An introduction to the role of HTA
Elias Mossialos
Professor of Health Policy, London School of Economics
Health Technology Assessment
Health Technology Assessment (HTA) is a
multi-disciplinary field of policy analysis,
which studies the medical, social, ethical
and economic implications of development,
diffusion and use of health technology.
Role of HTA in HC Innovation and
HTA systems seek to ascertain the relative effects of technology on health, the
availability and distribution of resources, and other aspects of the health system.
Helps to identify both cost-effective and cost-ineffective technologies and health
HTA provides a range of stakeholders with evidence-based information
for decision-making (e.g., reimbursement, pricing) and priority-setting.
Serves as a bridge between science and decision-making.
Governance of HTA in Europe
In the EU, programmes for HTA
have been established via
provision of new
agencies/institutes or in existing
academic or governmental
Many countries have several
bodies dedicated to HTA, with
somewhat unclear and
disparate roles and
Heterogeneity of existing HTA
bodies reflects the differentiated
environments of European
health care systems.
Federation of Austrian Social Insurance Institution/Drug
Evaluation Committee
National Institute for Sickness and Invalidity
Insurance/Commission for Reimbursement for Medicines
Reimbursement Committee/Danish Centre for Health
Technology Assessment
Pharmaceuticals Pricing Board (PPB)/FinOHTA
Federal Joint Committee/Institute for Quality and
Efficiency in Health Care/ German Agency for Health
Technology Assessment (DAHTA)
National Health Insurance Board/Committee for
Pharmaceutical Aid/Health Council
Pharmaceuticals Pricing Board/Norwegian Centre for
Health Technology Assessment
Pharmaceutical Benefits Board (TLV)/Swedish Council on
Technology Assessment in Health Care (SBU)
Swiss Federal Office of Public Health/Confederal Drug
Commission/Swiss Network for HTA
National Institute of Health and Clinical Excellence
(NICE)/National Coordinating Centre for Health
Technology Assessment (NCCHTA)/Scottish Medicines
Consortium (SMC)
Responsibility and Membership of
HTA Entities (1)
Most national HTA bodies can be categorised as serving an
advisory, regulatory, or coordination role.
Advisory = render reimbursement or pricing recommendations to a
national or regional gov’t, a ministerial department, or selfgovernance body (e.g., Netherlands, Demark).
Regulatory = accountable principally to health ministries; assume
primary responsibility for the listing and pricing of drugs, medical
devices, and other related services (e.g., Finland, France, Sweden –
Coordination = responsible for coordinating HTAs and/or developing
clinical guidance, and producing and disseminating reports (e.g.,
Sweden – SBU).
Responsibility and Membership of
HTA Entities (2)
Most HTA bodies either conduct the assessment in-house
or contract independent reviews to external organisations
(e.g., academic research institution)
Use of independent reviews presents both advantages and
+ (lends to greater transparency, helps prevent or resolve potential
appeals, widens available expertise, and brings broader perspectives
to process)
- (introduces disconnects between methodological approaches,
coordination inefficiencies, and divergent agendas)
Range of Technologies Evaluated
In several countries, the HTA effort focuses
on medicines, usually because of the remit
the HTA entity has been given (eg the CvZ
in the Netherlands)
Consideration of a broader range of
technologies is more likely to lead to overall
efficiency and gives a ‘level playing field’
(eg NICE)
Topic Selection (1)
Topic agendas are often set by national authorities (i.e,
MoH), Ministries of Health, or expert committees affiliated
with an HTA body.
Various stakeholders (e.g., industry, patient representatives,
providers) may submit topic suggestions or comment on priorities,
although the extent of engagement various by country.
While selection criteria differs across review body, they
typically include health benefit, disease burden, resource
impact, innovation capacity, clinical and political
relevance, and feasibility of assessment.
Topic Selection (2)
Several agencies have developed “early warning” or
“horizon scanning” systems to identify new and emerging
technologies that might require early or urgent evaluation.
Netherlands, Sweden, Finland, the UK have established such
Internationally connected via EuroScan Network
Many HTA agencies lack explicit and transparent processes
for prioritisation, including selection methods and
stakeholder involvement.
More emphasis should be placed on identifying topics for
potential disinvestment.
Types of Evidence Considered
For clinical evidence, some entities (eg IQWiG
in Germany) place a major emphasis on RCTs
Others (eg NICE) recognize the relevance of
observational data and economic modelling
Very few entities pay much attention to items
such as productivity gains, or patient/family
costs (Sweden is an exception)
Analytical Design
While almost all countries firstly consider therapeutic
benefit, other factors frame the analysis:
Disease burden
Patient quality of life (QoL)
Budget impact
Availability of alternative treatments
Health-related QoL is deemed the most appropriate criterion
for a technology’s added value from the patient perspective.
To a lesser extent, level of innovation, equity, and social
and ethical implications are considered.
Assessment Methods (1)
Cost-effectiveness (CE) and comparative clinical
effectiveness are most often considered appropriate
approaches for assessing relative benefits (and costs).
Assessment Methods (2)
All countries deem RCTs the most reliable and objective
evidence to classify product benefit. Demonstrate safety,
clinical effectiveness, adverse effects, possible risks
Even where definitive primary studies exist, however, there
are limitations to reliance on such evidence.
Preference is toward RCTs in naturalistic settings, in terms of
reflecting daily routines and country-specific care delivery.
Trials do not often collect a full range of economic data (e.g., indirect
Study time horizon may be too short to detect longer term outcomes.
Can restrict subgroup analyses.
Patient restrictions/ monitoring co-morbidity
Different types of studies should be combined or
synthesised to best inform effective decision-making.
Assessment Methods (3)
Observational studies
Real world practice settings (including co-morbidity)
Longer term studies
Selection bias
Assessment Methods (3)
Different Approaches to Selecting
Assessments are comparative
in nature -- choice of
comparator is important in
determining the outcomes of
economic evaluations.
Inclusion of relevant options is
crucial to adequately inform
Finland, Sweden (new drugs only): Require
that a product be compared with up to three
well-defined comparators. Appropriate
comparators typically include the most costeffective therapy, common practice, or leastexpensive alternative.
Sweden (existing products), Switzerland:
Products compared to all therapies of the
same therapeutic group, based on the WHO
ATC classification system.
France: Combines both approaches.
Assessment Methods - types of costs
Principal difference lies in the inclusion of direct and indirect costs (e.g.,
Sweden, allows all costs to be included; Netherlands uses only direct
costs to the health system).
Most costs are based on national data.
A high degree of transparency in cost calculations is imperative.
Includes adequately detailing all sources of data and any
assumptions employed.
Are Cochrane-Style Reviews
Always Helpful?
Respite care for frail older people: an appraisal of
effectiveness and cost-effectiveness
Number of hits (in the literature review)
Papers retrieved
No. of potential studies
Potential economic evaluations
Actual number of economic evaluations (EEs)
Number of EEs of respite care meeting criteria for inclusion 5
Number of such studies undertaken in the UK
Role of Stakeholders
Majority of HTA bodies involve a diverse array of
stakeholders (e.g., physicians, health economists, industry,
and patient group representatives).
Increased role for industry in the process has also been
Greater stakeholder involvement can facilitate better overall
assessment, lend to greater transparency, reduce appeals,
and result in improved implementation of recommendations
and guidance.
HTA Dissemination and
HTA are used to inform a wide range of decisions:
Shape the benefit catalogue
Plan resource capacities
Develop clinical practice guidance
Inform organisational investment decisions
Acquisition of new technology
Reimbursement decisions – risk sharing arrangements, procurement,
value-based co-payments
HTA Dissemination and
Some countries (e.g., Sweden, UK) have a formal appeals
process, whereby stakeholders can be heard if they object
to HTA evidence/decisions.
Re-evaluation is a key component to the HTA process.
Allows new data to be considered.
Accounts for uncertainty during the initial valuation process, which is
especially important for new, novel products.
Coverage restrictions for eligible anticancer drugs,
FDA approved 2004-2008
Partial restriction
Total restriction
No decision
HTA in CEE countries: challenges
and opportunities
Data requirements: patient and disease registries
Data quality
Capacity building: Government, regulatory agencies,
Clinical effectiveness or cost-effectiveness
International collaborations
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