- Email: [email protected]
ECONOMIC EVALUATIONS OF MEDICAL DEVICES IN CANADA: LENSX® FEMTOSECOND LASER-ASSISTED CATARACT SURGERY
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VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
PMD40 COST EFFECTIVENESS OF A MINIMALLY INVASIVE CELL SAMPLING DEVICE TO SCREEN FOR BARRETT’S ESOPHAGUS IN PATIENTS WITH GERD SYMPTOMS Heberle C R , Kong C Y , Hur C Massachusetts General Hospital, Boston, MA, USA .
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Objectives: The cytosponge is a novel noninvasive screening method for Barrett’s esophagus (BE). Patients with GERD symptoms are at heightened risk for BE and may warrant screening, particularly if other risk factors are present. We analyzed the effectiveness and cost-effectiveness of cytosponge as a first-line screening method with endoscopic confirmation, compared to endoscopy alone, within a cohort of GERD patients. Methods: We used a validated microsimulation model of the natural history of esophageal adenocarcinoma (EAC) and precursor states, which was previously calibrated to SEER data on EAC incidence and mortality. The model incorporated cytosponge and endoscopic screening to assess their impact on clinical outcomes. We analyzed a cohort of 60 year old US males with GERD symptoms, comparing three screening strategies: no screening (S0), cytosponge screening with endoscopic confirmation of positive results (S1), and endoscopic screening (S2). In both S1 and S2, confirmed BE cases underwent surveillance and were treated with radio-frequency ablation therapy if they progressed to high grade dysplasia. Cytosponge was assumed to cost $500 per screen. Results: Strategy S1 resulted in fewer total endoscopies compared to S2 (851/100K patients screened S1; 1868 S2) and was less costly ($2.1M/100K patients for S1, $2.3M for S2) but resulted in fewer average life-years (15091/100K patients in S1 versus 15092 in S2). S0 was the least costly ($1.0M), but resulted in the fewest average years of life (15076). The incremental cost-effectiveness ratios were $72,693/life-year for S1 compared to S0 and $156,681/life-year for S2 compared to S1. In a sensitivity analysis, S1 was not on the efficiency frontier when cytosponge cost $621 or more. Conclusions: Initial cytosponge could be cost-effective as a screening method for patients with GERD, but only below a price threshold of $621. PMD41 WHAT IS THE MOST COST-EFFECTIVE STRATEGY FOR THE DIAGNOSIS OF SEVERE BACTERIAL INFECTION IN INFANTS WITH FEVER WITHOUT SOURCE? Buendia Rodriguez J A 1, Sanchez Villamil J P 2 1University of Antioquia, Medellin, Colombia, 2Argenomics, Envigado, Colombia .
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Objectives: Infants who have a fever with no obvious source of infection present a diagnostic dilemma. A significant number of these patients may have a serious bacterial infection; making proper diagnosis and management important. Physical examination do not always identify patients with serious bacterial infection (SBI). If SBI are not recognized promptly can cause significant morbidity or mortality. The aim of this study was to determine the cost-effectiveness of 4 different screening strategies of Serious Bacterial Infections (SBI) in Children Presenting with Fever without Source (FWS) in Argentina Methods: A decision tree was designed to model a hypothetical cohort of 10,000 children with FWS. We compared the incremental cost-effectiveness of four strategies to detect SBI (Rochester criteria (RC), RC+ procalcitonin (PCT) , RC + C reactive protein (PCR) and no tests (NT).The analysis perspective was that of health-care payers, and we calculated only the direct medical costs.We conducted sensitivity analyses with Monte-Carlo simulation method to understand the key drivers and general sensitivity of the model. Results: ER+PCR result in US$ 784 per correctly diagnosed cases of SBI versus US$ 839 of ER+ PCT, US$ 1116 de NT or US$1193 de ER. The sensitivity analysis shows if the probability of IBS is equal or less than 14% the strategy of choice is NT Conclusions: RC+PCR is the strategy more cost- effective to detect SBI in children with Fever without Source in Argentina. When probability of IBS is equal or less than 14% the strategy of choice is NT. PMD42 COST EFFECTIVENESS OF DRUG-COATED BALLOON VERSUS PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY, BARE METAL STENT, AND DRUGELUTING STENT IN THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN LOWER LIMBS CANADA Orozco J J 1, Sadri H 2, Valencia J 3 1Medtronic PLC, Medellín, Colombia, 2Medronic PLC, Brampton, ON, Canada, 3Medtronic, Miami, FL, USA .
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Objectives: Cost-Effectiveness analysis of Drug Coated Balloon (DCB) vs. Percutaneous Transluminal Balloon Angioplasty (PTA), Bare Metal Stent (BMS) and Drug Eluting Stent (DES) in the treatment of Peripheral Arterial Disease in lower limbs in Canada. Methods: An analytical decision model was considered with Target Lesion Restenosis (TLR) Avoided and total cost at the end of two year horizon. An Excel model was developed. The effectiveness data (TLR rates) and distribution of revascularization modalities were obtained from a literature review and budget impact model by Jan et al., which pooled the clinical effectiveness of the four therapies based on published literature (1-3). A payer perspective was assumed. Total costs were taken from reimbursement values charged to payers in Canada. Because effectiveness and cost were taken as unique values at the end of the two years, discount rate was no applied. The sensitivity Univariate analysis was done for DCB vs. PTA. For the Probabilistic Sensitivity Analysis a Monte Carlo Simulation with 1000 iterations was done. Results: TLR Avoided probability with DCB was 0,841 vs. 0,604, 0,731 and 0,806 for PTA, BMS and DES respectively. DCB total cost was CAD$4.790 vs. CAD$4.735 for PTA, CAD$4.301 for BMS and CAD$6.316 for DES. DCB was dominant to DES, and had an ICER of CAD$231 respect to PTA and CAD$4.435 respect BMS. The Willingness-To-Pay (WTP) acceptability curves show that DCB, compared to other therapies, had a higher probability to be accepted for all the WTP values above CAD$4.200, reaching a probability of 73% for CAD$9.000 WTP value. Conclusions: DCB was dominant to DES and had an ICER of CAD$231 respect to PTA and CAD$4.435 respect BMS. The univariate sensitivity analysis shows the ICER of DEB vs. PTA was especially sensible to total costs of the therapies and the effectiveness of PTA.
PMD43 COST-EFFECTIVENESS ANALYSIS OF USING MIRNA BIOMARKER PANEL AS A SCREEN BEFORE ENDOSCOPY FOR GASTRIC CANCER DIAGNOSIS Kapoor R 1, Zhu F 1, So J B 1, Zou R 2, Zhou L 2, Too H 3, Yeoh K G 3, Yik-Ying T 3, Yoong J S 1 1National University of Singapore, Singapore, Singapore, 2Mirxes Pte Ltd., Singapore, Singapore, University of Singapore, singapore, Singapore .
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3National
Objectives: Gastric cancer though among the top lethal cancers, has a very low prevalence overall. To ensure early detection, patients presenting with gastric distress in clinics are investigated with endoscopy in Singapore. However, low prevalence even in this group (~0.7%) leads to an immense cost burden. This research analyses the cost-effectiveness of introducing a microRNA-based blood test as a cheap yet effective screen to stratify high-risk patients into gastric cancer risk-levels, enabling a more targeted prescription of endoscopy Methods: A 5-year decision tree model was developed with a healthcare systems perspective in TreeAgePro2013 to compare the two strategies among high-risk patients in Singapore specialist clinic setting: (a)miRNA test, followed by endoscopy for test-positive patients, (b) universal endoscopy. Modelling patients for four health stages – healthy, earlytreatable (stage1), advanced-treatable (Stage2&3), untreatable (stage4); stage-specific treatments, costs, utilities, outcomes and recurrence rates were considered. Missed patients were expected to be diagnosed later with advanced cancers (as per natural disease progression) and face corresponding health and cost implications. Using sensitivity and specificity values, local and published data and conservative assumptions favouring universal endoscopy, the ICER was evaluated on presentvalue basis at a 3% discount rate. Deterministic and probabilistic sensitivity analysis was done across different variables to verify the model robustness Results: The analysis confirmed the cost-effectiveness of using miRNA-based strategy (ICER: S$198,329/QALY) with a cost-saving of S$200/patient for an average loss of 0.001 QALY (WTP: 1 GDP per capita, S$71,318). Sensitivity analysis further reaffirmed the results with 100% of iterations in PSA favouring miRNA-based strategy up-to a WTP of S$100,000. Conclusions: The miRNA-based blood test not only offers a moderately to highly cost-effective screen in gastric cancer diagnosis, but with its easy administration and better patient experience in comparison to invasive endoscopy might also promote patient compliance for regular screening and check-ups. PMD44 COST-EFFECTIVENESS OF SILVER ALGINATE FOR INFECTED HARD-TO-HEAL WOUNDS TREATMENT IN BRAZIL Mensor L 1, Bastos D 1, Souza C 2, Contadin R 1 B.Braun S.A., Rio de Janeiro, Brazil, 2Sense Company, São Paulo, Brazil .
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1Laboratórios
Objectives: Silver dressings are used for years for reduction of bacterial load in wounds. Our objective was to assess cost-effectiveness of an alginate-based silver dressing versus calcium alginate for treatment of hard-to-heal wounds, either infected or critically colonized, under the perspective of the private healthcare system in Brazil. Methods: An analytical decision model was developed for simulating the cost-effectiveness ratio between silver alginate and calcium alginate for: diabetic foot ulcers, leg venous ulcers and pressure ulcers. Cost-effectiveness analysis considered clinical data obtained from a systematic review of literature and total treatment costs estimated throughout values from secondary databases. All epidemiological data and model assumptions were validated by Expert Panel. Results: The systematic review achieved evidence level “B”, according to the Oxford´s grade. Outcomes considered were clinical signs of infection and bacteriological status from lesions. Incremental cost-effectiveness ratios have shown cost-savings of approximately 40 thousand Brazilian Reais per patient, independent on the subgroup. Such results are driven from treatment costs lower in 35 to 40% for the silver group, compared to the control. Additionally, we could observe better results of improvement in bacteriological status and infection signs avoided (incremental effectiveness of 22% and 30% respectively). Conclusions: Patients treated with silver alginate develop lower trends on worsening infectious status in their lesions and its use can reduce total treatment costs. Thus, silver alginate can offer a feasible alternative for infected or critically colonized hard-to-heal wounds treatment. PMD45 SHOULD THE GOVERNMENT INTERVENE IN THE IMPLEMENTATION ON SAFETYENGINEERED DEVICES? EVIDENCE FROM A COST-EFFECTIVENESS ANALYSIS OF NEEDLESTICK INJURIES Fukuda H 1, Moriwaki K 2 University, Fukuoka, Japan, 2Kobe Pharmaceutical University, Kobe, Japan .
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1Kyushu
Objectives: To estimate the cost-effectiveness of safety-engineered devices (SEDs) relative to non-SEDs for winged steel needles, intravenous (IV) catheter stylets, suture needles, and insulin pen needles. Methods: We developed a decision-analytic model to estimate and compare the life-cycle costs and benefits for SED and non-SED needle devices. We utilized a hypothetical cohort of healthcare workers who utilized needle devices. For this cost-effectiveness analysis, we quantified the total direct medical cost per needlestick injury (NSI), number of NSIs avoided, and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to examine the robustness of the base-case analysis. Results: In the base-case analysis, we calculated the ICERs of SED winged steel needles, IV catheter stylets, suture needles, and insulin pen needles to be $2,633, $13,943, $1,792, and $1,269 per NSI avoided, respectively. Sensitivity analyses showed that the calculated ICER values for using SEDs did not fall below zero even after adjusting the values of each parameter. Conclusions: The use of SED needle devices would not produce cost savings for hospitals. Government intervention may be needed to systematically protect healthcare workers in Japan from the risk of bloodborne pathogen infections. PMD46 ECONOMIC EVALUATIONS OF MEDICAL DEVICES IN CANADA: LENSX® FEMTOSECOND LASER-ASSISTED CATARACT SURGERY Lee A 1, Keith M S 2, Prasad S 3, Kohli M 1, Ferreira A 2, Bouchet C 2 .
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1Optum, Burlington, ON, Canada, 2Alcon Laboratories, Inc, Fort Worth, TX, USA, 3Optum, Waltham, MA, USA
Objectives: Economic evaluations of medical devices pose some inherent challenges such as the difficulty in conducting randomized controlled trials (RCTs) and additional evidence development post-launch. We developed a cost-effectiveness model to evaluate the use of the LenSx® laser system for femtosecond laser-assisted cataract surgery (FLACS) compared to phacoemulsification cataract surgery (PCS) in medically necessary cataract removal in Canada. Methods: A decision analytic model was designed to determine the quality-adjusted life-years (QALYs) gained and costs from the Canadian hospital perspective. Patients received monofocal or toric intraocular lens. Corrected distance visual acuity (CDVA), distance spectacle dependence, complication rates, CDVA utilities, and spectacle dependence and complications disutilities were obtained from published literature; assumptions were made in cases of unavailable data. Costs were obtained to fit the local Canadian setting. Results: The cost-effectiveness ratios (ICERs) for FLACS vs PCS were $169,086/QALY, $37,790/QALY and $18,099/QALY for 1-year, 5-year and lifetime (~13.6 years) time horizons, respectively. The main difference observed in clinical outcomes was more PCS patients remaining spectacle dependent compared to FLACS. As CDVA were assumed to be comparable in the absence of RCTs that showed a difference, the impact of the change in the time horizon was therefore due to the disutility applied to distance spectacle dependence. The ICER was most sensitive to changes in mean age (affecting time horizon), and spectacle dependence and CDVA distribution efficacy parameters. Conclusions: Our analysis demonstrates that FLACS is a cost-effective treatment when compared to PCS, but highlights the need to continuously re-evaluate given the strength of evidence generation post-launch. PMD47 COST EFFECTIVENESS OF TRANSCATHETER AORTIC VALVE IMPLANTATION VERSUS SURGICAL AORTIC VALVE REPLACEMENT: THE COREVALVE HIGH RISK TRIAL FROM A DUTCH PERSPECTIVE Geisler B P 1, Osnabrugge R L 2, Huygens S A 2, Reardon M J 3, Kappetein A P 2, Pietzsch J B 1 Inc., Irvine, CA, USA, 2Erasmus Medical Centre, Rotterdam, The Netherlands, 3The Methodist Hospital, Houston, TX, USA .
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1Wing Tech
Objectives: To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in high risk surgical candidates in the Netherlands. Methods: A lifetime decision-analytic model projected quality-adjusted life years (QALYs), adverse events, and costs of the competing strategies. Event probabilities and utilities were derived from two-year follow-up data of the CoreValve High Risk Study after stratifying by Kansas City Cardiomyopathy Questionnaire (KCCQ) above and below 60 and stroke status. Costs were based on a single-center analysis of pre-operative diagnostics, procedural, index hospitalization, and long-term resource utilization. Costs and effects were discounted at 4% and 1.5% per annum, respectively. In addition to deterministic sensitivity analyses, a “lean scenario” was explored for TAVI which considered a reduced length of stay. Results: In the early post-operative period, a swifter recovery in health-related quality of life was observed after TAVI, along with improved functional cardiovascular outcomes evidenced by a higher proportion of patients in the higher KCCQ stratum. Undiscounted life expectancy increased by 0.65 (5.62 vs 4.97) years after TAVI. Over the lifetime horizon, TAVI was projected to add 0.41 (3.69 vs. 3.27) QALYs at increased cost of € 9,048 (€ 51,068 vs. € 42,020), resulting in an incremental cost-effectiveness ratio (ICER) of € 21,946 per QALY gained. Results were relatively insensitive to changes in input parameters. Threshold analysis of the “lean scenario” indicated that a further cost reduction of approximately € 5,400 would make TAVI the dominant strategy. Conclusions: TAVI for high-risk surgical candidates is a cost-effective treatment strategy at a level well below commonly accepted Dutch willingness-to-pay thresholds. This favorable health-economic value proposition can be expected to further improve in future years. PMD48 COST-UTILITY OF PCR DETECTION AMONG PATIENTS WITH SUSPECTED PERITONEAL CANDIDIASIS IN THE INTENSIVE CARE UNIT: A MODEL SIMULATION Pagès A , Iriart X , Molinier L , Massip P , Juillard-Condat B University Hospital of Toulouse, Toulouse, France .
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Objectives: The intra-abdominal candidiasis in intensive care units represents a significant cause of morbidity and mortality. The polymerase chain reaction (PCR) allows to detect Candida spp. faster than the fungal culture which is the gold standard. The aim of this study was to perform a cost-utility analysis of two PCR-based diagnostic strategies compared to the fungal culture-based strategy. One strategy involved the PCR detection of most common fluconazole resistant species (Candida krusei and Candida glabrata) and the other involved the PCR-based detection of all Candida strains regardless their species. Methods: A decision tree model was constructed to perform the cost-utility analysis. The parameters used in the model came from the literature (data published until 1st December 2015), the European and French guidelines and expert opinions when the data were unavailable. We performed the analysis from the perspective of the French national health insurance. Non-neutropenic patients with a suspected intra-abdominal candidiasis in the intensive care unit represented the target population. Results: Both PCR-based strategies were more effective and less expensive (cost saving) than the comparator. The probability of being cost saving versus fungal culture-based strategy was 81% for the PCR detection of Candida krusei and Candida glabrata and 77% for the PCR detection of all Candida spp. The results were sensitive to the prevalence of invasive candidiasis and the fungal culture sensitivity. Among the 3 strategies, PCR detection of all Candida spp. appeared to be the most cost-effective strategy (98.5% with a threshold of € 50,000 per Quality–Adjusted Life Year (QALY) gained). Conclusions: The model results suggest that the PCR detection of all Candida spp. is cost-effective for non-neutropenic patients with suspected fungal peritonitis in intensive care
units (€ 50,000/QALY threshold). Thus, a randomized controlled trial remains necessary to confirm the conclusions of this study. PMD49 COST EFFECTIVENESS OF LOCAL INSUFFLATION OF WARM HUMIDIFIED CO2 DURING OPEN AND LAPAROSCOPIC COLORECTAL SURGERY IN THE UNITED STATES Jenks M 1, Taylor M 1, Shore J 1, Oster G 2 1York Health Economics Consortium, York, UK, 2Policy Analysis Inc. (PAI) and Managing CoDirector, MINERVA Health Economics Network, Brookline, MA, USA .
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Objectives: To determine the cost-effectiveness of local insufflation (via a humidifier) of warm humidified CO2 (WH-CO2) compared with standard care in patients undergoing open or laparoscopic colorectal surgery. Methods: A decision-analytic model was developed to estimate the costs and quality-adjusted life years (QALYs) associated with open and laparoscopic colorectal surgery from a US payer perspective. WH-CO2 was compared with no insufflation in open surgery patients and with unheated CO2 (U-CO2) in laparoscopic surgery patients. Efficacy data for open surgery patients were derived from a published randomised controlled trial reporting on the proportion of patients with hypothermia and a United States (US) hospital database analysis of post-surgery hypothermia. Data for laparoscopic surgery patients were from a United Kingdom before and after study of laparoscopic surgery patients. Other parameter inputs were obtained from published literature. Clinical event cost estimates referred to the total cost of admission to hospital for a given event. Sensitivity and scenario analyses were conducted to assess the robustness of results. Results: Based on 200 patients using the device each year, WH-CO2 dominates standard care, as it is both cost saving ($2,355 per patient) and generates greater QALYs (0.004 per patient), over a one-year time horizon where 30% of the patients modelled underwent open surgery and 70% laparoscopic surgery. WH-CO2 dominated no insufflation in open surgery patients in 99.9% of model iterations and dominated U-CO2 in laparoscopic surgery in 99.4% of model iterations. WH-CO2 remained cost-effective at a willingness-to-pay threshold of $50,000 per QALY throughout all sensitivity analyses considered, except in the most extreme cases where the rate of clinical complications in laparoscopic patients was lower with U-CO2 than with WH-CO2. Conclusions: The analyses suggest that, based upon currently available clinical evidence, WH-CO2 is a cost-effective use of resources for patients undergoing open or laparoscopic colorectal surgery within the US. PMD50 COST-EFFECTIVENESS OF PERCUTANEOUS RENAL MASS BIOPSY IN THE MANAGEMENT OF SMALL RENAL MASSES Wang Y 1, Althaus A B 1, Leow J J 1, Tinay I 2, Gelpi-Hammerschmidt F J 1, Rosen D 1, Chang S L 1 and Women’s Hospital; Harvard Medical School, Boston, MA, USA, 2Marmara University School of Medicine, Istanbul, Turkey .
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1Brigham
Objectives: This study aimed to evaluate the cost-effectiveness of percutaneous renal mass biopsy (RMB) in the management of small renal masses (SRMs). Methods: A Markov model was developed to compare the lifetime costs and quality-adjusted life years (QALYs) of RMB with possible delayed treatment and immediate treatment from the societal perspective in a hypothetical cohort of 65-year-old healthy patients with asymptomatic unilateral SRMs. The treatments included percutaneous ablation (PA), laparoscopic ablation (LA), robotic partial nephrectomy, open partial nephrectomy (OPN), laparoscopic radical nephrectomy, and open radical nephrectomy. The willingness-to-pay threshold was $50,000/QALYgained. Robustness of the model was assessed using sensitivity analyses. Results: Among all the options, RMB with possible PA had the lowest total costs and QALYs. RMB with possible OPN was the optimal choice compared with RMB with possible PA (incremental cost-effectiveness ratio: $6,397/QALY-gained). In pairwise comparisons, RMB was preferred to the corresponding immediate treatment. If chronic kidney disease (CKD)-incurred costs were above the treatment-specific threshold, RMB was preferred. RMB with possible LA or partial nephrectomy was favored over the immediate treatment in old patients. RMB with possible radical nephrectomy was preferred to the immediate treatment regardless of age at diagnosis, tumor size and comorbidities. However, immediate PA was preferred to RMB in old patients with a large tumor. Conclusions: RMB with possible OPN was the optimal strategy. Among pairwise comparisons, RMB was preferred to immediate treatment. The results were sensitive to CKD-incurred costs, age and tumor size. PMD51 HEALTH ECONOMIC COMPARISON OF GD-EOB-DTPA-ENHANCED MRI VERSUS EXTRACELLULAR CONTRAST MEDIA-ENHANCED MRI AND MULTIDETECTOR CT FOR DIAGNOSIS OF HEPATOCELLULAR CARCINOMA IN CHINA AMONG PATIENTS AT RISK He X 1, Wu J 1, Holtorf A 2, Rinde H 2, Xie S 3, Shen W 3, Hou J 3, Li X 4, Li Z 4, Lai J 4, Wang Y 5, Zhang L 5, Wang J 5, Li X 5, Ma K 5, Ye F 6, Ouyang H 6, Zhao H 6 1Tianjin University, Tianjin, China, 2Health Outcomes Strategies, Basel, Switzerland, 3Tianjin First Center Hospital, Tianjin, China, 4The 1st affiliated Hospital, Sun Yat-sen University, Guangzhou, China, 5Southwest Hospital, Chongqing, China, 6Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China .
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Objectives: To compare the total cost of hepatocyte-specific Gd-EOB-DTPA enhanced MRI (PV-MRI) to extracellular contrast media-enhanced MRI (ECCMMRI) and multidetector CT (MDCT) as initial imaging procedures among patients with suspected hepatocellular carcinoma (HCC) from China healthcare perspective. Methods: A decision-tree model based on the Chinese clinical guidelines and validated by clinical experts was used to compare the diagnostic effectiveness of alternative initial imaging procedures to optimize therapeutic decisions for suspected HCC patients. Patients with suspected HCC as identified by ultrasound and alpha fetoprotein (AFP) levels entered the model. The three initial imaging methods were compared based on HCC prevalence in the included population, diagnostic accuracy (sensitivity and specificity) of the imaging alternatives, transition probabilities and costs as derived from published literature or expert opinion from 4
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
PMD40 COST EFFECTIVENESS OF A MINIMALLY INVASIVE CELL SAMPLING DEVICE TO SCREEN FOR BARRETT’S ESOPHAGUS IN PATIENTS WITH GERD SYMPTOMS Heberle C R , Kong C Y , Hur C Massachusetts General Hospital, Boston, MA, USA .
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Objectives: The cytosponge is a novel noninvasive screening method for Barrett’s esophagus (BE). Patients with GERD symptoms are at heightened risk for BE and may warrant screening, particularly if other risk factors are present. We analyzed the effectiveness and cost-effectiveness of cytosponge as a first-line screening method with endoscopic confirmation, compared to endoscopy alone, within a cohort of GERD patients. Methods: We used a validated microsimulation model of the natural history of esophageal adenocarcinoma (EAC) and precursor states, which was previously calibrated to SEER data on EAC incidence and mortality. The model incorporated cytosponge and endoscopic screening to assess their impact on clinical outcomes. We analyzed a cohort of 60 year old US males with GERD symptoms, comparing three screening strategies: no screening (S0), cytosponge screening with endoscopic confirmation of positive results (S1), and endoscopic screening (S2). In both S1 and S2, confirmed BE cases underwent surveillance and were treated with radio-frequency ablation therapy if they progressed to high grade dysplasia. Cytosponge was assumed to cost $500 per screen. Results: Strategy S1 resulted in fewer total endoscopies compared to S2 (851/100K patients screened S1; 1868 S2) and was less costly ($2.1M/100K patients for S1, $2.3M for S2) but resulted in fewer average life-years (15091/100K patients in S1 versus 15092 in S2). S0 was the least costly ($1.0M), but resulted in the fewest average years of life (15076). The incremental cost-effectiveness ratios were $72,693/life-year for S1 compared to S0 and $156,681/life-year for S2 compared to S1. In a sensitivity analysis, S1 was not on the efficiency frontier when cytosponge cost $621 or more. Conclusions: Initial cytosponge could be cost-effective as a screening method for patients with GERD, but only below a price threshold of $621. PMD41 WHAT IS THE MOST COST-EFFECTIVE STRATEGY FOR THE DIAGNOSIS OF SEVERE BACTERIAL INFECTION IN INFANTS WITH FEVER WITHOUT SOURCE? Buendia Rodriguez J A 1, Sanchez Villamil J P 2 1University of Antioquia, Medellin, Colombia, 2Argenomics, Envigado, Colombia .
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Objectives: Infants who have a fever with no obvious source of infection present a diagnostic dilemma. A significant number of these patients may have a serious bacterial infection; making proper diagnosis and management important. Physical examination do not always identify patients with serious bacterial infection (SBI). If SBI are not recognized promptly can cause significant morbidity or mortality. The aim of this study was to determine the cost-effectiveness of 4 different screening strategies of Serious Bacterial Infections (SBI) in Children Presenting with Fever without Source (FWS) in Argentina Methods: A decision tree was designed to model a hypothetical cohort of 10,000 children with FWS. We compared the incremental cost-effectiveness of four strategies to detect SBI (Rochester criteria (RC), RC+ procalcitonin (PCT) , RC + C reactive protein (PCR) and no tests (NT).The analysis perspective was that of health-care payers, and we calculated only the direct medical costs.We conducted sensitivity analyses with Monte-Carlo simulation method to understand the key drivers and general sensitivity of the model. Results: ER+PCR result in US$ 784 per correctly diagnosed cases of SBI versus US$ 839 of ER+ PCT, US$ 1116 de NT or US$1193 de ER. The sensitivity analysis shows if the probability of IBS is equal or less than 14% the strategy of choice is NT Conclusions: RC+PCR is the strategy more cost- effective to detect SBI in children with Fever without Source in Argentina. When probability of IBS is equal or less than 14% the strategy of choice is NT. PMD42 COST EFFECTIVENESS OF DRUG-COATED BALLOON VERSUS PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY, BARE METAL STENT, AND DRUGELUTING STENT IN THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN LOWER LIMBS CANADA Orozco J J 1, Sadri H 2, Valencia J 3 1Medtronic PLC, Medellín, Colombia, 2Medronic PLC, Brampton, ON, Canada, 3Medtronic, Miami, FL, USA .
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Objectives: Cost-Effectiveness analysis of Drug Coated Balloon (DCB) vs. Percutaneous Transluminal Balloon Angioplasty (PTA), Bare Metal Stent (BMS) and Drug Eluting Stent (DES) in the treatment of Peripheral Arterial Disease in lower limbs in Canada. Methods: An analytical decision model was considered with Target Lesion Restenosis (TLR) Avoided and total cost at the end of two year horizon. An Excel model was developed. The effectiveness data (TLR rates) and distribution of revascularization modalities were obtained from a literature review and budget impact model by Jan et al., which pooled the clinical effectiveness of the four therapies based on published literature (1-3). A payer perspective was assumed. Total costs were taken from reimbursement values charged to payers in Canada. Because effectiveness and cost were taken as unique values at the end of the two years, discount rate was no applied. The sensitivity Univariate analysis was done for DCB vs. PTA. For the Probabilistic Sensitivity Analysis a Monte Carlo Simulation with 1000 iterations was done. Results: TLR Avoided probability with DCB was 0,841 vs. 0,604, 0,731 and 0,806 for PTA, BMS and DES respectively. DCB total cost was CAD$4.790 vs. CAD$4.735 for PTA, CAD$4.301 for BMS and CAD$6.316 for DES. DCB was dominant to DES, and had an ICER of CAD$231 respect to PTA and CAD$4.435 respect BMS. The Willingness-To-Pay (WTP) acceptability curves show that DCB, compared to other therapies, had a higher probability to be accepted for all the WTP values above CAD$4.200, reaching a probability of 73% for CAD$9.000 WTP value. Conclusions: DCB was dominant to DES and had an ICER of CAD$231 respect to PTA and CAD$4.435 respect BMS. The univariate sensitivity analysis shows the ICER of DEB vs. PTA was especially sensible to total costs of the therapies and the effectiveness of PTA.
PMD43 COST-EFFECTIVENESS ANALYSIS OF USING MIRNA BIOMARKER PANEL AS A SCREEN BEFORE ENDOSCOPY FOR GASTRIC CANCER DIAGNOSIS Kapoor R 1, Zhu F 1, So J B 1, Zou R 2, Zhou L 2, Too H 3, Yeoh K G 3, Yik-Ying T 3, Yoong J S 1 1National University of Singapore, Singapore, Singapore, 2Mirxes Pte Ltd., Singapore, Singapore, University of Singapore, singapore, Singapore .
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3National
Objectives: Gastric cancer though among the top lethal cancers, has a very low prevalence overall. To ensure early detection, patients presenting with gastric distress in clinics are investigated with endoscopy in Singapore. However, low prevalence even in this group (~0.7%) leads to an immense cost burden. This research analyses the cost-effectiveness of introducing a microRNA-based blood test as a cheap yet effective screen to stratify high-risk patients into gastric cancer risk-levels, enabling a more targeted prescription of endoscopy Methods: A 5-year decision tree model was developed with a healthcare systems perspective in TreeAgePro2013 to compare the two strategies among high-risk patients in Singapore specialist clinic setting: (a)miRNA test, followed by endoscopy for test-positive patients, (b) universal endoscopy. Modelling patients for four health stages – healthy, earlytreatable (stage1), advanced-treatable (Stage2&3), untreatable (stage4); stage-specific treatments, costs, utilities, outcomes and recurrence rates were considered. Missed patients were expected to be diagnosed later with advanced cancers (as per natural disease progression) and face corresponding health and cost implications. Using sensitivity and specificity values, local and published data and conservative assumptions favouring universal endoscopy, the ICER was evaluated on presentvalue basis at a 3% discount rate. Deterministic and probabilistic sensitivity analysis was done across different variables to verify the model robustness Results: The analysis confirmed the cost-effectiveness of using miRNA-based strategy (ICER: S$198,329/QALY) with a cost-saving of S$200/patient for an average loss of 0.001 QALY (WTP: 1 GDP per capita, S$71,318). Sensitivity analysis further reaffirmed the results with 100% of iterations in PSA favouring miRNA-based strategy up-to a WTP of S$100,000. Conclusions: The miRNA-based blood test not only offers a moderately to highly cost-effective screen in gastric cancer diagnosis, but with its easy administration and better patient experience in comparison to invasive endoscopy might also promote patient compliance for regular screening and check-ups. PMD44 COST-EFFECTIVENESS OF SILVER ALGINATE FOR INFECTED HARD-TO-HEAL WOUNDS TREATMENT IN BRAZIL Mensor L 1, Bastos D 1, Souza C 2, Contadin R 1 B.Braun S.A., Rio de Janeiro, Brazil, 2Sense Company, São Paulo, Brazil .
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1Laboratórios
Objectives: Silver dressings are used for years for reduction of bacterial load in wounds. Our objective was to assess cost-effectiveness of an alginate-based silver dressing versus calcium alginate for treatment of hard-to-heal wounds, either infected or critically colonized, under the perspective of the private healthcare system in Brazil. Methods: An analytical decision model was developed for simulating the cost-effectiveness ratio between silver alginate and calcium alginate for: diabetic foot ulcers, leg venous ulcers and pressure ulcers. Cost-effectiveness analysis considered clinical data obtained from a systematic review of literature and total treatment costs estimated throughout values from secondary databases. All epidemiological data and model assumptions were validated by Expert Panel. Results: The systematic review achieved evidence level “B”, according to the Oxford´s grade. Outcomes considered were clinical signs of infection and bacteriological status from lesions. Incremental cost-effectiveness ratios have shown cost-savings of approximately 40 thousand Brazilian Reais per patient, independent on the subgroup. Such results are driven from treatment costs lower in 35 to 40% for the silver group, compared to the control. Additionally, we could observe better results of improvement in bacteriological status and infection signs avoided (incremental effectiveness of 22% and 30% respectively). Conclusions: Patients treated with silver alginate develop lower trends on worsening infectious status in their lesions and its use can reduce total treatment costs. Thus, silver alginate can offer a feasible alternative for infected or critically colonized hard-to-heal wounds treatment. PMD45 SHOULD THE GOVERNMENT INTERVENE IN THE IMPLEMENTATION ON SAFETYENGINEERED DEVICES? EVIDENCE FROM A COST-EFFECTIVENESS ANALYSIS OF NEEDLESTICK INJURIES Fukuda H 1, Moriwaki K 2 University, Fukuoka, Japan, 2Kobe Pharmaceutical University, Kobe, Japan .
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1Kyushu
Objectives: To estimate the cost-effectiveness of safety-engineered devices (SEDs) relative to non-SEDs for winged steel needles, intravenous (IV) catheter stylets, suture needles, and insulin pen needles. Methods: We developed a decision-analytic model to estimate and compare the life-cycle costs and benefits for SED and non-SED needle devices. We utilized a hypothetical cohort of healthcare workers who utilized needle devices. For this cost-effectiveness analysis, we quantified the total direct medical cost per needlestick injury (NSI), number of NSIs avoided, and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to examine the robustness of the base-case analysis. Results: In the base-case analysis, we calculated the ICERs of SED winged steel needles, IV catheter stylets, suture needles, and insulin pen needles to be $2,633, $13,943, $1,792, and $1,269 per NSI avoided, respectively. Sensitivity analyses showed that the calculated ICER values for using SEDs did not fall below zero even after adjusting the values of each parameter. Conclusions: The use of SED needle devices would not produce cost savings for hospitals. Government intervention may be needed to systematically protect healthcare workers in Japan from the risk of bloodborne pathogen infections. PMD46 ECONOMIC EVALUATIONS OF MEDICAL DEVICES IN CANADA: LENSX® FEMTOSECOND LASER-ASSISTED CATARACT SURGERY Lee A 1, Keith M S 2, Prasad S 3, Kohli M 1, Ferreira A 2, Bouchet C 2 .
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A305
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
1Optum, Burlington, ON, Canada, 2Alcon Laboratories, Inc, Fort Worth, TX, USA, 3Optum, Waltham, MA, USA
Objectives: Economic evaluations of medical devices pose some inherent challenges such as the difficulty in conducting randomized controlled trials (RCTs) and additional evidence development post-launch. We developed a cost-effectiveness model to evaluate the use of the LenSx® laser system for femtosecond laser-assisted cataract surgery (FLACS) compared to phacoemulsification cataract surgery (PCS) in medically necessary cataract removal in Canada. Methods: A decision analytic model was designed to determine the quality-adjusted life-years (QALYs) gained and costs from the Canadian hospital perspective. Patients received monofocal or toric intraocular lens. Corrected distance visual acuity (CDVA), distance spectacle dependence, complication rates, CDVA utilities, and spectacle dependence and complications disutilities were obtained from published literature; assumptions were made in cases of unavailable data. Costs were obtained to fit the local Canadian setting. Results: The cost-effectiveness ratios (ICERs) for FLACS vs PCS were $169,086/QALY, $37,790/QALY and $18,099/QALY for 1-year, 5-year and lifetime (~13.6 years) time horizons, respectively. The main difference observed in clinical outcomes was more PCS patients remaining spectacle dependent compared to FLACS. As CDVA were assumed to be comparable in the absence of RCTs that showed a difference, the impact of the change in the time horizon was therefore due to the disutility applied to distance spectacle dependence. The ICER was most sensitive to changes in mean age (affecting time horizon), and spectacle dependence and CDVA distribution efficacy parameters. Conclusions: Our analysis demonstrates that FLACS is a cost-effective treatment when compared to PCS, but highlights the need to continuously re-evaluate given the strength of evidence generation post-launch. PMD47 COST EFFECTIVENESS OF TRANSCATHETER AORTIC VALVE IMPLANTATION VERSUS SURGICAL AORTIC VALVE REPLACEMENT: THE COREVALVE HIGH RISK TRIAL FROM A DUTCH PERSPECTIVE Geisler B P 1, Osnabrugge R L 2, Huygens S A 2, Reardon M J 3, Kappetein A P 2, Pietzsch J B 1 Inc., Irvine, CA, USA, 2Erasmus Medical Centre, Rotterdam, The Netherlands, 3The Methodist Hospital, Houston, TX, USA .
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1Wing Tech
Objectives: To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in high risk surgical candidates in the Netherlands. Methods: A lifetime decision-analytic model projected quality-adjusted life years (QALYs), adverse events, and costs of the competing strategies. Event probabilities and utilities were derived from two-year follow-up data of the CoreValve High Risk Study after stratifying by Kansas City Cardiomyopathy Questionnaire (KCCQ) above and below 60 and stroke status. Costs were based on a single-center analysis of pre-operative diagnostics, procedural, index hospitalization, and long-term resource utilization. Costs and effects were discounted at 4% and 1.5% per annum, respectively. In addition to deterministic sensitivity analyses, a “lean scenario” was explored for TAVI which considered a reduced length of stay. Results: In the early post-operative period, a swifter recovery in health-related quality of life was observed after TAVI, along with improved functional cardiovascular outcomes evidenced by a higher proportion of patients in the higher KCCQ stratum. Undiscounted life expectancy increased by 0.65 (5.62 vs 4.97) years after TAVI. Over the lifetime horizon, TAVI was projected to add 0.41 (3.69 vs. 3.27) QALYs at increased cost of € 9,048 (€ 51,068 vs. € 42,020), resulting in an incremental cost-effectiveness ratio (ICER) of € 21,946 per QALY gained. Results were relatively insensitive to changes in input parameters. Threshold analysis of the “lean scenario” indicated that a further cost reduction of approximately € 5,400 would make TAVI the dominant strategy. Conclusions: TAVI for high-risk surgical candidates is a cost-effective treatment strategy at a level well below commonly accepted Dutch willingness-to-pay thresholds. This favorable health-economic value proposition can be expected to further improve in future years. PMD48 COST-UTILITY OF PCR DETECTION AMONG PATIENTS WITH SUSPECTED PERITONEAL CANDIDIASIS IN THE INTENSIVE CARE UNIT: A MODEL SIMULATION Pagès A , Iriart X , Molinier L , Massip P , Juillard-Condat B University Hospital of Toulouse, Toulouse, France .
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Objectives: The intra-abdominal candidiasis in intensive care units represents a significant cause of morbidity and mortality. The polymerase chain reaction (PCR) allows to detect Candida spp. faster than the fungal culture which is the gold standard. The aim of this study was to perform a cost-utility analysis of two PCR-based diagnostic strategies compared to the fungal culture-based strategy. One strategy involved the PCR detection of most common fluconazole resistant species (Candida krusei and Candida glabrata) and the other involved the PCR-based detection of all Candida strains regardless their species. Methods: A decision tree model was constructed to perform the cost-utility analysis. The parameters used in the model came from the literature (data published until 1st December 2015), the European and French guidelines and expert opinions when the data were unavailable. We performed the analysis from the perspective of the French national health insurance. Non-neutropenic patients with a suspected intra-abdominal candidiasis in the intensive care unit represented the target population. Results: Both PCR-based strategies were more effective and less expensive (cost saving) than the comparator. The probability of being cost saving versus fungal culture-based strategy was 81% for the PCR detection of Candida krusei and Candida glabrata and 77% for the PCR detection of all Candida spp. The results were sensitive to the prevalence of invasive candidiasis and the fungal culture sensitivity. Among the 3 strategies, PCR detection of all Candida spp. appeared to be the most cost-effective strategy (98.5% with a threshold of € 50,000 per Quality–Adjusted Life Year (QALY) gained). Conclusions: The model results suggest that the PCR detection of all Candida spp. is cost-effective for non-neutropenic patients with suspected fungal peritonitis in intensive care
units (€ 50,000/QALY threshold). Thus, a randomized controlled trial remains necessary to confirm the conclusions of this study. PMD49 COST EFFECTIVENESS OF LOCAL INSUFFLATION OF WARM HUMIDIFIED CO2 DURING OPEN AND LAPAROSCOPIC COLORECTAL SURGERY IN THE UNITED STATES Jenks M 1, Taylor M 1, Shore J 1, Oster G 2 1York Health Economics Consortium, York, UK, 2Policy Analysis Inc. (PAI) and Managing CoDirector, MINERVA Health Economics Network, Brookline, MA, USA .
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Objectives: To determine the cost-effectiveness of local insufflation (via a humidifier) of warm humidified CO2 (WH-CO2) compared with standard care in patients undergoing open or laparoscopic colorectal surgery. Methods: A decision-analytic model was developed to estimate the costs and quality-adjusted life years (QALYs) associated with open and laparoscopic colorectal surgery from a US payer perspective. WH-CO2 was compared with no insufflation in open surgery patients and with unheated CO2 (U-CO2) in laparoscopic surgery patients. Efficacy data for open surgery patients were derived from a published randomised controlled trial reporting on the proportion of patients with hypothermia and a United States (US) hospital database analysis of post-surgery hypothermia. Data for laparoscopic surgery patients were from a United Kingdom before and after study of laparoscopic surgery patients. Other parameter inputs were obtained from published literature. Clinical event cost estimates referred to the total cost of admission to hospital for a given event. Sensitivity and scenario analyses were conducted to assess the robustness of results. Results: Based on 200 patients using the device each year, WH-CO2 dominates standard care, as it is both cost saving ($2,355 per patient) and generates greater QALYs (0.004 per patient), over a one-year time horizon where 30% of the patients modelled underwent open surgery and 70% laparoscopic surgery. WH-CO2 dominated no insufflation in open surgery patients in 99.9% of model iterations and dominated U-CO2 in laparoscopic surgery in 99.4% of model iterations. WH-CO2 remained cost-effective at a willingness-to-pay threshold of $50,000 per QALY throughout all sensitivity analyses considered, except in the most extreme cases where the rate of clinical complications in laparoscopic patients was lower with U-CO2 than with WH-CO2. Conclusions: The analyses suggest that, based upon currently available clinical evidence, WH-CO2 is a cost-effective use of resources for patients undergoing open or laparoscopic colorectal surgery within the US. PMD50 COST-EFFECTIVENESS OF PERCUTANEOUS RENAL MASS BIOPSY IN THE MANAGEMENT OF SMALL RENAL MASSES Wang Y 1, Althaus A B 1, Leow J J 1, Tinay I 2, Gelpi-Hammerschmidt F J 1, Rosen D 1, Chang S L 1 and Women’s Hospital; Harvard Medical School, Boston, MA, USA, 2Marmara University School of Medicine, Istanbul, Turkey .
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1Brigham
Objectives: This study aimed to evaluate the cost-effectiveness of percutaneous renal mass biopsy (RMB) in the management of small renal masses (SRMs). Methods: A Markov model was developed to compare the lifetime costs and quality-adjusted life years (QALYs) of RMB with possible delayed treatment and immediate treatment from the societal perspective in a hypothetical cohort of 65-year-old healthy patients with asymptomatic unilateral SRMs. The treatments included percutaneous ablation (PA), laparoscopic ablation (LA), robotic partial nephrectomy, open partial nephrectomy (OPN), laparoscopic radical nephrectomy, and open radical nephrectomy. The willingness-to-pay threshold was $50,000/QALYgained. Robustness of the model was assessed using sensitivity analyses. Results: Among all the options, RMB with possible PA had the lowest total costs and QALYs. RMB with possible OPN was the optimal choice compared with RMB with possible PA (incremental cost-effectiveness ratio: $6,397/QALY-gained). In pairwise comparisons, RMB was preferred to the corresponding immediate treatment. If chronic kidney disease (CKD)-incurred costs were above the treatment-specific threshold, RMB was preferred. RMB with possible LA or partial nephrectomy was favored over the immediate treatment in old patients. RMB with possible radical nephrectomy was preferred to the immediate treatment regardless of age at diagnosis, tumor size and comorbidities. However, immediate PA was preferred to RMB in old patients with a large tumor. Conclusions: RMB with possible OPN was the optimal strategy. Among pairwise comparisons, RMB was preferred to immediate treatment. The results were sensitive to CKD-incurred costs, age and tumor size. PMD51 HEALTH ECONOMIC COMPARISON OF GD-EOB-DTPA-ENHANCED MRI VERSUS EXTRACELLULAR CONTRAST MEDIA-ENHANCED MRI AND MULTIDETECTOR CT FOR DIAGNOSIS OF HEPATOCELLULAR CARCINOMA IN CHINA AMONG PATIENTS AT RISK He X 1, Wu J 1, Holtorf A 2, Rinde H 2, Xie S 3, Shen W 3, Hou J 3, Li X 4, Li Z 4, Lai J 4, Wang Y 5, Zhang L 5, Wang J 5, Li X 5, Ma K 5, Ye F 6, Ouyang H 6, Zhao H 6 1Tianjin University, Tianjin, China, 2Health Outcomes Strategies, Basel, Switzerland, 3Tianjin First Center Hospital, Tianjin, China, 4The 1st affiliated Hospital, Sun Yat-sen University, Guangzhou, China, 5Southwest Hospital, Chongqing, China, 6Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China .
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Objectives: To compare the total cost of hepatocyte-specific Gd-EOB-DTPA enhanced MRI (PV-MRI) to extracellular contrast media-enhanced MRI (ECCMMRI) and multidetector CT (MDCT) as initial imaging procedures among patients with suspected hepatocellular carcinoma (HCC) from China healthcare perspective. Methods: A decision-tree model based on the Chinese clinical guidelines and validated by clinical experts was used to compare the diagnostic effectiveness of alternative initial imaging procedures to optimize therapeutic decisions for suspected HCC patients. Patients with suspected HCC as identified by ultrasound and alpha fetoprotein (AFP) levels entered the model. The three initial imaging methods were compared based on HCC prevalence in the included population, diagnostic accuracy (sensitivity and specificity) of the imaging alternatives, transition probabilities and costs as derived from published literature or expert opinion from 4