Study Index Date Research Articles

Prospective utility study of patients with multiple cardiovascular events

Objectives: The effects of acute coronary syndrome (ACS) events on health-related quality-of-life (HRQoL) and the time dependency of these effects are unknown. This study aimed to characterize health utilities in ACS patients to aid development of future economic models estimating the cost per quality-adjusted life-year impact of ACS events and potential treatments.Methods: Multi-center, non-interventional, longitudinal evaluation of health utility in patients experiencing ACS or stroke events. EuroQol-5 dimension 3 level (EQ-5D-3L) surveys were sent to patients (≥18 years) from three UK centers, 1 month after hospital discharge for myocardial infarction (MI), unstable angina (UA), or stroke. Patient demographics, lifestyle, and baseline utility score were collected in the first survey. Follow-up surveys were sent at 6, 12, 18, and 24 months to prospectively capture utility and subsequent health events. Two methods of patient identification were adopted—prospective, where the patient’s qualifying events occurred after the study index date, and retrospective, where the patient’s qualifying event occurred prior to the study index date. General healthy population utility values were assumed for pre-event HRQoL.Results: Between January 2011 and March 2014, 2,103 prospectively (n = 1,350)/retrospectively (n = 753) identified patients (mean age = 68.3 years; 67.9% male) responded: MI = 55.9% (n = 1,176), UA = 42.7% (n = 898), stroke = 1.4% (n = 29); 24% had type 2 diabetes. Post-event utility values were lower than general healthy population values, although significant differences in utility between subsequent 6 (n = 1,031, change = –0.002), 12 (n = 1,096, change = –0.008), 18 (n = 1,246, change = –0.007), and 24 (n = 1,277, change = –0.004) month timepoints were not detected. Through multivariate regression analyses, wheelchair use, current smoking, and secondary mental and joint health events were associated with the greatest statistically significant utility decrements.Conclusions: This study indicates that health utility decreases following a cardiovascular event and, although some improvement occurs over the subsequent 24 months, general healthy population utility is not necessarily attained.

Predictive factors associated with carcinoid syndrome in patients with gastrointestinal neuroendocrine tumors.

AIMTo discover unknown factors associated with carcinoid syndrome (CS) with the goal of earlier diagnosis of CS.METHODSIn this retrospective case-control study using United States administrative claims, patients (≥ 18 years) newly-diagnosed with gastrointestinal neuroendocrine tumors (GI NETs) without CS (controls) were exactly matched to patients with CS (cases) based on NET diagnosis date at a 3-to-1 ratio. Study index date was first CS diagnosis (controls: same distance from NET diagnosis as cases). The most observed conditions, excluding CS-associated symptoms/diagnoses, during the year before index date were assessed. Forward-stepwise logistic regression models were used to derive predictors, and were validation within another claims database.RESULTSIn the development database, 1004 patients with GI NETs were identified; 251 (25%) had CS and 753 (75%) were controls. In the validation database, 724 patients with GI NETs were identified; 181 (25%) had CS and 543 (75%) were controls. A total of 33 common diagnoses (excluding conditions already known to be associated with CS) in the development database were entered in forward step-wise logistic regression models. In the final, validated logistic regression model, three factors prior to CS diagnosis were found consistently associated with higher risks for CS, including liver disorder [odds ratio (95%CI): 3.38 (2.07-5.51)], enlargement of lymph nodes [2.13 (1.10-4.11)], and abdominal mass [3.79 (1.87-7.69)].CONCLUSIONGI NET patients with CS were 2-4 times as likely to have preexisting diagnoses (i.e., liver disorder, enlarged lymph nodes, abdominal mass) than non-CS patients.

Predictive factors of carcinoid syndrome among patients with gastrointestinal neuroendocrine tumors (GI NETs).

e15690 Background: Carcinoid syndrome (CS) is associated with a significant symptom burden and deleterious impacts on quality of life. Patients may experience delays in CS diagnosis of 5 to 7 years from initial onset of symptoms, as symptoms may be mistaken for other diseases, such as irritable bowel syndrome or menopause. The current study attempts to detect factors predictive of CS prior to CS diagnosis among patients with GI NETs. Methods: Using a US administrative claims database (IMS PharMetrics) and a retrospective case-control study design, patients (≥18 years) who were newly diagnosed with GI NETs without CS (controls) were exactly matched to patients with CS (cases) based on NET diagnosis date (month and year) at a 3-to-1 ratio. For CS patients, the study index date was the first CS diagnosis date. Each control patient was assigned to have the same index month and year as the matched case patient. The most frequently observed conditions other than symptoms/diagnoses known to be associated with CS during the 1 year prior to the index date were assessed. These conditions were entered into a forward-stepwise logistic regression model to derive predictive factors. Similar methods were applied to another administrative claims database (Truven Health Analytics MarketScan) to validate these predictors. Results: In the development database 1,004 patients with GI NETs were identified, among whom 251 (25%) had CS and 753 (75%) were controls. In both databases, three factors prior to CS diagnosis were found consistently associated with higher risks for CS, including liver disorder [odds ratio (95% CI): 3.38 (2.07 - 5.51)], enlargement of lymph nodes [2.13 (1.10 - 4.11)], and abdominal mass [3.79 (1.87 - 7.69)]. Conclusions: By assessing patients with GI NET from two independent US claim databases, this study suggested that patients diagnosed with CS were 2-3 times more likely to be diagnosed with liver disorder, enlargement of lymph nodes, or abdominal mass, than those without CS during the one year prior to CS diagnosis. Future studies using patients’ medical charts are warranted to validate and interpret the findings. These findings, when validated, may aid physicians to diagnose CS patients earlier.

Chronic Disease Case Definitions for Electronic Medical Records: A Canadian Validation Study

ABSTRACTObjectivesCanadians are investing heavily in electronic medical records (EMRs) to inform primary care practice improvements. The Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is a national practice-based network that has enrolled more than one million patients to date. Accurate CPCSSN EMR data are essential for unbiased research about chronic disease prevention and management. The study purpose was to test the accuracy of chronic disease case definitions in EMR data from one CPCSSN site.
 ApproachThis study linked CPCSSN EMR data, hospital records, physician billing claims, prescription drug records, and population registration files for the province of Manitoba. Individuals who had at least one encounter with a CPCSSN practice between 1998 and 2012, were at least 18 years of age, and had a minimum of two years of healthcare coverage before and after the study index date were included. Separate cohorts were defined for the following chronic diseases: chronic obstructive pulmonary disease (COPD), depression, diabetes, hypertension, and osteoarthritis. Validated case definitions based on diagnoses in physician and hospital records and prescription drug data were used estimate sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa of each EMR chronic disease case definition.
 ResultsMore than 74,000 individuals were included in each cohort, except for COPD which had 51,000. Approximately half of each cohort was comprised of urban residents. The average age ranged from 45.9 years for individuals with depression to 65.3 years for individuals with COPD. Hypertension had the highest prevalence (22.0%) in EMR data followed by depression (14.6%). Estimates of agreement (i.e., kappa) for EMR and administrative data ranged from 0.47 for COPD to 0.58 for diabetes. Sensitivity of the EMR data was lowest for COPD (37.4%; 95% CI 36.0-38.8) and highest for diabetes (57.6%; 95% confidence interval [CI] 56.6-58.6). PPV estimates were lowest for osteoarthritis (66.9%; 95% CI 66.0-67.8) and highest for hypertension (78.3%; 95% CI 77.7-78.9). Specificity estimates were consistently above 90% and NPV estimates were always greater than 80%. Validity estimates for the EMR case definitions were associated with demographic and comorbidity characteristics of the study cohorts.
 ConclusionsValidity of EMR data, when compared to administrative health data, for ascertaining five different chronic diseases was fair to good; it varied with the disease under investigation. Further research is needed to identify methods for improving the accuracy of chronic disease case definitions in EMR data.

Real-World Treatment Patterns in Relapsed or Refractory Multiple Myeloma: Evidence from a Medical Chart Review in the United Kingdom

Abstract INTRODUCTION: Despite advancements in induction and maintenance therapies leading to improved response rates and overall survival (OS), virtually all patients with multiple myeloma (MM) eventually relapse. Improvement in outcomes in relapsed and/or refractory multiple myeloma (RRMM) remains an area of unmet need, yet there is a shortage of data describing typical treatment patterns in these patients in real-world practice settings. Such data may help inform future health technology assessments and other regulatory evaluations of current and new therapies in RRMM. To help address this information gap, we analyzed retrospective data from a cohort of RRMM patients in the United Kingdom (UK). METHODS: A retrospective medical record review was conducted in a cohort (n = 216) of patients with RRMM in the UK. Patients were selected (based on randomly generated first letter of last name) from the caseloads of 41 hematology/oncology providers across the UK. Specific inclusion criteria were: ≥18 years of age at initial MM diagnosis; first determined to have RRMM between January 1, 2009 and December 31, 2011, where RRMM was defined by (1) receipt of a first-line (induction) treatment regimen of chemotherapy with or without stem cell transplant (SCT) and with or without post-induction/SCT maintenance therapy and (2) disease progression while on or at any time after completion of first-line therapy. Patients were retrospectively assessed on second- and third-line treatment regimens received, treatment duration, and reasons for treatment discontinuation from date of first relapse or progression (study index date). All analyses were descriptive and exploratory in nature. RESULTS: Demographic and clinical characteristics of the study sample are presented in Table 1. Mean (SD) age at study index (first relapse, or RRMM diagnosis) was 65.6 (8.7) years, with approximately half of patients (53%) having advanced age (≥65 years). The study sample was 62.5% male and more than two-thirds of patients (69%) were still alive at the time of the medical record review. Among the 216 patients studied, 208 (97%) received ≥1 additional line of systemic chemotherapy after first relapse (Table 2); 94 patients (43%) received ≥2 additional lines of therapy (i.e., at least second- and third-line therapy) during the observation period. The most common second-line regimen was bortezomib + dexamethasone with or without other agents (66% of second-line initiators), followed by lenalidomide + dexamethasone with or without other agents (20%). Median duration of second-line treatment was 6 cycles over a median of 5.4 months. Among the 98% of patients who discontinued second-line treatment, a majority (62%) stopped therapy due to reaching complete response with no additional benefit expected; 33 patients (16%) discontinued second-line treatment due to disease progression and 8% discontinued due to toxicities. Lenalidomide + dexamethasone with or without other agents was the predominant third-line regimen (67% of third-line initiators); bortezomib + dexamethasone with or without other agents was the next most common third-line regimen (14%). Among the 94 patients receiving third-line treatment, median duration was 6 cycles over a median of 5.7 months. The leading reason for third-line discontinuation was disease progression (48%); 30% of patients discontinued because they reached complete response with no anticipated additional benefit, and 20% discontinued because of loss or lack of response to therapy. CONCLUSIONS: In the RRMM cohort reviewed here, bortezomib-containing regimens were the predominant second-line therapy and lenalidomide + dexamethasone was the most common third-line regimen. The most common reasons for discontinuation of RRMM treatments were disease progression and physician-judged achievement of complete response with no additional benefit expected. While the most common reason for therapy discontinuation in second-line treatment was reaching complete response with no additional benefit expected, in third-line therapy it was disease progression. With growing evidence in the RRMM literature that treatment to progression may be superior to a fixed duration of therapy, as well as evidence of premature discontinuation being associated with inferior outcomes, the relatively short second-line duration reported here ( Download : Download high-res image (280KB) Download : Download full-size image Download : Download high-res image (383KB) Download : Download full-size image Disclosures Lin: Takeda: Employment. Davis: Takeda: Research Funding. Kaye: Takeda: Research Funding. Luptakova: Takeda Oncology: Employment. Nagar: Takeda: Research Funding. Seal: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

Real-World Treatment Patterns and Health Care Resource Utilization in Relapsed or Refractory Multiple Myeloma: Evidence from a Medical Chart Review in France

Abstract INTRODUCTION: Despite the introduction of numerous novel agents and treatment strategies leading to improved response rates and overall survival, virtually all patients with multiple myeloma (MM) eventually relapse. While relapsed and/or refractory multiple myeloma (RRMM) remains an area of unmet need, little data have been generated describing typical treatment patterns and resource utilization in these patients. To help address this information gap, we analyzed data from a cohort of RRMM patients in France. METHODS: A retrospective medical record review was conducted in 200 patients with RRMM in France. Patients were selected (based on randomly generated first letter of last name) from the caseloads of 40 hematology/oncology providers across France practicing mainly in academic hospitals. Inclusion criteria were: ≥18 years of age at initial MM diagnosis; first determined to have RRMM between January 1, 2009 and December 31, 2011, where RRMM was defined by (1) first-line (induction) regimen of chemotherapy with or without stem cell transplant (SCT) and with or without other post-induction/SCT therapy and (2) disease progression while on or at any time after completion of first-line therapy. Baseline cytogenetic risk was defined as follows: high-risk: cytogenetic abnormalities del(17p), t(4:14), or t(14;16); unknown/unassessed risk: patients for whom cytogenetics were unavailable or unassessed; or standard-risk: all patients with known cytogenetics not classified as high-risk. Patients were retrospectively assessed on second- and third-line treatment regimens received, treatment duration and reasons for discontinuation, and subsequent health care utilization from date of first relapse (study index date). All analyses were descriptive. RESULTS: Demographic and clinical characteristics are presented in Table 1. Altogether 55 high-risk and 113 standard-risk patients were selected; risk category was unknown for 32 patients. Among the 200 patients studied, 192 (96%) received ≥1 additional line of systemic chemotherapy after first relapse; 114 patients (57%) received ≥2 additional lines of systemic therapy (i.e., at least second- and third-line therapy). The most common second-line regimen was lenalidomide + dexamethasone (54%), followed by bortezomib + dexamethasone with or without a third agent (23%). Median duration of second-line treatment was 9 cycles over 9.4 months. Most patients (92%) discontinued second-line treatment, most commonly due to disease progression (37%), to reaching complete clinical response with no additional benefit expected (33%), to lack/loss of response (13%), or to toxicities/adverse events (8%). Among the 114 patients receiving a third-line treatment, regimens were more varied; bortezomib + dexamethasone with or without other third agents was the most common third-line regimen (27%). Median third-line duration (across all regimens) was 6 cycles over 5.9 months. The leading reason for third-line treatment discontinuation was disease progression (42%), followed by attainment of complete response with no addition benefit expected (21%). During the follow-up period from RRMM diagnosis until death or last medical record, 35% of patients had ≥1 hospitalization, with high-risk patients having a higher hospitalization incidence than standard-risk patients (34 vs. 15 admissions per 100 person-years; p CONCLUSIONS: Lenalidomide + dexamethasone was the most commonly observed second-line regimen in this medical record review. Second-line treatment duration was generally less than a year, which indicates an unmet need in these patients, particularly in light of the primary reasons cited for unplanned discontinuation (disease progression, loss of response, no perceived additional benefit, and toxicities). Hospitalizations and emergency department visits were common among these patients after first relapse, indicating a potentially high cost burden of disease, particularly for patients with high-risk cytogenetic abnormalities in whom health care utilization was generally higher than for patients with standard-risk disease. Download : Download high-res image (397KB) Download : Download full-size image Disclosures Lin: Takeda: Employment. Davis: Takeda: Research Funding. Kaye: Takeda: Research Funding. Luptakova: Takeda Oncology: Employment. Gao: Takeda: Employment. Nagar: Takeda: Research Funding. Seal: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

Real-World Clinical Outcomes By Cytogenetic Risk Category in Relapsed or Refractory Multiple Myeloma: Evidence from a Cohort Review in France

INTRODUCTION: Multiple Myeloma (MM) is an incurable hematologic cancer characterized by multiple recurrences. With each recurrence, patients have a lower probability of response and duration of response is shorter. Therefore, there is an unmet need to improve outcomes in relapsed/refractory multiple myeloma (RRMM). There is a shortage of data describing clinical features and outcomes in these patients in real-world practice, particularly with regard to differences in outcomes by baseline cytogenetic risk. To help address this information gap, this study analyzed data from a cohort of RRMM patients in France.METHODS: A retrospective observational review of medical records was conducted in a cohort of 200 patients with RRMM in France. Patients were selected (based on randomly generated first letter of last name) from the caseloads of 40 hematology/oncology providers across France practicing mainly in academic hospitals. Inclusion criteria were: ≥18 years of age at initial MM diagnosis; first determined to have RRMM between January 1, 2009 and December 31, 2011, where RRMM was defined by (1) first-line (induction) regimen of chemotherapy with or without stem cell transplant (SCT) and with or without other post-induction/SCT therapy and (2) disease progression while on or at any time after completion of first-line therapy. Patients could be alive or deceased at the time of record abstraction. Baseline cytogenetic risk was defined as follows: high-risk: cytogenetic abnormalities del(17p), t(4:14), or t(14;16); unknown/unassessed risk: patients for whom cytogenetics were unavailable; or standard-risk: all patients with known cytogenetics not classified as high-risk. Patients were assessed for treatment response, overall survival (OS) and progression-free survival (PFS) from date of first relapse (study index date). All analyses were descriptive. Survival was assessed using the Kaplan-Meier (K-M) method.RESULTS: Demographic and clinical characteristics of the study sample are presented in Table 1. A total of 55 high-risk and 113 standard-risk patients were identified; risk category was unknown or unassessed for 32 patients. Among all patients, mean (SD) age at RRMM diagnosis was 66.3 (8.9) years and 62% of the sample was male. Lenalidomide + dexamethasone was the most common second-line systemic regimen initiated (50% of high-risk patients, 59.5% of standard-risk patients receiving second-line treatment). A total of 114 patients (57%) initiated a third-line treatment. Despite clinical response in second-line treatment occurring sooner in high-risk patients (median: 106 days) than in standard-risk patients (median: 237 days), physician-assessed overall response rate (ORR) was lower in high-risk patients (63%: 17% complete response, 46% partial response) than standard-risk patients (91%: 26% complete response, 65% partial response) across all second-line treatments combined (Table 2).. For third-line treatment, ORR was lower in high-risk patients (54%: 12% complete response, 42% partial response) than standard-risk patients (74%: 9% complete response, 65% partial response). Among patients who initiated a second-line treatment (n = 192), 47.4% were deceased at the time of data collection. From second-line initiation, K-M estimates of 1- to 5-year OS and PFS were substantially lower for high-risk patients versus standard-risk. Specifically, the proportions of patients still alive 1, 3, and 5 years after second-line treatment initiation were 73%, 51%, and 36%, respectively, for high-risk patients and 94%, 73%, and 61% for standard-risk patients. The proportions of patients without disease progression at 1, 3, and 5 years after second-line initiation were 48%, 13.5%, and 5% for high-risk patients and 82%, 42%, and 14% for standard-risk patients.CONCLUSIONS: The importance of cytogenetic risk classification as a prognostic factor in RRMM was apparent in this retrospective review, in which patients with high-risk cytogenetics had less favorable outcomes in terms of ORR, OS, and PFS than standard-risk patients. Decreased response rate and lower PFS and OS was documented among patients with high-risk cytogenetics, which is in contrast to shorter time needed to achieve best clinical response in this subgroup. Results from this real-world study provide further confirmation of the unmet medical need presented by RRMM, especially for patients with high-risk cytogenetics. [Display omitted] [Display omitted] DisclosuresLin:Takeda: Employment. Davis:Takeda: Research Funding. Kaye:Takeda: Research Funding. Luptakova:Takeda Oncology: Employment. Gao:Takeda: Employment. Nagar:Takeda: Research Funding. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

Real-World Treatment Patterns in Relapsed or Refractory Multiple Myeloma: Evidence from a Cohort Review in the United Kingdom

INTRODUCTION: Despite advancements in induction and maintenance therapies leading to improved response rates and overall survival (OS), virtually all patients with multiple myeloma (MM) eventually relapse. Improvement in outcomes in relapsed and/or refractory multiple myeloma (RRMM) remains an area of unmet need, yet there is a shortage of data describing typical treatment patterns in these patients in real-world practice settings. Such data may help inform future health technology assessments and other regulatory evaluations of current and new therapies in RRMM. To help address this information gap, we analyzed retrospective data from a cohort of RRMM patients in the United Kingdom (UK).METHODS: A retrospective medical record review was conducted in a cohort (n = 216) of patients with RRMM in the UK. Patients were selected (based on randomly generated first letter of last name) from the caseloads of 41 hematology/oncology providers across the UK. Specific inclusion criteria were: ≥18 years of age at initial MM diagnosis; first determined to have RRMM between January 1, 2009 and December 31, 2011, where RRMM was defined by (1) receipt of a first-line (induction) treatment regimen of chemotherapy with or without stem cell transplant (SCT) and with or without post-induction/SCT maintenance therapy and (2) disease progression while on or at any time after completion of first-line therapy. Patients were retrospectively assessed on second- and third-line treatment regimens received, treatment duration, and reasons for treatment discontinuation from date of first relapse or progression (study index date). All analyses were descriptive and exploratory in nature.RESULTS: Demographic and clinical characteristics of the study sample are presented in Table 1. Mean (SD) age at study index (first relapse, or RRMM diagnosis) was 65.6 (8.7) years, with approximately half of patients (53%) having advanced age (≥65 years). The study sample was 62.5% male and more than two-thirds of patients (69%) were still alive at the time of the medical record review. Among the 216 patients studied, 208 (97%) received ≥1 additional line of systemic chemotherapy after first relapse (Table 2); 94 patients (43%) received ≥2 additional lines of therapy (i.e., at least second- and third-line therapy) during the observation period. The most common second-line regimen was bortezomib + dexamethasone with or without other agents (66% of second-line initiators), followed by lenalidomide + dexamethasone with or without other agents (20%). Median duration of second-line treatment was 6 cycles over a median of 5.4 months. Among the 98% of patients who discontinued second-line treatment, a majority (62%) stopped therapy due to reaching complete response with no additional benefit expected; 33 patients (16%) discontinued second-line treatment due to disease progression and 8% discontinued due to toxicities. Lenalidomide + dexamethasone with or without other agents was the predominant third-line regimen (67% of third-line initiators); bortezomib + dexamethasone with or without other agents was the next most common third-line regimen (14%). Among the 94 patients receiving third-line treatment, median duration was 6 cycles over a median of 5.7 months. The leading reason for third-line discontinuation was disease progression (48%); 30% of patients discontinued because they reached complete response with no anticipated additional benefit, and 20% discontinued because of loss or lack of response to therapy.CONCLUSIONS: In the RRMM cohort reviewed here, bortezomib-containing regimens were the predominant second-line therapy and lenalidomide + dexamethasone was the most common third-line regimen. The most common reasons for discontinuation of RRMM treatments were disease progression and physician-judged achievement of complete response with no additional benefit expected. While the most common reason for therapy discontinuation in second-line treatment was reaching complete response with no additional benefit expected, in third-line therapy it was disease progression. With growing evidence in the RRMM literature that treatment to progression may be superior to a fixed duration of therapy, as well as evidence of premature discontinuation being associated with inferior outcomes, the relatively short second-line duration reported here (<6 months) further highlights a potential unmet need in this disease area. [Display omitted] [Display omitted] DisclosuresLin:Takeda: Employment. Davis:Takeda: Research Funding. Kaye:Takeda: Research Funding. Luptakova:Takeda Oncology: Employment. Nagar:Takeda: Research Funding. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

Real-World Treatment Patterns and Health Care Resource Utilization in Relapsed or Refractory Multiple Myeloma: Evidence from a Cohort Review in France

INTRODUCTION: Despite the introduction of numerous novel agents and treatment strategies leading to improved response rates and overall survival, virtually all patients with multiple myeloma (MM) eventually relapse. While relapsed and/or refractory multiple myeloma (RRMM) remains an area of unmet need, little data have been generated describing typical treatment patterns and resource utilization in these patients. To help address this information gap, we analyzed data from a cohort of RRMM patients in France.METHODS: A retrospective medical record review was conducted in 200 patients with RRMM in France. Patients were selected (based on randomly generated first letter of last name) from the caseloads of 40 hematology/oncology providers across France practicing mainly in academic hospitals. Inclusion criteria were: ≥18 years of age at initial MM diagnosis; first determined to have RRMM between January 1, 2009 and December 31, 2011, where RRMM was defined by (1) first-line (induction) regimen of chemotherapy with or without stem cell transplant (SCT) and with or without other post-induction/SCT therapy and (2) disease progression while on or at any time after completion of first-line therapy. Baseline cytogenetic risk was defined as follows: high-risk: cytogenetic abnormalities del(17p), t(4:14), or t(14;16); unknown/unassessed risk: patients for whom cytogenetics were unavailable or unassessed; or standard-risk: all patients with known cytogenetics not classified as high-risk. Patients were retrospectively assessed on second- and third-line treatment regimens received, treatment duration and reasons for discontinuation, and subsequent health care utilization from date of first relapse (study index date). All analyses were descriptive.RESULTS: Demographic and clinical characteristics are presented in Table 1. Altogether 55 high-risk and 113 standard-risk patients were selected; risk category was unknown for 32 patients. Among the 200 patients studied, 192 (96%) received ≥1 additional line of systemic chemotherapy after first relapse; 114 patients (57%) received ≥2 additional lines of systemic therapy (i.e., at least second- and third-line therapy). The most common second-line regimen was lenalidomide + dexamethasone (54%), followed by bortezomib + dexamethasone with or without a third agent (23%). Median duration of second-line treatment was 9 cycles over 9.4 months. Most patients (92%) discontinued second-line treatment, most commonly due to disease progression (37%), to reaching complete clinical response with no additional benefit expected (33%), to lack/loss of response (13%), or to toxicities/adverse events (8%). Among the 114 patients receiving a third-line treatment, regimens were more varied; bortezomib + dexamethasone with or without other third agents was the most common third-line regimen (27%). Median third-line duration (across all regimens) was 6 cycles over 5.9 months. The leading reason for third-line treatment discontinuation was disease progression (42%), followed by attainment of complete response with no addition benefit expected (21%). During the follow-up period from RRMM diagnosis until death or last medical record, 35% of patients had ≥1 hospitalization, with high-risk patients having a higher hospitalization incidence than standard-risk patients (34 vs. 15 admissions per 100 person-years; p<0.05); a similar disparity was observed for emergency department utilization (25 vs. 15 visits per 100 person-years; p<0.05). Leading clinical burdens included bone pain (58%), fatigue/weakness (75%), impairment of daily activities (59%), anemia (55%), thrombocytopenia (44%), and neutropenia (40%).CONCLUSIONS: Lenalidomide + dexamethasone was the most commonly observed second-line regimen in this medical record review. Second-line treatment duration was generally less than a year, which indicates an unmet need in these patients, particularly in light of the primary reasons cited for unplanned discontinuation (disease progression, loss of response, no perceived additional benefit, and toxicities). Hospitalizations and emergency department visits were common among these patients after first relapse, indicating a potentially high cost burden of disease, particularly for patients with high-risk cytogenetic abnormalities in whom health care utilization was generally higher than for patients with standard-risk disease. [Display omitted] DisclosuresLin:Takeda: Employment. Davis:Takeda: Research Funding. Kaye:Takeda: Research Funding. Luptakova:Takeda Oncology: Employment. Gao:Takeda: Employment. Nagar:Takeda: Research Funding. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

Prospective Utility Study of Patients with Multiple Cardiovascular Events

Objectives The effects of acute coronary syndrome (ACS) events on health-related quality-of-life (HRQoL) and the time dependency of these effects are unknown. This study aimed to characterize health utilities in ACS patients to aid development of future economic models estimating the cost per quality-adjusted life-year impact of ACS events and potential treatments. Methods Multi-center, non-interventional, longitudinal evaluation of health utility in patients experiencing ACS or stroke events. EuroQol-5 dimension 3 level (EQ-5D-3L) surveys were sent to patients (≥18 years) from three UK centers, 1 month after hospital discharge for myocardial infarction (MI), unstable angina (UA), or stroke. Patient demographics, lifestyle, and baseline utility score were collected in the first survey. Follow-up surveys were sent at 6, 12, 18, and 24 months to prospectively capture utility and subsequent health events. Two methods of patient identification were adopted-prospective, where the patient's qualifying events occurred after the study index date, and retrospective, where the patient's qualifying event occurred prior to the study index date. General healthy population utility values were assumed for pre-event HRQoL. Results Between January 2011 and March 2014, 2,103 prospectively (n = 1,350)/retrospectively (n = 753) identified patients (mean age = 68.3 years; 67.9% male) responded: MI = 55.9% (n = 1,176), UA = 42.7% (n = 898), stroke = 1.4% (n = 29); 24% had type 2 diabetes. Post-event utility values were lower than general healthy population values, although significant differences in utility between subsequent 6 (n = 1,031, change = -0.002), 12 (n = 1,096, change = -0.008), 18 (n = 1,246, change = -0.007), and 24 (n = 1,277, change = -0.004) month timepoints were not detected. Through multivariate regression analyses, wheelchair use, current smoking, and secondary mental and joint health events were associated with the greatest statistically significant utility decrements. Conclusions This study indicates that health utility decreases following a cardiovascular event and, although some improvement occurs over the subsequent 24 months, general healthy population utility is not necessarily attained.

877P - Treatment patterns and BRCA testing practices in platinum-sensitive recurrent serous ovarian cancer: a Spanish medical record review

Platinum-based chemotherapy is considered standard treatment for platinum-sensitive recurrent ovarian cancer (PSR OC). Real-world data on BRCA mutation (BRCAm) testing, treatment patterns and characteristics of patients (pts) diagnosed with PSR OC will help to identify unmet medical needs in this population. We retrospectively reviewed a random sample of medical records of women having serous PSR OC after 1st-line platinum completion, during 2009-2013, to assess PSR OC treatment patterns and BRCAm testing. Study index date was defined as PSR OC diagnosis date. Data from 298 pts were collected in Spain. At diagnosis, median age: 58 years; ECOG 0, 1: 38%, 52%; advanced disease stage (≥IIb): 93%; high grade: 80%. Primary tumour sites: ovary (88%); fallopian tube (8%); primary peritoneum (4%). 70% of pts had received primary cytoreductive surgery, 88% received carboplatin + paclitaxel as 1st-line (with or without bevacizumab) (median number of cycles 6) and 4% received intraperitoneal treatment. 7% of pts received maintenance therapy after 1st-line, mainly bevacizumab (95%). The majority of pts (78%) received 2nd-line therapy: platinum based 91%; mainly carboplatin + paclitaxel (31%), gemcitabine (15%) or pegylated liposomal doxorubicin (9%); 20% concomitant bevacizumab. Median times from initial ovarian cancer diagnosis to index date and from index date to end of follow-up were 20 months. BRCA testing was performed in 83 (28%) of pts and 76 (92%) had a conclusive result available. Of those, 34% were BRCAm. 16% of total pts (69% of BRCAm pts) had family history of BRCA-related cancer (breast 81%; ovarian 41%). BRCA tests were performed on blood (76%) and tumour tissue (24%) samples. BRCA testing method unknown: 65%. When known, direct DNA sequencing was the most used BRCA testing method (16 pts, 55%). Platinum-based chemotherapy for PSR OC was the standard of care in this review. Bevacizumab was associated with chemotherapy in only 20% of pts. Family history of BRCA related cancer was absent in 31% of BRCAm pts. BRCA testing was not routinely performed. Physicians were mostly unfamiliar with the BRCA testing method used; when known, direct DNA sequencing was the most commonly used method.

Disease Control, Health Resource Use, Healthcare Costs, and Predictors in Gout Patients in the United States, the United Kingdom, Germany, and France: A Retrospective Analysis.

The present study aimed to assess disease control, health resource utilization (HRU), and healthcare costs, and their predictors in gout patients across the USA, UK, Germany, and France. Data were extracted from the PharMetrics Plus (USA), Clinical Practice Research Datalink-Hospital Episode Statistics (UK), and Disease Analyzer databases (Germany and France) for adult gout patients over a 3-year period: 2009-2011 (all dates +1year for France). Patients had "prevalent established gout" (i.e., were treated with urate-lowering therapy [ULT] or eligible for ULT based on American College of Rheumatology guidelines) in the preindex panel-year, with January 1 of the second study year as the study index date. Assessments of disease control (uncontrolled gout definition: ≥1 serum urate (sUA) elevation or ≥2 flares; analysis limited to the subpopulation with sUA) data, HRU, and costs were in the second post-index panel-year, while potential predictors (demographics and gout treatment characteristics) were identified in the first post-index panel-year. Treatment rates were high (>70% with chronic urate-lowering treatment in all countries but France), while between 31.3% (France) and 62.9% (USA) of patients remained uncontrolled. Predictors of control included female gender and high adherence. In Germany, the UK, and France, lack of disease control predicted increased gout-attributed costs and increased HRU, both gout-attributed (also in the USA) and non-gout-attributed. Gout management remains suboptimal, as many patients remain uncontrolled despite using urate-lowering treatment. Effective and convenient treatment options are needed to improve disease control and minimize additional HRU and costs. AstraZeneca.

Predicting frequent COPD exacerbations using primary care data.

PurposeAcute COPD exacerbations account for much of the rising disability and costs associated with COPD, but data on predictive risk factors are limited. The goal of the current study was to develop a robust, clinically based model to predict frequent exacerbation risk.Patients and methodsPatients identified from the Optimum Patient Care Research Database (OPCRD) with a diagnostic code for COPD and a forced expiratory volume in 1 second/forced vital capacity ratio <0.7 were included in this historical follow-up study if they were ≥40 years old and had data encompassing the year before (predictor year) and year after (outcome year) study index date. The data set contained potential risk factors including demographic, clinical, and comorbid variables. Following univariable analysis, predictors of two or more exacerbations were fed into a stepwise multivariable logistic regression. Sensitivity analyses were conducted for subpopulations of patients without any asthma diagnosis ever and those with questionnaire data on symptoms and smoking pack-years. The full predictive model was validated against 1 year of prospective OPCRD data.ResultsThe full data set contained 16,565 patients (53% male, median age 70 years), including 9,393 patients without any recorded asthma and 3,713 patients with questionnaire data. The full model retained eleven variables that significantly predicted two or more exacerbations, of which the number of exacerbations in the preceding year had the strongest association; others included height, age, forced expiratory volume in 1 second, and several comorbid conditions. Significant predictors not previously identified included eosinophilia and COPD Assessment Test score. The predictive ability of the full model (C statistic 0.751) changed little when applied to the validation data set (n=2,713; C statistic 0.735). Results of the sensitivity analyses supported the main findings.ConclusionPatients at risk of exacerbation can be identified from routinely available, computerized primary care data. Further study is needed to validate the model in other patient populations.

Healthcare resource use and costs of privately insured patients who switch, discontinue, or persist on anti-muscarinic therapy for overactive bladder

Objectives:To compare the healthcare costs of patients with overactive bladder (OAB) who switch vs persist on anti-muscarinic agents (AMs), describe resource use and costs among OAB patients who discontinue AMs, and assess factors associated with persisting vs switching or discontinuing.Methods:OAB patients initiating an AM between January 1, 2007 and March 31, 2012 were identified from a claims database of US privately insured beneficiaries (n ≈ 16 million) and required to have no AM claims in the 12 months before AM initiation (baseline period). Patients were classified as persisters, switchers, or discontinuers, and assigned a study index date based on their AM use in the 6 months following initiation. Baseline characteristics, resource use, and costs were compared between persisters and the other groups. Resource use and costs in the 1 month before and 6 months after the study index date (for switchers, the date of index AM switching; for persisters, a randomly assigned date to reflect the distribution of the time from AM initiation to switching among switchers) were also compared between persisters and switchers in unadjusted and adjusted analyses. Factors associated with persisting vs switching or discontinuing were assessed.Results:After controlling for baseline characteristics and costs, persisters vs switchers had significantly lower all-cause and OAB-related costs in both the month before (all-cause $1222 vs $1759, OAB-related $142 vs $170) and 6 months after the study index date (all-cause $7017 vs $8806, OAB-related $642 vs $797). Factors associated with switching or discontinuing vs persisting included index AM, younger age, and history of UTI.Conclusion:A large proportion of OAB patients discontinue or switch AMs shortly after initiation, and switching is associated with higher costs.

HOSPITALIZATIONS AND MEDICARE SPENDING IN AN ETHNICALLY DIVERSE COHORT WITH INCIDENT DEMENTIA

Methods: Patients with >2 claims for AD (ICD-9 CM: 331.0) were selected from de-identified administrative claims data for U.S. Medicare beneficiaries (5% random sample). Among these patients eventually diagnosed with AD, the earliest observed diagnosis of cognitive decline (ICD9 CM: 290.x, 291.1, 291.2, 292.82-83, 294.x, 331.x, 780.93) served as the study index date. Patients were required to have continuous Medicare coverage for 12 months pre-index (baseline) and >12 months following the first AD diagnosis, allowing for up to 6 years from index to AD diagnosis. Patient demographics, Charlson comorbidity index (CCI) during baseline, and annual all-cause medical resource use and costs (i.e., payments to providers) in baseline and follow-up periods were evaluated, stratified by whether the patient had >1 cognition-related visit to a specialist in the index quarter. Results: Approximately 26% of the 50,338 AD patients in the sample sought cognition-related care by a specialist within 3 months of their first cognitive decline diagnosis.Patients seen by specialists were younger (78.6 vs. 80.1 years old) and more likely to be male (36% vs. 32%). These patients were diagnosed with AD within 3.5 (vs. 5.3) quarters of initial cognitive decline diagnosis, on average, and had higher CCI, and higher medical resource use and costs at baseline (Table 1). Total per-patient annual medical resource use and costs were similar for the two groups starting in the second year post-index (Figure 1). Conclusions: AD patients seen by specialists within the 3month period including their first cognitive decline diagnosis are, on average, younger, and have higher CCI and costs at baseline. However, over time, their resource use and cost trajectories converge with that of patients not seen by specialists within similar proximity to their initial diagnosis.

Healthcare utilization and costs in children with stable and uncontrolled epilepsy

ObjectiveEpilepsy adversely affects childhood development, possibly leading to increased economic burden in pediatric populations. We compared annual healthcare utilization and costs between children (<12years old) with stable and uncontrolled epilepsy treated with antiepileptic drugs (AEDs). MethodsChildren (<12years old) with epilepsy (ICD-9-CM 345.xx or 780.39) in 2008 were identified in the MarketScan claims database from 2007 to 2009. Patients with “stable” epilepsy used the same AED for ≥12months, and patients with “uncontrolled” epilepsy were prescribed additional AED(s) during that period. For patients with uncontrolled epilepsy, the study index date was the start of additional AED(s); for patients with stable epilepsy, the study index date was a random AED fill date. Epilepsy-related utilization included medical services with 345.xx or 780.39 in any diagnosis field and AED fills. Epilepsy-related costs included AEDs, medical claims with epilepsy in any diagnosis field, and certain tests. We adjusted for baseline cohort differences (demographics, region, usual-care physician specialty, and comorbidities) using logistic regression and analysis of covariance. ResultsTwo thousand one hundred seventy patients were identified (mean: 7.5years; 45.3% were female; Charlson comorbidity index: 0.3; 422 (19.4%) patients with uncontrolled epilepsy). Patients with uncontrolled epilepsy faced more hospitalizations (30.1% vs. 12.0%) and greater overall ($30,343 vs. $18,206) and epilepsy-related costs ($16,894 vs. $7979) (all p<.001). Adjusting for baseline measures, patients with uncontrolled epilepsy had greater odds of hospitalization (OR: 2.5; 95% CI: 1.9–3.3) and costs (overall: $3908, p=.087; epilepsy-related: $5744, p<.001). ConclusionsChildren with uncontrolled epilepsy use significantly more healthcare resources and have a greater economic burden than children with stable epilepsy. However, epilepsy accounted for only half of overall costs, indicating that comorbid conditions may add substantially to the disease burden.

Association of Polypharmacy and Statin New-User Adherence in a Veterans Health Administration Population

The relationship between multiple medication consumption and medication adherence is not well understood. To determine the association between the number of active medications on the patient medication profile at baseline and adherence in new users of statins. This was a retrospective cohort study of new users of statin medications from the Veterans Health Administration. We explored the correlation between the number of baseline medications and adherence, grouping patients by number of active medications on the study index date via Cochran-Armitage trend test and multiple linear regression. The adherence metric calculated for each patient was the medication possession ratio (MPR). Adherence was defined as achieving a 0.8 MPR or greater in primary analysis and a 0.9 MPR or greater in the secondary analysis. There was a statistically significant trend of increasing proportion of adherent participants as baseline medication count grew (P value < .001). The regression further demonstrated that statin MPR was increased by 0.04, 0.07, 0.10, and 0.14 for the 6 to 10 medication count, 11 to 15 medication count, 16 to 20 medication count, and >20 medication count groups, respectively, in comparison with the reference 1 to 5 medication count group (P < .001 for all comparisons). An MPR threshold of 0.9 provided consistent evidence of improved adherence as number of medications increased (P < .001). Increased medication count at baseline was associated with improved adherence for new users of statins.

SAT0449 Progression from undifferentiated spondyloarthritis to ankylosing spondylitis: Is USPA a proxy for non-radiographic axial SPA?

BackgroundAxial spondyloarthritis (axSpA) is a new umbrella term including patients with ankylosing spondylitis (AS), as well as those with non-radiographic axSpA (nr-axSpA). The new classification provides accepted evidence-based criteria to...

Health Care Utilization and Associated Costs in Elderly Persons with Non-CML Myeloproliferative Neoplasms: Real-World Evidence From a United States Medicare Population

AbstractAbstract 4273 Background:Non-CML myeloproliferative neoplasms (MPNs), which include essential thrombocythemia (ET), polycythemia vera (PV), myelofibrosis (MF) and MPN not otherwise specified (MPN-NOS), are characterized by activation of JAK2 signaling and abnormal blood cell production. Median survival ranges from months to years for MF and up to a decade or more for PV and ET. Some symptomatic treatment options exist, but with the exception of hematopoietic stem cell transplant, none are curative. Although MPN incidence is highest in persons aged ≥65 years, little is known about overall health care utilization and costs in elderly persons with these diseases. MPNs are more prevalent in the elderly and therefore Medicare enrollees are a highly relevant source for US-based resource utilization and cost data for these diseases. Objective:To compare all-cause health care utilization and costs from four subtypes of elderly MPN patients (ET, PV, MF and MPN-NOS) with matched non-MPN/non-cancer controls. Methods:Retrospective data were taken from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database in the US, which combines clinical information from the SEER cancer registry (MPN reporting has been required since 2001) with medical and pharmacy claims for Medicare enrollees. Patients with a new MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were selected and evaluated for all-cause health care utilization and costs from Jan 1, 2008 (index date) through Dec 31, 2008 (follow-up end date). Patients were classified by MPN subtype based on the most recent diagnosis information (ICD-O-3 from the SEER registry or ICD-9-CM from Medicare claims) before the index date. Patients who died before follow-up end, had HMO or discontinuous Medicare enrollment during the follow-up year, had enrollment based on end stage renal disease, or a diagnosis of a non-MPN malignancy before follow-up end were excluded from the study. Separate non-MPN/non-cancer control groups were selected for each MPN subtype and matched (5:1) on birth year, gender, ethnicity, geography, and reason for Medicare eligibility. Per patient health care utilization and costs during the follow-up year were aggregated and stratified by care setting. Costs were adjusted to 2010 US$ and represent amounts reimbursed by Medicare to providers. Costs were compared between MPN cases and controls using univariate t-tests. Results:A total of 1,355 MPN patients (n = 445 ET, 684 PV, 81 MF, 145 MPN-NOS) were identified for study inclusion and assigned matching controls. For ET, PV, MF and MPN-NOS cases, respectively, mean [SD] age at index was 75.5 [9.7], 70.8 [11.3], 70.8 [10.4] and 74.1 [8.9] years and % female was 69.0, 43.9, 54.3, and 55.2. Mean [SD] years between first MPN diagnosis and study index date was 3.1 [2.0], 3.4[1.9], 2.7 [2.0], and 3.1 [2.1] for ET, PV, MF and MPN-NOS cases, respectively. A significantly (p<0.05) higher proportion of MPN cases, regardless of subtype, had ≥1 hospitalization during follow-up vs. controls (ET vs. control: 22% vs. 16%, PV vs. control: 27% vs. 15%, MF vs. control: 31% vs. 12%, MPN-NOS vs. control: 36% vs. 17%). Mean [SD] total days of hospital care were similarly higher in MPN cases (ET vs. control: 2.7 [12.8] vs. 1.6 [6.6], PV vs. control: 2.6 [7.0] vs. 1.7 [9.5], MF vs. control: 2.5 [6.2] vs. 1.2 [5.9], MPN-NOS vs. control: 4.0 [10.0] vs. 2.1 [13.7]), although the PV vs. control difference was not statistically significant. The ER visit rate during follow-up was also significantly (p<0.05) higher in MPN cases (ET vs. control: 34% vs. 24%, PV vs. control: 38% vs. 25%, MF vs. control: 46% vs. 21%, MPN-NOS vs. control: 44% vs. 29%). All-cause costs for MPN cases vs. matched controls are presented in the figure. Mean total costs per patient, driven equally by inpatient and outpatient services, were significantly (p<0.001) higher in MPN cases (ET vs. control: $11,259 vs. $8,897, PV vs. control: $13,337 vs. $8,530, MF vs. control: $20,917 vs. $7,367, MPN-NOS vs. control: $20,174 vs. $9,800). Conclusions:Total health care costs during a given year for elderly patients with MPNs are 1.3 to 3 times higher (depending on subtype) than those of matched controls. These findings may help inform future cost effectiveness evaluations of novel MPN treatments, as well as decision making in the provision of optimal MPN care within a Medicare system in which resources are finite and must be allocated ethically and efficiently. [Display omitted] Disclosures:Karve:RTI Health Solutions: Consultancy, Research Funding. Price:Eli Lilly and Company: Employment, Equity Ownership. Davis:Eli Lilly, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Eisai, Sanof-Aventis, Gilead Sciences, MedImmune: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Pohl:Eli Lilly and Company: Employment, Equity Ownership. Walgren:Eli Lilly and Company: Employment, Equity Ownership.

Comorbidity Burden in Elderly Persons with Non-CML Myeloproliferative Neoplasms: Real-World Evidence From a United States Medicare Population

AbstractAbstract 1734 Background:Non-CML myeloproliferative neoplasms (MPNs), which include essential thrombocythemia (ET), polycythemia vera (PV), myelofibrosis (MF) and MPN not otherwise specified (MPN-NOS), are characterized by activation of JAK2 signaling and abnormal blood cell production. MPN patients, especially those aged ≥65 years (in whom MPN incidence is highest), are at increased risk for cardiovascular and other comorbidities (Vannucchi et al. Blood 2007;110:840-6, Marchioli et al. J Clin Oncol 2005;23:2224-32). However, comorbidity rates in elderly MPN patients as compared with non-MPN controls have not been described in previous literature. MPNs are more prevalent in the elderly and therefore Medicare enrollees are a highly relevant source for US-based epidemiological data for these diseases. Objective:To compare comorbidity rates from four subtypes of elderly MPN patients (ET, PV, MF and MPN-NOS) with matched non-MPN/non-cancer controls. Methods:Retrospective data were taken from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database in the US, which combines clinical information from the SEER cancer registry (MPN reporting has been required since 2001) with medical and pharmacy claims for Medicare enrollees. Patients with a new MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were selected and evaluated for comorbidities from Jan 1, 2008 (index date) through Dec 31, 2008 (follow-up end date). Patients were classified by MPN subtype based on the most recent diagnosis information (ICD-O-3 from the SEER registry or ICD-9-CM from Medicare claims) before the index date. Patients who died before follow-up end, had HMO or discontinuous Medicare enrollment during the follow-up year, had enrollment based on end stage renal disease, or were diagnosed with a non-MPN malignancy before follow-up end were excluded. Comorbidities were defined by ICD-9-CM diagnosis codes comprising the Charlson Comorbidity Index (CCI) (Charlson et al. J Chron Dis 1987;40:373–83; Deyo et al. J Clin Epidemiol 1992;45:613-9) as well as other adverse conditions. Separate non-MPN/non-cancer control groups were selected for each MPN subtype and matched (5:1) on birth year, gender, ethnicity, geography, and reason for Medicare eligibility. The proportion of patients with individual comorbidities and mean CCI during the follow-up year were compared between MPN cases and controls using univariate chi-square tests and t-tests. Results:A total of 1,355 MPN patients (n = 445 ET, 684 PV, 81 MF, 145 MPN-NOS) were identified for inclusion and assigned matching controls. For ET, PV, MF and MPN-NOS cases, respectively, mean [SD] age at index was 75.5 [9.7], 70.8 [11.3], 70.8 [10.4] and 74.1 [8.9] years and % female was 69.0, 43.9, 54.3, and 55.2. Mean [SD] years between first MPN diagnosis and study index date was 3.1 [2.0], 3.4[1.9], 2.7 [2.0], and 3.1 [2.1] for ET, PV, MF and MPN-NOS cases, respectively. Comorbidity rates during the follow-up period for MPN cases and matched controls are shown in the figure. Compared with controls, ET, PV and MPN-NOS cases had significantly (p<0.05) higher rates of serious cardiovascular events and comorbidities during the follow-up year, including myocardial infarction (ET vs. control: 8.1% vs. 4.0%, PV vs. control: 8.6% vs. 4.3%, MPN-NOS vs. control: 9.7% vs. 5.0%), congestive heart failure (CHF) (ET vs. control: 16.4% vs. 12.7%, PV vs. control: 18.4% vs. 10.1%, MPN-NOS vs. control: 22.1% vs. 12.4%), peripheral vascular disease (PVD) (ET vs. control: 20.0% vs. 15.4%, PV vs. control: 19.4% vs. 13.6%, MPN-NOS vs. control: 27.6% vs. 15.7%), and stroke (ET vs. control: 17.8% vs. 13.4%, PV vs. control: 17.8% vs. 13.1%, MPN-NOS vs. control: 22.1% vs. 13.9%). MF cases also had higher rates of CHF, PVD and stroke, but due to small sample size, only congestive heart failure was significant. Other comorbidities were significantly higher in all MPN subtypes, notably thromboembolism, renal disease, moderate-to-severe liver disease, and infections. Conclusions:Medicare enrollees with MPNs generally experienced significantly higher comorbidity rates and overall comorbidity burden (based on mean CCI scores) than matched controls. These findings have implications for both the clinical management of MPN patients as well as for health economic assessments, since a substantial portion of the cost of care for MPNs may reside in treatment of comorbidities not directly coded to MPNs. [Display omitted] Disclosures:Davis:Eli Lilly, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Eisai, Sanof-Aventis, Gilead Sciences, MedImmune: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Price:Eli Lilly and Company: Employment, Equity Ownership. Karve:RTI Health Solutions: Consultancy, Research Funding. Pohl:Eli Lilly and Company: Employment, Equity Ownership. Walgren:Eli Lilly and Company: Employment, Equity Ownership.