Cadth 2015 a4 symposium 2015 jsh
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This document summarizes a session on new methods in health technology assessment to help policymakers understand how Canadians value health. The session aims to start a discussion on better integrating values into decisions through two topics: how values can be elicited and conducting economic evaluations. It outlines the speakers that will discuss using best-worst scaling and discrete choice experiments to estimate health state values on the QALY scale. The document also notes that presentations and an evaluation survey will be available after the session and lunch will follow. It poses questions about placing monetary values on life and suffering, potential hypothetical bias, and how to account for value considerations in willingness to pay or cost-effectiveness analyses.
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This document provides details about an update to the 3rd edition of CADTH's Guidelines for the Economic Evaluation of Health Technologies in Canada. It discusses that the methodology for economic evaluations is constantly evolving so it is important to provide up-to-date guidance. Key points include that CADTH and a working group are leading the update, topics from the 3rd edition will be reviewed and some identified for updates, new topics will be added, and stakeholders will provide feedback on gaps and challenges. Milestones include discussion sessions in 2015/2016 and posting a revised 4th edition for feedback in Spring 2016.
Cadth 2015 e1 deal prader willi cadth
This document summarizes a workshop on developing clinical care guidelines for growth hormone treatment in Prader-Willi syndrome. The workshop brought together over 40 experts, including endocrinologists, geneticists, clinicians with an interest in growth hormone research, patient advocates, and methodologists. It utilized a multi-criteria decision analysis framework to develop the guidelines, taking into account scientific evidence, disease impact, safety, and other criteria. The goal was to produce consensus guidelines that integrated evidence, values, and ethics to guide policy and clinical practice around this complex treatment decision.
Cadth 2015 e2 dd systemic review-ohtac aug13-2013_2
The document summarizes a literature review examining decision-making methodologies used in health technology appraisal processes. It describes common decision criteria identified in the literature, including efficacy, safety, disease burden, quality of evidence, ethics and cost-effectiveness. Decision-making methods reviewed integrate these criteria through approaches like assigning weights, ranking criteria or using decision rules. The literature search included publications from organizations in several countries.
Cadth 2015 e3 eq5 d
This document describes a study that used a discrete choice experiment with duration (DCEtto) to value health states described by the EQ-5D-5L instrument in Canada. It notes limitations of the traditional time trade-off (TTO) method, such as many respondents not understanding or engaging with the task. The study found the DCEtto method led to fewer exclusions, increasing representativeness. Health state values from the DCEtto were generally lower than the TTO but allowed valuing all respondents. The document discusses differences in the distributions and average levels of values from the two methods and impact of exclusions. It acknowledges limitations to interpreting DCEtto values that require further investigation.
Cadth 2015 e6 husereau rwe cadth
The document summarizes discussions from two roundtables on opportunities and barriers to using real-world evidence in Canada. Key points identified include the need to: 1) build a culture that recognizes real-world evidence can foster healthcare innovation; 2) increase understanding of real-world evidence's value to improve quality and efficiency; and 3) use common data structures and vocabularies to better link and analyze data. Next steps discussed building real-world evidence capacity in Canada through continued stakeholder discussions, leveraging existing data infrastructure, and balancing privacy concerns with the need for appropriate care.
Cadth 2015 e4 lourenco adaptive design april 2015 final
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Cadth 2015 e4 fields slides for adaptive panel final
This document discusses pCODR's experience with adaptive clinical trial designs and how they impact drug funding assessments. It provides examples of two clinical trials for chronic lymphocytic leukemia (CLL) and non-small cell lung cancer (NSCLC) that used adaptive designs. The CLL trial had early stopping rules and treatment switching based on interim analyses. The NSCLC trial allowed patients who progressed on chemotherapy to switch to the experimental drug crizotinib, introducing uncertainty into estimating the treatment's effectiveness and cost-effectiveness. pCODR will likely see more complex adaptive designs as cancer treatments increasingly target biomarker-defined subgroups and employ personalized medicine approaches, requiring continuous evolution of its assessment expertise.
Cadth 2015 e4 mcelwee cadth 041415 fnl
This document discusses adaptive clinical trial designs used by Merck for oncology studies. It provides examples of different types of adaptive designs including:
1) Dose-finding designs like modified toxicity profile interval designs that allow for dose escalation and de-escalation in a table-driven manner.
2) Single-arm response rate studies that can provide early access for patients and allow early interim analyses to discontinue biomarker-negative patient populations if no responses are found.
3) Comparative studies with dual primary endpoints of overall survival and progression-free survival that can adapt based on biomarker-selected patient populations at interim analyses.
4) Bayesian adaptive studies like I-SPY 2 that
Cadth 2015 e4 thorlund innovative trial designs in medical decision making
Adaptive clinical trial designs are increasingly used in commercial trials due to demands for faster evidence and more efficient trials. However, health technology assessment decision-making typically requires large parallel randomized controlled trials, creating a mismatch. Without long-term placebo/control data or trials that resemble approved treatment algorithms, innovative trial designs risk not providing sufficient evidence for reimbursement decisions. To address this, more education is needed on innovative designs for health technology assessors, and trials should apply these designs to further validate their ability to provide robust evidence for reimbursement.
Cadth 2015 e1 2015 04 cadth v2.0
This document summarizes a panel discussion on integrating evidence, values and ethics into healthcare decision-making using multicriteria decision analysis (MCDA). It discusses how MCDA can help address ethical dilemmas by explicitly considering multiple criteria, including efficacy, safety, costs, and other social values. It outlines the key steps in MCDA, including defining objectives and criteria, assigning weights to criteria, synthesizing evidence on the criteria, scoring performance on criteria, and aggregating scores to determine the overall value of interventions. The document emphasizes that MCDA supports making decisions in a way that is participatory, transparent, systematic and reflective of different stakeholder perspectives to arrive at decisions that optimize health in its widest sense.
Cadth 2015 e4 adaptive design april 2015 final lourenco
Health Canada regulates clinical trials and drug approvals. Adaptive clinical trial designs are increasing and can modify aspects of ongoing trials using accumulating data. Health Canada's main concerns are appropriate scientific questions, error control, and avoiding bias. Examples seen include adaptive randomization, sample size changes, and seamless phase 2/3 designs. Case studies demonstrate increased complexity, new statistical methods, and more simulation use. Health Canada recommends early consultation and education on adaptive designs.
Cadth symposium 2015 d3 pr os va. generic measures cadth 14th april 2015
This document discusses the use of generic and condition-specific patient-reported outcome measures (PROs) in value-based healthcare reimbursement decisions. It compares the EQ-5D-3L generic PRO to the PuQol_UI condition-specific PRO for pressure ulcers. The condition-specific measure was more sensitive to pressure ulcer severity levels compared to the generic measure. Using different PROs can lead to different assessments of treatment value and impact reimbursement decisions. The document concludes that using PROs in reimbursement requires care, as it can impede equitable decision-making and comparing "apples to oranges" treatments.
Cadth 2015 d5 symposium 2015 endonodal trials - version 2
This document discusses methods for incorporating single-arm study data into network meta-analyses (NMAs). Currently, NMAs primarily use data from randomized controlled trials. The document presents two methods for including single-arm evidence: 1) Using single-arm results to create informative priors in Bayesian NMA models, and 2) Creating "virtual comparisons" based on patient characteristics to include single-arm studies directly in the NMA. It provides examples applying these methods in analyses of treatments for cryptococcal meningitis and hepatitis C. The results showed inclusion of single-arm evidence can improve model fit and precision of treatment effect estimates in NMAs.
Cadth 2015 e5 ad panel discussion af
The document discusses guidelines from different committees on oral anticoagulants for atrial fibrillation stroke prevention that show some discordance despite being based on the same three landmark trials. It suggests that values influence guideline committees and prescribing specialists differently, and that patient values through shared decision making should also be considered to tailor therapy to individual patients.
Cadth 2015 e5 noac ad symposium_panel_14apr2015
This document summarizes a symposium on promoting evidence-based use of anticoagulants across Canada. It discusses the prevalence of atrial fibrillation, options for anticoagulation including warfarin and newer oral anticoagulants, and initiatives for collaboration between provinces to educate health professionals and patients on appropriate anticoagulant therapy. Speakers from various provinces outlined academic detailing programs and a CADTH systematic review comparing benefits and harms of anticoagulants.
Cadth 2015 b1 slides allan grill-pcodr-cadth_symposium2015presentationfinal
The document discusses discordance between recommendations from the pan-Canadian Oncology Drug Review (pERC) and provincial funding decisions for cancer drugs in Canada. It presents results from a survey of provincial drug funding decision-makers that identified several potential reasons for discordance, including differences in priorities, clinical evidence, and budget constraints between the levels. Challenges to alignment included issues with clinical trial evidence as well as pressure to expand access, while suggested solutions centered on strengthening consensus around treatment pathways and priorities nationally.
Cadth 2015 breakfast 2 excel hta tools presentation final
The document provides an overview of CADTH Excel-based health technology assessment tools that have been developed or are in development. It summarizes NetMetaXL, an Excel-based tool for conducting network meta-analyses of dichotomous outcomes. The presentation includes a live demo of NetMetaXL and previews of three other CADTH Excel-based HTA tools.
Cadth 2015 d7 burgess cadth 2015 20150414
This document discusses different forms of public engagement that could be appropriate for drug policy decisions. It notes that deliberative public engagement events can incorporate diverse perspectives but may not be fully representative. It advocates for participatory governance with advisory bodies that regularly refresh their engagement to better reflect the public. Experiments with different engagement methods should be assessed to help balance input with decision efficiency.
Cadth 2015 d7 presentation 2015 14 apr15
This document presents a framework for strengthening public and patient engagement in Health Quality Ontario's evidence review process. Key elements of the framework include articulating goals and principles, establishing a common language, describing a menu of engagement approaches matched to process stages, and identifying measures. The framework was developed through a review of literature and practices, expert consultation, and stakeholder dialogue. It recommends increasing transparency, incorporating diverse perspectives throughout stages, and evaluating engagement impacts. The framework provides guidance to enhance public and patient contributions to health technology decision-making in Ontario.
Cadth 2015 d4 lidia engel final
This document discusses challenges associated with going beyond health-related quality of life measures in cost-utility analysis. It notes that while economic evaluations often use quality-adjusted life years (QALYs) based on health-related quality of life instruments like EQ-5D, interventions can provide benefits beyond health alone. There are theoretical, normative, conceptual and methodological challenges to incorporating these broader outcomes. Measuring instruments have been developed to capture non-health domains, but valuing these outcomes poses challenges. Considering non-health outcomes increases complexity, but may provide a more comprehensive assessment.
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Cadth symp breakfast 4 Update to Guidelines for the Economic Evaluation of He...
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Cadth 2015 e4 lourenco adaptive design april 2015 final
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Cadth 2015 e4 fields slides for adaptive panel final
Cadth 2015 e4 thorlund innovative trial designs in medical decision making
Cadth 2015 e4 thorlund innovative trial designs in medical decision making
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Cadth symposium 2015 d3 pr os va. generic measures cadth 14th april 2015
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- 1. New Methods in HTA to Support Policy and Practice (session 1): Can We Better Understand How Canadians Value Health? April 13th, 2015 1
- 2. Objective: • Start a discussion on new methods that can help policy makers better understand the consequences of their decisions, ultimately improving the health of Canadians • Topic 1: Values, and how they can be integrated into decisions • Topic 2: Conducting and presenting economic evaluations (Session C2: 15:30 later today) 2
- 3. Before we begin… • Presentations will be made available on the CADTH website or through the mobile app the day after the session. • An evaluation survey will be sent out after the symposium and feedback on this session and the whole event. • Lunch will be served immediately following the session on the Salon Level near the Plenary Room. 3
- 4. Speakers: • Carlo Marra: Using Best Worst Scaling to elicit values • Nick Bansback: Using a discrete choice experiment with duration to estimate values for health states on the QALY scale • Dean Regier: The medium is the message: public engagement, value and bias • Mike Paulden: Transforming the cost- effectiveness threshold into a ‘value threshold’ 4
- 5. Questions • Placing monetary values on human life and suffering is anathema to those not trained in economics. • Does this, (together with the potential for hypothetical bias), render willingness to pay obsolete/outdated? • How should we account for value considerations? Modify WTP or E (or neither)? 5