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Joel W Hay - One of the best experts on this subject based on the ideXlab platform.
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good research practices for measuring Drug Costs in Cost effectiveness analyses issues and recommendations the ispor Drug Cost task force report part i
Value in Health, 2010Co-Authors: Joel W Hay, Jim Smeeding, Norman V Carroll, Michael Drummond, Louis P Garrison, Edward C Mansley, Daniel C Mullins, Jack M Mycka, B Seal, Lizheng ShiAbstract:Objectives: The assignment of prices or Costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic Cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how Drug Costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured Cost of a brand name pharmaceutical is not a true economic Cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how Drug Costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how Drug Costs should be measured for CEAs performed from a number of key analytic perspectives. Methods: ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how Drug Costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop Drug Cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results: Drug Cost measurements should be fully transparent and reflect the net payment most relevant to the user’s perspective. The Task Force recommends that for CEAs of brand name Drugs performed from a societal perspective, either 1) CEA analysts use a Cost that more accurately reflects true societal Drug Costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use Drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions: Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of Drug Costs to the analytic perspective, maintain clarity and transparency on Drug Cost measurement, and report the sensitivity of CEA results to reasonable Drug Cost
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good research practices for measuring Drug Costs in Cost effectiveness analyses medicare medicaid and other us government payers perspectives the ispor Drug Cost task force report part iv
Value in Health, 2010Co-Authors: Daniel C Mullins, B Seal, Enrique Seoanevazquez, Jayashri Sankaranarayanan, Carl V Asche, Ravishankar Jayadevappa, W C Lee, Dorothy Romanus, Junlin Wang, Joel W HayAbstract:Objectives: Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the Cost of Drugs financed by US public programs. The objective of this study was to provide standards for estimating the Cost of Drugs financed by US public programs for utilization in pharmacoeconomic evaluations. Methods: This report was prepared by the ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the Cost of Drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent Costing methods. Results: The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the Drug Cost paid by public programs; 2) Drug Cost must represent the actual acquisition Cost, incorporating any rebates or discounts; 3) transparency with respect to Cost inputs must be ensured; 4) inclusion of the public program’s perspective is recommended; 5) high Cost Drugs require special attention, particularly when Drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition Cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. Conclusions: As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of Drug Costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased
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good research practices for measuring Drug Costs in Cost effectiveness analyses an international perspective the ispor Drug Cost task force report part vi
Value in Health, 2010Co-Authors: Lizheng Shi, Joel W Hay, Michael Drummond, Meredith Hodges, Jeonghoon Ahn, Federico Augustovski, Jim SmeedingAbstract:Objectives: Major guidelines regarding the application of Costeffectiveness analysis (CEA) have recommended the common and widespread use of the “societal perspective” for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring Drug Costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Methods: Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. Results: The societal perspective can be defined by three conditions: 1) the inclusion of time Costs, 2) the use of opportunity Costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded Drug Costs have typically used actual acquisition Cost rather than the much lower social opportunity Costs that would reflect only short-run manufacturing and distribution Costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Conclusions: Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a “limited societal” or “health systems” perspective, using acquisition Drug prices while including indirect Costs and community preferences. The field of pharmacoeconomics also needs to acknowledge the limitations of this perspective when it comes to important questions of research and development Costs, and incentives for
Lizheng Shi - One of the best experts on this subject based on the ideXlab platform.
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good research practices for measuring Drug Costs in Cost effectiveness analyses issues and recommendations the ispor Drug Cost task force report part i
Value in Health, 2010Co-Authors: Joel W Hay, Jim Smeeding, Norman V Carroll, Michael Drummond, Louis P Garrison, Edward C Mansley, Daniel C Mullins, Jack M Mycka, B Seal, Lizheng ShiAbstract:Objectives: The assignment of prices or Costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic Cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how Drug Costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured Cost of a brand name pharmaceutical is not a true economic Cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how Drug Costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how Drug Costs should be measured for CEAs performed from a number of key analytic perspectives. Methods: ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how Drug Costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop Drug Cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results: Drug Cost measurements should be fully transparent and reflect the net payment most relevant to the user’s perspective. The Task Force recommends that for CEAs of brand name Drugs performed from a societal perspective, either 1) CEA analysts use a Cost that more accurately reflects true societal Drug Costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use Drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions: Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of Drug Costs to the analytic perspective, maintain clarity and transparency on Drug Cost measurement, and report the sensitivity of CEA results to reasonable Drug Cost
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good research practices for measuring Drug Costs in Cost effectiveness analyses an international perspective the ispor Drug Cost task force report part vi
Value in Health, 2010Co-Authors: Lizheng Shi, Joel W Hay, Michael Drummond, Meredith Hodges, Jeonghoon Ahn, Federico Augustovski, Jim SmeedingAbstract:Objectives: Major guidelines regarding the application of Costeffectiveness analysis (CEA) have recommended the common and widespread use of the “societal perspective” for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring Drug Costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Methods: Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. Results: The societal perspective can be defined by three conditions: 1) the inclusion of time Costs, 2) the use of opportunity Costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded Drug Costs have typically used actual acquisition Cost rather than the much lower social opportunity Costs that would reflect only short-run manufacturing and distribution Costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Conclusions: Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a “limited societal” or “health systems” perspective, using acquisition Drug prices while including indirect Costs and community preferences. The field of pharmacoeconomics also needs to acknowledge the limitations of this perspective when it comes to important questions of research and development Costs, and incentives for
Jim Smeeding - One of the best experts on this subject based on the ideXlab platform.
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good research practices for measuring Drug Costs in Cost effectiveness analyses issues and recommendations the ispor Drug Cost task force report part i
Value in Health, 2010Co-Authors: Joel W Hay, Jim Smeeding, Norman V Carroll, Michael Drummond, Louis P Garrison, Edward C Mansley, Daniel C Mullins, Jack M Mycka, B Seal, Lizheng ShiAbstract:Objectives: The assignment of prices or Costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic Cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how Drug Costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured Cost of a brand name pharmaceutical is not a true economic Cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how Drug Costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how Drug Costs should be measured for CEAs performed from a number of key analytic perspectives. Methods: ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how Drug Costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop Drug Cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results: Drug Cost measurements should be fully transparent and reflect the net payment most relevant to the user’s perspective. The Task Force recommends that for CEAs of brand name Drugs performed from a societal perspective, either 1) CEA analysts use a Cost that more accurately reflects true societal Drug Costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use Drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions: Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of Drug Costs to the analytic perspective, maintain clarity and transparency on Drug Cost measurement, and report the sensitivity of CEA results to reasonable Drug Cost
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good research practices for measuring Drug Costs in Cost effectiveness analyses an international perspective the ispor Drug Cost task force report part vi
Value in Health, 2010Co-Authors: Lizheng Shi, Joel W Hay, Michael Drummond, Meredith Hodges, Jeonghoon Ahn, Federico Augustovski, Jim SmeedingAbstract:Objectives: Major guidelines regarding the application of Costeffectiveness analysis (CEA) have recommended the common and widespread use of the “societal perspective” for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring Drug Costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Methods: Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. Results: The societal perspective can be defined by three conditions: 1) the inclusion of time Costs, 2) the use of opportunity Costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded Drug Costs have typically used actual acquisition Cost rather than the much lower social opportunity Costs that would reflect only short-run manufacturing and distribution Costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Conclusions: Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a “limited societal” or “health systems” perspective, using acquisition Drug prices while including indirect Costs and community preferences. The field of pharmacoeconomics also needs to acknowledge the limitations of this perspective when it comes to important questions of research and development Costs, and incentives for
Daniel C Mullins - One of the best experts on this subject based on the ideXlab platform.
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good research practices for measuring Drug Costs in Cost effectiveness analyses issues and recommendations the ispor Drug Cost task force report part i
Value in Health, 2010Co-Authors: Joel W Hay, Jim Smeeding, Norman V Carroll, Michael Drummond, Louis P Garrison, Edward C Mansley, Daniel C Mullins, Jack M Mycka, B Seal, Lizheng ShiAbstract:Objectives: The assignment of prices or Costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic Cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how Drug Costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured Cost of a brand name pharmaceutical is not a true economic Cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how Drug Costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how Drug Costs should be measured for CEAs performed from a number of key analytic perspectives. Methods: ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how Drug Costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop Drug Cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results: Drug Cost measurements should be fully transparent and reflect the net payment most relevant to the user’s perspective. The Task Force recommends that for CEAs of brand name Drugs performed from a societal perspective, either 1) CEA analysts use a Cost that more accurately reflects true societal Drug Costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use Drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions: Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of Drug Costs to the analytic perspective, maintain clarity and transparency on Drug Cost measurement, and report the sensitivity of CEA results to reasonable Drug Cost
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good research practices for measuring Drug Costs in Cost effectiveness analyses medicare medicaid and other us government payers perspectives the ispor Drug Cost task force report part iv
Value in Health, 2010Co-Authors: Daniel C Mullins, B Seal, Enrique Seoanevazquez, Jayashri Sankaranarayanan, Carl V Asche, Ravishankar Jayadevappa, W C Lee, Dorothy Romanus, Junlin Wang, Joel W HayAbstract:Objectives: Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the Cost of Drugs financed by US public programs. The objective of this study was to provide standards for estimating the Cost of Drugs financed by US public programs for utilization in pharmacoeconomic evaluations. Methods: This report was prepared by the ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the Cost of Drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent Costing methods. Results: The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the Drug Cost paid by public programs; 2) Drug Cost must represent the actual acquisition Cost, incorporating any rebates or discounts; 3) transparency with respect to Cost inputs must be ensured; 4) inclusion of the public program’s perspective is recommended; 5) high Cost Drugs require special attention, particularly when Drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition Cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. Conclusions: As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of Drug Costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased
Michael Drummond - One of the best experts on this subject based on the ideXlab platform.
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good research practices for measuring Drug Costs in Cost effectiveness analyses issues and recommendations the ispor Drug Cost task force report part i
Value in Health, 2010Co-Authors: Joel W Hay, Jim Smeeding, Norman V Carroll, Michael Drummond, Louis P Garrison, Edward C Mansley, Daniel C Mullins, Jack M Mycka, B Seal, Lizheng ShiAbstract:Objectives: The assignment of prices or Costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic Cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how Drug Costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured Cost of a brand name pharmaceutical is not a true economic Cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how Drug Costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how Drug Costs should be measured for CEAs performed from a number of key analytic perspectives. Methods: ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how Drug Costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop Drug Cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results: Drug Cost measurements should be fully transparent and reflect the net payment most relevant to the user’s perspective. The Task Force recommends that for CEAs of brand name Drugs performed from a societal perspective, either 1) CEA analysts use a Cost that more accurately reflects true societal Drug Costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use Drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions: Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of Drug Costs to the analytic perspective, maintain clarity and transparency on Drug Cost measurement, and report the sensitivity of CEA results to reasonable Drug Cost
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good research practices for measuring Drug Costs in Cost effectiveness analyses an international perspective the ispor Drug Cost task force report part vi
Value in Health, 2010Co-Authors: Lizheng Shi, Joel W Hay, Michael Drummond, Meredith Hodges, Jeonghoon Ahn, Federico Augustovski, Jim SmeedingAbstract:Objectives: Major guidelines regarding the application of Costeffectiveness analysis (CEA) have recommended the common and widespread use of the “societal perspective” for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring Drug Costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Methods: Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. Results: The societal perspective can be defined by three conditions: 1) the inclusion of time Costs, 2) the use of opportunity Costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded Drug Costs have typically used actual acquisition Cost rather than the much lower social opportunity Costs that would reflect only short-run manufacturing and distribution Costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Conclusions: Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a “limited societal” or “health systems” perspective, using acquisition Drug prices while including indirect Costs and community preferences. The field of pharmacoeconomics also needs to acknowledge the limitations of this perspective when it comes to important questions of research and development Costs, and incentives for
