Retrospective Claims Database Analysis Research Articles

Comparison of medical costs and healthcare resource utilization of post-menopausal women with HR+/HER2− metastatic breast cancer receiving everolimus-based therapy or chemotherapy: a retrospective claims database analysis

Objective:To analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among post-menopausal women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2−) metastatic breast cancer (mBC).Methods:Patients with HR+/HER2− mBC who discontinued a non-steroidal aromatase inhibitor and began a new line of treatment with everolimus-based therapy or chemotherapy (index therapy/index date) between July 20, 2012 and April 30, 2014 were identified from two large claims databases. All-cause, BC-related, and adverse event (AE)-related medical costs (in 2014 USD) and all-cause HRU per patient per month (PPPM) were analyzed for both treatment groups across patients’ first four lines of therapies for mBC. Adjusted differences in costs and HRU between the everolimus and chemotherapy treatment group were estimated pooling all lines and using multivariable generalized linear models, accounting for difference in patient characteristics.Results:A total of 3298 patients were included: 902 everolimus-treated patients and 2636 chemotherapy-treated patients. Compared to chemotherapy, everolimus was associated with significantly lower all-cause (adjusted mean difference = $3455, p < 0.01) and BC-related ($2510, p < 0.01) total medical costs, with inpatient ($1344, p < 0.01) and outpatient costs ($1048, p < 0.01) as the main drivers for cost differences. Everolimus was also associated with significantly lower AE-related medical costs ($1730, p < 0.01), as well as significantly lower HRU (emergency room incidence rate ratio [IRR] = 0.83; inpatient IRR = 0.74; inpatient days IRR = 0.65; outpatient IRR = 0.71; BC-related outpatient IRR = 0.57; all p < 0.01).Conclusions:This retrospective claims database analysis of commercially-insured patients with HR+/HER2− mBC in the US showed that everolimus was associated with substantial all-cause, BC-related, and AE-related medical cost savings and less utilization of healthcare resources relative to chemotherapy.

Monitoring for Pulmonary Hypertension Following Pulmonary Embolism: The INFORM Study

BackgroundPulmonary hypertension and chronic thromboembolic pulmonary hypertension may develop after a pulmonary embolism event. A ventilation-perfusion scan is recommended as a first-line modality for suspected chronic thromboembolic pulmonary hypertension. In this study, we determined the prevalence of pulmonary hypertension following incident pulmonary embolism and the disease-monitoring patterns in this population. MethodsWe conducted a retrospective claims database analysis of incident pulmonary embolism cases (July 1, 2010 to September 30, 2011) and extracted data for 1 year prior to and 2 years after the incident pulmonary embolism event. Data were analyzed for diagnoses and symptoms related to pulmonary hypertension, claims consistent with other heart or lung diseases, diagnostic imaging tests, and time to first diagnostic imaging test post pulmonary embolism. ResultsOf the 7068 incident pulmonary embolism patients that met eligibility criteria, 87% had a claim for a pulmonary hypertension-related symptom and 7.6% had a claim for pulmonary hypertension during follow-up. Only 55% of all pulmonary embolism patients had diagnostic procedural claim(s) post pulmonary embolism: echocardiogram, 47%; computed tomographic angiography, 20%; ventilation-perfusion scan, 6%; and right heart catheterization or pulmonary angiography, <1%. The mean time from pulmonary embolism diagnosis to first screening test was 131 days. ConclusionsDespite exhibiting pulmonary hypertension-related symptoms, many pulmonary embolism patients did not undergo imaging tests that could diagnose pulmonary hypertension or chronic thromboembolic pulmonary hypertension. This study suggests that physician education about the risk of pulmonary hypertension and chronic thromboembolic pulmonary hypertension after pulmonary embolism may need to be improved.

Severe Ocular Inflammation Following Ranibizumab or Aflibercept Injections for Age-Related Macular Degeneration: A Retrospective Claims Database Analysis

ABSTRACTPurpose: Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents including ranibizumab and aflibercept are used to treat patients with ocular disorders such as neovascular age-related macular degeneration (nAMD); however, the injections are associated with rare instances of severe ocular inflammation. This study compared severe ocular inflammation rates in patients treated with ranibizumab versus aflibercept.Methods: United States physician-level claims data covering an 18-month period for each therapy were analyzed. The primary analysis compared severe ocular inflammation event rates per 1000 injections. Sensitivity and subgroup analyses evaluated the impact of factors including intraocular surgery, intravitreal antibiotic administration, and previous intravitreal injections.Results: The analysis included 432,794 injection claims (ranibizumab n = 253,647, aflibercept n = 179,147); significantly, more unique severe ocular inflammation events occurred in patients receiving aflibercept than ranibizumab (1.06/1000 injections, 95% confidence interval [CI], 0.91–1.21, vs. 0.64/1000 injections, 95% CI 0.54–0.74; p < 0.0001). Comparable results were observed for analyses of patients who had undergone glaucoma or cataract surgeries, had antibiotic-associated endophthalmitis, had non-antibiotic-associated endophthalmitis, and were non-treatment-naive. In contrast, no significant differences in severe ocular inflammation claims were recorded in treatment-naive patients who had no record of anti-VEGF treatment in the 6 months preceding the index claim. No significant change occurred in the rate of severe ocular inflammation claims over time following ranibizumab treatment.Conclusions: Severe ocular inflammation was more frequent following intravitreal injection with aflibercept than with ranibizumab during routine clinical use in patients with nAMD. This highlights the importance of real-world, post-approval, observational monitoring of novel medicines, and may aid clinical decision-making, including choice of anti-VEGF agent.

Treatment Patterns and Healthcare Costs in Newly Diagnosed Patients with Chronic Myeloid Leukemia Receiving Dasatinib or Nilotinib As First-Line Therapy in the United States: A Retrospective Claims Database Analysis

Background: To date, no studies have directly compared the treatment patterns and economic outcomes of dasatinib and nilotinib as 1st-line therapy for Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This study aimed to address this gap using retrospective claims data. Method: Newly diagnosed adult pts with CML who received dasatinib or nilotinib as 1st-line therapy were identified from 2 large US administrative claims databases (Q1/2010 - Q4/2014). Pts with continuous health plan coverage for ≥6 months before (baseline period) and ≥1 month after the 1st-line TKI initiation (index date) were classified as dasatinib or nilotinib pts based on the 1st-line TKI. Pts were excluded from the study if they were enrolled in a clinical trial, had a stem-cell transplant, received chemotherapy (except hydroxyurea), had a metastatic cancer/solid tumor or end stage renal disease during the baseline period. Dose adjustment (dose decrease/increase of ≥20mg for dasatinib and ≥100mg for nilotinib vs the initial dose) were measured from the index date to treatment discontinuation (i.e., treatment gap of ≥60 days) or end of follow-up. Treatment adherence was measured using proportion of days covered (PDC) during a 6- and 12-month period following index date among pts with continuous health plan coverage during these periods. Treatment discontinuation, switching to another TKI, and healthcare resource utilization (HRU) and costs (pharmacy+medical costs; per person per month: PPPM; USD 2014) were measured from index date to end of follow-up. Outcomes were compared between cohorts using multivariate regression analyses adjusting for potential confounding factors identified at baseline/index date (age, gender, CML complexity, CCI, starting dose, and health plan type). Results: A total of 604 dasatinib and 418 nilotinib pts met the sample selection criteria with average follow-up of 17 months in both cohorts. Pts in dasatinib and nilotinib cohorts did not significantly differ in age (mean=51 vs 52, respectively; p=.114), sex (46% female in both cohorts; p=.834), and comorbidities (mean CCI=1.4 vs 1.5, respectively; p=.600). In dasatinib pts, 91% started with 100mg/day, 3% with Conclusions: Based on retrospective claims data, this study shows that dasatinib was associated with an increased risk of dose decrease despite majority of pts starting on the recommended dose, an increase risk of switching to another TKI, and higher total healthcare costs compared to nilotinib pts. No difference in adherence, discontinuation, and HRU was found. The study showed the association between nilotinib versus dasatinib as first-line therapy in CML patients and outcomes, not causation. The proportion of CML patients in accelerated phase or blast crisis by cohort at the first-line TKI initiation and its impact on results is unknown but was assumed to be marginal. Disclosures Chen:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Latremouille-Viau:Janssen-Cilag GmbH, Janssen-Ortho, Inc., Merck Frosst Canada, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Janssen Scientific Affairs, LLC, Centocor Ortho Biotech: Consultancy, Other: Dominick Latremouille-Viau is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations; AbbVie Inc., Alcon Laboratories, AstraZeneca, Bayer Healthcare Pharmaceuticals, LLC, Celgene Corporation, Forest Laboratories, Inc., Genentech, Inc., GlaxoSmithKline: Consultancy, Other: Dominick Latremouille-Viau is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations; Pfizer Canada, Inc., Savient Pharmaceuticals, Inc., Shire Pharmaceuticals Inc., Takeda Global Research & Development Center, Inc.,Takeda Pharmaceuticals U.S.A., Inc.: Consultancy, Other: Dominick Latremouille-Viau is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations. Guerin:GlaxoSmithKline, Janssen Scientific Affairs, Janssen-Ortho, Inc., Merck & Co., Inc., Merck Frosst Canada, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Ogilvy Renault, Ortho-Clinical Diagnostics, Inc., Otsuka America Pharmaceutical, Inc.,: Consultancy, Other: Annie Guerin is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations; Pfizer Canada, Inc., RXD AbbVie Inc., Alcon Laboratories, Bayer Healthcare Pharmaceuticals, LLC, Celgene Corporation, Cempra Inc., Centocor Ortho Biotech, Cooley LLP, Cyberonics, Inc., DLA Piper, Eli Lilly & Company, Forest Laboratories, Inc., Genentech, Inc.,: Consultancy, Other: Annie Guerin is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations. Nitulescu:Novartis Pharmaceuticals Corporation, Sunovion Pharmaceuticals Inc., AbbVie Inc., Otsuka America Pharmaceutical, Inc., Shire Pharmaceuticals Inc., Genentech, Inc., GlaxoSmithKline, Merck Frosst Canada: Consultancy, Other: Roy Nitulescu is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations. Gagnon-Sanschagrin:Novartis Pharmaceuticals Corporation, Genentech, Inc., AbbVie Inc., Takeda Pharmaceuticals U.S.A., Inc.: Consultancy, Other: Patrick Gagnon-Sanschagrin is an employee of Analysis Group Inc, which has received consultancy fees from the listed organizations.

External validation of the In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) multivariable prediction rule.

To validate the In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) multivariable prediction rule using admission claims data. Retrospective claims database analysis. This analysis was performed using Humana admission claims data from January 2007 to March 2014. We included adult patients admitted for their first PE during this period (International Classification of Diseases, ninth edition, Clinical Modification code of 415.1x in in the primary position or secondary position when accompanied by a primary code for a PE complication). The IMPACT rule, consisting of age plus 11 comorbidities, was used to estimate patients' probability of in-hospital mortality and classify risk. Low risk was defined as in-hospital mortality ≤ 1.5%. IMPACT was evaluated by evaluating prognostic test characteristic values and 95% confidence intervals (CIs). A total of 23,858 patients admitted for PE were included, and 3.3% died in-hospital. The IMPACT prediction rule classified 2371 (9.9%) as low-risk; with a sensitivity of 97.6%, 95% CI: 96.1-98.5, specificity of 10.2%, 95% CI: 9.8-10.6, negative and positive predictive values of 99.2% (95% CI: 98.7-99.5) and 3.5% (95% CI: 3.3-3.8) and c-statistic of 0.70, 95% CI: 0.0.68-0.72, for in-hospital mortality. IMPACT classified 42.7% of patients < 65 years old as low-risk; with a sensitivity, specificity and c-statistic of 85.0%, 95% CI: 77.4-90.5, 43.3%, 95% CI: 42.0-44.7 and 0.74, 95% CI: 0.69-0.78, respectively. The IMPACT prediction rule was valid when implemented in a database consisting largely of Medicare claims. Following further external validation and direct comparison to commonly used clinical prediction rules, IMPACT may become a valuable tool for payers and hospitals wishing to retrospectively assess whether their PE patients are being kept hospitalized for the optimal period of time.

Characteristics Relating to Adherence and Persistence to Basal Insulin Regimens Among Elderly Insulin-Naïve Patients with Type 2 Diabetes: Pre-Filled Pens versus Vials/Syringes.

IntroductionPrevious studies have found higher rates of adherence in patients with type 2 diabetes mellitus (T2DM) using insulin pens compared to vial and syringe administration; however, little evidence is available to support this observation in elderly patients.MethodsThis was a retrospective claims database analysis of a predominantly elderly Medicare Advantage with Prescription Drug (MAPD) insurance population consisting of 3172 insulin-naïve patients with T2DM who initiated basal insulin using pre-filled pens or vial and syringe (‘vial’). The index date was defined by the first pharmacy claim for basal insulin. Adherence, measured as proportion of days covered (PDC) and medication possession ratio (MPR), and persistence were evaluated in a 12-month follow-up period using an adjusted days’ supply. Multivariate regression analyses and a Cox proportional hazards model were used to identify characteristics associated with adherence and non-persistence, respectively, and compare findings between the pen and vial groups.ResultsThe pen cohort was slightly younger than the vial cohort (69.4 vs. 70.1 years, respectively; P = 0.0338). Similar proportions of male patients (53.3% vs. 56.8%; P = 0.0529) occurred in both cohorts, and lower Deyo–Charlson Comorbidity Index (4.4 vs. 5.0; P < 0.0001) was found for the pen cohort. Adjusted mean PDC was significantly higher in the pen cohort than the vial cohort (0.67 vs. 0.50; P < 0.001), as was mean MPR (0.75 vs. 0.57; P < 0.0001). Adjusted odds for adherence (PDC ≥ 80%) showed a positive association with use of an insulin pen (odds ratio = 2.19, 95% CI: 1.86–2.59). The adjusted risk of non-persistence (discontinuation) was significantly lower (58%) in the pen cohort relative to the vial cohort (hazard ratio = 0.42, 95% CI: 0.38–0.45). Key limitations include assumptions related to accuracy and comprehensiveness of claims data, and specifically days’ supply data used to measure insulin adherence.ConclusionThese findings suggest that pen devices improved insulin therapy adherence in a primarily elderly MAPD population with T2DM.FundingNovo Nordisk Pharmaceuticals, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0266-5) contains supplementary material, which is available to authorized users.

Current treatment patterns in patients with metastatic melanoma: A retrospective claims database analysis in the United States (US).

e20086 Background: Real-world evidence on the use of melanoma therapy is limited. This study was to describe the real-world treatment patterns of current melanoma therapies among patients with meta...

Incidence, direct costs and duration of hospitalization of patients hospitalized with community acquired pneumonia: A nationwide retrospective claims database analysis

BackgroundCommunity-acquired pneumonia (CAP) is one of the most common acute infections associated with a substantial clinical and economic burden. There have been few studies assessing incidence rate, duration of hospitalization, and costs of hospitalized CAP by age and care-setting. MethodsA retrospective study was conducted using a nationwide Dutch database containing healthcare claims data of 16.7 million inhabitants. Patients with at least one claim with a discharge diagnosis of CAP between January 2008 and December 2011 were selected. The main outcome measures considered were the incidence rate, duration of hospitalization, and the direct costs of hospitalized CAP stratified by age and care-setting. ResultsIn total, 195,372 CAP cases were included in the analysis resulting in an average incidence of 295 per 100,000 population per year. Sixty-three percent (123,357) of the included patients were hospitalized for 1 or more nights, of which 5.9% (n=7241) spent at least one night in the Intensive Care Unit (ICU). Overall, these 123,357 patients spent 824,985 days in the hospital of which 48,324 were spent on the ICU. The mean duration of hospitalization of ICU patients and general ward patients was 15.2 days and 6.2 days, respectively. The total costs related to all 195,372 CAP episodes during these 4 years were €711 million, with the majority (76%) occurring among those aged 50 years and older. Median (and mean) costs were dependent on age and type of care with costs ranging from €344 (€482) per episode for 0–9 year olds treated in the outpatient hospital setting up to €10,284 (€16,374) per episode for 50–64 year olds admitted to the ICU. ConclusionThere is a large variation in terms of incidence, disease burden and costs across different age groups and the treatment setting. Effective interventions, targeted at older adults, to prevent pneumonia could reduce the (financial) burden due to pneumonia.

PND71 - Healthcare Resource Utilization associated with dalfampridine Extended Release In Multiple Sclerosis: A Retrospective Claims Database Analysis

PND71 - Healthcare Resource Utilization associated with dalfampridine Extended Release In Multiple Sclerosis: A Retrospective Claims Database Analysis

PSS15 - Comparing total and disease specific Healthcare costs for Glaucoma Patients before and after their index Diagnosis: a retrospective claims database analysis

PSS15 - Comparing total and disease specific Healthcare costs for Glaucoma Patients before and after their index Diagnosis: a retrospective claims database analysis

Menstrual-Related Side Effects After Intrauterine Device Insertion or Tubal Ligation [245

INTRODUCTION: This retrospective claims database analysis compares menstrual-related side effects associated with the insertion of an intrauterine device (IUD) or tubal ligation. METHODS: The Clinformatics DataMart database from January 1, 2006, to September 30, 2012, was used. Women between ages 15 and 45 years were required to have an IUD inserted (Paragard or Mirena) or a tubal ligation (identified as index date) and have continuous insurance coverage from 1 year prior (preperiod) through 1 year postindex date (postperiod). χ2 statistics assessed associations between preperiod and postperiod menstrual-related side effects. RESULTS: The sample consisted of 107,516 women (11,864 Paragard; 56,661 Mirena; 38,991 tubal ligation). The majority were age 25–34 years (46.20%) or 35–45 years (45.22%), resided in the South (49.96%), and had point of service insurance (68.46%). There were significant differences in both preperiod and postperiod rates of dysmenorrhea, heavy menstrual bleeding, menorrhagia, anemia, and amenorrhea (all P<.001) among the three groups. Women who received a tubal ligation had the highest rates of preperiod and postperiod dysmenorrhea (3.93%; 4.77%), heavy menstrual bleeding (10.19%; 15.81%), menorrhagia (0.48%; 0.72%), and anemia (3.11%; 3.49%) and the highest preperiod rate of amenorrhea (21.60%). In contrast, women who used Paragard had the lowest reported rates of preperiod dysmenorrhea (1.47%), heavy menstrual bleeding (2.43%), menorrhagia (0.15%), anemia (2.31%), and postperiod menorrhagia (0.23%), whereas those who used Mirena had the lowest preperiod rates of amenorrhea (14.23%) and postperiod dysmenorrhea (2.27%), heavy menstrual bleeding (6.54%), anemia (1.82%), and amenorrhea (3.32%). CONCLUSION: Tubal ligation, compared with IUD insertion, is generally associated with higher rates of menstrual-related side effects.

PIN44 - Burden of Disease Caused by Influenza in Germany - A Retrospective Claims Database Analysis

PIN44 - Burden of Disease Caused by Influenza in Germany - A Retrospective Claims Database Analysis

PCN220 - Which is More Important for Doctors in a Low-Middle Income Country: a National Guideline or the Medical Literature? A Guideline Adherence Survey of Trastuzumab use for Breast Cancer in iran

Abstract Introduction Most national standard therapeutic guidelines in the world recommend a 52-week trastuzumab regimen for breast cancer treatment. In contrast, the national guideline published by the Iranian Ministry of Health recommends a nine-week regimen. Since guidelines are not necessarily followed in daily practice, we assessed the extent to which current routine practice in Iran as a middle-income country matches the recommendations found in these guidelines. Methods 128 Iranian oncologists were asked to complete an online anonymous questionnaire. Concurrently, a 3-year retrospective claims database analysis was conducted using data from the Social Security Organization, a health insurer which covers approximately 50% of the Iranian population, to enable comparisons with the questionnaire results. Results With a 41% (52/128) response rate, doctors reported a relatively high absolute adherence (86%) to the guideline for HER2 receptor testing but a low rate of absolute adherence (6%) to the guideline for duration of trastuzumab treatment. Doctors indicated that the planned duration was 9 weeks in only 33% of patients; in most cases, the plan was 52-week treatment. Patients with a 9-week treatment plan received trastuzumab for 8.6 weeks on average while patients with 52-week plans received treatment for 29.2 weeks. The general trends found in the survey were confirmed in the claims database analysis of 1295 HER2-positive patients. Conclusions Resource-sensitive guidelines may be beneficial in middle-income countries where limited budgets cannot accommodate all innovative technologies. However, Iranian physicians appear to rely more on the medical literature than on national guidelines regarding trastuzumab use. Policymakers, doctors and other stakeholders need to reach some consensus about the optimal way to treat patients. A national guideline needs to be accompanied with country-specific economic evaluations.

803Direct Costs and Duration of Hospitalization of Patients Hospitalized with Community Acquired Pneumonia: a Nationwide Retrospective Claims Database Analysis

803Direct Costs and Duration of Hospitalization of Patients Hospitalized with Community Acquired Pneumonia: a Nationwide Retrospective Claims Database Analysis

Compliance with Pharmacotherapy and Direct Healthcare Costs in Patients with Parkinson’s Disease: A Retrospective Claims Database Analysis

BackgroundParkinson’s disease (PD) is a progressive neurological disorder for which, at present, there is no cure. Current therapy is largely based on the use of dopamine agonists and dopamine replacement therapy, designed to control the signs and symptoms of the disease. The majority of current treatments are administered in tablet form and can involve multiple daily doses, which may contribute to sub-optimal compliance. Previous studies with small groups of patients suggest that non-compliance with treatment can result in poor response to therapy and may ultimately increase direct and indirect healthcare costs.ObjectiveTo determine the extent of non-compliance within the general PD population in the USA as well as the patient characteristics and healthcare costs associated with compliance and non-compliance.MethodsA retrospective analysis from a managed care perspective was conducted using data from the USA PharMetrics patient-centric claims database. PharMetrics claims data were complete from 31 December 2005 to 31 December 2009. Patients were included if they had at least two diagnoses for PD between 31 December 2005 and 31 December 2008, were older than 18 years of age, were continuously enrolled for at least 12 months after the date of the most recent PD diagnosis, and had no missing or invalid data. The follow-up period was the most recent 12-month block of continuous enrollment that occurred between 2006 and 2009. Patients were required to have at least one PD-related prescription within the follow-up period. The medication possession ratio (MPR) was used to categorise patients as compliant or non-compliant. Direct all-cause annual healthcare costs for patients with PD were estimated for each patient, and regression analyses were conducted to determine predictors for non-compliance.ResultsA total of 15,846 patients were included, of whom 46 % were considered to be non-compliant with their prescribed medication (MPR <0.8). Predictors of non-compliance included prescription of a medication administered in multiple daily doses (p < 0.0001), a period of <2 years since the initial PD diagnosis (p = 0.0002), a diagnosis of gastrointestinal disorder (p < 0.0001), and a diagnosis of depression (p < 0.0001). Non-compliance was also found to be related to age, with a lower odds of non-compliance in patients aged 41–80 years than in patients aged ≥81 years (p < 0.05). Although total drug mean costs were higher for compliant patients than non-compliant patients (driven mainly by the cost of PD-related medications), the mean costs associated with emergency room and inpatient visits were higher for patients non-compliant with their prescribed medication. Overall, the total all-cause annual healthcare mean cost was lower for compliant ($77,499) than for non-compliant patients ($84,949; p < 0.0001).ConclusionNon-compliance is prevalent within the general USA PD population and is associated with a recent PD diagnosis, certain comorbidities, and multiple daily treatment dosing. Non-compliance may increase the burden on the healthcare system because of greater resource usage compared with the compliant population. Treatments that require fewer daily doses may have the potential to improve compliance, which in turn could reduce the economic burden associated with PD.

P157 Reasons for a delayed diagnosis in inflammatory bowel disease

to follow-up, ADA-treated patients had significant reductions whereas IMS-treated patients had increases in UC-related hospitalizations and LOS (table). UC-related outpatient service utilization and costs, as well as total inpatient and outpatient service costs, decreased significantly for ADA-treated patients vs. a small increase for IMS-treated patients. ADA-treated patients also had a significantly greater reduction in hospital LOS for colectomy. Conclusions: In this retrospective claims database analysis, ADA therapy was associated with greater reductions in UCrelated hospitalization rates, length of hospitalization for colectomy, and total inpatient and outpatient medical service costs compared with IMS therapy.

Treatment patterns of castration-resistant prostate cancer: A retrospective claims database analysis.

198 Background: Prostate cancer is the most commonly diagnosed malignancy among men in the US; mortality rates are highest among those with castration-resistant prostate cancer (CRPC). Observational data on CRPC are limited. This study examined CRPC treatment patterns relative to NCCN guidelines in a large US health plan. Methods: This was a retrospective claims database analysis of commercial and Medicare Advantage enrollees with evidence of prostate cancer (ICD-9: 185.xx) between 07/01/06 – 03/31/11. CRPC patients were then identified based on prostate-specific antigen (PSA) progression (≥2 PSA increases based on ≥3 PSA values) and/or use of chemotherapy: docetaxel (DOC), mitoxantrone (MIT), estramustine (EST), or cabazitaxel (CAB). The CRPC index date was the first date of PSA progression or chemotherapy. Patients were continuously enrolled for 6 months before (baseline) and ≥6 months after the index date until 09/30/2011 or until death, if sooner (follow-up). Results: A total of 1651 patients met the CRPC selection criteria. Mean (SD) age was 70 ± 9 years, 1085 (66%) received DOC on the index date, and 467 (28%) died during follow-up. A third of patients with DOC received additional CRPC therapy during follow-up: 160 (15%) received MIT, EST, or CAB, and 239 (22%) received a secondary hormonal therapy (SHT: antiandrogens, aminoglutethimide, GnRH/LHRH antagonists, estrogen, or abiraterone acetate). Among 566 patients without DOC, 99 (17%) received a different chemotherapy (MIT = 45; EST = 52; CAB = 2), and 178 (31%) received a SHT. More than half 311 (55%) without DOC did not receive any other CRPC therapy during follow-up, of which 40 (13%) received bone-directed therapy (BDT: denosumab = 0; bisphosphonates = 27; radiation = 13). Conclusions: Consistent with NCCN guidelines, DOC was the most commonly used therapy. However, two-thirds of patients with DOC and over half of patients without DOC did not receive additional CRPC therapy after the index date. In addition, only 13% of patients with no CRPC therapy received any follow-up BDT. Additional research is warranted to understand whether clinical rationale, patient preference, or access to care may have resulted in patients not receiving additional therapy.

Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis

Objective:The safety and efficacy of the GLP-1 receptor agonists exenatide BID (exenatide) and liraglutide for treating type 2 diabetes mellitus (T2DM) have been established in clinical trials. Effective treatments may lower overall treatment costs. This study examined cost offsets and medication adherence for exenatide vs liraglutide in a large, managed care population in the US.Methods:This was a retrospective cohort analysis comprising adult patients with T2DM who initiated exenatide or liraglutide between 1/1/2010 and 6/30/2010 and had 6 months pre-index and post-index continuous eligibility. Patients were propensity score-matched to controls for baseline differences. Medication adherence was measured by proportion of days covered (PDC). Paired t-test and McNemar’s test were used to compare outcomes.Results:Matched exenatide and liraglutide cohorts (n = 1347 pairs) had similar average total 6-month follow-up costs ($6688 vs $7346). However, exenatide patients had significantly lower mean pharmacy costs ($2925 vs $3272, p < 0.001). Among liraglutide patients, patients receiving the 1.8 mg dose had significantly higher average total costs compared to those receiving the 1.2 mg dose ($8031 vs $6536, p = 0.026), with higher mean pharmacy costs in the 1.8 mg cohort ($3935 vs $3146, p < 0.001). There were no significant differences in inpatient or outpatient costs or medication adherence between groups (mean PDC: exenatide 56% vs liraglutide 57%, p = 0.088).Limitations:The study assumed that all information needed for case classification and matching of cohorts was present and not differential across cohorts. The study did not control for covariates that were unavailable, such as HbA1c and duration of diabetes.Conclusions:Patients initiating exenatide vs liraglutide for T2DM had similar medication adherence and total healthcare costs; however, exenatide patients had significantly lower total pharmacy costs. Patients prescribed 1.8 mg liraglutide had significantly higher costs compared to those on 1.2 mg.

Abstract 219: “Real World” Characterization of Patients with a Cardiac Event: A Case-Control Study

Background: Recent clinical intervention trials with neutral outcomes, enrolled patients with relatively well controlled risk cardiovascular (CV) risk factor profiles. The extent to which these patients reflect risks in the general population is unknown. Objective: To determine the baseline characteristics of new cardiac patients, and compare these with the general population and subjects enrolled in recent clinical trials. Methods: This was a retrospective claims database analysis. Cases were selected as patients with first occurrence of at least one cardiac event/procedure (coronary or cerebral event or revascularization procedure) between January 2005 and December 2008. The date of the event was set as the index date. Patients 18-64 years old with a lipid panel who enrolled during the year prior to the index date were selected. The cases were matched 1:3 on age, gender, and length of enrollment with controls who had no cardiac event but who also a lipid panel during the year prior. NCEP ATP III guidelines were used to determine lipid goals. Descriptive analyses were conducted to understand the similarities and differences between the cases and controls. Logistic regression was used to identify the potential predictors of cardiac events. Results: A total of 78,596 patients with an event were matched to 235,788 individuals in the general population. Average age was 54 years (SD 8.4) and 53.2% were men. Only 37.9% of cases compared to 49.3% of the general population had all three lipid values at goal. Irrespective of LDL-C levels, cases had higher a prevalence of elevated TG and depressed HDL-C than controls. In logistic regression, hypertension (OR 1.86 CI 1.82-1.89), diabetes (OR 1.31 CI 1.28-1.34), depression (OR 1.43 CI 1.39-1.47), dyslipidemia (OR 1.31 CI 1.28-1.34) elevated LDL-C (OR 1.31 CI 1.29 1.33) and depressed HDL-C (OR 1.31 CI 1.28-1.34) significantly (p&lt;0.05) increased the odds of having an event. Interpretation: Patients with a CV event had multiple lipid abnormalities and comorbidities known to increase CV risk. Patients with multiple cardiometabolic factors are at an increased risk for CV events and should be the focus of preventive strategies. Recent clinical intervention trials such as AIM-HIGH and ACCORD enrolled patients with significantly better controlled lipid variables than those observed in a ‘real world' population of patients who have cardiac events. These findings highlight the limited applicability of these recent trials to the general population at risk for cardiac events and encourage further study on the prevention of cardiac outcomes in cardiometabolic patients.

The NIMH-CATIE Schizophrenia Study: What Did We Learn?

It has been over 10 years since the initiation of the National Institute of Mental Health (NIMH) Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study and 5 years since the first publication of its primary results (1). In this period, the initial report has been cited in the literature over 1,600 times (2) while more than 80 articles from the study’s extensive database (Table 1), as well as a book serving as an archive of the study’s results and implications (3), have been published. In the meantime, several more randomized trials comparing the effectiveness of antipsychotics have been completed (4–6), meta-analyses that bear on the findings of the CATIE study have been performed (7, 8), and commentaries on CATIE’s findings and critiques of its methodology have been published (9–11). All of these help us to view the CATIE study in a broader context and enable us to determine what we really learned from it. When the CATIE study was designed in 1999– 2000, the prevailing opinion of researchers and clinicians alike was that the newer (second-generation) antipsychotic drugs were vastly superior to the older (first-generation) antipsychotic drugs in efficacy and safety. This largely reflected the results of studies sponsored by the manufacturers of the new drugs (12, 13), marketing messages of pharmaceutical companies and the hopes of many who wanted better treatments. Indeed, the hypothesis and expectation of the CATIE study investigators was that the firstgeneration antipsychotic perphenazine would be inferior to the newer agents. Consequently, the finding that perphenazine was similar in effectiveness to most other medications had a profound effect that extended beyond the scientific and psychiatric communities to the lay public and various stakeholder groups. Somewhat sensational news reports decried the preferential use and greater cost of the newer medications and the marketing practices that led to them. For example, the September 21, 2005, editorial page of The New York Times opined, “A government-financed study has provided the strongest evidence yet that the system for approving and promoting drugs is badly out of whack. The study compared five drugs used to treat schizophrenia and found that most of the newest, most heavily prescribed drugs were no better than an older drug that is far cheaper. The nation is wasting billions of dollars on heavily marketed drugs that have never proved themselves in head-to-head competition against cheaper competitors” (14). But what did we really learn from the CATIE study? In this commentary, we summarize its major implications and their relevance to clinical practice. We will also address some of the study’s most relevant critiques.