The document provides an overview of health technology assessment (HTA) processes and requirements in selected countries. It describes the status of HTA agencies, guidelines, selection criteria for drugs to review, preferred assessment approaches, weighting of clinical versus economic evidence, outcome measures, comparators, decision thresholds, cost perspectives, budget impact analysis requirements, and modeling and data requirements for each country. Countries discussed include Argentina, Colombia, Czech Republic, Hungary, Israel, Mexico, and Poland.
OHE Lecturing for Professional Training at International Centre of Parliament...Office of Health Economics
On 7th November 2018, Bernarda Zamora delivered a pro bono lecture to professionals from diverse countries enrolled at the Professional Certificate in Strategic Planning organised by the International Centre of Parliamentary Studies.
Author(s) and affiliation(s): Bernarda Zamora, Office of Health Economics
Conference/meeting: Professional Certificate in Strategic Planning organised by the International Centre of Parliamentary Studies
Location: Conference Centre, London
Date: Conference Centre, London
HCL's transformational Patient's first approach to HealthcareDebanjan Munsi
Digital Care management is the new buzzword in Healthcare technology, with the advent of digital technologies that track patient health, medicine subscriptions, dosages and create customized tracking, monitoring & delivery programs with regular dosage reminders, data driven insights on health vitals and patient routing to best possible treatment locations. Digital care management can not only reduce costs, but increase the vitality of healthcare programs, making them more efficient, decisive and customer friendly.
Dr. Shuli Brammli Greenberg Presentation 2017-10-25Etan Diamond
A presentation on how the work of the Myers-JDC-Brookdale Institute's Smokler Center for Health Policy impacts national reform of health policy, presented by Dr. Shuli Brammli Greenberg, Senior Researcher at the Smokler Center.
Deployment of the Medicare Access and CHIP Reauthorization ActPYA, P.C.
PYA Principal Martie Ross and Senior Manager Graham Fox presented, “Mastering MIPS" at the American College of Healthcare Executives’ Congress on Healthcare Leadership.
Learning objectives included:
Gaining an understanding of MIPS—why it was implemented and how it will impact reimbursement, governance, and strategic planning for healthcare organizations.
Identifying questions organizations must consider during MIPS implementation that will lead to financial and operational success.
OHE Lecturing for Professional Training at International Centre of Parliament...Office of Health Economics
On 7th November 2018, Bernarda Zamora delivered a pro bono lecture to professionals from diverse countries enrolled at the Professional Certificate in Strategic Planning organised by the International Centre of Parliamentary Studies.
Author(s) and affiliation(s): Bernarda Zamora, Office of Health Economics
Conference/meeting: Professional Certificate in Strategic Planning organised by the International Centre of Parliamentary Studies
Location: Conference Centre, London
Date: Conference Centre, London
HCL's transformational Patient's first approach to HealthcareDebanjan Munsi
Digital Care management is the new buzzword in Healthcare technology, with the advent of digital technologies that track patient health, medicine subscriptions, dosages and create customized tracking, monitoring & delivery programs with regular dosage reminders, data driven insights on health vitals and patient routing to best possible treatment locations. Digital care management can not only reduce costs, but increase the vitality of healthcare programs, making them more efficient, decisive and customer friendly.
Dr. Shuli Brammli Greenberg Presentation 2017-10-25Etan Diamond
A presentation on how the work of the Myers-JDC-Brookdale Institute's Smokler Center for Health Policy impacts national reform of health policy, presented by Dr. Shuli Brammli Greenberg, Senior Researcher at the Smokler Center.
Deployment of the Medicare Access and CHIP Reauthorization ActPYA, P.C.
PYA Principal Martie Ross and Senior Manager Graham Fox presented, “Mastering MIPS" at the American College of Healthcare Executives’ Congress on Healthcare Leadership.
Learning objectives included:
Gaining an understanding of MIPS—why it was implemented and how it will impact reimbursement, governance, and strategic planning for healthcare organizations.
Identifying questions organizations must consider during MIPS implementation that will lead to financial and operational success.
The Changing Healthcare System and Impact of MACRAPYA, P.C.
PYA Principal Lori Foley and Consulting Senior Aaron Elias co-presented “The Changing Healthcare System and Impact of MACRA” at the Physician Insurers Association of America’s CEO/COO Meeting.
The Medicare Access & CHIP Reauthorization Act (MACRA) dramatically affected Medicare reimbursements to healthcare providers, as well as provided a new framework for rewarding quality care and reporting on quality measurements. This incentive-based system has the potential not only to change how medicine is practiced, but influence patient perception of care. The presentation will provide the latest information on MACRA implementation, and will detail how the aforementioned changes will impact miscellaneous professional liability insurers.
PYA Highlights Next Steps of Meaningful UsePYA, P.C.
At the 2013 AICPA Healthcare Industry Conference, PYA Principal David McMillan and Senior Manager Chris Wilson recently explored the “new normal” of meaningful use as compliance and strategic standards in new care/reimbursement-model development.
State network-medicaid-expansion-tool-nga-webinar-finalsoder145
On September 27th, 2012, the National Governors Association (NGA) partnered with the State Network to host a webinar for state officials highlighting the Medicaid Expansion Analysis Tool in order to aid officials in their own state analyses. During the webinar, State Network experts from State Health Access Data Assistance Center, Center for Health Care Strategies, and Manatt Health Solutions walked through the cost and savings elements for Medicaid expansion financial analyses and state-specific assumption considerations. Additional financial impacts outside the table shell (e.g. disproportionate share hospital payments), as well as a list of state and national resources (with embedded hyperlinks), were included to help further guide states in conducting Medicaid expansion analyses.
Government cost containment methods in Asia-Pacific markets are as diverse as the cultures represented in the region, so what lessons are the markets leveraging from cost containment experiences? And what, in the end, are pharmaceutical companies supposed to do about it?
PYA Principal Carol Carden presented “Fundamentals of Healthcare Valuation” at the American Society of Appraisers (ASA) 2015 Advanced Business Valuation Conference. The presentation explored unique characteristics of the healthcare industry, particularly those relevant to appraisers for avoiding common mistakes in assessing risk and projecting cash flow.
PYA Principal Scott Clay presented “Pacing Volume-to-Value Transition” at the AlaHA Annual Meeting, June 8-11, 2016.
The presentation explored volume- to value-based reimbursement, and how the pace of change is unique to each organization. The presentation introduced a strategic framework to establish and communicate a pace of change befitting various organizations, explaining:
How government policies “set the floor” on the degree of change requested.
How to determine the pace of change in your market.
How to identify your organization’s current position and culture in relation to value-based payment models.
How to set and communicate the pace of transition consistent with your market and your organization’s culture.
In a C-Suite Resources presentation, Chairman Emeritus Don Wegmiller provided INTEGRATED with knowledge and insight into the state of the provider sector of healthcare today. Topics covered include new structures, reforms impacting providers, and provider challenges.
Financial Management In Healthcare PowerPoint Presentation SlidesSlideTeam
Presenting this set of slides with name - Financial Management In Healthcare Powerpoint Presentation Slides. This PPT deck displays fourty slides with in depth research. Our topic oriented Financial Management In Healthcare Powerpoint Presentation Slides presentation deck is a helpful tool to plan, prepare, document and analyse the topic with a clear approach. We provide a ready to use deck with all sorts of relevant topics subtopics templates, charts and graphs, overviews, analysis templates. Outline all the important aspects without any hassle. It showcases of all kind of editable templates infographs for an inclusive and comprehensive Financial Management In Healthcare Powerpoint Presentation Slides presentation. Professionals, managers, individual and team involved in any company organization from any field can use them as per requirement.
Section27 Health Reform Brief 1 July 2013Section 27
SECTION27 is proud to launch its Health Reform Briefs in an effort to broaden discussion about the different ways in which the health sector is changing. The briefs will look at reform in the health care sector through the lens of the Constitution and public interest, tying together economics, health systems theory and the law.
The first edition focuses on the design of NHI pilots. These briefs will be published every six weeks or so. If you would like to continue receiving these briefs, please send an email to: info@section27.org.za. And please share widely with others you think might be interested.
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
Sustainable financing of health and social services: Good health at low cost ...OECD Governance
This presentation was made by Mark Blecher, South Africa, at the 10th OECD-Asian Senior Budget Officials Annual Meeting held in Bangkok, Thailand, on 18-19 December 2014.
PYA Principal Martie Ross joined University of Kansas Medical Center’s Robert Moser, MD, and CIO Chris Hansen for the keynote presentation at the joint symposium by Heart of America Healthcare Information and Management Systems Society and Missouri Health Information Management Association, September 14, 2016, at Johnson County Community College in Overland Park, Kansas. They discussed insights related to the role of advanced analytics and technology in transforming and transitioning to new payment models.
Fiscal sustainability of health systems - Chris James & Camila Vammalle, OECDOECD Governance
This presentation was made by Chris James and Camila Vammalle, OECD, at the 4th meeting of the Joint DELSA/GOV-SBO Network on Fiscal Sustainability of Health Systems held in Paris, on 16-17 February 2015.
The Changing Healthcare System and Impact of MACRAPYA, P.C.
PYA Principal Lori Foley and Consulting Senior Aaron Elias co-presented “The Changing Healthcare System and Impact of MACRA” at the Physician Insurers Association of America’s CEO/COO Meeting.
The Medicare Access & CHIP Reauthorization Act (MACRA) dramatically affected Medicare reimbursements to healthcare providers, as well as provided a new framework for rewarding quality care and reporting on quality measurements. This incentive-based system has the potential not only to change how medicine is practiced, but influence patient perception of care. The presentation will provide the latest information on MACRA implementation, and will detail how the aforementioned changes will impact miscellaneous professional liability insurers.
PYA Highlights Next Steps of Meaningful UsePYA, P.C.
At the 2013 AICPA Healthcare Industry Conference, PYA Principal David McMillan and Senior Manager Chris Wilson recently explored the “new normal” of meaningful use as compliance and strategic standards in new care/reimbursement-model development.
State network-medicaid-expansion-tool-nga-webinar-finalsoder145
On September 27th, 2012, the National Governors Association (NGA) partnered with the State Network to host a webinar for state officials highlighting the Medicaid Expansion Analysis Tool in order to aid officials in their own state analyses. During the webinar, State Network experts from State Health Access Data Assistance Center, Center for Health Care Strategies, and Manatt Health Solutions walked through the cost and savings elements for Medicaid expansion financial analyses and state-specific assumption considerations. Additional financial impacts outside the table shell (e.g. disproportionate share hospital payments), as well as a list of state and national resources (with embedded hyperlinks), were included to help further guide states in conducting Medicaid expansion analyses.
Government cost containment methods in Asia-Pacific markets are as diverse as the cultures represented in the region, so what lessons are the markets leveraging from cost containment experiences? And what, in the end, are pharmaceutical companies supposed to do about it?
PYA Principal Carol Carden presented “Fundamentals of Healthcare Valuation” at the American Society of Appraisers (ASA) 2015 Advanced Business Valuation Conference. The presentation explored unique characteristics of the healthcare industry, particularly those relevant to appraisers for avoiding common mistakes in assessing risk and projecting cash flow.
PYA Principal Scott Clay presented “Pacing Volume-to-Value Transition” at the AlaHA Annual Meeting, June 8-11, 2016.
The presentation explored volume- to value-based reimbursement, and how the pace of change is unique to each organization. The presentation introduced a strategic framework to establish and communicate a pace of change befitting various organizations, explaining:
How government policies “set the floor” on the degree of change requested.
How to determine the pace of change in your market.
How to identify your organization’s current position and culture in relation to value-based payment models.
How to set and communicate the pace of transition consistent with your market and your organization’s culture.
In a C-Suite Resources presentation, Chairman Emeritus Don Wegmiller provided INTEGRATED with knowledge and insight into the state of the provider sector of healthcare today. Topics covered include new structures, reforms impacting providers, and provider challenges.
Financial Management In Healthcare PowerPoint Presentation SlidesSlideTeam
Presenting this set of slides with name - Financial Management In Healthcare Powerpoint Presentation Slides. This PPT deck displays fourty slides with in depth research. Our topic oriented Financial Management In Healthcare Powerpoint Presentation Slides presentation deck is a helpful tool to plan, prepare, document and analyse the topic with a clear approach. We provide a ready to use deck with all sorts of relevant topics subtopics templates, charts and graphs, overviews, analysis templates. Outline all the important aspects without any hassle. It showcases of all kind of editable templates infographs for an inclusive and comprehensive Financial Management In Healthcare Powerpoint Presentation Slides presentation. Professionals, managers, individual and team involved in any company organization from any field can use them as per requirement.
Section27 Health Reform Brief 1 July 2013Section 27
SECTION27 is proud to launch its Health Reform Briefs in an effort to broaden discussion about the different ways in which the health sector is changing. The briefs will look at reform in the health care sector through the lens of the Constitution and public interest, tying together economics, health systems theory and the law.
The first edition focuses on the design of NHI pilots. These briefs will be published every six weeks or so. If you would like to continue receiving these briefs, please send an email to: info@section27.org.za. And please share widely with others you think might be interested.
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
Sustainable financing of health and social services: Good health at low cost ...OECD Governance
This presentation was made by Mark Blecher, South Africa, at the 10th OECD-Asian Senior Budget Officials Annual Meeting held in Bangkok, Thailand, on 18-19 December 2014.
PYA Principal Martie Ross joined University of Kansas Medical Center’s Robert Moser, MD, and CIO Chris Hansen for the keynote presentation at the joint symposium by Heart of America Healthcare Information and Management Systems Society and Missouri Health Information Management Association, September 14, 2016, at Johnson County Community College in Overland Park, Kansas. They discussed insights related to the role of advanced analytics and technology in transforming and transitioning to new payment models.
Fiscal sustainability of health systems - Chris James & Camila Vammalle, OECDOECD Governance
This presentation was made by Chris James and Camila Vammalle, OECD, at the 4th meeting of the Joint DELSA/GOV-SBO Network on Fiscal Sustainability of Health Systems held in Paris, on 16-17 February 2015.
Webinar 3: Alternative Approaches to Innovative Drug Pricing – 12:00pm on Wednesday, May 13, 2020. The third webinar will review Canada’s approach to managing drug prices with approaches used in other jurisdictions. A panel will discuss experiences with oncology therapies, rare disease drugs, and therapies for pandemics and other urgent situations as points of reference toward evolving alternatives to the proposed PMPRB guidelines.
Panel:
Martina Garau, Director, Office of Health Economics, UK;
Sandra Anderson, Senior VP, Innomar Strategies
PG Forest, Director, School of Public Policy, University of Calgary
Durhane Wong-Rieger, President & CEO, CORD
Moderator: Bill Dempster, 3Sixty Public Affairs
Rowena Cullen
Victoria University of Wellington
(Friday, 11.00, Telehealth/mHealth)
In the evaluation of many technology-based interventions in the health sector there is a lack of information about the costs and benefits of the application. This is markedly so in the case of telemonitoring of home care patients with chronic diseases such as Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF). This paper provides a brief overview of the effectiveness of such systems as reported in the literature, and identifies a lack of rigorous cost benefit analysis in such reports. The paper investigates some issues related to cost benefit analysis where there are multiple levels of care providers involved in the delivery of care, and suggests that these issues need to be resolved in order to gain a better understanding of the true costs and benefits of telemonitoring chronic care support systems. This would assist the government, as the social planner, to identify the most cost effective solution, as well as the optimal clinical solution, for all stakeholders involved in telemonitoring programmes. It would also help identify the contribution of new telecommunications channels in optimising the returns on telehealth initiatives.
2023 — Focus on the Margin (Vitalware by Health Catalyst)Health Catalyst
In this webinar, we will look at pressures exerted in 2023 on the margin and explore how cost management and complete charge capture can protect and enhance the margin. We will provide details on patient activity costing versus the cost-to-charge ratio (CCR), looking at common themes for lost charges and providing an example of where patient activity cost management was able to provide insight into cost containment and practice patterns of a system provider.
Productivity in the health sector - Ivor Beazley, OECD SecretariatOECD Governance
This presentation was made by Ivor Beazley, OECD Secretariat, at the 7th meeting of the Joint OECD DELSA/GOV Network on Fiscal Sustainability of Health Systems held at the OECD Conference Centre, Paris, on 14-15 February 2019
Comparative assessment of stakeholder feedback capt-poster presentation-2019Naghmeh Foroutan
The present study was designed for obtaining Canadian pricing and reimbursement stakeholders’ opinion on a list of proposed recommendations for updating the 2007 Patented Medicine Prices Review Board (PMPRB) Budget Impact Analysis guidelines. Methods: Stakeholders from different perspectives including policymakers (public and private payers) and industry experts/consultants were invited to participate in the study (private payer and industry perspectives were not included in the PMPRB 2007 BIA guidelines). Using a mixed methods approach, an interview guide and a written survey were developed based on discordance between the PMPRB 2007 BIA guidelines recommendations and Canadian provincial, and other national or transnational BIA guidelines. A thematic content analysis was applied for the qualitative data analysis. Results: We conducted nine interviews with policymakers and twenty-seven surveys with industry experts/consultants. Most interviewees were positive about the usefulness of BIA in disinvestment decisions and believed that reviewing cost-effectiveness analysis (CEA) and BIA together, at the same time, could be particularly informative for setting value-based prices. Fifty-six percent of the proposed recommendations were approved (e.g., the use of post-market real-world data for assessing the reliability of BIAs first-year forecasts), whereas, 30% were not supported by stakeholders (e.g., indirect costs). Some recommendations will need further input from public and private payers before being included in a revised version of the PMPRB BIA guidelines (e.g., inclusion of cost offsets). Conclusions: In the present study, Canadian payers and manufacturers’ views on the BIA recommendations, obtained through qualitative and quantitative methods, provide additional insight to help define BIA guidelines from a Canadian perspective. This information may also be of value for updating or creating BIA guidelines worldwide.
Today, there is a strong media coverage on the increasing cost of health care in the United States andin many other countries around the world. This gives rise to a common concern in these countries. So, the question is how best to control the rate of growth in health care expenditures whilst still delivering good healthcare.
Delivered by Prof Frances Ruane, Chairperson of the Expert Group on Resource Allocation in the Health Sector, Executive Director of the ESRI at the IPHA Annual Meeting 2010.
A critical analysis of purchasing mechanism in China's Rural Health Insurance...resyst
This presentation was given at the International Health Economics Association (iHEA) World Congress in Milan, in July 2015. It includes results and policy implications from the RESYST Purchasing Study conducted in China.
Collaboration across the pharma enterpriseAmy Morgan
This paper examines key success factors for effective collaboration in the pharmaceutical industry. In an industry where speed to market is critical and where informed and timely decisions can have large financial implications, collaboration is a key factor to ensure value is delivered. Consequently, considerable investment is being made by pharmaceutical companies to enable project teams to work more effectively together across departmental, functional, company and geographic boundaries.
Market access the challenges for medical devices Amy Morgan
With increased incidences of reimbursement rejections by payers and a growing usage of pricing and reimbursement tools market access is becoming increasingly restricted…
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Couples presenting to the infertility clinic- Do they really have infertility...
Hta in emerging markets
1. Overview of Selected Countries
March 2010
Parioforma Ltd
55 Princes Gate
Exhibition Road
South Kensington
London SW7 2PN
United Kingdom
www.parioforma.com
2. PARIOFORM
A
Pharma markets in Emerging Markets (EMs) have been
continuously witnessing robust growth on account of:
◦ Increasing prevalence of diseases
◦ Rising healthcare spending
◦ Increasing affordability
Political and economic transition since the 1990s has resulted in
many changes in the health sectors of these countries. Many have
adopted social health insurance (SHI) models in attempts to move
away from centrally planned and state controlled healthcare
financing and coverage.
Healthcare reforms have been accompanied by a need for increased
spending driven by:
◦ Economic growth
◦ Ageing populations
◦ Advances in medical technology
◦ Expanding expectations on the part of national populations
Reforms and increased spending have brought new challenges
highlighting the need for:
◦ Cost containment
◦ Improvements in quality of services
◦ Improvements in equity of access
◦ Assurance of rational and transparent spending decisions
Increased attention is now being paid to the implementation of
measures to manage costs and obtain better value for money:
◦ Reimbursement and pricing controls – e.g. reference pricing systems
◦ Establishment of positive lists
◦ Cost sharing – e.g. co-payments
◦ Adoption of HTA in healthcare decision making
The institutionalization of HTA had been defined as “promoting the
structures and processes suitable to produce technology
assessments that will be powerful in guiding policy and clinical
practice toward the best possible health and cost outcomes.”
Until recently, many EMs have implemented new technologies with
little or no regard for costs or effectiveness but in many of these
countries, HTA is now in the process of becoming established and
institutionalized.
2
4. PARIOFORM
A
HTA Background
After the 2002 financial crisis, an HTA commission was created within the regulatory
body of the Social Security (SSS) that covers 50% of the population, to evaluate
reimbursement of its mandatory package of services. However, even though Argentina
was the first country in the region to require formal health economic evidence for the
adoption of technologies into the mandatory benefit package of the social security – in
2006, HTA was abandoned as a formal requirement. Nevertheless, many private HTA
agencies exist – not centrally regulated but following international guidelines.
HTA Agency
Unidad Coordinadora de
Evaluación y Ejecución de
Tecnologías en Salud
(UCEETS) created within
the MoH October 2009.
Methodological
Guidelines
Guidelines are very new
and mostly directional
rather than mandatory.
No solid specifications on
data requirements as yet.
Selection Criteria for
Drugs to Review
HTA anticipated as a
requirement for all new
technologies applying for
reimbursement – not
mandatory as yet.
Preferred or Required
Assessment Approach
Recommendations:
−CEA primarily
−CUA secondary
Weight of Clinical vs.
Economic Evidence
Clinical benefits most
important.
Principle Outcome
Measures
Classical hard endpoints
preferred over quality
adjusted life years - but no
formal guidelines
Choice of Comparator
Current standard of care -
best if included in the
compulsory medical
package.
Decision Threshold
Not yet explicitly
established by UCEETS.
3x GDP per capita for a
QALY or DALY rule
informally used.
Cost perspective
Payer perspective
recommended - one for
each type of payer (social,
private, public) as unit
costs and resources vary.
Costs
Studies can include direct
and indirect costs - but
essentially only direct
medical costs tend to be
considered.
Budget Impact Analysis
Many HMOs request BIA.
Cost per year or per
treatment of interest.
BIA Time Horizon 1 – 5 years
Modelling
Not explicitly specified by UCEETS. Some HMOs are content with a simple incremental
cost-effectiveness indicator. More complex models are accepted but not explicitly
required. Foreign models can be adapted to the local context.
Requirements for Local
Data
Local data preferred followed by regional communicators, followed by international
data. In the absence of local data, QALYs and/or tariffs from other countries can be
extrapolated - depending on the quality of data. Local context required for costs.
Sensitivity Analysis
Mostly univariate - no
formal guidelines
Discounting Rates
Not yet explicitly
established by UCEETS.
Typically 3 - 5% for both
costs and effects but no
local consensus.
4
5. PARIOFORM
A
HTA Background
The government has defined the need for an HTA agency. Resources for this agency are
expected to be drawn from the universities that already have experience in this field.
This concept has the support of the Commission Reguladora de Salud (CRES) - who
currently have limited knowledge and resources for economic evaluation. The
Government suggest that the agency be housed and led by the National Health Institute.
HTA Agency
No formal agency – but
CRES (part of MoH) is a new
body under law that will
request economic analysis
(along with clinical
information)
Methodological
Guidelines
New methodological
guidelines just being
introduced.
Selection Criteria for
Drugs to Review
To be defined. Probably in
the future it will cover new
technologies that intend to
be included in the national
benefit plan.
Preferred or Required
Assessment Approach
In the future: CEA
Weight of Clinical vs.
Economic Evidence
Currently cost effectiveness
not taken into account; but
the trend is towards
increased use of CEA.
Principle Outcome
Measures
Not defined but “natural”
endpoints preferred:
mortality, incidence,
complications, etc.
Choice of Comparator
The new methodological
guidelines adopt the
standard of care.
Decision Threshold
No explicit threshold -
some researches use WHO
guidelines (per capita GDP
per life year saved) but the
guidelines suggest the use
of an efficiency frontier as
in Germany.
Cost perspective
Societal perspective
defined in guidelines –
payer perspective more
practical due to a lack of
indirect cost data.
Costs
Depends on study
perspective.
Cost data very poor with
much regional variation.
Budget Impact
Analysis
BIA requirements under
discussion. Would like to
see drug costs per capita
per year.
BIA Time Horizon Not defined.
Modelling
No specific criteria defined. All modeling very new - new guidelines propose only simple
models e.g. Markov, decision trees. Western European or US models can be adapted for
Columbia subject to validation by local experts.
Requirements for
Local Data
Foreign data is accepted because of the lack of local information. NICE guidelines and
recommendations used as reference cases. Can adapt regional data - such as Mexico -
for Columbia. Local context required for costs expressed in local currency.
Sensitivity Analysis
Not defined – simple
approach preferred.
Discounting Rates
Not defined.
Can be 0%, 3% or 5% .
5
6. PARIOFORM
A
HTA Background
The pharmacoeconomic Society prepared general guidelines in 2009. The MoH accept
the need for guidelines but the Reimbursement Act is currently so prohibitive that it is
almost impossible to get these accepted as part of the decision making process.
A new draft of the Reimbursement Act will hopefully be passed before elections in May
2010. An urgent need for formalized HTA and a HTA agency as healthcare costs are
spiraling. Any future HTA agency not expected to have decision making power – only to
act as an advisory body.
HTA Agency No HTA agency.
Methodological
Guidelines
General guidelines – not
binding.
Selection Criteria for
Drugs to Review
Intended as part of the
application for coverage
under the public health
insurance.
Preferred or Required
Assessment Approach
Very simple CEA - an
optional extra as a
supporting argument for
BIA.
Weight of Clinical vs.
Economic Evidence
Clinical evidence
technically more
important – but
comparative cost
effectiveness in terms of
budget impact plays a role
in decision making.
Principle Outcome
Measures
Preference for hard
endpoints - mortality and
morbidity play a much
more important role than
patient QoL data.
Choice of Comparator
That usually used in
practice - guidelines very
weak on this.
Decision Threshold
No guidelines on
willingness to pay –
ongoing discussions at the
Pharmacoeconomics
Society involving all
stakeholders.
Cost perspective
Viewpoint of Public Health
Insurance preferred (a
State funded body).
Costs
Direct healthcare costs -
those incurred by the
health insurance funds.
Budget Impact Analysis
Required - but shortage of
relevant epidemiology and
cost sources.
BIA Time Horizon
1 - 5 years accepted - but
usually 3 years.
Modelling
It is recommended to use models already developed for other countries and adapt
them to the local context. Simple models preferred. Thorough explanation of results
more important than complexity.
Requirements for Local
Data
Foreign RCTs fully accepted - general acceptance of clinical effectiveness data from
abroad - particularly Europe. A basic requirement has just been introduced - any
pharmacoeconomic evidence presented must be re-calculated using Czech prices.
Sensitivity Analysis
According to guidelines -
appropriate to state the
influence of discounting in
the sensitivity analysis.
Discounting Rates
No rules - between 3-5%
accepted.
6
7. PARIOFORM
A
HTA Background
HTA dates back to 1993. In 2004, the Transparency Secretariat (TS) and Technology
Appraisal Committee (TAC) was formed to assess the therapeutic value of drugs and to
compare them with existing therapies to prepare decisions on reimbursement
applications. Also in 2004, the National Institute for Strategic Health Research of the
MoH was established, which assists with decision making in four major areas of health
policy and financing: medical informatics and information policy, health economics,
health services research, and HTA.
HTA Agency
The National Institute for
Strategic Health Research
(ESKI) governed by the
MoH.
Methodological
Guidelines
First published in 2002 -
an update is now under
construction.
Selection Criteria for
Drugs to Review
Full HTA dossier required
for all new indications,
new actives, new
strengths.
Preferred or Required
Assessment Approach
CEA and CUA.
If there is information on
QoL then CUA more
appropriate.
Weight of Clinical vs.
Economic Evidence
Clinical evidence the basic
level of evidence - without
strong clinical evidence,
economic evidence not
even considered.
Principle Outcome
Measures
Hard endpoints preferred
- intermediate surrogate
outcomes not widely used.
Choice of Comparator
The currently accepted
standard therapy
(therapies) that the new
intervention is intended to
replace.
Decision Threshold
No formal threshold.
Informally, less than 8
million Hungarian Florins
representing 3x GDP per
capita.
Cost perspective
Payer perspective
[National Health Insurance
Fund Administration -
NHIFA].
Costs
Direct medical and direct
non-medical.
Budget Impact Analysis
BIA essential to
understand the financial
commitment required.
BIA Time Horizon 3 – 5 years.
Modelling
Simple models and presentations are fine, but more detailed descriptions of what is
being presented now required – i.e. full explanations of methods, input parameters,
time horizons, perspective, estimations, results, etc.
Presenting the model itself is “nice to have” but not obligatory.
Requirements for Local
Data
Hungarian data preferred if available – but because HTAs based on national data are
not always available, foreign HTAs are also applied – e.g. using demography,
epidemiology, standard care, healthcare utilization, unit costs, and cost-effectiveness
data from NICE analyses.
Sensitivity Analysis
Univariate generally
sufficient - but if
probalistic can be
presented this is stronger.
Discounting Rates
Current guidelines state
5% for all; new guidelines
to be published this year
state 3.7%.
7
8. PARIOFORM
A
HTA Background
HTA first became a requirement around 10 years ago. Companies wishing for their
products to enter the National List of Health Services (NLHS) health basket were asked
to provide an economic evaluation - but nothing was binding. The Israeli Centre for
Technology Assessment in Health Care (ICTAHC) was established in 1998 at the Gertner
Institute for Epidemiology and Health Policy Research. The Centre is an independent
multidisciplinary research centre – although it maintains strong links with the MoH, it is
not the official HTA agency.
HTA Agency Still no formal HTA agency
Methodological
Guidelines
Updated guidelines
beginning 2010.
Selection Criteria for
Drugs to Review
Under new guidelines
-obligatory for all new
technologies with a
budget impact > 100,000
shekels (~£20K) pa.
Preferred or Required
Assessment Approach
CUA
Weight of Clinical vs.
Economic Evidence
Each technology applying
for the health basket is
ranked according to
various criteria. Weight
given to clinical evidence
is much higher than that
given to EE.
Principle Outcome
Measures
Hard endpoints preferred
- surrogate endpoints
have to be translated to
QALYs for economic
analysis.
Choice of Comparator
Standard-of-care
technologies included in
the Israeli National List of
Health Services (INLHS).
Decision Threshold
No formal threshold – but
decisions to date imply
most technologies added
have a cost effectiveness
ratio of < $50 per QALY.
Cost perspective
Payer perspective: MoH,
HMOs.
Costs
Direct medical costs for
the supplier and
consumer.
Budget Impact Analysis
To make decisions for
inclusion in the health
basket the estimated
annual cost of each new
technology based on
budget impact
estimations is required.
BIA Time Horizon 3 years.
Modelling
No specific guidelines. Starting from 2009, models presented to the MoH are passed to
the Gertner Institute for evaluation who require the model itself (Excel file).
Requirements for Local
Data
Economic evaluations conducted abroad should be adapted to Israeli settings - mostly
by adapting to local costs (clinical data normally accepted but a KoL opinion may be
needed). Both evaluations should be included. Any major Western market acceptable.
Sensitivity Analysis
Sensitivity analyses should
be performed for both
costs and benefits as
needed.
Discounting Rates 3%
8
9. PARIOFORM
A
HTA Background
Mexico is just in the first steps of using pharmacoeconomics in decision making – but
cost effectiveness data has been a requirement since 2004. With regards to cost
effectiveness, current regulation states that the applicant must submit with the request
for submission all pharmacoeconomic tests.
HTA Agency
No HTA agency for
pharmaceuticals so the
Consejo de Salubridad
General (CSG) review the
PE evidence. A second
review is carried out at
Institutional level.
Methodological
Guidelines
Submissions should follow
the guidelines released in
2009.
Selection Criteria for
Drugs to Review
Mandatory for a new
drugs to be included in the
National Formulary.
Preferred or Required
Assessment Approach
CEA – can be
supplemented by CUA but
this is not obligatory.
CMA – if well justified.
Weight of Clinical vs.
Economic Evidence
For innovative drugs
clinical evidence is the
most important criteria.
Principle Outcome
Measures
Morbidity, mortality and
QoL most frequently used
– but no restrictions on
endpoints as long as
justified in the model.
Choice of Comparator
Standard of care available
in the National and
Institutional formularies.
Decision Threshold
No formal threshold.
A very informal cost
effectiveness threshold of
~50,000 pesos per patient.
Cost perspective
Societal or payer
perspective – but indirect
costs are very difficult to
obtain. Payer perspective
(Institutions: i.e. IMSS,
ISSSTE, PEMEX) preferred.
Costs
Direct costs the most
important consideration.
Budget Impact Analysis
Required in the guidelines
but not perceived as
obligatory.
BIA Time Horizon
No specific requirements -
1-2 years sufficient.
Modelling
No need to present the actual model. Complexity not required – just asking for a clear,
model with full explanation of inputs and outputs supported by local research or
literature research, and a local expert.
Requirements for Local
Data
Acceptable to use foreign data on efficacy/ effectiveness - UK, EU or US data
acceptable. Models created for other countries can be that adapted with Mexican costs
and epidemiology.
Sensitivity Analysis
Sensitivity analysis of
relevant variables
affecting the model.
All methods acceptable if
applicable to the model,
Discounting Rates
Guidelines have set a 5%
discount for costs and
benefits. Recommended
to explore ranges 3% - 7%
for costs and 0% - 7% for
benefits in the sensitivity
analysis.
9
10. PARIOFORM
A
HTA Background
The Agency for Health Technology Assessment in Poland (AHTAPol) was established as
a state financed institute in Sep 2005. But in Jan 2009, it was granted a more formal
responsibility as the government HTA Agency. AHTAPol now has influence at the
highest level of the MoH – however, its role is advisory only and its decisions are not
binding on the MoH.
HTA Agency
AHTAPol (Polish acronym:
AOTM)
Methodological
Guidelines
A "full dossier" of relevant
HTA documents required
by ATOM – guidelines
issued April 2009
Selection Criteria for
Drugs to Review
All new active substances
coming to the market
seeking reimbursement.
Preferred or Required
Assessment Approach
CEA
CUA
Weight of Clinical vs.
Economic Evidence
Clinical and safety data
represents about 80 - 85%
of decision making.
Economic evidence is
given less weight.
Principle Outcome
Measures
Preference for hard
endpoints e.g. measured
in "x" years of life gained.
Surrogate endpoint
accepted if appropriate.
Choice of Comparator
Comparator must be one
used in normal Polish
practice.
Decision Threshold
WHO threshold: 3x GDP
per capita
Cost perspective
Societal perspective very
rare.
Most analyses assessed
from National Health Fund
(NFZ) point of view (payer
perspective)
Costs
2009 guidelines widened
costs to include all direct
and indirect costs.
Budget Impact Analysis
BIA obligatory.
AOTM look closely at the
impact on Polish
Healthcare Budget - high
priority. Particularly
interested in ICERs.
BIA Time Horizon
2009 guidelines state 2
years – previously 5 years.
Modelling
If required, the structure of the model should be as simple as possible – situations
requiring modelling defined in guidelines. Model structure should be presented.
Assumptions of the model should be clear, well justified and tested in a sensitivity
analysis. If data in model extrapolated over a time horizon of the primary trials, the
following scenarios should be analysed: optimistic, pessimistic and neutral.
Requirements for Local
Data
Foreign data from US and European markets acceptable – but strongly recommend the
use of clinical data "transferable" to the Polish situation. Need to consider local
treatment protocols and practices as well as costs.
Sensitivity Analysis
One- or multi-way
sensitivity analysis often
not enough - probabilistic
also recommended; best
to provide CE acceptability
curve.
Discounting Rates
Previously 5% - 2009
guidelines state: 5% for
costs and 3.5% for effects
10
11. PARIOFORM
A
HTA Background
In 2001 the National Health Insurance House (NHIH) was involved in a project funded
by the European Commission to build Institutional capacity of the national health
system in Romania - a small component focused on evidence-based practices. This was
the first time this topic had ever been considered in project form in Romania - the
project ran for about 3 years. Unfortunately after the project ended there was no
Institution that took on the responsibility to follow-up and to build further on any of
the methods that had been identified during the project.
HTA Agency
No HTA agency - no
"body" to feasibly take
this on at the moment.
Methodological
Guidelines
No formal guidelines.
Selection Criteria for
Drugs to Review
HTA/ EE not required –
but good to have available
as very simple analyses.
Preferred or Required
Assessment Approach
Expected to be CEA or
CUA in the future (2-3
years).
Weight of Clinical vs.
Economic Evidence
Efficacy and safety are the
criteria for access to
reimbursement list - some
negotiations on price, but
no formal consideration of
CE/ HTA.
Principle Outcome
Measures
Hard endpoints preferred.
Choice of Comparator
If applicable it would be
standard of care.
Decision Threshold
No formal threshold – but
for expensive drugs
expensive drugs the NHIH
often place restrictions on
prescribing.
Cost perspective
Payer perspective
expected in future.
Societal perspective would
be very difficult – in terms
of collecting relevant data.
Costs
No requirements – but
direct medical costs are
easier to access than
indirect medical costs.
Access to cost data still
problematic.
Budget Impact Analysis
Not a requirement. The
NHIH perform their own
budget impact simulation.
BIA Time Horizon Not a requirement.
Modelling
Data provided must only show the results and basic approach. It should be noted that
there is no “body” or “function” assigned or trained to evaluate economic evidence.
Requirements for Local
Data
European medical guidelines accepted. No formal requirements for local data - but
informally there is the consensus that it is good to have Romanian data. Treatment
settings are often different - i.e. out-patient treatments in other countries are most
often an in-patient treatments in Romania - e.g. chemotherapy, dialysis, etc.
Sensitivity Analysis N/A Discounting Rates N/A
11
12. PARIOFORM
A
HTA Background
Russia has no HTA Agency or formal department assigned to review economic
submissions. In 2002, the Russian chapter of ISPOR (RSPOR) created methodological
guidelines - which were approved by the MoH. However, although not rescinded, they
are not used or adhered to by the MoH. PE data is required for drug applications for
inclusion in the DLO (supplementary drug list for certain social groups – mainly elderly,
disabled, veterans or long-term sick) or the EDL (Essential Drug List). Decentralization of
funding means that data has to be submitted at both national and regional levels - but
regional evaluations are even less sophisticated.
HTA Agency No HTA agency.
Methodological
Guidelines
Guidelines not adhered to
– MoH requests PE data
with no specifications on
what is required.
Selection Criteria for
Drugs to Review
Reimbursement under
DLO or EDL.
Preferred or Required
Assessment Approach
CEA and CMA where
appropriate - the MoH
want to see
demonstrations of savings
in treatment costs.
Weight of Clinical vs.
Economic Evidence
Clinical evidence is the
most important factor.
Principle Outcome
Measures
Hard endpoints preferred
Choice of Comparator
Not specified – but local
Russian comparators are
important.
Decision Threshold No threshold.
Cost perspective
Not specified – payer
perspective most
applicable.
Costs
Direct medical and
indirect medical costs.
Cost data difficult to
obtain.
Budget Impact Analysis No formal requirement. BIA Time Horizon N/A
Modelling
No specifications or guidance on modelling requirements. It should be noted that there
is no “body” or “function” assigned or trained to look at models submitted. The MoH
want to see simple data only: cost of drug + cost of complications + cost of
administration/ management. Summed all together this gives an illustration of the
economic value of the drug.
Requirements for Local
Data
Foreign data on efficacy and effectiveness often used – but a preference for adaptation
to the local situation. Treatment standards and practices are often very different to
those used in Western Europe or the US – hence the emphasis on local comparators.
Costs all very different – e.g. a long hospitalization will often be 10x cheaper than giving
the patient an expensive drug. Also standard Western out-patient treatments are in-
patient in Russia.
Sensitivity Analysis Not specified Discounting Rates Not specified
12
13. PARIOFORM
A
HTA Background
HTA just starting in the Kingdom. Health technology registration process control has
been moved from the MoH to the Saudi Food and Drug Authority [SFDA] - the SFDA are
now trying to introduce the concept of economic evaluations. HTA submission
guidelines are currently being drawn up by the SFDA in conjunction with leading
academic experts.
HTA Agency
SFDA hope to be the
appointed HTA agency.
Methodological
Guidelines
Guidelines under
construction – but
regulations perhaps 2-4
years away.
Selection Criteria for
Drugs to Review
Expected to apply to all
new technologies - no
distinguishes made at this
stage.
Preferred or Required
Assessment Approach
No requirements – but
CEA most commonly used
to date. Results for CEA or
CUA should be reported as
ICERs.
Weight of Clinical vs.
Economic Evidence
Decisions based on clinical
and safety evidence – very
limited consideration of
CE at present.
Principle Outcome
Measures
Hard endpoints required -
morbidity, mortality, QoL -
intermediate endpoints
not accepted.
Choice of Comparator
Not specified - choice of
comparator should relate
to the study population,
and the local context or
practice.
Decision Threshold
No threshold defined yet -
but a threshold value must
be set to understand the
level of cost effectiveness
that deserves premium
pricing.
Cost perspective
Not specified - societal
preferred but the lack of
local data on costs makes
this difficult. Next best is
MoH perspective as this is
the largest provider.
Costs
No requirements -
depends on the study
perspective. Costs
excluded from the analysis
and their impact must be
clearly specified.
Budget Impact Analysis Not looking at BIA yet. BIA Time Horizon Not required.
Modelling
Complex models not required. All endpoint data and all the sources of input data need
to be explained clearly. Model structure should be included. Presentation and results of
the model should be clear and tested by sensitivity analysis.
Requirements for Local
Data
No specific requirements for local data. Efficacy/effectiveness data from other
countries acceptable - but when international data is presented, its applicability to the
local situation needs to be justified. Required to define the differences and explore
their effects when extrapolating international data to the local population.
Sensitivity Analysis
Required but method not
specified.
Discounting Rates Not specified.
13
14. PARIOFORM
A
HTA Background
Currently PE/ HTA has a very limited role in decision-making. Committee for
Pharmacoeconomics and Clinical Outcomes of Slovak Ministry of Health was founded
late 2007 – this is an advisory body to Reimbursement Committee. PE/ HTA practices
expected to align closer with standard European practice over the next 2 years.
HTA Agency
No HTA agency -
Committee for Pharmaco-
economics and Clinical
Outcomes responsible for
evaluating economic
analyses.
Methodological
Guidelines
First guidelines were
brought in for Sep 2008.
Selection Criteria for
Drugs to Review
New drugs seeking
coverage by Health
Insurance Companies
Preferred or Required
Assessment Approach
Can be: CMA, CEA, or CUA
- depending on the clinical
problem being addressed.
Weight of Clinical vs.
Economic Evidence
Clinical evidence has more
weight – PE/HTA all very
new.
Principle Outcome
Measures
Hard outcomes preferred -
morbidity, mortality and
changes in QoL. Clinically
significant surrogate
endpoints accepted.
Choice of Comparator
Currently accepted
standard therapy that the
new intervention is
intended to replace.
Decision Threshold
Level 1: €18,000, Level 2:
€26,500. An official
threshold - but no drug
has been refused on this
basis (measured in cost
per QALY).
Cost perspective
In new guidelines, societal
preferred - in 2008 it was
payer perspective.
Costs
Direct healthcare costs,
direct non-healthcare
costs and indirect costs.
Budget Impact Analysis
Mandatory for all drugs -
but only very basic data
required.
BIA Time Horizon
Impact on annual budget
and the cumulative impact
over 5 years.
Modelling
No preferences on modeling – but complexity not required. Results are most important
- these need to be fully explained and presented transparently to assist decision
making. Common for international models to be adapted using local cost data.
Requirements for Local
Data
Foreign data accepted - preferably from Hungary, Poland and Czech Rep. if available.
Base-case analysis is needed to present direct adaptation of resource use data from a
foreign study. If comparison shows clinical practice is different then base-case should
be supplemented with an analysis that tries to adjust for practice differences.
Sensitivity Analysis
Sensitivity analysis must
be performed on all
uncertain data/
assumptions included in
the model. Methodology
not specified – univariate
most common.
Discounting Rates
Future health gains and
costs should be
discounted at 5%.
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15. PARIOFORM
A
HTA Background
No independent HTA body to assess the findings of such work or to evaluate it against
internationally accepted standards. The MoH called for the establishment of an
HTA commission in April 2008. HTA evidence is not mandatory at this stage to support
new drug submissions. However, in the next year, HTA will be formally recognized
under the law - in terms of both organization and application. The new HTA
commission will prepare the guidelines and discuss the future development and
implementation of HTA in Slovenia.
HTA Agency
No HTA agency. No
indication that a "single"
national agency will be
adopted at this point - a
HTA network is proposed.
Methodological
Guidelines
No guidelines.
Selection Criteria for
Drugs to Review
Very basic EE and BIA is
required if applying for
reimbursement status -
this became law on 1st
January 2009.
Preferred or Required
Assessment Approach
CEA for hospital drugs along
with estimation of ICER
values.
Weight of Clinical vs.
Economic Evidence
Clinical effectiveness
remains the major focus -
economic evaluations all
very new.
Principle Outcome
Measures
Everything is acceptable -
but "hard" endpoints carry
more weight.
Choice of Comparator
Standard of care in
Slovenia
Decision Threshold
Drugs ranked by ICER – but
this is not the only ranking
criteria. ICER > €45000 per
QALY considered cost
ineffective. ICERs €30000 -
€45000 considered
moderately cost effective;
ICERs < €30000 considered
cost effective.
Cost perspective
No actual preference -
payer perspective normal.
But a desire for societal in
future.
Costs
Depends on study
perspective.
Budget Impact Analysis Basic BIA only. BIA Time Horizon No guidelines yet.
Modelling
No specifications for modelling – no capabilities for anything complex. No requirement
to present the actual model - just a scheme of how it performs and a full explanation of
the results.
Requirements for Local
Data
EE analyses from other countries can be presented but companies are required to
provide an estimation of how the information could be applied in Slovenia – often by
adapting with local data. New HTA network expected to use EUnetHTA tools to adapt
foreign data for Slovenia.
Sensitivity Analysis
Required but method not
specified. Univariate
common.
Discounting Rates
Not specified but under
review for developing
guidelines.
15
16. PARIOFORM
A
Parioforma Ltd. is an international business consultancy founded
in 2005 and headquartered in London, UK.
We deliver market access intelligence based on primary research
to help our customers formulate market access strategies.
Specific activities include:
◦ Payer, provider and/ or prescriber research
Profiling/ mapping
Surveys
Testing attitudes
Switching criteria
Unmet needs
Evidence requirements
◦ Market research
Pricing & reimbursement
Environment mapping/ profiling
Market modeling
Trend analysis & opportunity identification
◦ Parioforma designs and delivers strategic workshops to help
our clients understand and internalize information for tool
development.
LONDON OFFICE ASSOCIATE OFFICES
Contact: Charles Rowlands
charles.rowlands@parioforma.com
55 Prince’s Gate
Exhibition Road
London SW7 2PN
United Kingdom
Tel: +44 (0) 7803 907577
www.parioforma.com
USA Intrix Corp, Darien
Connecticut
Eastern
Europe
Vanguard, Moscow
Brazil Intrix Corp, São Paulo
Japan TRN, Tokyo
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