Technologies that enhance the precision and effect of therapies can make a critical contribution to ensuring value for money and improving patient care. Methods and processes for assessing value, however, still are imperfect. This presentation reviews the challenges and identifies some approaches for meeting them.
An Introduction Patient Reported Outcome Measures (PROMS)Keith Meadows
An introduction to the key concepts of patient Reported Outcome Measures, including reliability and validity, generic versus disease specific,selection criteria and their adaptation for different cultural groups.
> 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
Understanding applicability, also referred to as relevance, the extent to which published results are likely to reflect expected outcomes when an intervention is applied broadly across populations.
An Introduction Patient Reported Outcome Measures (PROMS)Keith Meadows
An introduction to the key concepts of patient Reported Outcome Measures, including reliability and validity, generic versus disease specific,selection criteria and their adaptation for different cultural groups.
> 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
Understanding applicability, also referred to as relevance, the extent to which published results are likely to reflect expected outcomes when an intervention is applied broadly across populations.
The Importance of measuring outcomes, including Patient Reported Outcome Measures (PROMS)
BAOT Lifelong Learning Event
10 November 2010
Dr Alison Laver-Fawcett
Head of Programme, BHSC(Hons) Occupational Therapy
York St John University
Concise explaining of Evidence-Based Medicine and discussing the following: 1-What is Evidence-Based Medicine?
2-Why Evidence-based Medicine?
3-Options for changing clinicians' practice behaviour
4- EBM Process- Five Steps
5-Seven alternatives to evidence-based medicine
Getting evidence from economic evaluation into healthcare practicecheweb1
Seminar:Understanding the underutilisation of evidence from economic evaluations in healthcare: a mixed methods design. Speaker: Gregory Merlo, Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Australia.
OHE’s Professor Nancy Devlin has researched, written and spoken widely on the use of the EQ-5D, and related measures, both in her capacity as the Director of Research at the OHE and as Chair of the Executive Committee of the EuroQol Group.
In May, Nancy was invited to participate in the “Workshop on measuring patient-reported outcomes using the EQ-5D”, which was organised by the Swedish National Board of Health and Welfare in collaboration with the EuroQol Group. The workshop brought together policy makers and researchers in Sweden interested in measuring patients’ health outcomes.
Sweden has included the EQ-5D in some of its quality registries and in population health surveys for many years. The Swedish National Board of Health and Welfare now is exploring whether and how to extend use of patient reported outcomes measures in the health care system, including the EQ-5D, to both monitor the quality of providers and services and to facilitate health technology appraisal.
Nancy’s talk, shown below, introduced the EQ-5D instrument; discussed how data from it can be analysed; identified some of the challenges in analysis; and commented on the future of outcomes measurement.
Real effectiveness medicine pursuing best effectiveness in the ordinary care ...Malmivaara Antti
These slides present a new concept of Real-Effectiveness Medicine (REM), which pursues the best effectiveness of patient care in the real-world setting. In order to reach the goal, four layers of information are needed: 1) expertise or the health care personnel, 2) use of up-to-date scientific evidence, 3) continuous documentation of performance and quality improvement, and 4) benchmarking between providers. The new framework is suggested for clinicians, organizations, policy-makers, and researchers.
The Importance of measuring outcomes, including Patient Reported Outcome Measures (PROMS)
BAOT Lifelong Learning Event
10 November 2010
Dr Alison Laver-Fawcett
Head of Programme, BHSC(Hons) Occupational Therapy
York St John University
Concise explaining of Evidence-Based Medicine and discussing the following: 1-What is Evidence-Based Medicine?
2-Why Evidence-based Medicine?
3-Options for changing clinicians' practice behaviour
4- EBM Process- Five Steps
5-Seven alternatives to evidence-based medicine
Getting evidence from economic evaluation into healthcare practicecheweb1
Seminar:Understanding the underutilisation of evidence from economic evaluations in healthcare: a mixed methods design. Speaker: Gregory Merlo, Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Australia.
OHE’s Professor Nancy Devlin has researched, written and spoken widely on the use of the EQ-5D, and related measures, both in her capacity as the Director of Research at the OHE and as Chair of the Executive Committee of the EuroQol Group.
In May, Nancy was invited to participate in the “Workshop on measuring patient-reported outcomes using the EQ-5D”, which was organised by the Swedish National Board of Health and Welfare in collaboration with the EuroQol Group. The workshop brought together policy makers and researchers in Sweden interested in measuring patients’ health outcomes.
Sweden has included the EQ-5D in some of its quality registries and in population health surveys for many years. The Swedish National Board of Health and Welfare now is exploring whether and how to extend use of patient reported outcomes measures in the health care system, including the EQ-5D, to both monitor the quality of providers and services and to facilitate health technology appraisal.
Nancy’s talk, shown below, introduced the EQ-5D instrument; discussed how data from it can be analysed; identified some of the challenges in analysis; and commented on the future of outcomes measurement.
Real effectiveness medicine pursuing best effectiveness in the ordinary care ...Malmivaara Antti
These slides present a new concept of Real-Effectiveness Medicine (REM), which pursues the best effectiveness of patient care in the real-world setting. In order to reach the goal, four layers of information are needed: 1) expertise or the health care personnel, 2) use of up-to-date scientific evidence, 3) continuous documentation of performance and quality improvement, and 4) benchmarking between providers. The new framework is suggested for clinicians, organizations, policy-makers, and researchers.
Policy Implications of Healthcare Associated InfectionsAlbert Domingo
On February 19, 2014 at the Ateneo School of Medicine and Public Health in Pasig City, Dr. Albert Domingo presented an introduction to the economic impact of healthcare associated infections (HAIs) as well as related concepts in health policy and management. The speaker discussed common approaches taken to ascertain the economic impact of HAIs, followed by factors/considerations in Philippine health policy and management that must be understood and adjusted in order to minimize HAIs.
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.
Placing the Evolution of HTA In Emerging Markets in Context of Health System ...Office of Health Economics
These slides were presented by Professor Adrian Towse at the 9th World Congress of the International Health Economics Association in July 2013. The presentation examined how the development of health care systems affect the evolution of the use of health technology assessment. Three countries provide case studies: Brazil, China and Taiwan.
ICN Victoria presents Dr Dashiell Gantner, research fellow at the Monash University in Melbourne. Here he talks about translating ICU research into clinical practice.
OHE presents a series of lunchtime seminars throughout the year. The most recent seminar, held in late April, considered the influence of cost-effectiveness and other factors on NICE decisions.
Similar to Improving Methods and Processes for Assessing Codependent Technologies (20)
On 31 October 2019, Adrian Towse and Chris Henshall from the Office of Health Economics (OHE) presented at the G20 meeting on antimicrobial drugs R&D in Paris organised by the Wellcome Trust. The topic of their presentation was HTA and payment mechanisms for new drugs to tackle antimicrobial resistance.
This presentation looks at ways in which governments can set prices, including “cost plus”, value, and the external referencing of prices elsewhere. It looks at the role that competition can play in keeping down prices. In that context it briefly discusses pricing proposals being considered in Malaysia. It makes the case for using HTA to inform pricing decisions.
Adrian Towse
% GDP spending in UK, G5 countries and OECD upper middle income countries. W...Office of Health Economics
This presentation looks at rates of GDP spend on health care, distinguishing between categories of country (i.e. levels of GDP pre capita). It looks at the relationship between rates of spending and moves to universal health coverage, and explores alternative ways of increasing expenditure and making decisions about which services to provide with the money available.
The role of real world data and evidence in building a sustainable & efficien...Office of Health Economics
This presentation defines RWD and RWE in the context of digital health, and looks at potential uses for RWD and RWE. It briefly sets out the current landscape in Malaysia and looks at the challenges in using RWE. In particular, the issues of access, governance and ensuring good quality are considered.
The aim of this educational symposium was to discuss why we should seek value across the health care system and how we can apply existing research methods to measure the value of services. While considerable political attention in developed countries continues to be focused on drug spending, there is also growing awareness of the significant contribution of non-drug components of health care (e.g., hospital services and inefficient care delivery) to overall spending growth and patient affordability. At the same time, there is growing interest in making greater use of value assessment and value-based payment to control spending and better align it with care quality. In order to promote greater value, and to do so in ways that respond to the needs of payers and patients, it is essential to assess value across both drug- and non-drug interventions and health care services. This panel will offer expert viewpoints to identify and discuss gaps in value information, rationale and approaches to track and reduce system-wide low value care, and research methods for how to measure health care services.
Role Substitution, Skill Mix, and Provider Efficiency and Effectiveness : Les...Office of Health Economics
Graham participated in an organised session on Monday July 15th 2019. In the session he presented his paper with his co-author Ioannis Laliotis from the London School of Economics. The paper revisits the relationship between workforce and maternity outcomes in the English NHS in an attempt to contribute knowledge to an important policy question for which there has been a paucity of research.
This research explores the feasibility of introducing an Outcome-Based Payment approach for new cancer drugs in England. A literature review explored the current funding landscape in England, the available evidence on existing OBP schemes internationally, and
which outcomes cancer patients value most. Two focus groups and an online survey with patients and carers, as well as interviews with NHS and government stakeholders, healthcare
professionals, and pharmaceutical industry representatives, provided additional evidence on the feasibility and suitability of OBP schemes
Understanding what aspects of health and quality of life are important to peopleOffice of Health Economics
Poster presentation from the EuroQol Plenary Meeting 2019, Brussels, Belgium. By Koonal Shah, Brendan Mulhern, Patricia Cubi-Molla, Bas Janssen, and David Mott.
Koonal presented as part of an organised session on ‘moving beyond conventional economic approaches in palliative and end of life care’. He summarised the empirical evidence on the extent of pubic support for an end of life premium, before discussing some novel approaches that have been used in recent studies. His presentation was discussed by Helen Mason of Glasgow Caledonian University.
Author(s) and affiliation(s): Koonal Shah, Office of Health Economics
Event: iHEA Congress
Date: 17/07/2019
Location: Basel, Switzerland
Assessing the Life-Cycle Value Added of Second Generation Antipsychotics in S...Office of Health Economics
This research presented in a poster at HTAi 2019, Cologne (Germany) by a team of OHE and IHE researchers, estimates the value added by second generation antipsychotics over their life-cycle in the UK and Sweden. It concludes that considering the entire life-cycle, the value added by SGAs to the system is higher than the expected value estimated at launch. P&R decisions should consider how to measure, capture and take into account the value added by medicines over the long-run.
Author(s) and affiliation(s): Mikel Berdud (Office of Health Economics, London), Niklas Wallin-Bernhardsson (Institute for Health Economics, Stockholm), Bernarda Zamora (Office of Health Economics, London), Peter Lindgren (Institute for Health Economics, Stockholm), Adrian Towse (Office of Health Economics, London)
Event: HTAi 2019 Annual Meeting
Date: 18/06/2019
Location: Cologne, Germany
There is growing recognition that HTA and contracting systems for antimicrobials need to be adapted to help fight the threat of antimicrobial resistance (AMR), but there is little agreement on how. This poster reports findings from a literature review, expert interviews and face-to-face discussions at a Forum on the current HTA and payment systems for antibiotics across Europe and a number of recommendations for adapting these systems to respond to the challenges of AMR.
Author(s) and affiliation(s): Margherita Neri (OHE) Grace Hampson (OHE) Christopher Henshall (OHE visiting fellow, independent consultant) Adrian Towse (OHE)
Event: HTAi annual conference 2019
Date: 18/06/2019
Location: Cologne, Germany
Assessing the Life-cycle Value Added of Second-Generation Antipsychotics in S...Office of Health Economics
This study aims to guide access decisions and drive the discussion on access and price, through recognition of the dynamic nature of value added by pharmaceutical innovation over the long-run. The analysis of the life-cycle value of risperidone estimates the value generated in the UK and Sweden. Results show that health systems were able to appropriate most of the life-cycle value generated, and this is larger than estimated at launch.
Author(s) and affiliation(s): Mikel Berdud(1), Niklas Wallin-Bernhardsson(2), Bernarda Zamora(1), Peter Lindgren(2), and Adrian Towse(1) (1) Office of Health Economics (2) The Swedish Institute for. Health Economics
Event: XXXIX JORNADAS DE ECONOMÍA DE LA SALUD
Date: 12/06/2019
Location: Albacete, Spain
Prescribed Specialised Services (PSS) Commissioning for Quality and Innovation (CQUIN) schemes were launched in 2013 in England with the aim of improving the quality of specialised care and achieving value for money. During this presentation, Marina Rodes Sanchez described the key features of the schemes and discussed its strengths and weaknesses based on international pay-for-performance literature.
Author(s) and affiliation(s): Yan Feng, Queen Mary University of London; Søren Rud Kristensen, Imperial College London; Paula Lorgelly, King’s College London; Rachel Meacock, University of Manchester; Marina Rodes Sanchez, Office of Health Economics; Luigi Siciliani, University of York; Matt Sutton, University of Manchester
Event: XXXIX Spanish Health Economics Association Conference
Date: 12/06/2019
Location: Albacete, Spain
In this session, Meng Li sets out estimates of real option value for drugs arguing that option value matters and can be calculated. Adrian Towse sets out likely payer concerns about incorporating real option value into decision making. Meng Li responds to these concerns. Jens Grueger sets out how industry considers investment opportunities, arguing that if patients (and society) have preferences these need to be reflected in P&R decisions.
Author(s) and affiliation(s): Meng Li, Postdoctoral Research Fellow, Leonard D Schaeffer Center, University of Southern California, Los Angeles, CA, USA. Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Jens Grueger, formerly Head of Global Access, Senior Vice President at F. Hoffmann-La Roche
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
MCDA OR WEIGHTED CEA BASED ON THE QALY? WHICH IS THE FUTURE FOR HTA DECISION ...Office of Health Economics
In this ISPOR session Chuck Phelps and Adrian Towse debated the case for and against using MCDA to support HTA decision making, as compared to weighting or augmenting a QALY based ICER approach. Chuck Phelps argued for use of MCDA, Adrian Towse for weighting the QALY. Nancy Devlin set the scene and moderated.
Author(s) and affiliation(s): Nancy Devlin, Director, Centre for Health Policy, University of Melbourne, Australia Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Chuck Phelps, University of Rochester, Rochester, NY USA
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
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.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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 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.
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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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Improving Methods and Processes for Assessing Codependent Technologies
1. Assessing the Value of Co-dependent Technologies:
How Can Current Methods and Processes Be Improved?
ScHARR Seminar, University of Sheffield
16 April 2013 ● Sheffield, UK
Martina Garau, Office of Health Economics
2. Adrian Towse (OHE) and the other authors of:
Garau, M., Towse, A., Garrison, L., Housman, L. and Ossa, D.
(2012) Can and should value based pricing be applied to
molecular diagnostics? Personalized Medicine. 10(1), 61-72.
Acknowledgements
3. • What is the value of co-dependent technologies?
• Framework for assessing value
• How prove value?
• How aggregate value dimensions?
• Proposed institutional processes
• International experience
• Australia
• NICE
• Conclusions
Agenda
4. • “Technologies that are dependent on another technology
either to achieve their intended effect or to enhance their
intended effect” (www.health.gov.au)
• In particular, a diagnostic test (Dx) can be used to identify
patients most likely to:
• Respond or fail to respond to a drug treatment (Tx)
• Exhibit adverse events
But also to:
• Monitor responses to drugs
• Determine the risk of developing a disease
Definition of co-dependent technologies
5. 1. Key elements of value are:
• Health effects for patients (clinical effectiveness measured by the
QALY)
• Cost offsets (savings to the health care system)
What is the value of co-dependent technologies? (1)
Traditionally, ICERs do not capture benefits beyond health attributes
NHS,PSS Cost of Treatment A - NHS,PSS Cost of Treatment B
ICER =
Health effects of Treatment A - Health effects of Treatment B
The focus is on downstream effects of treatments not recognising the additional
value brought by use of Dx
6. • Other value dimensions
• Societal preferences giving priority to certain patients or
diseases
• Quality of life aspects not reflected in generic measures
used in CE analyses
• Other effects beyond those to patients and NHS
(productivity gains)
• Health care process related aspects (dignity, time and
location of treatment)
• Information for the patient independent of health
effects
What is the value of co-dependent technologies? (2)
7. • The value created is a “joint product” and there are no rules
for the attribution of the value to one or the other
• Garrison and Austin (2007) pointed out that how value is
allocated across patients, payers, Dx manufactures and Tx
manufacturers depends on the institutional context
• E.g. whether the Tx was priced before the Dx was available; the
relative strength of intellectual property protection for Dx and Tx
• This will have consequences in terms of incentives for
evidence generation and subsequent innovation
The issue of attribution of value of
co-dependent technologies
8. Value
1. Reducing
drug adverse
effects
2. Reducing
time delays in
selecting
optimal Tx
3.Increasing
adherence or
willingness to
start Tx
4. Enabling Tx
effective in a
small fraction
to be made
available
5.Reducing
uncertainty
about value
Framework for assessing value of
co-dependent technologies
Value dimensions
derived from:
• Characteristics of
Dx recently
introduced
• Literature review
on the economics
of personalised
medicine and
value of
information of Dx
9. Availability of Dx can improve average benefit-risk ratio
so, depending on the severity of side effects:
• Tx obtains marketing authorisation, or
• Use of a licensed Tx in clinical practice increases
Example: HLA-B*5701
• Allele associated with hypersensitivity to abacavir for HIV-1
• Identification of the marker has increased prescribing of abacavir, which
now is recommended for HLA-B*5701-negative patients in European and
US guidelines
1. Reducing or avoiding drug adverse effects
10. Identifying non-responders and switching them to an alternative
treatment regime/care can:
• Improve survival and/or quality of life (particularly in diseases at advanced
stages)
• Avoid or reduce the cost of treating non-responders
• Avoid or reduce inconvenience to patients
Example: BCR-ABL
• Test identifies chronic myelogenous leukemia (CML) patients who are
receiving treatment, but not responding to it
• Can prevent the disease from progressing to blast crisis and death, and
enables stopping first-line treatment when no longer effective
2. Reducing time delays in selecting optimal Tx
11. • Patients are more motivated if they know (ex-ante) the
intervention is likely to work
• Issue of non-responders who might experience disutility (they
can feel “left-behind”)
Example: PreDx Diabetes Risk test
• Test estimates the patient’s risk for developing Type 2 diabetes
over the next five years
• This can further encourage patients to follow a healthy lifestyle
and take other preventive measures.
3. Increasing adherence or willingness to under-
take Tx or other interventions
12. A biomarker or other genetic characteristic allowing for
patient stratification can:
1. “Rescue” Tx that otherwise may either not have been licensed or
have been withdrawn
2. Increase the chance of a Tx meeting reimbursement criteria (if
targeting responders improves cost -effectiveness)
3. Accelerate R&D process for Tx (if stratification ascertained at an
early development stage)
4. Enabling Tx effective in a small fraction to be
made available
13. • Gefitinib for non-small-cell lung cancer (NSCLC) initially licensed, but
withdrawn when Phase III failed to show a survival benefit. With the
identification of EGFR mutations and its association with response rate to
TKIs, gefitinib was approved in the EU and other markets in combination with
the EGFR mutation test.
• NICE recommended trastuzumab for advanced and early-stage breast cancer
in HER2/neu positive patients identified with HER2/neu test. The Dx-Tx cost
per QALY was found to be below the standard threshold.
• Crizotinib targets a small subset of NSCLC patients with an ALK-positive
molecular abnormality. The development of the ALK FISH test has
accelerated the development process and increased the likelihood of
crizotinib delivering health benefits and commercial value.
4. Enabling Tx effective in a small fraction to be
made available – Examples
14. • Uncertainty around expected health effects and costs; influences the risk of poor
value for money for payers
• Value of information to patients about their medical condition independent of the
health outcome (Ash, et al, 1990)
• “Empowerment” (Payne, et al, 2012)
• Effect of reassurance (measured with EQ-5D?) (Kenen, 1996)
• Lifestyle choices and planning (Lee, et al, 2010)
• Example of Oncotype DX ® and MammaPrint ®
• Multi-gene assays estimating the risk of recurrence in breast cancer patients
following surgery
• Can guide intervention decisions and reduce the risk of dispensing unnecessary
chemotherapy (reduce resource costs to the healthcare system and adverse effect
for the patient)
5. Reducing uncertainty about value
15. • Low accuracy of Dx will decrease potential net gains to
patients and healthcare system
• False positive and false negative patients will not get most appropriate
therapy
• Tx can be more cost effective when used on its own
• When Dx does not provide binary response, depending on the size of
the subset for which the Dx does not provide clear-cut result and the
Dx cost relative to Tx
• When Dx has low accuracy
Other factors affecting value of
co-dependent technologies
16. • Barriers to evidence generation
• Cost and feasibility of certain study designs
• Protection of intellectual property rights of Dx
• Regulatory processes for diagnostics
• Assessment of competitive tests with similar clinical use
How prove value of co-dependent technologies?
17. How is value aggregated? Key issues Key merits
Net benefit As the sum of the benefits,
each assessed in monetary
terms
Challenges estimating the value in
monetary terms of each type of value
Allocating a monetary value to health has
been always one of the mayor criticisms
Arguably, a better grounding in economic theory
Facilitates the comparison of value and value for money across health
and other sectors
Use of monetary value may resonate better with some (private)
payers
MCDA As the sum of the points
assigned to each aspect of
value
The cost -effectiveness threshold would
need to be re-assessed in terms of the
cost per incremental “point”
A pragmatic approach, widely used in the UK public sector.
A more transparent (compared to a weighted QALY, or deliberative
process alone) means of addressing multiple criteria
MCDA is used in local NHS commissioning – potential to develop a
consistent priority-setting framework for both new and existing
health care technologies
Weighted
adjusted
QALYs
1. By QALYs gained, up-rated
or down-rated by one or
multiple weights to represent
the magnitudes of other
aspects of value; or
2. Direct estimation of how
people trade off QALY gains
with other value elements
Assumes that all other sources of value
are proportional to the number of QALYs
gained.
Implications for the threshold. If the value
of new technologies is assessed in terms
of a range of criteria, then opportunity
cost also must be considered in the same
terms, not just QALYs foregone. Even if a
simple social weighting or QALYs is
applied, opportunity cost will change
Is it relevant to state here the classic arguments in favour of the QALY
such as:
- Allows for comparisons across therapeutic areas in the NHS
- “A QALY is a QALY” argument
- Well established in the UK within HTA bodies (and academic
centres)
- Understood by health economics community
Deliberative
process
Weights are assigned by a
committee to each relevant
aspect of value
The weights are often implicit
Are implications for the threshold
Provides an element of flexibility
Is a well-recognised approach taken by HTA bodies around the world.
How aggregate value dimensions?
Source: adapted from Sussex, et al, 2013
18. • A joint Dx-Tx review of “at launch” technologies; to be done by a drug
committee to exploit synergies across Dx and Tx
• However, there is a need to address the lack of expertise of most drug
committees in the Dx area
• A separate Dx committee to develop Dx-specific expertise and to assess
multiple tests with similar clinical use
• However, there may be a trade-off if there are not enough decisions to justify
a distinct committee
• A comprehensive and consistent approach to assessing value of both Dx
and Tx
Proposed institutional processes for
co-dependent technologies
19. Proposed institutional processes
New Dx
Dx linked to a Tx
(companion Dx)
Dx-Tx pair
launched
simultaneously
Dx-Tx joint
assessment via
Drug process
Single Dx
launched
separately
Dx assessed via
Diagnostic-
dedicated process
Multiple Dx with
same clinical use
Dx assessed via
Diagnostic-
dedicated process
Dx not linked to a
Tx
Dx assessed via
Diagnostic-
dedicated process
20. • Until recently, Dx and associated Tx assessed via different
committees (MSAC and PBAC)
• No clear structure for consideration of the interactions and benefits
from joint use
• New coordinated process and decision framework for “co-
dependent technologies”
• “Integrated” applications combining information from Dx and Tx
manufacturers
• Reimbursement decisions are made jointly by PBAC and MSAC to
ensure optimal clinical use (Merlin, et al, 2012)
• The preferred type of evidence to show clinical benefit is a randomised
clinical trial
International experience: Australia
21. • NICE has dedicated-process for stand-alone Dx that follows
very closely that used for drugs
• Strong preference for measuring health gains with the QALY
• Value dimensions beyond health effects, such as value of information
to patients and process-related benefits, are not explicitly factored in
• “At launch” combinations are appraised via the drug review
programme (TAs)
• No explicit consideration of test-related parameters (accuracy, costs)
• Value dimensions beyond health effects are not explicitly factored in
International experience: NICE in England
and Wales
22. • The use of Dx-Tx combinations can deliver health gains and cost savings within the
health care system, but also generate broader benefits to patients and society
• To ensure efficient use of limited resources, health decision makers should take
account of the full value generated by health technologies
• Clear incentives are needed to encourage evidence collection
• HTA and other decision making systems need coordinated and consistent approach
to assessing value of Dx and Tx
• NICE is heading in this direction, but does not yet have a comprehensive approach
to assessing the value of Dx or Tx
• In Australia, the common methodology needs to be supported by a realistic view of
evidence development
Conclusions
23. Ash, D.A., Patton, J.P. and Hershey, J.C. (1990) Knowing for the sake of knowing: The value of prognostic information. Medical
Decision Making. 10(1), 47-57.
Garau, M., Towse, A., Garrison, L., Housman, L. and Ossa, D. (2012) Can and should value based pricing be applied to molecular
diagnostics? Personalized Medicine. 10(1), 61-72.
Garrison, L.P. and Austin, M.J.F. (2007) The economics of personalized medicine: A model of incentives for value creation and
capture. Drug Information Journal. 41(1), 501-509.
Lee, D.W., Neumann, P.J. and Rizzo, J.A. (2010) Understanding the medical and nonmedical value of diagnostics testing. Value in
Health. 13(2), 310-314.
Merlin, T., Farah, C., Schubert, C., Mitchell, A., Hiller, J.E. and Ryan, P. (2012) Assessing personalized medicines in Australia: A
national framework for reviewing codependent technologies. Medical Decision Making. 33(3), 333-342.
Kenen, R.H. (1996) The at-risk health status and technology: A diagnostic invitation and the gift of knowing. Social Science &
Medicine. 42(11), 1545-1553.
Payne, K., McAllister, M. and Davies L. (2012) Valuing the economic benefits of complex interventions: When maximising health is
not sufficient. Health Economics. 22(3), 258-271.
Sussex, J., Towse, A. and Devlin, N. (2013) Operationalising value based pricing of medicines: A taxonomy of approaches.
Pharmacoeconomics. 13(1), 1-10.
References
key pathways of value that the use of Dx to inform treatment or intervention decisions
Dx can be available to select patients that are more or less likely to develop adverse effects a. allow a treatment to receive marketing authorisation by improving the benefit-risk ratio associated with the treatment b. increase adoption of the treatment, in cases where a treatment is licensed, but is not widely used because of its perceived unfavourable average benefit-risk balance when considered across a broad patient population
Avoid trial and error approach and identify the most suitable intervention First two points captured in CE analysis; last one notI will illustrate those points using the exampleit avoids or reduces inconvenience to patients who do not need to experience a long diagnostic process or try different therapies to identify the one most suitable
Patients are more motivated if they know the intervention is likely to work. In the case of companion diagnostics, however, patients found to be non-responders might experience disutility as they can feel ‘left-behind’, and lose hope and even motivation to pursue any other, less effective, but appropriate therapy.
Dx to stratify patientsThree cases where Dx have a positive impact and it is introduced in the market at different stages of the Tx lifecyclepatient stratification in oncology clinical trials could reduce attrition rates in overall clinical development and, in particular, attrition rates from Phase II to Phase III
Measured by EQ5D but may not be captured as patients focus on Tx effects rather than on the overall experience of Dx-Tx
Those were the five pathways through which co-dependent technologies such as Dx and Tx can generate value as compared to a situation where the intervention is used on its own
Only third poikey issue for the assessment of co-dependent technologies is that they are perceived as a joint product so there is no an approach to allocate the value brought by each part.) I then discussed a framework identifying how Dx can bring additional value to Dx-Tx pairs. Here I discuss briefly which the type of process can help ensuring those elements are assessed and considered in the HTA or P&R system. nt
Guide for submission sets a high standard of evidence to demonstrate impact of the test on patient outcomesWhich raises important questions as to how value should be demonstrated and who can generate the evidence