Background-Oral anticoagulation therapy is the primary tool in reducing stroke risk in patients with nonvalvular atrial fibrillation but is underused. Patients nonpersistent with therapy contribute to this underuse. The objective of this study was to compare persistence rates in newly diagnosed nonvalvular atrial fibrillation patients treated with warfarin versus dabigatran as their oral anticoagulation. Methods and Results-US Department of Defense administrative claims were used to identify patients receiving warfarin or dabigatran between October 28, 2010, and June 30, 2012. Patient records were examined for a minimum of 12 months before index date to restrict the analyses to those newly diagnosed with nonvalvular atrial fibrillation and naive-to-treatment, identifying 1775 on warfarin and 3370 on dabigatran. Propensity score matching was used to identify 1745 matched pairs. Persistence was defined as time on therapy to discontinuation. Kaplan-Meier curves were used to depict persistence over time. Cox proportional hazards model was used to determine the factors significantly associated with persistence. Using a 60-day permissible medication gap, the persistence rates were higher for dabigatran than for warfarin at both 6 months (72% versus 53%) and 1 year (63% versus 39%

SRSE is associated with high mortality and morbidity, which place a high burden on healthcare resources. Projections based upon the findings of this study suggest an estimated 25,821-41,959 cases of SRSE may occur in the US each year, but more in-depth studies are required.

PurposePatients with bone metastases are at an increased risk of experiencing morbidity due to bone complications, and bone-targeting agents (BTA) are indicated for the prevention of these complications. Population-based estimates of the prevalence of bone metastases associated with solid tumors, and current treatment patterns for these patients, are limited. This study was undertaken to estimate the prevalence of bone metastases from solid tumors and to describe recent trends in the use of BTA in the US.MethodsWe estimated the prevalence of bone metastases in the US in 2012 using data from Medicare fee-for-service and PharMetrics Plus, a large commercial claims database. We evaluated the proportion of patients with bone metastases who were treated with BTA in 2012, timing of initiation of BTA relative to bone metastasis diagnosis, and persistence on BTA, overall and by primary tumor type and treatment.ResultsThere were ~330,000 (168,063 Medicare fee-for-service; 162,239 other) patients aged ≥18 years living with solid tumors and bone metastases in 2012. BTA were used by 43% (Commercial) to 47% (Medicare) of patients in 2012, with the greatest use among breast cancer patients. Over half (Medicare: 57%; Commercial: 53%) of BTA-treated patients initiated BTA after experiencing a bone complication.ConclusionOf the estimated 330,000 solid tumor patients living with bone metastases in the US in 2012, many may have received less than optimal care to prevent bone complications during the calendar year.

Chronic hepatitis C virus (HCV) infection can lead to advanced liver disease (AdvLD), including cirrhosis, decompensated cirrhosis, and liver cancer. The aim of this study was to determine recent historical rates of HCV patient progression to AdvLD and to project AdvLD prevalence through 2015. We first determined total 2008 US chronic HCV prevalence from the National Health and Nutrition Evaluation Surveys. Next, we examined disease progression and associated non-pharmacological costs of diagnosed chronic HCV-infected patients between 2007–2009 in the IMS LifeLink and CMS Medicare claims databases. A projection model was developed to estimate AdvLD population growth through 2015 in patients diagnosed and undiagnosed as of 2008, using the 2007–2009 progression rates to generate a “worst case” projection of the HCV-related AdvLD population (i.e., scenario where HCV treatment is the same in the forecasted period as it was before 2009). We found that the total diagnosed chronic HCV population grew from 983,000 to 1.19 million in 2007–2009, with patients born from 1945–1964 accounting for 75.0% of all patients, 83.7% of AdvLD patients, and 79.2% of costs in 2009, indicating that HCV is primarily a disease of the “baby boomer” population. Non-pharmacological costs grew from $7.22 billion to $8.63 billion, with the majority of growth derived from the 60,000 new patients that developed AdvLD in 2007–2009, 91.5% of whom were born between 1945 and 1964. The projection model estimated the total AdvLD population would grow from 195,000 in 2008 to 601,000 in 2015, with 73.5% of new AdvLD cases from patients undiagnosed as of 2008. AdvLD prevalence in patients diagnosed as of 2008 was projected to grow 6.5% annually to 303,000 patients in 2015. These findings suggest that strategies to diagnose and treat HCV-infected patients are urgently needed to increase the likelihood that progression is interrupted, particularly for patients born from 1945–1964.

Despite higher pharmacy costs for NVAF patients initiated on dabigatran vs warfarin, this was more than offset by lower utilization of medical care resources.

No abstract

Background Chronic Graft-Versus-Host Disease (cGVHD) is a complication of hematopoietic cell transplantation (HCT). While the clinical outcomes of cGVHD are well documented, few studies have assessed its treatment practices in the real-world. The objectives of this study are to quantify the prevalence of cGVHD, to examine provider prescribing patterns, and to evaluate the healthcare cost and resource utilization (HCRU) in a real-world US cGVHD population. Methods This study analyzed de-identified claims from the Medicare FFS 5% sample for beneficiaries enrolled from 2013-2016 and Pharmetrics commercial 2013-2018 databases to identify cGVHD in allogenic HCT patients. cGVHD was identified based on ICD-9/10 diagnosis codes for cGVHD or unspecified GVHD with a first diagnosis >180 days post HCT, or subsequent unspecified GVHD diagnosis >12 months post index diagnosis. Chronic GVHD prevalence was estimated by calculating age-adjusted prevalence rates within the Medicare and Pharmetrics sample populations and applying rates to the total US patient subpopulations as determined by CMS and Census data. Prevalence estimates were based on the last complete year of both Medicare FFS and Pharmetrics data (2016). Longitudinal and Line of Therapy (LOT) analyses were based on data from 2013-2018. A new LOT was defined as starting with the addition of systemic therapy to a patient's cGVHD regimen, regardless of prior lines of therapy or prior treatment. Treatments that stopped and restarted within 60 days were considered continuous treatment. Healthcare costs were calculated by adding the inpatient, outpatient, and pharmacy insurer and beneficiary paid amounts for the commercially insured population. Total HCRU was assessed using the number of inpatient and outpatient visits following the initial cGVHD diagnosis. Results In 2016, the projected prevalence of cGVHD in the US based on the Medicare FFS and Pharmetrics commercial databases was 14,017 individual patients. Within 3 years post allogeneic HCT, 42% of patients developed cGVHD; 66% of cGVHD patients had a prior diagnosis of acute GVHD. The majority of cGVHD patients received at least one systemic therapy; 71% and 47% of cGVHD patients progressed to a second and third LOT, respectively (Table 1). Of patients that received a second and third LOT, the average time from diagnosis to the second and third LOT was approximately 7 months and 10 months, respectively. Over 80% of cGVHD patients received systemic corticosteroid therapy for the treatment of cGVHD within 12 months post diagnosis, and 41% of cGVHD patients were receiving a corticosteroid within the 30 days prior to diagnosis. Within the 12 months post cGVHD diagnosis, most patients received a corticosteroid or a corticosteroid combination as a first LOT (57%), which decreased slightly as patients progressed to second and third line of therapy (49% and 48%, respectively). A total of 25 unique therapeutic agents and over 150 combinations were used in second and third LOT. While newer agents, such as ibrutinib and ruxolitinib, are continuing to increase in utilization among cGVHD patients, these therapies are only used among 1% (ibrutinib) and 1-3% (ruxolitinib) of patients through their first three lines of therapy in the patients captured in Pharmetrics commercial database through June 2018. In the 12 months post diagnosis, cGVHD patients had an average of 21.0 GVHD-related inpatient and outpatient visits (2.8 inpatient and 18.2 outpatient visits). In 2016 the average total annual cost per commercially insured cGVHD patient was $291,357. Conclusion A significant proportion of allogenic HCT patients continue to develop cGVHD, and despite advances in the understanding of cGVHD, corticosteroids remain the mainstay of therapy. However, most cGVHD patients are not adequately managed with first line corticosteroids, and many patients are cycling through several therapies, likely in part due to lack of efficacy and toxicity associated with currently available treatments. Real-world utilization of systemic therapies is highly variable, particularly for patients who progress beyond the first LOT, which highlights the need for evidence-based treatment approaches. cGVHD is a highly burdensome complication of allogenic HCT, and safer, more effective treatments are needed as many patients are not currently well managed on available therapies. Disclosures Bachier: Viracyte: Consultancy; Kadmon Corporation, LLC: Consultancy; Sanofi: Speakers Bureau. Aggarwal:Kadmon Corporation, LLC: Employment, Equity Ownership. Hennegan:Kadmon Corporation, LLC: Consultancy. Milgroom:Kadmon Corporation, LLC: Consultancy. Francis:Kadmon Corporation, LLC: Consultancy. Rotta:Jazz: Speakers Bureau; Kadmon Corporation, LLC: Consultancy.

Introduction: Population-based cancer registries, such as the National Cancer Institute Surveillance, Epidemiology and End Results (SEER) program and the North American Association of Central Cancer Registries (NAACCR) are the largest sources of information for cancer epidemiology and statistics. The most recent acute myeloid leukemia incidence estimate from SEER (2011) is 17.5 per 100,000 (N=7,245) among the US ≥65 year-old population; however, recent studies suggest these registries may underreport cancer rates due to reasons including sequencing of diagnoses and inpatient reporting requirements. For cancers such as myelodysplastic syndrome (MDS) and acute and chronic myeloid leukemia (AML & CML), this is concerning as they are more likely to occur after initial diagnosis of other cancers. A recent study independently calculated MDS, AML and CML cases from 2000-2005 using a Medicare claims-based algorithm and concluded that SEER and NAACCR failed to capture a substantial number of cases and the true incidence was 50-75% greater than reported (Cogle, et al., 2012). Updated AML epidemiology statistics outside of SEER and NAACCR have not been published. Objective: To employ a Medicare claims-based algorithm to estimate gender- and age-specific AML incidence and prevalence among the 2012 US Medicare fee-for-service (FFS) population. Methods: A retrospective analysis of claims using 2012 Centers for Medicare and Medicaid Services (CMS) data included an Institutional sample (100%) and random Non-Institutional Carrier samples (5%) which together represented the healthcare utilization of Medicare Part A & B (Medicare FFS) beneficiaries. AML diagnoses were identified using ICD-9 codes and AML treatments identified using HCPCS J Codes and ICD-9 infusion codes. Prevalent AML patients were defined as having ≥2 AML diagnoses associated with medical claims OR 1 AML medical claim and 1 AML treatment. A sub-population of all prevalent AML patients without historical AML diagnoses or treatments during the prior 2 years were identified as new (incident) AML patients.Analyses were computed by gender and two age-cohorts (<65 and ≥65 years old). Patients in the Institutional 100% dataset were considered census and no weighting was required but appropriate weights were used to project the 5% random carrier sample (<9% of AML patients) to the Medicare FFS population. Results: Of 34.2 million Medicare FFS beneficiaries, 15,976 had AML, a prevalence rate of 0.05% (Table). Most were ≥65 years old (N=11,936; 75%) and prevalence did not vary between age groups; however, women ≥65 years old had a significantly lower prevalence than men ≥65 years old (0.03% vs. 0.06%; z=31.2, p<.001) as men were nearly twice as likely to be diagnosed with AML (RR=1.86, 95% CI: 1.78, 1.95). There were no gender differences in incidence among younger patients (18.6 per 100,000 for men vs. 18.4 per 100,000 for women). A high proportion of AML patients were newly diagnosed (N=9,074; 57%). Conclusions : Our AML incidence estimate for the ≥65 year Medicare FFS cohort of 29.0 per 100,000 (N=7,582) is substantially higher than incidence estimate reported by SEER for this age group. As only 70-80% of the ≥65 year-old population is covered under Medicare FFS, the total number of ≥65 incident patients is likely higher than reported by SEER. Registries may be underreporting AML due to methodological differences. Furthermore, the 15,976 prevalent patients in Medicare FFS alone may be much higher than previously known. Claim-based algorithms may provide higher AML estimates than current SEER methodology. Further research should investigate claims data in the remaining ≥65 year-old population covered under Medicare Advantage and a younger, non-Medicare FFS population sample more representative of persons <65 years of age. Table One-year Prevalence and Incidence Rates of AML in the Medicare FFS Population, 2012 Population, N 1-year AML Incident per 100,000, n (%) 1-Year AML Prevalence, n (%) Overall 34,216,076 9,074 (26.5) 15,976 (0.05) <65 years 8,064,566 1,492 (18.5) 4,040 (0.05) ≥65 years 26,151,510 7,582 (29.0) 11,936 (0.05) Male 15,329,040 5,181 (33.8) 8,854 (0.06) Female 18,887,036 3,893 (20.6) 7,121 (0.04) Male, <65 years 4,137,155 770 (18.6) 2,061 (0.05) Male, ≥65 years 11,191,885 4,410 (39.4) 6,793 (0.06) Female, <65 years 3,927,411 722 (18.4) 1,978 (0.05) Female, ≥65 years 14,959,625 3,171 (21.2) 5,143 (0.03) Disclosures Turbeville: Sunesis Pharmaceuticals, Inc.: Employment. Morrison:Sunesis Pharmaceuticals, Inc.: Employment.