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Background: Nonalcoholic fatty liver disease (NAFLD) is associated with substantial morbidity, mortality, and economic burden. With currently no approved treatment, an effective pharmaceutical intervention for this disease must be both clinically- and cost-effective., Methods: A Markov model was constructed to estimate the clinical outcomes, costs, and quality of life impact of a hypothetical pharmaceutical intervention. Lifetime clinical outcomes, life-years, quality-adjusted life-years (QALYs), costs (2020 $US), incremental cost-effectiveness ratios (ICERs), and economically justifiable prices (EJPs) were quantified. Only patients with fibrosis stage F2-F4 were assumed eligible to initiate pharmaceutical treatment., Results: Over a mean life expectancy of approximately 21 years in the simulated cohort, drug treatment reduced liver-related mortality by 6.0% (2.7% absolute reduction). Assuming an annual drug cost of $36,000, total discounted medical costs were $574,238 and $120,312 for drug and usual care, respectively, with discounted QALYs estimated to be 9.452 and 9.272 for the two comparators. This yielded an ICER of $2,517,676/QALY gained. The EJP of the drug at an ICER threshold of $150,000/QALY gained was $2,633, a 93% reduction from a base case. Sensitivity analyses suggest that, without a substantial decrease in the drug price, ICERs would exceed $500,000/QALY gained even with the most favorable efficacy assumptions., Conclusions: For a pharmaceutical intervention to be considered cost-effective in the NAFLD fibrosis population, the substantial clinical benefit will need to be coupled with a modest annual price. Annual drug costs exceeding $12,000 likely will not provide reasonable value, even with favorable efficacy. More work is needed to estimate the cost-effectiveness of lifestyle modifications.

Aims: Protocol T (NCT01627249) was a head-to-head study conducted by the Diabetic Retinopathy Clinical Research Network that compared intravitreal aflibercept, bevacizumab, and ranibizumab for the treatment of diabetic macular edema (DME). A cost-effectiveness analysis accompanying the 1-year data of Protocol T revealed that aflibercept was not cost-effective vs ranibizumab for all patients, but could have been cost-effective in certain patient sub-groups if the 1-year results were extrapolated out to 10 years. The present study evaluated the cost-effectiveness of US Food and Drug Administration-approved anti-vascular endothelial growth factor agents (ranibizumab, aflibercept) for treatment of DME using the 2-year data from Protocol T. Methods: Costs of aflibercept 2.0 mg or ranibizumab 0.3 mg, visual acuity (VA)-related medical costs, and quality-adjusted life-years (QALYs) were simulated for eight VA health states. Treatment, adverse event management, and VA-related healthcare resource costs (2016 US dollars) were based on Medicare reimbursement and published literature. VA-related health utilities were determined using a published algorithm. Patients were stratified by baseline VA: 20/40 or better; 20/50 or worse. Results: Total 2-year costs were higher, and QALYs similar, for aflibercept vs ranibizumab in the full cohort ($44,423 vs $34,529; 1.476 vs 1.466), 20/40 or better VA sub-group ($40,854 vs $31,897; 1.517 vs 1.519), and 20/50 or worse VA sub-group ($48,214 vs $37,246; 1.433 vs 1.412), respectively. Incremental cost-effectiveness ratios in the full cohort and 20/50 or worse VA sub-group were $986,159/QALY and $523,377/QALY, respectively. These decreased to $711,301 and $246,978 when analyses were extrapolated to 10 years. Limitations: Key potential limitations include the fact that VA was the only QALY parameter analyzed and the uncertainty surrounding the role of better- and worse-seeing eye VA in overall functional impairment. Conclusions: This analysis suggests that aflibercept is not cost-effective vs ranibizumab for patients with DME, regardless of baseline vision.

Unlabelled: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Multiple treatment alternatives exist for localised prostate cancer, with few high-quality studies directly comparing their comparative effectiveness and costs. The present study is the most comprehensive cost-effectiveness analysis to date for localised prostate cancer, conducted with a lifetime horizon and accounting for survival, health-related quality-of-life, and cost impact of secondary treatments and other downstream events, as well as primary treatment choices. The analysis found minor differences, generally slightly favouring surgical methods, in quality-adjusted life years across treatment options. However, radiation therapy (RT) was consistently more expensive than surgery, and some alternatives, e.g. intensity-modulated RT for low-risk disease, were dominated - that is, both more expensive and less effective than competing alternatives., Objective: To characterise the costs and outcomes associated with radical prostatectomy (open, laparoscopic, or robot-assisted) and radiation therapy (RT: dose-escalated three-dimensional conformal RT, intensity-modulated RT, brachytherapy, or combination), using a comprehensive, lifetime decision analytical model., Patients and Methods: A Markov model was constructed to follow hypothetical men with low-, intermediate-, and high-risk prostate cancer over their lifetimes after primary treatment; probabilities of outcomes were based on an exhaustive literature search yielding 232 unique publications. In each Markov cycle, patients could have remission, recurrence, salvage treatment, metastasis, death from prostate cancer, and death from other causes. Utilities for each health state were determined, and disutilities were applied for complications and toxicities of treatment. Costs were determined from the USA payer perspective, with incorporation of patient costs in a sensitivity analysis., Results: Differences across treatments in quality-adjusted life years across methods were modest, ranging from 10.3 to 11.3 for low-risk patients, 9.6-10.5 for intermediate-risk patients and 7.8-9.3 for high-risk patients. There were no statistically significant differences among surgical methods, which tended to be more effective than RT methods, with the exception of combined external beam + brachytherapy for high-risk disease. RT methods were consistently more expensive than surgical methods; costs ranged from $19 901 (robot-assisted prostatectomy for low-risk disease) to $50 276 (combined RT for high-risk disease). These findings were robust to an extensive set of sensitivity analyses., Conclusions: Our analysis found small differences in outcomes and substantial differences in payer and patient costs across treatment alternatives. These findings may inform future policy discussions about strategies to improve efficiency of treatment selection for localised prostate cancer., (© 2012 BJU International.)

Purpose: We critically evaluated the clinical outcomes and cost characteristics of alternative procedural treatment options for symptomatic benign prostatic hyperplasia., Materials and Methods: An outcomes and cost analysis was performed for benign prostatic hyperplasia treatments, including photoselective vaporization, microwave thermotherapy, transurethral needle ablation, interstitial laser coagulation and transurethral resection. Clinical outcomes were measured by the percent improvement in American Urological Association/International Prostate Symptom Score, the maximum uroflowmetry rate and quality of life score. An economic simulation model was constructed to estimate the expected cost of benign prostatic hyperplasia procedural therapies from a payer perspective. The model included costs of initial treatment, followup care, adverse events and re-treatment. Sensitivity and threshold analyses tested the impact of changing model inputs on base case results., Results: Ablative therapies showed better improvement in symptom score, flow rate and quality of life score compared to thermotherapy procedures. Photoselective vaporization resulted in the largest beneficial changes in American Urological Association/International Prostate Symptom Score, the maximum uroflowmetry rate and the quality of life score at all time points evaluated, followed by transurethral resection and then interstitial laser coagulation. The estimated cost was lower for photoselective vaporization than for any other procedural option at any interval studied. Sensitivity analyses indicated that the results of baseline analyses were robust to reasonable changes in clinical and economic inputs to the model., Conclusions: Compared to alternative treatment options photoselective vaporization of the prostate is a clinically efficacious and cost-effective treatment for symptomatic benign prostatic hyperplasia.

Objective: Endovascular repair has proven to be an effective treatment for many abdominal aortic aneurysms (AAA). Aneurysms that require open repair have usually been disqualified from an endovascular approach as a result of a variety of anatomic constraints, which may also make open repair more difficult. Our purpose was to review open AAA repair and assess the complexity of the operative procedure and associated morbidity and mortality data in the era of endovascular stent grafting., Methods: We retrospectively reviewed the records of 606 patients undergoing elective open AAA repair at a single tertiary care community hospital from January 1, 1996, to December 31, 2004. Patients with ruptured aneurysms and all endovascular repairs were excluded. Patients were grouped into two categories. Group 1 included 301 patients who underwent open repair before the initiation of an endovascular stent grafting program in November 1999. Group 2 included 305 patients who underwent open repair after the initiation of the stent graft program. Operative reports were reviewed to determine the location of the proximal aortic cross clamp, management of the renal vein, associated iliac aneurysmal or occlusive disease, and type of surgical reconstruction. Morbidity, mortality, and disposition data were compared for the two groups and subjected to chi2 analysis., Results: Suprarenal aortic cross-clamp placement was required in 6% of group 1 patients and 20% of group 2 patients (P < .05). Division of the renal vein was necessary in 11% of group 1 patients and 18% of group 2 patients (P < .05). Iliac aneurysms were present in 25% of group 1 patients and 42% of group 2 patients (P < .05). The incidence of associated iliac occlusive disease was 12% in group 1 and 20% in group 2 (P < .05). The type of reconstruction required (aortoaorto, aortoiliac, aortofemoral) was not found to be statistically significant. All major sources of morbidity, including renal insufficiency, myocardial infarction, stroke, and intubation times, were similar between the two groups. The length of stay was 9.2 days in both groups, and 11.3% of group 1 patients and 26% of group 2 patients were discharged to an extended-care facility rather than directly home. The overall mortality rate was 2.0% for patients in group 1 and 3.8% for group 2 patients. This was not a statistically significant difference., Conclusions: Surgeons performing open repair of AAA in the era of endovascular stent grafting are operating on patients who require more complex repairs, including a greater frequency of suprarenal cross clamping, renal vein division, and management of associated iliac aneurysmal and occlusive disease. Despite this, morbidity and mortality rates are similar to those in patients operated on before the initiation of an endovascular stent grafting program.

This study evaluated the cost effectiveness of bortezomib in relapsed, refractory myeloma, relative to best supportive care (BSC) and thalidomide. Data were derived from the phase 2 pivotal study of bortezomib, a Delphi panel of six myeloma thought leaders, and published literature. Objective assumptions regarding treatment choices and consequences (response and complications), and actual cost data were used. Bortezomib was found to be cost effective relative to BSC and thalidomide. Sensitivity analyses demonstrated the robustness of the results. These data suggest that bortezomib provides a cost-effective treatment option and the best value (in terms of cost/life-yr gained) among the currently available therapeutic options for relapsed, refractory myeloma.

Foodborne illnesses impose a substantial economic and quality-of-life burden on society by way of acute morbidity and chronic sequelae. We developed an economic model to evaluate the potential cost-effectiveness of a disinfection program that targets high-risk food preparation activities in household kitchens. For the United States, Canada, and the United Kingdom, we used published literature and expert opinion to estimate the cost of the program (excluding the educational component); the number of cases of Salmonella, Campylobacter, and Escherichia coli O157:H7 infections prevented; and the economic and quality-of-life outcomes. In our primary analysis, the model estimated that approximately 80,000 infections could be prevented annually in U.S. households, resulting in 138 million dollars in direct medical cost savings (e.g., physician office visits and hospitalizations avoided), 15,845 quality-adjusted life-years (QALYs) gained, 788 million dollars in program costs, and a favorable cost-effectiveness ratio of 41,021 dollars/QALY gained. Results were similar for households in Canada and the United Kingdom (21,950 dollars Can/QALY gained and 86,341 pounds sterling/QALY gained, respectively). When we evaluated implementing the program only in U.S. households with high-risk members (those less than 5 years of age, greater than 65 years of age, or immunocompromised), the cost-effectiveness ratio was more favorable (10,163 dollars/QALY gained). Results were similar for high-risk households in Canada and the United Kingdom (1,915 dollars Can/QALY gained and 28,158 pounds sterling/QALY gained, respectively). Implementing a targeted disinfection program in household kitchens in the United States, Canada, and the United Kingdom appears to be a cost-effective strategy, falling within the range generally considered to warrant adoption and diffusion (<100,000 dollars/QALY gained).

Multiple sclerosis is a disabling disease that, until recently, had few effective treatment options. With the advent of new medical technologies to treat multiple sclerosis has come the need to assess the long-term clinical, economic and quality of life trade-offs associated with these treatments to inform medical decision-making, as well as equitable resource allocation. Assessing these trade-offs in multiple sclerosis is particularly challenging. Therefore, considering an appropriate evaluation strategy prior to initiating a health outcomes study in multiple sclerosis is essential. This review presents an overview of multiple sclerosis, the challenges facing researchers and offers strategies and a framework for assessing economic and quality of life outcomes in patients with multiple sclerosis.

Introduction: The aim of this study is to describe implantation techniques and lead performance for biventricular pacing, dual-chamber implantable cardioverter defibrillators (ICDs)., Methods and Results: A dual-chamber ICD with biventricular pacing was implanted in 87 patients with congestive heart failure (ejection fraction: 0.21 +/- 0.09), prolonged QRS duration (161 +/- 22 msec), and an indication for ICD therapy. Left ventricular pacing was achieved with a thoracotomy approach (n = 21) or a nonthoracotomy approach (n = 66). With a thoracotomy, biventricular devices were implanted successfully in all patients. During follow-up (17 +/- 11 months), 9 patients died (43%), 2 underwent transplantation, and 2 required left ventricular lead revision. At last follow-up, biventricular sensing and capture threshold were 11 +/- 5 mV and 1.5 +/- 0.8 V, respectively. For nonthoracotomy procedures, two types of coronary sinus (CS) leads were implanted: an over-the-wire lead (n = 45) and a shaped lead (n = 21). The rate of successful implantation (overall: 89%) (over-the-wire 93% vs shaped 81%; P = 0.1) and durations for CS lead placement (66 +/- 50 vs 58 +/- 34 min, P = 0.6) and the procedure (133 +/- 58 vs 129 +/- 33 min, P = 0.8) were not different between the two CS leads. During follow-up (11 +/- 9 months), 9 patients died (14%), and the shaped CS lead dislodged in 3 patients (3 shaped vs 0 over-the-wire, P = 0.01). At last follow-up, biventricular sensing and capture threshold were 10 +/- 4 mV and 1.8 +/- 0.7 V, respectively, and there was no difference between over-the-wire and shaped leads. By multivariate analysis, mortality was associated with absence of spironolactone therapy but not procedural features., Conclusion: Nonthoracotomy CS lead implantation is feasible, with a success rate of about 90% and few adverse events. For the remaining 10%, a thoracotomy approach can be completed safely in these ill patients without increased risk for death.

Objective: To assess the economic impact, from a societal perspective, of a multidimensional infection control education program (ICEP) in a preschool for children with Down syndrome., Methods: Krilov et al implemented a comprehensive ICEP in a specialized preschool setting and reported a significant decrease in medical resource utilization and days absent from school. Clinical and economic data from Krilov et al and other sources were incorporated into a health-state transition (Markov) decision analysis model that estimated annual expected costs for the baseline and intervention years. Procedure and diagnosis codes were assigned to all physician office visits, emergency department visits, hospitalizations, and laboratory and diagnostic tests. Cost estimates then were derived using 1999 national reimbursement schedules and other sources. Productivity losses for parents were estimated using national wage rates. The costs of the ICEP were compared with the reduction in the costs of illness (direct medical costs plus costs associated with lost parental working time). The outcomes measured were mean annual costs of illness per child, total annual ICEP costs, and net annual costs or savings., Results: With a comprehensive ICEP, the mean costs of illness in the baseline year was $1235 per child, of which 68% and 14% were for productivity losses and physician visits, respectively. In the intervention year, the mean costs of illness per child was $615, of which 71% and 20% were for productivity losses and physician visits, respectively. The cost of the preexisting infection control (IC) practices in place at the onset of the study (baseline year) was $716. The comprehensive ICEP cost (intervention year) was $75 627, 92% of which was spent to hire a cleaning service to decontaminate toys 3 times per week. When a secondary analysis was performed to reflect a less intensive ICEP in a nonspecialized preschool setting, the mean costs of illness in the baseline and intervention years were $962 and $614 per child, respectively, representing a total annual cost-of-illness savings of $13 224 for the 38 children who participated in the study by Krilov et al. The annual incremental cost of the less intensive ICEP was $2371; therefore, the estimated net annual savings of the less intensive ICEP in a nonspecialized preschool was $10 853., Conclusions: This study suggests that the reduction in the costs of illness could more than offset the cost of implementing a multidimensional ICEP in a preschool setting.

Background: This study evaluated the cost-effectiveness of catheter ablation therapy versus amiodarone for treating ventricular tachycardia (VT) in patients with structural heart disease. The analysis used a societal perspective for a hypothetical cohort of VT patients with implantable cardioverter-defibrillators, who were experiencing frequent shocks., Methods and Results: We calculated incremental cost-effectiveness of ablation relative to amiodarone over 5 years after treatment initiation. Event probabilities were from the Chilli randomized clinical trial (Chilli Cooled Ablation System, Cardiac Pathways Corporation, Sunnyvale, Calif), the literature, and a consensus panel. Costs were from 1998 national Medicare reimbursement schedules. Quality-of-life weights (utilities) were estimated using an established preference measurement technique. In a hypothetical cohort of 10 000 patients, 5-year costs were higher for patients undergoing ablation compared with amiodarone therapy ($21 795 versus $19 075). Ablation also produced a greater increase in quality of life (2.78 versus 2.65 quality-adjusted life-years [QALYs]). This yielded a cost-effectiveness ratio of $20 923 per QALY gained for ablation compared with amiodarone. Results were relatively insensitive to assumptions about ablation success and durability. In less severe patients with good ejection fractions who suffer their first VT episode, the incremental cost-effectiveness ratio was $6028 per QALY gained. These cost-effectiveness ratios are within the range generally thought to warrant technology adoption., Conclusions: This study demonstrates that, from a societal perspective, catheter ablation appears to be a cost-effective alternative to amiodarone for treating VT patients.

Objective: Port-access coronary bypass grafting (CABG)was performed in an attempt to impact the clinical course of patients with coronary artery disease., Methods: One hundred patients (56 men and 44 women) with a median age of 61 years underwent port-access coronary revascularization. The clinical and financial profiles of these patients were compared with fiscal year 1997 patients (n = 531) who underwent standard median sternotomy coronary bypass., Results: Preoperative clinical demographics were similar in both groups of patients. Among the port-access population there were no incidences of aortic dissection, deep vein thrombosis, conversion to median sternotomy, or death. Total time in the Intensive Care Unit (ICU), incidence of atrial fibrillation, transfusion requirements, and (subjective) pain rating at 28 days postoperatively were less in the port-access group. The average hospital cost per case was $2703.00 (US dollars) more in the port-access patients, despite a similar length of stay versus conventional sternotomy patients., Conclusions: Coronary bypass surgery can be performed safely with port-access technology with significant clinical benefits in selected patients. Currently these benefits are attained at a significant cost to the institution.

One hundred four patients were placed emergently on the Bard CPS portable femoro-femoral bypass system over a 4 year period. Thirty-two patients (31%) were discharged from the hospital. Seventy-six of these patients (73%) required emergency bypass following cardiac arrest, and twenty-eight patients (26%) were in cardiogenic shock or respiratory failure. In the arrest group, no one survived an unwitnessed arrest and those with cardiopulmonary resuscitation times less than 30 minutes had a better survival rate. The highest survival rate was in those patients who did not arrest prior to bypass. Fifty-two percent of these patients were released. The 74 patients receiving interventional therapy on bypass had a higher survival rate than those unable to be treated. Of the thirty patients receiving no intervention, only three (10%) were eventually discharged. For the 19 patients receiving treatment only in the cardiovascular laboratory, the discharge rate was 26%. Of the 55 patients taken to the operating room for surgical correction, 24 (44%) were discharged from the hospital. No patients placed on bypass at an outlying hospital or treated using CPS within 72 hours of a previous open heart procedure survived.

Acute dissection of the aortic arch with an aberrant subclavian artery is a rare finding. This report documents the successful treatment of this unusual problem. A 56-year-old man, brought into the emergency room with severe epigastric, chest, and interscapular pain, was treated medically until stabilized. Operation was then recommended and accepted; whereupon, dissection and control of the arch vessels, including the aberrant right subclavian artery, was accomplished. At follow-up, 3 months after discharge, the patient is active, without pain, and his blood pressure is well controlled.