The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
How to Measure Health Outcomes that Matter to EveryoneHealth Catalyst
To measure health outcomes that matter to everyone, it’s important to ask several questions before starting out:
How do regulatory requirements differ from outcomes improvement?
Do the measurements align with organizational goals and values?
Are the measurements worth the resources required to document them?
Will the metrics actually be applied to outcomes improvement?
Who are the beneficiaries of the outcomes improvement initiative?
The answers to these questions help save time and resources, sustain and expand the improvement effort, refine the list of measures to those that truly improve outcomes, and most of all, help avoid the outcomes measures graveyard.
Population-adjusted treatment comparisons: estimates based on MAIC (Matching-...cheweb1
This document summarizes a seminar on population-adjusted treatment comparisons using the matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) methods. It discusses how these methods can be used to adjust for imbalances in effect modifiers between trials when indirectly comparing treatments that have not been directly compared head-to-head. The seminar outlines the assumptions of these methods, provides recommendations for their appropriate use, and emphasizes the importance of justifying choices, specifying the target population, and adhering to reporting guidelines.
The document discusses alternative forms of health financing being tested or used in various countries to help people afford healthcare and avoid poverty from medical costs, such as community-funded insurance, microcredit services for insurance, taxes on goods like tobacco, and prioritizing resources currently spent on non-essential activities. Examples of health financing systems used in African countries include general tax revenue, donor funding, mandatory and voluntary insurance, community-based insurance, and exemptions from fees. While increasing tax revenue is difficult, improving tax compliance and efficiency along with gradually introducing alternative financing options may help fund healthcare.
Australia has a mixed public-private healthcare system. The public system is funded through Medicare, which provides universal healthcare access and subsidizes medical costs. Medicare is funded through a 2% tax levy. The government also jointly funds public hospitals with state governments. Private health insurance can be used to cover additional costs. Overall, Australia's healthcare system is considered high-quality and affordable.
- Canada has a publicly funded healthcare system that is administered on a provincial/territorial level and provides universal coverage to all Canadian citizens for medical treatments, hospitals, and dental surgery.
- The system is decentralized, with each province and territory responsible for funding and delivering most healthcare services. It is publicly financed through taxes but has faced political debates around privatization and wait times.
- Canada boasts high life expectancy and low infant mortality rates attributed to its healthcare system, though it faces challenges around physician shortages and balancing federal/provincial roles in healthcare governance.
This document discusses discounting in health economic evaluation. It begins by explaining that discounting is used to adjust future costs and health outcomes to their present value due to time preference. Individuals prefer benefits now rather than in the future. It then discusses guidelines for discount rates, debates around uniform vs. differential discounting, and how discounting impacts evaluations. It emphasizes the need for consistent discounting principles and the role of governments in setting rates considering national priorities and development status.
This document provides an introduction to budget impact analysis (BIA). It discusses that BIA is an economic assessment that estimates the financial consequences of adopting a new healthcare intervention. It notes that BIA is an essential part of comprehensive economic assessments along with cost-effectiveness analysis. The document outlines the key components of a BIA, including estimating the eligible patient population, time horizon, current and future treatment costs, and changes in disease-related costs. It also discusses presenting the changes in annual healthcare budget impact. The document compares BIA and economic evaluation, and provides considerations for BIA such as substitution, combination, and expansion effects of new interventions.
A Review of Health Financing in NamibiaHFG Project
This document reviews health financing in Namibia. It finds that while Namibia's GDP growth is expected to slow in the short term, limiting additional resources for health, GDP growth is projected to improve after 2017. Currently, Namibia relies heavily on indirect taxes and SACU revenues, though it aims to broaden its tax base. High unemployment and a large informal sector pose challenges. The government provides most health services, while the private sector is financed through medical aid funds. Overall, Namibia's fiscal capacity indicates potential to increase health spending in the medium term by expanding its domestic revenue and improving government efficiencies.
How to Measure Health Outcomes that Matter to EveryoneHealth Catalyst
To measure health outcomes that matter to everyone, it’s important to ask several questions before starting out:
How do regulatory requirements differ from outcomes improvement?
Do the measurements align with organizational goals and values?
Are the measurements worth the resources required to document them?
Will the metrics actually be applied to outcomes improvement?
Who are the beneficiaries of the outcomes improvement initiative?
The answers to these questions help save time and resources, sustain and expand the improvement effort, refine the list of measures to those that truly improve outcomes, and most of all, help avoid the outcomes measures graveyard.
Population-adjusted treatment comparisons: estimates based on MAIC (Matching-...cheweb1
This document summarizes a seminar on population-adjusted treatment comparisons using the matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) methods. It discusses how these methods can be used to adjust for imbalances in effect modifiers between trials when indirectly comparing treatments that have not been directly compared head-to-head. The seminar outlines the assumptions of these methods, provides recommendations for their appropriate use, and emphasizes the importance of justifying choices, specifying the target population, and adhering to reporting guidelines.
The document discusses alternative forms of health financing being tested or used in various countries to help people afford healthcare and avoid poverty from medical costs, such as community-funded insurance, microcredit services for insurance, taxes on goods like tobacco, and prioritizing resources currently spent on non-essential activities. Examples of health financing systems used in African countries include general tax revenue, donor funding, mandatory and voluntary insurance, community-based insurance, and exemptions from fees. While increasing tax revenue is difficult, improving tax compliance and efficiency along with gradually introducing alternative financing options may help fund healthcare.
Australia has a mixed public-private healthcare system. The public system is funded through Medicare, which provides universal healthcare access and subsidizes medical costs. Medicare is funded through a 2% tax levy. The government also jointly funds public hospitals with state governments. Private health insurance can be used to cover additional costs. Overall, Australia's healthcare system is considered high-quality and affordable.
- Canada has a publicly funded healthcare system that is administered on a provincial/territorial level and provides universal coverage to all Canadian citizens for medical treatments, hospitals, and dental surgery.
- The system is decentralized, with each province and territory responsible for funding and delivering most healthcare services. It is publicly financed through taxes but has faced political debates around privatization and wait times.
- Canada boasts high life expectancy and low infant mortality rates attributed to its healthcare system, though it faces challenges around physician shortages and balancing federal/provincial roles in healthcare governance.
This document discusses discounting in health economic evaluation. It begins by explaining that discounting is used to adjust future costs and health outcomes to their present value due to time preference. Individuals prefer benefits now rather than in the future. It then discusses guidelines for discount rates, debates around uniform vs. differential discounting, and how discounting impacts evaluations. It emphasizes the need for consistent discounting principles and the role of governments in setting rates considering national priorities and development status.
This document provides an introduction to budget impact analysis (BIA). It discusses that BIA is an economic assessment that estimates the financial consequences of adopting a new healthcare intervention. It notes that BIA is an essential part of comprehensive economic assessments along with cost-effectiveness analysis. The document outlines the key components of a BIA, including estimating the eligible patient population, time horizon, current and future treatment costs, and changes in disease-related costs. It also discusses presenting the changes in annual healthcare budget impact. The document compares BIA and economic evaluation, and provides considerations for BIA such as substitution, combination, and expansion effects of new interventions.
A Review of Health Financing in NamibiaHFG Project
This document reviews health financing in Namibia. It finds that while Namibia's GDP growth is expected to slow in the short term, limiting additional resources for health, GDP growth is projected to improve after 2017. Currently, Namibia relies heavily on indirect taxes and SACU revenues, though it aims to broaden its tax base. High unemployment and a large informal sector pose challenges. The government provides most health services, while the private sector is financed through medical aid funds. Overall, Namibia's fiscal capacity indicates potential to increase health spending in the medium term by expanding its domestic revenue and improving government efficiencies.
- Cluster randomization trials are experiments where intact social units like medical practices, communities, or hospitals are randomly assigned to intervention groups rather than independent individuals. This is done when the intervention is naturally applied at a cluster level or to avoid treatment contamination between groups.
- Challenges of cluster randomization trials include having a unit of randomization that differs from the unit of analysis and reduced power due to intracluster correlation. Statistical methods like mixed models that account for clustering are needed to properly analyze results.
- Proper sample size calculations are also more complex in cluster randomization trials due to the need to adjust for the intracluster correlation coefficient and design effect. Ensuring enough clusters are enrolled is important to maintain adequate power
Lect 1.b THE BUILDING BLOCKS OF A HEALTH SYSTEM - notes pp.pptxAYONELSON
The document discusses the six building blocks of a health system according to the WHO framework: service delivery, health workforce, health information, medical products and technologies, health financing, and leadership/governance. These building blocks constitute the essential functions of a health system and must be strong to achieve goals of improved health, responsiveness, social/financial risk protection, and efficiency. Uganda employs this framework to strengthen its health system through programs focused on these building blocks at district and national levels.
Health financing strategies uhc 27 09 12Vikash Keshri
This document discusses health financing strategies for universal health coverage. It begins by defining universal health coverage and providing historical perspectives. It then discusses the current state of health financing in India, including low public spending, high private out-of-pocket expenditures, and variations between states. The document outlines that achieving universal health coverage requires raising sufficient funds, removing financial barriers, and using resources efficiently. It examines strategies for generating more health resources, utilizing resources effectively to prevent waste, and proposes the key recommendations of India's High Level Expert Group on universalizing access to affordable healthcare.
This document discusses different types of economic analyses used to evaluate health interventions and policies, including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It defines each type of analysis, how costs and outcomes are measured, and how alternatives are compared. Cost-effectiveness analysis is the most commonly used type for health care decisions. It compares interventions based on cost per unit of health outcome gained, such as cost per life-year or cost per case prevented. Conducting a cost-effectiveness analysis involves defining objectives, structuring alternatives, calculating costs and outcomes, and comparing cost-effectiveness ratios to determine the most efficient intervention.
The document discusses the history and implementation of the Affordable Care Act (ACA) in the United States. It passed in 2010 with the goals of increasing access to healthcare and reducing costs. While it helped reduce the uninsured rate, there have been ongoing issues with the healthcare exchanges and limited provider networks. The execution of the ACA has contributed to a shortage of primary care doctors due to compensation rates and impacted jobs and small businesses with its coverage mandates. Educating new doctors and nurses will take years to address the increased demand caused by the ACA.
This document provides an overview of randomized control trials (RCTs). It discusses key aspects of RCT design including types of RCTs based on interventions evaluated (explanatory vs pragmatic), participants exposed (parallel vs crossover), number of participants (from n-of-1 trials to mega-trials), blinding of investigators/participants, and accounting for participant preferences. It also covers randomization techniques and their advantages, sample size calculations, and references for further information.
This document discusses criteria for determining causal association. It defines association and different types of association, including spurious, indirect, and direct causal association. Bradford Hill's criteria for making causal inferences are described, including strength of association, dose-response relationship, consistency of findings, biological plausibility, specificity of association, and temporal relationship. Examples for each criterion are provided, such as the relationship between smoking and lung cancer. The document concludes with a summary of association types and causal association criteria.
The document discusses different types of epidemiological studies, including descriptive studies like case reports and case series that focus on person, place and time to create hypotheses. Analytical studies like case-control and cohort studies are used to test hypotheses by being either observational or interventional. Randomized controlled trials are the gold standard for comparing new interventions. Observational analytical studies include cross-sectional, cohort and case-control designs, while interventional analytical studies are clinical trials. The appropriate study design depends on the research goals and objectives.
Healthcare Crisis| Canada and Ontario| Analysis and Commentary| May 2019paul young cpa, cga
This presentation will look at funding of healthcare along with the issues facing the delivery of healthcare dollars by the provinces and territories as part of improving patient care.
Cost effective analysis in health care (Nursing) Naveen J HNaveen j h
Cost-effective analysis (CEA) is used to identify the most cost-effective way to achieve social and health goals when directly quantifying benefits in monetary terms is difficult. CEA calculates a cost-effectiveness ratio by dividing total costs by units of effectiveness. For example, comparing the costs and patient outcomes of different medical diagnostic machines. While one machine costs less per diagnosis, a more expensive machine could diagnose many more patients. CEA is applied in the document to compare costs and outcomes of different wound care and antenatal visit approaches. CEA seeks the best alternative to minimize resource use and achieve desired results.
Health is important for overall well-being and quality of life. Maintaining good physical and mental health requires making healthy lifestyle choices related to diet, exercise, stress management, and avoiding risky behaviors. Living a healthy lifestyle can help prevent disease and disability and allow people to stay active and independent as they age.
Drug dose adjustment for liver diseasesNeha Suresh
This document discusses drug dose adjustment for liver diseases. It explains that the liver is important for drug elimination and abnormalities can affect drug clearance and metabolism. Diseases like hepatitis, carcinoma, necrosis and cirrhosis impact drug elimination by decreasing hepatic clearance and increasing half-life. The hepatic extraction ratio determines if a drug is highly, intermediately or poorly extracted by the liver, affecting how liver disease impacts dosing. Drugs with low hepatic extraction are more dependent on liver function, so doses may need adjustment for liver disease. Antipyrine, which is only eliminated by the liver, is used to assess hepatic abnormalities.
Us health care system final presentation.Wendi Lee
Wendi Evans is pursuing a degree in health care administration. This presentation will provide an overview of the history and current state of the US healthcare system, including defining key terms, outlining milestones from 1900 to present, comparing the US system to Canada's, and discussing reforms and stakeholders. The summary will discuss the establishment of organized medicine in the US in the 1900s, the passage of Medicare and Medicaid in the 1960s, the implementation of the Affordable Care Act in 2010, and reforms aimed at improving quality and lowering costs.
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
This document provides an overview of cost-effectiveness analysis (CEA) and how it can be used to compare different interventions that aim to reduce the same outcome, such as diarrhea. CEA measures the cost of an intervention relative to its impact on a single predefined outcome. The document outlines CEA of different interventions to reduce diarrhea incidence and their associated impacts and costs. It then discusses how to conduct a comparative CEA of education programs, including standardizing cost and impact estimates to common units to facilitate comparison.
The Ottawa Charter for Health Promotion was developed at the first International Conference on Health Promotion in 1986. It outlines five areas of action to achieve health promotion by the year 2000: build healthy public policy, create supportive environments, strengthen community actions, develop personal skills, and reorient health services toward health promotion. The Charter calls for governments, health services, and communities to work together to support policies and actions that create physical and social environments conducive to health.
The document describes the System of Objectified Judgement Analysis (SOJA) process for rational drug selection. SOJA involves prospectively defining criteria for drug selection, determining the relative weight of each criterion, and scoring each drug on how well it fulfills the criteria. An expert panel determines the scores and weights based on factors like clinical efficacy, safety, dosing frequency, drug interactions, and cost. The document provides details on how SOJA addresses and scores each selection criterion in a standardized, evidence-based manner to facilitate objective, transparent comparisons among drugs.
This document provides an overview of budgeting in health care systems and health care financing. It defines budgeting as a statement of future plans in quantitative and monetary terms for a specific period, usually one year. It discusses the types of budgets, approaches to budgeting such as incremental, performance-based and zero-based budgeting. The document also outlines the budgeting procedure in India and highlights challenges to health care budgeting. Finally, it defines health care financing, discusses its principles and models, and trends in financing health care in India.
This document provides an overview of conceptual frameworks for understanding health systems. It defines a health system as all organizations, people and actions whose primary intent is to promote, restore or maintain health. It discusses several frameworks developed by the WHO and others to conceptualize the different components, actors and relationships within health systems. It acknowledges that health systems are complex and dynamic, with unpredictable paths of implementation for interventions. The document emphasizes that health systems should be viewed holistically as interconnected systems centered around people.
This document discusses the four types of conditionals in English. Type 0 conditionals use the present simple tense and are used to express general truths. Type 1 conditionals use the present simple and future simple tenses to express possible conditions and probable results. Type 2 conditionals use the past simple and present continuous tenses to express hypothetical conditions and probable results. Type 3 conditionals use the past perfect and conditional perfect tenses to express unreal past conditions and probable past results. Examples are provided for each type of conditional.
Este documento discute las encuestas en línea y su ventaja sobre las encuestas en papel. Explica que las encuestas en línea permiten una distribución más rápida a miles de encuestados de manera simultánea con costos reducidos. También menciona que las redes sociales como Facebook son una herramienta útil para la comunicación corporativa y distribución de encuestas debido a su alcance global e interactividad. Finalmente, señala que los resultados de las encuestas en línea son más fáciles de analizar e interpretar a
- Cluster randomization trials are experiments where intact social units like medical practices, communities, or hospitals are randomly assigned to intervention groups rather than independent individuals. This is done when the intervention is naturally applied at a cluster level or to avoid treatment contamination between groups.
- Challenges of cluster randomization trials include having a unit of randomization that differs from the unit of analysis and reduced power due to intracluster correlation. Statistical methods like mixed models that account for clustering are needed to properly analyze results.
- Proper sample size calculations are also more complex in cluster randomization trials due to the need to adjust for the intracluster correlation coefficient and design effect. Ensuring enough clusters are enrolled is important to maintain adequate power
Lect 1.b THE BUILDING BLOCKS OF A HEALTH SYSTEM - notes pp.pptxAYONELSON
The document discusses the six building blocks of a health system according to the WHO framework: service delivery, health workforce, health information, medical products and technologies, health financing, and leadership/governance. These building blocks constitute the essential functions of a health system and must be strong to achieve goals of improved health, responsiveness, social/financial risk protection, and efficiency. Uganda employs this framework to strengthen its health system through programs focused on these building blocks at district and national levels.
Health financing strategies uhc 27 09 12Vikash Keshri
This document discusses health financing strategies for universal health coverage. It begins by defining universal health coverage and providing historical perspectives. It then discusses the current state of health financing in India, including low public spending, high private out-of-pocket expenditures, and variations between states. The document outlines that achieving universal health coverage requires raising sufficient funds, removing financial barriers, and using resources efficiently. It examines strategies for generating more health resources, utilizing resources effectively to prevent waste, and proposes the key recommendations of India's High Level Expert Group on universalizing access to affordable healthcare.
This document discusses different types of economic analyses used to evaluate health interventions and policies, including cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. It defines each type of analysis, how costs and outcomes are measured, and how alternatives are compared. Cost-effectiveness analysis is the most commonly used type for health care decisions. It compares interventions based on cost per unit of health outcome gained, such as cost per life-year or cost per case prevented. Conducting a cost-effectiveness analysis involves defining objectives, structuring alternatives, calculating costs and outcomes, and comparing cost-effectiveness ratios to determine the most efficient intervention.
The document discusses the history and implementation of the Affordable Care Act (ACA) in the United States. It passed in 2010 with the goals of increasing access to healthcare and reducing costs. While it helped reduce the uninsured rate, there have been ongoing issues with the healthcare exchanges and limited provider networks. The execution of the ACA has contributed to a shortage of primary care doctors due to compensation rates and impacted jobs and small businesses with its coverage mandates. Educating new doctors and nurses will take years to address the increased demand caused by the ACA.
This document provides an overview of randomized control trials (RCTs). It discusses key aspects of RCT design including types of RCTs based on interventions evaluated (explanatory vs pragmatic), participants exposed (parallel vs crossover), number of participants (from n-of-1 trials to mega-trials), blinding of investigators/participants, and accounting for participant preferences. It also covers randomization techniques and their advantages, sample size calculations, and references for further information.
This document discusses criteria for determining causal association. It defines association and different types of association, including spurious, indirect, and direct causal association. Bradford Hill's criteria for making causal inferences are described, including strength of association, dose-response relationship, consistency of findings, biological plausibility, specificity of association, and temporal relationship. Examples for each criterion are provided, such as the relationship between smoking and lung cancer. The document concludes with a summary of association types and causal association criteria.
The document discusses different types of epidemiological studies, including descriptive studies like case reports and case series that focus on person, place and time to create hypotheses. Analytical studies like case-control and cohort studies are used to test hypotheses by being either observational or interventional. Randomized controlled trials are the gold standard for comparing new interventions. Observational analytical studies include cross-sectional, cohort and case-control designs, while interventional analytical studies are clinical trials. The appropriate study design depends on the research goals and objectives.
Healthcare Crisis| Canada and Ontario| Analysis and Commentary| May 2019paul young cpa, cga
This presentation will look at funding of healthcare along with the issues facing the delivery of healthcare dollars by the provinces and territories as part of improving patient care.
Cost effective analysis in health care (Nursing) Naveen J HNaveen j h
Cost-effective analysis (CEA) is used to identify the most cost-effective way to achieve social and health goals when directly quantifying benefits in monetary terms is difficult. CEA calculates a cost-effectiveness ratio by dividing total costs by units of effectiveness. For example, comparing the costs and patient outcomes of different medical diagnostic machines. While one machine costs less per diagnosis, a more expensive machine could diagnose many more patients. CEA is applied in the document to compare costs and outcomes of different wound care and antenatal visit approaches. CEA seeks the best alternative to minimize resource use and achieve desired results.
Health is important for overall well-being and quality of life. Maintaining good physical and mental health requires making healthy lifestyle choices related to diet, exercise, stress management, and avoiding risky behaviors. Living a healthy lifestyle can help prevent disease and disability and allow people to stay active and independent as they age.
Drug dose adjustment for liver diseasesNeha Suresh
This document discusses drug dose adjustment for liver diseases. It explains that the liver is important for drug elimination and abnormalities can affect drug clearance and metabolism. Diseases like hepatitis, carcinoma, necrosis and cirrhosis impact drug elimination by decreasing hepatic clearance and increasing half-life. The hepatic extraction ratio determines if a drug is highly, intermediately or poorly extracted by the liver, affecting how liver disease impacts dosing. Drugs with low hepatic extraction are more dependent on liver function, so doses may need adjustment for liver disease. Antipyrine, which is only eliminated by the liver, is used to assess hepatic abnormalities.
Us health care system final presentation.Wendi Lee
Wendi Evans is pursuing a degree in health care administration. This presentation will provide an overview of the history and current state of the US healthcare system, including defining key terms, outlining milestones from 1900 to present, comparing the US system to Canada's, and discussing reforms and stakeholders. The summary will discuss the establishment of organized medicine in the US in the 1900s, the passage of Medicare and Medicaid in the 1960s, the implementation of the Affordable Care Act in 2010, and reforms aimed at improving quality and lowering costs.
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
This document provides an overview of cost-effectiveness analysis (CEA) and how it can be used to compare different interventions that aim to reduce the same outcome, such as diarrhea. CEA measures the cost of an intervention relative to its impact on a single predefined outcome. The document outlines CEA of different interventions to reduce diarrhea incidence and their associated impacts and costs. It then discusses how to conduct a comparative CEA of education programs, including standardizing cost and impact estimates to common units to facilitate comparison.
The Ottawa Charter for Health Promotion was developed at the first International Conference on Health Promotion in 1986. It outlines five areas of action to achieve health promotion by the year 2000: build healthy public policy, create supportive environments, strengthen community actions, develop personal skills, and reorient health services toward health promotion. The Charter calls for governments, health services, and communities to work together to support policies and actions that create physical and social environments conducive to health.
The document describes the System of Objectified Judgement Analysis (SOJA) process for rational drug selection. SOJA involves prospectively defining criteria for drug selection, determining the relative weight of each criterion, and scoring each drug on how well it fulfills the criteria. An expert panel determines the scores and weights based on factors like clinical efficacy, safety, dosing frequency, drug interactions, and cost. The document provides details on how SOJA addresses and scores each selection criterion in a standardized, evidence-based manner to facilitate objective, transparent comparisons among drugs.
This document provides an overview of budgeting in health care systems and health care financing. It defines budgeting as a statement of future plans in quantitative and monetary terms for a specific period, usually one year. It discusses the types of budgets, approaches to budgeting such as incremental, performance-based and zero-based budgeting. The document also outlines the budgeting procedure in India and highlights challenges to health care budgeting. Finally, it defines health care financing, discusses its principles and models, and trends in financing health care in India.
This document provides an overview of conceptual frameworks for understanding health systems. It defines a health system as all organizations, people and actions whose primary intent is to promote, restore or maintain health. It discusses several frameworks developed by the WHO and others to conceptualize the different components, actors and relationships within health systems. It acknowledges that health systems are complex and dynamic, with unpredictable paths of implementation for interventions. The document emphasizes that health systems should be viewed holistically as interconnected systems centered around people.
This document discusses the four types of conditionals in English. Type 0 conditionals use the present simple tense and are used to express general truths. Type 1 conditionals use the present simple and future simple tenses to express possible conditions and probable results. Type 2 conditionals use the past simple and present continuous tenses to express hypothetical conditions and probable results. Type 3 conditionals use the past perfect and conditional perfect tenses to express unreal past conditions and probable past results. Examples are provided for each type of conditional.
Este documento discute las encuestas en línea y su ventaja sobre las encuestas en papel. Explica que las encuestas en línea permiten una distribución más rápida a miles de encuestados de manera simultánea con costos reducidos. También menciona que las redes sociales como Facebook son una herramienta útil para la comunicación corporativa y distribución de encuestas debido a su alcance global e interactividad. Finalmente, señala que los resultados de las encuestas en línea son más fáciles de analizar e interpretar a
Tips for Selecting the Right Learning Management SystemLambda Solutions
This document discusses tips for selecting the right learning management system (LMS). It outlines the key benefits of an LMS, including automating management, centralized training, blended learning, assigning training to groups, assessing learning, and improving compliance tracking and reporting. The document also discusses important business considerations like cost, time, human resources, and requirements. Additionally, it covers the different LMS options of proprietary vs. open source systems and key features to look for in a modern LMS like integration and reporting/analytics.
Ta'lim Muta'allim - Bab 13 - Rizki Dan Panjang Usia Bagian 2Fatkul Amri
Materi kitab Ta'lim Muta'allim bab 13 bagian kedua yang membahas tentang hal-hal yang bisa mendatangkan rizki dan menjauhkannya, dan yang memperpanjang usia serta mengurangi usia.
Este documento presenta información sobre la comunicación a lo largo de la historia. Explica que los primeros humanos utilizaban lenguajes primitivos para comunicarse y realizaban pinturas como primeras formas de expresión escrita. Luego, las primeras civilizaciones como los sumerios y egipcios desarrollaron sistemas de escritura más complejos en tablillas de arcilla y papiro. A través de los griegos y romanos, los alfabetos evolucionaron hasta llegar al alfabeto latino moderno. La invención de la imprent
Emerging & High-Growth Markets: The Next Mobile GenerationAdvertiseMint
Presentation provided by team at https://www.facebook.com/blueprint
In this Webinar, Jennifer Spies, Pancham Gajjar, and Ashley Zandy talk about advertising strategies that help you succeed in an emerging mobile-centric world. Not only do they give you tips and current statistics about mobile, but they also provide predictions for 2020.
Presentation uploaded by team at https://www.advertisemint.com/
Este documento presenta información sobre la comunicación a lo largo de la historia. Explica que los primeros humanos utilizaban lenguajes primitivos para comunicarse y realizaban pinturas como primeras formas de expresión escrita. Luego, las primeras civilizaciones como los sumerios y egipcios desarrollaron sistemas de escritura más complejos en tablillas de arcilla y papiro. A través de los años, los alfabetos evolucionaron y se extendieron por el mundo. La invención de la imprenta revolucionó la comunicación al permit
Este documento presenta una visión personal sobre el desarrollo full stack. Comienza explicando la motivación del autor para aprender sobre las diferentes capas de un sistema, y cómo esto le permite tomar mejores decisiones. Luego describe su viaje personal desde los stacks académicos hasta los profesionales, incluyendo ejemplos de diferentes stacks como web, móvil y escritorio. Finalmente, discute conceptos como bloques de construcción, arquitecturas de capas y comunicaciones entre microservicios.
The document considers three potential locations for taking photos for a magazine: Gadebridge Park, the Old Town, and Camden in London. Gadebridge Park has varied areas and lighting options but natural light could be impacted by weather. The Old Town has different backgrounds close to Gadebridge Park but also relies on natural light. Camden offers diverse backgrounds but would be difficult to access and is always busy, potentially interfering with photos.
5 Ways Enterprise Companies Can Respond to Reviews Glassdoor
Best practices for responding to Glassdoor reviews.
Angela Mancuso, Chief People Officer at Pampered Chef
Dominique Sorresso, Senior Account Manager at Gla
Este documento resume las características y usos de tres tecnologías biométricas: NFC, lectores de retina y lectores de huella digital. NFC permite la comunicación inalámbrica de dispositivos móviles a corta distancia. Los lectores de retina analizan los vasos sanguíneos en la retina para identificación y los lectores de huella digital leen y almacenan patrones únicos de huellas dactilares para autenticación.
Este documento presenta una prueba de entrada para niños de 3 años que evalúa habilidades en matemáticas y comunicación. La prueba de matemáticas incluye tareas como encerrar figuras, colorear formas geométricas, y relacionar números con grupos. La prueba de comunicación implica identificar rimas, unir partes para formar figuras, y describir imágenes. También se pide al niño imitar sonidos de animales y dibujar "Un día en el parque".
Lesson 2 Understanding Linux File SystemSadia Bashir
The document provides an overview of Linux file systems and file types. It discusses:
1) The main types of files in Linux including directories, special files, links, sockets and pipes.
2) The standard Linux directory structure and the purpose of directories like /bin, /sbin, /etc, and /usr.
3) Common Linux file extensions and hidden files that begin with a dot.
4) Environment variables and how they can be used to customize a system.
5) Symbolic links and how they create references to files without copying the actual file.
El legado andalusí y la Escuela de Arte de Granada han participado en el encuentro que, recientemente, ha tenido lugar en Budapest. Allí, El legado andalusí ha presentado a esta Escuela como ejemplo de buenas prácticas, en el apartado Acceso a la innovación en el diseño y asistencia financiera a la pequeña y mediana empresa, con la explicación de los proyectos “Mi proyecto en la Red” y “Educación y cultura emprendedora”. La presentación corrió a cargo de Susana Vellarino, profesora de fotografía artística de la Escuela.
“Mi proyecto en la red” es una oferta complementaria de formación que se lleva a cabo con la colaboración de Conecta13. La finalidad es que los alumnos participantes puedan iniciar su actividad profesional en la web utilizando, para ello los canales más adecuados y evaluar su impacto, a la vez que comienzan a construir una red de profesionales y personas interesadas en sus creaciones y actividades en torno a ellos.
El proyecto “Educación y cultura emprendedora” es también una oferta complementaria de formación, con el objetivo de impulsar el espíritu emprendedor y fomentar las vocaciones empresariales. Cuenta con la colaboración de la Asociación de Jóvenes Empresarios (AJE Granada) y Fundación Andalucía Emprende. Ambos proyectos están dirigidos al alumnado de los Estudios que se imparten en el centro: Estudios Superiores de Diseño. Ciclos de Grado Medio de Artes Plásticas y Diseño. Ciclos de Grado Superior de Artes Plásticas y Diseño. Bachillerato de Artes Plásticas, Diseño e Imagen.
Ein Strategie für viele Marken - IA Konferenz 2016 - BerlinLutz Schmitt
Wie der Schweizer Detail-Händler Coop seine Online-Aktivitäten neu strukturiert. Ein Vortrag von Lutz Schmitt zum IA Konferenz-Thema "Vision, Strategie, Produkt".
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.
WHITE PAPER: What’s Next in US Payor Communications: The Impact of FDA's Prop...Nathan White, CPC
This white paper from ApotheCom discusses new FDA guidance on communicating healthcare economic information to payors as outlined in the 21st Century Cures Act. Key points:
- The Cures Act establishes guidelines for communicating information on the economic impact of drugs and devices to payors.
- In response, FDA issued draft guidance to clarify what can be communicated about approved drugs to payors.
- The guidance defines payors as including formulary committees and outlines standards for ensuring communicated analyses are scientifically valid and relate to approved drug indications.
- The changes aim to increase transparency while allowing industry to demonstrate treatment value to payors.
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
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.
What quality measures does the MCO have in placeSolutionManag.pdfformicreation
What quality measures does the MCO have in place?
Solution
Managed care organizations (MCOs) are responsible for ensuring that persons enrolled in their
plans receive quality health care. In addition, MCOs publicly funded through the Medicare and
Medicaid programs are required by State and Federal governments to meet certain quality
standards.
To fulfill their responsibilities, MCOs need ready access to a comprehensive array of evidence-
based clinical information and other clinical performance measures to enable them to evaluate
their providers\' performance and identify areas where improvement is needed. They also need to
know how their members feel about the care they receive and the way they are treated. Finally,
they need to ensure that both their providers and members are aware of the most recent
preventive care recommendations.
Valid, reliable, and cost-effective measurement tools must be available to make such
determinations, but these tools have not always been available. Furthermore, because the science
of performance measurement is relatively new, additional measures need to be developed and
those that have been developed can be improved. Therefore, to ensure that their enrollees in
MCOs receive high-quality care, MCOs need a reliable source to provide the most current and
scientifically sound tools.
In response to this need, the Agency for Healthcare Research and Quality (AHRQ) has funded
research to compile a database of evidence-based clinical guidelines and to develop clinical
performance measures, member satisfaction surveys, and preventive care recommendations that
can help MCOs meet their responsibilities. Additionally, AHRQ funds research and develops
performance measures and guidelines that MCOs, insurers, providers, and consumers can trust.
This report describes these tools and how they have been used and provides information on
where to learn more about them.
Background
Around one-half of insured Americans are enrolled in some form of managed care. However, as
the number of persons enrolled in MCOs increased in the 1990s, health care purchasers,
policymakers, and other stakeholders became concerned about the potential for health care
quality to diminish. In their view, the policies and practices imposed by MCOs to reduce what
MCOs define as unnecessary care might result in patients not receiving needed care. Therefore,
MCOs faced accreditation systems and other requirements to ensure that patients were receiving
the most appropriate care.
More recently, MCOs have had to address other emerging concerns such as: Rapid introduction
of new technologies, Data showing unexplained variations in the provision of care, Severe cost
pressures.
These factors have provided additional motivation to MCOs to develop systematic ways of
preserving and enhancing health care quality and cost-effectiveness.
Evidence-based practice guidelines and performance measures were developed to help ensure
that patients always receive the most appropri.
The late phase research environment has become more complex due to increased regulatory demands from the FDA and EMA for comprehensive safety data. Sponsors must begin planning late phase studies earlier in the investigative process and work with strategic research partners to effectively plan studies that address therapeutic, regulatory and economic concerns. Failing to take early action can result in costly delays and failure to obtain drug approval. Effective planning is essential to navigating today's complex late phase research landscape.
1) The document discusses how to capture patient-reported outcomes (PROs) and patient experiences to demonstrate value from the patient's perspective when securing access to treatments.
2) It notes that traditional clinical measures cannot capture how patients feel or function, so patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are needed.
3) The document argues that capturing the patient voice through PROMs/PREMs and involving patient groups can help define patient-relevant outcomes and the full value of treatment, including quality of life benefits, which are increasingly important to health technology assessments and payers.
New microsoft office power point presentationEmani Aparna
Therapeutic guidelines are clinical practice guidelines that focus on treatment recommendations. They are developed by healthcare providers through a systematic process involving a literature review, obtaining expert opinions, developing recommendations, and assessing quality of evidence. Therapeutic guidelines provide standardized treatment protocols to improve patient outcomes and reduce healthcare costs. They are published in medical databases, websites of organizations like the American Heart Association, and government sources.
This webinar provides insight into how the drug approval process affects what prescription drugs are available to patients in Canada. The presentation will cover the following topics: Who is responsible for prescription drug approval in Canada? How does the drug approval process impact patient access to medication? How can patients be involved in the drug approval process?
The Role of Real-World Evidence in Supporting a Product's Value StoryCovance
Randomized clinical trials (RCTs) are the gold standard for gaining regulatory approval for marketing authorization for medical products. RCTs typically measure short-term efficacy and safety of a product compared to placebo in a fairly homogeneous population and under ideal, controlled conditions. In contrast, the real world consists of a heterogeneous population in which patient care is much less controlled and thus, more complex. Treatment decisions made in this setting are predicated on a wider array of co-morbid conditions, competing medications, physician preference and risk of adverse events than those observed in RCT populations. Evidence generated from real-world settings reflects this complexity, complementing evidence derived from rigorously controlled RCTs.
About this Webinar: This presentation will discuss the pathway to pharmaceutical treatments in Canada that involve health technology assessment reviews and decision making. Observations on the current challenges and the importance of patient input to inform decision making will also be discussed. Finally, the key elements that can be critical to successful outcomes will be presented.
The document provides an overview of the Agency for Healthcare Research and Quality's (AHRQ) Effective Health Care Program. It describes the program's goals of conducting comparative effectiveness research to inform healthcare decisions. It outlines the key players and their roles, including Evidence-based Practice Centers that conduct evidence syntheses, stakeholders that provide input, and dissemination of findings to patients and policymakers.
This document provides an overview and agenda for an Applicant Town Hall meeting hosted by the Patient-Centered Outcomes Research Institute (PCORI) on August 22, 2013. The agenda includes introductions of PCORI staff, an overview of PCORI's mission and focus on comparative clinical effectiveness research, details on funding opportunities and requirements, and a question and answer session. Key points covered are PCORI's focus on patient-centered outcomes research, engagement of patients and stakeholders, and criteria for funding including impact, potential to improve outcomes, technical merit, and patient-centeredness.
The Canadian Hemophilia Society advocated for access to the innovative drug emicizumab (Hemlibra) for Canadians with hemophilia A between 2018-2021. After initial delays, the drug was approved for patients with inhibitors in May 2019 but advocacy continued for broader access. Health technology assessments recommended against funding due to perceived lack of evidence, though patients reported a high disease burden. Advocacy efforts included surveys, letters, media stories, and behind-the-scenes discussions. In August 2021, Quebec partially approved funding while the rest of Canada approved broader public funding in September 2021.
Clinical Pharmacology: Leveraging Science to Provide AccessE. Dennis Bashaw
1) The document discusses the paradigm shift in biomarker development from a "learn and confirm" model to an "identify, confirm, refine, and learn" model to continuously learn from clinical trials.
2) It outlines policies used by the FDA to incentivize orphan drug development, including expedited programs, marketing exclusivity, and fee reductions. International collaboration is important for developing policies tailored to individual countries.
3) Successful partnerships between the FDA, NIH, patient groups, and industry have helped advance rare disease drug development, including through biospecimen repositories and training programs.
This document discusses regulatory approval and reimbursement for new medical technologies. It notes challenges with rising costs and uncertainty of drug development. It describes expedited FDA pathways like Fast Track, Priority Review, and Breakthrough Therapy Designation. While approval and coverage don't always align, experiences with parallel FDA/CMS review and conditional approvals in Europe aim to better link evidence standards. Adaptive pathways could approve technologies for narrow uses with commitments for further study. The goal is improving development efficiency and patients' access to promising new options.
> 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
Similar to What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance on Communication of Healthcare Economic Information (20)
The Rise of Value-Based Contracting for Biopharmaceuticals and Medical Techno...Nathan White, CPC
ICON Access, Commercialisation & Outcomes (ACC) - November 2017 Pricing & Market Access Briefing
AUTHORS:
Michael Pace
Senior Principal, Pricing and Market Access
Guy Sherwin
Lead Consultant, EU Pricing and Market Access
The document provides an overview of an educational session on outcomes-based contracting between specialty pharmaceutical manufacturers and payers. It begins with four learning objectives, which focus on explaining the benefits of outcomes-based contracting, identifying considerations in designing such contracts, and describing tools for assessing patient response to therapy. It then provides information on continuing education credit for attendees, discloses the presenters' financial relationships, and reviews antitrust guidelines. The presentation aims to educate on the rationale for and experience with outcomes-based contracting programs.
This document summarizes a virtual conference on market access in the era of specialty and biotech drugs. It notes that by 2016, 8 of the top 10 worldwide drugs will be specialty drugs. It also discusses industry trends of developing more targeted therapies, a substantial pipeline of specialty drugs, and the need to demonstrate value to payers facing high costs. Upcoming sessions at the conference will address recent payment developments like accountable care organizations, comparative effectiveness research, and CMS coverage policies.
This document discusses considerations for launching a specialty product. It emphasizes the importance of demonstrating value through clinical and cost effectiveness data, ensuring patient access to therapy, and generating data to support value claims. It provides tips for defining goals, building an integrated team, and refining a launch strategy focused on these priorities. The strategy should consider innovative contracting, outcomes-based agreements, and communicating the right evidence to the right audiences. Overall, the document stresses that demonstrating value is critical for specialty product launches, especially with increased attention on healthcare costs.
The document discusses the future of patient assistance programs (PAPs) and integrated patient assistance programs (IPAPs). It notes that PAPs of the future could serve as an evidence development platform by collecting premium patient data and establishing patient bases for outcomes studies. It also discusses the growing importance of outcomes data in risk sharing agreements and billions in federal funding for comparative effectiveness research. Finally, it outlines the role of the Patient Centered Outcomes Research Institute in administering federal research contracts and identifies next steps for engaging in partnerships to conduct outcomes research using PAP/IPAP patient populations.
BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011Nathan White, CPC
This document summarizes a presentation on creating an optimal commercial reimbursement landscape for pharmaceutical products. The presentation discusses the complexities of proving value to payers in light of healthcare reform uncertainties and a changing regulatory environment. It provides two case studies on companies that failed to consider reimbursement challenges and offers lessons on strategic planning to meet regulatory and reimbursement needs. The goal is developing a clinical and regulatory strategy that ensures reimbursement resonance with payers and reduces patient access barriers.
WEBINAR: Developing Payer Evidence: The Role of Post Approval ProgramsNathan White, CPC
This document discusses the role of post-approval programs in developing evidence for payers. It notes that payers are increasingly interested in using patient-reported outcomes (PROs) to guide coverage decisions. Commercial programs that interact with patients after drug approval, such as reimbursement support, patient assistance, and adherence programs, can help generate real-world evidence on effectiveness and outcomes. Observational studies and registries established in the post-approval period can help manufacturers meet safety surveillance requirements while also documenting a treatment's clinical, economic, and humanistic value.
Three companies faced challenges commercializing new products in the US healthcare system:
Company A scrapped a lab diagnostic project due to lack of differentiated clinical value and reimbursement approval.
Company B's injectable biologic faced poor adoption due to label restricting administration and causing coverage under medical instead of pharmacy benefit with more hurdles.
Company C helped increase utilization of its artificial disc replacement through an appeals program that collected patient quality of life data to submit personalized appeal packages on behalf of surgeons and patients, lowering administrative burden.
G There is an increased trend toward the use of health-economic and value terminology in medical journals from 2006 to 2009, with "cost effectiveness" appearing most frequently.
G Of the four key terms identified ("cost effectiveness", "comparative effectiveness", "reimbursement", and "coverage"), "comparative effectiveness" saw the largest increase over this period in core clinical journals.
G However, there is observed to be a lack of consistency in how these health-economic terms are used and understood within the context of evolving definitions related to healthcare value.
The document discusses challenges facing the healthcare industry and opportunities for collecting patient-reported outcomes data to inform coverage decisions. It notes the industry faces a "perfect storm" of healthcare reform uncertainties like expanding coverage and cost containment. Patient-reported outcomes data from registries, reimbursement programs, and adherence programs could provide evidence of effectiveness and be valuable to payers, but how and whether it will be used by decision-makers remains unclear. The document calls for developing more effective patient-reported outcomes instruments and engaging payers on how this data can be integrated into their coverage policies.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance on Communication of Healthcare Economic Information
1. ApotheCom Educational Series
What’s Next In US Payor Communications:
The Impact of FDA’s Proposed Guidance on
Communication of Healthcare Economic Information
March 23, 2017
New York | Philadelphia (Yardley) | San Diego | San Francisco | London | Dubai | Auckland | Shanghai | Singapore
2. For more than 15 years, Mr. White has been offering clients advice on global, US, and European market access and reimbursement
challenges. Nathan began his career at Express Scripts, working in leadership, field-based, and internal operational roles in the specialty
pharmacy and reimbursement support program divisions. He spent more than five years designing and implementing reimbursement
operational solutions at PAREXEL Consulting and inVentiv Health, before shifting into global market access consulting roles as Director of
Market Access at Nucleus Global and Managing Director and Head of Market Access at eMAX Health Systems. In 2016, he joined
ApotheCom to lead the Access Pathways and Outcomes practice. Nathan has a BS in Community Health from State University of New
York and is a Certified Professional Coder (CPC) in medical billing/coding.
Today’s
Presenter
● Environmental impact assessment
● Competitive analysis
● Internal value assessment workshops
About Us
ApotheCom, part of Huntsworth Health, is an integrated global medical affairs, RWE, and market access solutions firm, providing market
access and value research/analytics, medical education and marketing, and scientific publication services to the life sciences industries.
NATHAN WHITE, CPC
Executive Vice President and Global Practice Lead
Access Pathways and Outcomes
● Mixed method market research
● Advisory boards
● HTA/payor consultations
● HTA analysis
● Internal evidence assessment
● HTA/payor archetyping
● Burden of disease research
● Value message development
● Message resonance testing
● HTA submissions
● Value dossiers and payor comm. tools
● Outcomes-based contracting strategy
● RWE generation
● Health economic modeling
● Patient programs
3. Learning Objectives
Upon completion of this session, participants should be able to:
Understand history in communications of health economic information
in the US
Understand the proposed guidance by the FDA surrounding communications
with payors about healthcare economic information, related to both approved
and investigational drugs and medical devices
Relate the guidance to practical, operational, and organizational changes
that need to occur in medical affairs, market access, and HEOR departments
1
2
3
NOTE: Quotations throughout this training are derived from Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers. Guidance
for Industry and Review Staff. Published Jan 2017.
4. History of US HEOR Communications Policy
FDAMA first defined healthcare economic information (HCEI) in an amendment of the
FD&C Act (21 U.S.C. 352(s)) (section 502(a)).
For nearly 35 years, the health economics field continued to develop until it was formally
recognized in US health policy with the modernization of the FDA (FDAMA).
1930 2017
Food Drug
and Cosmetic
Act passed
FDA
Modernization
Act enacted
21st Century
Cures Act
enacted
Health
economics
field begins
1938 1963 1997 2016
5. CURES Provisions For Industry
CURES will change the review and approval process as provisions are implemented over the coming years.
Becoming law on December 13, 2016, CURES gives 7 key provisions to manufacturers,
viewed as mostly positive to industry interests.
Expedited review process for certain drugs
Facilitate recognition of drug outcome measures
Acknowledge RWE as a valuable tool for
regulatory approval
Priority Review Vouchers (PRV) for national
security threat countermeasures
Continuation of rare pediatric disease PRVs
Scope and appropriateness of HCEI
dissemination
Publication requirement of manufacturer
expanded access policies
• CURES requires FDA to develop and implement a framework for an RWE evaluation program
by end of 2018 (section 3022)
• Support approval of a new indication for an approved drug and support/satisfy post-approval study requirements
6. RWE Provisions in CURES
The design of the framework is left largely up to the HHS Secretary –
it may include public/private partnerships and 3rd party research organizations.
CURES requires the HHS Secretary to implement a framework for evaluation of RWE by
December 2018 and publish draft guidance on the program by December 2021.
1. Support approval for a
new indication for a
previously approved drug
2. Support or satisfy
requirements for
postapproval studies
PROGRAM GOALS
CONTENTS OF FRAMEWORK
• Sources of real world evidence, including ongoing safety surveillance,
observational studies, registries, claims, and patient-centered outcomes
research activities
• Gaps in data collection activities
• Standards and methodologies for collection and analysis of real world evidence
• Priority areas, remaining challenges, and potential pilot opportunities
Circumstances for use of RWE, standards, and methodologies
will be outlined in draft guidance from HHS.
7. Definition of HCEI
The guidance adds that HCEI can be presented in an evidence dossier, publication reprint,
budget impact model, or modelling software (not a comprehensive list).
“HCEI pertains to the economic consequences related to the clinical outcomes of treating a
disease (or specific aspect of a disease) or of preventing or diagnosing a disease.”
• Any analysis that identifies, measures, or describes the economic consequences
• Including the clinical data, inputs, clinical or other assumptions, methods,
results, and other components underlying or comprising the analysis
• May be based on the separate or aggregated clinical consequences of the
represented health outcomes, of the use of a drug
• Analysis may be comparative to:
• Use of another drug
• Another health care intervention
• No intervention
8. Introduction To Draft FDA Guidance
Guidance doesn’t establish legally enforceable responsibilities,
but describes FDA’s thinking and recommendations.
Guidance released in January 2017 aims to answer common questions surrounding communication of
HCEI to payors, formulary committees, and similar entities with expertise in healthcare economic analysis.
Communication of HCEI to payors regarding
approved drugs
Communications to payors about investigational
drugs and devices (investigational products)
1
2
Drug and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities –
Questions and Answers
Guidance for Industry and Review
Staff
10. Potential Recipients of HCEI
“Other multidisciplinary entities” “review scientific and technology assessments to make drug selection, formulary
management, and/or coverage and reimbursement decisions on a population basis for health care organizations.”
In order to be considered an audience to receive HCEI, the audience should have significant
knowledge and expertise in healthcare economic analysis.
Payors Formulary
Committees
Technology
Assessment
Panels
Drug
Information
Centers
PBMsOther
Multidisciplinary
Entities
HCPs Consumers
NOT
COVERED
11. Evidentiary Support
CARSE standards apply to all components of HCEI, including clinical outcomes
(e.g. safety and efficacy).
Based on “competent and reliable scientific evidence”
Based on good research practices developed by “authoritative bodies”
(e.g. ISPOR, PCORI)
Must include study design, methodology, generalizability, limitations, sensitivity
analysis, and information to provide a “balanced and complete presentation”
HCEI considered NOT false or misleading
IF
12. What is CARSE and why is it important?
CARSE is important because it is the pre-established framework for determining is information is
false or misleading, and required by law in the context of communicating HCEI.
CARSE is “generally-accepted scientific standards, appropriate for the information being conveyed
that yield accurate and reliable results.”
SOURCES: https://www.ftc.gov/sites/default/files/attachments/training-materials/substantiation.pdf
COMPETENT
AND
RELIABLE
SCIENTIFIC
EVIDENCE
CARSE is:
• Tests, studies or other scientific research
• Based on expertise of professionals in field
• Objectively conducted by qualified people
• Using procedures accepted as accurate
CARSE is not:
• Anecdotal evidence from customers
• Newspapers or magazine articles
• Sales material
• Low return rate or money-back guarantee
13. HCEI Analyses Related To Approved Indication
FDA provides the above examples of HCEI analyses that could be considered
“related to an approved indication of a drug.”
HCEI analyses should relate to the disease/condition, manifestation of the disease/condition, or symptoms
associated with the disease/condition in the FDA-approved-label patient population.
Duration of treatment
Practice setting
Burden of illness
Dosing
Patient subgroups
Length of hospital stay
Validated surrogate endpoints
Clinical outcome assessments or other health
outcome measure
Persistence Comparisons
14. HCEI Analyses NOT Related To Approved Indication
The following HCEI analyses are not considered to relate to an approved indication.
An economic analysis of disease
course modification related to use of
a drug that is approved only to treat
the symptoms of the disease
HCEI analyses derived from
studies in patient populations that
are not within the indicated
patient population
15. What To Include
FDA provides guidance on the five key components to include as part of their communication
of HCEI in order to maintain compliance with the law.
Study design and
methodology
Generalizability
Limitations
Sensitivity analysis
Additional material for a balanced
and complete presentation
16. Study Design and Methodology
• Describe the study type (e.g., cost minimization analysis, cost-effective analysis,
cost-utility analysis, cost benefit analysis, cost-consequence analysis)
• Include the rationale for choice of the type of analysis
Type of analysis
• Describe modeling technique, choice, scope, key parameters/variables
• Rationale and consequences
Modeling
• Number of patients and relevant demographic information, such as age, gender,
ethnicity, clinical characteristics, and socio-economic statusPatient population
• Clearly stated so payors can understand the rationale of selection of inputs
• Guides audience to determine relevance to their healthcare organizations
Perspective/
viewpoint
1
2
3
4
17. • Other drugs, other medical care, no treatment
Treatment
comparator
• Relation to major clinical and economic outcomes (e.g. safety, efficacy, economic
consequences)Time horizon
• Describe clinical and non-clinical data sources
• Example measures: PROs, QALYs
Outcome measures
• Resource items for treatment pathway valuation, price/cost data sources
• Disclosure of manipulations and assumptions (e.g. currency conversions, inflation)
Cost estimates
• Information related to patient demographics or characteristics, natural disease
course, disease management/clinical practice, and cost of clinical eventsAssumptions
5
6
7
8
9
Study Design and Methodology
18. What does “balanced and complete presentation” mean?
In addition to information related to study design/methodology, limitations, generalizability, and sensitivity
analysis, FDA further details what should be included in order to be considered balanced and complete.
Conspicuous and
prominent
statement
describing
material
differences FDA-approved
indication/ FDA-
approved labeling
Disclosure of
omitted studies or
data sources
Risk
information
Financial/
affiliation
biases
19. COAs and Other Health Outcome Measures
Patient health status data capture methodology
and rationale for inclusion in analysis
Health outcomes valuation methodology and
appropriateness for patient population, disease,
and/or condition
1
2
These two aspects
should be considered
to “facilitate
interpretability and
comprehensibility of
the information:”
20. OPDP Requirements
“HCEI disseminated in accordance with section 502(a) is promotion, and, therefore, is subject to FDA’s
requirements for submission of promotional materials.”
“These include, but are not limited to, the
post-marketing requirement at 384 21 CFR
314.81(b)(3)(i) to submit such materials to
FDA at the time of initial publication or
dissemination (using
Form FDA 2253 (Transmittal of 386
Advertisements and Promotional
Labeling for Drugs and Biologics for
Human 387 Use)”
“For HCEI about drugs submitted for
approval under the accelerated approval
pathway or about drugs approved based
on animal studies, the requirements
regarding pre-dissemination submission of
promotional materials”
21. Investigational Drugs and Devices
Communications by Firms to Payors Regarding
Investigational Drugs and Devices
22. Introduction
FDA provides much less guidance in communication with payors prior to FDA approval,
but does outline 7 key informational requirements.
“unbiased, factual, accurate, and non-misleading”
&
Product information
Information about the indication sought
Factual presentations of studies
Anticipated timeline for
approval/clearance
Product pricing information
Targeting/marketing strategies
Product-related programs/services
23. What additional information should be included?
FDA also suggest that manufacturers follow-up with payors as information becomes obsolete
due to new data and product information becoming available.
In addition to the 7 key informational requirements, FDA suggests that a investigational status
statement be accompanied by product development stage information.
“Clear statement that the
product is under investigation
and that the safety or
effectiveness of the product
has not been established”
“Information related to the stage
of product development”
25. Unanswered Questions
The public comment period ends on April 19, 2017; final guidance will be
published at a future unknown date.
ApotheCom will be working through questions and comments with key industry partners to identify
additional unanswered questions to submit to FDA during the public comment period.
Is FDA truly prepared for the additional workload for OPDP review of HCEI communications?
When and how frequently should a particular HCEI analysis be submitted to OPDP?
Do the required statements and supporting information need to be stated at every presentation of
each HCEI analysis, or just as the initial presentation? For example, does an abstract submission
containing HCEI need to include the supporting information if a poster will include the supporting
information? Will supporting information be required in an initial publication of a journal article?
Does clinical information from a pivotal trial become HCEI if it is used in the context of a model after
FDA approval?
Regarding communications with payors on investigational products, pricing and marketing strategies
may prove to be a challenge due to the highly sensitive nature of this information. How will industry
be assured confidentiality on these topics?
26. Key Learnings
The definitions of HCEI and payors are broad and therefore covers a wide range of study and analysis types, as well as
audience types.1
HCEI should not be false or misleading – in order to demonstrate that it is not, manufacturers should follow CARSE and good
practice guidance from authoritative bodies, as well as include detailed information on methodology, generalizability,
limitations, sensitivity analysis, and information to demonstrate a balanced and complete presentation.
2
HCEI should be related to an approved indication through one of a variety of analytical methods and study designs.3
HCEI communications with payors for approved products is considered promotional; thus, following regulatory guidance on
submission of promotional materials should be followed.4
Many unanswered questions remain related to practical implementation issues, particularly in relation to communication of
HCEI to payors on approved products.5