World Health Organization 14 April 2017 Priority Setting in Universal Health Coverage The role of Health Intervention & Technology Assessment Dr. Kees de Joncheere Director EMP department EMP Technical Briefing Seminar, November 2014

World Health Organization Outline 14 April 2017 Concept of UHC and Priority Setting What is Health Intervention and Technology Assessment Ongoing programmes of work contributing to HITA in WHO HTA for medicines evaluation The way forward

Universal health coverage (UHC) World Health Organization Universal health coverage (UHC) 14 April, 2017 The goal of universal health coverage is to ensure that all people obtain the health services they need without suffering financial hardship when paying for them. A strong, efficient, well-run health system that meets priority health needs Affordability – a financing system to avoid financial hardship Access to essential medicines and other health technologies Sufficient capacity of well-trained, motivated health workers to provide the services needed Resources are scarce in all settings and forms of priority setting are inevitable WHO has a commitment to supporting member states as they move towards universal health coverage. An important dimension of UHC is providing access to essential medicines and health technologies. Making sure that quality assured essential medicines are available requires properly functioning pharmaceutical systems.

World Health Organization 14 April 2017 Three Dimensions to Consider When Moving Towards Universal Coverage Priority Setting a. Between dimensions of the cube: if more funds become available, should they be spent on adding interventions, improving quality, covering more people, or reducing out of pocket payments? b. Along a single dimension ( population, services and costs) HITA contributes to decisions along the service dimension – which services (involving what medicines and medical technologies) should be covered, how they should be delivered

Considerations in priority setting World Health Organization Considerations in priority setting 14 April 2017 In moving towards UHC, questions focus on: The population covered by the package of interventions: Who ? The services that can be provided: Which services ? The proportion of service costs that can be covered: How much ? Health technology assessment (HITA) is an important process to aid priority-setting within the services axis of the UHC cube Important to note that priority setting is broader than just health technology assessment, however in deciding which services to offer, technology assessment provides a framework to compare and contrast alternative options More broadly priority setting includes considerations of the other two dimensions of the UHC cube

What is Health Intervention & Technology Assessment? World Health Organization What is Health Intervention & Technology Assessment? 14 April 2017 Health technology is the application of organized knowledge and skills in the form of interventions, devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology. HITA does not make the decisions, however the systematic assessment of the evidence makes the trade-offs between alternative actions clear Health technology assessment is not only about pharmaceuticals and devices but also about interventions and delivery systems.

The continuum of HITA activities World Health Organization 14 April 2017 Fragile states: Essential services Emergency kits Disaster planning Low income countries with low coverage, Primary health care packages Middle income countries with low coverage, Guaranteed packages of care Strong health system Marginal analysis for additions to packages Health Systems Health technology assessment (HITA) provides a decision-making framework for different types of decisions and can be applied in all health care systems, but needs differ In fragile health systems: to identify essential guaranteed services In middle-income countries with limited coverage: to decide how to extend the package of health care services provided In systems with established UHC: to inform decisions ‘at the margin’: what extra services to provide and at what cost Continuum of HTA Activities

Uses of HITA methods in WHO World Health Organization Uses of HITA methods in WHO 14 April 2017 WHO Model List of Essential Medicines Package of Essential Noncommunicable (PEN) disease interventions for primary health care, 'best buys' for NCDs WHO-CHOICE, CHOosing Interventions that are Cost Effective global database of around 500 health technologies OneHealth Tool designed to inform national strategic health planning in low- and middle-income countries. Assessing medical devices and assistive devices for an ageing population

Examples of ongoing HITA in WHO World Health Organization Examples of ongoing HITA in WHO 14 April 2017 WHO Model List of Essential Medicines First published in 1977 Updated every 2 years 156 countries have essential medicines lists OneHealth Tool for Costing and Strategic planning Development began in 2008 Released in 2012 Has to date been used in over 25 countries WHO-CHOICE Ongoing since 1998 Development of cost-effectiveness analyses of interventions covering all WHO regions

WHO-CHOICE example results World Health Organization 14 April, 2017 This slide shows results from the CHOICE project, measured as healthy life years saved per $1,000 international. The greatest health gain is seen in Vitamin A and Zinc fortification in children under 5, almost ten times greater than the health gain due to any of the other interventions for the same price (note compression of x axis between 10 and 60 healthy life years). Other services listed in the figure are also highly cost-effective, such as testing and treatment for tuberculosis, prevention and treatment of malaria, and primary prevention (for very-high-risk individuals) and treatment of myocardial infarction and stroke.

World Health Organization What is needed for HITA? 14 April 2017 Assessment is based on collecting, evaluating, and systematically reviewing all available evidence for the intervention or technology being considered Types of data include epidemiological, economic, health impact, expert opinion Methods include assessing the quality of available information, systematic review and meta-analysis, surveys, feasibility, affordability and ethical considerations Multidisciplinary skills are needed to assemble and interpret the data Countries with the greatest need often have the least capacity Different types of HITA vary in scope, time and resources required Full scale health technology assessment report Contextualization of reports produced by others "marginal" analysis of the sort done in high income countries requires fewer data and skills than the "non-marginal" analysis relevant in lower income settings, yet in practice the availability of data and skills is usually in the opposite direction. Multidisciplinary teams can include: Biomedical Engineers Epidemiologists Ethicists Health Economists Librarians Lawyers Nurses Patient organizations Pharmacists Public Health Specialists

Evaluation of new medicines For market entry : quality, efficacy, safety ; benefit/risk assessment For reimbursement Medical need and severity of disease Health gain and added therapeutic value Availability of alternatives Cost-effectiveness Budget impact Equity considerations …

Evaluation of new medicines For medical practice Evaluation by drug bulletins, professional associations on the “place in therapy” of a new medicine Consistency between reimbursement indications and therapeutic guidelines ? Reviews by national HTA bodies

Implications of cost-effectiveness analysis for reimbursement Health-based reason to justify a price premium for the proposed drug Relate extent and nature of health gain to justify price increase, including cost off-sets in health sector Common outcome measure (QALY, life year gained,.. ) Pristine value judgement

Economic evaluations Two main approaches on a “cost-minimisation” basis as “acceptably cost-effective” Two main “levers” restrict to particular patients price of the proposed drug

Reimbursement decision-making process : after the initial reimbursement decision … Post-listing reviews (at least annually) prices restrictions and listings Post-listing monitoring (at least annually) usage (including predicted versus actual) cost to reimbursement system Coordinate post-listing activities

International collaboration on evaluation of medicines Health care systems are different Issues tend to be the same : costs drivers and evidence Basis for common guidance, and exchange of information, and “lessons learned” ? ! MEDEV EU network of Pricing and Reimbursement authorities EUnetHTA INAHTA, ISPOR, HTAi HiTAP and South East Asia network REDETSA Latin America network PPRI and PHIS networks

Making cost-effectiveness evaluations work (1) ( do countries have the resources to do this ?) Separate licensing and reimbursement decisions Positive list Price negotiations Ability to restrict indications Adequate guidelines for submissions Competent evaluations of submissions Consistent and informed decision-maker

Making cost-effectiveness evaluations work : decision-making process (2) Inclusiveness in decision-making and input from all stakeholders Reimbursement committees with external experts : managing potential conflict-of-interests Health Technology Assessment agencies and committees often not directly linked with reimbursement decisions

Use of cost-effectiveness analysis in reimbursement Growing requirements and increasing need for resources “Silo-budgeting” limits application Shift to “risk-sharing” with patient registries : from paying for the medicine to buying an agreed upon therapeutic outcome CEA needs to relate to goals, values, and priorities of the health care systems RCTs do not provide all information needed : discuss with industry the need for additional trials How to deal with “point-decisions” vis-à-vis re-assessment of the evidence ? Discussions on appropriateness of QALY`s Discussions on thresholds

World Health Organization The way forward 14 April 2017 WHO HQ plans to undertake a global mapping survey of current capacity and perceived needs for HITA in member states A focus of moving forward should be on Advocacy and promotion of priority setting (including HITA) best practices Facilitate sharing of technology assessment and experiences among countries including through the development of platforms for information exchange Capacity building activities including networks where appropriate Resolution EB134.R14 Health intervention and technology assessment in support of universal health coverage