Budget impact of prophylactic treatment of rVIII-SingleChain in moderate and severe hemophilia A in Italy.

INTRODUCTION: rVIII-SingleChain, a recombinant factor VIII (rFVIII), has demonstrated safety and efficacy in patients with hemophilia A in clinical trials and real-world evidence. This analysis aimed to estimate the potential budget impact of increasing the usage of rVIII-SingleChain for the prophylactic treatment of hemophilia A over 3 years in Italy. METHODS: Patients with moderate and severe hemophilia A receiving prophylaxis were included in the analysis. Epidemiological data were obtained from published literature. Mean product consumption and mean annual bleeding rate for rVIII-SingleChain, rFVIIIFc, octocog alfa and BAY 81-8973 were based on pooled real-world data from Italy, Germany and US. A budget impact model has been developed in order to compare two scenarios: a base-case scenario where current rVIII-SingleChain shares are kept constant over 3 years and an alternative scenario where rVIII-SingleChain shares increase by taking from other rFVIII products. Analysis 1 was based on the current Italian list prices and Analysis 2 considered current regional acquisition prices for both scenarios. RESULTS: Annually, adult patients treated with rVIII-SingleChain prophylaxis are expected to consume 324,589 units per patient, resulting in annual costs of €240,196 per patient. In Analysis 1, comparing the base case (constant market share of 9% rVIII-SingleChain over time) with the alternative scenario (higher rVIII-SingleChain market share and increasing from 15% in the first year to 25% in the third year), the total expenditure for prophylaxis using rFVIII products is expected to decrease by €1.4 million in Year 1, by €3.1 million in Year 2 and by €5.4 million in Year 3. In Analysis 2 based on regional prices, the results remained consistent. DISCUSSION/CONCLUSION: This analysis suggests that increasing utilization of rVIII-SingleChain in hemophilia A patients may lead to cost savings as a result of reduced consumption with uncompromised efficacy in bleed protection.

Why was the study done? Hemophilia A is a rare inherited bleeding disorder. People with severe hemophilia are more likely to bleed compared to people without hemophilia and bleeds can occur spontaneously or in response to trauma. Patients are treated with medication to reduce the chance of bleeding. However, the cost of treating patients with hemophilia can be high and place demands on the healthcare system.What did we do and find?This study looked at the cost of treating people with hemophilia in Italy and used a type of economic analysis (called budget impact modelling) to estimate the effect of increasing the use of a particular medication (rVIII-SingleChain), compared to other medications that are available. Different variations of the model were tested to compare a range of scenarios.The results of this analysis suggested that increasing the use of rVIII-SingleChain may lead to cost-savings for the Italian healthcare system, compared to using the other currently available treatments. This analysis suggests that the use of rVIII-SingleChain enables people with hemophilia A to remain protected from bleeds, whilst using less product compared to other available medications.What is the influence of this study on the wider field?This type of analysis can be useful to healthcare systems, to guide the decision-making process regarding which medications to use or when making decisions related to healthcare policy.

Budget impact of niraparib as maintenance treatment in recurrent ovarian cancer following platinum-based chemotherapy.

Aim: To estimate financial implications of adopting niraparib as maintenance treatment in recurrent ovarian cancer. Materials & methods: A model was developed to estimate the budget impact of treating patients with niraparib compared with alternative maintenance treatment options (olaparib, rucaparib, bevacizumab or 'watch and wait') over 3 years. Results: For a hypothetical plan with 1 million lives representative of US/Medicare-only populations, projected cost savings with niraparib were US$78,721/$293,723, $276,671/$1,009,729 and $353,585/$1,289,712 at years 1, 2 and 3, respectively. Sensitivity analyses showed prices of niraparib, rucaparib and olaparib to have the most significant impact on the budget. Conclusion: Factoring in all treatment-related costs, the use of niraparib could result in significant cost savings compared with other maintenance treatment options.

Effect of Diabetes Treatment-Related Attributes on Costs to Type 2 Diabetes Patients in a Real-World Population.

BACKGROUND: Type 2 diabetes mellitus (T2DM) results in a substantial economic burden on patients, health care systems, and society. Most literature assessing the cost of T2DM focuses on the long-term complications of the disease, the association between glucose control and cost, and patient characteristics resulting in poor and costly outcomes. However, it is likely that attributes specific to diabetes therapy can affect the use of costly resources. OBJECTIVE: To estimate the effect of diabetes treatment-related attributes, such as improved efficacy, adherence, and reduced risk for hypoglycemia, on costs to T2DM patients. METHODS: An observational, retrospective study was conducted using the Optum Clinformatics Database, which links medical and pharmacy claims to laboratory results. Patients aged ≥ 18 years with T2DM who had ≥ 1 antidiabetic medication claim; ≥ 1 hemoglobin A1c (A1c) test result; continuous enrollment in the health plan from April 1, 2010, to March 31, 2011; and at least 1 follow-up day were included. Nondiabetes specific total, inpatient, outpatient, emergency room, and other costs (along with antidiabetes medication costs) were defined for each patient. Generalized linear models with logarithm link were used to predict the 1-year and cumulative 3-year costs. Demographic factors and comorbidities were included as covariates in addition to the diabetes treatment-related attributes. RESULTS: In the entire analysis cohort, the average 3-year cost per patient was $74,862. The percentage effect on cost of diabetes treatment-related variables ranged from -18% to 429%. Drug adherence was associated with lower inpatient, outpatient, and emergency room costs and higher drug costs. Hypoglycemia was associated with higher inpatient, outpatient, emergency room, and other direct costs (except antidiabetic drug costs). Compared with A1c values ≤ 7%, patients with higher levels were associated with higher total and drug costs. CONCLUSIONS: Study results demonstrate the association between diabetes treatment-related attributes and costs, including inpatient, outpatient, drug, and total costs. This association raises the question: what would the effect of a new diabetes therapy, with high efficacy, high adherence, and reduced risk of hypoglycemia have on economic outcomes? DISCLOSURES: Funding from Sanofi supported this study. Tong was an employee of ProUnlimited, under contract with Sanofi during the time of the study. Kitio-Dschassi was a Sanofi employee at time of the analysis. Meng, Casciano, Stern, and Gultyaev are employees of LASER Analytica, which received research funds from Sanofi to conduct this database analysis. Lee was an employee at LASER Analytica at the time of the analysis and has received grants from Sanofi. This manuscript was presented as a poster at the American Diabetes Association, 76th Scientific Sessions; New Orleans, Louisiana; June 10-14, 2016. Study concept and design were contributed by Meng, Casciano, Gultyaev, and Kitio-Dschassi. Meng and Stern collected the data, and data interpretation was performed by Casciano, Lee, Tong, and Kitio-Dschassi. The manuscript was written primarily by Lee, along with Meng and Stern, and revised by Stern, Meng, Tong, Kitio-Dschassi, and Lee.

The Real-World Utilization Pattern of Increased Utilization of Advanced Topical Adjunctive Hemostats in a Vertically Integrated Healthcare System.

Hemostasis products, such as SURGICEL®, have been increasingly used across a wide variety of surgical procedures to mitigate bleeding-related risks and complications. This retrospective observational study described the utilization pattern of the SURGICEL® family of oxidized regenerated cellulose products (SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL SNoW®) in a large, vertically integrated healthcare system, by utilizing electronic medical records (EMR) extracted from August 2013 through June 2015 at Henry Ford Health System (HFHS). Descriptive measurements were compared between SURGICEL® ORIGINAL and advanced SURGICEL® products (SURGICEL® FIBRILLAR™ and SURGICEL SNoW®) for pooled common surgical procedures. Among 1471 patients, 450 received SURGICEL® ORIGINAL, and 1021 received advanced SURGICEL® products. A significantly greater proportion of patients given advanced SURGICEL® products had comorbidities (91.0% vs 85.6%, p=.0024), prior bleeding conditions (49.9% vs 30.9%, p<.0001), and prior use of anticoagulants (27.7% vs 5.3%, p<.0001). Advanced SURGICEL® products were more likely to be used in coronary artery bypass grafting (13.7% vs 1.6%, p<.0001). Among a sub-set of 1420 patients with complete package size information (988 Advanced and 432 ORIGINAL), significantly fewer mean normalized units of Advanced SURGICEL® were used per patient case (3.9 vs 5.5, p<.0001). Despite Advanced SURGICEL® products being utilized in higher risk bleeding situations compared to cases where SURGICEL® ORIGINAL was utilized, fewer overall normalized units of Advanced SURGICEL® were required per patient case. Further research is needed to investigate the implications of topical hemostat use in continuous oozing bleeding situations on outcomes, hospital costs, and resources.

The burden of preserved ejection fraction heart failure in a real-world Swedish patient population.

OBJECTIVES: To evaluate resource use and associated costs in patients with a diagnosis of heart failure with preserved ejection fraction (HF-PEF) in Sweden. METHODS: This retrospective study identified real-world patients with an ICD-10 diagnosis code for heart failure (I50) for the period between July 1, 2005 and December 31, 2006 from electronic medical records of primary care centers in Uppsala County Council, and in the Swedish patient registry data. Patients were categorized as having HF-PEF (left ventricle ejection fraction [LVEF] > 50%) during the index period. The study assessed medication utilization, outpatient visits, hospitalizations, and associated healthcare costs, as well as the incidence rates and time to all-cause and heart failure mortality following the index period. RESULTS: The study included 137 HF-PEF patients with a mean age of 77.1 (SD = 9.1) years. Over 50% of HF-PEF patients were female and hypertensive. Nearly all patients received ≥ 1 medication post-index. Patients had an average of 1.5 heart failure related hospitalizations per follow-up year. The average annual per patient cost for the management of a HF-PEF patient was found in Sweden to be Swedish Krona (SEK) 108,246 (EURO [EUR] 11,344). Hospitalizations contributed to more than 80% of the total cost. All-cause mortality over the 18-month study period was 25.5%, and more than 50% of these deaths occurred within 1 year of index. LIMITATIONS: Due to the limitations of registry data, it is not possible to confirm the HF diagnosis, and therefore the accuracy of registry records must be assumed. Other factors such as short follow-up time, the study-mandated LVEF assessment, and a lack of drug duration data may also have an impact on the study results. CONCLUSIONS: All-cause mortality was high in the HF-PEF population, with more than half of patients dying within 1 year of study follow-up. Study results also indicate that 60% of HF-PEF patients have ≥ 1 hospitalization during follow-up. Hospitalizations, especially heart failure related admissions, represent a substantial proportion of the total healthcare burden of patients with HF-PEF in Sweden.

United States-based practice patterns and resource utilization in advanced neuroendocrine tumor treatment.

AIM: To assess advanced neuroendocrine tumor (NET) treatment patterns and resource utilization by tumor progression stage and tumor site in the United States. METHODS: United States Physicians meeting eligibility criteria were provided with online data extraction forms to collect patient chart data on recent NET patients. Resource utilization and treatment pattern data were collected over a baseline period (after diagnosis and before tumor progression), as well as initial and secondary progression periods, with progression defined according to measureable radiographic evidence of tumor progression. Resource categories used in the analysis include: Treatments (e.g., surgery, chemotherapy, radiotherapy, targeted therapies), hospitalizations and physician visits, diagnostic tests (biomarkers, imaging, laboratory tests). Comparisons between categories of resource utilization and tumor progression status were examined using univariate (by tumor site) and multivariate analyses (across all tumor sites). RESULTS: Fifty-five physicians were included in the study and completed online data extraction forms using the charts of 110 patients. The physician sample showed a relatively even distribution for those affiliated with academic versus community hospitals (46% vs 55%). Forty (36.3%) patients were reported to have pancreatic NET (pNET), while 70 (63.6%) patients had gastrointestinal tract (GI)/Lung as the primary NET site. Univariate analysis showed the proportion of patients hospitalized increased from 32.7% during baseline to 42.1% in the progression stages. While surgeries were performed at similar proportions overall at baseline and progression, pNET patients, were more likely than GI/Lung NET patients to have undergone surgery during the baseline (33.3% vs 25.0%) and any progression periods (26.7% vs 23.4%). While peptide-receptor radionuclide and targeted therapy utilization was low across NET types and tumor stages, GI/Lung types exhibited greater utilization of these technologies compared to pNET. Chemotherapy utilization was also greater among GI/Lung types. Multivariate analysis results demonstrated that patients in first progression period were over 3 times more likely to receive chemotherapy when compared to baseline (odds ratio: 3.31; 95%CI: 1.46-7.48, P = 0.0041). Further, progression was associated with a greater likelihood of having a study physician visit [relative risk (RR): 1.54; 95%CI: 1.10-2.17, P = 0.0117], and an increased frequency of other physician visits (RR: 1.84; 95%CI: 1.10-3.10, P = 0.0211). CONCLUSION: Resource utilization in advanced NET in the United States is significant overall and data suggests progression has an impact on resource utilization regardless of NET tumor site.

Key issues in addressing the clinical and humanistic burden of short bowel syndrome in the US.

BACKGROUND: The purpose of this analysis was to provide a concise report of the literature on the burden of intestinal failure associated with short bowel syndrome (SBS-IF) in adults, focused on clinical and humanistic issues important to clinicians and payers. SCOPE: A literature search was performed using the National Library of Medicine PubMed database ( http://www.ncbi.nlm.nih.gov/pubmed ) with the search term 'short bowel syndrome' limited to adult populations and English-language reports published from January 1, 1965, to January 18, 2013. Citations were assessed for relevance and excluded articles focused on single case studies, colon fermentation, absorption of medications with PN/IV, surgical technique, mesenteric artery complications/surgery, and transplantation focus. Additional hand searches were performed using the terms 'short bowel syndrome' AND 'cost', and 'home parenteral nutrition' AND 'cost', along with the exclusion criteria described above. FINDINGS: Despite advances in management in recent decades, SBS-IF continues to carry a high burden of morbidity and mortality. In the absence of sufficient intestinal adaptation following resection, many patients remain dependent on long-term parenteral nutrition and/or intravenous fluids (PN/IV). Although potentially life saving, PN/IV is costly, invasive, and associated with numerous complications and deleterious effects on health and quality of life. Surgical interventions, especially intestinal transplantation, are costly and are associated with substantial morbidity and high mortality. New therapies, which show promise in promoting intestinal rehabilitation and reducing dependence on PN/IV therapy, are the subject of active research. CONCLUSIONS: Overall, the available literature suggests that although SBS-IF affects a relatively small population, the clinical and humanistic burden is significant, and there is an unmet need for effective therapeutic options that target the underlying problem of inadequate absorptive capacity of the remaining intestine. Consequently, many patients with SBS-IF remain dependent on long-term PN/IV support, adding to the burden imposed by the underlying disorder.

International practice patterns and resource utilization in the treatment of neuroendocrine tumors.

OBJECTIVES: This study compared resource use and practice patterns in patients with advanced neuroendocrine tumors (NETs) on disease progression, across countries, and by tumor type. METHODS: Physicians in the United States, United Kingdom, Germany, France, Brazil, and Italy completed data extraction forms to extract chart data of patients with NET relating to health care resource utilization and treatment practice. Data were assessed in a cross-sectional manner, by country, and by NET subtype. Univariate and multivariate analyses were performed to compare categories of resource use by disease progression status. RESULTS: A total of 197 physicians provided data on 394 patients. Overall resource utilization was high across tumor types, countries, and progression. Nearly half of all patients received chemotherapy (49%); moreover, high rates of hospitalization (65%), surgery (47%), and use of somatostatin analog (77%) were observed, with lower rates of peptide receptor radionuclide therapy (10%) and targeted therapies (6%). These patterns were consistent across gastrointestinal tract/lung NET and pancreatic NET. However, a certain variation in resource utilization was observed across countries. Disease progression was associated with increasing utilization of chemotherapy, hospitalization, and targeted therapy. CONCLUSIONS: Advanced NET is associated with significant resource use across subtypes and countries, and resource utilization is likely to increase on disease progression. There remains an unmet need for therapeutic options after disease progression.

Resource utilization and cost of heart failure associated with reduced ejection fraction in Swedish patients.

AIM: The purpose of this study was to assess healthcare utilization and costs for heart failure patients with reduced ejection fraction (HF-REF) in Sweden. METHODS AND RESULTS: This was a retrospective, population-based cohort study of patients diagnosed with HF-REF during a period of 18 months at 31 primary care centers in Uppsala County, Sweden. Data was obtained from computerized records from these centers, the Swedish Patient Registry, the Swedish Prescription Registry, the Cause of Death Registry, and a local echocardiography registry maintained by the Department of Physiology, Uppsala University Hospital. Main outcome measures were cardiovascular and heart-failure-related hospitalizations, outpatient visits, medication utilization, mortality (all-cause, cardiovascular, and heart-failure), and healthcare costs for HF-REF patients. During the index period, 252 heart failure patients had a left ventricular ejection fraction measurement ≤ 40% and were categorized as having HF-REF. More than half of the patients had ≥ 1 cardiovascular or heart failure-related hospitalization. On average, patients had >2 such hospitalizations annually. They also averaged ∼1 cardiovascular or heart-failure-related outpatient visit per year. All-cause mortality was high: 15.9% patients died within 1 year after the index date. The mean annual cost per patient for heart-failure-related hospitalizations was SEK 72,613 (EUR 7610). In contrast, annual prescription costs were low, on average 3% of total cost (SEK 3503, EUR 367 per patient) LIMITATIONS: The main limitations of this study include a short follow-up time and small sample size. Also, certain data were missing, such as echocardiograms (available for only 28% of patients), and information on patients' New York Heart Association (NYHA) functional class, validity period for prescriptions or the units of medication prescribed, and medication dosing. Furthermore, the overall mortality could have been under-estimated, as only the primary cause of death was included in the analysis. CONCLUSIONS: The main burden associated with HF-REF is related to hospitalizations for heart-failure events. Effective treatment options that decrease hospitalization rates could reduce patients' suffering and potentially offer considerable cost savings.

Economic impact of enoxaparin versus unfractionated heparin for venous thromboembolism prophylaxis in patients with acute ischemic stroke: a hospital perspective of the PREVAIL trial.

BACKGROUND: The PREVAIL (Prevention of VTE [venous thromboembolism] after acute ischemic stroke with LMWH [low-molecular-weight heparin] and UFH [unfractionated heparin]) study demonstrated a 43% VTE risk reduction with enoxaparin versus UFH in patients with acute ischemic stroke (AIS). A 1% rate of symptomatic intracranial and major extracranial hemorrhage was observed in both groups. OBJECTIVE: To determine the economic impact, from a hospital perspective, of enoxaparin versus UFH for VTE prophylaxis after AIS. DESIGN: A decision-analytic model was constructed and hospital-based costs analyzed using clinical information from PREVAIL. Total hospital costs were calculated based on mean costs in the Premier™ database and from wholesalers acquisition data. Costs were also compared in patients with severe stroke (National Institutes of Health Stroke Scale [NIHSS] score ≥14) and less severe stroke (NIHSS score <14). RESULTS: The average cost per patient due to VTE or bleeding events was lower with enoxaparin versus UFH ($422 vs $662, respectively; net savings $240). The average anticoagulant cost, including drug-administration cost per patient, was lower with UFH versus enoxaparin ($259 vs $360, respectively; net savings $101). However, when both clinical events and drug-acquisition costs were considered, the total hospital cost was lower with enoxaparin versus UFH ($782 vs $922, respectively; savings $140). Hospital cost-savings were greatest ($287) in patients with NIHSS scores ≥14. CONCLUSIONS: The higher drug cost of enoxaparin was offset by the reduction in clinical events as compared to the use of UFH for VTE prophylaxis after an AIS, particularly in patients with severe stroke.

The effectiveness of adjustable gastric banding: a retrospective 6-year U.S. follow-up study.

BACKGROUND: This study aimed to assess the efficacy of laparoscopic adjustable gastric banding (LAGB) during a 6-year follow-up period. METHODS: A retrospective database analysis of patients who underwent LAGB at New York University Medical Center between 1 January 2000 and 29 February 2008 was conducted. Patients were included for the efficacy analysis if they were 18 years old or older at the surgery date and had one or more visits with a recorded weight after surgery. Efficacy was assessed using percentage of excess weight loss (%EWL) at 1-year intervals after surgery. Missing weight values were interpolated using a cubic spline function. Linear regression models were used to assess the characteristics that affected the last available %EWL. All patients had implantation of the LAP-BAND system. RESULTS: The inclusion criteria for the efficacy analysis were met by 2,909 patients. The majority of the patients were white (83.3%) and female (68.4%). The mean patient age was 44.6 years, and the mean baseline body mass index (BMI) was 45.3 kg/m2. The %EWL 3 years after surgery was 52.9%, which was sustained thereafter. In multivariate models, increased number of office visits, younger age, female gender, and Caucasian race were significantly associated with a higher maximum %EWL. CONCLUSIONS: The LAP-BAND patients achieved a substantial and sustainable weight loss of approximately 50% at 6 years after surgery.

Economic impact of enoxaparin after acute ischemic stroke based on PREVAIL.

The efficacy and safety of low-molecular-weight heparins (LMWHs) versus unfractionated heparin (UFH) has been demonstrated for the prevention of venous thromboembolism (VTE) after acute ischemic stroke. Few data exist regarding the economic impact of LMWHs versus UFH in this population. A decision-analytic model was constructed using clinical information from the Prevention of VTE after Acute Ischemic stroke with LMWH Enoxaparin (PREVAIL) study, and drug costs and mean Centers for Medicare & Medicaid Services event costs. When considering the total cost of events and drugs, enoxaparin was associated with cost-savings of $895 per patient compared with UFH ($2018 vs $2913). Findings were retained within the univariate and multivariate analyses. From a payer perspective, enoxaparin was cost-effective compared with UFH in patients with acute ischemic stroke. The difference was driven by the lower clinical event rates with enoxaparin. Use of enoxaparin may help to reduce the clinical and economic burden of VTE.

Healthcare charges in patients who transition from ocular hypertension to primary open-angle glaucoma based on ophthalmic coding data.

INTRODUCTION: The purpose of this research was to assess the impact of transition from ocular hypertension (OHT) to primary open-angle glaucoma (POAG) on healthcare charges. METHODS: A case-control group was identified using PharMetrics claims database (1998-2005). Cases (n=1055) had a transition from OHT to POAG based on International Classification of Disease, Ninth Edition coding (ICD-9=365.11). Controls (n=2110) retained an ICD-9 code for OHT (ICD-9=365.04) and were matched to cases (2:1) on gender, age, diagnosis year, and follow-up time post-diagnosis. The index date marked the transition for cases and a date of similar duration after OHT diagnosis for controls. Conditional logistic regression and multiple linear regression models determined the impact of transitioning on healthcare charges. RESULTS: Cases had significantly higher increases in ophthalmology-related charges ($797 vs. -$385, P<0.0001) but similar total healthcare charges ($1689 vs. $1386, P=0.8277) from the year pre- to year post-index date when compared with controls. After adjusting for key covariates, cases were 1.56 times (95% CI: 1.33-1.82) more likely to have increased total charges and 5.26 times (95% CI: 4.27-6.47) more likely to have increased ophthalmology-related charges compared with controls. In multiple linear regression analyses, cases experienced $48 (55%) higher increases in ophthalmology-related charges from the year pre- to year post-index date compared with controls ($85 vs. $37, respectively; P<0.0001). CONCLUSION: Patients with a transition from OHT to POAG based on ICD-9 coding had higher ophthalmology-related charges the year after transition compared with patients who retained a code for OHT. Prevention of this transition could result in healthcare resource savings.

Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a single integrated health network.

OBJECTIVE: To determine the association between the discontinuation of clopidogrel therapy prior to 1 year and the risk of acute myocardial infarction (AMI) hospitalization, coronary intervention or all-cause mortality in a cohort of managed-care patients following AMI hospitalization or stent insertion. RESEARCH DESIGN AND METHODS: This observational cohort study included 1152 patients enrolled in the Health Alliance Plan who were hospitalized for AMI, or who underwent coronary stent placement. Clopidogrel use was assessed using pharmacy claims data. The association between discontinuation of clopidogrel prior to 1 year following the initial ACS event and the primary outcome of AMI hospitalization/procedure was assessed using Cox proportional hazards models. Additionally, an analysis was conducted to determine the association of discontinuation prior to 1 year with a secondary composite outcome of AMI hospitalization/coronary stent procedure or all-cause mortality. MAIN OUTCOME MEASURES: The primary outcome was AMI hospitalization or procedure. The secondary outcome was a composite of AMI hospitalization/ procedure, or all-cause mortality. RESULTS: Discontinuation of clopidogrel in the total cohort of patients was associated with a significantly higher risk of the primary outcome of AMI hospitalization/ coronary intervention (HR 2.712, 95% CI 1.634-4.502). Consistent with this finding, discontinuation of clopidogrel was also associated with a significantly higher risk of the secondary composite endpoint (HR 1.844, 95% CI 1.281-2.653). CONCLUSIONS: In patients enrolled in an integrated health network, clopidogrel discontinuation prior to 1 year following AMI hospitalization or stent placement is associated with adverse outcomes including greater risk of death, AMI hospitalization or coronary intervention. These results should be interpreted within the context and limitations of observational research, which cannot attribute causality.

Pharmacotherapy compliance in patients with ocular hypertension or primary open-angle glaucoma.

PURPOSE: The aim of this study was to compare rates of pharmacotherapy coverage in patients with ocular hypertension (OH) and patients with primary open-angle glaucoma (POAG). METHODS: Retrospective cohort study analysis of a nationally representative, multimanaged health plan database (PharMetrics; 1998-2005) which included 4818 medicated OH patients and 52,985 medicated POAG patients with at least 1 year of continuous enrollment and at least one prescription for IOP-lowering medication during the first year of follow-up. Patients selected for the current study were nested within the cohort of OH patients (n = 36,767) and POAG patients (n =72,412) previously reported. Of the previously reported OH cohort, only 13.1% of patients filled at least one prescription, as compared to 73.2% of the previously reported POAG cohort. Medication coverage was defined as the percent of days during which a patient was in possession of IOP-lowering therapy over the first year of follow-up (medication coverage = number of covered days/365). Compliant patients were defined as those with >or= 75th percentile medication coverage. RESULTS: POAG patients had slightly longer mean length of enrollment in the database (2.5 years, SD = 1.2) than did OH patients (2.4 years, SD = 1.1; P < 0.0001). The mean medication coverage was 50% for the POAG cohort (SD = 0.26) and 40% for the OH cohort (SD = 0.25; P < 0.0001). In multivariate models controlling for key covariates of interest, POAG patients were 1.9 (95% CI: 1.7 to 2.0) times more likely to be compliant with their pharmacotherapy than OH patients. CONCLUSION: In general, pharmacotherapy coverage was poor. Patients with POAG, a more severe condition, were significantly more covered with pharmacotherapies than patients with OH. It is important to implement strategies to help improve patient coverage prior to occurrence of more severe disease.

Healthcare charges in patients with glaucoma who undergo laser trabeculoplasty.

INTRODUCTION: The objective of this study was to assess the impact of laser trabeculoplasty (LTP) on healthcare charges in patients with primary open-angle glaucoma (POAG). METHODS: Using a managed care database (PharMetrics; Watertown, MA, USA), we formed a case-control group nested within a POAG cohort (n=72,412) formed using International Classification of Disease, Ninth Edition (ICD-9) coding data. Cases (n=1145) had LTP (Current Procedural Terminology code: 65855) with ≥1 year of continuous enrollment both prior to, and following LTP index date in PharMetrics from 1998-2005. Using the date of LTP as the index date, controls (n=2290) without LTP were matched to cases on gender, age, and index year in a 2:1 ratio. Cases and controls had ≥6 months of continuous enrollment in PharMetrics prior to receiving a diagnosis of POAG (ICD-9 code: 365.11). One-year total and ophthalmology healthcare charges were calculated in the year pre- and post-index date (excluding charges for LTP at the index date). Conditional logistic regression models and multiple linear regression models determined the impact of LTP on healthcare charges, while controlling for glaucoma duration and other key covariates. RESULTS: While the mean age of cases (60.1±13.1 years) and controls (60.3±13.6 years) was similar (P=0.5589), cases had more comorbid systemic conditions (P<0.05) and underwent more cataract surgery in the year after index date (4.4% vs. 2.1%; P=0.002). In the year after index date, ophthalmology-related charges increased by $1364 for cases vs. $30 for controls (P=0.0003). Total healthcare charges increased by $5084 for cases and $1594 for controls in the year after index date (P=0.0085). Cases and controls experienced similar increases in ophthalmology-related pharmacy charges from the year pre- to the year post-index date ($26 vs. $43, P=0.385). In both logistic regression and linear regression models, which adjusted for several covariates, performing LTP was associated with increased total healthcare and ophthalmology-related charges. CONCLUSION: Among patients with POAG in this study, performing LTP was associated with increased total and ophthalmology-related healthcare charges, while ophthalmology pharmacy charges did not decline.

Advances in contraception: IUDs from a managed care perspective.

Contraceptive use in the United States is virtually universal among women of reproductive age. However, unplanned pregnancies continue to occur and can be largely attributed to the nonuse and misuse of contraception. Reducing unintended pregnancies constitutes a critical goal for managed care and the public. This can be achieved in part with intrauterine devices (IUDs), which are an effective method of contraception that require a one-time insertion and stay in place for 5-10 years. Therefore, compliance issues are largely mitigated, and actual use efficacy is the same as perfect use efficacy. The IUD is also reversible, unlike tubal ligation, and could potentially be the contraceptive of choice in today's environment. Unfortunately, safety concerns surrounding the use of older IUDs have precluded many women from recognizing the benefits of their use. Currently, the only approved IUDs in the United States are ParaGard, the copper IUD, and Mirena, the levonorgestrel-releasing intrauterine system (LNG-IUS). These devices offer superior safety profiles compared with those products that were withdrawn from the market in the 1970s. In addition to a favorable safety and tolerability profile, the LNG-IUS offers an advantage over copper IUDs, demonstrating improved efficacy in preventing intrauterine and ectopic pregnancies. Successful communication between patients and providers regarding the improved safety and efficacy of newer IUDs will ensure an appropriate place in therapy. Thus, greater numbers of women will recognize the IUD as a safe, cost-effective means to contraception, thereby reducing the economic and social burdens associated with unplanned pregnancies.

Contraceptive and noncontraceptive benefits of the LNG-IUS in a vertically integrated HMO.

BACKGROUND: The study was conducted to assess outcomes among women using the levonorgestrel-releasing intrauterine system (LNG-IUS). STUDY DESIGN: The data were collected via a retrospective claims database analysis of 152 women. Two nested cohorts were further distinguished based on length of follow-up: two and three continuous years (n=73 and n=29, respectively). RESULTS: Over 90% had a single insertion, and fewer than 4% experienced an LNG-IUS-related complication. Thirteen percent of women experienced menorrhagia in the year preceding insertion; this figure dropped to 12.5%, 1.2% and 0% in the 1, 2 and 3 years postinsertion. Mean number of gynecology-related visits decreased from four to two in the overall cohort, from seven to four in the cohort with 2 years of follow-up and from nine to four in the cohort with 3 years of follow-up. CONCLUSION: LNG-IUS use prevented pregnancy in all patients and was associated with decreased vaginal bleeding starting in the second year postinsertion.

Anemia, transfusions and hospital outcomes among critically ill patients on prolonged acute mechanical ventilation: a retrospective cohort study.

INTRODUCTION: Patients requiring prolonged acute mechanical ventilation (PAMV) represent one-third of those who need mechanical ventilation, but they utilize two-thirds of hospital resources devoted to mechanical ventilation. Measures are needed to optimize the efficiency of care in this population. Both duration of intensive care unit stay and mechanical ventilation are associated with anemia and increased rates of packed red blood cell (pRBC) transfusion. We hypothesized that transfusions among patients receiving PAMV are common and associated with worsened clinical and economic outcomes. METHODS: A retrospective analysis of a large integrated claims database covering a 5-year period (January 2000 to December 2005) was conducted in adult patients receiving PAMV (mechanical ventilation for >/= 96 hours). The incidence of pRBC transfusions was examined as the main exposure variable, and hospital mortality served as the primary outome, with hospital length of stay and costs being secondary outcomes. RESULTS: The study cohort included 4,344 hospitalized patients receiving PAMV (55% male, mean age 61.5 +/- 16.4 years). Although hemoglobin level upon admission was above 10 g/dl in 75% of patients, 67% (n = 2,912) received at least one transfusion, with a mean of 9.1 +/- 12.0 units of pRBCs transfused per patient over the course of hospitalization. In regression models adjusting for confounders, exposure to pRBCs was associated with a 21% increase in the risk for hospital death (95% confidence interval [CI] = 1.00 to 1.48), and marginal increases in length of stay (6.3 days, 95% CI = 5.1 to 7.6) and cost ($48,972, 95% CI = $45,581 to $52,478). CONCLUSION: Patients receiving PAMV are at high likelihood of being transfused with multiple units of blood at relatively high hemoglobin levels. Transfusions independently contribute to increased risk for hospital death, length of stay, and costs. Reducing exposure of PAMV patients to blood may represent an attractive target for efforts to improve quality and efficiency of health care delivery in this population.

The impact of indirect (herd) protection on the cost-effectiveness of pneumococcal conjugate vaccine.

BACKGROUND: The heptavalent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) confers protection against invasive pneumococcal disease (IPD) caused by serotypes that are responsible for substantial morbidity and mortality throughout the world. In 2000, the 7 serotypes covered by PCV7 accounted for 80% to 90% of serotypes isolated from the blood or cerebrospinal fluid of children aged <6 years in the United States. A previous review of the literature spanning the years 1998 to 2005 pertaining to the incidence of IPD among nonimmunized individuals in countries with universal PCV7 immunization suggested an indirect protective effect (herd protection, or community immunity) after widespread vaccination. Consideration of indirect protection against IPD may enhance cost-benefit evaluations of vaccination programs. OBJECTIVE: The objective of this analysis was to review the literature on cost-effectiveness analyses of PCV7 vaccination to determine whether inclusion of the indirect effect in decision-analysis models substantially affects the cost-effectiveness findings in favor of vaccination. METHODS: A literature review of cost-effectiveness analyses of PCV7 vaccination was conducted using the DIMDI (Deutschen Institut fur Medizinische Dokumentation und Information) superbase, which comprises 12 databases, to identify articles published between January 2000 and October 2006 using the search terms 7-valent pneumococcal conjugate vaccine AND herd immunity/herd effect, and 7-valent pneumococcal conjugate vaccine AND cost-effectiveness, cost-utility, or cost-benefit analyses. Monetary values were converted to euros and inflated to 2006 values, and events avoided were converted to rates per 100,000 vaccinated to allow comparison across studies. The sensitivity analyses from the models that included indirect effects were examined. RESULTS: There was wide variability in the health-economic results of the 16 studies that met the inclusion criteria. In studies that did not include indirect effects, the adjusted cost per life-year gained ranged from cost saving to euro140,723 from the societal perspective and from euro56,724 to euro324,218 from the payer perspective. In the 4 studies that included indirect effects, a significant and consistent improvement was seen in the health-economic results in favor of vaccination with PCV7. No trends in variability across time or geographic region were observed. CONCLUSIONS: Indirect effects had a significant effect on cost-effectiveness, as seen in the sensitivity analyses. Future models should include indirect effects in evaluating the cost-effectiveness of PCV7.