Health Technology Assessment: Comparison between UK and Canada Processes by Dr Tayaba Khan
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Comparison of Health Technology Assessment Processes between Canada and UK
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Health Technology Assessment: Comparison between UK and Canada Processes by Dr Tayaba Khan
- 1. Similarities and Differences Between the Canadian and UK Health Technology Assessment (HTA) Processes Dr Tayaba Khan 11 March, 2020
- 2. Outline • Countries Snapshot • What is HTA • UK HTA system • Canada HTA system • Comparisons • Summary • Future Directions
- 3. United Kingdom Snapshot • Population: 66.4m (2017) 1 • Life expectancy at birth: 81.2 years2 • Health spending per capita per year: USD 3901.632 • Healthcare spending as a percentage of GDP: 9.80%2
- 4. Canada Snapshot • Population: 37.1m (2017)1 • Life expectancy at birth: 82.2 years2 • Health spending per capita per year: USD 4900.482 • Healthcare spending as a percentage of GDP: 10.70%2
- 5. Health Technology Assessment What is HTA? ‘The systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies’3 Rationalizing HTA • Global burden • Increased availability of generic drugs (less expensive) • Rising costs of new medicines • Limited (or even shrinking) healthcare budgets1
- 6. Health Technology Assessment • Carried out by independent agencies or university departments at the request of health authorities • Highly practical, expert applied research, assimilating and synthesizing research evidence about effectiveness, costs, improvements to quality of life to patients of the treatment proposed • Technologies assessed include medicines, programmes to prevent ill-health, procedures and devices Criteria for consideration (Dunnel’s Funnel)4 • Necessary healthcare • Effective treatment • Efficient ( cost benefits) • Should it be assigned to patient as own expense and responsibility
- 8. The HTA Steps & Uses HTA can be used: • As an input into the pricing and/or reimbursement process • As an input into market access decision • As a determinant of the use of the medicine by affecting guidance to physicians or even possibly the patients themselves • In the development of clinical guidelines and public health policies5
- 9. Stakeholders Major Stakeholders • Physicians • HTA Agency and experts • Payers • Hospitals • Pharma group (Innovative) • Research organizations • Patients and patient organizations Minor Stakeholders • Pharmacists • Pharma group (Generic)9 High Quality in Patient Care Patient Evidence Clinical Evidence Economic Evidence Ultimate Outcome
- 10. Assessment of HTA Principles across UK and Canada5 Principle UK Canada 1. HTAs should have explicit and relevant goals and scope ++ ++ 2. HTAs should be unbiased, rigorous and transparent ++ ++ 3. HTAs should include all relevant technologies ++ 4. HTAs should have a clear system for setting priorities ++ 5. HTAs should incorporate appropriate methods for assessing costs and benefits ++ ++ 6. HTAs should consider a wide range of evidence and outcomes ++ ++ 7. HTAs should consider a full societal perspective ++ 8. HTAs should explicitly characterise uncertainty surrounding estimates ++ ++
- 11. Assessment of HTA Principles across UK and Canada5 Principle UK Canada 9. HTAs should consider and address issues of generalisability and transferability ++ 10. HTAs should actively engage all key stakeholder groups ++ ++ 11. Those undertaking HTAs should actively seek all available data ++ ++ 12. The implementation of HTA findings need to be monitored + 13. HTA should be timely but separate from other regulatory review + + 14. HTA findings need to be communicated appropriately to different decision makers ++ ++ 15. The link between HTA findings and decision making processes needs to be transparent and clearly defined + ++
- 12. Commonalities in HTA Processes of UK and Canada • Shared history • Common liberal, basic security, welfare state ideology • A national HTA body • Universal health care funded by taxation • Reimbursement recommendations guided by clinical efficacy, cost-effectiveness, and explicit quality-adjusted life-year threshold • Frameworks including patient input at various levels of decision making6
- 13. Commonalities in HTA Processes of UK and Canada (cont.) According to Wilsdon and Serota5, the best performing HTA organizations are NICE (UK) and CADTH (Canada) • Consideration of a wide variety of data sources including: • scientific studies (e.g. clinical trials, observational studies), • national statistics, • clinical practice guidelines, • registry data, • surveys, • expert opinion and • other evidence from pharmaceutical manufacturers7 • Speed of update of in technology very similar in certain disease areas5
- 14. UK HealthCare System • National Health Services • Nationalized healthcare: providers, facilities, services • Universal coverage, single payer • Financing: income tax, general taxes, general fund • District budgets control spending • Physicians work for NHS
- 15. HTA in UK • In 1999 the National Institute of Clinical Excellence (NICE), an HTA organization, was established in the United Kingdom • Globally renowned for methodological rigor • Assessment guidelines are globally adopted as models • NICE undertakes new medicines and indications formally requested for review by the Secretary State of Health6 • NICE recommendations must be complied with and made available up to three months after the recommendation is published8 Key factors considered during evaluation: • balance between benefits and costs (i.e. cost- effectiveness) • the degree of clinical need of patients • broad clinical priorities for the NHS • effective use of resources encouraging innovation • any guidance issued by the Secretary of State6
- 16. Clinical Translation of Approved Technologies in UK5 • Primary Care Trust is legally obliged to fund drugs recommended by NICE • It can decide whether or not to fund drugs not recommended or reviewed by NICE • Usage of new technology is influenced by NICE restrictions and guidelines on use of medicine
- 17. Canada Healthcare System • National Health Insurance (NHI) • Universal coverage, single payer with budgets on provincial level • Financing: taxes from general fund • Provincial budgets control spending • Physicians salaried and fee for service • Most hospitals self managed and private • Decisions regarding which technologies to be put in reside with individual provinces • Federal government role is limited to premarket approval, and in case of patented pharmaceutical price regulation5
- 18. HTA in Canada Canada has two national HTA programs: • For most meds: Canadian Agency for Drugs and Technologies in Health’s (CADTH’s) Common Drug Review (CDR) • For Cancer meds: Pan- Canadian Oncology Drug Review (pCODR), which was transferred to CADTH in April 2014. All provinces participate in CDR and pCODR, except Quebec • Independent not for profit organization • Major producer of HTA for drugs, devices, diagnostics and procedures • Funding through Health Canada, Provinces and Territories Factors • Recommendations issued by the CDR are not mandatory • CDR replaces the independent review processes of the provincial, federal, and territorial drug plans, but maintains their decision on final reimbursement decisions • The drug plans negotiate a price directly with the manufacturer • CDR may issue a recommendation “do not list at the submitted price” to indicate when a revised lower price may lead to a positive recommendation6
- 19. Clinical Translation of Approved Technologies in Canada5 • Regional Drug Plan decisions based on CDR assessment and own price negotiations with the manufacturer • Usage influenced by Drug Plan restrictions and guidelines on use of medicine
- 20. HTA in Canada and UK5 Key Attributes Canada UK Principle HTA Agency CADTH NICE Objective Therapeutic Value, Value for Money, Regional Disparities Therapeutic Value, Value for Money, Regional Disparities HTA Separate/Part of P&R Process Part. Recommendations may or may not be followed regionally. Separate Influence on price, reimbursement and market access Access only Access only Impact Limited to price and reimbursement decisions, therefore lesser impact or effect on usage. Significant impact on usage of different medicines. NICE produces mandatory government guidelines. Impact of HTA decision on price Common Drug Review recommendations usually associated with upward price volatility for several quarters after recommendation publication Trend effect of immediate increase in price following recommendation, moderating after 6-9 months5 Patient Involvement CADTH systematically collect patient views Patients participate through the whole process but do not hold voting rights in the appraisal committee
- 21. Priority Setting Criteria8 Criterion CADTH NICE Clinical Impact Y Y Economic Impact Y Y Burden of Disease Y Y Budgetary Impact Y Y Expected Level of Interest Y Existing Evidence Y Opportunity for Revision Y Rate of Use Variation Y Ethical, Legal or Psychosocial Implications Technology of Controversial Nature Existing Alternatives Y Questions about Under or Over Utilization Benefits from the assessment Y High likelihood that results will influence decision making Y
- 22. Other Comparisons8 Criterion CADTH NICE Number of applications processed per annum 20-24 per year 44 per year Length of review process 6-12 months 9-18 months Funding (in USD) $17.9m $48.6m Permanent staff Over 100 270 HTA is conducted independently of parties with a vested interest in the outcome ++ + HTA conducted separately from market authorization ++ ++ The rationale for HTA decisions/recommendations is clearly stated ++ ++ Scientific evidence is available to manufacturers during development stage to enable the availability of evidence required or HTA + ++ HTA or proportion of HTA is conducted for pharmaceuticals, devices, procedures, diagnostics, and treatment strategies ++ ++ Legend ++ Meets and applies best practices + Meets principles in guidelines but no evidence to assess situation in reality -Guidelines not consistent with best practice principles
- 23. Other comparisons8 Criterion CADTH NICE HTA conducted for old as well as new technologies ++ ++ The process and rationale for selecting and prioritising topics is clearly defined and publicly available ++ ++ Selected topics reflect stated priorities ++ + HTA includes input from /references other national or international agencies on the same of closely related projects ++ + Cost of HTA (Wilsdon and Serota, 2011) 18m Pounds of which 4m pounds on CDR 71m NICE of which 7m on health technology evaluation HTA considers unpublished trial data ++ + HTA considers data not from RCTs ++ ++ Legend ++ Meets and applies best practices + Meets principles in guidelines but no evidence to assess situation in reality -Guidelines not consistent with best practice principles
- 24. Other comparisons8 Criterion CADTH NICE HTA takes into account: cost on public purse; nonhealthcare and indirect costs and benefits to patients and society + - Outcomes are published on a publicly accessible website ++ ++ Decisions are explained in several levels of clinical/technical detail so that all relevant audiences may understand the decision (manufacturers, health plans, general population, patient groups) + ++ Transparency regarding assessment process ++ ++ Measures to oversee impact ++ ++ Effects of HTA decisions are monitored and data is collected to evaluate clinical impact over time - ++ Information is used to modify/ revise HTA process/methodology ++ ++ Legend ++ Meets and applies best practices + Meets principles in guidelines but no evidence to assess situation in reality -Guidelines not consistent with best practice principles
- 25. Summary • Both UK and Canada demonstrate many similarities in their approach towards HTA process • Their activities, however, vary because of different mandates as well as unique political, social, and population needs6, 8 • Divergence occurs in rejection of new medicines due to factors such as cost-effectiveness, comparator choice, clinical benefit, safety, trial design, and submission timing • Therefore, the differences in recommendations could be considered because of the agencies’ approaches to risk perception
- 26. Future Directions • HTA remains an evolving field as changes in role of pricing and reimbursement system come into play • Different innnovations may be valued differently invarious therapeutic areas e.g. rheumatoid arthritis versus multiple sclerosis
- 27. References 1. Papanicolas I, Mossialos E, Gundersen A, Woskie L, Jha AK, 2019. Performance of UK National Health Service Compared with Other High-Income Countries: Observational Study. BMJ 2019; 367: l6326. 2. Health Expenditure and Financing, 2019. OECD Stat. https://stats.oecd.org/Index.aspx?DataSetCode=SHA 3. Definition Health Technology Assessment. HTA Gloassary.net. International Network of Agencies for Health Technology Assessment. http://htaglossary.net/health+technology+assessment+%28HTA%29?highlight=health+technology+assessment 4. Dunning’s Funnel - derived from Government Committee on Choices in Health Care. Choices in Health Care. Zoetermeer: Ministry of Welfare, Health and Cultural Affairs (1992) 5. Wilsdon T and Serota A, 2011. A Comparative Analysis of the Role and Impact of Health Technology Assessment. Charles River Associates. https://www.efpia.eu/media/25695/a-comparative-analysis-of-the-role- and-impact-of-health-technology-assessment-2011.pdf 6. Allen N, Walker SR, Liberti L, Salek S, 2017. Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland. Value in Health March 2017; 20(3):320–328 DOI https://doi.org/10.1016/j.jval.2016.10.014 7. Angelis A, Lange A, Kanavos P, 2018. Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries. Eur J Health Econ; 19:123–152 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773640/pdf/10198_2017_Article_871.pdf 8. Roehrig C and Kargus K, 2003. Health Technology Assessment in Canada and the G-7 Countries: A Comparative Analysis of the Role of HTA Agencies in the Decision-Making Process. Health Care System Division. http://www.medicine.mcgill.ca/epidemiology/courses/EPIB654/Summer2010/Policy/HTA%20Paper%20Canada .pdf 9. Fundamentals of Health Technology Process, 2020. European Patient Academy. https://www.eupati.eu/health-technology-assessment/fundamentals-of-health-technology-assessment- process/
- 28. Image Credits Title Image; https://cdn.pixabay.com/photo/2016/04/06/08/47/wire- rack-1311161_960_720.jpg UK Country Image https://image.shutterstock.com/image-photo/big- ben-260nw-407993692.jpg Canada Country Image https://image.shutterstock.com/image- photo/canadian-flag-front-view-false-260nw-549375997.jpg Health technology assessment process EUPATI https://www.eupati.eu/health-technology-assessment/fundamentals- of-health-technology-assessment-process/ Arriving at an HTA recommendation https://www.eupati.eu/health- technology-assessment/patient-involvement-in-the-hta-decision- making-process/ Dunnel Funnel. Dunning’s Funnel - derived from Government Committee on Choices in Health Care. Choices in Health Care. Zoetermeer: Ministry of Welfare, Health and Cultural Affairs (1992)
- 29. Concluded
Hinweis der Redaktion
- In simple terms we study the clinical effectiveness of a medical intervention such as a new drug What the economical impact of making this intervention available to patients will be How health policy might be impacted by this new intetvevention becomes available What rhe social and ethical implications might be for patients and wider society. What? A process which examines multiple aspects of the value of the new or existing health technology such as a new drug, with the purpose of informing decisions that have to be made about the adoption of the technology. Decisions may be whether to adopt a technology at all, in which kind of patients, or for how long. All these issues may be assess in a single health technology assessment HTAs can be used in many instances, including to: • Make changes in clinical practice guidelines; • Classify the stage of development of new technologies; • Limit over-enthusiastic, early use of developing technologies; • Avoid the purchase of new technologies that will not be used for lack of human or financial resources to operate them; and/or • Identify knowledge gaps related to new technologies and their potential.
- HTA is a form of research that generates information about the clinical and cost effectiveness of health technologies (European Patients academy). This In health care, the term health technology (or in short ‘technology’) can include medicinal products (medicines, including biologics), medical devices, equipment, and supplies; medical and surgical procedures; public health programmes and support systems; and organisational and managerial systems used in prevention, screening, diagnosis, treatment, and rehabilitation. Examples include: Medicines Programmes to prevent ill-health (e.g. childhood vaccination programmes) Procedures (such as surgeries) Devices (equipment or machinery that deliver healthcare interventions or assist with activities of daily living, such as an insulin pump or an epinephrine auto-injector)
- Processes and methods There is great variation in the scope, selection of methods and level of detail in the practice of HTA. In a condensed form, an HTA can be characterised by three phases: Assessment: collation and critical review of scientific evidence Appraisal: review of the assessment with consideration of all other (policy) factors by a committee to make a recommendation Decision-making: implementation of the recommendation Each of these three phases comprises various structures and functions. Not all HTA programmes conduct all of these steps, in fact ‘decision making’ is rarely, if ever, in the remit of an HTA body. Figure 1 shows a general (simplified) HTA process. It highlights the goal of the HTA process: communicating information from health research (science) to decision-making and, ultimately, to the population.
- HTA can be used: As an input into the pricing and/or reimbursement process. That is the HTA forms an integral part in the decision-making process that determines the price or the reimbursement of the medicine; As an input into market access decision. That is the HTA determines the degree to which payers fund a medicine once it has a price and reimbursement decision As a determinant of the use of the medicine by affecting guidance to physicians or even possibly the patients themselves. in the development of clinical guidelines and public health policies (Wilsdon and Serota, 2011).
- Based on principles of HTA from Academic Perspective
- Based on principles of HTA from Academic Perspective
- Shared history Common liberal , basic security welfare state ideology A national HTA body to assess the added therapeutic value and cost effectiveness of new medicines(Allen, Walker, Liberti, 2017) Australia, Canada, England, and Scotland all provide universal health care funded by taxation and share a long history of HTA(Allen, Walker, Liberti, 2017) At present, all four countries have a national HTA agency and reimbursement recommendations that are guided by both clinical efficacy and cost-effectiveness and have a framework that includes patient input. T(Allen, Walker, Liberti, 2017) These agencies share common factors, such as considering clinical efficacy and cost-effectiveness of new medicines, and have an implicit or explicit quality-adjusted life-year threshold. T(Allen, Walker, Liberti, 2017)
- The topic is identified and allocated to four different evaluation streams These streams adopt slightly different methods as the objectives of the work, and the nature of NICE’s guidance, is slightly different The larger stream is that of technology appraisals. This essentially looks at high cost drugs and devices There also the diagnostic appraisal program, looking at diagnostic technologies The medical technology evaluation program focusing on low-cost devices Highly specialized technologies program which examines high cost drugs in very rare conditions
- Canada’s NHI – overview, origins and history Canada has a national health insurance program NHI (a government run health insurance system covering the entire population for a well defined medical benefits package). Health insurance coverage is universal. General taxes finance NHI through a single payer system (only one third-party payer is responsible for paying health care providers for medical services). Consumer co-payments are negligible and physician choice is unlimited. Production of health care services is private; physicians receive payments on a negotiated fee for service and hospitals receive global budget payments (Method used by third party payers to control medical care costs by establishing total expenditure limits for medical services over a specified period of time). Canada’s health care system is known as Medicare (the term should not be confused with the Medicare program for the elderly in the U.S.) Canada’s population is about 31 million people and the country is divided into 10 provinces and two territories. Most of the population lives within 100 miles of the United States border. From the American point of view, Canada provides a good comparison and contrast in terms of the structure of its health care systems. U.S. and Canada share a similar heritage in terms of language and culture; the two countries also share a long border and have similar economic institutions (Folland et al 542). (Ridic, Gleason and Ridic, 2012)
- In 1989 the Canadian HTA Agency, Canadian Coordinating Office for Health Technology Assessment - CCOHTA (renamed Canadian Agency for Drugs and Technologies in Health - CADTH in 2006) was established, and funded by federal, provincial and territorial governments,