Presentation on theme: "World Health Organization"— Presentation transcript:
1 World Health Organization 1 April 2017Health technology assessment of medical devicesPresented By[Presenter Name][Presenter Title]Date
2 Introduction Definition of HTA, where it fits in & how to use it HTA around the world – your partnersChallenges and issuesOpportunities and enablersStrategic actions for advancing HTA into developing and emerging countriesWorking group session
3 DefinitionHTA is “the systematic evaluation of properties, effects, and/or impacts of health-care technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. Its main purpose is to inform technology-related policy-making in health care. HTA is conducted by interdisciplinary groups using explicit analytical frameworks drawing from a variety of methods”HTA Glossary
4 Importance of HTAOptimization of decision making processes – balance access, quality and sustainabilityInform practice and governancecontextualization of global knowledgetransparent decision-makingoverall vision of equity and accountabilityLegitimate decisions, policy and practiceDiffusion of innovation
5 To ensure improved access of safe, quality medical devices Research and developmentInnovativetechnologiesRegulationsRegulations of medical devicesResearch and development based on needsApproved high cost Medical devicesApproved Medical devices(including innovations)Post market surveillance and Adverse event reportingNeeds Assessments/SelectionDonationsInstallation,Inventories; CMMS, MaintenanceUser training and clinical effectivenessHealth Technology AssessmentProcurementAssessmentManagementDecommissioning, ReplacementHuman resourcesPoliciesGlossary on Medical devicesPolicies of medical devicesHuman resources for Medical devices
6 World Health Organization Resolution WHA 60.29World Health Organization1 April 2017Health technologies(+ pharmaceuticals, interventions, procedures, organizational systems,…)MedicaldevicesHealth Technology- The application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.Medical Device-An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means.« medical devices as a major subset of health technologies »6
7 Purpose of documentTo provide a background to the concept, best practice and programme of HTA around the worldTo highlight the contribution that HTA can make to informed policy- and decision-makingTo describe strategic actions for advancing HTA into developing and emerging countriesTo support informed decision-making on the introduction of HTA into the health systems of developing and emerging countries.
8 Evidence for informing decision-making Political, social,economicconditionsTechnological, ethical,legislative+EvidenceIntuitivedecision-making
9 World Health Organization 1 April 2017Evidence…My facts Your factsAdequate facts Bare factsNeutral facts Made up factsDisputable facts Indisputable factsThe process of evidence generation and use may be more important than the evidence itself.9
10 Context is essential for evidence-informed decision making World Health OrganizationContext is essential for evidence-informed decision making1 April 2017There are decisions that…in contexttake good evidence …… and use it wellwithout context… and use it poorlypoor evidence …Adapted from Shaxson, L 2004: Evidence-based policy making: if it exists what makes it robust? Available at
11 World Health Organization Canadian Society for International Health Approach to Health System Strengthening1 April 2017Health information systemsdata for decision-makingResource for development (Evidence-based planning and policy-making)Evidence-based decision-making (clinical and community-based)Health human resourcesHealth financing and resource allocationService delivery - treatments and programsCommunity interventions and health promotionStewardship and leadershipTransparent and accountable public/private sectorSocial determinants of health framework“ “Health in all policies”Vision: equity and accountabilityStrong and vibrant civil society11
12 Improving health by improving decision-making GovernanceDecisionsHealth impactAppropriate useHealthtechnology
13 Where can HTA have an impact? HTA and diffusion of health technologies
14 HTA products HTA report Rapid review Information service Horizon scanningAlwaysPolicy orientedResearch questionContext embeddedMethodologically sound
15 Health technology assessment Health technology regulation HTR and HTAHealth technology assessmentHealth technology regulationCharacteristicsEfficacy, effectiveness and appropriatenessSafety and efficacyPerspectiveRecommendation on complex technologiesMandatoryRequirementMaximize clinical and cost effectivenessPrevent harmRole
16 Health technology assessment Health technology management HTM and HTAHealth technology assessmentHealth technology managementCharacteristicsSocietalHealth facilityPerspectivePopulation healthCommunity servedOrientationSystematic critical review, meta-analysisProject management, technology life-cycleMethodClinical effectiveness, cost effectiveness, appropriatenessNeeds analysis, alternatives, specificationsCriteriaPolicy/decision/practiceDecisionOutcome
18 World Health Organization Layers of questions & layers of evidence1 April 2017How should we do it here?ImplementationShould we do it here?AppropriatenessHealth technology assessmentEffectivenessCan it work here?EfficacyClinical EffectivenessThe extent to which a specific intervention, procedure, regimen, or service does what it is intended to do under ordinary circumstances, rather than controlled conditions. (INAHTA Glossary)Clinical PerformanceThe ability of a medical device to achieve its intended use as claimed by the manufacturer (GHTF/SC(PD3)/N4:2007)Can it work?RegulationTechnicalPerformance18
23 HTA & innovation Kind of innovation Subjectivity of innovation What is new?Product, process, input, organizational, socialSubjectivity of innovationNew for whom?Individual, group, organization, industry, societyDegree of innovationHow new?Market, technology, organization, environment
24 International collaborations in HTA International Network of Agencies in Health Technology Assessment (INAHTA)Health Technology Assessment international (HTAi)European network for Health Technology Assessment (EUnetHTA)WHO collaborating centres
25 HTAi Annual international meetings – global networking 2010 HTAI signed an MOU with WHO for wide-ranging collaboration on HTA promotion, particularly in developing countriesHTAi Policy Forum – open discussion global leaders from HTA bodies and industryInternational Journal of Technology Assessment in Health Care, HTAi official academic journal
26 HTAiHTAi scholarship program specifically for capacity-building in Africa (can support academic programs, internships, even appropriate short courses in HTA or related fields). Travel grants to attend our annual meetingsHTAI Developing Countries Interest Sub-Group, Joseph MathewSIGNET Newsletter-June2010.pdf.HTAi participated in the WHO's First Global Forum on Medical Devices 2010HTAi resources on the web
27 ChallengesBalancing access, quality of care and sustainability of the health care systemManaging expectationsPopulation health benefitWhat results in the greatest clinical benefits to the community?Are the interventions cost effective?Can we afford this? (appraisal)
28 Challenges Different epidemiological environments Physical environmentsFinancial resourcesHealth care financing and distribution mechanismsCultural acceptance of health care interventionsValues for personal choice, equity, efficiencyTechnology maintenance capacityCivil and health care infrastructureSkilled human resourcesTraining and educationRegulatory environmentHealth professional standardsProfitability of health care mkts
29 ChallengesAvailable data is not context-specific (often from high- income countries with different contexts)Desirable or acceptable levels of safety, effectiveness, cost-effectiveness, and other attributes of a technology, as well as acceptable trade-offs among these, may vary in different communities, countries, or other circumstancesPlanning and regulatory systems are often in their infancy
30 7 enablers for supporting use of evidence to inform policy Collaborate with othersEstablish strong links with policy makers and involve stakeholders in the workBe independent and manage conflicts of interestBuild capacity among those working in organizationsUse good methods and be transparentStart small, with clear audience, scope and address important questionsBe attentive to implementation considerations
31 HTA country pilot projects Contextualize the pilot to the settingIdentify a local organization and champion responsible for the pilot and become the country focal point for HTALink the pilot to the government and credible government official with a commitment to sustaining the projectDevelop and nurture appropriate national and international linkages & exchange to the international HTA community and WHO Collaborating Centers
32 HTA country pilot projects Identify and prioritize relevant and timely HTA projectsDevelop a pilot implementation plan with realistic and attainable results in HTA, dissemination and policy engagementEvaluate the pilot with lessons learned and opportunities for improvement.
33 Role of the HTA Focal Point Become recognizedDevelop and sustain a network of HTA stakeholders within policy communityFacilitate flow of information international to local and vice versaPrimary contact for HTA resources and informationOrganize & facilitate meetings and workshops to those wanting to use, interpret and use HTAIdentify and articulate the HTA needs and priorities of key audiencesFacilitate interaction between HTA producers and users with sustained relationship and build capacity and capability within a global context
35 Implementation of HTAChase D et al. Development of a toolkit and glossary to aid in the adaptation of health technology assessment (HTA) reports for use in different contexts. Health Technology Assessment, 2009, 13:59McGregor M, Brophy J. End-user involvement in health technology assessment (HTA) development: a way to increase impact. International Journal of Technology Assessment in Health Care, 2005, 21(02):263–267.Juzwishin D. Framework for regional health authorities to make optimal use of health technology assessment. Edmonton, Alberta Heritage Foundation for Medical Research,Juzwishin D, Schneider W. Screening procedure for use when considering the implementation of health technology. Edmonton, Alberta Heritage Foundation for Medical Research, 2002.Rubinstein A, Pichon-Riviere A, Augustovski F. Development and implementation of health technology assessment in Argentina: two steps forward and one step back. International Journal of Technology Assessment in Health Care, 2009, 25(S1):260–269.
36 Case study: ThailandTeerawattananon Y et al. Historical development of health technology assessment in Thailand. International Journal of Technology Assessment in Health Care, 2009, 25(S1):241–252.What were the challenges?What were the opportunities?What were the enablers?
37 Resources availableThe Health technology assessment handbook by the Danish Centre for Health Technology AssessmentHTA adaptation toolkit developed as part of the European Network for HTA (EUnetHTA) collaborationHailey D. Elements of effectiveness for health technology assessment programs. Edmonton, Alberta Heritage Foundation for Medical Research, 2003
39 ResourcesResources for health technology assessment. Health Technology Assessment international and the International Network of Agencies for Health Technology Assessment, 2005esources_for_HTA.pdfMakundi E, Kapiriri L, Norheim O. Combining evidence and values in priority setting: testing the balance sheet method in a low-income country. BMC Health Services Research, 2007, 7(1):152.
40 Working group sessionWhat are the opportunities for advancing HTA with the HTM and HTR communities?What are the challenges?What actions can we take to advance an integrated approach to mobilize HTANext steps? End
41 WHO Medical Device technical Series Training module of :Health technology assessment of medical devicesDeveloped by Dr Reiner Banken and Dr Don JuzwishinApril 2011Global Initiative on Health Technologies, WHOSupported by the Bill & Melinda Gates Foundation
42 Thanks! Contacts: http://www.who.int/medical_devices/en/ Phone:Fax:Skype: WHOHQGVA1 (then dial 11239)Other: (presenters name and )Objective: to ensure improved access, quality and use of medical devices.