WHO Workshop, Bangkok, 11.09.2010

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

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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 2001-2003

President HTAi 2005-2007

+ My thanks to Dr Cliff Goodman , Vice President of HTAi, for letting me use some of his slides

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, biotechnology-derived 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,

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Health Technology: Clinical Purpose

� Prevention

� Screening

� Diagnosis

� Treatment

� Rehabilitation

� Palliation

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Health Technology: Stage of Diffusion

� Future / Experimental (laboratory or animal testing)

� Investigational (clinical studies)

� Established (standard approach)

� Obsolete (disinvestment)

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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.

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HTA asks the following questions:

� Does it work?

� For whom does it work?

� At which costs does it work?

� Compared to alternatives?

Use of HTA(Slightly modified from Kent Woods, UK)

Health TechnologyAssessment /HTA

Identifying the consequences

Organization Patient perspective Ethics/Law Resources Education

Politics

GuidelinesScientific documentation:

Clinical effect

Cost-effectiveness

AssessmentClinical research

Clinical practice

Rembursement

Priority-settings

Properties and Impacts Assessed

Main categories:

� Technical properties

� Efficacy and effectiveness

� Safety

� Cost and other economic attributes

� Social, legal, ethical, or political impacts

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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

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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)

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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.

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Systematic reviews

(Meta-analyses)

Well-designed RCT

Well-designed CT

Not -experimental

(Cohort, Case-Control)

Patient-series,

Register-studies

Experts, Consensus- conferences,

Case-reports

The Golden Standard

The Basic Evidence Hierarchy

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

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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)

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

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Systematic Review addressing formulated key questions

relevance

Systematic

literature search

• Medline

• Embase

• Cochrane

CCTR

• Manual

• excluded studies

- not relevant

- not acceptable

quality

relevance

quality

• 2227 publications • 635 publications • 90 publications

Identifying evidence Selecting evidence

HTA Challenge:

Meta-analysis:

September 17, 2010 19

20.5 Favors treatment 1 Favors control

Study 1

Study 2

Study 3

Study 4

Study 5

Total

HTAi: Doing and Using HTA

Governments

Industry

Hospitals

Universities/

Research

Institutes

WHO, OECD, EU

Public Health

Institutions

Agencies

LOCAL-REGIONAL

NATIONAL

GLOBAL

HTAi External relations

� INAHTA –International Network of Agencies Exchange of methodology and reports/MoU

� COCHRANE COLLABORATION Systematic Reviews

� REGIONAL HTA-SOCIETIESJoint membership

� OECDSurvey New technologies /Health project

� WHO Information/ Essential technologies/MoU

� EUNetHTANetwork / Methodology: Core HTA/ Clearinghouse

� G-I-N Guidelines International Network� ISPOR HTA-program� LMIC Mexico, Korea, China, Thailand, Malaysia..........

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

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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:

� http://www.htai.org/vortal

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HTAi Vortal for all doers and users

(www.htai.org) � 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

�

Current trends in HTA

greater emphasis on cost-effectiveness and economic impacts, rapid reviews / checklistsusing surrogate endpointsusing 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, reportsincluding patients viewsincluding needs for training (procedures and devices)

industry more aware of and interested in HTA

horizon scanning , disinvestment, priority-setting, ………

(Primary)ResearchInnovation

Assessment(global)

Impact & applicability

(local)

Technologies

(drugs,

devices ...)

SRs and HTA in the Knowledge chains

EvaluationDissemination

UtilizationDecisionAppraisalSynthesisResearch

White Paper to WHO, 2005 :

Doing and using HTA (HTAi and INAHTA)

HTAi and INAHTA’s White Paper to WHO,2005

(Primary)ResearchInnovation

Synthesis/assessment(SR & CEA)

(global)

Impact & applicabilityappraisal(local)

Health systeminterventions

Populationinterventions(public health)

Individual interventions(clinical practice)

Technologies (drugs, devices...)

SRs and HTA in the Knowledge chains

EvaluationMonitoring

EvaluationUtilizationDecisionAppraisalSynthesisResearch

EvaluationUtilizationDecisionAppraisalSynthesisResearch

EvaluationUtilizationDecisionAppraisalSynthesisResearch

EvaluationUtilizationDecisionAppraisalSynthesisResearch

Decisionmaking

DisseminationUtilization

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

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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)

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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?

A National Council (NC) for Priority Setting in 2007Terms 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.

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 HTA-documents were instrumental in the judgments of HPV-vaccine against the priority setting criteria

Available documents (incl. HTAs) :

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.

– SafetyConcerns 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-effectivenessEmphasis was put on the costs, judged to be high, but not too high to not recommend the vaccine.

Results (II):

4. Organizational consequencesThe vaccine is to be integrated into a national cervix censer-program which also include the existing screening program.

5. Ethical aspectsEthical 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).

Conclusions:

– The process leading to the MoH’s decision to include HPV-vaccine 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

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!