Economic Outcomes In Patients Research Articles

Real world health and economic outcomes in patients with non-stem cell transplant (NSCT) multiple myeloma initially treated with lenalidomide and/or bortezomib-based regimens.

8038Background: Our objective was to evaluatereal world health and economic outcomes in patients (pts) with newly treated multiple myeloma (MM) receiving common first line (1L) treatments (Tx). Met...

Health Costs and Outcomes Associated with Medicare Part D Prescription Drug Cost-Sharing in Beneficiaries on Dialysis.

High out-of-pocket costs for prescription medications have been associated with poor patient outcomes. A previous study found that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. It is not known what effect the decreased use of prescription drugs associated with the coverage gap had on utilization and spending for other medical care. To determine the relationship between the Part D prescription drug cost-sharing structure and health and economic outcomes in Medicare beneficiaries on dialysis. A retrospective analysis using data from the United States Renal Data System (2006-2008) was conducted for Medicare-eligible patients receiving dialysis. Patients were grouped in 1 of 4 cohorts based on low-income subsidy (LIS) receipt and benefit phase in 2007: Cohort 1 (non-LIS and did not reach the coverage gap); Cohort 2 (non-LIS and reached the coverage gap); Cohort 3 (non-LIS and reached catastrophic coverage after the gap); and Cohort 4 (received an LIS, and none of the LIS patients reached the coverage gap). Outcomes included medical care utilization, direct medical costs, and mortality. A total of 11,732 subjects met the inclusion criteria. Patients in Cohorts 1, 2, and 3 had $3,222 lower, $2,457 lower, and $1,182 higher adjusted pharmacy costs (P less than 0.001), but their adjusted hospitalization costs were $1,499 (P = 0.09), $2,287 (P = 0.01), and $2,959 (P = 0.01) higher, respectively, compared with Cohort 4 (LIS). In the propensity score-matched cohorts, patients who reached the coverage gap (Cohort 2) had higher rates of hospitalization (relative risk [RR] = 1.02, 95% CI = 0.94-1.10), outpatient visits (RR = 1.16, 95% CI = 1.08-1.25), and other visits (RR = 1.17, 95% CI = 1.03-1.32) compared with those who had an LIS (Cohort 4). Patients in Cohort 3 had a higher rate of outpatient visits compared with those in Cohort 4 (RR = 1.14, 95% CI = 1.03-1.25). There were no differences in medical care utilization between patients in Cohort 1 and Cohort 4. Compared with patients in Cohort 4 (LIS), patients in Cohort 2 (those who reached the coverage gap) had 9% higher hospitalization costs (RR = 1.09, 95% CI = 1.01-1.18) and 6% higher outpatient costs (RR = 1.06, 95% CI = 0.97-1.17), respectively. During the 1-year follow-up period, patients in Cohort 2 had a 20% (HR = 1.20, 95% CI = 1.05-1.37) and a 22% (HR = 1.22, 95% CI = 1.01-1.47) increased risk of all-cause and cardiovascular-related mortality compared with those in Cohort 4, respectively. Our findings suggest that reaching the Part D coverage gap was associated with unfavorable clinical and economic outcomes in patients undergoing dialysis.

Clinical and Economic Burden of Visual Impairment in an Aging Society of South Korea.

Whereas the incidence of visual impairment and blindness (VI&B) is decreasing, the total number of VI&B is increasing due to the growth of elderly population. To compare the clinical and economic outcomes of patients with and without VI&B (ie, cases and controls) in Korea, a case-control study was performed using the Health Insurance Review and Assessment Service-National Patients Sample data. Cases had higher prevalence for all of the Charlson Comorbidity Index components, depression, fracture, and injury as well as eye diseases compared to age- and sex-matched controls. In regression after adjustment of concomitant diseases, cases had 2.7 times (95% confidence interval = 2.3-3.2) higher medical expenditure than controls. The results of this study confirm that patients with VI&B have significantly higher direct medical expenditures and concomitant diseases than those without VI&B and highlight the need for a public health strategy to reduce potentially avoidable costs attributed to VI&B.

The effect of a diabetes collaborative care management program on clinical and economic outcomes in patients with type 2 diabetes.

Clinical pharmacy services (CPS) in the primary care setting have been shown to help patients attain treatment goals and improve outcomes. However, the availability of CPS in community-based primary care is not widespread. One reason is that current fee-for-service models offer limited reimbursement opportunities for CPS in the community setting. Furthermore, data demonstrating the value of CPS in this setting are limited, making it difficult for providers to determine the feasibility and sustainability of incorporating CPS into primary care practice. To (a) evaluate the association between a pharmacist-led, diabetes collaborative drug therapy management program and patient outcomes, including glycemic control and health care costs, and (b) assess short-term economic outcomes in a primary care setting. A retrospective cohort analysis was conducted using medical record data. This study was conducted using patients with uncontrolled type 2 diabetes (T2DM), defined as HbA1c ≥ 7.0%. Outcomes were compared between patients referred to a diabetes collaborative care management (DCCM) intervention from 2009-2012 and patients who did not participate in the DCCM program. To illustrate the difference in HbA1c between the 2 cohorts over the follow-up period, mean time adjusted HbA1c values were estimated using a panel-type random effects regression model, with results plotted at 90-day intervals from index date through the end of the study period. To help control for confounding by other factors, multivariate regression models were run. A difference-in-difference model was employed to estimate the effect of the program on resource utilization and all-cause charges. A total of 303 DCCM and 394 comparison patients were included. Mean (95% CI) age was 57.4 years (55.963, 58.902) versus 59.9 years (58.613, 61.276; P < 0.001) with 48% and 44% female for DCCM and comparison patients, respectively (P = 0.49). Mean baseline HbA1c was higher for DCCM (10.3%; 10.10, 10.53) than comparison patients (8.4%; 8.26, 8.61; P < 0.001). The greatest reduction in HbA1c was seen for both groups at 9 and 12 months post-index date. At these time points, the mean time adjusted difference in HbA1c between groups was no longer significant. Multivariate modeling identified that the DCCM program was associated with a -0.44% (-0.64, -0.25; P < 0.001) lower HbA1c at follow-up relative to the comparison group controlling for potential confounders, including baseline HbA1c. Change in resource utilization from pre- to post-index date did not differ between groups. However, in the difference-in-difference multivariate analysis the difference in mean all-cause charges from the 12-month pre- to post-index periods DCCM patients experienced a smaller average increase in charges ($250) than comparison patients ($1,341; coefficient = -0.423; 95% CI = -0.779, -0.068). A pharmacist-led diabetes collaborative care management program in a patient-centered primary care setting was associated with significantly better follow-up glycemic control relative to comparison patients. Further, the data suggest that the DCCM program was associated with a less substantial increase in all-cause total costs in patients with uncontrolled T2DM relative to comparison patients, which could translate into reduced costs and improved outcomes to managed care payers.

Impact of Medication Adherence and Persistence on Clinical and Economic Outcomes in Patients with Type 2 Diabetes Treated with Liraglutide: A Retrospective Cohort Study

IntroductionAdherence to diabetes medication has been linked to improved glycemic levels and lower costs, but previous research on adherence has typically involved oral antidiabetic medication or insulin. This study examines how adherence and persistence to once-daily liraglutide impact glycemic control and economic outcomes in a real-world population of adult type 2 diabetes (T2D) patients.MethodsA retrospective cohort study using administrative claims data from July 2009 through September 2013. Patients aged ≥18 years with T2D treated with liraglutide were identified (index date = first liraglutide prescription). Adherence was based on the proportion of days covered (PDC); with PDC ≥0.80 classified as adherent. Non-persistent patients were those with a gap in therapy of >90 days. Lab results for glycated hemoglobin (A1C) were used to identify whether patients achieved target levels of <7.0% and ≤ 6.5%, or experienced a reduction of ≥1.0% in A1C from pre-index (baseline) to post-index (follow-up). Logistic regression was used to estimate the likelihood of achieving the A1C goals, adjusted for baseline characteristics. Diabetes-related medical, pharmacy, and total costs were modeled and estimated for the adherence and persistence cohorts.ResultsA total of 1321 patients were identified. The mean PDC was 0.59 and 34% of patients were classified as adherent, while 60% were persistent over 12 months of follow-up. Adherent and persistent patients were more likely to achieve each of the A1C goals than their non-adherent and non-persistent counterparts after adjusting for patient characteristics. Adherence and persistence were associated with higher adjusted diabetes-related pharmacy and total healthcare costs during follow-up; whereas persistent patients had significantly lower diabetes-related medical costs than non-persistent patients.ConclusionsAdherence and persistence to liraglutide are associated with improved A1C outcomes. Persistent patients showed significantly lower medical costs versus those discontinuing liraglutide. Total healthcare costs were higher for adherent and persistent cohorts driven by higher pharmacy costs.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0199-z) contains supplementary material, which is available to authorized users.

Clinical and economic outcomes of patients with coronary artery stenosis on the basis of fractional flow reserve measurement during daily practice

Clinical and economic outcomes of patients with coronary artery stenosis on the basis of fractional flow reserve measurement during daily practice

Real-world clinical and economic outcomes of liraglutide versus sitagliptin in patients with type 2 diabetes mellitus in the United States.

IntroductionThe objective of this study was to compare the clinical effectiveness of liraglutide with sitagliptin and assess the associated economic outcomes in patients with type 2 diabetes mellitus (T2DM) treated in real-world practice in the United States (US).MethodsThis retrospective cohort study used a large US claims database to identify patients with T2DM who initiated liraglutide or sitagliptin between January 2010 and December 2012. Adults (≥18 years old) with persistent use of therapy for ≥3 months were included. Changes in glycated hemoglobin A1c (A1C) and the proportion of patients achieving A1C targets (≤6.5% and <7%) were examined at 6-month follow-up. Diabetes-related total, medical, and pharmacy costs over the follow-up period were assessed. Multivariable regression models were used to estimate the outcomes associated with liraglutide relative to sitagliptin, adjusting for differences in patient demographics and clinical characteristics.ResultsThe study included 1,465 patients with T2DM who initiated liraglutide (N = 376) or sitagliptin (N = 1,089) (mean age [standard deviation (SD)]: 54 [8.9] vs. 58 [10.8] years; 43.9% vs. 61.8% males; both P < 0.01). After controlling for confounding factors, liraglutide patients experienced 0.31% points greater reduction in A1C (0.95% vs. 0.63% points; P < 0.01) at 6-month follow-up than sitagliptin patients and were more likely to reach A1C targets of ≤6.5% (odds ratio [OR]: 2.00; P < 0.01) and <7% (OR: 1.55; P < 0.01). Liraglutide patients had $994 lower mean diabetes-related medical costs ($1,241 vs. $2,235; P < 0.01), but $544 higher diabetes-related pharmacy costs ($2,100 vs. $1,556; P < 0.01) during the follow-up. No difference was found in the total mean diabetes-related costs between the two cohorts.ConclusionLiraglutide showed greater improvement in glycemic outcomes than sitagliptin among adult patients with T2DM in real-world clinical practice. Although diabetes-related pharmacy costs for patients using liraglutide were higher compared with sitagliptin, these were offset by significantly lower diabetes-related medical costs, resulting in similar total diabetes-related costs between the two treatment groups.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-014-0084-9) contains supplementary material, which is available to authorized users.

Adverse drug events among patients receiving postsurgical opioids in a large health system: risk factors and outcomes.

Results of a study of postsurgical opioid-related adverse drug events (ORADEs) within a large health system are reported. In a retrospective cohort study, data from the information database of an 11-hospital Texas health system were analyzed to (1) describe postsurgical opioid use among adult patients undergoing elective or emergency surgery over a one-year period, (2) identify ORADE risk factors and associated costs, and (3) compare clinical and economic outcomes in patients who experienced ORADEs and those who did not. Multivariate logistic regression was used to identify ORADE risk factors. Propensity score-matched comparisons of outcomes in patients with and without ORADEs were conducted. Among 6,285 patients in the study population, 6,274 (99.8%) received postsurgical opioids; 11.5% of those patients experienced an ORADE. ORADE risk factors included age (≥65 years), male sex, prior opioid use, chronic obstructive pulmonary disease, cardiac dysrhythmias, regional enteritis, diverticulitis, and ulcerative colitis. Patients with multiple risk factors had higher mean hospitalization costs ($21,073) relative to patients with one risk factor ($14,110) or no risk factor ($11,433) and accounted for a disproportionately large share of overall costs; patients who experienced ORADEs were more likely to be cost and length of stay (LOS) outliers. Analysis of information from a large database demonstrated that opioid-treated postsurgical inpatients who had multiple risk factors for ORADEs were more likely to have higher mean costs, greater readmission rates, and longer LOS than patients with fewer risk factors.

Clinical and economic outcomes of nutrition interventions across the continuum of care.

Optimal nutrition across the continuum of care plays a key role in the short- and long-term clinical and economic outcomes of patients. Worldwide, an estimated one-quarter to one-half of patients admitted to hospitals each year are malnourished. Malnutrition can increase healthcare costs by delaying patient recovery and rehabilitation and increasing the risk of medical complications. Nutrition interventions have the potential to provide cost-effective preventive care and treatment measures. However, limited data exist on the economics and impact evaluations of these interventions. In this report, nutrition and health system researchers, clinicians, economists, and policymakers discuss emerging global research on nutrition health economics, the role of nutrition interventions across the continuum of care, and how nutrition can affect healthcare costs in the context of hospital malnutrition.

Abstract 249: Economic Outcomes for Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Receiving Prasugrel or Ticagrelor: A Retrospective US Hospital Database Analysis

Objectives: To compare all-cause healthcare resource utilization and costs with prasugrel (pras) vs. ticagrelor (ticag) with real world data in patients (pts) with ACS managed with PCI. Methods: The IMS Patient-Centric Data Warehouse was used to identify ACS-PCI pts ≥18 years with an in-hospital claim for pras or ticag (index date) between 8/1/11 and 4/30/13. The baseline period began on 1/1/08 with the follow-up period spanning until 7/29/13. The two drug groups were propensity-matched (PM) based upon demographic and clinical characteristics. Three cohorts were pre-defined and analyzed: ACS-PCI (primary cohort), ACS-PCI without prior TIA or stroke (label cohort), and ACS-PCI patients without prior TIA or stroke and if age ≥75 years required evidence of diabetes or prior MI (core cohort). Hospital specific cost:charge ratios were used to determine costs and adjusted to 2013 US dollars. Total costs were the sum of medical costs, including lab and diagnostic tests, and pharmacy costs during hospitalization. Generalized estimating equations were used to evaluate PM-adjusted differences in length of stay (LOS) and costs. Costs are reported on a per patient basis. Resource utilization and costs were assessed during index hospitalization, 30 and 90 days post-discharge. Results: 16,098 pts were in the primary cohort (pras: 13,134 [82%] and ticag: 2,964 [18%]). Compared to ticag pts, pras pts were younger, more likely men, and less likely to have cardiovascular or bleeding risk factors (P&lt;0.05). In all 3 cohorts, unadjusted data showed that PCI characteristics (stent type, number of stents and vessels) were similar between pras and ticag, but ticag patients tended to have higher use of lab and diagnostic tests compared to pras during index hospitalization. For the index hospitalization, the unadjusted CCU/ICU and post-PCI LOS were shorter for pras vs. ticag, but overall LOS was not significantly different after adjustment. PM-adjusted mean all-cause total, medical, and pharmacy costs are presented in the table. Conclusion: Economic outcomes of ACS-PCI pts receiving pras were similar to ticag for the primary population with significant savings in total and medical costs for pts without prior TIA or stroke. These data indicate that ticag has no economic advantage compared with pras in routine clinical practice.

Economic Outcomes in Patients Receiving Anti-epileptic Drug (AED) Adjunctive Therapy (P5.051)

Economic Outcomes in Patients Receiving Anti-epileptic Drug (AED) Adjunctive Therapy (P5.051)

Impact of extended‐spectrum β‐lactamase–producing organisms on clinical and economic outcomes in patients with urinary tract infection

To compare clinical and economic outcomes between patients with urinary tract infection (UTI) due to extended-spectrum β-lactamase-producing Escherichia coli and Klebsiella species (ESBL-EK) versus patients with non-ESBL-EK UTI. Eighty-four (3.6%) of 2345 patients admitted between September 1, 2011 and August 31, 2012 with UTI were positive for ESBL-EK. Fifty-five ESBL-EK UTI (cases) and matched controls (non-ESBL-EK UTI) were included in the analysis. Clinical and economic outcomes were compared between cases and controls for statistical significance. Cases were more likely to have diabetes mellitus, a history of recurrent UTIs, recently received antibiotics, recently been hospitalized, and had previous isolation of an ESBL-producing organism compared with controls. Failure of initial antibiotic regimen (62% vs 6%; P < 0.001) and time to appropriate antibiotic therapy (51 vs 2.5 hours; P < 0.001) were greater in cases. The median cost of care was greater (additional $3658; P = 0.02) and the median length of stay (LOS) prolonged for cases (6 vs 4 days; P = 0.02) despite similar hospital reimbursement (additional $469; P = 0.56). Although not significant, infection-related mortality (7.2% vs 1.8%) and 30-day UTI readmission (7.2% vs 3.6%) were higher in ESBL-EK cases. UTI caused by ESBL-EK is associated with significant clinical and economic burden. The cost of care and LOS of patients with ESBL-EK UTI were 1.5 times those caused by non-ESBL-EK. Importantly, the additional cost of care is a liability to the hospital, as this is not offset by reimbursement. Appropriate and timely initial antibiotics may minimize the ESBL-EK impact on outcomes of patients with UTI.

Clinical and economic outcomes of patients with brain metastases based on symptoms: an argument for routine brain screening of those treated with upfront radiosurgery.

Insurers have started to deny reimbursement for routine brain surveillance with magnetic resonance imaging (MRI) after stereotactic radiosurgery (SRS) for brain metastases in favor of symptom-prompted imaging. The authors investigated the clinical and economic impact of symptomatic versus asymptomatic metastases and related these findings to the use of routine brain surveillance. Between January 2000 and December 2010, 442 patients underwent upfront SRS for brain metastases. In total, 127 asymptomatic patients and 315 symptomatic patients were included. Medical records were used to determine the presenting symptoms, distant and local brain failure, retreatment, and need for hospital and rehabilitative care. Cost-of-care estimates were based on Medicare payment rates as of January 2013. Symptomatic patients had an increased hazard for all-cause mortality (hazard ratio, 1.448) and were more likely to experience neurologic death (42% vs 20%; P < .0001). Relative to asymptomatic patients, symptomatic patients required more craniotomies (43% vs 5%; P < .0001), had more prolonged hospitalization (2 vs 0 days; P < .0001), were more likely to have Radiation Therapy Oncology Group grade 3 and 4 post-treatment symptoms (24% vs 5%; P < .0001), and required $11,957 more on average to manage per patient. Accounting for all-cause mortality rates and the probability of diagnosis at each follow-up period, the authors estimated that insurers would save an average $1326 per patient by covering routine surveillance MRI after SRS to detect asymptomatic metastases. Patients who presented with symptomatic brain metastases had worse clinical outcomes and cost more to manage than asymptomatic patients. The current findings argue that routine brain surveillance after radiosurgery has clinical benefits and reduces the cost of care.

Stewardship Approach for Optimizing Antimicrobial Therapy through Use of a Rapid Microarray Assay on Blood Cultures Positive for Enterococcus Species

Enterococci are a major cause of bloodstream infections in hospitalized patients and have limited antimicrobial treatment options due to their many resistance mechanisms. Molecular technologies have significantly shortened the time to enterococcal isolate identification compared with conventional methods. We evaluated the impact of rapid organism identification and resistance detection with the Verigene Gram-positive blood culture microarray assay on clinical and economic outcomes for patients with enterococcal bacteremia. A single-center preintervention/postintervention quasiexperimental study compared inpatients with enterococcal bacteremia from 1 February 2012 to 9 September 2012 (preintervention period) and 10 September 2012 to 28 February 2013 (postintervention period). An infectious disease and/or critical care pharmacist was contacted with the microarray assay results, and effective antibiotics were recommended. The clinical and economic outcomes for 74 patients were assessed. The mean time to appropriate antimicrobial therapy was 23.4 h longer in the preintervention group than in the postintervention group (P = 0.0054). A nonsignificant decrease in the mean time to appropriate antimicrobial therapy was seen for patients infected with vancomycin-susceptible Enterococcus isolates (P = 0.1145). For patients with vancomycin-resistant Enterococcus bacteremia, the mean time to appropriate antimicrobial therapy was 31.1 h longer in the preintervention group than in the postintervention group (P < 0.0001). In the postintervention group, the hospital length of stay was significantly 21.7 days shorter (P = 0.0484) and mean hospital costs were $60,729 lower (P = 0.02) than in the preintervention group. The rates of attributed deaths in the two groups were not statistically different. Microarray technology, supported by pharmacy and microbiology departments, can decrease the time to appropriate antimicrobial therapy, the hospital length of stay, and health care costs.

Clinical and Economic Outcomes of Patients With Brain Metastases Based on Whether Metastases Are Symptomatic or Not: An Argument for Routine Brain Screening

Clinical and Economic Outcomes of Patients With Brain Metastases Based on Whether Metastases Are Symptomatic or Not: An Argument for Routine Brain Screening

Leukodepletion for patients undergoing heart valve surgery

There is some evidence for the benefits of leukodepletion in patients undergoing coronary artery surgery. Its effectiveness in higher risk patients, such as those undergoing heart valve surgery, particularly in terms of overall clinical outcomes, is currently unclear. To assess the beneficial and harmful effects of leukodepletion on clinical, patient-reported and economic outcomes in patients undergoing heart valve surgery. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 3 of 12) in The Cochrane Library, the NHS Economic Evaluations Database (1960 to April 2013), MEDLINE Ovid (1946 to April week 2 2013), EMBASE Ovid (1947 to Week 15 2013), CINAHL (1982 to April 2013) and Web of Science (1970 to 17 April 2013) on 19 April 2013. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), the US National Institutes of Health (NIH) clinical trials database and the International Standard Randomised Controlled Trial Number Register (ISRCTN) in April 2013 for ongoing studies. No language or time period restrictions were applied. We examined the reference lists of all included randomised controlled trials and contacted authors of identified trials. We searched the 'grey' literature at OpenGrey and handsearched relevant conference proceedings. Randomised controlled trials comparing a leukocyte-depleting arterial line filter with a standard arterial line filter, on the arterial outflow of the heart-lung bypass circuit, in elective patients undergoing heart valve surgery. Data were collected on the study characteristics, three primary outcomes (1. post-operative in-hospital all-cause mortality within three months, 2. post-operative all-cause mortality excluding inpatient mortality < 30 days, 3. length of stay in hospital, 4. adverse events and serious adverse events) and seven secondary outcomes (1. tubular or glomerular kidney injury, 2. validated health-related quality of life scales, 3. validated renal injury scales, 4. use of continuous veno-venous haemo-filtration, 5. length of stay in intensive care, 6. costs of care). Data were extracted by one author and verified by a second author. Insufficient data were available to perform a meta-analysis or sensitivity analysis. Eight studies were eligible for inclusion in the review but data on prespecified review outcomes were available from only one, modestly powered (24 participants) study (Hurst 1997). There were no differences between a leuko-depleting versus standard filter in length of stay in the intensive care unit (ICU) (mean difference (MD) 0.80 days; 95% confidence interval (CI) -0.24 to 1.84) or length of hospital stay (MD 0.20 days; 95% CI -1.78 to 2.18). There are currently insufficient good quality trials with valve surgery patients to inform recommendations for changes in clinical practice. A future National Institute for Health Research (NIHR)-funded feasibility study (recruiting mid-year 2013) comparing leukodepletion with a standard arterial line filter in patients undergoing elective heart valve surgery (the ROLO trial) will be the largest study to date and will make a significant contribution to future updates of this review.

An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal

BackgroundOpioid analgesics are effective for postsurgical pain but are associated with opioid-related adverse events, creating a significant clinical and economic burden. Gastrointestinal surgery patients are at high risk for opioid-related adverse events. We conducted a study to assess the impact of an opioid-sparing multimodal analgesia regimen with liposome bupivacaine, compared with the standard of care (intravenous [IV] opioid-based, patient-controlled analgesia [PCA]) on postsurgical opioid use and health economic outcomes in patients undergoing ileostomy reversal.MethodsIn this open-label, multicenter study, sequential cohorts of patients undergoing ileostomy reversal received IV opioid PCA (first cohort); or multimodal analgesia including a single intraoperative administration of liposome bupivacaine (second cohort). Rescue analgesia was available to all patients. Primary outcome measures were postsurgical opioid use, hospital length of stay, and hospitalization costs. Incidence of opioid-related adverse events was also assessed.ResultsTwenty-seven patients were enrolled, underwent the planned surgery, and did not meet any intraoperative exclusion criteria; 16 received liposome bupivacaine-based multimodal analgesia and eleven received the standard IV opioid PCA regimen. The multimodal regimen was associated with significant reductions in opioid use compared with the IV opioid PCA regimen (mean, 20 mg versus 112 mg; median, 6 mg versus 48 mg, respectively; P < 0.01), postsurgical length of stay (median, 3.0 days versus 5.1 days, respectively; P < 0.001), and hospitalization costs (geometric mean, $6482 versus $9282, respectively; P = 0.01).ConclusionA liposome bupivacaine-based multimodal analgesic regimen resulted in statistically significant and clinically meaningful reductions in opioid consumption, shorter length of stay, and lower inpatient costs than an IV opioid-based analgesic regimen.

Liposome bupivacaine (EXPAREL&amp;reg;) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial

BackgroundPostoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol.MethodsIn this single-center, open-label study, patients undergoing ileostomy reversal received postsurgical pain therapy via multimodal analgesia that included a single intraoperative administration of liposome bupivacaine or opioid-based patient-controlled analgesia (PCA) with intravenous morphine or hydromorphone. Rescue analgesia (intravenous [IV] opioids and/or oral opioid + acetaminophen) was available to all patients. Primary efficacy measures included postsurgical opioid use, hospital length of stay (LOS), and hospitalization costs. Secondary measures included: time to first rescue opioid use; patient satisfaction with analgesia; additional medical intervention; and opioid-related adverse events.ResultsForty-three patients were enrolled and met eligibility criteria (IV opioid PCA group = 20; liposome bupivacaine-based multimodal analgesia group = 23). Postsurgical opioid use was significantly less in the multimodal analgesia group compared with the IV opioid PCA group (mean [standard deviation]: 38 mg [46 mg] versus 68 mg [47 mg]; P = 0.004). Postsurgical LOS between-group differences (median: 3.0 days versus 3.8 days) and geometric mean hospitalization costs (US $6,611 versus US$6,790) favored the multimodal analgesic group but did not achieve statistical significance. Median time to first opioid use was 1.1 hours versus 0.7 hours in the multimodal analgesia and IV opioid PCA groups, respectively; P = 0.035. Two patients in the multimodal analgesia group and one in the IV opioid PCA group experienced opioid-related adverse events.ConclusionA liposome bupivacaine-based multimodal analgesic regimen reduced postoperative opioid consumption in patients undergoing ileostomy reversal under a fast-track discharge protocol. A reduction of 21% in LOS (0.8 days) was noted which, although not statistically significant, may be considered clinically meaningful given the already aggressive fast-track discharge program.

The cost-effectiveness of exenatide once weekly compared with exenatide twice daily and insulin glargine for the treatment of patients with type two diabetes and body mass index ≥30 kg/m2 in Spain

Objective:The objective of this analysis was to estimate the cost-effectiveness of exenatide once weekly (EQW) for the treatment of type two diabetes mellitus (T2DM) in Spain. EQW was compared against exenatide twice daily (EBID) and insulin glargine (IG).Methods:The IMS CORE Diabetes Model was used to project clinical and economic outcomes for patients with T2DM treated with EQW, EBID, and IG. Treatment effects and patient baseline characteristics were taken from the DURATION 3 and pooled DURATION 1 and 5 studies, in the comparison against IG and EBID, respectively. Unit costs and health state utility values were derived from published sources. To reflect diabetes progression, patients started on EQW or EBID, switching to insulin glargine after 3 years. The analysis was conducted from the perspective of the Spanish National Health Service over a time horizon of 35 years with costs and outcomes discounted at 3%. The base case included patients with a BMI > 30 kg/m2, which is in line with current prescription restrictions in Spain. Uncertainty was addressed through extensive one-way sensitivity analyses around key model parameters and a comprehensive probabilistic sensitivity analysis.Results:When compared with EBID, EQW was the dominant strategy, i.e., less costly and more effective. When compared to IG, the incremental cost-effectiveness ratio was estimated at €12,084 per QALY gained. Sensitivity analysis indicated that the model projections were robust to the various scenarios tested.Limitations:Primary limitations of the analysis are common to other T2DM analyses and include the extrapolation of short-term clinical data to the 35 year time horizon and uncertainty around optimum treatment durations.Conclusion:The analyses indicate that EQW is a cost-effective option for the treatment of T2DM patients in Spain for patients with a BMI > 30 kg/m2 considering a willingness-to-pay threshold of €30,000 per QALY gained.

Clinical and Economic Outcomes Among Patients With Diabetes Mellitus Initiating Insulin Glargine Pen Versus Vial

Background: Insulin pens may help patients reach glycated hemoglobin (HbA1c) target levels, but a substantial proportion of patients continue to use insulin vials/syringes. The objective of the current study was to evaluate real-world clinical and economic outcomes of patients with type 2 diabetes mellitus (T2DM) initiating insulin glargine via pen delivery (pen) or vial/syringe (vial) within a large managed-care population in the United States. Methods: This retrospective administrative claims study used data on adult, insulin-naïve patients with T2DM treated with ≥ 1 oral antidiabetic or glucagon-like peptide-1 receptor agonist at baseline. The index date was the earliest pen or vial prescription date. Propensity score matching (1:1) of patients in the pen and vial cohorts was used when comparing 1-year outcomes, including treatment persistence and adherence, HbA1c levels, hypoglycemia rates, and all-cause and diabetes-related health care costs (computed as paid amounts on claims). Results: Patients in the matched cohorts (n=73 3 per cohort) were well balanced with regard to demographics (mean age 52 years; 43% women), clinical measures (mean HbA1c level, 9.4%; mean Quan-Modified Charlson Comorbidity Index score, 0.9), and health care utilization at baseline. Following initiation of insulin glargine, pen patients were more persistent (60.6% vs 50.1%; P < 0.001) and adherent (medication possession ratio, 0.73 vs 0.57; P < 0.001), with lower HbA1c levels during follow-up (mean adjusted change, −1.05 vs −0.73; P < 0.001), compared with vial patients. Hypoglycemic events occurred at similar rates across pen and vial cohorts (3.8% vs 5.2%, respectively; P = 0.21). Study drug costs were higher among pen users ($1164 vs $762, respectively; P < 0.001), but this did not translate into higher total all-cause or diabetes-related costs. Conclusion: For patients with diabetes newly initiating insulin glargine, using an insulin pen device was associated with increased therapy persistence and adherence, and lower HbA1c levels relative to vial/syringe, without increasing total all-cause or diabetes-related costs.