- Email: [email protected]
Drugprice Developments After Patent Expiry
A668
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
PHP91 Difference Between Annual National Health Statistics And 1-Complete-Year Medical Use In Cost-Estimation
shown that during CABG surgery, Evicel is associated with lower bleeding events and lower health-resource utilization/cost than Tisseel.
Hong S, Jang J, Nam JH, Song HJ, Park J, Lee E School of Pharmacy, Sungkyunkwan University, Suwon, Korea, Republic of (South)
PHP94 Evaluating The Cost-Utility Of Immunosuppressive Regimens In Liver Transplant Recipients In Canada
Objectives: Annual national health statistics are valuable reference for healthcarerelated cost researches. However, there is a gap between cost of 1-calendar-year and that for 1-complete-year, depending on the patient’s date of first hospital visit. This research aims to quantitatively identify the difference between healthcare cost in the annual national health statistics and that for 1-complete-year according to chronic or acute diseases. Methods: Annual cost per patient was calculated by two Methods: the 1-calendar-year method in which the study period spanned from January 1 to December 31, 2012 regardless of patient’s date of first visit, and the 1-complete-year method which estimated the cost for one year from patient’s date of first visit. The target diseases were the 20 most prevalent diseases in South Korea, divided into acute (acute tonsillitis, common cold, etc.) and chronic diseases (hypertension, diabetes mellitus, etc.). National Sample Cohort data provided by the South Korea National Health Insurance Service was used, and patients coded with applicable diseases were selected in 2012. To provide basis for the results, we additionally investigated the distribution of the date of first visit and consequent annual cost of each patient. Results: The average ratios of 1-calendar-year cost to 1-complete-year cost for acute and chronic diseases were 0.87 (± 0.03) and 0.85 (± 0.02), respectively. When the dates of first visit were analyzed according to quarters, significantly more patients with chronic diseases were identified in the 1st quarter than acute diseases. The annual cost increased as the first visit occurred earlier, which was more apparent in chronic than acute diseases. Conclusions: Healthcare cost reported by annual national health statistics was 85~87% level of 1-complete-year cost, which was similar for both acute and chronic diseases. These ratios could compensate the structural limitations of annual national health statistics and enable researchers to make elaborate estimations in socioeconomic burdens from diseases. PHP92 Drugprice Developments After Patent Expiry Vondeling GT1, Cao Q2, Visser S3, Postma MJ2, Rozenbaum MH4 1University of Groningen, Zuidhorn, The Netherlands, 2University of Groningen, Groningen, The Netherlands, 3Datascientia, Groningen, The Netherlands, 4Pfizer NL, Capelle aan den IJssel, The Netherlands
Objectives: To investigates the impact of patent expiry on drug prices in the Netherlands. Methods: All drugs that faced patent expiration in the Netherlands between January 1999 and December 2016 were identified. Patent expiration was defined as the time at which the first generic drug entered the market (obtained a list price) with a ATC code identical to the originator drug. Monthly drug prices and prescription were extracted from a national price and sales database. This data was used to calculate the average monthly price per DDD for every drug weighted by the corresponding prescriptions of every strength, package size and administration form. All data was combined to calculate the overall price ratio-, the generic to brand price ratio and the price development of the originator compared to moment of patent expiry. Results: In total 257 drugs faced generic competition between 1999 and 2016. The relative price decreases after 24 months differed significantly among different drugs varying from -89% to +89%. The overall price ratio 24 months after patent expiry was 0.66 (0.19-0.99;10th-90th percentile range). The generic to brand price ratio was 0.56 (0.15-0.94; 10th-90th percentile range) and the price ratio of the originator decreased to 0.80 (0.45-1.00; 10th-90th percentile range). Sales revenue before patent expiry significantly impacted the price decreases after patent expiration with higher sales resulting in lower price ratios. Conclusions: Patent expiry leads to significantly lower drug prices. As drug prices are dynamic over time and generic entry leads to savings on the national healthcare budget, this should be taken into account when making predictions on future healthcare expenditures. PHP93 The Economic Impact Of Fibrin Sealants Used For Hemostasis In Coronary Artery Bypass Grafting Surgery; An Italian Perspective Parago V1, Jamous N2 & Johnson Medical Devices, Pomezia, Italy, 2Johnson & Johnson Medical Ltd, Berkshire, UK
1Johnson
Objectives: Bleeding is a serious complication related to Coronary Artery Bypass Grafting (CABG) surgery with a potential high impact on clinical outcomes and health care services expenditure. The aim of this study is to evaluate the impact on economic resource consumption associated with the use of fibrin sealants in a comparative analysis between Evicel and Tisseel. Methods: Analysis was developed to estimate the impact on costs associated with use of Evicel and Tisseel from the Italian National Healthcare System perspective with a 30-day time horizon, including the following item costs: fibrin sealant use, blood transfusion, readmissions. A literature research was performed to assess efficacy data in terms of blood transfusion rate and 30-day readmission rate associated with both fibrin sealants. The economic data on blood transfusion and fibrin sealant use were estimated on basis of the corresponding national reimbursement fees, while the costs associated with readmission were estimated according to DRG tariffs. Univariate sensitivity analysis was conducted to determine whether results were insensitive to variations in uncertain parameters. Results: The literature research showed a lower blood transfusion rate on the index CABG surgery date (19% versus 34%) and after index date (9% versus 15%), as well as, a lower readmission rate (16% vs. 31.9%) in favor of use of Evicel. The economic analysis showed a lower transfusion cost for Evicel than Tisseel 22.64% (€ 65.60 versus € 84.80) and a lower readmission costs of 43.75% (€ 1,148.87 versus € 2,042.43), showing a total cost savings of € 1,045.20 per patient, including fibrin sealant cost. The sensitivity analysis shows that resulting cost-saving was most sensitive to 30-day readmission associated with the fibrin sealants. Conclusions: Detailed comparative analysis of the data has specifically
Pollock RF1, Schwartz J2, Howell J3, Spalding J2 Health Economics and Communications GmbH, Basel, Switzerland, 2Astellas Pharma Global Development, Inc., Northbrook, IL, USA, 3Astellas Pharma Global Development, Inc., Markham, ON, Canada
1Ossian
Objectives: Liver transplantation is the only effective treatment option for patients with end-stage liver disease. While one-year graft survival rates are over 80% and longer-term graft and patient survival have increased dramatically since the first liver transplants, non-adherence to immunosuppression is still common and confers an increased risk of graft rejection and loss. Prolonged-release tacrolimus (PR-TAC) is a once-daily formulation of tacrolimus that may improve adherence and cause less interference with the daily activities of the patient. The present study evaluated the cost-utility of PR-TAC relative to immediate-release tacrolimus (IR-TAC) and cyclosporine in liver transplant recipients in Canada. Methods: A three-state Markov model was developed to evaluate cost and utility outcomes in adult de novo liver transplant recipients using IR-TAC, PR-TAC, or cyclosporine as the primary immunosuppressive regimen. Costs were derived from Canadian sources and reported in 2016 Canadian dollars, with future costs and effects discounted at 1.5% per annum. Underlying probabilities of mortality were based on a least squares exponential model fit to data from the Canadian Organ Replacement Register, while incremental rates were determined by the results of a network metaanalysis (NMA). Results: Over a 25-year time horizon, quality-adjusted life expectancy (QALE) increased from 12.22 quality-adjusted life years (QALYs) with IR-TAC to 13.04 QALYs with PR-TAC with an accompanying increase in costs of CAD 38,899, resulting in an incremental cost-effectiveness ratio of CAD 47,351 per QALY gained. Cyclosporine increased costs by CAD 4,478 and reduced QALE by 0.37 QALYs relative to IR-TAC. Sensitivity analysis showed the model to be most sensitive to mortality odds ratios and tacrolimus unit costs. Conclusions: Cost-utility modeling using modern data from a NMA and Canadian cost data showed that PR-TAC would likely be cost-effective relative to IR-TAC in Canada. Higher per-milligram acquisition costs need not, therefore, present a barrier to its reimbursement. PHP95 Cost-Effectiveness of A Physical Activity Promotion Intervention For People With Disabilities: A Markov Model Approach Lee D, Lee Y, Oh I Kyung Hee University, Seoul, Korea, Republic of (South)
Objectives: This study aims to evaluate the cost-effectiveness of a physical activity promotion intervention for people with disabilities in Korea. Methods: A Markov model illustrating five disease states (ischemic heart disease, ischemic stroke, type 2 diabetes, colorectal and breast cancer) was employed to consider the long-term economic consequence of the intervention. The model was simulated over the lifetime of the 2012 Korean population with disabilities by age and gender. For the estimation of model inputs, incidence and mortality of the diseases related to physical activity among the people with disabilities were obtained from Korean National Health Insurance Claims Database. Health care cost and utilization incurred among them by experiencing those diseases was also derived from the same source. The result from a meta-analysis was used for an intervention effect on physical activity promotion. Costs were estimated from the health care system perspective. Health outcomes were measured by Disability-adjusted Life Years (DALYs). In accordance with the recommendation of World Health Organization (WHO), Incremental CostEffectiveness Ratio (ICER) was assessed by the amount of Gross Domestic Product (GDP) per capita in Korea. Results: Considering that currently there is no nationwide intervention promoting physical activity for people with disabilities in Korea, implementing the intervention across the country may cost 13 million US dollars (Intervention cost: $ 13,824,024, Cost offsets: $ 710,491) and averted 476 DALYs. The ICER of the intervention is $ 27,538 per DALY averted. Conclusions: Based on the cost-effectiveness criteria, $ 25,722 (the Korean GDP per capita in 2012), implementing a physical activity promotion intervention for people with disabilities is cost-effective compared to no intervention. PHP96 Increasing Trend On Turkish Un-Licenced Medicine Market: A General Overview Analysis Kockaya G1, Yenilmez FB2, Sharaf A1, Ammar H1 1CarthaGenetics, Pully, Switzerland, 2Akıl Consultancy, London, UK
Objectives: Turkish Medicines and Medical Device Agency(TITCK) leads nonlicensed innovative medicines to access patients under name patient sales. If commission under TITCK approves for the use of patient, then Turkish Pharmacist Association imports the medicine and delivers to patient for out-of-pocket or under reimbursement by Social Security Institution(SGK). The former studies reported that unlicensed medicines market increased in from 232 billion TL to747 billion TL between 2011 and 2013. SGK has already started direct import process of unlicensed medicines to lowering budget since May 2017. The aim of this study is to estimate current situation with the latest published data. Methods: Published data of consumption of unlicensed medicines in first half of 2016 has been taken from official web page of TITCK. Full year consumption was estimated for 2016. Average TL/EURO exchange rate has been taken as 3.54 for 2016. Only reimbursed medicines were included. Descriptive analysis has been conducted for top 100 unlicensed reimbursed medicines market and compared with former data. Results: 307.133 units of unlicensed medicines had been imported in 2016. Total market volume was calculated as 1.820.003.274 TL for top 100 unlicensed medicines market. Cost per unit was was calculated as 5925 TL. Compound annual growth rate was calculted as 40.93% from 2011 to 2016 in TL. Conclusions: Turkey has a
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
PHP91 Difference Between Annual National Health Statistics And 1-Complete-Year Medical Use In Cost-Estimation
shown that during CABG surgery, Evicel is associated with lower bleeding events and lower health-resource utilization/cost than Tisseel.
Hong S, Jang J, Nam JH, Song HJ, Park J, Lee E School of Pharmacy, Sungkyunkwan University, Suwon, Korea, Republic of (South)
PHP94 Evaluating The Cost-Utility Of Immunosuppressive Regimens In Liver Transplant Recipients In Canada
Objectives: Annual national health statistics are valuable reference for healthcarerelated cost researches. However, there is a gap between cost of 1-calendar-year and that for 1-complete-year, depending on the patient’s date of first hospital visit. This research aims to quantitatively identify the difference between healthcare cost in the annual national health statistics and that for 1-complete-year according to chronic or acute diseases. Methods: Annual cost per patient was calculated by two Methods: the 1-calendar-year method in which the study period spanned from January 1 to December 31, 2012 regardless of patient’s date of first visit, and the 1-complete-year method which estimated the cost for one year from patient’s date of first visit. The target diseases were the 20 most prevalent diseases in South Korea, divided into acute (acute tonsillitis, common cold, etc.) and chronic diseases (hypertension, diabetes mellitus, etc.). National Sample Cohort data provided by the South Korea National Health Insurance Service was used, and patients coded with applicable diseases were selected in 2012. To provide basis for the results, we additionally investigated the distribution of the date of first visit and consequent annual cost of each patient. Results: The average ratios of 1-calendar-year cost to 1-complete-year cost for acute and chronic diseases were 0.87 (± 0.03) and 0.85 (± 0.02), respectively. When the dates of first visit were analyzed according to quarters, significantly more patients with chronic diseases were identified in the 1st quarter than acute diseases. The annual cost increased as the first visit occurred earlier, which was more apparent in chronic than acute diseases. Conclusions: Healthcare cost reported by annual national health statistics was 85~87% level of 1-complete-year cost, which was similar for both acute and chronic diseases. These ratios could compensate the structural limitations of annual national health statistics and enable researchers to make elaborate estimations in socioeconomic burdens from diseases. PHP92 Drugprice Developments After Patent Expiry Vondeling GT1, Cao Q2, Visser S3, Postma MJ2, Rozenbaum MH4 1University of Groningen, Zuidhorn, The Netherlands, 2University of Groningen, Groningen, The Netherlands, 3Datascientia, Groningen, The Netherlands, 4Pfizer NL, Capelle aan den IJssel, The Netherlands
Objectives: To investigates the impact of patent expiry on drug prices in the Netherlands. Methods: All drugs that faced patent expiration in the Netherlands between January 1999 and December 2016 were identified. Patent expiration was defined as the time at which the first generic drug entered the market (obtained a list price) with a ATC code identical to the originator drug. Monthly drug prices and prescription were extracted from a national price and sales database. This data was used to calculate the average monthly price per DDD for every drug weighted by the corresponding prescriptions of every strength, package size and administration form. All data was combined to calculate the overall price ratio-, the generic to brand price ratio and the price development of the originator compared to moment of patent expiry. Results: In total 257 drugs faced generic competition between 1999 and 2016. The relative price decreases after 24 months differed significantly among different drugs varying from -89% to +89%. The overall price ratio 24 months after patent expiry was 0.66 (0.19-0.99;10th-90th percentile range). The generic to brand price ratio was 0.56 (0.15-0.94; 10th-90th percentile range) and the price ratio of the originator decreased to 0.80 (0.45-1.00; 10th-90th percentile range). Sales revenue before patent expiry significantly impacted the price decreases after patent expiration with higher sales resulting in lower price ratios. Conclusions: Patent expiry leads to significantly lower drug prices. As drug prices are dynamic over time and generic entry leads to savings on the national healthcare budget, this should be taken into account when making predictions on future healthcare expenditures. PHP93 The Economic Impact Of Fibrin Sealants Used For Hemostasis In Coronary Artery Bypass Grafting Surgery; An Italian Perspective Parago V1, Jamous N2 & Johnson Medical Devices, Pomezia, Italy, 2Johnson & Johnson Medical Ltd, Berkshire, UK
1Johnson
Objectives: Bleeding is a serious complication related to Coronary Artery Bypass Grafting (CABG) surgery with a potential high impact on clinical outcomes and health care services expenditure. The aim of this study is to evaluate the impact on economic resource consumption associated with the use of fibrin sealants in a comparative analysis between Evicel and Tisseel. Methods: Analysis was developed to estimate the impact on costs associated with use of Evicel and Tisseel from the Italian National Healthcare System perspective with a 30-day time horizon, including the following item costs: fibrin sealant use, blood transfusion, readmissions. A literature research was performed to assess efficacy data in terms of blood transfusion rate and 30-day readmission rate associated with both fibrin sealants. The economic data on blood transfusion and fibrin sealant use were estimated on basis of the corresponding national reimbursement fees, while the costs associated with readmission were estimated according to DRG tariffs. Univariate sensitivity analysis was conducted to determine whether results were insensitive to variations in uncertain parameters. Results: The literature research showed a lower blood transfusion rate on the index CABG surgery date (19% versus 34%) and after index date (9% versus 15%), as well as, a lower readmission rate (16% vs. 31.9%) in favor of use of Evicel. The economic analysis showed a lower transfusion cost for Evicel than Tisseel 22.64% (€ 65.60 versus € 84.80) and a lower readmission costs of 43.75% (€ 1,148.87 versus € 2,042.43), showing a total cost savings of € 1,045.20 per patient, including fibrin sealant cost. The sensitivity analysis shows that resulting cost-saving was most sensitive to 30-day readmission associated with the fibrin sealants. Conclusions: Detailed comparative analysis of the data has specifically
Pollock RF1, Schwartz J2, Howell J3, Spalding J2 Health Economics and Communications GmbH, Basel, Switzerland, 2Astellas Pharma Global Development, Inc., Northbrook, IL, USA, 3Astellas Pharma Global Development, Inc., Markham, ON, Canada
1Ossian
Objectives: Liver transplantation is the only effective treatment option for patients with end-stage liver disease. While one-year graft survival rates are over 80% and longer-term graft and patient survival have increased dramatically since the first liver transplants, non-adherence to immunosuppression is still common and confers an increased risk of graft rejection and loss. Prolonged-release tacrolimus (PR-TAC) is a once-daily formulation of tacrolimus that may improve adherence and cause less interference with the daily activities of the patient. The present study evaluated the cost-utility of PR-TAC relative to immediate-release tacrolimus (IR-TAC) and cyclosporine in liver transplant recipients in Canada. Methods: A three-state Markov model was developed to evaluate cost and utility outcomes in adult de novo liver transplant recipients using IR-TAC, PR-TAC, or cyclosporine as the primary immunosuppressive regimen. Costs were derived from Canadian sources and reported in 2016 Canadian dollars, with future costs and effects discounted at 1.5% per annum. Underlying probabilities of mortality were based on a least squares exponential model fit to data from the Canadian Organ Replacement Register, while incremental rates were determined by the results of a network metaanalysis (NMA). Results: Over a 25-year time horizon, quality-adjusted life expectancy (QALE) increased from 12.22 quality-adjusted life years (QALYs) with IR-TAC to 13.04 QALYs with PR-TAC with an accompanying increase in costs of CAD 38,899, resulting in an incremental cost-effectiveness ratio of CAD 47,351 per QALY gained. Cyclosporine increased costs by CAD 4,478 and reduced QALE by 0.37 QALYs relative to IR-TAC. Sensitivity analysis showed the model to be most sensitive to mortality odds ratios and tacrolimus unit costs. Conclusions: Cost-utility modeling using modern data from a NMA and Canadian cost data showed that PR-TAC would likely be cost-effective relative to IR-TAC in Canada. Higher per-milligram acquisition costs need not, therefore, present a barrier to its reimbursement. PHP95 Cost-Effectiveness of A Physical Activity Promotion Intervention For People With Disabilities: A Markov Model Approach Lee D, Lee Y, Oh I Kyung Hee University, Seoul, Korea, Republic of (South)
Objectives: This study aims to evaluate the cost-effectiveness of a physical activity promotion intervention for people with disabilities in Korea. Methods: A Markov model illustrating five disease states (ischemic heart disease, ischemic stroke, type 2 diabetes, colorectal and breast cancer) was employed to consider the long-term economic consequence of the intervention. The model was simulated over the lifetime of the 2012 Korean population with disabilities by age and gender. For the estimation of model inputs, incidence and mortality of the diseases related to physical activity among the people with disabilities were obtained from Korean National Health Insurance Claims Database. Health care cost and utilization incurred among them by experiencing those diseases was also derived from the same source. The result from a meta-analysis was used for an intervention effect on physical activity promotion. Costs were estimated from the health care system perspective. Health outcomes were measured by Disability-adjusted Life Years (DALYs). In accordance with the recommendation of World Health Organization (WHO), Incremental CostEffectiveness Ratio (ICER) was assessed by the amount of Gross Domestic Product (GDP) per capita in Korea. Results: Considering that currently there is no nationwide intervention promoting physical activity for people with disabilities in Korea, implementing the intervention across the country may cost 13 million US dollars (Intervention cost: $ 13,824,024, Cost offsets: $ 710,491) and averted 476 DALYs. The ICER of the intervention is $ 27,538 per DALY averted. Conclusions: Based on the cost-effectiveness criteria, $ 25,722 (the Korean GDP per capita in 2012), implementing a physical activity promotion intervention for people with disabilities is cost-effective compared to no intervention. PHP96 Increasing Trend On Turkish Un-Licenced Medicine Market: A General Overview Analysis Kockaya G1, Yenilmez FB2, Sharaf A1, Ammar H1 1CarthaGenetics, Pully, Switzerland, 2Akıl Consultancy, London, UK
Objectives: Turkish Medicines and Medical Device Agency(TITCK) leads nonlicensed innovative medicines to access patients under name patient sales. If commission under TITCK approves for the use of patient, then Turkish Pharmacist Association imports the medicine and delivers to patient for out-of-pocket or under reimbursement by Social Security Institution(SGK). The former studies reported that unlicensed medicines market increased in from 232 billion TL to747 billion TL between 2011 and 2013. SGK has already started direct import process of unlicensed medicines to lowering budget since May 2017. The aim of this study is to estimate current situation with the latest published data. Methods: Published data of consumption of unlicensed medicines in first half of 2016 has been taken from official web page of TITCK. Full year consumption was estimated for 2016. Average TL/EURO exchange rate has been taken as 3.54 for 2016. Only reimbursed medicines were included. Descriptive analysis has been conducted for top 100 unlicensed reimbursed medicines market and compared with former data. Results: 307.133 units of unlicensed medicines had been imported in 2016. Total market volume was calculated as 1.820.003.274 TL for top 100 unlicensed medicines market. Cost per unit was was calculated as 5925 TL. Compound annual growth rate was calculted as 40.93% from 2011 to 2016 in TL. Conclusions: Turkey has a