A new cancer drug clears the European Medicines Agency. The press release goes out, patient organisations start calling their health ministry, and everyone waits. In most countries, the honest answer to “when can we have it?” is: not yet, and possibly never at this price.
Marketing authorisation means a product is allowed on the market. It does not mean anyone has agreed to pay for it. Between approval and a patient actually receiving a treatment sits a second process, run by different institutions and asking a different question.
That process is health technology assessment, usually shortened to HTA.
Two questions, two sets of gatekeepers
Regulators ask whether a product works and whether its risks are acceptable given its benefits. That is essentially a yes-or-no gate. Once a product is through it, the regulator’s job is done.
HTA bodies pick up where regulators stop. Their question is comparative and financial at the same time: what does this technology add compared with what we already use, and is that addition worth the money, knowing the same money could be spent on something else?
| Decision stage | Primary question | Typical focus |
|---|---|---|
| Regulatory assessment | Can the technology be placed on the market? | Efficacy, safety, quality and benefit-risk balance. |
| Health technology assessment | What additional value does it provide compared with current care? | Comparative clinical value, costs, uncertainty and wider system consequences. |
| Pricing and reimbursement | Will the system fund it, and under what conditions? | National priorities, budget impact, negotiation and implementation. |
This is why a single clinical trial can be read very differently by two institutions on the same continent. They are not necessarily disagreeing about the data. They are answering different questions.
The definition the HTA community finally agreed
For most of HTA’s history, agencies worked from their own definitions. In 2020, a joint task group co-led by INAHTA and HTAi, with input from ISPOR, EUnetHTA, HTAsiaLink, RedETSA and the HTA Glossary Committee, published a single definition after an open consultation with the wider community.
HTA is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle, with the purpose of informing decisions that support an equitable, efficient and high-quality health system.
Three words in that definition carry most of the weight.
Multidisciplinary
HTA is not a clinical review with a budget line attached. Epidemiologists, statisticians, health economists, clinicians, lawyers and ethicists may all contribute.
Explicit methods
Methods and assumptions should be visible. Others can examine the reasoning, challenge it and rerun the analysis.
Lifecycle
Assessment may begin before launch and continue after it, from horizon scanning and scientific advice to reassessment using real-world data.
“Health technology” is broader than most people assume
A health technology is any intervention developed to prevent, diagnose or treat a medical condition, promote health, provide rehabilitation or organise the delivery of care.
If it is intended to improve health and it uses limited resources, it can be assessed.
What a full assessment actually covers
European practice has been shaped by the HTA Core Model developed within EUnetHTA. It organises assessment into nine domains.
The non-clinical domains are especially tied to local context. A technology may fit one country’s staffing model and not another’s. It may raise different equity concerns, face different legal constraints or have a very different budget impact.
Not every assessment covers all nine domains. Rapid relative effectiveness assessments may focus on clinical domains, while full reports go wider when the decision problem requires it.
The comparison is the whole exercise
Newcomers often assume the core question is “does this drug work?” It is not. The question is “how much better is it than the relevant alternative, and at what extra cost?”
Change the comparator and you may change the result. That is why comparator selection is one of the most contested steps in HTA.
ICERs and QALYs
When costs are formally weighed against outcomes, a common output is the incremental cost-effectiveness ratio, or ICER: the extra cost of the new option divided by its extra health gain.
Health gain is often measured in quality-adjusted life years, or QALYs. A QALY combines how long people live with how well they live, allowing very different interventions to be compared within a common decision framework.
Different countries, different machinery
| System | How value is used | What this illustrates |
|---|---|---|
| England | NICE applies a cost-effectiveness range. From April 2026, the cited range is £25,000–£35,000 per QALY gained. | Cost-effectiveness may be linked to an explicit decision range. |
| Germany | Under AMNOG, IQWiG and the G-BA assess added benefit against an appropriate comparator, and the result informs price negotiation. | HTA can shape price without using a universal market-access threshold. |
Thresholds and decision rules are not universal. HTA is a shared discipline, but the institutional machinery differs substantially between countries.
Who does this work?
INAHTA reports 54 publicly funded HTA agencies across 33 countries, serving health systems that cover more than a billion people. Well-known institutions include:
Their methods, remit and influence differ. Some conclusions are closely tied to reimbursement, some feed into negotiation, and others support broader policy or implementation decisions.
Interest in HTA is not limited to wealthy systems. In 2014, the World Health Assembly adopted resolution WHA67.23, urging member states to consider national HTA systems as part of the drive toward universal health coverage.
What changed in Europe in 2025?
European cooperation in HTA was previously voluntary and project-based. Regulation (EU) 2021/2282 introduced a permanent legal framework, and the first joint clinical assessments began on 12 January 2025.
For products within scope, clinical documentation is submitted alongside the EMA marketing authorisation process. An assessor and co-assessor prepare a joint clinical assessment for use across the European Union.
Joint clinical assessment does not centralise appraisal, pricing or reimbursement. Those decisions remain national.
Brussels is standardising part of the evidence review. It is not deciding what each country pays or which technologies each national health system ultimately funds.
Why any of this matters
HTA is the mechanism through which a health system decides what it will and will not buy on behalf of the population it serves. Those decisions are made under budget constraints that do not disappear because a treatment is genuinely effective, and they affect people who are waiting.
Doing HTA well means being explicit about the evidence, assumptions, uncertainty and trade-offs, then making the reasoning open enough to be examined and challenged.
Key takeaways
- Regulatory approval and HTA answer different questions.
- HTA is comparative: the choice of comparator can change the conclusion.
- Value includes clinical outcomes, costs and wider organisational, ethical, legal and social consequences.
- HTA methods are shared internationally, but decision rules remain country-specific.
- The EU now shares joint clinical assessment, while reimbursement decisions stay national.
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Frequently asked questions
HTA basics
What is health technology assessment?
HTA is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle and inform health-system decisions.
Is HTA the same as regulatory approval?
No. Regulatory assessment asks whether a product can be marketed based on quality, efficacy and safety. HTA asks what it adds compared with existing care and whether that added value justifies its cost and wider consequences.
Which technologies can be assessed?
HTA can cover medicines, vaccines, devices, diagnostics, procedures, screening programmes, digital health tools, rehabilitation and organisational changes in care.
What are the main domains of HTA?
The EUnetHTA Core Model describes nine domains spanning the health problem, technology, safety, clinical effectiveness, economics, ethics, organisation, patient and social aspects, and legal aspects.
What are ICERs and QALYs?
An ICER expresses the extra cost of a technology divided by its extra health gain. Health gain is often measured in QALYs, which combine length and quality of life.
Did the EU centralise reimbursement decisions?
No. The EU framework introduced joint clinical assessments for products in scope. Appraisal, pricing and reimbursement remain national responsibilities.
Sources
- O’Rourke B, Oortwijn W, Schuller T. The new definition of health technology assessment: a milestone in international collaboration. International Journal of Technology Assessment in Health Care, 2020.
- “Announcing the New Definition of Health Technology Assessment.” Value in Health, 2020.
- INAHTA.
- World Health Assembly resolution WHA67.23, Health intervention and technology assessment in support of universal health coverage, 2014.
- World Health Organization: Evaluating properties, effects and impacts of health technology.
- EUnetHTA HTA Core Model, version 3.0.
- Regulation (EU) 2021/2282 on health technology assessment.
- European Commission: Joint Clinical Assessments.
- NICE: Changes to cost-effectiveness thresholds confirmed, December 2025.
- IQWiG: The AMNOG procedure.
- IQWiG: European health technology assessment.