Economic and healthcare resource utilization assessments of PET imaging in Coronary Artery Disease diagnosis: a systematic review and discussion of opportunities for future economic evaluations.

AIMS: This systematic literature review (SLR) consolidated economic and healthcare resource utilization (HCRU) evidence for positron emission tomography (PET) and single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to inform future economic evaluations. MATERIALS AND METHODS: An electronic search was conducted in MEDLINE, Embase, and Cochrane databases from 2012-2022. Economic and HCRU studies in adults who underwent PET- or SPECT-MPI for coronary artery disease (CAD) diagnosis were eligible. A qualitative methodological assessment of existing economic evaluations, HCRU, and downstream cardiac outcomes was completed. Exploratory meta-analyses of clinical outcomes were performed. RESULTS: The search yielded 13,439 results, with 71 records included. Economic evaluations and comparative clinical trials were limited in number and outcome types (HCRU, downstream cardiac outcomes, and diagnostic performance) assessed. No studies included all outcome types and only one economic evaluation linked diagnostic performance to HCRU. The meta-analyses of comparative studies demonstrated significantly higher rates of early- and late-invasive coronary angiography and revascularization for PET- compared to SPECT-MPI; however, the rate of repeat testing was lower with PET-MPI. The rate of acute myocardial infarction was lower, albeit non-significant with PET- vs. SPECT-MPI. LIMITATIONS AND CONCLUSIONS: This SLR identified economic and HCRU evaluations following PET- and SPECT-MPI for CAD diagnosis and determined that existing studies do not capture all pertinent outcome parameters or link diagnostic performance to downstream HCRU and cardiac outcomes, thus, resulting in simplified assessments of CAD burden. A limitation of this work relates to heterogeneity in study designs, patient populations, and follow-up times of existing studies. Resultingly, it was challenging to pool data in meta-analyses. Overall, this work provides a foundation for the development of comprehensive economic models for PET- and SPECT-MPI in CAD diagnosis, which should link diagnostic outcomes to HCRU and downstream cardiac events to capture the full CAD scope.

A device category economic model of electrosurgery technologies across procedure types: a U.S. hospital budget impact analysis.

AIMS: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer. METHODS: A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included. RESULTS: The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings. CONCLUSIONS: Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.

Successful Implementation of Femtosecond Laser-Assisted Cataract Surgery: A Real-World Economic Analysis.

PURPOSE: To calculate the minimum number of Femtosecond laser-assisted cataract surgery (FLACS) procedures required per month to pay off the fixed investment cost over 5 years to achieve break-even. SETTING: A rural ophthalmology practice located in the mid-West United States. DESIGN: An economic analysis, based on real-world, retrospectively collected data over 12 months, from an ambulatory surgical care perspective. METHODS: FLACS was initiated in 2017 with the LenSx® laser (Alcon Vision LLC., Fort Worth, TX). The incremental cost of FLACS, cases needed to break-even, return on investment (ROI), patient education, and marketing efforts were assessed. The financial analysis considered cataract volume, conversion rates, fixed (eg, principal) and variable (eg, supplies) costs, and revenue in the first 12 months. RESULTS: The clinic performed 2717 cataract surgeries in the 12-month period, with 1304 (48%) of patients converting to FLACS. Of FLACS procedures, 613 (47%) selected an advanced-technology intraocular lens (AT-IOL; eg, toric or lifestyle IOL), and the remaining patients selected a monofocal IOL with laser astigmatism correction. FLACS increased AT-IOL use by 113 procedures (23%) compared to volumes in the year prior to FLACS. Overall, FLACS was predicted to be profitable, with only 13 cases required per month to break even in 5 years. If both facility and physician fees are considered revenue, only eight cases per month are required to break-even in 5 years. CONCLUSION: The practice experienced a greater-than-anticipated conversion to FLACS and increased selection of AT-IOLs, well above the break-even volume required, contributing to a rapid return on their investment.

Comparative Assessment of Ergonomic Experience with Heads-Up Display and Conventional Surgical Microscope in the Operating Room.

PURPOSE: Musculoskeletal pain issues are prevalent in ophthalmic surgeons and can impact surgeon well-being and productivity. Heads-up displays (HUD) can improve upon conventional microscopes by reducing ergonomic stress. This study compared ergonomic outcomes between HUD and a conventional optical microscope in the operating room, as reported by ophthalmic surgeons in the US. METHODS: An online questionnaire was distributed to a sample of surgeons who had experience operating with HUD. The questionnaire captured surgeon-specific variables, the validated Nordic Musculoskeletal Questionnaire, and custom questions to compare HUD and conventional microscope. A multivariable model was built to identify variables that were likely to predict improvement in pain-related issues. RESULTS: Analysis was conducted on 64 surgeons (37 posterior-segment, 25 anterior-segment, and two mixed) with a mean 14.9 years of practice and 2.3 years using HUD. Most surgeons agreed or strongly agreed that HUD reduced the severity (64%) and frequency (63%) of pain and discomfort, improved posture (73%), and improved overall comfort (77%). Of respondents who experienced headaches, or pain and discomfort during operation, 12 (44%) reported their headaches improved and 45 (82%) reported feeling less pain and discomfort since they started using HUD. The multivariable model indicated the odds of reporting an improvement in pain since introducing the HUD in the operating room were 5.12-times greater for those who used HUD in >50% of their cases (P=0.029). CONCLUSION: This study indicates that heads-up display may be an important tool for wellness in the operating room as it can benefit ophthalmic surgeons across several ergonomic measures.

A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.

BACKGROUND: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

Value of single-level circumferential fusion: a 10-year prospective outcomes and cost-effectiveness analysis comparing posterior facet versus pedicle screw fixation.

PURPOSE: To compare the clinical and economic outcomes of facet versus pedicle screw instrumentation for single-level circumferential lumbar spinal fusion. METHODS: Outcomes included self-assessment of back and leg pain, pain drawing, ODI, pain medication usage, and procedure success. The CEA was based on the 10-year data collected, and the base-case was from a US payer perspective. Costs included the index surgery, additional surgeries, outpatient/ED visits, and medications. To determine quality-adjusted life years (QALYs), ODI scores were used to predict SF-6D utilities. Sensitivity analyses were performed from a modified payer perspective including device costs and from a societal perspective including productivity loss. Discounted and undiscounted incremental costs and QALYs were calculated. Bootstrapping was performed to estimate the distribution of incremental costs and effects. RESULTS: Clinical improvement was significant from pre-op to 10-year follow-up for both groups (p < 0.01 for all outcomes scales). Outcomes were significantly better for back pain and ODI for the facet versus pedicle group at all follow-up periods > 1 year (p < 0.05). In the CEA base-case, facets had more QALYs (0.68) and lower costs (- $8650) per person compared with pedicle screws. Therefore, facets were dominant (i.e., provided cost savings and greater QALYs) compared with pedicle screws. Facets had a 97% probability of being below a willingness-to-pay threshold of $20,000 per QALY gained and were estimated to be dominant over pedicle screws in 84% of the simulations. CONCLUSION: One-level circumferential spinal fusion using facet screws was clinically superior and provided cost savings compared with pedicle screw instrumentation in the USA.

Reduced Hospital Costs for Ultrasound-guided Vacuum-assisted Excision Compared with Open Surgery in Patients with Benign Breast Masses and High-risk Lesions.

OBJECTIVE: Benign breast masses represent a substantial proportion of breast cancer screening results and may require multiple follow-up visits and biopsy. Even with a preceding benign core biopsy, benign masses have been excised via open surgery for a variety of reasons. This study compared the procedural costs of US-guided vacuum-assisted excision (US-VAE) versus open surgical excisions for benign breast masses and high-risk lesions (HRL). METHODS: In this retrospective cohort study, female outpatients receiving US-VAE or open excision of benign breast masses between 2015 and 2018 were identified within the Premier Healthcare Database. A secondary analysis was conducted for patients with HRLs. Propensity score matching and multivariate regression adjusted for patient demographics, encounter level covariates, and hospital characteristics. The total procedural costs were reported from a hospital perspective. RESULTS: A total of 33 724 patients underwent excisions for benign breast masses (8481 US-VAE and 25 242 open surgery). Procedural costs were significantly lower in unmatched patients who received US-VAE ($1350) versus open surgery ($3045) (P < 0.0001). After matching, a total of 5499 discharges were included in each group, with similar findings for US-VAE ($1348) versus open surgery ($3101) (P < 0.0001). A secondary analysis of matched HRL patients (41 discharges in each group) also showed significantly lower procedural costs with US-VAE ($1620) versus open surgery ($3870) (P < 0.0001). CONCLUSION: Among patients with benign breast masses or HRLs, US-VAE was associated with significantly lower procedural costs versus open surgery. If excision is performed and expected clinical outcomes are equal, US-VAE is preferable to reduce costs without compromising the quality of care.

Global hospital and operative costs associated with various ventral cavity procedures: a comprehensive literature review and analysis across regions.

Objectives: The aim of this literature review was to provide a comprehensive report on hospital costs, and cost components, for a range of ventral cavity surgical procedures across three regions of focus: (1) Americas, (2) Europe, Middle East and Africa (EMEA), and (3) Asia-Pacific. Methods: A structured search was performed and utilized a combination of controlled vocabulary (e.g., "Hepatectomy", "Colectomy", "Costs and Cost Analysis") and keywords (e.g. "liver resection", "bowel removal", "economics"). Studies were considered eligible for inclusion if they reported hospital-related costs associated with the procedures of interest. Cost outcomes included operating room (OR) time costs, total OR costs, ward stay costs, total admission costs, OR cost per minute and ward cost per day. All costs were converted to 2018 USD. Results: Total admission costs were observed to be highest in the Americas, with an average cost of $15,791. The average OR time cost per minute was found to vary by region: $24.83 (Americas), $14.29 (Asia-Pacific), and $13.90 (EMEA). A cost-breakdown demonstrated that OR costs typically comprised close to 50%, or more, of hospital admission costs. This review also demonstrates that decreasing OR time by 30 min provides cost savings approximately equivalent to a 1-day reduction in ward time. Conclusion: This literature review provided a comprehensive assessment of hospital costs across various surgical procedures, approaches, and geographical regions. Our findings indicate that novel processes and healthcare technologies that aim to reduce resources such as operating time and hospital stay, can potentially provide resource savings for hospital payers.

A US hospital budget impact analysis of a skin closure system compared with standard of care in hip and knee arthroplasty.

BACKGROUND: Medicare's mandatory bundle for hip and knee arthroplasty necessitates provider accountability for quality and cost of care to 90 days, and wound closure may be a key area of consideration. The DERMABOND® PRINEO® Skin Closure System (22 cm) combines a topical skin adhesive with a self-adhering mesh without the need for dressing changes or suture or staple removal. This study estimated the budget impact of the Skin Closure System compared to other wound closure methods for hip and knee arthroplasty. METHODS: A 90-day economic model was developed assuming 500 annual hip/knee arthroplasties for a typical US hospital setting. In current practice, wound closure methods for the final skin layer were set to 50% sutures and 50% staples. In future practice, this distribution shifted to 20% sutures, 20% staples, and 60% Skin Closure System. Health care resources included materials (eg, staplers, steri-strips, and traditional/barbed sutures), standard or premium dressings, outpatient visits, and home care visits. An Expert Panel, comprised of three orthopedic physician assistants, two orthopedic surgeons, and a home health representative, was used to inform several model parameters. Other inputs were informed by national data or literature. Unit costs were based on list prices in 2016 US dollars. Uncertainty in the model was explored through one-way sensitivity and alternative scenario analyses. RESULTS: The analysis predicted that use of Skin Closure System in the future practice could achieve cost savings of $56.70 to $79.62 per patient, when standard or premium wound dressings are used, respectively. This translated to an annual hospital budgetary savings ranging from $28,349 to $39,809 when assuming 500 arthroplasties. Dressing materials and postoperative health care visits were key model drivers. CONCLUSIONS: Use of the Skin Closure System may provide cost savings within hip and knee arthroplasties due to decreases in resource utilization in the postacute care setting.

Procedure costs associated with the use of Harmonic devices compared to conventional techniques in various surgeries: a systematic review and meta-analysis.

BACKGROUND: As compared to conventional techniques, recent meta-analyses have reported cost savings with Harmonic devices; however, only in thyroidectomy. Thus, the aim of this study was to evaluate the costs associated with Harmonic devices versus conventional techniques across a range of surgical procedures. METHODS: A systematic search of MEDLINE, EMBASE, and Cochrane Library was conducted from inception to October 01, 2016 without language restrictions to identify randomized controlled trials comparing Harmonic devices to conventional techniques and reporting procedure costs (operating time plus operating equipment/consumables/device costs). Costs were pooled using the ratio of geometric means, and a random effects model was applied. Sensitivity analyses varying statistical methods, number of included studies, and cost outcomes were completed to test the robustness of the results. RESULTS: Thirteen studies met the inclusion criteria. A total of 561 and 540 participants had procedures performed with Harmonic devices and conventional methods, respectively, with procedures including gastrectomy, thyroidectomy, colectomy, cholecystectomy, Nissen fundoplication, and pancreaticoduodenectomy. As compared to conventional methods, Harmonic devices reduced total procedure costs by 8.7% (p=0.029), resulting in an absolute reduction of US$227.77 from mean conventional technique costs, derived primarily from a reduction in operating time costs. When operating time costs, excluding operating equipment/consumables/device costs, were analyzed, costs were reduced by $544 per procedure with the use of Harmonic devices. The results from all sensitivity analyses demonstrated cost reductions with Harmonic devices. CONCLUSION: This systematic review and meta-analysis showed that despite a higher device cost, Harmonic devices provide a statistically significant reduction in procedure costs, derived primarily from a reduction in operating time costs, across surgical procedures. In addition to functionality benefits, Harmonic devices may represent a potentially cost saving method to reduce overall hospital resource use. Future research should focus on potential costs and benefits from use of Harmonic devices in procedures not covered here.

Length of stay and hospitalization costs for patients undergoing lung surgery with Progel pleural air leak sealant.

AIM: Progel Pleural Air Leak Sealant (Progel) is currently the only sealant approved by the FDA for the treatment of air leaks during lung surgery. This study was performed to determine whether Progel use improves hospital length of stay (LOS) and hospitalization costs compared with other synthetic/fibrin sealants in patients undergoing lung surgery. METHODS: The US Premier hospital database was used to identify lung surgery discharges from January 1, 2010 to June 30, 2015. Eligible discharges were categorized as "Progel Sealant" or "other sealants" using hospital billing data. Propensity score matching (PSM) was performed to control for hospital and patient differences between study groups. Primary outcomes were hospital LOS and all-cause hospitalization costs. Clinical outcomes, hospital re-admissions, and sealant product use were also described. RESULTS: After PSM, a total of 2,670 discharges were included in each study group; baseline characteristics were balanced between groups. The hospital LOS (mean days ± standard deviation, median) was significantly shorter for the Progel group (9.9 ± 9.6, 7.0) compared with the other sealants group (11.3 ± 12.8, 8.0; p < .001). Patients receiving Progel incurred significantly lower all-cause hospitalization costs ($31,954 ± $29,696, $23,904) compared with patients receiving other sealants ($36,147 ± $42,888, $24,702; p < .001). LIMITATIONS: It is not possible to say that sealant type alone was responsible for the findings of this study, and analysis was restricted to the data available in the Premier database. CONCLUSIONS: Among hospital discharges for lung surgery, Progel use was associated with significantly shorter hospital LOS and lower hospitalization costs compared with other synthetic/fibrin sealants, without compromising clinical outcomes.

An Economic Analysis of Stent Grafts for Treatment of Vascular Access Stenosis: Point-of-Care and Medicare Perspectives in the United States.

PURPOSE: To conduct an economic analysis on the impact of increased stent graft (SG) use for treatment of arteriovenous graft (AVG) anastomotic stenosis or arteriovenous fistula (AVF)/AVG in-stent restenosis (ISR) from United States point-of-care (POC) and Medicare perspectives. MATERIALS AND METHODS: The analyses compared initial device and reintervention costs over 2 years between current and projected treatment mixes, including percutaneous transluminal angioplasty (PTA), bare metal stents (BMSs), and SGs. In projected scenarios, the absolute increase in SG use was approximately 3%. Costs included procedure reimbursement rates (Medicare) and device list prices (POC) for index procedures and reinterventions. Reintervention rates and types were informed by the RENOVA and RESCUE randomized trials. Reinterventions were primarily PTA only; however, stent use occurred a proportion of the time. BMS reintervention rates were assumed to be identical to PTA based on observational data. A population size of 1,000 patients was assumed. RESULTS: To the POC (n = 1,000), increased SG use was predicted to result in cost savings ranging from $4,106 to $34,420 for AVG anastomotic stenosis. For AVF/AVG ISR, increased SG use was predicted to result in either a cost increase of $17,187 or a cost savings of $13,159. To Medicare (n = 1,000), increased SG use was predicted to save costs for both populations, with savings ranging from $57,401 to $169,544. CONCLUSIONS: The use of SG for treatment of AVG anastomotic stenosis and AVF/AVG ISR appears to be economically favorable for POC providers and Medicare. Further data on reintervention rates are required from other SG trials to validate findings.

Barriers to and Budget Impact of Lumbar Total Disc Replacement Utilization.

: Evidence on the favorable efficacy, safety, and cost effectiveness of lumbar total disc replacement (TDR) compared with fusion for lumbar degenerative disc disease is mounting; however, a key barrier identified for TDR utilization is lack of coverage by US health insurers. Although economic considerations in a fee-for-service model should not be a determining factor in patient access, concerns regarding the budget impact of lumbar TDR surgery may unfortunately underlie coverage decisions. On the basis of the data available and economic modeling, the panel agreed that there is no indication that there would be a dramatic increase in patients seeking lumbar TDR. Considering several possible scenarios on potential growth in TDR utilization with coverage, as well as growth in the overall surgical pool of patients, economic modeling demonstrated that adoption of lumbar TDR would result in minimal or no budget impact for commercial insurance plans. Considering these model results and the economic literature, the panel concluded that adopting lumbar TDR within a coverage policy is expected to remain cost neutral for the insurer.

Time and resources of peripherally inserted central catheter insertion procedures: a comparison between blind insertion/chest X-ray and a real time tip navigation and confirmation system.

BACKGROUND: The Sherlock 3CG™ Tip Confirmation System (TCS) provides real-time peripherally inserted central catheter (PICC) tip insertion information using passive magnetic navigation and patient cardiac electrical activity. It is an alternative tip confirmation method to fluoroscopy or chest X-ray for PICC tip insertion confirmation in adults. The purpose of this study was to evaluate time and cost of the Sherlock 3CG TCS and blind insertion with chest X-ray tip confirmation (BI/CXR) for PICC insertions. METHODS: A cross-sectional, observational Time and Motion study was conducted. Data were collected at four hospitals in the US. Two hospitals used Sherlock 3CG TCS and two hospitals used BI/CXR to place/confirm successful PICC tip location. Researchers observed PICC insertions, collecting data from the beginning (ie, PICC kit opening) to catheter tip confirmation (ie, released for intravenous [IV] therapy). An economic model was developed to project outcomes for a larger population. RESULTS: A total of 120 subjects were enrolled, with 60 subjects enrolled in each arm and 30 enrolled at each of the four US hospitals. The mean time from initiation of the PICC procedure to the time to release for IV therapy was 33.93 minutes in the Sherlock 3CG arm and 176.32 minutes in the BI/CXR arm (p < 0.001). No malpositions were observed for PICC insertions using the Sherlock 3CG TCS, while 20% of subjects in the BI/CXR arm had a malposition. BI/CXR subjects had significantly more total malpositions (mean 0.23 vs. 0, p < 0.001). For a hypothetical population of 1,000 annual patients, adoption of Sherlock 3CG TCS was predicted to be cost saving compared with BI/CXR in all three analysis years. CONCLUSION: The results from this study demonstrate that Sherlock 3CG TCS, when compared with BI/CXR, is a superior alternative with regard to time to release subject to therapy, malposition rates, and minimization of X-ray exposure.

Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

BACKGROUND: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE: To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS: A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS: The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS: Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.

BACKGROUND: Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities. The objective of this study was to conduct a hospital cost analysis of the fibrin sealant patch versus standard of care in soft tissue and hepatic surgical bleeding. METHODS: The analysis quantified the 30-day costs of each comparator from a hospital perspective. Published US unit costs were applied to resource use (ie, initial treatment, retreatment, operating time, hospitalization, transfusion, and ventilator) reported in four trials. A "surgical" analysis included resources clinically related to the hemostatic benefit of the fibrin sealant patch, whereas a "hospital" analysis included all resources reported in the trials. An exploratory subgroup analysis focused solely on coagulopathic patients defined by abnormal blood test results. RESULTS: The surgical analysis predicted cost savings of $54 per patient with the fibrin sealant patch compared with standard of care (net cost impact: -$54 per patient; sensitivity range: -$1,320 to $1,213). The hospital analysis predicted further cost savings with the fibrin sealant patch (net cost impact of -$2,846 per patient; sensitivity range: -$1,483 to -$5,575). Subgroup analyses suggest that the fibrin sealant patch may provide dramatic cost savings in the coagulopathic subgroup of $3,233 (surgical) and $9,287 (hospital) per patient. Results were most sensitive to operating time and product units. CONCLUSION: In soft tissue and hepatic problematic surgical bleeding, the fibrin sealant patch may result in important hospital cost savings.

Hospital costs associated with thyroidectomy performed with a Harmonic device compared to conventional techniques: a systematic review and meta-analysis.

OBJECTIVES: Harmonic devices have become a world-wide standard for dissection and hemostasis in thyroidectomy. Numerous systematic reviews have reported superior operating times, blood loss, post-operative pain, length of stay, and overall safety outcomes. What has not been extensively evaluated in a robust manner is their economic impact. The purpose of this study is to evaluate the hospital costs associated with open thyroidectomy using Harmonic devices compared with conventional techniques for hemostasis. METHODS: A systematic review of Medline, Scopus, and CENTRAL was performed from January 1, 2000 to May 23, 2014 without language restrictions for randomized clinical trials comparing Harmonic surgical devices to conventional methods in thyroidectomy. The main outcome measure was total reported costs. Costs were pooled using the ratio of means and a random effects model. Sensitivity analyses assessed whether differences in patient and trial characteristics, healthcare setting, or choice of statistical model affected outcomes. RESULTS: Seven studies met the inclusion criteria. A total of 476 participants had procedures performed with Harmonic devices and 478 with conventional monopolar electrosurgery and clamp, cut and tie techniques. Compared with conventional techniques, Harmonic devices reduced total reported costs by 10% (p = 0.007), resulting in a $229 US dollars (USD) absolute reduction from mean baseline costs. Results remained relatively robust to additional sensitivity analyses. CONCLUSIONS: This systematic review and meta-analysis demonstrates that the Harmonic family of surgical devices is associated with a reduction in total reported costs in thyroidectomy compared with conventional techniques. A large portion of the overall savings derives from a reduction in operative costs.

Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database.

BACKGROUND: Bleeding remains a common occurrence in surgery. Data describing the burden of difficult-to-control bleeding and topical absorbable hemostat use are sparse. This study was conducted to estimate the clinical and economic impact that remains associated with uncontrolled surgical bleeding, even when hemostats are used during surgery. METHODS: This US retrospective analysis used the Premier Perspectives Database. Hospital discharges from 2012 were used to identify patients treated with hemostats during eight surgery types. Patients were included if they were ≥18 years, had an inpatient hospitalization with one of the eight surgeries, and received a hemostat on the day of surgery. Patients were stratified by procedure and presence or absence of major bleeding (uncontrolled) despite hemostat use. Outcomes were all-cause hospitalization costs, hemostat costs, length of stay, reoperation, and surgery-related complications (eg, mortality). Statistical significance was tested through chi-square or t-tests. Multivariate analyses were conducted for all-cause costs and length of stay using analysis of covariance. RESULTS: Among 25,048 procedures, major bleeding events occurred in 14,251 cases. Despite treatment with hemostats, major bleeding occurred in 32%-68% of cases. All-cause costs were significantly higher in patients with uncontrolled bleeding despite hemostat use versus controlled bleeding (US$24,203-$61,323 [uncontrolled], US$14,420-$45,593 [controlled]; P<0.001). Hemostat costs were significantly greater in the uncontrolled bleeding cohort for all surgery types except cystectomy and pancreatic surgery. Reoperation and mortality rates were significantly higher in the uncontrolled bleeding cohort in all surgical procedures except cystectomy and radical hysterectomy. CONCLUSION: Uncontrolled intraoperative bleeding despite hemostat use is prevalent and associated with significantly higher hospital costs and worse clinical outcomes across several surgical procedures compared to controlled bleeding. There is an unmet need for newer hemostats that can more effectively control bleeding, improve outcomes, and reduce hospital resource use.

How rebates, copayments, and administration costs affect the cost-effectiveness of osteoporosis therapies.

PURPOSE: Because of rising drug expenditures, cost considerations have become essential, necessitating the requirement for cost-effectiveness analyses for managed care organizations (MCOs). The study objective is to examine the impact of various drug-cost components, in addition to wholesale acquisition cost (WAC), on the cost-effectiveness of osteoporosis therapies. DESIGN: A Markov model of osteoporosis was used to exemplify different drug cost scenarios. METHODOLOGY: We examined the effect of varying rebates for oral bisphosphonates--risedronate and ibandronate--as well as considering the impact of varying copayments and administration costs for intravenous zoledronate. The population modeled was 1,000 American women, > or = 50 years with osteoporosis. Patients were followed for 1 year to reflect an annual budget review of formularies by MCOs. The cost of therapy was based on an adjusted WAC, and is referred to as net drug cost. The total annual cost incurred by an MCO for each drug regimen was calculated using the net drug cost and fracture cost. We estimated cost on a quality adjusted life year (QALY) basis. PRINCIPAL FINDINGS: When considering different rebates, results for risedronate versus ibandronate vary from cost-savings (i.e., costs less and more effective) to approximately $70,000 per QALY. With no risedronate rebate, an ibandronate rebate of approximately 65% is required before cost per QALY surpasses $50,000. With rebates greater than 25% for risedronate, irrespective of ibandronate rebates, results become cost-saving. Results also showed the magnitude of cost savings to the MCO varied by as much as 65% when considering no administration cost and the highest coinsurance rate for zoledronate. CONCLUSION: Our study showed that cost-effectiveness varies considerably when factors in addition to the WAC are considered. This paper provides recommendations for pharmaceutical manufacturers and MCOs when developing and interpreting such analyses.

Cost analysis of four major drug-eluting stents in diabetic populations.

AIM: To use an indirect comparisons approach and conduct a cost analysis comparing four drug-eluting stents (DES) from a United States (US) payer (i.e., fixed-fee reimbursement) perspective. METHODS AND RESULTS: Studies were chosen that randomised two or more DES in diabetic patients. A one-year target lesion revascularisation (TLR) risk for Taxus was first derived. Risk Ratios (RRs) for each DES versus Taxus were calculated through meta-analyses. The RRs were multiplied by the average TLR risk for Taxus to estimate DES TLR risks. Estimates were added to a budget-impact model, along with utilisation and reimbursement rates for diagnosis-related groups. Budgets were calculated, assuming 100% stent use and 200,000 diabetic beneficiaries. One-year TLR risks were estimated to be 3.2%, 7.1%, 6.9% and 7.9% for Cypher, Endeavor, Taxus and Xience respectively. By substituting Cypher for DES with higher TLR, results predicted annual cost-savings greater than $146 million per population ($ 733 per patient). Results were comparable when assuming no difference in TLR risk between Endeavor, Taxus and Xience. CONCLUSIONS: When outcomes from trials of diabetic populations are analysed and used in a budget-impact model from a US payer perspective, the use of Cypher is associated with lower TLR rates, which translates into large potential cost savings.