis. VTE hazard was calculated on a daily basis and smoothed through LOESS regression. RESULTS: The analysis included 11,139 medically ill patients, 46.7% and 8.8% of whom received pharmacological thromboprophylaxis during hospitalization and after discharge, respectively. The mean duration of prophylaxis during hospitalization was 5.0 days. Of the 11,139 patients, 366 (3.3%) experienced a symptomatic VTE event. VTE events were most frequent during days 0-9 (97 events), followed by days 10-19 (82 events). The mean length of hospital stay was 5.3 days, and 56.6% of all VTE events occurred after discharge. VTE hazard peaked at day 8, with 1.05 events per 1000 person-days. CONCLUSIONS: The time course of VTE in medical patients shows that risk of symptomatic VTE is highest during the first 19 days after hospital admission, and extends into the period after discharge. Future research is warranted to investigate risks and benefits of reducing the incidence of VTE after discharge, including the role of improving thromboprophylaxis practices in the inpatient setting and extending thromboprophylaxis after hospitalization.

Treatment of lung cancer patients and concomitant use of drugs interacting with cytochrome P450 isoenzymes.

OBJECTIVE: The majority of anticancer medicines used in the therapy of lung cancer patients are metabolized by cytochrome P450 (CYP450) enzymes, but little is known about the frequency of prescribed concomitant medicines interacting via the same enzyme system. This study analyzed the use of medications that could cause drug-drug interactions (inhibition or induction) in lung cancer patients before and during anticancer treatment. RESEARCH DESIGN AND METHODS: In this retrospective cross sectional study, all lung cancer patients (ICD-9 codes 162.2-162.9, 231.2) aged ≥18 years who received any anticancer medicines between 1/1/2004 and 6/30/2008 were identified in the US Thomson Reuters MarketScan(®) Claims Database. Patients had to have data for at least 12 months prior to (pre-period) and during their treatment, had no other cancer or use of other anticancer treatment in the pre-period. Patients with renal disease, renal failure, or liver failure were excluded. Drugs known to induce or inhibit P450 enzymes and used before and during lung cancer treatment were categorized with respect to their potency (strong, moderate, low). RESULTS: Out of 144,959 lung cancer patients, 6647 (4.6%) patients met the study entry criteria. Mean age was 67 years, 53% were men, and mean Charlson combordity index was 3.5. 99% of patients received at least one drug known as a substrate, inhibitor or inducer of P450 (98% inhibitors, 93% inducers, 98% substrates) during the patient's anticancer treatment episode. Mean co-treatment duration with any CYP450 agent was 99 days (76% of the episode length); ≥2 different CYP450 agents were prescribed during 98% of episodes, and ≥10 different CYP450 agents were prescribed during 44% of episodes. Use of CYP450 agents was similar in the pre-treatment period: at least one CYP450 agent was prescribed during 99% of episodes (99% inhibitors, 79% inducers, 98% substrates). CONCLUSIONS: Drugs which may cause drug-drug interactions while affecting the CYP 450 enzymes are frequently prescribed both before and during anticancer treatment of lung cancer patients.

Cost burden of second fracture in the US health system.

OBJECTIVES: This retrospective claim-based study assessed 1-year medical costs associated with second fracture(s) for patients over 50 years old with an initial closed hip, clinical vertebral or non-hip non-vertebral (NHNV) fracture using 2002-2008 MarketScan® Commercial and Medicare Supplemental Databases. METHODS: Patients with incident fracture and ≥12-month pre-period and follow-up period from the incident fracture were extracted. Index date was the first subsequent fracture date for patients with subsequent fracture during the 12-month (cases); index dates for patients without subsequent fractures during the 12-month follow-up (controls) were randomly assigned based on the distribution of index dates of cases. Total costs were examined during the 12-month follow-up period using generalized linear models. A decomposition analysis of the incremental costs attributable to the second fracture was conducted to examine what proportion of the difference was due to different patient characteristics and what proportion was due to different model structures between cases and controls. RESULTS: For privately insured patients with hip, vertebral, or NHNV fracture, the 1-year second fracture rate was 8.0%, 5.1%, and 4.0%, and 1-year incremental costs were $47,351, $43,238, and $23,852, respectively; for Medicare patients, the corresponding rates and costs were 8.8%, 9.2%, and 8.2%, and $18,645, $19,702, and $19,697. Nationally projected annual cost of second fracture was $834 (95% confidence interval: $763-$914) million for patients with commercial insurance and $1.13 (95% confidence interval: $1.09-$1.17) billion for Medicare patients. CONCLUSIONS: The average cost of patients with subsequent fracture(s) was substantial. Effective management of first fractures may help reduce the long-term economic and clinical burden.

Increasing prevalence of atrial fibrillation and flutter in the United States.

The prevalence data for atrial fibrillation (AF) are dated. The present retrospective study estimated the current and projected prevalence of AF and atrial flutter (AFL) in the United States using a large national database. Claims data drawn from July 2004 to December 2005 from the MarketScan research databases from Thomson Reuters were used to identify patients aged >or=20 years with nontransient AF and/or AFL and age- and gender-matched controls without these conditions. Of the 21,648,681 patients in the databases, 242,903 (1.12%) had nontransient AF and/or AFL (222,605 AF only, 5,376 AFL only, and 14,922 AF and AFL). Patients with AF only, AFL only, and AF and AFL had a greater (p <0.001) prevalence of co-morbidities, including hypertension (62.0%, 61.3%, and 57.0%, respectively) and coronary artery disease (43.0%, 44.7%, and 44.5%, respectively), than matched controls (45.1% hypertension and 19.4% coronary artery disease). Applying the US Census Bureau population estimates to the prevalence rates for AF and/or AFL in the databases, it was estimated that 3.03 million persons in the United States had AF only, 0.07 million had AFL only, and 0.19 million had AF and AFL in 2005. The projected prevalence for 2050 was 7.56 million for AF only, 0.15 million for AFL only, and 0.44 million for AF and AFL. In conclusion, the current prevalence of AF and AFL is high and is projected to increase considerably by 2050. The current and projected increases in the prevalence of AF are greater than predicted by a previous sentinel study and might reflect more than the aging of the population.