Financial Impact of PEVAR Compared With Standard Endovascular Repair in Canadian Hospitals.

OBJECTIVES: The percutaneous endovascular abdominal aortic repair (PEVAR) approach is a minimally invasive technique that has demonstrated clinical benefit over traditional surgical cut down associated with standard endovascular abdominal aortic aneurysm (AAA) repair (EVAR). The objective of our study was to evaluate the budget impact to a Canadian hospital of changing the technique for AAA repair from the EVAR approach to the PEVAR approach. METHODS: We examined the budget impact of replacing the EVAR approach with the PEVAR approach in a Canadian hospital that performs 100 endovascular AAA repairs annually. The model incorporates the costs associated with surgery, length of stay, and postoperative complications occurring within 30 days. RESULTS: The use of PEVAR in AAA repair is associated with increased access device costs when compared with the EVAR approach (CAD$1000 vs CAD$400). However, AAA repair completed with the PEVAR approach demonstrates reduced operating time (101 minutes vs 133 minutes), length of stay (2.2 days vs 3.5 days), time in the recovery room (174 minutes vs 193 minutes), and postoperative complications (6% vs 30%), which offset the increased device costs. The model establishes that switching to the PEVAR approach in a Canadian hospital performing 100 AAA repairs annually would result in a potential cost avoidance of CAD$245,120. CONCLUSIONS: A change in AAA repair technique from EVAR to PEVAR can be a cost-effective solution for Canadian hospitals.

Bariatric surgery: a systematic review of the clinical and economic evidence.

CONTEXT: Use of bariatric surgery for severe obesity has increased dramatically. OBJECTIVE: To systematically review 1. the clinical efficacy and safety, 2. cost-effectiveness of bariatric surgery, and 3. the association between number of surgeries performed (surgical volume) and outcomes. DATA SOURCES: MEDLINE (from 1950), EMBASE (from 1980), CENTRAL, EconLit, EURON EED, Harvard Center for Risk Analysis, trial registries and HTA websites were searched to January 2011. STUDY SELECTION: 1. Randomized controlled trials (RCTs) and 2. cost-utility and cost-minimisation studies comparing a contemporary bariatric surgery (i.e., adjustable gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy) to another contemporary surgical comparator or a non-surgical treatment or 3. Any study reporting the association between surgical volume and outcome. DATA EXTRACTION: Outcomes included changes in weight and obesity-related comorbidity, quality of life and mortality, surgical complications, resource utilization, and incremental cost-utility. RESULTS: RCT data evaluating mortality and obesity-related comorbidity endpoints were lacking. A small RCT of 16 patients reported that adjustable gastric banding reduced weight by 27% (p < 0.01) compared to diet-treated controls over 40 weeks. Six small RCTs reported comparisons of commonly used, contemporary procedures. Gastric banding reduced weight to a lower extent than gastric bypass and sleeve gastrectomy and resulted in shorter operating times, fewer serious complications, lower weight loss efficacy, and more frequent reoperations compared to gastric bypass. Sleeve gastrectomy and gastric bypass reduced weight to a similar extent. A 2-year RCT in 50 adolescents reported that gastric banding substantially reduced weight compared to lifestyle modification (35 kg vs. 3 kg; p <0.001). Based on findings of 14 observational studies, higher volume centers and surgeons had lower mortality and complication rates. Surgery resulted in long-term incremental cost-utility ratios of $ <1.000-$40,000 (2009 USD) per quality-adjusted-life-year compared with non-surgical treatment. CONCLUSIONS: Contemporary bariatric surgery appears to result in sustained weight reduction with acceptable costs but rigorous, longer-term (≥5 year) data are needed and a paucity of RCT data on mortality and obesity related comorbidity is evident. Procedure-specific variations in efficacy and risks exist and require further study to clarify the specific indications for and advantages of different procedures.

Subcutaneously Administered Anti-TNFs for the Treatment of Ulcerative Colitis: A Retrospective, Propensity Score-Matched, US Health Claims Analysis.

INTRODUCTION: Adalimumab and golimumab are subcutaneously administered anti-tumor necrosis factor α (TNFα) biologics used in the treatment of ulcerative colitis (UC). To date, no studies have directly compared treatment patterns and healthcare resource utilization (HRU) among patients with UC receiving these therapies in a real-world setting. The objective of this study was to compare these outcomes among patients with UC treated with either adalimumab or golimumab using a US claims database. METHODS: Patients with UC treated with golimumab or adalimumab were identified using the US Optum Clinformatics® Data Mart database. Outcomes of interest included treatment patterns (discontinuations, dose optimizations, persistence, and concomitant medication use) and HRU (outpatient office visits, emergency room [ER] visits, and inpatient stays). Propensity score matching (PSM) was used to account for differences in confounding variables between groups. RESULTS: Overall, 990 patients were identified (golimumab: n = 277; adalimumab: n = 713). After PSM, 246 patients were included in each group. There were no significant differences between the adalimumab and golimumab groups over the full follow-up period in terms of treatment discontinuations (53.7% vs. 51.2%; P = 0.5881), dose optimizations (35.4% vs. 39.4%; P = 0.3515), or persistence (338.2 vs. 361.2 days; P = 0.4194). During the year after initiating therapy, there were no significant differences in concomitant immunosuppressant (21.9% vs. 21.7%; P = 0.9686) or corticosteroid use (74.7% vs. 78.8%; P = 0.3573) or in HRU outcomes including outpatient office visits (93.3% vs. 94.0%; P = 0.7660), ER visits (15.2% vs. 10.9%; P = 0.2238), and inpatient stays (15.2% vs. 13.6%; P = 0.6680). CONCLUSIONS: In this nationwide PSM cohort study of patients with UC receiving golimumab or adalimumab, no significant differences were observed between groups for treatment patterns or HRU outcomes. High rates of concomitant corticosteroid use, treatment discontinuations, and HRU while on therapy highlight key unmet needs in the treatment of UC.

Treatment sequence network meta-analysis in Crohn's disease: a methodological case study.

OBJECTIVE: Several biologic therapies are available for the treatment of mild-to-moderate Crohn's disease (CD). This network meta-analysis (NMA) aimed to assess the comparative efficacy of ustekinumab, adalimumab, vedolizumab and infliximab in the maintenance of clinical response and remission after 1 year of treatment. METHODS: A systematic literature search was performed to identify relevant randomized controlled trials (RCTs). Key outcomes of interest were clinical response (CD activity index [CDAI] reduction of 100 points; CDAI-100) and remission (CDAI score under 150 points; CDAI < 150). A treatment sequence Bayesian NMA was conducted to account for the re-randomization of patients based on different clinical definitions, the lack of similarity of the common comparator for each trial and the full treatment pathway from the induction phase onwards. RESULTS: Thirteen RCTs were identified. Ustekinumab 90 mg q8w was associated with statistically significant improvement in clinical response relative to placebo and vedolizumab 300 mg. For clinical remission, ustekinumab 90 mg q8w was associated with statistically significant improvement relative to placebo and vedolizumab 300 mg q8w. Findings from sub-population analyses had similar results but were not statistically significant. CONCLUSIONS: The NMA suggest that ustekinumab is associated with the highest likelihood of reaching response or remission at 1 year compared with placebo, adalimumab and vedolizumab. Results should be interpreted with caution because this is a novel methodology; however, the treatment sequence analysis may be the most methodologically sound analysis to derive estimates of comparative efficacy in CD in the absence of head-to-head evidence.

Economic analysis of epoetin alfa in critically ill trauma patients.

BACKGROUND: Recent randomized control trials (RCTs) suggest that epoetin alfa reduces mortality in critically ill trauma patients; however, epoetin alfa is also costly and associated with adverse events. This study evaluates the cost-effectiveness of epoetin alfa in surgical trauma patients in an intensive care unit setting. METHODS: We constructed a decision analytic model to compare adjunctive use of epoetin alfa with standard care in trauma patients from the perspective of a Canadian payer. Baseline risks of events, relative efficacy, and resource use were obtained from RCTs and observational studies. One-way and probabilistic sensitivity analyses were conducted and longer time horizons explored through Markov models. RESULTS: Epoetin alfa was associated with a cost per quality-adjusted life year (QALY) gained of $89,958 compared with standard care at 1 year. One-way sensitivity analyses indicated that results were sensitive to plausible ranges of mortality risk, risk of thrombosis, relative risk of mortality, relative risk of thrombosis, and quality of life estimates. Cost-effectiveness acceptability curves generated from probabilistic sensitivity analysis indicated that the probability that epoetin alfa would be considered attractive ranged from 0% to 85% over a willingness-to-pay range of $25,000 to $120,000/QALY. Consideration of lifetime time horizons reduced the cost per QALY gained to $7,203, but results were sensitive to the effect of epoetin alfa on mortality. CONCLUSION: Although the cost per QALY gained with epoetin alfa use may fall into an acceptable range, there is significant uncertainty about its true cost-effectiveness. If data regarding long-term efficacy and safety are confirmed in future trials, epoetin alfa could potentially be cost-effective in this population. LEVEL OF EVIDENCE: Economic analysis, level I.

Identification of factors driving differences in cost effectiveness of first-line pharmacological therapy for uncomplicated hypertension.

BACKGROUND: Published practice guidelines and economic evaluations have come to different conclusions regarding optimal pharmacotherapy for the treatment of uncomplicated hypertension. The drivers of these disparities are not clear. Greater understanding is needed for clinicians, researchers and policy makers to determine the most effective and sustainable strategies. OBJECTIVES: To identify how cost and cost-effectiveness considerations are used to generate recommendations by major hypertension guidelines, and determine key drivers of cost-effectiveness conclusions in available economic evaluations. METHODS: A systematic search and narrative review of major hypertension guidelines and health technology assessments of first-line antihypertensive therapy were performed. RESULTS: Of the eight guidelines identified, formal cost-effectiveness analysis was rarely integrated in the formulation of recommendations. When guidelines considered costs, recommendations remained incongruent. Two economic evaluations were identified (United Kingdom and Canada); however, these differed in their conclusion of the most cost-effective agent and attractiveness of calcium channel blockers. Review of these economic evaluations suggests that cost-effectiveness conclusions are strongly influenced by relative costs of drug classes; when relative differences in drug costs are lower, the impact on associated conditions such as heart failure and diabetes influences cost-effectiveness conclusions. CONCLUSION: In the setting of finite health care resources and significant budget impact due to high population prevalence, cost effectiveness is an important consideration in the treatment of uncomplicated hypertension. Identification of key drivers of cost effectiveness will assist interpretation and conduct of current and future economic evaluations.