This presentation discusses pharmacoeconomic assessment through different phases of drug development and approval. It provides an overview of different types of pharmacoeconomic analyses including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and budget impact modeling. It emphasizes the importance of real-world pharmacoeconomic assessment to demonstrate the true cost-effectiveness and safety of drugs based on real-world data rather than clinical trials alone. The presentation outlines considerations for planning and implementing real-world pharmacoeconomic assessments, including study design, data collection from multiple sources like electronic health records, and ongoing analysis of updated data streams.
This document discusses the topic of pharmacoeconomics. It begins with introducing health economics and defining pharmacoeconomics as the analysis of the costs and benefits of drug therapy. It then outlines different types of pharmacoeconomic evaluations including partial evaluations like cost-of-illness and cost-consequence analyses, as well as full evaluations like cost-minimization, cost-benefit, cost-effectiveness, and cost-utility analyses. Specific examples are provided for some of these evaluation types. The document also discusses the importance of pharmacoeconomics and references organizations like ISPOR and NCPE.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as a branch of health economics that compares the value of drug therapies. The key points covered include: pharmacoeconomics identifies, measures, and compares the costs and health outcomes of drug therapies; common perspectives in evaluation include patients, providers, payers, and society; and methodologies include cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Quality patient care requires balancing economic, humanistic, and clinical outcomes.
This document discusses various pharmacoeconomic methods used to evaluate the costs and benefits of drug therapies including cost-benefit analysis, cost-effectiveness analysis, cost-utility analysis, cost-minimization analysis, and cost of illness studies. It provides details on how each method is conducted and examples of how they are applied. Cost-benefit analysis compares monetary costs of a drug to its health benefits, while cost-effectiveness analysis expresses health outcomes in units like lives saved rather than dollars. Cost-utility analysis uses quality-adjusted life years to incorporate both mortality and morbidity.
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document defines pharmacoeconomics as identifying, measuring, and comparing the costs, risks, and benefits of healthcare programs, services, or therapies. It differentiates between types of pharmacoeconomic evaluations including cost-of-illness, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Considerations for designing and evaluating pharmacoeconomic studies are discussed such as perspective, discounting, sensitivity analysis, and ensuring accuracy. The roles of pharmacists in applying pharmacoeconomic principles to clinical decision making and resource allocation are also reviewed.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as the application of economic analysis to pharmaceutical products and services, focusing on costs and outcomes. The document then covers:
- The history and perspectives of pharmacoeconomics
- Common methodologies like cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis
- How pharmacoeconomics can be applied at different stages of drug development and to support pricing and reimbursement decisions
- The relationships between pharmacoeconomics, outcomes research, and pharmaceutical care
In 3 sentences or less, this document summarizes key concepts in pharmacoeconomics like its definition, common methodologies, and applications in drug
This document discusses the topic of pharmacoeconomics. It begins with introducing health economics and defining pharmacoeconomics as the analysis of the costs and benefits of drug therapy. It then outlines different types of pharmacoeconomic evaluations including partial evaluations like cost-of-illness and cost-consequence analyses, as well as full evaluations like cost-minimization, cost-benefit, cost-effectiveness, and cost-utility analyses. Specific examples are provided for some of these evaluation types. The document also discusses the importance of pharmacoeconomics and references organizations like ISPOR and NCPE.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as a branch of health economics that compares the value of drug therapies. The key points covered include: pharmacoeconomics identifies, measures, and compares the costs and health outcomes of drug therapies; common perspectives in evaluation include patients, providers, payers, and society; and methodologies include cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Quality patient care requires balancing economic, humanistic, and clinical outcomes.
This document discusses various pharmacoeconomic methods used to evaluate the costs and benefits of drug therapies including cost-benefit analysis, cost-effectiveness analysis, cost-utility analysis, cost-minimization analysis, and cost of illness studies. It provides details on how each method is conducted and examples of how they are applied. Cost-benefit analysis compares monetary costs of a drug to its health benefits, while cost-effectiveness analysis expresses health outcomes in units like lives saved rather than dollars. Cost-utility analysis uses quality-adjusted life years to incorporate both mortality and morbidity.
It is a sub-discipline of health economics , Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another.
Pharmacoeconomics deals with identifying, measuring, and comparing the costs and consequences of pharmaceutical products and services.
This document defines pharmacoeconomics as identifying, measuring, and comparing the costs, risks, and benefits of healthcare programs, services, or therapies. It differentiates between types of pharmacoeconomic evaluations including cost-of-illness, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Considerations for designing and evaluating pharmacoeconomic studies are discussed such as perspective, discounting, sensitivity analysis, and ensuring accuracy. The roles of pharmacists in applying pharmacoeconomic principles to clinical decision making and resource allocation are also reviewed.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as the application of economic analysis to pharmaceutical products and services, focusing on costs and outcomes. The document then covers:
- The history and perspectives of pharmacoeconomics
- Common methodologies like cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis
- How pharmacoeconomics can be applied at different stages of drug development and to support pricing and reimbursement decisions
- The relationships between pharmacoeconomics, outcomes research, and pharmaceutical care
In 3 sentences or less, this document summarizes key concepts in pharmacoeconomics like its definition, common methodologies, and applications in drug
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document provides an overview of cost-utility analysis (CUA) as a form of pharmacoeconomic evaluation. It defines CUA and distinguishes it from cost-effectiveness analysis by noting that CUA compares outcomes in terms of quality-adjusted life years (QALYs). The document discusses how QALYs combine both survival time and health-related quality of life into a single metric. It also describes approaches to measuring health utility values and calculating QALYs. Finally, the document provides examples of when CUA would and would not be appropriate to use and outlines factors like incremental cost-utility ratios used to interpret CUA results.
This document provides an overview of pharmacoeconomics. It defines key terms like health economics and pharmacoeconomics. It discusses the history and components of pharmacoeconomics. The document outlines different types of costs, perspectives, and methodologies used in pharmacoeconomics like cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It also discusses the need, applications, and challenges of pharmacoeconomics evaluations.
This document provides an overview of pharmacoeconomics and discusses different types of pharmacoeconomic analyses including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. It describes key components of pharmacoeconomic studies such as assessing costs, measuring outcomes, perspectives, and discount rates. Examples are provided to illustrate cost-minimization analysis and cost-benefit analysis.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
Cost utility analysis of interventions to return employees to work following ...ScHARR HEDS
The document describes the Health Economics and Decision Science (HEDS) section within the School of Health and Related Research (ScHARR) at the University of Sheffield. HEDS conducts research to promote excellence in healthcare resource allocation and supports the implementation of research results through education and training. Its research portfolio includes areas like evidence synthesis, health economics modeling, and more. HEDS also offers post-graduate programs and short courses. It focuses on a wide range of disease areas and provides consultancy services including modeling for clinical trials and health economics analyses. The decision modeling team at HEDS specializes in cost-effectiveness analyses to support healthcare decision making.
This document provides an overview of the pharmacoeconomics research process. It discusses the uses and need for pharmacoeconomics research, as well as the main types of analyses including cost-minimization analysis, cost-effectiveness analysis, cost-benefit analysis, cost-utility analysis, and cost-consequence analysis. The key steps in conducting a pharmacoeconomic evaluation are defined such as identifying the problem, alternative interventions, outcomes and costs. Sensitivity analysis and discounting are also summarized.
This document discusses pharmacoeconomics and its importance in balancing the interests of stakeholders in the healthcare industry. It begins by defining health economics and pharmacoeconomics, and explaining their relationship. It then discusses the shift in focus of healthcare consumers towards disease prevention. The document outlines various challenges faced by the healthcare industry and how pharmacoeconomic solutions can address the perspectives of patients, physicians, insurers, manufacturers, researchers and policymakers. It provides a case study on drug selection for osteoarthritis using pharmacoeconomic analysis. Finally, it discusses the global presence and potential for establishing pharmacoeconomics in India.
This document provides an overview of pharmacoeconomics. It discusses the history and basics, including definitions of key terms like QALY. Methods of pharmacoeconomic evaluation are outlined, including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. Challenges in pharmacoeconomic evaluations are also summarized, such as the need for training and standardization of methods.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
This document discusses the history, definition, methodologies and limitations of pharmacoeconomics. It begins with the origins and definition of pharmacoeconomics in the 1970s-1980s as the study of the costs and outcomes of pharmaceutical products and services. It describes different pharmacoeconomic methodologies including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, cost-utility analysis. It outlines the steps to evaluate an economic analysis and highlights limitations including difficulty in implementation and bias. The document provides an overview of pharmacoeconomics as a tool to inform decision-making and optimize the allocation of healthcare resources.
This document discusses pharmacoeconomics and provides an overview of key concepts. It defines pharmacoeconomics as identifying, measuring, and comparing the costs, risks, and benefits of drug therapies to determine the most cost-effective option. The document outlines different types of economic evaluations including cost-effectiveness analysis, cost-utility analysis, and quality-adjusted life years. It also discusses the current state of pharmacoeconomics in India and its potential to help inform healthcare decisions by considering both clinical and economic outcomes of drug therapies.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
1. The document discusses pharmacoeconomics in India, including guidelines for conducting pharmacoeconomic evaluations. Some key guidelines covered include identifying relevant perspectives and comparators, choosing appropriate analytical techniques, establishing appropriate time horizons, and properly accounting for costs and effects.
2. Case studies on the cost-effectiveness of treating osteoarthritis pain and deep vein thrombosis are provided. For osteoarthritis, NSAIDs may be more cost-effective than COX-II inhibitors due to lower costs and risks, depending on risk of GI issues. For deep vein thrombosis, low molecular weight heparin enables outpatient treatment due to lower monitoring needs despite higher costs.
3. Pharmacoeconomics can help inform healthcare decisions
Pharmacoeconomics evaluates the costs and outcomes of pharmaceutical products and services. It involves choosing a perspective such as patient or payer, identifying costs which can be direct, indirect, or intangible, and identifying outcomes which can be clinical, economic, or humanistic. Common pharmacoeconomic methodologies include cost-consequence analysis, cost-of-illness evaluation, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Pharmacoeconomics is important for achieving maximum benefits with limited costs and aids decision making for formularies, policies, and resource allocation.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
Pharmacoeconomics evaluates the costs and outcomes of pharmaceutical products and programs. It aims to improve resource allocation and healthcare spending. The document outlines key pharmacoeconomics concepts like perspectives, methodologies, and applications. Cost-benefit analysis compares monetary costs and benefits. Cost-effectiveness analysis expresses outcomes in natural units to compare cost per outcome. Pharmacoeconomics informs decisions on drug development, reimbursement, and policy to optimize value from limited healthcare resources.
Strategy to incorporate pharmacoeconomics into pharmacotherapy Ravi Kumar Yadav
Pharmacoeconomics of the health care intervention is equally important like the safety and efficacy of drug. The various strategies are available to incorporate pharmacoeconomics into pharmacotherapy. The most popular strategies for applying pharmacoeconomics to assess the value of pharmaceutical products and services include using the results of published pharmacoeconomic studies, building economic models, and conducting pharmacoeconomic research.
Health outcomes research is seen as a cost-effective investment in measuring and defining value of new innovations in health care. We provide an overview of field and its applications
This document defines pharmacoeconomics and outlines its key principles and methods. Pharmacoeconomics is defined as the description and analysis of the costs of drug therapy to health systems and society. It considers the economic relationships of drug research, production, distribution, and use. Methods of pharmacoeconomics include cost-of-illness analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to evaluate healthcare programs and therapies to determine the optimal use of resources. Pharmacoeconomics can help inform decisions around drug formularies, new drug approvals, and pharmaceutical policies.
Pharmacoeconomic Assessment through Market Approval and Beyond: Theory and Op...Medpace
Pharmacoeconomic assessment of a drug, medical device, or other healthcare product can take on many forms and occur at multiple points in the development cycle. Cost-effectiveness analysis, a major component of pharmacoeconomic assessment, has traditionally occurred in the later phases of product development—either as a piggy-back to a phase III or pivotal clinical trial, or peri-authorization.
The document discusses improving health outcomes and reducing costs through better use of molecular diagnostics. It notes that health care expenditures have significantly increased worldwide over recent decades and are predicted to continue rising. The current model of developing new diagnostics provides inadequate incentives and validation may not reflect real-world use. The Partnership for Precision Medicine (PPM) introduces a new, collaborative model of diagnostic development that engages health systems and payers. PPM aims to identify high-impact diagnostic opportunities, validate promising candidates within healthcare settings, and assess real-world impact on patient management and costs.
The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
b) A cost analysis of a single intervention
c) A comparison of costs per life-year gained for two interventions
d) An estimation of the total costs of a disease to the society
12/10/2018
DEPARTMENT OF PHARMACOLOGY
KMCH COLLEGE OF PHARMACY
42
Which one of the following is an example of a partial
pharmaco-economic evaluation
This document provides an overview of cost-utility analysis (CUA) as a form of pharmacoeconomic evaluation. It defines CUA and distinguishes it from cost-effectiveness analysis by noting that CUA compares outcomes in terms of quality-adjusted life years (QALYs). The document discusses how QALYs combine both survival time and health-related quality of life into a single metric. It also describes approaches to measuring health utility values and calculating QALYs. Finally, the document provides examples of when CUA would and would not be appropriate to use and outlines factors like incremental cost-utility ratios used to interpret CUA results.
This document provides an overview of pharmacoeconomics. It defines key terms like health economics and pharmacoeconomics. It discusses the history and components of pharmacoeconomics. The document outlines different types of costs, perspectives, and methodologies used in pharmacoeconomics like cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It also discusses the need, applications, and challenges of pharmacoeconomics evaluations.
This document provides an overview of pharmacoeconomics and discusses different types of pharmacoeconomic analyses including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. It describes key components of pharmacoeconomic studies such as assessing costs, measuring outcomes, perspectives, and discount rates. Examples are provided to illustrate cost-minimization analysis and cost-benefit analysis.
This document discusses principles of pharmacoeconomics and their impact on pharmaceutical research and development. It describes how pharmacoeconomic evaluations measure health gains and costs to compare medical procedures. Randomized controlled trials are required to prove efficacy and safety, but real-world studies are also needed to evaluate long-term health benefits and costs. Economic modeling can be used alongside clinical trials to estimate benefits like quality-adjusted life years to determine appropriate pricing and reimbursement strategies for new drugs. Understanding pharmacoeconomics principles is important for pharmaceutical R&D decision making.
Cost utility analysis of interventions to return employees to work following ...ScHARR HEDS
The document describes the Health Economics and Decision Science (HEDS) section within the School of Health and Related Research (ScHARR) at the University of Sheffield. HEDS conducts research to promote excellence in healthcare resource allocation and supports the implementation of research results through education and training. Its research portfolio includes areas like evidence synthesis, health economics modeling, and more. HEDS also offers post-graduate programs and short courses. It focuses on a wide range of disease areas and provides consultancy services including modeling for clinical trials and health economics analyses. The decision modeling team at HEDS specializes in cost-effectiveness analyses to support healthcare decision making.
This document provides an overview of the pharmacoeconomics research process. It discusses the uses and need for pharmacoeconomics research, as well as the main types of analyses including cost-minimization analysis, cost-effectiveness analysis, cost-benefit analysis, cost-utility analysis, and cost-consequence analysis. The key steps in conducting a pharmacoeconomic evaluation are defined such as identifying the problem, alternative interventions, outcomes and costs. Sensitivity analysis and discounting are also summarized.
This document discusses pharmacoeconomics and its importance in balancing the interests of stakeholders in the healthcare industry. It begins by defining health economics and pharmacoeconomics, and explaining their relationship. It then discusses the shift in focus of healthcare consumers towards disease prevention. The document outlines various challenges faced by the healthcare industry and how pharmacoeconomic solutions can address the perspectives of patients, physicians, insurers, manufacturers, researchers and policymakers. It provides a case study on drug selection for osteoarthritis using pharmacoeconomic analysis. Finally, it discusses the global presence and potential for establishing pharmacoeconomics in India.
This document provides an overview of pharmacoeconomics. It discusses the history and basics, including definitions of key terms like QALY. Methods of pharmacoeconomic evaluation are outlined, including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. Challenges in pharmacoeconomic evaluations are also summarized, such as the need for training and standardization of methods.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
This document discusses the history, definition, methodologies and limitations of pharmacoeconomics. It begins with the origins and definition of pharmacoeconomics in the 1970s-1980s as the study of the costs and outcomes of pharmaceutical products and services. It describes different pharmacoeconomic methodologies including cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, cost-utility analysis. It outlines the steps to evaluate an economic analysis and highlights limitations including difficulty in implementation and bias. The document provides an overview of pharmacoeconomics as a tool to inform decision-making and optimize the allocation of healthcare resources.
This document discusses pharmacoeconomics and provides an overview of key concepts. It defines pharmacoeconomics as identifying, measuring, and comparing the costs, risks, and benefits of drug therapies to determine the most cost-effective option. The document outlines different types of economic evaluations including cost-effectiveness analysis, cost-utility analysis, and quality-adjusted life years. It also discusses the current state of pharmacoeconomics in India and its potential to help inform healthcare decisions by considering both clinical and economic outcomes of drug therapies.
Following topics are covered in this slide deck:
Role and use of Pharmacoeconomics and health outcomes research | Impact of price regulation in India | Factors affecting drug pricing | Need, challenges and components of pharmacoeconomics | Aims, Objectives and principle of Pharmacoeconomic Evaluation | Different types of cost measurement | The Methods of Pharmacoeconomic Evaluation | Cost Analysis (CUA)
1. The document discusses pharmacoeconomics in India, including guidelines for conducting pharmacoeconomic evaluations. Some key guidelines covered include identifying relevant perspectives and comparators, choosing appropriate analytical techniques, establishing appropriate time horizons, and properly accounting for costs and effects.
2. Case studies on the cost-effectiveness of treating osteoarthritis pain and deep vein thrombosis are provided. For osteoarthritis, NSAIDs may be more cost-effective than COX-II inhibitors due to lower costs and risks, depending on risk of GI issues. For deep vein thrombosis, low molecular weight heparin enables outpatient treatment due to lower monitoring needs despite higher costs.
3. Pharmacoeconomics can help inform healthcare decisions
Pharmacoeconomics evaluates the costs and outcomes of pharmaceutical products and services. It involves choosing a perspective such as patient or payer, identifying costs which can be direct, indirect, or intangible, and identifying outcomes which can be clinical, economic, or humanistic. Common pharmacoeconomic methodologies include cost-consequence analysis, cost-of-illness evaluation, cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Pharmacoeconomics is important for achieving maximum benefits with limited costs and aids decision making for formularies, policies, and resource allocation.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
Pharmacoeconomics evaluates the costs and outcomes of pharmaceutical products and programs. It aims to improve resource allocation and healthcare spending. The document outlines key pharmacoeconomics concepts like perspectives, methodologies, and applications. Cost-benefit analysis compares monetary costs and benefits. Cost-effectiveness analysis expresses outcomes in natural units to compare cost per outcome. Pharmacoeconomics informs decisions on drug development, reimbursement, and policy to optimize value from limited healthcare resources.
Strategy to incorporate pharmacoeconomics into pharmacotherapy Ravi Kumar Yadav
Pharmacoeconomics of the health care intervention is equally important like the safety and efficacy of drug. The various strategies are available to incorporate pharmacoeconomics into pharmacotherapy. The most popular strategies for applying pharmacoeconomics to assess the value of pharmaceutical products and services include using the results of published pharmacoeconomic studies, building economic models, and conducting pharmacoeconomic research.
Health outcomes research is seen as a cost-effective investment in measuring and defining value of new innovations in health care. We provide an overview of field and its applications
This document defines pharmacoeconomics and outlines its key principles and methods. Pharmacoeconomics is defined as the description and analysis of the costs of drug therapy to health systems and society. It considers the economic relationships of drug research, production, distribution, and use. Methods of pharmacoeconomics include cost-of-illness analysis, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These methods are used to evaluate healthcare programs and therapies to determine the optimal use of resources. Pharmacoeconomics can help inform decisions around drug formularies, new drug approvals, and pharmaceutical policies.
Pharmacoeconomic Assessment through Market Approval and Beyond: Theory and Op...Medpace
Pharmacoeconomic assessment of a drug, medical device, or other healthcare product can take on many forms and occur at multiple points in the development cycle. Cost-effectiveness analysis, a major component of pharmacoeconomic assessment, has traditionally occurred in the later phases of product development—either as a piggy-back to a phase III or pivotal clinical trial, or peri-authorization.
The document discusses improving health outcomes and reducing costs through better use of molecular diagnostics. It notes that health care expenditures have significantly increased worldwide over recent decades and are predicted to continue rising. The current model of developing new diagnostics provides inadequate incentives and validation may not reflect real-world use. The Partnership for Precision Medicine (PPM) introduces a new, collaborative model of diagnostic development that engages health systems and payers. PPM aims to identify high-impact diagnostic opportunities, validate promising candidates within healthcare settings, and assess real-world impact on patient management and costs.
This presentation explains the main features of medicines which will be developed and authorised via the adaptive pathways. It provides a definition of real world evidence and the caveats associated with the use and analysis of real world evidence in drug development.
Four strategies to upgrade clinical trial quality in this computerized world ...Pubrica
• Biostatistics Services is important for collecting, reviewing, presenting, and interpreting data in clinical research.
• Applications of clinical biostatistics services are in different areas, such as epidemiology, clinical trials, population genetics, the biology of structures, and more.
Reference : https://pubrica.com/services/research-services/biostatistics-and-statistical-programming-services/
Continue Reading: http://bit.ly/36nwtcs
Why Pubrica?
When you order our services, Plagiarism free|onTime|outstanding customer support|Unlimited Revisions support|High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44- 74248 10299
How to Define Effective and Efficient Real World TrialsTodd Berner MD
This document discusses strategies for designing effective and efficient real-world clinical trials. It covers topics such as using real-world evidence to inform clinical trial design, the differences between efficacy and effectiveness, challenges around representativeness in trial populations, and the value of pragmatic clinical trials. It also discusses leveraging electronic health records for condition-specific prompts and clinical decision support to improve performance and quality of care.
How to design effective and efficient real world trials TB Evidence 2014 10.2...Todd Berner MD
This document discusses strategies for designing effective and efficient real-world clinical trials. It covers topics such as using real-world evidence to inform clinical trial design, the differences between efficacy and effectiveness, challenges in defining quality metrics, and strategies for improving performance within healthcare systems. The document provides information on pragmatic clinical trials and how real-world evidence could reduce costs compared to traditional clinical trials.
Paying for performance to improve the delivery of health interventions in LMICsReBUILD for Resilience
This presentation from Sophie Witter & Karin Diaconu of Queen Margaret University, UK outlines the findings from a Cochrane review undertaken by the team on paying for performance to improve the delivery of health interventions in low and middle-income countries.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
The document discusses the growing importance of demonstrating value through evidence for biotech companies when engaging with payers. It outlines how health technology assessments and real-world evidence are being used by payers globally to determine coverage, reimbursement, and contracting. Additionally, it explores emerging innovative contracting models between payers and manufacturers that are shifting focus to outcomes over utilization and sharing risk.
Quality, Risk & Compliance: Risk Management for Sponsors, Site, and CROsMedpace
This document discusses risk management in clinical trials from multiple perspectives. It provides statistics on the high costs and time required to bring new drugs to market. It defines quality as an absence of errors that matter and compliance as adherence to regulatory and GCP requirements. Key aspects of risk management are identified, including risk identification, evaluation, control, and review. Process mapping and risk assessment tools are presented. Quality by design and continual improvement concepts are also covered.
This document summarizes the proceedings of an advisory panel meeting to discuss potential research topics for improving healthcare systems and patient outcomes. It provides an overview of the Patient-Centered Outcomes Research Institute's (PCORI) mission to fund research that discovers new information, allows for better decision making, and leads to better patient outcomes. Key areas of focus for potential research include care for chronic conditions, cancer, palliative care, pregnancy, and patients with multiple chronic conditions. The document discusses criteria for prioritizing research topics and provides brief summaries of 15 potential research topics for the advisory panel to review and rate.
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Predicting Patient Adherence: Why and HowCognizant
To contain costs and improve healthcare outcomes, players across the value chain must apply advanced analytics to measure and understand patients’ failure to follow treatment therapies, and to then determine effective remedial action. This white paper lays out a framework for enabling patient adherence management and some general prescriptions on how to convert lofty concepts to meaningful action.
This document provides an overview of pharmacoeconomics. It defines pharmacoeconomics as the discipline concerned with optimal allocation of resources to maximize population health from medicine use. It discusses different types of pharmacoeconomic analyses including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It also covers key concepts in pharmacoeconomics like cost classification, outcomes, perspectives, and the cost-effectiveness plane. The document concludes that pharmacoeconomics relates patients, society, and the economy to drug therapy.
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
Evaluating the impact of HTA and ‘better decision-making’ on health outcomescheweb1
This document outlines a conceptual framework for assessing the impact of health technology assessments (HTA). It begins by discussing what is already known about evaluating HTA, including the limited literature on long-term effects and barriers to implementation. The document then presents two case studies and proposes a theory-driven, realist approach to impact assessment using configurations of context, mechanism, and outcomes. Interviews and primary data collection are suggested to test an initial program theory regarding how and why HTA influences policy and practice. The goal is to produce guidance on effective implementation by understanding what works, for whom, and in what contexts.
The document discusses evidence-based medicine (EBM) and its role in healthcare decision making. Some key points:
- EBM involves systematically reviewing and appraising clinical research to determine the most effective treatments.
- Decisions about healthcare provision and resources are increasingly driven by evidence on clinical effectiveness and outcomes.
- Multiple sources of evidence are evaluated to establish levels of evidence, with randomized controlled trials considered the gold standard.
- Systematic reviews and meta-analyses that synthesize data from multiple studies can provide more precise estimates of treatment effects.
- EBM informs guidelines and policies at strategic, tactical and individual levels to encourage use of proven effective practices.
Similar to Pharmacoeconomic Assessment through Market Approval and Beyond (20)
2. Agenda for Today’s Presentation
2 Physician Led | Therapeutically Focused
o Eat Lunch
o Try to Stay Awake!!!
o Overview of Pharmacoeconomic (PE) Assessment
o Planning PE Assessment
o Real World PE (RWPE) Assessment
o Implementing RWPE Assessment
o Working with Data
o Closing Considerations
o Questions
4. Types of PE Assessment to be Discussed
4 Physician Led | Therapeutically Focused
o Cost-minimization analysis
o Cost-effectiveness analysis
o Cost-utility analysis
o Budget impact modeling
5. Cost-Minimization Analysis (CMA)
5 Physician Led | Therapeutically Focused
o Compare costs of two or more drugs or therapies
to determine least costly option
Baseline costs include acquisition costs as well as
costs of preparation and administration
Additional costs depend on perspective of analysis
o Main benefit: cheaper and easier than cost-
effectiveness analysis
o Main drawback: assumption that two drugs or
therapies are used at equivalently effective doses
6. Cost-Effectiveness Analysis (CEA)
6 Physician Led | Therapeutically Focused
o Considers both costs and effectiveness of two or
more drugs or therapies
Costs measured in monetary unit of interest (Eg, $)
Effectiveness generally measured using one or more
clinical outcome (Eg, years of life saved)
o Main outcome is incremental cost-effectiveness
ratio (ICER): (∆ Costs / ∆ Effectiveness)
Eg, incremental cost per life year saved
o ICER compared against willingness-to-pay (WTP)
thresholds to determine if cost-effective, cost-
saving, or cost-neutral
8. Cost-Utility Analysis (CUA)
8 Physician Led | Therapeutically Focused
o CEA accounting for quality of time gained or lost
o Quality of life (QOL) measured using utility
Generally ranges from 0 (dead) to 1 (perfect QOL)
o Most common ICER assessed in CUA is cost per
quality-adjusted life year (QALY) gained
9. Budget Impact Modeling (BIM)
9 Physician Led | Therapeutically Focused
o Generally designed for specific audiences,
particularly third party payers
o Measures net cumulative treatment cost with drug
or therapy of interest for specified number of
patients in particular population
o Impact of particular drug or therapy is assessed
as effect on cost per member per month (PMPM)
10. Perspective of PE Assessment
10 Physician Led | Therapeutically Focused
o Who pays for treatment and who benefits?
o Potential perspectives include:
Healthcare provider
Third party payer
Society
o Different perspectives mean different considerations
13. PE Assessment at Different Phases
13 Physician Led | Therapeutically Focused
o Phase II
o Earlier phase III
o Phase III piggyback studies
o Peri-authorization
o Post-authorization
o Contemporaneous with later Phase III is common
but can consider earlier Phase III or Phase II
o Collection of RWPE data?
14. Planning PE Assessment
14 Physician Led | Therapeutically Focused
o Plan must consider:
Disease area
• Acute vs. chronic vs. oncology?
• Recurrence timeframe?
All relevant phases
Sponsor budget
• CEA for publication vs. BIM for use with payers?
16. Why RWPE?
16 Physician Led | Therapeutically Focused
o Differentiation in costly yet lucrative landscape
$2.6 billion to bring new drug to market (Tufts CCSD)
o Development cycle does not end with approval
Real world research, including RWPE, can drive new
earlier phase research, in turn driving new real world
research
Sustain value across product lifecycle
o Collect extensive effectiveness and safety data
More relevant than literature-based models
More robust than earlier phase clinical data
o True cost-effectiveness rather than cost-efficacy
17. Are Payers the True Decision Makers?
17 Physician Led | Therapeutically Focused
o Roles of FDA and payers, including Medicare and
Medicaid, are constantly evolving
Correcting Signals for Innovation in Healthcare
Medicaid expansion under Affordable Care Act
o Drug approval becoming “easier” (Forbes)?
2008: 50% of NMEs approved by FDA
2014: 88% of NMEs approved
o US District Court ruling re: Amarin’s Vascepa®
o Increased emphasis on generation and
dissemination of evidence aimed at payers
Real World Evidence/Outcomes liaisons
18. 18 Physician Led | Therapeutically Focused
o Three recommendations:
1. Replace tax exclusion for employer-provided health
insurance with tax credit
2. Strengthen Medicare coverage determination
process
3. Experiment with reference pricing for certain
therapies in Medicare
o RWPE can inform last two recommendations
19. Epidemiologic Study Designs
(by Traditional Strength of Evidence)
19 Physician Led | Therapeutically Focused
1. Randomized controlled trial
2. Community trial
3. Prospective cohort study
4. Retrospective cohort study
5. Case-control study
6. Cross-sectional study
7. Ecologic study
8. Case report or case series
Observational
Interventional
Descriptive
Analytic
Strength of evidence: ability to establish causal link
20. Real World/Observational Epidemiology
20 Physician Led | Therapeutically Focused
o Data gathered in naturalistic (real world) setting
o Variables of interest include:
Exposure
• Harmful (Eg, behavior) or protective (Eg, drug, vaccine)
Outcome
• Disease or health state
• Time to event
Potential confounders
o If treatment involved, prescribed in usual manner
Therapy assignment not decided in advance by protocol
No diagnostic or monitoring procedures other than those
ordinarily applied
21. RWPE Builds on Observational Epidemiology
o Registries are cohort studies
Specifically prospective and retrospective cohort studies
21 Physician Led | Therapeutically Focused
24. RWPE Means Dynamic
Data Collection and Analysis
24 Physician Led | Therapeutically Focused
o Specifically, continually updated data streams
allow for refinement of CEA and BIMs to reflect
most up-to-date data, providing consistently
refreshed ICER and PMPM cost estimates
o How is this implemented?
Dedicated processes
25. Dedicated Processes for RWPE
o Protocol must describe study challenges and
methods for resolution, while addressing (Giezen
et al. 2009, Kiri 2012):
Ecological validity
Achievable study objectives
Tailored operational processes
Study Design and Protocol
25 Physician Led | Therapeutically Focused
26. Dedicated Processes for RWPE
o Ensure straightforward navigation for electronic
case report forms (eCRFs)
o Provide guidance for online queries
o Design database to be flexible and easy to use
o Include all stakeholders in design as well as any
changes
Sites
Analysts
Submissions team (if relevant)
eCRF Design and Development
26 Physician Led | Therapeutically Focused
27. Dedicated Processes for RWPE
o Obtain permissions and licenses
o Validate per FDA guidance
o Address HIPAA and security concerns
o Plan for incorporating PRO data into PE
assessment
Ie, primary EQ-5D scores are preferred source of
utility data for NICE
Patient Reported Outcomes (PROs)
27 Physician Led | Therapeutically Focused
28. Dedicated Processes for RWPE
o Incorporate alerts into analysis dataset programs
o Use templates designed for repeated delivery
o Design output programs with locked, validated
modules as well as modules that are intended to
evolve and change
o Structure eCRF rules to promote easy updates
o Normalize dataset design and use of metadata to
support multiple data cuts
Programming and Data Governance
28 Physician Led | Therapeutically Focused
30. Merging Data from Multiple Sources
o RWPE involves coordination with healthcare
providers and payers to collect regularly
refreshed, relevant data such as electronic health
records (EHR), PROs, and costs/reimbursements
o Timing and costs of implementation are concerns
o Therefore, data collection must be as efficient as
possible
Efficiency derives from well-designed and well-
integrated electronic data capture (EDC) system
The Crux of the Matter for RWPE
30 Physician Led | Therapeutically Focused
31. Cost/Reimbursement Data Sources
31 Physician Led | Therapeutically Focused
o Patient records at doctor’s office
CMS 1450 (UB04 Uniform Bill)
o Claims databases
Medicare and private
o Coding
CPT, other codes
o RED BOOK
o Published literature
o Government reports
32. o Real world effectiveness study
Prospective cohort
Retrospective cohort
o Claims data
Standalone
Link with study data
Data Sources: Effectiveness and Claims
32 Physician Led | Therapeutically Focused
=
Payer
Study
Payer Study
33. Merging Data from Multiple Sources
CDISC Healthcare Link Initiative
33 Physician Led | Therapeutically Focused
34. Merging Data from Multiple Sources
FDA EHR Demonstration Project
34 Physician Led | Therapeutically Focused
35. Merging Data from Multiple Sources
National Claims Database?
35 Physician Led | Therapeutically Focused
36. Merging Data from Multiple Sources
o Standardize any coding as well as definitions of events
and outcomes (Abbing et al. 2010, Blake et al. 2012,
Andrews et al. 2012)
o Foster harmonization across multiple sources by using
common data model (Coloma et al. 2011)
Standardized input files can be created from each
database, linked via patient ID, and managed locally
o Develop storage system making individual databases
accessible from common platform as anonymized data
at appropriate level
Based on common data model in compliance with
guidelines relevant for each database (Trifirò et al. 2014)
Process should involve stakeholders for each database
Some Thoughts
36 Physician Led | Therapeutically Focused
37. Target Data for Hybrid EHR Sourcing
37 Physician Led | Therapeutically Focused
Problem data for
EHR systems
Stop dates
Scaled data
Surveys/PROs
Costs
Better data for
EHR systems
Coded for payments
Already transactional
(lab systems,
pharmacy)
Most problematic
data for sites
High volume
Complex
Query-prone
Research vs.
Healthcare
Labs
Meds
39. Recruitment and Retention
39 Physician Led | Therapeutically Focused
o Well-integrated EDC, EHR, and ePRO will
enhance retention of sites and patients
o Recruitment populations for RWPE studies differ
from populations for interventional trials
o RWPE studies tend to be longer
Direct impact on site motivation
o Gauging and developing site experience and
motivation are essential in optimizing enrollment
Establishing study expectations from outset
Capacity for integration with EDC?
Training?
40. Too Much of a Good Thing?
40 Physician Led | Therapeutically Focused
41. In Other Words…
41 Physician Led | Therapeutically Focused
o … is RWPE worth the hassle?
o Blommenstein et al. conclude…
o In short, YES, if done properly and efficiently
42. Future Considerations
42 Physician Led | Therapeutically Focused
o Product development cycle does not end with
approval
o PE assessment in earlier and later phases,
including RWPE, is essential to demonstrating
product value
o Real world research, including RWPE, can drive
innovation
o RWPE demonstrates market leadership
o Flexibility is essential