WHO Workshop, Bangkok, Health Technology Assessment

Transcription

1 WHO Workshop, Bangkok, Health Technology Assessment 1. Introduction to Health Technology Assessment (HTA) Berit Mørland, Norway 2. HTA & Government Keng Ho PWEE, Singapore 3. HTA and Clinical Decision Making Joseph Mathew, India 4. International activities and networks; closing discussion 1 1

2 1. Introduction to HTA*) - Health technology - Health technology assessment (HTA) -Current trends in HTA *) Berit Mørland; DDS Dr philos Establishing the national HTA agency in Norway 1998 Chair INAHTA President HTAi My thanks to Dr Cliff Goodman, Vice President of HTAi, for letting me use some of his slides

3 What is Health Technology? - and what do we (HTA) include by health technology: Physical Nature Drugs: e.g., aspirin, antibiotics, chemotherapy Devices, equipment, supplies: e.g., cardiac pacemaker, MRI scanner, mosquito netting Biologics: e.g., vaccines, blood products, biotechnologyderived substances Medical and surgical procedures: e.g., acupuncture, cancer chemotherapy, cesarean section Public health: e.g. screening, lifestyle advice etc Support systems: e.g., clinical laboratory, drug formulary, patient record system Organizational, delivery, managerial systems: e.g., vaccination program, health care payment system, 3 3

4 Health Technology: Clinical Purpose Prevention Screening Diagnosis Treatment Rehabilitation Palliation 4 4

5 Health Technology: Stage of Diffusion Future / Experimental (laboratory or animal testing) Investigational (clinical studies) Established (standard approach) Obsolete (disinvestment) 5 5

6 What Is Health Technology Assessment? HTA is the systematic evaluation of properties, effects, or other impacts of health care technology. The main purpose of HTA is to inform policy / decision-making ( at macro, meso, micro- levels) for technology in health care. HTA may address the direct and intended consequences of technologies, as well as the indirect and unintended consequences of technologies. HTA is conducted by interdisciplinary groups. HTA uses explicit analytical frameworks and a variety of methods. 6 6

7 HTA asks the following questions: Does it work? For whom does it work? At which costs does it work? Compared to alternatives?

8 Use of HTA (Slightly modified from Kent Woods, UK) Health Technology Assessment /HTA Politics Clinical research Assessment Identifying the consequences Scientific Organization documentation: Patient perspective Clinical effect Ethics/Law Cost-effectivenessResources Education Rembursement Guidelines Prioritysettings Clinical practice

9 Properties and Impacts Assessed Main categories: Technical properties Efficacy and effectiveness Safety Cost and other economic attributes Social, legal, ethical, or political impacts 9 9

10 Measuring Efficacy/Effectiveness Health outcomes/endpoints ( benefits and harms ) mortality morbidity adverse events Quality of life, also: functional status patient satisfaction Intermediate or surrogate endpoints e.g., blood pressure, lab values, EKG, ( biomarkers ) Accuracy of tests (screening, diagnosis, monitoring) sensitivity specificity 10 10

11 Clinical research and its Hierarchy Large randomized controlled trial Small randomized controlled trial Nonrandomized trial w/ contemporaneous controls Nonrandomized trial w/ historical controls Cohort study (prospective) Case-control study (retrospective) Cross-sectional study Surveillance (e.g., w/ databases or registries) Series of consecutive cases Single case report (anecdote) 11 11

12 Attributes of Stronger Evidence ( less biased), In General: Prospective studies are stronger than retrospective. Controlled studies are stronger than uncontrolled ones. Studies with contemporaneous control groups are stronger than studies with historical control groups. Randomized studies are stronger than non-randomized Large studies (with enough patients to detect true treatment effects) are stronger than small ones. Blinded studies (patients, providers do not know which intervention is being used) are stronger than unblinded. Studies that clearly define study populations, interventions, and outcome measures are stronger than those that do not

13 The Golden Standard The Basic Evidence Hierarchy Systematic reviews (Meta-analyses) Well-designed RCT Well-designed CT Not -experimental (Cohort, Case-Control) Patient-series, Register-studies Experts, Consensus- conferences, Case-reports

14 But RCT is Not Always the Best Method to Answer Clinical Questions. Others May Include: Prognosis? Patient Cohort studies with follow-up Identification of risk factors for diseases, disorders, adverse events? Case control studies Complication rates from surgery or other procedures? Case series Safety? Registries

15 Economic Evaluation Costs Consequences (Outcomes) Cost Effectiveness Analysis (CEA): costs in monetary units, outcomes in quantitative non-monetary units, e.g., reduced mortality, morbidity; life-years saved Cost Utility Analysis: form of CEA, outcomes in terms of utility or quality of life, e.g., quality-adjusted life-years (QALYs) 15 15

16 HTA : Secondary data analyses A form of structured literature review that addresses one or more key questions that are formulated to be answered by analysis of evidence Involves: objective means of searching the literature applying predetermined inclusion and exclusion criteria to this literature critically appraising the relevant literature extraction and synthesis of data from evidence base to formulate answers to key questions May include meta-analysis a quantitative /statistical analysis of data and evidence 16 16

17 Systematic Review addressing formulated key questions Identifying evidence Selecting evidence Systematic literature search Medline Embase Cochrane CCTR Manual relevance relevance quality 2227 publications 635 publications 90 publications excluded studies - not relevant - not acceptable quality

18 HTA Challenge:

19 Meta-analysis: Study 1 Study 2 Study 3 Study 4 Study 5 Total 0.5 Favors treatment 1 Favors control 2 September 17,

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21 HTAi: Doing and Using HTA Agencies Universities/ Research Institutes Governments Industry LOCAL-REGIONAL NATIONAL GLOBAL Hospitals WHO, OECD, EU Public Health Institutions

22 HTAi External relations INAHTA International Network of Agencies Exchange of methodology and reports/mou COCHRANE COLLABORATION Systematic Reviews REGIONAL HTA-SOCIETIES Joint membership OECD Survey New technologies /Health project WHO Information/ Essential technologies/mou EUNetHTA Network / Methodology: Core HTA/ Clearinghouse G-I-N Guidelines International Network ISPOR HTA-program LMIC Mexico, Korea, China, Thailand, Malaysia...

23 HTA Priorities: What Gets Attention? High individual burden of morbidity/mortality Large number of patients affected High unit or aggregate cost of disease High unit or aggregate cost of technology Substantial variations in practice Unexpected adverse event reports Evidence that available findings not well disseminated or adopted by practitioners Sufficient research findings available upon which to base assessment HTA findings likely to have impact on practice Political pressure 23 23

24 Commonly Used Bibliographic Databases for HTA MEDLINE/PubMed EMBASE Health Technology Assessment (HTA) Database Cochrane Library CINAHL PsycINFO Health Economic Evaluations Database (HEED) (US) NLM Databases and Electronic Records HTAi Vortal: 24 / 24

25 HTAi Vortal for all doers and users ( How to do HTA HTA Data Sets HTA Glossaries HTA Information Resources Clinical Practice Guidelines Evaluated Sources Grey Literature Health Economics Information Literature Searching Search Engines - Medical Virtual Libraries Keeping Up: Stuff for Librarians & Info Specialists Methodology & Clinical Trials Information Resources HTA Methodology Resources Quality of Life Pharmacogenomics Web Usability

26 Current trends in HTA greater emphasis on cost-effectiveness and economic impacts, rapid reviews / checklists using surrogate endpoints using evidence from real-world practice (registries, surveillance, databases,) qualitative research (narrative synthesis) tailoring HTA methods to particular types of technology, looking at contexts international collaboration in HTA methods, reports including patients views including needs for training (procedures and devices) industry more aware of and interested in HTA horizon scanning, disinvestment, priority-setting,

27 White Paper to WHO, 2005 : Doing and using HTA (HTAi and INAHTA) SRs and HTA in the Knowledge chains Technologies (drugs, devices...) Research Synthesis Appraisal Decision Dissemination Utilization Evaluation (Primary) Research Innovation Assessment (global) Impact & applicability (local)

28 HTAi and INAHTA s White Paper to WHO,2005 SRs and HTA in the Knowledge chains Health system interventions Research Synthesis Appraisal Decision Utilization Evaluation Population interventions (public health) Research Synthesis Appraisal Decision Utilization Evaluation Individual interventions (clinical practice) Research Synthesis Appraisal Decision Utilization Evaluation Technologies (drugs, devices...) Research Synthesis Appraisal Decision Utilization Evaluation (Primary) Research Innovation Synthesis/ assessment (SR & CEA) (global) Impact & applicability appraisal (local) Decision making Dissemination Utilization Evaluation Monitoring

29 Horizon-Scanning Special Form of HTA Provides rapidly completed, brief descriptions of new/emerging technologies and their potential impacts Trade-off: Incomplete information early enough to act vs. better information when it may be too late to act effectively Can be used to: Identify technologies that have potentially major implications for health care Manage adoption and use of new technologies Identify areas of technological change Identify inappropriately used (including under- and over-used) technologies Enable health care providers, payers to plan for, adapt to technological change Plan data collection to monitor adoption, use, and impacts 29 29

30 Horizon-Scanning Programs - Examples EuroScan (members from INAHTA; secretariat at NHSC, UK) National Horizon Scanning Centre (NHSC, UK) Australia & New Zealand Horizon Scanning Network (ANZHSN) Canadian Agency for Drugs and Technologies in Health (CADTH) Horizon Scanning Service US Centers for Medicare and Medicaid Services Council on Technology and Innovation ECRI Emerging Technology Services (USA and Europe) 30 30

31 Growing interest: HTA in Disinvestment (or Reinvestment) Obsolete technologies: Those technologies whose clinical benefit, safety or cost-effectiveness has been superseded by other available alternatives, or demonstrated to be ineffective or harmful Medical waste Economic waste Sarah Gardner, NICE: When you give recommendation on a new technology- do you relate this to those that may be removed?

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33 A National Council (NC) for Priority Setting in 2007 Terms of reference: Produce more comprehensiveness and transparency around the work on quality and prioritisation in the health service, by basing the discussions and conclusions on the best documented evidence, often in the form of HTA reports.

34 Example: Introduction of HPV vaccine A study of the decision-making process of whether or not introduce HPV-vaccination in Norway was performed Particularly attention was paid to how HTAdocuments were instrumental in the judgments of HPV-vaccine against the priority setting criteria

35 Available documents (incl. HTAs) :

36 Results (I): 1. Efficacy Expected outcomes of the intervention: The Council concluded that sufficient evidence existed on the protective effect of HPV vaccines on cervical cancer. Safety Concerns about safety aspects (esp. long term) of the vaccines were expressed by all NC-members. The main cause of dispute during the debate. 3. Cost-effectiveness Emphasis was put on the costs, judged to be high, but not too high to not recommend the vaccine.

37 Results (II): 4. Organizational consequences The vaccine is to be integrated into a national cervix censer-program which also include the existing screening program. 5. Ethical aspects Ethical concerns were expressed throughout the discussions. Arguments were made both against and in favour of introducing the vaccine. 6. The decision making process: Stakeholders and NC-members have all emphasised the importance of having a transparent process (through open access to all meetings and all documents).

38 Conclusions: The process leading to the MoH s decision to include HPVvaccine into the National Immunization Program is, by most of the stakeholders, considered to be thorough. Specially drafted HTA-documents provided valuable support for members of the NC when asked to make an advise in this complex case Of particular importance was the documents providing information on: i) Medical efficacy and safety of the vaccines ii) Health economic analyses iii) Ethical and organizational aspects of the decision

39 Concluding remarks: The commitment by decision makers to base their discussion on best evidence, implies an important and continuous role for HTA when considering the implementation of new technologies. There are, on the other hand, limitations to the kind of answers HTA can provide. In these cases other kind of methods and documentation will become important ( epidemiological studies, ethical studies etc) The context (needs and culture) of the health care systems is always important!