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Pharmacoeconomic Evaluation of Sorafenib As First-Line Treatment for Advanced Hepatocellular Carcinoma
A736
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
PRM32 Medical Transportation Costs In France: Which Source To Estimate Them In Health-Economic Analysis? Messaoudi S, Sivignon M, Roze S HEVA HEOR Sarl, Lyon, France
Objectives: French Health Authority guidelines recommend to adopt a collective perspective in cost efficacy and cost utility studies. Consequently, medical transportation costs should be included in these studies. Medical transportation expenditures covered by the French Health Insurance were amounted to € 4 billion in 2013. Nevertheless, detailed and specific data sources in France are limited to collect the medical transportation costs. The main objective is to determinate a standardized method allowing to estimate medical transportation costs in French health economics analysis. Methods: Medical transportation costs sources have been collected from efficiency opinions published by the French Health Autority (HAS). Then, these costs and their methodologies have been analyzed and completed by a literature search. Results: Out of 31 efficiency opinions analyzed, 70% (22) revealed not to use any medical transportation costs or the specific methodology used for this cost was not mentioned. In the other 30% (9) efficiency opinions, a significant variation in transportation costs was observed ranging from € 9.89 up to € 96.90. One reference is mainly used. The Cour des comptes report, published in 2012, allows to determine the percentage of patients which is reimbursed by the French Health Insurance and the mean cost per transportation. Two methods can be distinguished, resulting in very different mean cost of transportation to use. The first takes into account the percentage of patients who is reimbursed by the French Health Insurance and patients who are not reimbursed. The second only considers reimbursed cost for all patients. Conclusions: Medical transportation cost estimation collected in efficiency opinions from HAS underlines a high degree of heterogeneity on these costs as well as a poor data source available in the literature or on database. Recommendations are needed to avoid this problem. PRM33 Broadening The Valuation Space In Health Technology Assessment: The Case of Monitoring Individuals With Ocular Hypertension Hernández R1, Vale L2, Ryan M1, Burr J3 1Health Economics Research Unit, University of Aberdeen, Aberdeen, UK, 2Newcastle University, Newcastle upon Tyne, UK, 3University of St andrews, St Andrews, Fife, UK
Objectives: The economic evaluation (EE) component of health technology assessments (HTA) often defines value in terms of health related quality of life, with many HTA agencies requiring the use of EQ-5D based Quality Adjusted Life Years (QALYs). These approaches do not capture value derived from patient experience factors and the process of care. This thesis widens the valuation space beyond this limited perspective, taking account of such factors, using monetary values generated from a discrete choice experiment (DCE), incorporating these into a discrete event simulation (DES) and conducting a cost-benefit analysis (CBA). Methods: The case study is monitoring individuals with ocular hypertension. Five strategies were compared using a DES: ‘Treat All’ at ocular hypertension diagnosis with minimal follow-up; Biennial monitoring (either in primary or secondary care) with treatment according to predicted glaucoma risk; and monitoring and treatment according to the UK National glaucoma guidance (either conservative or intensive). DCE based Willingness to pay (WTP) estimates for relevant health outcomes (e.g. risk of developing or progressing glaucoma and treatment side effects), patient experience factors (e.g. communication and understanding with the health care professional) and process of care (e.g. monitoring setting) were obtained. Conditional logit, mixed logit preference space and mixed logit WTP-space (rarely used within health economics) econometric specifications were used. These WTP valuations were aggregated in the DES, as fixed mean values or allowing variation between simulated individuals. Results: While the standard cost-utility analysis (CUA) using EQ-5D implied ‘Treat All’ was most likely cost-effective, CBA with broadened valuation space identified, consistently across different econometric specifications, ‘Biennial hospital’ as the best choice. Conclusions: This thesis proposes an approach to broaden the valuation space that can be promptly used for EE-HTA. Researchers should be attentive of the valuation space considered in their EE and choose wisely the EE approach to be used (e.g. CUA and/or CBA). PRM34 Cost –Effectiveness of Obinutuzumab As Frontline Treatment For Unfit Patients With Chronic Lymphocytic Leukemia In Republic of Macedonia Kapedanovska Nestorovska A, Sterjev Z, Naumovska Z, Grozdanova A, Dimovski A, Suturkova L ISPOR Republic of Macedonia regional chapter, Skopje, Macedonia
Objectives: According to the results from the CLL-11 trial, obinutuzumab+ chlorambucil (G-Clb) is superior to rituximab+chlorambucil (R-Clb) leading to an 13.8 month increase in median progression-free survival (PFS), longer time to next antileukemic treatment, higher rates of complete response and improved healthrelated quality of life in previously un-treated chronic lymphocytic leukemia (CLL) patients with comorbidities. The value of obinutuzumab as first line treatment for unfit CLL patients in Republic of Macedonia has not yet been reported. Methods: Cost effectiveness analysis was performed using decision-analytic Markov model. Health states considered were PFS, disease progression and death. Transitional probabilities of each state in the model were based on the rates observed in CLL-11 study. Costs (2016 Euro) were collected from official, national health system data. Only direct costs (drug price, treatment administration and monitoring and post progression therapy) were included. Health states utilities were derived from the literature. Outcomes (discounted at 3% annual rate) were measured in quality adjusted life years (QALY) and costs and reported per patient as incremental cost per QALY gained ratio (ICER). Probabilistic sensitivity analysis (PSA) assessed the uncertainty around key model parameters (varied over range ±25%) and their impact on the base-case results. The model used a time horizon of 20 years. Results: An
incremental gain of 0.25 QALYs was estimated for GClb compared to R-Clb at additional cost of € 7357.85 per patient. Corresponding ICER was 29 436.00 € /QALY. The associated cost per relapse for G-Clb as first line therapy was significantly lower compared to R-Clb (G-Clb vs. R-Clb= 4815.6 € vs. 6946.1€ ). Sensitivity analyses showed the robustness of the base case results. The PSA demonstrated that the probability of cost effectiveness was 84% for G-Clb compared to R-Clb. Conclusions: G-Clb represents a cost - effective treatment strategy for unfit CLL patients in R.Macedonia. PRM35 Assessment of Healthcare Costs of Infants In Exclusive Breastfeeding Versus Mixed or Artificial Breastfeed Hidalgo A1, Santacruz-Salas E2, Aranda-Reneo I2 1University of Castilla-La Mancha, Toledo, Spain, 2University of Castilla-La Mancha, Talavera de la Reina, Spain
Objectives: We aimed to analyse whether breastfeeding is related to lower healthcare costs. Methods: We included women admitted to the hospital to give birth between June and August of 2014. Women with multiple births, mothers requiring special hospital admission due to complications at birth, infants admitted to the neonatal unit, and children given up for adoption were excluded. Socioeconomic data, type of breastfeeding (exclusive breastfeeding, formula feeding, or mixed), consumption of health resources made by the child at birth, at discharge, at 1 month and at 6 months were collected. Health costs were estimated using official unit cost sources. The project was evaluated by the Ethics Committee of the hospital. Results: We included 236 women, mean age 32.3 (SD = 5.3). At baseline, 69.5% would have started exclusive breastfeeding and 15.2% mixed or formula. At 6 months, only 19.5% indicated to maintain exclusive breastfeeding while 28.4% indicated mixed and 45.8% artificial breastfeeding. The total healthcare cost of infants without exclusive breastfeeding amounted to € 1,044 (CI95%: 718.5-1,370.4) versus 652.8 (CI95%: 496.2-809.4) for infants in exclusive breastfeeding at month. At six months, € 882.4 (CI95%: 702.61,062.27) and 385.4 (CI95%: 166.2-604.63). There was a higher consumption of health resources (€ 497.1) in primary care (€ 163.6), hospital (€ 217.1) and pharmacy (€ 24.5) in children without exclusive breastfeeding. Conclusions: Children who received exclusive breastfeeding versus mixed or formula required fewer health resources and had lower healthcare cost related. Exclusive breastfeeding seems to be an option to save resources to the NHS in addition to achieving health benefits for infants. PRM36 Pharmacoeconomic Evaluation of Sorafenib As First-Line Treatment for Advanced Hepatocellular Carcinoma Naumovska Z1, Kapedanovska Nestorovska A1, Grozdanova A2, Suturkova L3, Dimovski A2, Sterjev Z3 1Faculty of Pharmacy, Skopje, Macedonia, The former Yugoslav Republic of, 2ISPOR Republic of Macedonia regional chapter, Skopje, Macedonia, 3Faculty of Pharmacy, UKIM-Skopje, Skopje, Macedonia
Objectives: Sorafenib significantly improve the overall survival of patients with advanced hepatocellular carcinoma (HCC). Conducted research aimed to assess the pharmaco-economic implications of sorafenib as first-line treatment for advanced HCC in comparison with best symptomatic treatment without systemic chemotherapy also known as supportive care (BSC). Methods: A Markov model was developed with three health states included : progression-free survival (PFS), progressed disease, and death in order to estimate the outcomes and costs in 10-year time horizon. ((TreeAge Pro 2016 Suite Inc.Williamstown, MA). The clinical data and utility values used in the pharmacoeconomic model were taken from the pivotal SHARP study with the data from the placebo arm used as a proxy for BSC. Based on this approximation and the results obtained from the GIDEON study In Republic of Macedonia approximately 25 patient/per year are eligible for sorafenib treatment. The drug acquisition cost of sorafenib was calculated based on the mean dose per day and mean treatment duration used in the study. A range of other health state costs was integrated in the model, GP and specialists’ visits, laboratory and radiological tests, hospitalizations and specific medicinal procedures. Official publicly available data in R. Macedonia for medicinal unit cost were used in the model. Discount rate for all cost and outcomes was 3%. Sensitivity analyses evaluated the impact of several essential variables. Results: The incremental cost-effective ratio was € 14 363.00 per QALY for sorafenib versus best supportive care (BSC). The sensitivity analysis confirmed that the results were sensitive to the overall survival estimates, the cost of BSC and the utility values. Conclusions: Sorafenib is not a cost-effective option as a first-line treatment for patients with advanced HCC. Reduction in the price of sorafenib, or appropriate assistance program should be considered to improve the cost-effectiveness of advanced HCC treatment. PRM37 Work Accident Costs. Security, Healthcare and Human Resources Departments Links Tanaka GK1, Alves TF2, Coan MF2, Lozovey JC3, Tanaka F2, Tanaka E4 1PEQUENO PRINCIPE SCHOOL OF MEDICINE, CURITIBA , PARANÁ , BRAZIL, Brazil, 2FEDERAL UNIVERSITY OF PARANÁ, CURITIBA , PARANÁ , BRAZIL, Brazil, 3UNIVERSIDADE FEDERAL DO PARANÁ, CURITIBA , PARANÁ, Brazil, 4ICS, CURITIBA , PARANÁ , BRAZIL, Brazil
Introduction: Workplace accidents are important in the day-to-day of a productive society. Security, Healthcare and Human Resources Departments (SHHS) struggle to show that they are not part of a company merely to follow rules, laws and regulations that might be established, but that they are a group of people, a team, with the same goal: warn the employees of a company about the risks and consequences of work-related accidents. Objectives: Show the importance of SHHS, presenting work accident costs. Methods: In the present work, two types of expenses in a food company were considered: the costs of lost hours due to work accidents with leave of absence in a one year period; and the costs with medical supplies, medicines and worker’s health. Results: A total of 12 workers required a leave of absence after work-related accidents. The period of absence of these
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
PRM32 Medical Transportation Costs In France: Which Source To Estimate Them In Health-Economic Analysis? Messaoudi S, Sivignon M, Roze S HEVA HEOR Sarl, Lyon, France
Objectives: French Health Authority guidelines recommend to adopt a collective perspective in cost efficacy and cost utility studies. Consequently, medical transportation costs should be included in these studies. Medical transportation expenditures covered by the French Health Insurance were amounted to € 4 billion in 2013. Nevertheless, detailed and specific data sources in France are limited to collect the medical transportation costs. The main objective is to determinate a standardized method allowing to estimate medical transportation costs in French health economics analysis. Methods: Medical transportation costs sources have been collected from efficiency opinions published by the French Health Autority (HAS). Then, these costs and their methodologies have been analyzed and completed by a literature search. Results: Out of 31 efficiency opinions analyzed, 70% (22) revealed not to use any medical transportation costs or the specific methodology used for this cost was not mentioned. In the other 30% (9) efficiency opinions, a significant variation in transportation costs was observed ranging from € 9.89 up to € 96.90. One reference is mainly used. The Cour des comptes report, published in 2012, allows to determine the percentage of patients which is reimbursed by the French Health Insurance and the mean cost per transportation. Two methods can be distinguished, resulting in very different mean cost of transportation to use. The first takes into account the percentage of patients who is reimbursed by the French Health Insurance and patients who are not reimbursed. The second only considers reimbursed cost for all patients. Conclusions: Medical transportation cost estimation collected in efficiency opinions from HAS underlines a high degree of heterogeneity on these costs as well as a poor data source available in the literature or on database. Recommendations are needed to avoid this problem. PRM33 Broadening The Valuation Space In Health Technology Assessment: The Case of Monitoring Individuals With Ocular Hypertension Hernández R1, Vale L2, Ryan M1, Burr J3 1Health Economics Research Unit, University of Aberdeen, Aberdeen, UK, 2Newcastle University, Newcastle upon Tyne, UK, 3University of St andrews, St Andrews, Fife, UK
Objectives: The economic evaluation (EE) component of health technology assessments (HTA) often defines value in terms of health related quality of life, with many HTA agencies requiring the use of EQ-5D based Quality Adjusted Life Years (QALYs). These approaches do not capture value derived from patient experience factors and the process of care. This thesis widens the valuation space beyond this limited perspective, taking account of such factors, using monetary values generated from a discrete choice experiment (DCE), incorporating these into a discrete event simulation (DES) and conducting a cost-benefit analysis (CBA). Methods: The case study is monitoring individuals with ocular hypertension. Five strategies were compared using a DES: ‘Treat All’ at ocular hypertension diagnosis with minimal follow-up; Biennial monitoring (either in primary or secondary care) with treatment according to predicted glaucoma risk; and monitoring and treatment according to the UK National glaucoma guidance (either conservative or intensive). DCE based Willingness to pay (WTP) estimates for relevant health outcomes (e.g. risk of developing or progressing glaucoma and treatment side effects), patient experience factors (e.g. communication and understanding with the health care professional) and process of care (e.g. monitoring setting) were obtained. Conditional logit, mixed logit preference space and mixed logit WTP-space (rarely used within health economics) econometric specifications were used. These WTP valuations were aggregated in the DES, as fixed mean values or allowing variation between simulated individuals. Results: While the standard cost-utility analysis (CUA) using EQ-5D implied ‘Treat All’ was most likely cost-effective, CBA with broadened valuation space identified, consistently across different econometric specifications, ‘Biennial hospital’ as the best choice. Conclusions: This thesis proposes an approach to broaden the valuation space that can be promptly used for EE-HTA. Researchers should be attentive of the valuation space considered in their EE and choose wisely the EE approach to be used (e.g. CUA and/or CBA). PRM34 Cost –Effectiveness of Obinutuzumab As Frontline Treatment For Unfit Patients With Chronic Lymphocytic Leukemia In Republic of Macedonia Kapedanovska Nestorovska A, Sterjev Z, Naumovska Z, Grozdanova A, Dimovski A, Suturkova L ISPOR Republic of Macedonia regional chapter, Skopje, Macedonia
Objectives: According to the results from the CLL-11 trial, obinutuzumab+ chlorambucil (G-Clb) is superior to rituximab+chlorambucil (R-Clb) leading to an 13.8 month increase in median progression-free survival (PFS), longer time to next antileukemic treatment, higher rates of complete response and improved healthrelated quality of life in previously un-treated chronic lymphocytic leukemia (CLL) patients with comorbidities. The value of obinutuzumab as first line treatment for unfit CLL patients in Republic of Macedonia has not yet been reported. Methods: Cost effectiveness analysis was performed using decision-analytic Markov model. Health states considered were PFS, disease progression and death. Transitional probabilities of each state in the model were based on the rates observed in CLL-11 study. Costs (2016 Euro) were collected from official, national health system data. Only direct costs (drug price, treatment administration and monitoring and post progression therapy) were included. Health states utilities were derived from the literature. Outcomes (discounted at 3% annual rate) were measured in quality adjusted life years (QALY) and costs and reported per patient as incremental cost per QALY gained ratio (ICER). Probabilistic sensitivity analysis (PSA) assessed the uncertainty around key model parameters (varied over range ±25%) and their impact on the base-case results. The model used a time horizon of 20 years. Results: An
incremental gain of 0.25 QALYs was estimated for GClb compared to R-Clb at additional cost of € 7357.85 per patient. Corresponding ICER was 29 436.00 € /QALY. The associated cost per relapse for G-Clb as first line therapy was significantly lower compared to R-Clb (G-Clb vs. R-Clb= 4815.6 € vs. 6946.1€ ). Sensitivity analyses showed the robustness of the base case results. The PSA demonstrated that the probability of cost effectiveness was 84% for G-Clb compared to R-Clb. Conclusions: G-Clb represents a cost - effective treatment strategy for unfit CLL patients in R.Macedonia. PRM35 Assessment of Healthcare Costs of Infants In Exclusive Breastfeeding Versus Mixed or Artificial Breastfeed Hidalgo A1, Santacruz-Salas E2, Aranda-Reneo I2 1University of Castilla-La Mancha, Toledo, Spain, 2University of Castilla-La Mancha, Talavera de la Reina, Spain
Objectives: We aimed to analyse whether breastfeeding is related to lower healthcare costs. Methods: We included women admitted to the hospital to give birth between June and August of 2014. Women with multiple births, mothers requiring special hospital admission due to complications at birth, infants admitted to the neonatal unit, and children given up for adoption were excluded. Socioeconomic data, type of breastfeeding (exclusive breastfeeding, formula feeding, or mixed), consumption of health resources made by the child at birth, at discharge, at 1 month and at 6 months were collected. Health costs were estimated using official unit cost sources. The project was evaluated by the Ethics Committee of the hospital. Results: We included 236 women, mean age 32.3 (SD = 5.3). At baseline, 69.5% would have started exclusive breastfeeding and 15.2% mixed or formula. At 6 months, only 19.5% indicated to maintain exclusive breastfeeding while 28.4% indicated mixed and 45.8% artificial breastfeeding. The total healthcare cost of infants without exclusive breastfeeding amounted to € 1,044 (CI95%: 718.5-1,370.4) versus 652.8 (CI95%: 496.2-809.4) for infants in exclusive breastfeeding at month. At six months, € 882.4 (CI95%: 702.61,062.27) and 385.4 (CI95%: 166.2-604.63). There was a higher consumption of health resources (€ 497.1) in primary care (€ 163.6), hospital (€ 217.1) and pharmacy (€ 24.5) in children without exclusive breastfeeding. Conclusions: Children who received exclusive breastfeeding versus mixed or formula required fewer health resources and had lower healthcare cost related. Exclusive breastfeeding seems to be an option to save resources to the NHS in addition to achieving health benefits for infants. PRM36 Pharmacoeconomic Evaluation of Sorafenib As First-Line Treatment for Advanced Hepatocellular Carcinoma Naumovska Z1, Kapedanovska Nestorovska A1, Grozdanova A2, Suturkova L3, Dimovski A2, Sterjev Z3 1Faculty of Pharmacy, Skopje, Macedonia, The former Yugoslav Republic of, 2ISPOR Republic of Macedonia regional chapter, Skopje, Macedonia, 3Faculty of Pharmacy, UKIM-Skopje, Skopje, Macedonia
Objectives: Sorafenib significantly improve the overall survival of patients with advanced hepatocellular carcinoma (HCC). Conducted research aimed to assess the pharmaco-economic implications of sorafenib as first-line treatment for advanced HCC in comparison with best symptomatic treatment without systemic chemotherapy also known as supportive care (BSC). Methods: A Markov model was developed with three health states included : progression-free survival (PFS), progressed disease, and death in order to estimate the outcomes and costs in 10-year time horizon. ((TreeAge Pro 2016 Suite Inc.Williamstown, MA). The clinical data and utility values used in the pharmacoeconomic model were taken from the pivotal SHARP study with the data from the placebo arm used as a proxy for BSC. Based on this approximation and the results obtained from the GIDEON study In Republic of Macedonia approximately 25 patient/per year are eligible for sorafenib treatment. The drug acquisition cost of sorafenib was calculated based on the mean dose per day and mean treatment duration used in the study. A range of other health state costs was integrated in the model, GP and specialists’ visits, laboratory and radiological tests, hospitalizations and specific medicinal procedures. Official publicly available data in R. Macedonia for medicinal unit cost were used in the model. Discount rate for all cost and outcomes was 3%. Sensitivity analyses evaluated the impact of several essential variables. Results: The incremental cost-effective ratio was € 14 363.00 per QALY for sorafenib versus best supportive care (BSC). The sensitivity analysis confirmed that the results were sensitive to the overall survival estimates, the cost of BSC and the utility values. Conclusions: Sorafenib is not a cost-effective option as a first-line treatment for patients with advanced HCC. Reduction in the price of sorafenib, or appropriate assistance program should be considered to improve the cost-effectiveness of advanced HCC treatment. PRM37 Work Accident Costs. Security, Healthcare and Human Resources Departments Links Tanaka GK1, Alves TF2, Coan MF2, Lozovey JC3, Tanaka F2, Tanaka E4 1PEQUENO PRINCIPE SCHOOL OF MEDICINE, CURITIBA , PARANÁ , BRAZIL, Brazil, 2FEDERAL UNIVERSITY OF PARANÁ, CURITIBA , PARANÁ , BRAZIL, Brazil, 3UNIVERSIDADE FEDERAL DO PARANÁ, CURITIBA , PARANÁ, Brazil, 4ICS, CURITIBA , PARANÁ , BRAZIL, Brazil
Introduction: Workplace accidents are important in the day-to-day of a productive society. Security, Healthcare and Human Resources Departments (SHHS) struggle to show that they are not part of a company merely to follow rules, laws and regulations that might be established, but that they are a group of people, a team, with the same goal: warn the employees of a company about the risks and consequences of work-related accidents. Objectives: Show the importance of SHHS, presenting work accident costs. Methods: In the present work, two types of expenses in a food company were considered: the costs of lost hours due to work accidents with leave of absence in a one year period; and the costs with medical supplies, medicines and worker’s health. Results: A total of 12 workers required a leave of absence after work-related accidents. The period of absence of these