Introducing Health Technology Assessment (HTA)
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1 Introducing Health Technology Assessment (HTA) Laura Sampietro-Colom, MD, PhD Deputy Director on Innovation. Hospital Clinic Barcelona President Health Technology Assessment International Workshop: HTA-what do I need to know as national patient advocate EMSP Annual and Youth Congress Crowne Plaza Le Palace City Centre Brussels, May 12-13, 2011
2 Outline Health Technologies (HTs): basic concepts What Health Technology Assessment (HTA) is? Basis for HTs market approval What is assessed in HTA? Basic steps of HTA Who is who in HTA What you can do to get involved
3 Health Technologies: Material Nature Medical Devices, equipments & supplies Medical/Surgical Procedures Drugs Support Systems Biologics Organizational and managerial Systems
4 Health Technologies: Purpose or application Prevention: protect against disease Eg. Immunization, hospital infection control program Screening: detect abnormality, disease or risk factor Eg. Tuberculin test Diagnosis: identify the cause of disease Eg. X-ray for possible broken bone Treatment: improve or maintain health status Eg. Coronary artery by-pass, psychotherapy Rehabilitation: restore, maintain or improve disable s person function Eg. Exercise program for post-stroke patients
5 Health Technology: Stage of Diffusion Adoption Early adopters Obsolete I + D & i Emerging New Tech. Established Technology Time Future Experimental Investigational Established Obsolete
6 What Health Technology Assessment (HTA) is? It is the research-based, practice-oriented assessment of relevant available knowledge on the direct and intended consequences of technologies, as well as the indirect and unintended consequences The goal of health technology assessment is to provide input to decision making in policy and practice HTAi Corporate Strategy:
7 What Health Technology Assessment is? Research Basic/Applied Assessment Decision HTA deals with: Global scientific evidence Local evidence and other information HTA approaches/orientation to HTs: Technology-oriented: Focused on specific HTs (STA) Health Problem oriented: Solutions for managing a particular problem (MTA) Project-oriented: local placement or use of a HT in a particular insitution (mini-hta, rapid-hta)
8 Possibilities of HTA & health systems MACRO To Inform Coverage Distribution and allocation resource Design of payment systems Entry Schemes mechanism To guide disinvestments decisions To guide Scientific and Industrial Policy Identification of research gaps. Info valorization & transfer MESO To Inform Investments (innovation in ) Research To support Valorization & transfer (own innovat) Assessment in-time To teach Decision makers MICRO To Feed CPG development To Support Adequate use oh Health Technol To Teach Professionals & citizens To disseminate Mas-media, users associati
9 What is the basis for HTs market approval? Regulatory Agencies: PMA (FDA), CE Mark Can it work? Safety & Efficacy (Absolute) Performance Benefits & Risks Ideal conditions: Best centers Best doctors Selected patients Drugs: Pharmacokinetics Medical Devices: Quality Source information: Clinical evidence (RCT: Phase I, II, III) Source information: Technical tests
10 What is assessed in HTA? Health Technology Assessment Regulation: CE Mark, FDA-PMA Can it work here? Benefits & Risks Real world: Our centers Our doctors Average patients Can it work? Comparative Effectiveness How much better/safer? Effectiveness Safety & Efficacy (Absolute) Performance Source information: Global evidence: MegaTrials, nonexperimental Local evidence: Pragmatic Trials Country info, EHR, Registries.. Quality of evidence
11 What is assessed in HTA? Health Technology Assessment Should we do it here? Can it work here? Context Effectiveness Source information: Economic evaluation studies Regulation: CE Mark, FDA-PMA Can it work? Safety & Efficacy (Absolute) Performance
12 What is assessed in HTA?
13 What is assessed in HTA? Health Technology Assessment Should we do it here? Can it work here? Context Effectiveness Source information: Economic evaluation studies Budget impact Ethical, Legal appraisal Organizational analysis Regulation: CE Mark, FDA-PMA Can it work? Safety & Efficacy (Absolute) Performance
14 Basic steps of HTA 1. Identify assessment topics 2. Specify the assessment problem (definition of policy question) 3. Determine the scope of the assessment 4. Search and retrieve evidence 1. Appraise/interpret evidence (Quality!) 2. Integrate/synthesize evidence 3. Collect new primary data (as appropriate) 5. Formulate findings and recommendations 1. +/- Appraisal 6. Disseminate findings and recommendations 7. Monitor impact
15 Why are different HTA based-decisions are made in different jurisdictions? More about Context!!!!! Evidence Policy Agenda Values Experience Resources Other criteria in final decision: Need Available alternatives Innovativeness Burden / severity disease Relevance for public health Equity
16 Who is who in HTA? Only public HTA agencies Doers and users HTA More than 1,200 individuals Organizational members 48 Non-Profit 16 For-Profit 10 Interest Subgroup: Patient and Citizens INAHTA: Consumer involvement
17 What can you do to get involved? Listen to: Liuska Sanna!!!
18 Thank you for your attention!
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