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Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany
A696
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
1CHU Toulouse, Toulouse, France, 2Assistance
Publique des Hôpitaux de Paris (AP-HP), Paris, France, 3Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France
Objectives: The cfDNA test detects T21 with a higher accuracy than conventional prenatal screening. Cost-effectiveness, as well as other domains (e.g. ethics, preferences, organisation), must be assessed in order to recommend its use in France. Our aims were to systematically review cost-effectiveness analyses on the cfDNA test for T21 screening and to summarize the evidence. Methods: An update of the systematic review of the Belgian Health Care Knowledge Center, published in 2009, was performed by the French National Authority for Health up to April 2016. Inclusion was performed independently by two researchers; a third researcher resolved discrepancies. The following data was extracted: study type, perspectives, population, model type, time horizon, screening and diagnostic strategies, assumptions, effectiveness and cost measures, outcomes and sensitivity analyses. Results: Twenty-one publications were included out of 137 identified: 12 explicitly featured a decision-tree model and a short-time horizon, 10 reported an ICER but only 1 used QALYs, 11 reported costs and benefits separately. The prenatal screening strategies included were: conventional screening (N= 18/21), contingent cfDNA test screening (N= 17/21), universal cfDNA test screening (N= 16/21), hybrid cfDNA test screening (N= 2/21), cfDNA test as a diagnostic test (N= 3/21). The main reported outcomes were cost per strategy (N= 15/21), number of procedure-related fetal losses (N= 14/21) and number of T21 detected cases (N= 14/21). cfDNA test screening strategies induced fewer fetal losses, offered a better T21 detection and were more expensive than conventional screenings. According to sensitivity analyses, the key drivers of cost-effectiveness were cfDNA test prices and test performances. Conclusions: This systematic literature review supports a contingent use of cfDNA test regarding its current high price and underlines several parameters to be further investigated: cut-off risk for T21, real-life cfDNA test failure rate and uptake. These results are not easily transferable to the French context where a specific CEA is needed. PMD64 Cost-Effectiveness of Test Strips for Glucose Monitoring Martin Saborido C, Antón Rodriguez C, Monge Martín D Universidad Francisco de Vitoria, Pozuelo de Alarcón, Spain
Objectives: To develop an economic evaluation to compare individually and vial-packaged strips for glucose monitoring. Methods: A model was developed to compare the costs and effects (hypoglycemic events, nosocomial infections and use of strips) of using individual vs. vial-packaged strips (IP vs. VP) including three different settings which represents the pathway of a diabetic patient: home, hospital and primary care. For each alternative (IP and VP), a simulated cohort of 1000 patients went through the model accounting for costs and effects, and the results were expressed as hypoglycemic events, nosocomial infection events, use/ waste of strips and incremental cost-effectiveness ratio Three different scenarios were modelled where different rates of hypoglycemic events, waste of strips and nosocomial infections were used. Sources of parameters is wide and uncertainty is high. Due to the lack of information about certain parameters, a group of assumptions were made. Uncertainty was tested using one-way sensitivity analysis and probabilistic sensitivity analysis. Cost-effectiveness acceptability curve with a threshold of 25.000€ /QALY was drawn. Probabilistic results were depicted using a Cost-effectiveness plane. Results: Globally, IP saved money (9.4 € per patient) and get more QALYs (0.0005 per patient) (DOMINANCE) with no reduction in nosocomial events, 25% less hypoglycemic events and 26% reduction in the use of strips. We found that the differences in costs between options are quite similar between Home, PC and Hospitalization (€ 4,227.14, € 4,155.26 and € 4,932.88 respectively) whereas Home module accounted for more QALYs than PC and Hospitalization (0.36, 0.14 and 0.15 QALYs respectively). Differences remained in the three scenarios. Sensitivity analysis did not offer any change in deterministic results. Conclusions: Under the assumption of wrong measurements due to bad storage and manipulation, the use of individual packaged strips could avoid between 12% and 43% of hypoglycemic events and save between 4% and 8 % of total costs. PMD65 Faecal Calprotectin as A Diagnostic Marker of Inflammatory Bowel Disease in Patients with Gastrointestinal Symptoms - is It Cost-Effective Procedure in Primary Care in Poland? Petryszyn P1, Trznadel A1, Staniak A1, Well M2, Ekk-Cierniakowski P3 1Wroclaw Medical University, Wroclaw, Poland, 2Wroclaw Uiversity of Economics, Wroclaw, Poland, 3Warsaw School of Economics, Warsaw, Poland
Objectives: To evaluate the cost-effectiveness of introducing the calprotectin test into primary health care in Poland to differentiate inflammatory bowel disesese (IBD) from functional disorders (IBS) and other organic diseases of gastrointestinal (GI) tract. Methods: Medical databases (Medline, Embase, Cochrane) were searched. The predefined inclusion criteria comprised RCTs or cohort studies on adults with GI symptoms, calprotectin as index test and colonoscopy as reference test being performed and data on/enabling the calculation of diagnostic test accuracy parameters being present. The clinical and methodological heterogeneity of the included studies was assessed and meta-analysis performed. The decision tree opposing two strategies: Test an Don’t test (all patients undergoing colonoscopy) was built. CEA was done from the public payer’s perspective. Results: 710 studies were firstly identified and as a result of selection process 17 were farther included into meta-analysis. The total number of patients was 4130. The pooled sensitivity and specificity were estimated at 0.89 and 0.74, respectively. The diagnostic odds ratio was 36.69 and the area under the SROC curve was 0.90. The ‘test’ strategy dominated over ‘don’t test’ strategy and was associated with the savings of 94.95 PLN per patient. Conclusions: Faecal calprotectin concentration measurement is an useful screening test in patients with suspected IBD to rule out this disease. The introduction of faecal calprotectin to differentiate IBD from other diseases in primary health care in Poland is cost-effective.
PMD66 Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany McQueen RB1, Breton M2, Ott M3, Campbell JD4 of Colorado, Aurora, CO, USA, 2University of Virginia, Charlottesville, CO, USA, 3Ascensia Diabetes Care, Leverkusen, Germany, 4University of Colorado Anschutz Medical Campus, Denver, CO, USA
1University
Objectives: To simulate and compare the clinical and economic outcomes of selfmonitoring of blood glucose (SMBG) devices along ranges of accuracy from a German payer perspective. Methods: We programmed a long-term type 1 diabetes natural history and treatment cost-effectiveness model. In phase one, using past in-silico evidence (UVa/Padova simulator, accepted by the Food and Drug Administration for pre-clinical studies), we associated changes in SMBG error to changes in HbA1c, and separately, changes in severe hypoglycemia and hyperglycemia requiring an inpatient stay. In phase two, using Markov cohort simulations, we estimated the lifetime clinical and economic outcomes based on a German payer perspective. The primary comparison was a SMBG device with strip price € 0.56 Euros and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with the same strip price and 15% error (accuracy meeting ISO 15197:2013). Outputs for the average patient over a 5-year time horizon, discounted at 3% per annum, were severe hypoglycemic and hyperglycemic events requiring an inpatient stay, quality-adjusted life years (QALYs), and cost differences per patient. Results: Assuming the benefits translate into HbA1c improvements only, an SMBG device with 10% versus 15% error was associated with an increase of 0.023 QALYs and a cost savings of € 100 Euros per patient over 5 years. Assuming the benefits translate into reduced severe hypoglycemic and hyperglycemic events requiring an inpatient stay only, an SMBG device with 10% versus 15% error was associated with a combined decrease in severe hypoglycemic and hyperglycemic events of 0.86 and cost savings of € 976 Euros per patient over 5 years. Conclusions: Investing in devices with improved accuracy (less error) appears to be an affordable strategy with improved quality of life for type 1 diabetes patients. PMD67 Cost-Effectiveness of A Preventive Testing Strategy in Relatives of Patients with BRCA Mutated Ovarian Cancer Versus A No Test Strategy Cicchetti A1, Ruggeri M2, Di Brino E3 1Catholic University of Sacred Heart, Rome, Italy, 2ALTEMS, Università Cattolica del Sacro Cuore (UCSC), Postgraduate School of Health Economics and Management, Rome, Italy, 3ALTEMS (Postgraduate School of Health Economics and Management), Catholic University of the Sacred Heart, Roma, Italy
Objectives: According to AIOM estimates, the prevalence rate of ovarian cancer is 1.3%. 8–13% of women diagnosed with epithelial OC have a germline BRCA1 or BRCA2 mutation. Specifically, the lifetime risk for OC in patients with BRCA1 mutations is 39–46% compared with 10–27% in patients with BRCA2 mutation. This study aims to estimate the cost-effectiveness ratio of a preventive testing strategy for relatives of patients with BRCA mutated cancer versus a no test strategy. Methods: The BRCA testing pathway was elaborated by a panel of experts. Based on this, Cost-effectiveness analysis was carried out from the Italian National Health Service perspective through a decision analytic model, within 5 years times horizon. Two alternatives were considered: 1) Preventive BRCA testing for relatives of ovarian cancer patients with positive mutation BRCA1 and BRCA2; 2) No test . Cost and effectiveness data derived from literature were discounted by 3%. Costs were analyzed from Italian payer perspective. Both deterministic and probabilistic sensitivity analyses were performed. Results: Considering a cost-effectiveness threshold of € 40,000/QALY, the probabilistic sensitivity analyses showed that scenario 1 was costeffective in 97% of simulations compared with scenario 2. The ICER of scenario 1 vs 2 was dominant. Conclusions: Preventive genetic testing in relatives of patients with ovarian cancer is cost-effective. Further research needs to be carried for applications also to breast cancer screening. PMD68 Cost-Effectiveness Analysis of Serum Free Light Chain Assay (FREELITE®) for The Diagnosis of Monoclonal Gammopathy in The Brazilian Public and Private Healthcare Systems Riveros BS1, Caporal F1, Soares E2, Facco F2 1Federal University of Parana, Curitiba, Brazil, 2The Binding Site, Curitiba, Brazil
Objectives: To assess the efficiency of SFLC for the diagnosis of MG in the Brazilian Public Healthcare System (SUS) and Brazilian Private Healthcare System (BPHS) perspectives Methods: From a study already published in literature, data of 652 patients under suspect of MG were used to populate the decision tree model. This model is capable to distinguish which diagnosis protocol provides the highest value to each monetary unit invested. Three strategies were tested: standard protocol (SP) that considers serum electrophoresis (SPEP) as screening test, and two comparators, SP plus SFLC (PP1) and SP plus SFLC and Serum Immunofixation Electrophoresis (SIFE) (PP2). Probabilistic sensitivity analysis was carried out to assess model’s parametric uncertainty. Results are interpreted as the amount of currency (BRL) spent for each incremental correct diagnosis of MG (benefit). Results: Probabilistic simulation pointed an average ICER of BRL 1,192 and BRL 1,470 for PP1 and PP2, respectively in SUS. For BPHS, ICERs were BRL 3,620 and 4,193, respectively. Considering a willingness-to-pay over BRL 1,500 (SUS) and BRL 4,000 (BPHS), PP1 is the strategy more likely to be the cost-effective. PP2 is costlier and promotes more sensitivity compared to SP, resulting in similar efficiency with a trend favouring PP1, though. Conclusions: In SUS and BPHS perspective, adding SFLC in the initial diagnostic work up of MG improves efficiency of financial resources allocated to MG diagnosis regardless its concomitancy to SIFE. The strategy considering SFLC+SPEP for screening purposes adds more value for money compared to SFLC+SPEP+SIFE.
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 3 4 7 – A 7 6 6
1CHU Toulouse, Toulouse, France, 2Assistance
Publique des Hôpitaux de Paris (AP-HP), Paris, France, 3Haute Autorité de Santé (HAS), Saint-Denis La Plaine, France
Objectives: The cfDNA test detects T21 with a higher accuracy than conventional prenatal screening. Cost-effectiveness, as well as other domains (e.g. ethics, preferences, organisation), must be assessed in order to recommend its use in France. Our aims were to systematically review cost-effectiveness analyses on the cfDNA test for T21 screening and to summarize the evidence. Methods: An update of the systematic review of the Belgian Health Care Knowledge Center, published in 2009, was performed by the French National Authority for Health up to April 2016. Inclusion was performed independently by two researchers; a third researcher resolved discrepancies. The following data was extracted: study type, perspectives, population, model type, time horizon, screening and diagnostic strategies, assumptions, effectiveness and cost measures, outcomes and sensitivity analyses. Results: Twenty-one publications were included out of 137 identified: 12 explicitly featured a decision-tree model and a short-time horizon, 10 reported an ICER but only 1 used QALYs, 11 reported costs and benefits separately. The prenatal screening strategies included were: conventional screening (N= 18/21), contingent cfDNA test screening (N= 17/21), universal cfDNA test screening (N= 16/21), hybrid cfDNA test screening (N= 2/21), cfDNA test as a diagnostic test (N= 3/21). The main reported outcomes were cost per strategy (N= 15/21), number of procedure-related fetal losses (N= 14/21) and number of T21 detected cases (N= 14/21). cfDNA test screening strategies induced fewer fetal losses, offered a better T21 detection and were more expensive than conventional screenings. According to sensitivity analyses, the key drivers of cost-effectiveness were cfDNA test prices and test performances. Conclusions: This systematic literature review supports a contingent use of cfDNA test regarding its current high price and underlines several parameters to be further investigated: cut-off risk for T21, real-life cfDNA test failure rate and uptake. These results are not easily transferable to the French context where a specific CEA is needed. PMD64 Cost-Effectiveness of Test Strips for Glucose Monitoring Martin Saborido C, Antón Rodriguez C, Monge Martín D Universidad Francisco de Vitoria, Pozuelo de Alarcón, Spain
Objectives: To develop an economic evaluation to compare individually and vial-packaged strips for glucose monitoring. Methods: A model was developed to compare the costs and effects (hypoglycemic events, nosocomial infections and use of strips) of using individual vs. vial-packaged strips (IP vs. VP) including three different settings which represents the pathway of a diabetic patient: home, hospital and primary care. For each alternative (IP and VP), a simulated cohort of 1000 patients went through the model accounting for costs and effects, and the results were expressed as hypoglycemic events, nosocomial infection events, use/ waste of strips and incremental cost-effectiveness ratio Three different scenarios were modelled where different rates of hypoglycemic events, waste of strips and nosocomial infections were used. Sources of parameters is wide and uncertainty is high. Due to the lack of information about certain parameters, a group of assumptions were made. Uncertainty was tested using one-way sensitivity analysis and probabilistic sensitivity analysis. Cost-effectiveness acceptability curve with a threshold of 25.000€ /QALY was drawn. Probabilistic results were depicted using a Cost-effectiveness plane. Results: Globally, IP saved money (9.4 € per patient) and get more QALYs (0.0005 per patient) (DOMINANCE) with no reduction in nosocomial events, 25% less hypoglycemic events and 26% reduction in the use of strips. We found that the differences in costs between options are quite similar between Home, PC and Hospitalization (€ 4,227.14, € 4,155.26 and € 4,932.88 respectively) whereas Home module accounted for more QALYs than PC and Hospitalization (0.36, 0.14 and 0.15 QALYs respectively). Differences remained in the three scenarios. Sensitivity analysis did not offer any change in deterministic results. Conclusions: Under the assumption of wrong measurements due to bad storage and manipulation, the use of individual packaged strips could avoid between 12% and 43% of hypoglycemic events and save between 4% and 8 % of total costs. PMD65 Faecal Calprotectin as A Diagnostic Marker of Inflammatory Bowel Disease in Patients with Gastrointestinal Symptoms - is It Cost-Effective Procedure in Primary Care in Poland? Petryszyn P1, Trznadel A1, Staniak A1, Well M2, Ekk-Cierniakowski P3 1Wroclaw Medical University, Wroclaw, Poland, 2Wroclaw Uiversity of Economics, Wroclaw, Poland, 3Warsaw School of Economics, Warsaw, Poland
Objectives: To evaluate the cost-effectiveness of introducing the calprotectin test into primary health care in Poland to differentiate inflammatory bowel disesese (IBD) from functional disorders (IBS) and other organic diseases of gastrointestinal (GI) tract. Methods: Medical databases (Medline, Embase, Cochrane) were searched. The predefined inclusion criteria comprised RCTs or cohort studies on adults with GI symptoms, calprotectin as index test and colonoscopy as reference test being performed and data on/enabling the calculation of diagnostic test accuracy parameters being present. The clinical and methodological heterogeneity of the included studies was assessed and meta-analysis performed. The decision tree opposing two strategies: Test an Don’t test (all patients undergoing colonoscopy) was built. CEA was done from the public payer’s perspective. Results: 710 studies were firstly identified and as a result of selection process 17 were farther included into meta-analysis. The total number of patients was 4130. The pooled sensitivity and specificity were estimated at 0.89 and 0.74, respectively. The diagnostic odds ratio was 36.69 and the area under the SROC curve was 0.90. The ‘test’ strategy dominated over ‘don’t test’ strategy and was associated with the savings of 94.95 PLN per patient. Conclusions: Faecal calprotectin concentration measurement is an useful screening test in patients with suspected IBD to rule out this disease. The introduction of faecal calprotectin to differentiate IBD from other diseases in primary health care in Poland is cost-effective.
PMD66 Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices in Germany McQueen RB1, Breton M2, Ott M3, Campbell JD4 of Colorado, Aurora, CO, USA, 2University of Virginia, Charlottesville, CO, USA, 3Ascensia Diabetes Care, Leverkusen, Germany, 4University of Colorado Anschutz Medical Campus, Denver, CO, USA
1University
Objectives: To simulate and compare the clinical and economic outcomes of selfmonitoring of blood glucose (SMBG) devices along ranges of accuracy from a German payer perspective. Methods: We programmed a long-term type 1 diabetes natural history and treatment cost-effectiveness model. In phase one, using past in-silico evidence (UVa/Padova simulator, accepted by the Food and Drug Administration for pre-clinical studies), we associated changes in SMBG error to changes in HbA1c, and separately, changes in severe hypoglycemia and hyperglycemia requiring an inpatient stay. In phase two, using Markov cohort simulations, we estimated the lifetime clinical and economic outcomes based on a German payer perspective. The primary comparison was a SMBG device with strip price € 0.56 Euros and 10% error (exceeding accuracy requirements by International Organization for Standardization (ISO) 15197:2013) versus a SMBG device with the same strip price and 15% error (accuracy meeting ISO 15197:2013). Outputs for the average patient over a 5-year time horizon, discounted at 3% per annum, were severe hypoglycemic and hyperglycemic events requiring an inpatient stay, quality-adjusted life years (QALYs), and cost differences per patient. Results: Assuming the benefits translate into HbA1c improvements only, an SMBG device with 10% versus 15% error was associated with an increase of 0.023 QALYs and a cost savings of € 100 Euros per patient over 5 years. Assuming the benefits translate into reduced severe hypoglycemic and hyperglycemic events requiring an inpatient stay only, an SMBG device with 10% versus 15% error was associated with a combined decrease in severe hypoglycemic and hyperglycemic events of 0.86 and cost savings of € 976 Euros per patient over 5 years. Conclusions: Investing in devices with improved accuracy (less error) appears to be an affordable strategy with improved quality of life for type 1 diabetes patients. PMD67 Cost-Effectiveness of A Preventive Testing Strategy in Relatives of Patients with BRCA Mutated Ovarian Cancer Versus A No Test Strategy Cicchetti A1, Ruggeri M2, Di Brino E3 1Catholic University of Sacred Heart, Rome, Italy, 2ALTEMS, Università Cattolica del Sacro Cuore (UCSC), Postgraduate School of Health Economics and Management, Rome, Italy, 3ALTEMS (Postgraduate School of Health Economics and Management), Catholic University of the Sacred Heart, Roma, Italy
Objectives: According to AIOM estimates, the prevalence rate of ovarian cancer is 1.3%. 8–13% of women diagnosed with epithelial OC have a germline BRCA1 or BRCA2 mutation. Specifically, the lifetime risk for OC in patients with BRCA1 mutations is 39–46% compared with 10–27% in patients with BRCA2 mutation. This study aims to estimate the cost-effectiveness ratio of a preventive testing strategy for relatives of patients with BRCA mutated cancer versus a no test strategy. Methods: The BRCA testing pathway was elaborated by a panel of experts. Based on this, Cost-effectiveness analysis was carried out from the Italian National Health Service perspective through a decision analytic model, within 5 years times horizon. Two alternatives were considered: 1) Preventive BRCA testing for relatives of ovarian cancer patients with positive mutation BRCA1 and BRCA2; 2) No test . Cost and effectiveness data derived from literature were discounted by 3%. Costs were analyzed from Italian payer perspective. Both deterministic and probabilistic sensitivity analyses were performed. Results: Considering a cost-effectiveness threshold of € 40,000/QALY, the probabilistic sensitivity analyses showed that scenario 1 was costeffective in 97% of simulations compared with scenario 2. The ICER of scenario 1 vs 2 was dominant. Conclusions: Preventive genetic testing in relatives of patients with ovarian cancer is cost-effective. Further research needs to be carried for applications also to breast cancer screening. PMD68 Cost-Effectiveness Analysis of Serum Free Light Chain Assay (FREELITE®) for The Diagnosis of Monoclonal Gammopathy in The Brazilian Public and Private Healthcare Systems Riveros BS1, Caporal F1, Soares E2, Facco F2 1Federal University of Parana, Curitiba, Brazil, 2The Binding Site, Curitiba, Brazil
Objectives: To assess the efficiency of SFLC for the diagnosis of MG in the Brazilian Public Healthcare System (SUS) and Brazilian Private Healthcare System (BPHS) perspectives Methods: From a study already published in literature, data of 652 patients under suspect of MG were used to populate the decision tree model. This model is capable to distinguish which diagnosis protocol provides the highest value to each monetary unit invested. Three strategies were tested: standard protocol (SP) that considers serum electrophoresis (SPEP) as screening test, and two comparators, SP plus SFLC (PP1) and SP plus SFLC and Serum Immunofixation Electrophoresis (SIFE) (PP2). Probabilistic sensitivity analysis was carried out to assess model’s parametric uncertainty. Results are interpreted as the amount of currency (BRL) spent for each incremental correct diagnosis of MG (benefit). Results: Probabilistic simulation pointed an average ICER of BRL 1,192 and BRL 1,470 for PP1 and PP2, respectively in SUS. For BPHS, ICERs were BRL 3,620 and 4,193, respectively. Considering a willingness-to-pay over BRL 1,500 (SUS) and BRL 4,000 (BPHS), PP1 is the strategy more likely to be the cost-effective. PP2 is costlier and promotes more sensitivity compared to SP, resulting in similar efficiency with a trend favouring PP1, though. Conclusions: In SUS and BPHS perspective, adding SFLC in the initial diagnostic work up of MG improves efficiency of financial resources allocated to MG diagnosis regardless its concomitancy to SIFE. The strategy considering SFLC+SPEP for screening purposes adds more value for money compared to SFLC+SPEP+SIFE.