Time to diagnosis among young patients with cancer.

BACKGROUND: Sociodemographic and clinical factors associated with diagnostic delays in pediatric, adolescent, and young adult cancers are poorly understood. METHODS: Using the Optum Labs Data Warehouse's de-identified claims data for commercial health plan enrollees, we identified children (0-14 years) and adolescents/young adults (AYAs) (15-39 years) diagnosed with one of 10 common cancers from 2001 to 2017, who were continuously enrolled for 6 months preceding diagnosis. Time to diagnosis was calculated as days between first medical encounter with possible cancer symptoms and cancer diagnosis date. Median times from first symptom to diagnosis were compared using Wilcoxon rank sum test. Multivariable unconditional logistic regression identified sociodemographic factors associated with longer time (>3 months) to cancer diagnosis (from symptom onset). RESULTS: Of 47,296 patients, 87% presented prior to diagnosis with symptoms. Patients with central nervous system (CNS) tumors were most likely to present with symptoms (93%), whereas patients with cervical cancer were least likely (70%). Symptoms varied by malignancy. Of patients with symptoms, thyroid (105 days [range: 50-154]) and cervical (104 days [range: 41-151]) cancer had the longest median time to diagnosis. Females and patients at either end of the age spectrum were more likely to experience diagnosis delays of more than 3 months. CONCLUSION: In a commercially insured population, time to diagnosis varies by cancer type, age, and sex. Further work is needed to understand the patient, provider, and health system-level factors contributing to time from symptom onset to diagnosis, specifically in the very young children and the young adult patient population going forward.

Outcomes Associated with Treatment with and Without Medications for Opioid Use Disorder.

There is limited research on outcomes for patients who start treatment for opioid use disorder (OUD) with only psychosocial treatment compared to those who initiate treatment with either medications for OUD (MOUD) or the combination of psychosocial treatment and MOUD. Cox proportional hazards regression was used on a database of individuals with commercial health insurance or Medicare Advantage to estimate the associations of treatment type with opioid overdose and self-harm (separately). Logistic regression was used to estimate the association of treatment type with prescription opioid fill following treatment initiation. Relative to patients who initiated treatment with only psychosocial treatment, patients who also initiated treatment with MOUD had lower risk of having an overdose inpatient or emergency department (ED) encounter, a self-harm inpatient or ED encounter, and a prescription opioid filled following treatment initiation. Starting treatment with MOUD was associated with better patient outcomes than initiating treatment with only psychosocial treatment.

Factors Associated With Initial Treatment Choice, Engagement, and Discontinuation for Patients With Opioid Use Disorder.

OBJECTIVE: Pharmacotherapy for opioid use disorder is effective but underused from a clinical perspective, and average treatment duration is shorter than current recommendations. In this analysis, the authors examined factors associated with initiation of, engagement in, and duration of treatment among patients with opioid use disorder. METHODS: Using the OptumLabs Data Warehouse (a large, national, deidentified database of commercial or Medicare Advantage plan enrollees), the authors identified a sample of 204,225 patients with opioid use disorder between July 1, 2010, and April 1, 2019. Factors associated with initial treatment type were identified with multinomial logistic regression. The odds of treatment engagement, defined as two claims for treatment and a treatment episode of ≥30 days, were estimated with logistic regression. The hazard ratios for treatment discontinuation were estimated with a Cox proportional hazards model. RESULTS: Treatment initiation with pharmacotherapy (alone or in combination with psychosocial therapy) was associated with higher odds of treatment engagement and a lower hazard of treatment discontinuation. Patients with certain behavioral health conditions (e.g., anxiety or mood disorders) had higher odds of initiating treatment with pharmacotherapy and engaging in treatment and a lower hazard of discontinuing treatment. Patients with certain painful general health conditions (e.g., fibromyalgia or musculoskeletal disorders) had lower odds of initiating and engaging in treatment. CONCLUSIONS: Treatment initiation with pharmacotherapy was associated with treatment engagement and duration. Previous contact with behavioral health treatment may support initiating, engaging in, and remaining in treatment. Patients with painful conditions may benefit from provider support in initiating treatment for opioid use disorder.

Relative Cost Differences of Initial Treatment Strategies for Newly Diagnosed Opioid Use Disorder: A Cohort Study.

BACKGROUND: Relative costs of care among treatment options for opioid use disorder (OUD) are unknown. METHODS: We identified a cohort of 40,885 individuals with a new diagnosis of OUD in a large national de-identified claims database covering commercially insured and Medicare Advantage enrollees. We assigned individuals to 1 of 6 mutually exclusive initial treatment pathways: (1) Inpatient Detox/Rehabilitation Treatment Center; (2) Behavioral Health Intensive, intensive outpatient or Partial Hospitalization Services; (3) Methadone or Buprenorphine; (4) Naltrexone; (5) Behavioral Health Outpatient Services, or; (6) No Treatment. We assessed total costs of care in the initial 90 day treatment period for each strategy using a differences in differences approach controlling for baseline costs. RESULTS: Within 90 days of diagnosis, 94.8% of individuals received treatment, with the initial treatments being: 15.8% for Inpatient Detox/Rehabilitation Treatment Center, 4.8% for Behavioral Health Intensive, Intensive Outpatient or Partial Hospitalization Services, 12.5% for buprenorphine/methadone, 2.4% for naltrexone, and 59.3% for Behavioral Health Outpatient Services. Average unadjusted costs increased from $3250 per member per month (SD $7846) at baseline to $5047 per member per month (SD $11,856) in the 90 day follow-up period. Compared with no treatment, initial 90 day costs were lower for buprenorphine/methadone [Adjusted Difference in Differences Cost Ratio (ADIDCR) 0.65; 95% confidence interval (CI), 0.52-0.80], naltrexone (ADIDCR 0.53; 95% CI, 0.42-0.67), and behavioral health outpatient (ADIDCR 0.54; 95% CI, 0.44-0.66). Costs were higher for inpatient detox (ADIDCR 2.30; 95% CI, 1.88-2.83). CONCLUSION: Improving health system capacity and insurance coverage and incentives for outpatient management of OUD may reduce health care costs.

Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder.

Importance: Although clinical trials demonstrate the superior effectiveness of medication for opioid use disorder (MOUD) compared with nonpharmacologic treatment, national data on the comparative effectiveness of real-world treatment pathways are lacking. Objective: To examine associations between opioid use disorder (OUD) treatment pathways and overdose and opioid-related acute care use as proxies for OUD recurrence. Design, Setting, and Participants: This retrospective comparative effectiveness research study assessed deidentified claims from the OptumLabs Data Warehouse from individuals aged 16 years or older with OUD and commercial or Medicare Advantage coverage. Opioid use disorder was identified based on 1 or more inpatient or 2 or more outpatient claims for OUD diagnosis codes within 3 months of each other; 1 or more claims for OUD plus diagnosis codes for opioid-related overdose, injection-related infection, or inpatient detoxification or residential services; or MOUD claims between January 1, 2015, and September 30, 2017. Data analysis was performed from April 1, 2018, to June 30, 2019. Exposures: One of 6 mutually exclusive treatment pathways, including (1) no treatment, (2) inpatient detoxification or residential services, (3) intensive behavioral health, (4) buprenorphine or methadone, (5) naltrexone, and (6) nonintensive behavioral health. Main Outcomes and Measures: Opioid-related overdose or serious acute care use during 3 and 12 months after initial treatment. Results: A total of 40 885 individuals with OUD (mean [SD] age, 47.73 [17.25] years; 22 172 [54.2%] male; 30 332 [74.2%] white) were identified. For OUD treatment, 24 258 (59.3%) received nonintensive behavioral health, 6455 (15.8%) received inpatient detoxification or residential services, 5123 (12.5%) received MOUD treatment with buprenorphine or methadone, 1970 (4.8%) received intensive behavioral health, and 963 (2.4%) received MOUD treatment with naltrexone. During 3-month follow-up, 707 participants (1.7%) experienced an overdose, and 773 (1.9%) had serious opioid-related acute care use. Only treatment with buprenorphine or methadone was associated with a reduced risk of overdose during 3-month (adjusted hazard ratio [AHR], 0.24; 95% CI, 0.14-0.41) and 12-month (AHR, 0.41; 95% CI, 0.31-0.55) follow-up. Treatment with buprenorphine or methadone was also associated with reduction in serious opioid-related acute care use during 3-month (AHR, 0.68; 95% CI, 0.47-0.99) and 12-month (AHR, 0.74; 95% CI, 0.58-0.95) follow-up. Conclusions and Relevance: Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments. Strategies to address the underuse of MOUD are needed.

Healthcare resource utilization and costs in patients with HIV-1 who switched first-line antiretroviral therapy.

Objectives: This study compared healthcare utilization and costs associated with switching the first-line protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) based antiretroviral (ARV) regimen due to reasons other than virologic failure among patients with HIV-1. Methods: This was a retrospective analysis of commercial and Medicare Advantage with Part D enrollees in two US administrative claims databases. The study population comprised adults with HIV-1 infection initiating antiretroviral therapy (ART) on PI- or NNRTI-containing regimens from 1 January 2006 to 31 December 2015. Patients with a subsequent change in anchor agent were assigned to the switch cohort; the non-switch cohort was constructed using propensity score matching of three non-switching patients for each patient in the switch cohort. Patient characteristics and per patient per month healthcare resource utilization and costs were compared between the cohorts during the pre-switch, switch (15 days before and after switching) and post-switch periods. Costs during the switch period were also estimated with a multivariable-adjusted model. Results: The matched study population consisted of 1204 patients who switched their first-line PI- or NNRTI-based regimen and 3612 patients who did not. Compared with the non-switch cohort, patients who switched had higher healthcare resource utilization during the pre-switch, switch and post-switch periods. Mean unadjusted non-ART costs in the switch cohort were nearly double ($2944 versus $1530, p < .001), more than double ($2562 versus $1215, p < .001) and 1.5 times higher ($1473 versus $968, p < .001) than costs in the non-switch cohort in the pre-switch, switch and post-switch periods, respectively. Conclusions: Patients with HIV-1 who initiated PI- or NNRTI-based regimens and switched ARTs for reasons other than virologic failure used more healthcare resources and incurred greater costs relative to patients in the non-switch cohort. This study highlights the importance of initiating patients on appropriate first-line ART to avoid the need to switch due to reasons other than virologic failure.

Comparison of healthcare resource utilization and costs in patients with type 2 diabetes initiating dapagliflozin versus sitagliptin.

AIMS: To compare healthcare costs and utilization in patients with type 2 diabetes (T2D) who initiated dapagliflozin (DAPA) with costs and utilization in those who initiated sitagliptin (SITA) in a real-world setting. MATERIALS AND METHODS: This was a retrospective study of health plan enrollees in two US commercial claims databases or Medicare Part D. The study population comprised adult patients with T2D who initiated DAPA or SITA between January 1, 2014 and April 30, 2015. DAPA and SITA initiators were propensity-score-matched, and healthcare utilization and costs during the 1-year follow-up period were compared. Analyses were conducted separately for patients with evidence of oral antidiabetic drug (OAD) monotherapy use at baseline. RESULTS: A total of 2722 patients were included in each matched cohort. Follow-up unadjusted all-cause costs ($16 065 and $17 281; P = 0.135) and diabetes-related costs ($9697 and $9354; P = 0.539) were similar in the DAPA and SITA cohorts. Higher office and outpatient visit costs in the SITA group were offset by higher pharmacy costs in the DAPA group. In the subgroup of 1804 patients with OAD monotherapy use at baseline, patients in the SITA group had higher total all-cause costs compared with those in the DAPA group ($14 884 vs. $12 353; P = 0.026). CONCLUSION: Patients who initiated DAPA or SITA had similar all-cause and diabetes-related healthcare costs over 1 year of follow-up. In the subgroup of patients treated with OAD monotherapy at baseline (84% metformin monotherapy), those who initiated DAPA as add-on therapy had lower costs than patients who added SITA.

Real-world outcomes in patients with chronic obstructive pulmonary disease initiating long-acting mono bronchodilator therapy.

BACKGROUND: Randomized clinical trials have shown long-acting mono bronchodilator therapy to be efficacious in improving lung function and dyspnea, while reducing exacerbations; however, less is known regarding the effectiveness in routine clinical practice. This study examined treatment patterns, rescue medication use, healthcare resource utilization and costs, and exacerbations in patients with chronic obstructive pulmonary disease (COPD) who initiated long-acting mono bronchodilator therapy in real-world settings. METHODS: This retrospective study used US claims data from adult patients with COPD initiating long-acting mono bronchodilator therapy between 1 January 2008 and 31 January 2015. Patients were required to have continuous health plan enrollment 12 months prior to (baseline period) and 12 months following therapy initiation (follow-up period). Outcomes, including treatment patterns, rescue medication use, exacerbations, and healthcare utilization and costs, were measured until the earliest of treatment augmentation or discontinuation, death, health plan disenrollment, or the end of the study period. Results were analyzed descriptively for all measures. Baseline and follow-up measures of all-cause and COPD-related healthcare costs and exacerbations [per patient per month (PPPM)] were compared using paired t tests. RESULTS: Among 27,394 patients with a mean follow up of 6.3 months, 18.2% augmented, 74.2% discontinued, and 7.6% continued long-acting mono bronchodilator therapy. Rescue medication use was prevalent during the follow-up period, with an average of 1.0 short-acting ß agonist (SABA) fills/month and 0.8 short-acting muscarinic antagonist (SAMA) fills/month, among patients with at least one fill for the medication of interest. PPPM mean number of exacerbations was more than triple (0.17 versus 0.05, p < 0.001) and PPPM exacerbation-related costs were more than double over the follow-up period compared with baseline ($1070 versus $485). COPD-related costs accounted for 50% of all-cause costs during the follow-up period and were significantly higher compared with baseline ($1206 versus $592, p < 0.001). CONCLUSIONS: Patients initiating long-acting mono bronchodilator therapy had high rates of medication discontinuation or augmentation. Patients used more rescue medications and experienced significantly more COPD exacerbations with higher healthcare costs compared with baseline. Further research is warranted to determine whether more aggressive initial therapy would result in symptom improvement.

Herpes zoster incidence and cost in patients receiving autologous hematopoietic stem-cell transplant.

OBJECTIVE: Among patients receiving autologous hematopoietic stem cell transplant (Auto-HSCT), this study estimated the incidence of herpes zoster (HZ), compared healthcare costs among patients with and without HZ, and evaluated antiviral prophylaxis (AP) use. RESEARCH DESIGN AND METHODS: A retrospective study was conducted using data from a large health plan to identify patients ≥18 years with ≥1 claim for an Auto-HSCT procedure during 2006-2011 (n = 2,530). Patients were followed from date of Auto-HSCT until risk-end date, defined as development of HZ, end of enrollment, death, or December 31, 2011. HZ incidence was calculated as cases observed after Auto-HSCT, divided by accrued time-at-risk in person-years (PY). AP use and duration were defined by prescription fills. One-year medical and pharmacy costs were calculated as combined health plan and patient paid amounts. MAIN OUTCOME MEASURES: HZ incidence and healthcare costs were calculated using administrative claims data. RESULTS: Overall HZ incidence was 62.2/1,000 PY (95% CI = 54.3-70.9). Most (72.3%) patients were prescribed AP. During the first 90-days post-Auto-HSCT, patients without AP had increased incidence (151.6/1,000 PY, 95% CI = 88.3-242.6) compared to those prescribed AP pre- (30.9/1,000 PY, 95% CI = 11.3-67.2) or post-Auto-HSCT (33.0/1,000 PY, 95% CI = 13.3-67.9). Total adjusted mean 1-year all-cause healthcare costs were $74,875 for patients who developed HZ and $70,279 for patients who did not (difference = $4,596 (cost ratio = 1.07, 95% CI = 0.86-1.32, p = .566)). CONCLUSIONS: HZ incidence was high, despite AP use. Mean annual healthcare costs were higher for patients with HZ, but the difference was not statistically significant. An effective vaccine against HZ could be useful in decreasing both incidence of and cost for HZ in this population.

Treatment Discontinuation, Adherence, and Real-World Effectiveness Among Patients Treated with Ledipasvir/Sofosbuvir in the United States.

INTRODUCTION: Ledipasvir/sofosbuvir (LDV/SOF) for hepatitis C virus (HCV) treatment provides an oral interferon-free treatment regimen with high rates of sustained virologic response (SVR). This study assessed treatment discontinuation, factors associated with treatment completion, and real-world effectiveness. METHODS: Patients with HCV treated with LDV/SOF between October 2014 and June 2015 and enrolled in a large US health plan were identified. Expected treatment duration was calculated based on IDSA/AASLD treatment guidelines and US labels using data for genotype, initial treatment regimen, baseline cirrhosis, and prior treatments. Logistic regression was used to identify factors associated with treatment completion, controlling for patient characteristics. RESULTS: The study included 1483 LDV/SOF patients. Mean age was 59.7 years, most were male (63.9%), had commercial insurance (51.9%), and were treatment-naïve (85.6%). Cirrhosis or end stage liver disease was present in 46.1%. Among patients with an expected 8-week treatment regimen, 49.4% were treated for longer. Most patients (99.8%) with expected 12-week treatment durations were adherent to the expected treatment duration. Treatment-experienced patients [odds ratio (OR) 0.124, p < 0.001] and those on Medicare (OR 0.382, p = 0.039) had lower odds of completing the expected treatment regimen, while males were more likely to complete treatment than females (OR 3.235, p = 0.003). SVR12 in patients treated with LDV/SOF was 89.4% (n = 76/85). CONCLUSION: Half of patients eligible for an 8-week treatment regimen with LDV/SOF were treated longer, while most patients with a 12-week regimen were adherent to the expected treatment duration. Prior HCV treatment, female gender, and Medicare Advantage insurance were associated with lower odds of treatment completion. Overall SVR12 was 89.4%. FUNDING: Merck & Co. Inc.

Disease Burden, Early Discontinuation, and Healthcare Costs in Hepatitis C Patients with and without Chronic Kidney Disease Treated with Interferon-Free Direct-Acting Antiviral Regimens.

BACKGROUND: Hepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited. OBJECTIVE: This study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Comorbidities, early discontinuation rates, and healthcare costs were compared between patients with and without CKD. METHODS: Patients with HCV who were treated with oral DAAs between November 2013 and June 2015, and who were enrolled in a US health plan, were identified. Early discontinuation was calculated based on observed versus expected treatment duration, and expected treatment duration was based on genotype, initial treatment regimen, baseline cirrhosis, and prior treatments. Healthcare costs were calculated during the baseline, treatment, and post-treatment periods. RESULTS: This study included 3438 patients receiving oral DAAs, of whom 6.9% had a CKD diagnosis. CKD patients were more often male (70.8 vs. 62.9%, p = 0.02) and older (mean age 62.0 vs. 58.8 years, p < 0.001) than non-CKD patients, and had a higher prevalence of most comorbidities. Among early discontinuers, CKD patients were more likely to experience anemia (19.4 vs. 7.7%, p = 0.028). CONCLUSIONS: Few patients with CKD receive DAA treatment for HCV infections. HCV patients with CKD had significantly more comorbidities and higher baseline healthcare costs than patients without CKD. Compared with non-CKD patients, CKD patients were equally likely to discontinue DAA treatment early but had higher rates of anemia. This study highlights the need for more renal-friendly HCV therapies.

Healthcare utilization and costs among patients with herpes zoster and solid tumor malignancy on chemotherapy: A retrospective cohort study.

Immunosuppressed patients with solid tumor malignancies (STMs) are particularly vulnerable to herpes zoster (HZ). This study estimated the incidence of HZ and evaluated healthcare resource utilization and costs for persons with STM receiving chemotherapy with and without incident HZ.We conducted a retrospective claims study of adults with STM receiving chemotherapy between January 1, 2010 and June 30, 2014. Patients were followed from their first chemotherapy date through development of HZ, health plan disenrollment, the study end date, or 24 months. HZ incidence was calculated and stratified by patient characteristics. Adjusted HZ incidence was estimated using Poisson regression. Healthcare resource utilization and costs were compared between patients with HZ (cases) and propensity score-matched controls without HZ during a variable follow-up period. Adjusted healthcare costs were estimated using Lin regression to control for informative censoring.Of 155,480 patients with STM receiving chemotherapy, 3100 (2.0%) developed HZ, yielding an adjusted HZ incidence rate of 13.8/1000 person-years (PY). HZ cases (n = 3004) had significantly higher healthcare resource utilization than matched controls (n = 15,020). Adjusted annual costs were $48,077 for cases vs $41,645 for matched controls, corresponding to a differential cost of $6432 annually.After adjustment for potential confounders, patients with STM receiving chemotherapy had an HZ incidence of 13.8/1000 PY; those who developed HZ used more healthcare resources and incurred higher costs than those who did not. These findings suggest that HZ prevention by vaccination could improve outcomes and reduce costs in this population.

Longitudinal treatment patterns among US patients with atherosclerotic cardiovascular disease or familial hypercholesterolemia initiating lipid-lowering pharmacotherapy.

BACKGROUND: The most recent American College of Cardiology-American Heart Association guidelines recommend high-dose statin therapy for most patients with confirmed atherosclerotic cardiovascular disease (ASCVD) and patients with high cardiovascular risk. There is limited information regarding long-term treatment patterns among these patients. OBJECTIVE: To examine longitudinal treatment modifications in patients with ASCVD or familial hypercholesterolemia (FH). METHODS: This retrospective analysis of administrative claims data identified patients initiating statin or ezetimibe therapy between January 1, 2007, and December 31, 2012, who had evidence of ASCVD or FH. Patients were followed for up to 3 years and up to 4 treatment episodes. After initial treatment, subsequent treatment episodes began on the date of a treatment modification, which included discontinuation, statin dose change, switching, and augmentation. RESULTS: A total of 92,621 patients (mean age 64.7 years, 57.3% male) were identified; 91,740 had ASCVD, 937 had FH (56 had both). Most ASCVD (89.6%) and FH (85.8%) patients initiated on statin monotherapy. The most common treatment modification in the first treatment episode was discontinuation (ASCVD: 42.0%; FH: 58.4%); among patients who discontinued, most reinitiated therapy (70.5% of ASCVD, 76.8% of FH). Most ASCVD (68.2%) and FH (71.1%) patients initiated on moderate-dose statins; statin dose increase occurred in 10.3% of ASCVD and 18.5% of FH patients in the first episode. CONCLUSION: Among patients with high cardiovascular risk, most initiated on moderate-dose statins with infrequent uptitration. In light of the recent American College of Cardiology-American Heart Association guidelines, statin initiation practices will need to change to ensure appropriate therapy for high-risk patients.

Persistence and compliance among U.S. patients receiving pazopanib or sunitinib as first-line therapy for advanced renal cell carcinoma: a retrospective claims analysis.

BACKGROUND: For first-line therapy options for advanced renal cell carcinoma (RCC), clinical trials have demonstrated similar efficacy for pazopanib and sunitinib as well as differing side-effect profiles, which may affect patient persistence in self-administration of these oral medications. However, the treatment patterns of each drug in real-world clinical practice, as opposed to the controlled environment of a trial, have not been directly compared. OBJECTIVE: To compare persistence and compliance (adherence) with pazopanib versus sunitinib in a real-world setting. METHODS: This was a retrospective claims analysis using 2 databases: Optum Research Database and Impact National Benchmark Database. Eligible patients included adult patients (aged ≥ 18 years) with ≥ 2 RCC diagnoses and evidence of first-line therapy with ≥ 1 subsequent pharmacy claim for pazopanib or sunitinib between October 2009 and July 2012. The date of the first pazopanib or sunitinib claim was defined as the index date. Additional requirements included continuous enrollment in the health plan for 2 months prior (baseline period) through 6 months after (follow-up period) the index date and no cancers other than those associated with RCC. Propensity score matching was used to minimize selection bias. Persistence with the index drug was compared using days to discontinuation, estimated level of persistence (ELPT) at 180 days, and proportion of days covered (PDC). PDC was defined by dividing the number of days covered with the index drug by the number of follow-up days. Compliance was estimated using medication possession ratio (MPR). For matched cohort pairs with > 1 fill, MPR was defined by dividing the number of days covered with the index drug by the number of days between the first and last index medication fill. RESULTS: We identified 84 matched pairs among 97 patients prescribed pazopanib and 349 prescribed sunitinib. Among the matched population, mean comorbidity index score was 5.8 (95% CI = 1.8-6.0) for pazopanib, and 6.1 (95% CI =1.8-6.0) for sunitinib (P = 0.133). Evidence of any radiation therapy during the baseline period was significantly higher among the sunitinib cohort prior to matching (9% vs. 18%, P = 0.043), and evidence of surgery was higher in the pazopanib cohort after matching (12% vs. 7%, P = 0.046). Cohorts were balanced according to demographic and clinical characteristics with mean (SD) age of 63.0 (9.0) years and 77.4% male. During the 6-month period after drug initiation, there was no significant difference (P > 0.05) by drug cohort in the duration of index drug therapy or the percentage of patients who discontinued their index drugs. The mean (SD) time to discontinuation was 133.4 (62.8) days and 139.9 (55.6) days among the matched pazopanib and sunitinib cohorts, respectively (P = 0.445). In both cohorts, more than 40% of patients discontinued their index drugs (46.4% pazopanib and 44.1% sunitinib, P = 0.732). In addition, there was no significant difference by drug cohort in the ELPT at any time examined between 30 and 180 days after initiation of therapy. PDC with the index drug during the fixed 6-month follow-up was also examined. Although the mean PDC was significantly higher among the sunitinib cohort (0.77 vs. 0.68 for pazopanib, P = 0.037), there was no difference by cohort in the percentage of patients with high PDC (defined as ≥ 80%): 52.4% versus 56.0% for pazopanib and sunitinib, respectively (P = 0.622). Mean MPR among matched pairs with at least 2 fills for the index drug was significantly higher among the sunitinib cohort, although there was no difference by cohort in the percentage of patients with high MPR (defined as ≥ 80%): 81.4% versus 93.2% for pazopanib and sunitinib, respectively (P > 0.071). CONCLUSIONS: In the first 6 months of treatment, persistence and compliance to pazopanib and sunitinib were similar. Future studies are needed, including those assessing larger cohorts and longer follow-up periods.

Diagnostic testing managed by hematopathology specialty and other laboratories: costs and patient diagnostic outcomes.

BACKGROUND: Successful management of patients with hematologic malignancies depends upon accurate and timely diagnosis, which frequently requires integration and interpretation of multiple tests. Our retrospective analysis compared diagnostic uncertainty, resource utilization, and costs for patients with diagnostic bone marrow (BM) tests managed by commercial laboratories. METHODS: Patients with BM biopsies and suspected hematologic cancer/condition were identified from claims (2005-2011) within a large US health plan (coverage ≥6 pre- and ≥3-months post-biopsy). Cohorts defined by laboratories performing BM morphologic assessment/directing testing sequence: Genoptix (GX, specialty hematology-testing laboratory), large commercial laboratories (LL), other laboratories (OL). One-year post-biopsy changes in diagnosis or treatments, tests performed, and diagnostic/treatment medical costs (measured as per-patient-per-month [PPPM]) were examined. RESULTS: The study population included 1,387 GX, 4,162 LL, and 19,115 OL patients with suspected hematologic malignancy/disease and BM morphology assessment. GX had lower diagnostic uncertainty measured between 2 time periods by diagnostic stability (no conditions the same; 6.16% GX, 8.04% LL, 9.73% OL; p < 0.001) and changes (≥1 condition different; 7.88% GX, 11.19% LL, and 14.08% OL; p < 0.001), fewer repeat BM biopsies, and fewer chemotherapy changes (30-days and 60-days post-initiation). One-year PPPM costs adjusted for patient characteristics differences were $8,202 GX, $7,711 LL, and $10,302 OL (p < 0.05); adjusted PPPM costs (excluding testing period) were $6,019 GX, $6,649 LL, and $7,801 OL (p < 0.05). CONCLUSIONS: Our data suggests that a hematopathology specialty laboratory may result in earlier final diagnosis, fewer subsequent diagnosis changes, reduced need for follow-on testing requiring repeat biopsy procedures, and may result in lower downstream healthcare costs. Further evaluations using medical chart abstractions or registries will be valuable.