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This study assessed healthcare costs of first-line treatment failure (TF) in patients with chronic lymphocytic leukemia (CLL), a subtype of non-Hodgkin's lymphoma.Pre-diagnosis treatment-naïve adults with ≥2 CLL diagnoses initiated on an antineoplastic agent (index date) after their first CLL diagnosis with ≥12 and ≥6 months of continuous observation pre- and post-index, respectively, were selected from the Truven Health MarketScan Research Databases. Patients had no solid malignancies in the pre-index period nor selected blood malignancies at any time. Initial therapy included antineoplastic agents initiated in the first 30 days post-index. TF occurred at the earliest of: initiation of a new antineoplastic agent, treatment resumption following a ≥3 month break, non-chemotherapy intervention (stem cell transplant or radiotherapy), hospice care or hospital mortality. The cost of TF was evaluated as the healthcare cost difference between patients with and without first-line TF using ordinary least square regressions adjusted for baseline characteristics. Non-parametric bootstrap was used to evaluate statistical significance.Among 2226 patients identified (mean age: 68 years; female: 41%), 46% experienced first-line TF. The average TF cost was $3011 per patient per month (p .001). When stratifying patients by event indicating TF and by most common therapies, non-chemotherapy intervention ($7582 per patient per month; p .0001) and fludarabine/cyclophosphamide/rituximab ($4758; p .001) were associated with the highest TF cost, respectively.The cost of first-line TF is high and varies across first-line therapies. This should be considered when selecting the initial therapy in these patients.

Purpose To assess the clinical and economic outcomes among patients with chemotherapy-induced anemia (CIA) treated with United States Food and Drug Administration-approved fixed dosing regimens of erythropoiesis-stimulating agents (ESA). Methods Data were employed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) registry to evaluate CIA patients who were initiated on either epoetin alfa (EPO) 40,000 Units (U) or darbepoetin alfa (DARB) 500 micrograms (mcg) between January 1, 2006 and May 8, 2009. Study measurements included ESA treatment dose and dose ratio, changes in hemoglobin (Hb) levels from baseline, and cumulative ESA costs. Results Five hundred forty patients treated in 44 clinical centers were evaluated, of which 420 were initiated on EPO 40,000 U and 120 were initiated on DARB 500 mcg. Both cohorts had similar baseline characteristics, although EPO patients were less likely than DARB patients to have received iron supplementation before ESA initiation (11.4% EPO vs. 20.0% DARB, p = 0.015). The EPO-to-DARB dose ratio based on cumulative ESA dose was 169:1 (U EPO: mcg DARB). EPO patients showed statistically greater Hb improvement compared to DARB patients, and compared to EPO patients, a greater proportion of DARB patients required a blood transfusion (13.9% EPO vs. 22.5% DARB, p = 0.026). Mean cumulative ESA cost was significantly lower for EPO patients than DARB patients ($4,261 EPO vs. $8,643 DARB, p

OBJECTIVE To compare drug-utilization patterns and costs in patients with chronic kidney disease (CKD), not on dialysis, yet receiving epoetin alfa (EPO) or darbepoetin alfa (DARB) in a long-term care setting. DESIGN A retrospective analysis of pharmacy dispensing from January 2007 through March 2009, was conducted using the AnalytiCareSM LTC database. SETTING Long-term care. PATIENTS, PARTICIPANTS Patients>or=18 years of age, with >or=1 EPO or DARB dose dispensed, were included. Patients dispensed both agents, diagnosed with cancer, receiving chemotherapy, radiation therapy, or renal dialysis, were excluded. MAIN OUTCOME MEASURES Mean cumulative erythropoiesis-stimulating agent (ESA) dose was used to calculate drug cost (using April 2009 wholesale acquisition cost) and dose ratio (Units EPO:mcg DARB). Results were also stratified by payer types. RESULTS A total of 2,259 patients were identified (EPO 1,640; DARB 619). EPO patients were slightly older (76.1 vs. 74.8 years of age, P=0.021), with similar proportion of women, compared with DARB patients. Mean (SD) cumulative dose was 98,420 (122,381) Units for EPO and 360 (428) mcg for DARB, resulting in a dose ratio of 273:1 (Units EPO:mcg DARB). The corresponding drug cost was 42% higher with DARB than with EPO ($1,734 vs. $1,217, P

e19037 Background: Treatment failure (TF) is associated with significant cost burden in patients with non-Hodgkin’s lymphoma (NHL) in the US. This study assessed treatment patterns and healthcare cost burden of first-line (FL) TF in patients with chronic lymphocytic leukemia (CLL), a subtype of NHL, overall, and for the top 5 FL regimens. Methods: A retrospective study of a large national claims database identified adult patients with CLL who initiated an antineoplastic agent (AA) after their first CLL diagnosis (index date) from 01/2011- 07/2016. Patients included had ≥12 and ≥6 months of observation pre- and post-index, respectively, and were treatment-naïve with no solid or selected blood malignancies in the pre-index period. FL therapy included AA administered within the first 30 days post-index. TF occurred at the earliest of: initiation of a new AA, resumption of initial treatment following a gap of ≥3 months, radiotherapy, stem cell transplant, or hospice care. The total cost difference between patients with and without FL TF was estimated using ordinary least squares regressions adjusted for baseline characteristics. Non-parametric bootstrap was used to estimate confidence intervals (CI) and p-values. Results: Among the 2,226 patients included (mean age: 68 years; female: 41%), 46% experienced FL TF. Overall, the average adjusted total cost difference between patients with and without FL TF was $3,011 per patient per month (PPPM) (95% CI: 2,400, 3,583; P < 0.001). Among the 5 most common FL regimens, fludarabine / cyclophosphamide / rituximab (FCR) regimen was associated with the highest PPPM cost of TF (N = 281; $4,758; 95% CI: 2,652, 7,346), followed by other cyclophosphamide-based regimens (N = 142; $4,579; 95% CI: 2,474, 6,311), chlorambucil-based regimens (N = 223; $3,761; 95% CI: 2,029, 5,602), bendamustine / rituximab (BR) regimen (N = 592; $3,163; 95% CI: 2,206, 4,148), and other rituximab-based regimens (N = 474; $3,030; 95% CI: 2,164, 3,956) (P < 0.001 for all). Conclusions: The most common FL regimens used in patients with CLL were associated with 46% treatment failure. Clinicians should consider the cost of treatment failure when selecting the initial therapy in these patients.

e18529 Background: Management of older patients with acute myeloid leukemia (AML) is challenging due to a higher comorbidity burden, poorer performance status and less favorable biology. This study assessed treatment patterns and healthcare resource utilization (HRU) in the US in patients diagnosed with AML aged ≥65 years who did not receive intensive chemotherapy. Methods: Patients aged ≥65 years with ≥2 diagnoses for AML were identified from the Truven Health MarketScan Analytics Databases (01/01/2011-07/31/2016). Patients had ≥1 bone marrow diagnosis procedure (BX; first AML diagnosis following BX defined as the index date), ≥12 months of continuous eligibility pre-index, no treatment with intensive chemotherapy at any time, no diagnosis for AML relapse or remission or stem cell transplant before BX, and

Abiraterone acetate, an androgen biosynthesis inhibitor, received FDA approval in 2011 for metastatic castration-resistant prostate cancer (mCRPC) patients who have received prior chemotherapy containing docetaxel.To estimate the projected budgetary impact of adopting abiraterone for mCRPC patients from a U.S. health plan perspective.A decision analytic model compared mCRPC treatment cost before and after abiraterone acetate adoption based on a hypothetical 1,000,000-member plan. Plan mCRPC prevalence was derived from prostate cancer incidence reported in U.S. epidemiology statistics and disease progression data from published trials. Market shares for comparator mCRPC treatments (prednisone alone; cabazitaxel + prednisone; mitoxantrone + prednisone; docetaxel retreatment + prednisone) were derived from market research simulation. Abiraterone + prednisone uptake (8% - scenario 1 to 55% - scenario 3) was based on assumptions for illustrative purposes. Treatment costs were computed using prescribing information, treatment duration from phase III trials, and drug costs considering common U.S. cost listing and reimbursement schemes. Prevalence and costs of managing treatment-related toxicities were estimated from literature, treatment guidelines, and expert clinical opinion. The model evaluated the perspectives of a commercial payer with no Medicare beneficiaries and a commercial payer with a subset of Medicare beneficiaries. Sensitivity analyses were conducted to assess changing input values.In each modeled scenario, 57 patients with prior docetaxel therapy received treatment for mCRPC. For the commercial perspective, the incremental per-member-per-month (PMPM) cost attributable to abiraterone ranged from $0.0019 in scenario 1 to $0.0133 in scenario 3. For the commercial/Medicare perspective, the incremental PMPM ranged from $0.0026 in scenario 1 to $0.0176 in scenario 3. The average incremental PMPM cost over 3 scenarios is $0.0112. When testing key sensitivity scenarios, the model indicated that abiraterone treatment duration and cabazitaxel market share were the main drivers of cost.The model results indicate that reimbursement for abiraterone may have a neutral impact on a U.S. health plan budget given the relatively small size of the eligible prostate cancer population and expected lower toxicity-related costs as compared with chemotherapy. The sensitivity analyses addressing the components of uncertainty in the model show that the budgetary impact of abiraterone is likely low.

INTRODUCTION AND OBJECTIVES: In advanced prostate cancer, competing therapies often offer prolongation of life or improvement in quality of life but not both. Previous studies have reported that patients with advanced cancer are not distressed by prognostic and treatment information. 2 These observations suggest that discussion of the expected benefits of each treatment option can facilitate shared decision-making allowing for incorporation of patient preferences and values into the treatment plan. We sought to understand how metastatic castrate-resistant prostate cancer (mCRPC) patients and their physicians discuss treatment goals. METHODS: This institutional review board-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant, observational, linguistic study analyzed conversations between mCRPC patients and their oncologist or urologist during a naturally-occurring clinic visit in 2011. The videotaped clinic visits had no 3rd-party observers present and both participants were interviewed separately after the visit using standardized questionnaires. All conversations were analyzed with standard anthropology and discourse analysis techniques. RESULTS: We observed a number of information gaps during 42 clinic visits involving mCRPC patients (69% African-American) and their physician (7 urologists; 7 oncologists). In particular, explicit conversation about the patients’ goals for therapy or the terminal nature of the disease did not occur in any physician-patient discussion. In postvisit interviews, physicians primarily viewed the care plan as preserving quality of life while patients tended to believe their care plan focused on extending life. Both patients and physicians assumed that their views on treatment goals were aligned with each other. The absence of direct dialogue allowed this gap to persist. CONCLUSIONS: Universally, the discussion of “quality” versus “quantity” of life is understood to be difficult. In this research, discussions about setting or revisiting treatment goals was notably absent from the patient-physician dialogue. This research highlights a need to enhance communication between patients and providers that facilitate alignment of treatment goals and expectations in mCRPC patients. Fowler FJ et al. JAMA 2000;283(24):3217-3222 Smith TJ et al. J Supportive Onc 2011;9(2):79-86.

In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level

Background: Multiple myeloma is an incurable disease with poor survival rate. Recently, novel treatments have focused on addressing unmet needs among heavily pre-treated patients who have failed prior therapies. The purpose of this analysis was to describe the characteristics of patients who are heavily pre-treated vs patients who were not, within 2 years of initiating MM therapy. Results of this analysis will help to understand the characteristics, including treatment patterns and burden, of MM patients who progress through lines of therapy over a relatively short time period. Methods: Using a US administrative claims database (Truven Health MarketScan® Database), adult patients (age ≥18) were included in the analysis if they had 1) ≥2 MM diagnoses codes (ICD-9 203.0x) on different dates between Jan 1, 2005-Mar 31, 2014 (study period); 2) MM treatment between Jan 1, 2007-Mar 31, 2012 and within 90 days of an MM diagnosis code (date of the first MM treatment set as the index date); and 3) continuous eligibility for medical insurance 24 months pre/postindex. Patients were excluded if they had 1) MM treatment during 24 months preindex; or during 24 month pre/post index had 2) moved from commercial insurance to Medicare; 3) non-MM chemotherapy; 4) pregnancy-related or stem cell transplant codes; or 5) HIV diagnosis during study period. An algorithm using dispensing dates and days supply was developed to define line of therapy (LOT) and double refractory. A new LOT was identified where there was a ≥60 day gap with no treatment, a ≥60 day gap followed by retreatment with the same drug, or where there was a change in therapy based on 30 day windows and the summed days supply of medication was >60 days. Refractory events were defined when a PI or IMiD had days supply for Results: A total of 1109 patients were included in the analysis. The percent of patients with 1, 2, 3, 4 or >4 LOT were 39.8%, 33.0%, 15.4% and 6.1% and 5.7%, respectively. A single refractory event occurred in 66 (6.0%) patients and 2 (0.2%) patients were identified as double refractory. There were 80 (7.2%) patients who were heavily pre-treated. The heavily pre-treated group had a similar percent of males (56.3%) as the non-heavily pre-treated group (54.9%; p=0.82). The heavily pre-treated group was slightly younger (66.1 vs 70.9 years; p=0.0008) and had a lower percent with Medicare coverage (55.0% vs 71.1%; p=0.0024). The heavily pre-treated group had a substantially higher percent of regimens that included both PI and IMiD in the 1st LOT (28.8% vs 7.4%; p Conclusions: In this analysis, 7.2% of non-stem cell transplant patients were heavily pre-treated at 2 years after initiating MM therapy. Heavily pre-treated patients had a faster time to initiation of 2nd LOT. They also tended to be younger. Moreover, heavily pre-treated patients were more likely to have had both a PI and IMiD as their initial therapy. Patients who were heavily pre-treated in this analysis may have had faster disease progression, which may have led to becoming heavily pre-treated within the follow-up time of the study. Additional research should further explore the disease and economic burden of these patients. Disclosures Maiese: Janssen Scientific Affairs, LLC: Employment. Macomson:Janssen Scientific Affairs, LLC: Employment. Kozma:Janssen Scientific Affairs, LLC: Consultancy. Slaton:Janssen Scientific Affairs, LLC: Consultancy. Senbetta:Janssen Scientific Affairs, LLC: Employment.

S218 506 Diffuse Large B-Cell Lymphoma in adults aged 65 years and older: A retrospective multicenter analysis of clinical characteristics and therapeutic outcomes Mehmet Hilmi Dogu, Muzaffer Keklik, Hatice Terzi, Serdal Korkmaz, Mehmet Ali Erkurt, Gulsum Akgun Cagliyan, Leylagul Kaynar, Serdar Sivgin, Ismail Sari, Ali Keskin, Mehmet Sencan, Fevzi Altuntas, Osman Ilhan Department of Hematology, Pamukkale University Faculty of Medicine; Department of Hematology, Erciyes University Faculty of Medicine; Department of Hematology, Cumhuriyet University Faculty of Medicine; Department of Hematology, Inonu University Faculty of Medicine; Department of Hematology, Bozyaka Training and Research Hospital; Department of Hematology, Yildirim Beyazit University, Ankara Oncology Hospital; Department of Hematology, Ankara University, Ibni Sina Hospital

22 Background: Patients with chronic lymphocytic leukemia (CLL) who eventually experience disease progression are offered a limited choice of treatments. This retrospective observational study assesses healthcare resource utilization and costs in patients with CLL who have received one prior therapy and experience treatment failure (TF). Methods: Adult patients with ≥1 diagnosis of CLL and ≥1 claim for a medication used to treat CLL were identified in the IMS PharMetrics Plus database (01/2008 – 09/2013). Patients were excluded if they had evidence of a non-hematologic malignancy, used a non-CLL antineoplastic agent, or received a stem cell transplant during the 12-month baseline period. TF was identified based on earliest occurrence of one of the following events: initiation of a new treatment for CLL that was not part of the 1st-line therapy, resumption of any CLL treatment following a minimum of 3-month break in treatment, stem cell transplant, radiotherapy, hospital mortality, or hospice care. Resource utilization was reported as monthly incidence rates, and costs were reported in 2013 $US per patient per month (PPPM), comparing patients with and without TF. Results: A total of 6,015 patients with CLL were identified (mean patient age: 63 years old; proportion female: 36%), of which 2,734 (45%) experienced TF. Patients with TF tended to require more OP visits (3.2 vs. 2.5). Average total cost PPPM was $7,850 for patients with TF and $4,555 for patients without TF. The main cost drivers were outpatient (OP) costs ($4,355 for patients with TF; $3,022 for patients without TF) and hospitalization costs ($2,659 for patients with TF; $1,038 for patients without TF). Once adjusted for baseline characteristics, average total cost difference between patients with and without TF was $3,757 PPPM. This difference was largely due to hospitalization (45%) and to OP costs (46%). Conclusions: Patients with CLL experiencing TF appear to require more OP visits and to be associated with higher OP and hospitalization costs PPPM compared to those without TF. These data help in our understanding of the healthcare resource utilization and costs associated with the treatment of patients with CLL.

Aim: Current frontline treatments for mantle cell lymphoma (MCL) have high initial response rate. However, most patients develop refractory or recurrent disease. This retrospective observational study describes course of treatment and occurrence of treatment failure (TF) in patients with MCL. Methods: Adult patients with ≥1 diagnosis of MCL and ≥1 claim for a medication used to treat MCL were identified in the IMS PharMetrics Plus database (January 2008 - September 2013). Patients were excluded if they had evidence of a non-hematologic malignancy, used a non-MCL antineoplastic agent, or received a stem cell transplant during the 12-month baseline period. Initial therapy was defined as the single agent or the combination of medications used to treat MCL that was given to patients in the first 30 days following the 1st claim for a medication (index date) used to treat MCL. TF was identified based on earliest occurrence of one of the following events: initiation of a new treatment for MCL that was not part of the initial therapy, resumption of any MCL treatment following a minimum of 3-month break in treatment, stem cell transplant, radiotherapy, hospital mortality, or hospice care. Results: A total of 1,316 patients with MCL were identified (mean patient age: 62 years old; proportion female: 28%). Patients were observed for 21.3 months on average following treatment initiation. Median time between 1st MCL diagnosis and 1st claim for a medication used to treat MCL was 32 days. Mean Charlson comorbidity index was 3.5. Of the 1,316 patients with MCL, 811 (62%) experienced TF. Main observed measures for TF were initiation a new MCL treatment that was not part of the initial therapy (36%; mean time to TF (TTF): 206 days), resumption of any MCL treatment (26%; TTF: 285 days), stem cell transplant (22%; TTF: 139 days), and radiotherapy (16%; TTF: 138 days). Conclusions: A majority (62%) of patients with MCL experienced TF, which was mainly observed through initiation of alternative therapies or the need for a holiday after initial therapy. These data help stakeholders understand MCL treatment failure patterns. Further research evaluating the reasons and economic implications of treatment failure is warranted. Disclosure: M.S. Senbetta: is an employee of Janssen Scientific Affairs, LLC and is a stockholder of Johnson & Johnson; M. Robitaille: is a paid consultant to Janssen Scientific Affairs, LLC; R.S. McKenzie: is an employee of Janssen Scientific Affairs, LLC and is a stock holder of Johnson & Johnson stock; P. Lefebvre: Patrick Lefebvre is a paid consultant to Janssen Scientific Affairs, LLC.

e19553 Background: In the US approximately 4,000 incident cases of mantle cell lymphoma (MCL) and 1,000 attributed deaths occur annually. Management of relapsed/refractory (R/R) MCL is challenging,...

256 Background: Data on age-specific comparisons in metastatic prostate cancer (MPC) is limited. This analysis evaluated socio-demographic and clinical characteristics among men with MPC aged Methods: Eighty-four US men aged ≥18 years with self-reported MPC completed a cross-sectional survey in January-February 2011 which collected data on socio-demographic and clinical characteristics including treatment history and source of care. Results: Forty-nine men were aged 0.05) between groups for marital status (80% of those 0.05). In addition, those Conclusions: In this study of men with MPC, those aged

229 Background: Discussions of therapeutic risk or benefit have a different tone in patients facing metastatic cancer. The literature predicts misalignment on therapy selection and communication gaps between patients and physicians. Gaps in assumed reasons for therapy selection may hinder the mCRPC patient’s ability to make fully informed decisions. (Fine, E. et al; J. Palliative Med, 2010, 13(5); 595-603.) Methods: This IRB-approved, observational, linguistic study describes naturally occurring conversations between mCRPC patients (n=42; 69% African American) and their treating urologist (n=7) or oncologist (n=7) during a normal clinic visit in Summer 2011. Clinic interactions were videotaped without 3rd party observers present. Patients and physicians were interviewed again separately after the clinic visit. All conversations were transcribed and analyzed using standard techniques from anthropology and discourse analysis fields. Results: At both a lexical and goal-oriented level, several disparities were observed. When discussing treatment options and goals for mCRPC, lexically, words used by physicians differed from those used by patients. This difference was found in physicians’ use of technical language and in language describing goals and results of therapy. Of interest, physicians consistently used vague language to describe therapeutic effect (e.g. “working”), and frequently presented treatment options without presenting treatment risks (e.g. “maybe go to another treatment altogether”). Patients and physicians also differed in the way they framed goals of therapy. Conclusions: The current research highlights communication gaps between clinicians and mCRPC patients about treatment options and risks. These results suggest that patient decision making may be hindered by a lack of clear understanding of treatment choice implications and poorly defined treatment goals. Treatments with an optimum balance of efficacy and tolerability may present an opportunity to improve this dialogue.

e16518 Background: To examine epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment patterns and erythropoiesis stimulating agent (ESA) costs in patients with cancer receiving chemotherapy (CRC). Additionally, we compared the results observed in the total study population (TSP) with a propensity score matched population (PSMP) to account for potential baseline difference that may affect ESA utilization. Methods: A medical claims analysis was conducted from 1/1/2004-7/31/2009 using the HealthCore Integrated Research Database. Patients were age ≥18 years, newly initiated on EPO or DARB, received ≥2 ESA doses, and had ≥1 claim for cancer and chemotherapy proximate to ESA treatment. Patients with myeloid leukemia, chronic kidney disease, receiving dialysis, or treated with both agents were excluded. Propensity score matching was used to identify similar populations in the EPO and DARB groups. January 2010 wholesale acquisition cost was used to calculate drug cost. Mean cumulative ESA dose and drug costs we...

PATIENT CHARACTERISTICS ASSOCIATED WITH CONTINUED ERYTHROPOIESIS STIMULATING AGENT TREATMENT IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS Marie-Helene Lafeuille, Robert A. Bailey, Mekre Senbetta, Patrick Lefebvre;Groupe d’analyse, Ltee, Montreal, Quebec, Canada; Centocor Ortho Biotech Services, LLC, Horsham, PA, USA This study describes the baseline characteristics associated with continued use of erythropoiesis-stimulating agents (ESAs) in a chronic kidney disease (CKD) population not on dialysis. Health insurance claims from the i3 InVision Data Mart (Ingenix, Eden Prairie, MN) between 10/2005 and 12/2009 were analyzed. Selected patients were ≥18 years old, had ≥1 claim for CKD, ≥1 ESA dose, and ≥90 days of follow-up after the date of the index ESA treatment. The observation period (up to one year of follow-up) was censored one month prior to the first dialysis claim for patients initiating renal dialysis during the study. Patients with cancer, myelodysplastic syndrome, or receiving chemotherapy were excluded. Patients were classified into continuedESA treatment (C-ESA, ≥3 ESA doses) and limited-ESA treatment (LESA, ≤2 ESA doses) groups. Both univariate and multivariate (logistic regression) analyses were conducted to compare baseline characteristics between the two groups. Of the 1,107 patients identified, 837 (76%) were classified into C-ESA. At index date, 62.2% of patients with L-ESA treatment were treated by a nephrologist, compared to 58.7% for the C-ESA group. Adjusted analysis revealed that lower Hb at baseline (Hb

26 PERCUTANEOUS KIDNEY BIOPSIES IN A SOUTHEASTERN TEACHING HOSPITAL: INDICATIONS, BIOCHEMICAL PROFILES, AND RECOVERED HISTOLOGICAL DIAGNOSES. Justin Bain, David Pruett, Lajos Zsom, Albert Dreisbach, T. Fulop. University of Mississippi Medical Center, Jackson, MS. Indications for procedures may evolve over time and display a regional pattern of variation as well. We sought to review our current experience with percutaneous kidney biopsy (PKB) in our institution. We have performed a retrospective data review of PKB obtained via renal trainees over a 3-year period (01/2007 12/2009) at the University of Mississippi Medical Center. We collected information on baseline parameters, underlying diagnoses, PKB indications and the recovered diagnoses. Data was analyzed with PAWS Statistics 18 and results expressed as either percents (%) or means with standard deviation (SD). The study was reviewed and approved by the University of Mississippi Human Research Office. Results from 70 PKB (71.4% native, 24.3% deceased donor) were analyzed; main indications for biopsy were impaired renal function in 37 (52.9%) and proteinuria in 33 (47.1%) patients. Baseline Blood Urea Nitrogen was 38 (29.8) mg/dL, creatinine 3.15 (3.09) mg/dL, and random urine protein/creatinine (UPC) ratio 5.85 (7.27). Mean platelet count was 274,770 (101,301)/mm3, PT 10.4 (1.1) sec, PTT 25.9 (3.1) sec. Major recovered histological diagnoses included lupus nephritis (23.5%), focal sclerosis (20.6%), chronic scarring (20.6%), acute tubular necrosis (11.8%), diabetes (7.4%), acute cellular or humoral rejection (7.4%) and membranous nephropathy (4.4%). Diabetes and lupus on biopsy correlated closely with proceeding history (r 0.580 and 0.847; p

204 Background: In metastatic prostate cancer (MPC) patients, treatment options include hormonal therapies, chemotherapy, and radiotherapy. This study quantifies the real-world healthcare resource utilization of MPC patients. Methods: Health insurance claims from 40 self-insured companies across the US (Employer [E]; 01/1999-02/2009), and from the Medicare 5% ([M]; 1999-2008) databases were analyzed. Patients with a metastasis diagnosis (ICD-9: 196-199) following 2 prostate cancer diagnoses (ICD-9: 185, V10.46) within 365 days were identified. Patients with other malignant diagnoses at baseline, defined as 365 days prior to metastasis diagnosis (index date), were excluded. Patients were evaluated for baseline medical history and for chemotherapy, hormonal agents, radiation, and corticosteroids utilization during both baseline and observation periods. Hospitalization rates and prostate cancer-related procedures post index date were also reported. Results: The study population comprised 11,725 patients (E: 3,227; M: 8,498). Mean age (SD) was 72.8 (10.2) in Employer and 78.1 (7.7) in Medicare. Mean observation period (SD) was 803 (753) days in Employer and 9.2 (8.2) quarters in Medicare. During the baseline period, chemotherapy, hormonal agents, radiation therapy, and corticosteroids were administered to 5%, 52%, 9%, and 21% of Employer, and 2%, 45%, 8%, and 12% of Medicare patients respectively, whereas these interventions increased to 22%, 55%, 39%, and 46% for Employer, and to 21%, 50%, 33%, and 29% for Medicare during the observation period. A total of 66% Employer and 79% Medicare patients were hospitalized post index date. Most patients (E: 92%; M: 98%) had prostate cancer-related procedures, including prostate specific-antigen testing (E: 39%; M: 80%), computerized axial tomography scan (E: 72%; M: 81%), prostate biopsy (E: 47%; M: 54%), X-ray (E: 11%; M: 64%), bone scan (E: 56%; M: 60%), and magnetic resonance imaging scan (E: 35%; M: 37%). Conclusions: This observational study describes real-world utilization patterns in patients with advanced prostate cancer. [Table: see text]

Abstract 4761 Introduction: THR/TKR surgery can be accompanied by high blood loss and need for transfusion in the perioperative period. This claims-based analysis describes the use of blood transfusion and selected clinical and economic outcomes in elective THR/TKR surgery patients Methods: Patients aged 18 to 64 years with a THR/TKR surgery claim (index) between 1/1/06 and 12/31/08 were identified in the Thomson Reuters MarketScan® Commercial and Medicare Supplemental Databases. Eligible patients had continuous health plan enrollment for ≥6 months before the index surgery admission and ≥6 months following surgery discharge. Patients were excluded if their surgery was associated with multiple joint procedures, revision surgery, or trauma diagnosis. Patients with a claim for myelosdysplastic syndrome, chronic kidney disease, renal dialysis, human immunodeficiency virus infection, cancer, chemotherapy, sickle cell anemia, or a hospitalization or emergency room visit 6 months before surgery were excluded. Patients were categorized into 2 groups based on transfusion status during index surgery stay. The transfused (T) group had a blood transfusion claim while the non-transfused (NT) did not. The outcomes evaluated included the proportion of patients with an infection claim (wound site infection, pneumonia, urinary tract infection, Clostridium difficile, septicemia, or other), transfusion, transfusion reaction (TR), length of stay (LOS), intensive care unit (ICU) stay, discharge destination, and inpatient costs. Descriptive statistics were used to assess mean, median, and standard deviation (SD). Differences between T and NT groups were assessed by chi-square or two-sample t-tests. Results: A total of 64,014 patients met the study criteria. Mean age of the population was 56.1 ± 6.1 years, 57% were female, and 99% were insured. The mean LOS was 4.3 days. Median inpatient cost was US$24,027. During THR/TKR admission, 3.4% of patients had an ICU stay and 2.4% had an infection claim. The majority of patients (82%) were discharged home (45.9% with self-care; 35.8% required home health services), 10% were transferred to another facility, and 8% had unknown or other destinations. A transfusion claim was found in 8.3% of patients (n=5,302), and of these, 0.2% (n=11) had a TR claim. As reported in the table below, comparisons of outcomes between T and NT groups revealed differences in LOS, proportion of patients with an infection, proportion of patients with an ICU stay, and discharge destination. Median inpatient costs were $26,906 and $23,780 for T and NT groups, respectively. Conclusion: This retrospective claims-based analysis describes outcome parameters associated with inpatient THR/TKR surgery patients Disclosures: Ellis: Centocor Ortho Biotech Services, LLC: Employment. Bailey:Centocor Ortho Biotech Services, LLC: Employment. Forlenza:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Landsman-Blumberg:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.

Abstract 3814 Introduction: This retrospective claims analysis describes transfusion use and outcomes following discharge from elective THR/TKR surgery in patients Methods: Patients aged 18 to 64 years with a THR/TKR surgery claim (index) between 1/1/06 and 12/31/08 were identified in the Thomson Reuters MarketScan® Commercial and Medicare Supplemental Databases. Eligible patients had continuous health plan enrollment for ≥6 months before the surgery admission and ≥6 months following surgery discharge. Patients were excluded if their surgery was associated with multiple joint procedures, revision surgery, or trauma diagnosis. Inpatient joint revision surgeries were excluded from readmission analyses. Patients with a claim for myelosdysplastic syndrome, chronic kidney disease, renal dialysis, human immunodeficiency virus infection, cancer, chemotherapy, sickle cell anemia, or a hospitalization or emergency room visit 6 months before surgery were excluded. Patients were categorized into 2 groups based on transfusion status during index surgery stay. The transfused (T) group had a blood transfusion claim while the non-transfused (NT) did not. Outcomes evaluated included the proportion of patients with an infection claim (wound site infection, pneumonia, urinary tract infection, Clostridium difficile, septicemia, or other) within 30 days of discharge, proportion of patients readmitted within 180 days of discharge, time to first readmission, readmission length of stay (rLOS), and readmission cost. Descriptive statistics included mean, median, and standard deviation (SD). Differences between the T and NT groups were assessed by chi-square or two-sample t-tests. Results: A total of 64,014 patients met the inclusion criteria. Mean age of the population was 56.1 ± 6.1 years, 57% were female, and 99% were insured. A transfusion claim was found for 8.3% of patients during index admission. Within 180 days after surgery discharge, 12.6% of patients were readmitted; mean time to first readmission was 79 days. Approximately 57% of first readmissions occurred ≤ 90 days after discharge while 43% occurred 90 to 180 days after discharge. The average rLOS for all readmissions was 5.3 days and median cost was $18,917. A claim for infection within 30 days of THR/TKR discharge was noted for 1.9% of patients. As reported in the table below, 2.6% in the T group had a claim for infection within 30 days of discharge versus 1.9% in the NT group (p Conclusions: The proportion of THR/TKR patients with a readmission and rLOS did not differ between T and NT groups in this claims-based analysis. However, this study observed a higher proportion of patients with a transfusion claim during THR/TKR surgery having an infection within 30 days after surgery, a shorter time to readmission and higher readmission costs as compared to patients without a transfusion claim. Further research is needed to confirm these observations in other data sources. Disclosures: Ellis: Centocor Ortho Biotech Services, LLC: Employment. Bailey:Centocor Ortho Biotech Services, LLC: Employment. Forlenza:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Landsman-Blumberg:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.

e16507 Background: Two ESAs (darbepoetin alfa, epoetin alfa) are FDA-approved for reducing transfusions in patients (pts) with CIA. Clinical trial data have reported adverse safety signals in this population with ESA treatment targeting hemoglobin (Hb) > 12g/dL. In April 2007, UnitedHealthcare implemented a non-coverage policy for non-Medicare pts with Hb > 12g/dL. Previously, no Hb restrictions existed. The impact of this policy change on the proportion of ESA-treated pts with CIA requiring transfusion was evaluated. Methods: Retrospective claims of the i3 Innovus database from 7/1/2005 to 6/30/2008 were analyzed. Subjects were commercial enrollees ≥ 18 years with cancer and chemotherapy treatment, ≥ 2 ESA claims, and ≥ 1 qualifying treatment episode, which was defined as number of days from first to last ESA administration (no ESA claim for 90 days prior to first claim and 90 days after last claim). Subjects with claims for surgical procedures or dialysis were excluded. Proportion of pts transfused was ...

e16559 Background: Cancer patients often experience CIA and may be treated with ESAs. Recent observational data on PT-Hb levels in ESA-treated patients with CIA have not been reported. This analysi...

Abstract 2472 Poster Board II-449 Background: The Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA in July 2007 restricting ESA administration to those with hemoglobin (Hb) less than 10 g/dL and contingent on specific achieved Hb levels. Data assessing CIA patients regardless of ESA treatment pre- and post-NCD are scarce. This study evaluated Pre- and Post-NCD data in patients with CIA from a single oncology clinic in the northeastern United States to understand anemia treatment patterns, hematologic outcomes, and resource utilization. The oncology clinic, which is a part of a multi-specialty capitated integrated medical group, implemented the ESA NCD policy in September 2007. Methods: Medical, laboratory, and administrative claims data between 1/2005 and 4/2008 were retrospectively analyzed. Assessed patients had a diagnosis of malignant cancer (ICD-9-CM 140.XX-208.xx), received chemotherapy, and were anemic (Hb < 11 g/dL) during the chemotherapy treatment period. Patients diagnosed with myelodysplasia, acute leukemia, or chronic kidney disease who received dialysis, and those enrolled in ESA clinical trials were excluded. Data were categorized and analyzed in two time frames (Pre-NCD: 07/06-05/07, Post-NCD: 09/07-04/08). Baseline characteristics, ESA treatment patterns, hematologic outcomes (transfusion and available Hb levels), and resource utilization were assessed during the 20 week observation period following the index date of Hb < 11 g/dL. Results: 359 patients were identified (241 Pre-NCD; 118 Post-NCD). Baseline age, gender, race, weight, height, and distribution of tumor type were similar between groups. In the Post-NCD group, a significantly higher proportion of patients had comorbidities of congestive heart failure, coronary artery disease, and chronic obstructive pulmonary disease. The Post-NCD group had a significantly lower proportion of patients treated with ESAs (Pre-NCD 64%, Post-NCD 47%, p=0.0023). Among patients on ESA therapy (≥ 2 ESA injections), there was a trend toward shorter duration of ESA treatment in the Post-NCD arm [mean (SD): Pre-NCD 57.9 days (39.1), Post-NCD 47.3 days (38.1), p=0.08]. As noted in the table below, transfusion-independent Hb levels were lower in the Post-NCD group at baseline, Week 8, and Week 12. The proportion of patients transfused and blood utilization were similar in the Pre- and Post-NCD groups. The average number of oncology/hematology visits per patient was lower in the Post-NCD group [mean (SD): Pre-NCD 8.8 (5.9), Post-NCD 7.4 (6.5), p=0.01], however, a significantly higher proportion of patients in the Post-NCD period had a hospital admission (Pre-NCD 37.8%, Post-NCD 50.8%, p=0.02) or an emergency room (ER) visit (Pre-NCD 44.8%, Post-NCD 55.9%, p=0.048). Conclusion: Data from this single center observational study reported a lower proportion of patients initiated on ESAs, similar blood utilization, and an increased proportion of patients with hospitalization and ER visits in CIA patients with Hb < 11 g/dL in the Post-NCD as compared to the Pre-NCD time period. Further study assessing the impact of CIA NCD policy on healthcare resource utilization in multiple clinical centers is warranted. Disclosures: Burton: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Boulanger:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. McKenzie:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Lopez:Centocor Ortho Biotech Services, LLC: Employment. Sundaresan:Centocor Ortho Biotech Services, LLC: Consultancy. Preusse:Centocor Ortho Biotech Services, LLC: Consultancy. Seidler:Centocor Ortho Biotech Services, LLC: Consultancy.

Abstract 2491 Poster Board II-468 Introduction: In July 2007, the Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA through an NCD, which limits ESA utilization in patients with CIA to hemoglobin (Hb) levels of less than 10 g/dL at ESA initiation and after the initial 4 weeks of treatment. The primary objective of this study was to compare transfusion rates in patients with breast, colorectal or lung cancer who developed CIA before and after the NCD, regardless of treatment with ESAs. Patients and Methods: Chart data from adult cancer patients with Medicare as their primary payer and treated at community oncology clinics were abstracted for 12 weeks following the beginning of a CIA episode, provided that the entire episode occurred either before or after the change in policy. CIA was defined as Hb level < 11 g/dL, while receiving chemotherapy or within 8 weeks (60 days) of the last dose of chemotherapy. Logistic regression was used to calculate the odds of transfusion following the Hb < 11 g/dL index date. A negative binomial model was used to assess the change in units of blood transfused per patient. Multivariate models controlled for differences in age, gender, cancer type, line of therapy, ECOG performance status, history of antecedent transfusion and exposure to platinum, anthracyclines, antimetabolites and plant alkaloids. Results: 1794 patients were identified (800 Pre-NCD and 994 Post-NCD) from 49 sites. Patient groups were similar with respect to age, gender, race, weight, tumor type, line of treatment and recent exposure to radiation or surgery. As shown in the table below, there were significant differences in the chemotherapy class exposure in the Post- vs. Pre-NCD period. In addition, Hb levels were lower in the Post-NCD period, with a decrease in the proportion of ESA-treated patients and ESA treatment duration. The odds of receiving a transfusion were significantly higher Post-NCD (OR 1.41, 95% CI; 1.05 - 1.89; p=0.02) with an overall increase in adjusted units transfused of 53% (OR 1.53, 95% CI; 1.15 - 2.04; p=0.003). The table below summarizes patient characteristics and unadjusted Hb and transfusion outcomes. Conclusion: This large multicenter chart review reported decreased frequency and duration of ESA administration in CIA patients with Hb < 11 g/dL in the Post-NCD period compared to the Pre-NCD period. This was accompanied by a modest but statistically significant increase in blood utilization and decrease in Hb values. Further studies are warranted to assess other outcomes. Disclosures: McKenzie: Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Schulman:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Stepanski:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.

Abstract 2482 Poster Board II-459 Background: National coverage limitations for ESA treatment in cancer patients with CIA were established by the Centers for Medicare & Medicaid Services in July 2007. Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic and hospitalization outcomes in CIA patients treated in Pre- and Post-NCD time periods, an analysis of data from the D.O.S.E. (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted. Methods: ESA-treated cancer patients with CIA were selected if they initiated ESA treatment 12/01/2005-04/01/2007 (Pre-NCD) or 10/01/2007-02/01/2009 (Post-NCD), had ≥ 2 ESA administrations, and had both a baseline and ≥ 1 transfusion-independent post-ESA initiation hemoglobin (Hb) assessment. Assessed outcomes included proportion of patients receiving blood transfusion, number of units/study patient, Hb levels (at baseline and at weeks 4, 8, 12, 16) and hospitalization rates (admissions, number of hospital days) adjusted for ESA therapeutic duration (defined as time (days) from first to last ESA administration + patient-specific ESA treatment interval). Results: This analysis included 836 patients (Pre-NCD 585; Post-NCD 251) from 54 sites. Patients in the Pre-NCD and Post-NCD cohorts were similar in gender distribution and weight. The Post-NCD cohort was significantly older (64.7 yrs vs. 61.9 yrs; p The rate of hospital admissions was significantly greater in the Post-NCD group [Admissions/100-patient ESA therapeutic days (95% CI): Post-NCD 0.42 (0.34, 0.53), Pre-NCD 0.28 (0.24, 0.33)] as was the number of hospital days [Hospital days/100-patient ESA therapeutic days (95% CI): Post-NCD 2.3 (2.1, 2.5), Pre-NCD 1.3 (1.2, 1.4)]. Conclusions: Significantly greater blood utilization and lower Hb levels were observed in ESA-treated CIA patients in the Post-NCD period compared to the Pre-NCD period. Rates of hospitalizations and hospital length of stay were also significantly greater in the Post-NCD group. Study of comparative hematologic and resource utilization outcomes before and after the NCD is warranted in additional clinical centers. Disclosures: Apgar: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Ellis:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.