Health Technology Assessment:

Introduction and Fundamental

Concepts
Goodman CS. HTA 101: Introduction to Health Technology
Assessment. Bethesda, MD: National Library of Medicine (US);
2014.

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Factors That Reinforce the Market for
Health Technology
• Advances in science and • Public demand driven by direct-to-
engineering consumer advertising, mass media
• reports, social media, and consumer
Intellectual property, especially
awareness and advocacy
patent protection
• Off-label use of drugs, biologics, and
• Aging populations devices
• Increasing prevalence of chronic • “Cascade” effects of unnecessary
diseases tests, unexpected results, or patient
• Emerging pathogens and other or physician anxiety
diseases threats • Clinician specialty training at
• Third party payment, especially academic medical centers
fee-for-service payment • Provider competition to offer state-
of-the-art technology
• Financial incentives of technology
companies, clinicians, hospitals, • Malpractice avoidance
and others • Strong or growing economies
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Origins of HTA
• Technology assessment (TA) arose in the mid-
1960s from an appreciation of the critical role of
technology in modern society and its potential for
unintended, and sometimes harmful,
consequences.
• TA was conceived as a way to identify the
desirable first-order, intended effects of
technologies as well as the higher-order,
unintended social, economic and environmental
effects.
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Origins of HTA
• The term “technology assessment” was introduced in
1965 during deliberations of the Committee on Science
and Astronautics of the US House of Representatives.
• Congressman Emilio Daddario emphasized that the
purpose of TA was to serve policymaking:
– [T]echnical information needed by policymakers is frequently
not available, or not in the right form. A policymaker cannot
judge the merits or consequences of a technological program
within a strictly technical context. He has to consider social,
economic, and legal implications of any course of action (US
Congress, House of Representatives 1967).

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What is HTA?
• (Health) technology assessment … is a
multidisciplinary field of policy analysis. It
studies the medical, social, ethical, and
economic implications of development,
diffusion, and use of health technology.

-From INAHTA (International Network of Agencies for Health

Technology Assessment); www.inahta.org

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Health Technology
• Technology is the practical application of
knowledge.
• Health technology is the practical application
of knowledge to improve or maintain
individual and population health.
• Three ways to describe health technology
include its physical nature, its purpose, and its
stage of diffusion.

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Physical Nature
• Drugs: e.g., aspirin, beta-blockers, antibiotics, cancer chemotherapy
• Biologics: e.g., vaccines, blood products, cellular and gene therapies
• Devices, equipment and supplies: e.g., cardiac pacemaker, magnetic resonance
imaging (MRI) scanner, surgical gloves, diagnostic test kits, mosquito netting
• Medical and surgical procedures: e.g., acupuncture, nutrition counseling,
psychotherapy, coronary angiography, gall bladder removal, bariatric surgery,
cesarean section
• Public health programs: e.g., water purification system, immunization
program, smoking prevention program
• Support systems: e.g., clinical laboratory, blood bank, electronic health record
system, telemedicine systems, drug formulary,
• Organizational and managerial systems: e.g., medication adherence program,
prospective payment using diagnosis-related groups, alternative health care
delivery configurations

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Purpose or Application
• Prevention: protect against disease by preventing it from occurring, reducing the risk of
its occurrence, or limiting its extent or sequelae (e.g., immunization, hospital infection
control program, fluoridated water supply)
• Screening: detect a disease, abnormality, or associated risk factors in asymptomatic
people (e.g., Pap smear, tuberculin test, screening mammography, serum cholesterol
testing)
• Diagnosis: identify the cause and nature or extent of disease in a person with clinical
signs or symptoms (e.g., electrocardiogram, serological test for typhoid, x-ray for
possible broken bone)
• Treatment: intended to improve or maintain health status or avoid further deterioration
(e.g., antiviral therapy, coronary artery bypass graft surgery, psychotherapy)
• Rehabilitation: restore, maintain or improve a physically or mentally disabled person's
function and well-being (e.g., exercise program for post-stroke patients, assistive device
for severe speech impairment, incontinence aid)
• Palliation: improve the quality of life of patients, particularly for relief of pain,
symptoms, discomfort, and stress of serious illness, as well as psychological, social, and
spiritual problems.
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Stage of Diffusion
• Future: in a conceptual stage, anticipated, or in the earliest
stages of development
• Experimental: undergoing bench or laboratory testing using
animals or other models
• Investigational: undergoing initial clinical (i.e., in humans)
evaluation for a particular condition or indication
• Established: considered by clinicians to be a standard
approach to a particular condition or indication and
diffused into general use
• Obsolete/outmoded/abandoned: superseded by other
technologies or demonstrated to be ineffective or harmful
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Purposes of HTA
HTA can be used in many ways to advise or inform technology-related policies
and decisions. Among these are to advise or inform:
• Regulatory agencies about whether to permit the commercial use (e.g.,
marketing) of a drug, device or other regulated technology
• Payers (health care authorities, health plans, drug formularies, employers,
etc.) about technology coverage (whether or not to pay), coding (assigning
proper codes to enable reimbursement), and reimbursement (how much
to pay)
• Clinicians and patients about the appropriate use of health care
interventions for a particular patient’s clinical needs and circumstances
• Health professional associations about the role of a technology in clinical
protocols or practice guidelines
• Hospitals, health care networks, group purchasing organizations, and other
health care organizations about decisions regarding technology acquisition
and management
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Purposes of HTA contd.
• Standards-setting organizations for health technology and health care delivery
regarding the manufacture, performance, appropriate use, and other aspects
of health care technologies
• Government health department officials about undertaking public health
programs (e.g., immunization, screening, and environmental protection
programs)
• Lawmakers and other political leaders about policies concerning technological
innovation, research and development, regulation, payment and delivery of
health care
• Health care technology companies about product development and marketing
decisions
• Investors and companies concerning venture capital funding, acquisitions and
divestitures, and other transactions concerning health care product and service
companies
• Research agencies about evidence gaps and unmet health needs
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Basic HTA Orientations
• Technology-oriented assessments are
intended to determine the characteristics or
impacts of particular technologies.
– For example, a government agency may want to
determine the clinical, economic, social,
professional, or other impacts of cochlear
implants, cervical cancer screening, PET scanners,
or widespread adoption of electronic health
record systems.

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Basic HTA Orientations
• Problem-oriented assessments focus on solutions
or strategies for managing a particular disease,
condition, or other problem for which alternative
or complementary technologies might be used.
– For example, clinicians and other providers
concerned with the problem of diagnosis of dementia
may call for HTA to inform the development of clinical
practice guidelines involving some combination or
sequence of clinical history, neurological examination,
and diagnostic imaging using various modalities.

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Basic HTA Orientations
• Project-oriented assessments focus on a local
placement or use of a technology in a particular
institution, program, or other designated project.
– For example, this may arise when a hospital must
decide whether or not to purchase a PET scanner,
considering the facilities, personnel, and other
resources needed to install and operate a PET
scanner; the hospital’s financial status; local market
potential for PET services; competitive factors; etc.

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Properties and Impacts Assessed
• Technical properties
– include performance characteristics and conformity with
specifications for design, composition, manufacturing,
tolerances, reliability, ease of use, maintenance, etc.
• Safety
– is a judgment of the acceptability of risk (a measure of
the probability of an adverse outcome and its severity)
associated with using a technology in a given situation,
e.g., for a patient with a particular health problem, by a
clinician with certain training, or in a specified treatment
setting.
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Properties and Impacts Assessed

• Efficacy and/or effectiveness

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Properties and Impacts Assessed
• Economic attributes or impacts
Can be microeconomic and macroeconomic.
• Microeconomic concerns include costs, prices, charges, and
payment levels associated with individual technologies.
• Health technology can have or contribute to a broad range of
macroeconomic impacts. These include impacts on: a nation’s
gross domestic product, national health care costs, and
resource allocation across health care and other industrial
sectors, and international trade.
• Health technology can also be a factor in national and global
patterns of investment, innovation, competitiveness,
technology transfer, and employment (e.g., workforce size and
mobility).
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Properties and Impacts Assessed
• Social, legal, ethical and/or political impacts
– Arise in HTA in the form of normative concepts (e.g., valuation
of human life); choices about how and when to use
technologies; research and the advancement of knowledge;
resource allocation; and the integrity of HTA processes
themselves.
– For example, an integral component of the Human Genome
Project of the US National Institutes of Health is the Ethical,
Legal and Social Implications (ELSI) Research Program.
– One recently proposed broader framework, “HELPCESS,”
includes consideration of: humanitarian, ethical, legal, public
relationships, cultural, economic, safety/security, and social
implications.
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Methods Used for Ethical Analysis in HTA

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For Whom?
• Government policy and decision makers
(macro)
• Public drug plan managers (macro)
• Regional health authorities (meso)
• Hospitals and other health care facilities
(meso)
• Health professionals (micro)
• Patients (micro)
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Decision-Maker Needs
• Timeliness – decisions can’t wait for perfect
evidence
• Relevance – answering the real policy questions
• Messaging – concise, understandable
• Context around decisions – social, legal, ethical,
political, patient, public
• Policy analysis to support decision making
• Support to users to interpret and apply the
information
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The Role of HTA
• Provide basis for informed decisions about:
– adoption, acquisition, diffusion, appropriate use, disinvestment
– HTA is not, in and of itself, the decision
• Reliable and timely provision of (synthesized, appraised)
evidence:
– Is it safe?
– For whom does it work and when?
– Is it better than what we already have/do?
– Does it provide value for money?
– Can we afford it? Can we afford not to?
– What else needs to be considered?

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What is HTA (2)?
• “…systematic evaluation of properties, effects,
and/or impacts of health care technology. It
addresses the direct, indirect, intended and
unintended consequences … Its main purpose is to
inform technology-related policymaking in health
care. HTA is conducted by interdisciplinary groups
using explicit analytical frameworks drawing from a
variety of methods.”

Health Technology Assessment International (www.htai.org)

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What’s the HTA Process?

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Examples of Unintended Effects

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Measuring Health Outcomes
• Mortality (death rate)
• Morbidity (disease rate)
• Adverse health events (e.g., harmful side
effects)
• Quality of life
• Functional status
• Patient satisfaction

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Roles of certain health outcomes
• A biomarker (or biological marker) is an objectively
measured variable or trait that is used as an indicator of a
normal biological process, a disease state, or effect of a
treatment.
• An intermediate endpoint is a non-ultimate endpoint
(e.g., not mortality or morbidity) that may be associated
with disease status or progression toward an ultimate
endpoint such as mortality or morbidity.
• A surrogate endpoint is a measure (typically a biomarker)
that is used as a substitute for a clinical endpoint of
interest, such as morbidity and mortality.
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Quality of Life Measures
• Quality of life (QoL) measures, or “health-related quality of
life” measures or indexes, are increasingly used along with
more traditional outcome measures to assess efficacy and
effectiveness, providing a more complete picture of the ways
in which health care affects patients.
• QoL measures capture such dimensions (or domains) as:
physical function, social function, cognitive function,
anxiety/distress, bodily pain, sleep/rest, energy/fatigue and
general health perception.
• These measures may be generic (covering overall health) or
disease-specific. They may provide a single aggregate score or
yield a set of scores, each for a particular dimension.
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Health‐
Adjusted Life
Years: QALYs,
DALYs, and
More

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HTA supports evidence-informed decisions

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Timing of Assessment

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Expertise for Conducting HTA
• Physicians, nurses, other • Epidemiologists
clinicians
• Biostatisticians
• Managers of hospitals, clinics,
nursing homes, and other health • Economists
care institutions • Social scientists
• Pharmacists and pharmacologists • Decision scientists
• Laboratory technicians, radiology
technicians, and other allied • Ethicists
health professionals • Lawyers
• Biomedical and clinical engineers • Computer
• Patients and community scientists/programmers
representatives
• Librarians/information
specialists
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Basic HTA Frameworks
1. Identify assessment topics
2. Specify the assessment problem or questions
3. Determine organizational locus or responsibility for
assessment
4. Retrieve available relevant evidence
5. Generate or collect new evidence (as appropriate)
6. Appraise/interpret quality of the evidence
7. Integrate/synthesize evidence
8. Formulate findings and recommendations
9. Disseminate findings and recommendations
10. Monitor impact
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Challenges to Managing Technologies
• Technological innovation
• Evidence-base
• HTA methodology
• Capacity
• Evidence-informed decision making
• Stakeholder interests
• Inertia….and constant change

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General Recommendations
• HTA exists to support informed policy & practice
decisions
– HTA processes must be flexible given that it exists in a world
of flux
• Flexibility must be balanced with systematic approach
• Transparency
– Much room for improvement
– Tradeoffs….increased interaction & dialogue increases costs,
and length of time taken

Tsoi et al., 2013

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Banta DH, Thacker SB.
Historical controversy in health technology
assessment: the case of electronic fetal
monitoring.
Obstet Gynecol Surv.
2001 Nov;56(11):707-19.

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Historical controversy in health technology
assessment: the case of electronic fetal
monitoring.

• Electronic fetal monitoring (EFM) was introduced in

the late 1950s as an alternative to the traditional
auscultation with a stethoscope or fetoscope in the
management of labor.
• This new technology is seen as a valuable tool in the
prevention of cerebral palsy and other adverse fetal
outcomes and is spreading rapidly into clinical
practice.
• In the late 1970s, some skeptics began to question
the evidence on the effectiveness of EFM.
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Historical controversy in health technology
assessment: the case of electronic fetal monitoring.

• In 1979 the authors published a systematic review of

evidence which concluded that there was insufficient
evidence regarding the effectiveness of the routine use of
EFM and there was a marked increase in the rate of
cesarean section associated with its use.
• This analysis was based on a thorough review of about 600
books and articles, but focused heavily on the evidence of
four published randomized clinical trials (RCTs).
• Further economic analysis underscores the importance of
this issue.

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Historical controversy in health technology
assessment: the case of electronic fetal monitoring.

• The report received harsh and personal criticism from

doctors, both in public and in the medical literature.
• Later additional RCTs and other analyzes were
published, and in 1987 the American College of
Obstetricians and Gynecologists recommended that
auscultation be an acceptable alternative to EFM in
routine labor.
• However, today EFM continues to be the standard of
practice, used in 80% of deliveries in the United States.

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 Historical controversy in health technology
assessment: the case of electronic fetal monitoring.

The most important conclusion to be drawn

from this experience is the need to evaluate
new technologies before they are widely
disseminated into clinical practice.

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Martis R, Emilia O, Nurdiati DS, Brown J.
Intermittent auscultation (IA) of fetal heart rate
in labor for fetal well-being. Cochrane Database
of Systematic Reviews 2017, Issue 2. Art. No.:
CD008680.

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Intermittent auscultation (IA) of fetal
heart rate in labor for fetal well-being
• Using a hand-held Doppler and intermittent CTG with
abdominal transducer without tracing paper for IA in labor is
associated with an increase in cesarean section due to fetal
distress.
• There was no clear difference in neonatal outcome (low Apgar
score five minutes after birth, neonatal seizures or perinatal
death).
• Long-term outcomes for infants (including
neurodevelopmental disability and cerebral palsy) were not
reported.
• The quality of evidence was rated as moderate to very very
low and several important outcomes were not reported which
means that uncertainty remains about the use of IA for
monitoring DJA in labor.
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Intermittent auscultation (IA) of fetal
heart rate in labour for fetal well-being

• As intermittent and Doppler CTG are associated with a

higher rate of cesarean sections compared with routine
monitoring with a Pinard stethoscope, women, healthcare
practitioners and policy makers should consider these
results given the lack of evidence of short-term and long-
term benefits for mother or baby.
• Large, high-quality, randomized clinical trials are needed,
especially in low-income settings.
• Clinical trials should assess short-term and long-term
outcomes, comparing different monitors and timing of IA.
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