How assessment differs between countries and is coordinated across them
Health technology assessment differs with national health systems, priorities and methods. International networks and shared assessment frameworks coordinate overlapping work while leaving some decisions and evidence needs local.
National use and methods
In 2021 the UK and Canada were described as high users of health technology assessment (HTA), and the US as a low user. HTA appeared more widely used with national health services or insurance, although the reasons were uncertain; more than 1,000 private US insurers made the relevance of one central assessment less clear across diverse settings.
Pharmaceutical HTA had become a formal part of reimbursement approval in several countries. In the Netherlands, Sweden and the UK, manufacturers supplied economic evaluations of incremental cost per quality-adjusted life-year (QALY) gained against standard care, while France and Germany emphasised added clinical value to guide price negotiation. Possible explanations included national culture and values, administrative tradition and healthcare organisation.
Fifteen proposed good-practice principles were grouped by programme structure and independence, methods and the costs and benefits considered, stakeholder processes, and transparent use of results in decisions. Their application to programmes worldwide produced benchmarking questions, with relevance varying by local setting and stage of HTA development.
A WHO global survey following its HTA resolution found assessments concentrated on safety and effectiveness, then economics and budgets, with less attention to ethics, equity and feasibility. They were mostly advisory rather than mandatory, and barriers included inadequate resources, limited institutionalisation and lack of awareness of HTA’s importance. A separate 2021 ethics commentary attributed the prioritisation of safety, effectiveness and economics to the resolution itself as a recommendation, rather than to the survey as a finding.
HTA also operates within hospitals: the EU-funded AdHopHTA project produced a handbook, a toolkit for establishing and running a unit, and a report database, maintained with its website by HTAi’s hospital-based HTA interest group in 2021. Its principle was to introduce technology using relevant, objective, comprehensive and reliable evidence in the particular hospital’s context.
US payment policy and economic evidence
In 2013 many European national systems had long used health economics in coverage decisions, while US recognition was more recent. US private insurers used it for drug coverage, conditions and prices, and hospital purchasers for durable equipment. Expenditure exceeding general inflation, increased chronic disease and expanding treatment volumes encouraged attention to economic evidence; costs were then projected to rise by more than 6% annually to 2020.
The 2009 American Recovery and Reinvestment Act funded priority setting for comparative-effectiveness research, and the 2010 Affordable Care Act created the Patient-Centered Outcomes Research Institute (PCORI) to commission evidence comparing preventive and treatment options for patient and provider decisions. A 2013 account described the Act as barring PCORI from using a dollar-per-QALY instrument to set a cost-effectiveness threshold, while leaving private insurers free to choose their approach. A 2021 account stated the restriction more broadly as barring measures such as the QALY and said PCORI did not generally fund economic evaluations.
Resistance described in 2013 included belief that resources were unconstrained, political opposition, distrust between payers and manufacturers, concern that economic requirements could inhibit innovation, untimely or opaque information and insufficient decision-maker expertise. A 2012 critique argued that US cost debates avoided resource constraints and the uncomfortable trade-offs needed to control growth.
International networks and dissemination
HTA agencies operated within governments, universities and other institutions, while global and regional networks supported collaboration, knowledge sharing and reduced duplication. The networks listed in 2021 were:
| Network | Established | Membership described in 2021 |
|---|---|---|
| International Network of Agencies for Health Technology Assessment (INAHTA) | 1992 | 49 agencies |
| International Society for Pharmacoeconomics and Outcomes Research (ISPOR) | 1995 | All healthcare stakeholder groups |
| Health Technology Assessment International (HTAi) | 2003 | Individuals and agencies; predecessor ISTAHC dated to 1995 |
| European Network for Health Technology Assessment (EUnetHTA) | 2006 project | Organisations across 30 countries |
| RedETSA, the Americas network | 2011 | Organisations across 19 countries |
| HTAsiaLink, the Asia-Pacific network | 2010 | 33 agencies |
| ISPOR regional chapters | Various | Regional chapters |
RedETSA’s formation in 2011 was separately described as spanning 12 countries. HTAi and ISPOR offered conferences and education, with ISPOR promoting health economics and outcomes research. A collaborative task group from INAHTA, HTAi, ISPOR, EUnetHTA, HTAsiaLink, RedETSA and the HTA Glossary Committee developed a shared HTA definition.
Peer-reviewed publication and indexing in Medline and EMBASE made assessments easier to find than searching agency or government grey literature, while open-access and other publication models widened availability. Journals listed in 2021 included:
| Journal | Established |
|---|---|
| International Journal of Technology Assessment in Health Care | 1985 |
| Value in Health | 1998 |
| Value in Health Regional Issues | 2012 |
| Medical Decision Making | 1981 |
| Health Technology Assessment | 1997 |
| International Journal of Hospital Based Health Technology Assessment | 2016 |
European cooperation and shared assessment models
European HTA became a political priority in 2004; 35 government-appointed organisations responded in 2005, leading to the EUnetHTA Project in 2006, the Collaboration in 2009, and Joint Actions in 2010–2012 and 2012–2015. Its strategic objectives were:
- More collaborative production of timely, fit-for-purpose information usable in national and regional HTA and decisions
- Greater reliability, quality and relevance for policymaking
- Increased HTA capacity
In 2013 shared standard information sets were progressing, but individual bodies still requested different information and formats. National priorities and systems made assessments specific to a country while leaving substantial overlapping work.
The HTA Core Model supplied a common methodological framework and reporting structure for producing and sharing full and rapid assessments internationally. Relative-effectiveness guidance covered clinical, composite and surrogate endpoints, health-related quality of life, internal validity, applicability, comparators, direct and indirect comparisons, and safety. The Planned and Ongoing Projects database supported collaboration on planned, ongoing and recently published work, while EVIDENT stored reimbursement or coverage status and requested additional studies. Joint Action 2 sought practical use of these tools and a sustainable-collaboration proposal under Article 15 of Directive 2011/24/EU.
Version 3.0 of the Core Model, developed through the 2012–2015 Joint Action, defined nine domains:
- Health problem and current technology use
- Description and technical characteristics
- Safety
- Clinical effectiveness
- Costs and economic evaluation
- Ethical analysis
- Organisational aspects
- Patient and social aspects
- Legal aspects
The first four were considered more general and the last five more jurisdiction-specific. The 2015 rapid relative-effectiveness model, version 4.2, focused on the first four within a limited timeframe; economic appraisal remained national, while ethical, organisational, social and legal issues were represented by a checklist. It covered pharmaceuticals, diagnostics, medical and surgical interventions, and screening technologies.
By 2021 agencies could also use INAHTA’s International HTA Database of completed and ongoing assessments to avoid duplication, and systematic reviews could be registered on the UK Centre for Reviews and Dissemination’s PROSPERO database.
EMA cooperation and the transition to joint assessment
Development data support both regulatory benefit–risk assessment for authorisation and HTA of relative effectiveness for decisions on use, price and reimbursement. The first European joint EMA–EUnetHTA project, reported in 2014, improved the structure and presentation of European Public Assessment Reports (EPARs) to make efficacy information clearer and more useful in rapid relative-effectiveness assessments. Collaboration also covered early scientific advice, methodological guidance, post-licensing evidence and orphan medicines, with regular meetings, public minutes and a joint three-year work plan. Cooperation was expected potentially to shorten patient-access times and reduce development costs by shaping programmes to generate evidence for both audiences.
EUnetHTA 21 ceased operating on 16 September 2023, with preparations for the HTA Regulation continuing under the HTA Coordination Group. Its preceding three-year work with EMA included:
- Seven parallel joint scientific consultations for medicines
- Discussion of oncology advanced-therapy evidence, indirect comparisons and post-licensing evidence gaps
- Training patients and healthcare professionals for participation in regulatory and HTA processes, with collaborative work on engagement methods
- Recommendations for reports by EMA’s human medicines committee (CHMP) to document eligible populations, comparators, endpoints and subgroup relevance systematically
In September 2023 EMA’s implementation priorities included a single evidence plan, harmonised views on evidence strength and participation by patients and clinical experts.
EU joint assessment framework
Regulation (EU) 2021/2282 became applicable on 12 January 2025, covering cooperation between regulators and HTA bodies and selected high-risk medical devices. EMA’s January 2025 announcement described three supporting roles:
- Providing regulatory-assessment information for joint clinical assessments of relative effectiveness and safety by the HTA Coordination Group
- Parallel joint scientific consultations to help developers generate evidence for both regulatory and HTA needs
- Information exchange on upcoming applications and technologies for planning and horizon scanning
The announced timetable began with new active substances for cancer and all advanced therapy medicinal products, expanding to orphan medicines in January 2028 and all centrally authorised medicines in 2030; selected high-risk devices were scheduled from 2026. EMA had a legal duty to notify the European Commission, the coordination group’s secretariat, of in-scope marketing-authorisation applications, and began identifying them in June 2024. A member-state coordination group and stakeholder network were intended to sustain cooperation and reduce duplicate national and industry effort.