Health Technology Assessment

Health Technology Assessment

Health technology assessment (HTA) connects evidence about a technology with a specific decision in a specific health system, which is why similar evidence can lead to different conclusions in different settings. This page explains what HTA examines, which technologies and forms of evidence it can cover, and how assessment differs from appraisal and decision-making. It follows the HTA process from the initial question through implementation and reassessment, showing why uncertainty, local context and stakeholder involvement can affect the conclusion.

What health technology assessment examines

HTA brings together evidence about the value and consequences of a health technology. Its purpose is to help a particular health system make a reasoned decision about funding, adoption, use, restriction, implementation, continued coverage or reassessment.

An international joint task group co-led by INAHTA and HTAi, with EUnetHTA, HTAsiaLink, RedETSA and ISPOR as members and WHO as an observer, developed a common definition, published in 2020: "HTA is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system." The definition places value, explicit methods and the whole lifecycle at the centre, rather than a single assessment at the point of market entry.

HTA is broader than clinical-effectiveness analysis or economic evaluation alone. Depending on the technology, decision and institution’s remit, it may consider:

• the health problem and unmet need;
• the technology’s technical characteristics and intended use;
• safety, efficacy and real-world effectiveness;
• patient-relevant outcomes and treatment burden;
• comparative costs and health consequences;
• affordability and budget impact;
• organisational and workforce requirements;
• implementation feasibility;
• ethical, legal, social and cultural implications;
• equity and effects on health inequalities;
• patient, carer, professional and public perspectives;
• uncertainty, evidence gaps and research needs; and
• consequences across the technology lifecycle.

The domains included should follow from the decision question rather than from a fixed checklist. A rapid or focused HTA may intentionally examine fewer domains than a comprehensive national assessment.

Any material omission should be stated clearly. A narrow assessment should not be presented as though it considered every aspect of the technology’s value.

Defining the HTA question

A clear HTA question establishes what is being assessed, for whom, against which alternatives and for what decision.

The question should identify:

• the population and health problem;
• the technology and its intended place in care;
• the relevant comparator or comparators;
• the outcomes that matter to patients and decision-makers;
• the healthcare setting and jurisdiction;
• the perspective and time horizon where applicable;
• the technology’s lifecycle stage;
• the intended users of the assessment; and
• the funding, coverage, adoption, implementation or reassessment decision being informed.

Poorly defined questions can produce technically sophisticated assessments that do not answer the decision-maker’s actual problem.

What counts as a health technology

A health technology is not limited to a medicine or physical device. It can be any intervention or organised approach intended to prevent, diagnose or treat a condition, improve health, provide rehabilitation, support care or organise healthcare delivery.

Technologies assessed through HTA may include:

• medicines and vaccines;
• medical devices;
• diagnostic and screening tests;
• surgical and clinical procedures;
• rehabilitation interventions;
• digital health technologies;
• public-health programmes;
• preventive services;
• service-delivery models;
• organisational systems; and
• combinations of technologies used within a care pathway.

Different technologies require different evidence and methods. For example, a medicine, diagnostic test, digital tool and service redesign may raise different questions about effectiveness, learning effects, implementation, infrastructure, interoperability and future modification.

Assessment, appraisal and decision-making

Assessment, appraisal and decision-making are connected, but they are not interchangeable.

Assessment

Assessment identifies, critically appraises, analyses and synthesises the relevant evidence. Its typical output is an evidence report describing the technology’s benefits, harms, costs, uncertainties and wider consequences.

Assessment should distinguish observed evidence from analytical assumptions and identify limitations that could affect the findings.

Appraisal

Appraisal interprets the assessment using the criteria, values and institutional rules relevant to the decision. It considers what the evidence means within the organisation’s remit and decision context.

Its typical output is a documented judgement or recommendation.

Decision

Decision-making is the exercise of the relevant legal, financial or policy authority. Its output may be coverage, pricing, adoption, restricted use, conditional access, rejection, disinvestment or another defined action.

Some organisations formally separate assessment, appraisal and decision-making, while others combine parts of them. In either structure, transparent reasoning should show how the evidence and contextual considerations led to the recommendation or decision.

An evidence report does not automatically dictate a funding decision. Different organisations can reach different recommendations after reviewing similar evidence because their responsibilities, budgets, criteria, values and local circumstances may differ.

The HTA process

HTA is a process rather than a single calculation. It begins with a decision need and may continue through scoping, evidence assessment, appraisal, implementation, monitoring and reassessment.

The precise process varies between institutions and technologies, but the principal functions commonly include the following.

1. Identify candidate technologies

Horizon scanning, regulatory developments, stakeholder requests, clinical variation, expenditure patterns or emerging evidence may identify technologies that require assessment.

2. Prioritise the topic

The responsible organisation determines whether the topic warrants assessment given its potential effect on patients, services, budgets, equity and health outcomes.

3. Define the decision question

The population, technology, comparators, outcomes, setting, lifecycle stage and intended decision are specified.

4. Establish the scope

The assessment identifies the evidence domains, analytical methods, stakeholder contributions, timelines and outputs required.

5. Find and evaluate evidence

Reviewers search for, critically appraise and synthesise relevant research and data.

6. Conduct the analyses

The assessment completes the necessary clinical, economic, budgetary, organisational and wider analyses.

7. Characterise uncertainty

Evidence gaps, analytical assumptions, transferability concerns and unresolved questions are identified and examined.

8. Obtain stakeholder input

Patients, carers, clinicians, manufacturers, payers, service managers and other relevant groups may contribute evidence, experience or comments.

9. Appraise the evidence

The responsible body interprets the findings using applicable decision criteria, values and institutional rules.

10. Formulate the recommendation

The appraisal produces a recommendation or another documented conclusion with a stated rationale.

11. Make and implement the decision

The authorised decision-maker determines whether and how the technology will be funded, adopted, restricted or used.

12. Monitor and reassess

The technology may be reviewed again when important evidence, prices, utilisation, safety findings, comparators or implementation conditions change.

Transparent methods, declared conflicts of interest and documented reasoning strengthen the legitimacy of the process. Consultation and appeal arrangements may also be important when decisions have significant consequences.

Choosing the comparator

HTA evaluates a technology in relation to the decision actually facing the health system. The comparator should normally represent relevant current care, another available technology or the activity likely to be displaced.

The comparator should not automatically be placebo or no treatment. An inappropriate comparator can make a technology appear more or less clinically effective, cost-effective or affordable than it would be against actual practice.

More than one comparator may be required when:

• clinical practice varies;
• different patient groups receive different care;
• several relevant technologies are available;
• the technology could enter at different points in a pathway; or
• current practice is expected to change.

The selected comparators and the reasons for choosing them should be reported clearly.

Evidence used in HTA

The evidence required depends on the technology, decision, lifecycle stage and consequences of making the wrong choice. Evidence quality, relevance and transferability matter alongside the quantity of available research.

HTA may use:

• randomised controlled trials;
• non-randomised and observational studies;
• systematic reviews and meta-analyses;
• indirect treatment comparisons and network meta-analysis;
• diagnostic-accuracy and test-performance studies;
• epidemiological and natural-history evidence;
• economic evaluations;
• budget impact analyses;
• administrative and routinely collected data;
• real-world evidence;
• qualitative research;
• patient-experience evidence;
• organisational and implementation evidence;
• ethical, legal and social analysis; and
• expert judgement when important evidence remains incomplete.

Expert judgement should be identified transparently and should not be presented as though it were directly observed empirical evidence.

Clinical and patient-relevant outcomes

HTA should examine outcomes that matter to patients and decision-makers rather than relying only on outcomes that are convenient to measure.

Relevant outcomes may include:

• mortality;
• morbidity;
• symptoms;
• health-related quality of life;
• functional status;
• adverse effects;
• treatment burden;
• caregiver effects;
• healthcare utilisation;
• patient experience; and
• consequences for daily life.

Surrogate outcomes may be useful when final outcomes are unavailable, but the relationship between the surrogate and the patient-relevant outcome should be examined. Uncertainty about that relationship should remain visible in the assessment.

Economic evaluation within HTA

Economic evaluation compares the costs and consequences of alternative courses of action. It may form an important part of HTA, but it does not represent the complete multidisciplinary assessment.

An economic evaluation should clearly specify:

• the decision problem;
• population and subgroups;
• intervention and comparators;
• analytical perspective;
• time horizon;
• outcome measure;
• costs and resource use;
• discounting;
• modelling assumptions;
• uncertainty; and
• decision rule.

A technology can be cost-effective without being affordable. Conversely, a technology with a substantial budget impact may still offer good value relative to the health displaced elsewhere in the system.

For this reason, cost-effectiveness and budget impact should be examined separately.

Budget impact and affordability

Budget impact analysis estimates the financial consequences of adopting a technology within a specified budget and time period.

It may consider:

• the eligible population;
• expected uptake;
• displacement of existing treatments;
• acquisition and administration costs;
• infrastructure and workforce requirements;
• changes in healthcare utilisation;
• implementation costs;
• contractual or pricing arrangements; and
• uncertainty about adoption and expenditure.

Affordability is not established by an incremental cost-effectiveness ratio alone. Decision-makers may need to consider implementation pace, financial risk, available budgets and competing priorities.

Organisational and implementation consequences

A technology that performs well in research may not produce the same results when implemented in routine care.

HTA may therefore examine:

• workforce and training needs;
• infrastructure and equipment;
• information systems and interoperability;
• changes to care pathways;
• service capacity;
• procurement and supply;
• maintenance and technical support;
• patient access;
• professional acceptance;
• adherence and uptake;
• geographical variation; and
• implementation costs and timelines.

Implementation barriers should not be treated as minor operational details when they could materially change effectiveness, cost, access or equity.

Ethical, legal and social considerations

Technologies can create consequences that are not captured fully by clinical outcomes or economic models.

HTA may examine questions involving:

• informed consent;
• privacy and data governance;
• autonomy;
• discrimination;
• fairness;
• access;
• stigma;
• cultural acceptability;
• responsibility for care;
• legal requirements;
• effects on carers and families; and
• distribution of benefits, harms and costs.

These considerations should be connected to the actual decision rather than included as a generic list.

Equity and distributional effects

An average result can conceal important differences between population groups. HTA should consider whether benefits, harms, access barriers or financial consequences are distributed unevenly.

Relevant groups may differ by:

• disease severity;
• age;
• disability;
• sex or gender;
• socioeconomic position;
• ethnicity;
• geography;
• access to services;
• comorbidity; or
• another characteristic relevant to the decision.

Equity considerations should be reported explicitly when they influence the recommendation. They should not be hidden within an unexplained adjustment to the cost-effectiveness result.

How HTA handles uncertainty

HTA decisions are frequently made before every relevant fact is known. Uncertainty can arise from limited evidence, immature outcomes, modelling assumptions, indirect comparisons, local implementation or future changes in care.

Important sources include:

• Clinical uncertainty: Limited studies, small samples, surrogate outcomes or short follow-up.
• Comparative uncertainty: Lack of direct evidence against the relevant alternatives.
• Parameter uncertainty: Uncertainty in numerical inputs used in an analysis.
• Structural uncertainty: Uncertainty about how a model represents the disease or care pathway.
• Extrapolation uncertainty: Uncertainty when short-term evidence is projected beyond the observed period.
• Transferability uncertainty: Differences between the evidence setting and the decision setting.
• Implementation uncertainty: Uncertain uptake, adherence, capacity or workforce effects.
• Future uncertainty: Changing prices, indications, comparators or clinical practice.
• Distributional uncertainty: Incomplete evidence about equity or effects across population groups.

Sensitivity analysis, scenario analysis, probabilistic analysis and value-of-information methods can help examine uncertainty.

Possible policy responses include:

• requesting additional evidence;
• restricting use to a defined population;
• negotiating price or contractual terms;
• adopting the technology conditionally;
• collecting evidence during use;
• delaying the decision; or
• establishing a reassessment date.

The appropriate response depends on the consequences of making the wrong decision and whether delaying or reversing adoption is feasible.

Stakeholder involvement

Patients, carers, clinicians, manufacturers, payers, service managers and members of the public may possess different forms of relevant knowledge.

Stakeholder involvement can identify:

• outcomes overlooked by formal studies;
• treatment burden;
• effects on carers and families;
• variation in clinical practice;
• implementation barriers;
• unmet needs;
• acceptability concerns;
• access problems; and
• uncertainty not visible in quantitative evidence.

Stakeholder involvement does not replace critical appraisal. The process should explain:

• who contributed;
• how contributors were selected;
• what evidence or experience they provided;
• how conflicts of interest were managed;
• how their contribution affected the assessment; and
• how disagreements were handled.

HTA and regulatory assessment

Regulatory assessment, economic evaluation and HTA may examine some of the same evidence, but they answer different questions.

Regulatory assessment

Regulatory assessment considers whether a technology satisfies the applicable requirements for quality, safety, efficacy or performance. Its central question is whether the technology may enter or remain on the market for the proposed use.

Economic evaluation

Economic evaluation compares the costs and consequences of alternative courses of action. Its central question is whether the technology offers value relative to the relevant alternatives under the specified analytical assumptions.

Health technology assessment

HTA examines the technology’s clinical, economic, organisational, social, ethical and other relevant consequences within a defined decision context. Its central question is whether and how the technology should be funded, adopted, restricted, implemented or reassessed in that setting.

Regulatory authorisation does not establish cost-effectiveness or affordability. Economic evaluation may form an important part of HTA, but it does not represent the complete multidisciplinary assessment.

HTA should not replace the regulator’s determination of whether a technology satisfies the legal requirements for market authorisation.

Why HTA conclusions differ between health systems

Evidence produced in one setting may be reusable, but the resulting recommendation is not automatically transferable.

Health systems may differ in:

• population health needs;
• disease prevalence and baseline risk;
• clinical pathways;
• relevant comparators;
• prices and resource use;
• available budgets;
• service capacity;
• workforce;
• legal requirements;
• equity priorities;
• social values;
• implementation feasibility; and
• institutional decision rules.

Two organisations can therefore interpret a similar evidence base differently without either organisation necessarily misunderstanding the science.

A shared clinical assessment can reduce duplicated scientific work. It does not replace local economic analysis, appraisal, pricing, reimbursement or implementation decisions.

The European Union has put this into law. Regulation (EU) 2021/2282 on health technology assessment applies from 12 January 2025 and introduces joint clinical assessments at EU level. For medicines, they are phased in according to when the marketing authorisation application is submitted: from 12 January 2025 for cancer medicines with new active substances and for advanced therapy medicinal products, from 13 January 2028 for orphan medicinal products, and from 13 January 2030 for all other medicines within scope. Selected class IIb and III medical devices and class D in vitro diagnostic medical devices are also eligible, chosen by Commission decision at least every two years. The Regulation states that joint clinical assessments do not predetermine national decisions on pricing and reimbursement, which remain solely a matter of national competence, and Member States are required to give due consideration to the joint reports in their own HTA processes.

HTA across the technology lifecycle

HTA can occur before market entry, during pricing or coverage decisions, after implementation and when continued use is questioned.

The assessment question and available evidence may change as the technology progresses through its lifecycle.

Early HTA

Early HTA may help identify promising uses, evidence requirements, development priorities and potential implementation challenges before extensive adoption.

Initial assessment

An initial assessment may support coverage, pricing, procurement, adoption or implementation decisions when the technology becomes available.

Post-adoption assessment

Evidence collected during routine use may help examine effectiveness, safety, utilisation, access, budget impact and implementation.

Reassessment

Reassessment considers whether an earlier recommendation remains appropriate.

Potential triggers include:

• new evidence about benefits or harms;
• a new indication or patient population;
• a material price change;
• unexpected uptake or budget impact;
• real-world evidence about performance;
• a new comparator;
• changes in clinical practice;
• implementation problems;
• emerging equity concerns; or
• evidence that continued use no longer represents appropriate value.

Reassessment should respond to a meaningful change that could alter the original judgement. It should not merely give an old assessment a new date.

Managed access and evidence development

When a technology appears promising but important uncertainty remains, a health system may consider conditional or managed access.

Possible arrangements include:

• coverage with evidence development;
• outcomes-based agreements;
• restricted use;
• patient registries;
• additional comparative research;
• price agreements;
• utilisation controls; and
• scheduled reassessment.

These arrangements are not automatically appropriate. They require clear responsibilities, feasible data collection, enforceable terms and a credible plan for acting on the new evidence.

Horizon scanning and prioritisation

HTA organisations cannot assess every emerging technology at the same depth. Horizon scanning identifies technologies that may create important clinical, financial, organisational or social consequences.

Prioritisation may consider:

• expected patient benefit;
• unmet need;
• potential harm;
• likely budget impact;
• uncertainty;
• variation in practice;
• equity implications;
• implementation consequences;
• public or professional interest; and
• the opportunity cost of conducting the assessment.

Prioritisation determines which topics receive assessment attention. It does not establish whether the technology should ultimately be adopted.

Disinvestment and reassessment of existing care

HTA is not limited to new technologies. It can also evaluate existing practices that may be ineffective, harmful, inefficient or no longer appropriate.

Disinvestment may involve:

• withdrawing a technology;
• restricting its use;
• replacing it with a better alternative;
• reducing inappropriate variation;
• changing a care pathway; or
• targeting use to patients most likely to benefit.

Removing established care can be more difficult than deciding whether to adopt a new technology. Existing professional practice, patient expectations, infrastructure and contractual arrangements may affect implementation.

Transparency and governance

Transparent governance helps make HTA legitimate, understandable and reviewable.

A transparent process should identify:

• who commissioned the assessment;
• who conducted the analysis;
• who appraised the evidence;
• who made the final decision;
• the criteria used;
• stakeholder involvement;
• conflicts of interest;
• opportunities for consultation;
• appeal or review procedures;
• publication arrangements; and
• reassessment conditions.

Transparency does not require every organisation to use identical criteria. It requires the organisation to explain which criteria it used and how they influenced the conclusion.

What HTA can and cannot tell decision-makers

HTA can:

• integrate clinical, economic and wider evidence;
• connect evidence to a defined policy or practice decision;
• identify important uncertainty and evidence gaps;
• clarify implementation requirements;
• support transparent recommendations;
• help compare alternatives; and
• support monitoring and reassessment.

HTA cannot:

• eliminate every uncertainty;
• guarantee identical decisions across institutions;
• convert weak evidence into certainty;
• establish affordability from cost-effectiveness evidence alone;
• remove the need for judgement;
• resolve every ethical or social disagreement; or
• replace the authority responsible for the final decision.

An HTA conclusion applies to its stated technology, population, comparator, evidence, setting, date and institutional remit. It should not be treated as a universal answer for every health system.

What a transparent HTA report should show

A transparent HTA report should identify:

• the commissioning body and intended decision;
• the population and health problem;
• the technology and intended use;
• the relevant comparators;
• the outcomes and evidence domains assessed;
• the jurisdiction and lifecycle stage;
• the evidence-search and appraisal methods;
• the clinical evidence;
• the economic analysis;
• the budget impact;
• the organisational and implementation findings;
• ethical, legal, social and equity considerations where relevant;
• patient and stakeholder involvement;
• analytical assumptions;
• evidence gaps;
• uncertainty;
• transferability limitations;
• conflicts of interest;
• appraisal criteria and value judgements;
• the recommendation or decision;
• the rationale for the conclusion; and
• implementation, monitoring or reassessment arrangements.

The report should distinguish factual findings, analytical assumptions, stakeholder evidence, appraisal judgements and the final exercise of decision-making authority.

Key distinction

HTA is a structured, multidisciplinary process that connects evidence with a real healthcare decision. It does not merely calculate cost-effectiveness, summarise clinical studies or determine whether a technology may enter the market.

Its value lies in making the evidence, uncertainty, context, criteria and reasoning behind a recommendation visible and open to scrutiny.

Sources

• World Health Organization. Health technology assessment [health topic page]. https://www.who.int/health-topics/health-technology-assessment. Accessed 28 Sep 2026.
• INAHTA, HTAi and partners. HTA Glossary: Health technology assessment (HTA). https://htaglossary.net/health-technology-assessment. Accessed 28 Sep 2026.
• O'Rourke B, Oortwijn W, Schuller T; International Joint Task Group. The new definition of health technology assessment: a milestone in international collaboration. International Journal of Technology Assessment in Health Care. 2020;36(3):187-190.
• Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union L 458. 22 December 2021, p. 1.
• EUnetHTA Joint Action 2, Work Package 8. HTA Core Model, version 3.0. 25 January 2016.
• National Institute for Health and Care Excellence. NICE technology appraisal and highly specialised technologies guidance: the manual (PMG36). Published 2022; updated 2026.