Health Technology Assessment in Five EU Countries: UK, France, Germany, Spain, and Italy Assessment
Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, economic, social, and ethical implications of healthcare technologies. It plays a crucial role in informing healthcare policy and decision-making, ensuring that healthcare interventions provide value for money and improve patient outcomes. In Europe, HTA practices vary significantly across countries. This blog post explores the HTA frameworks in five key European Union countries: the United Kingdom, France, Germany, Spain, and Italy.
HTA in United Kingdom
The United Kingdom has a well-established HTA system primarily led by the National Institute for Health and Care Excellence (NICE). Established in 1999, NICE provides guidance on the clinical and cost-effectiveness of new and existing health technologies, including medications, medical devices, diagnostics, and procedures.
NICE’s assessment process involves several stages:
- Scoping: Defining the scope of the assessment and the key issues to be addressed.
- Evidence Review: Gathering and evaluating clinical and economic evidence.
- Consultation: Engaging stakeholders, including healthcare professionals, patients, and industry representatives.
- Decision Making: Developing recommendations based on the evidence and stakeholder input.
NICE employs a cost-effectiveness threshold, typically around £20,000 to £30,000 per Quality-Adjusted Life Year (QALY) gained, to determine whether a technology should be recommended for use in the National Health Service (NHS).
HTA in France
In France, the Haute Autorité de Santé (HAS) is responsible for HTA. HAS evaluates health technologies to inform coverage decisions made by the Comité Économique des Produits de Santé (CEPS), which oversees pricing and reimbursement of medical products.
HAS conducts comprehensive assessments that include:
- Clinical Evaluation: Reviewing the therapeutic value and safety of the technology.
- Economic Evaluation: Analyzing cost-effectiveness and budget impact.
- Public Health Impact: Considering the broader impact on public health.
HAS uses a five-tier system to rate the therapeutic benefit (ASMR) of new drugs, which influences their pricing and reimbursement status. Technologies with a higher ASMR rating receive more favorable reimbursement terms.
HTA in Germany
Germany’s HTA system is characterized by the role of the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) and the Federal Joint Committee (G-BA). IQWiG conducts benefit assessments of medical interventions, focusing on their comparative effectiveness and safety.
The German HTA process includes:
- Early Benefit Assessment: Required for new drugs entering the market. Manufacturers submit a dossier to IQWiG, which assesses the added benefit compared to standard care.
- Public Consultation: Stakeholders can comment on the assessment results.
- Negotiation: Based on IQWiG’s assessment, the G-BA decides on the reimbursement status and negotiates prices with manufacturers.
Germany does not use a fixed cost-effectiveness threshold but relies on a negotiated pricing model that considers the added benefit of the technology.
HTA in Spain
In Spain, HTA is conducted at both the national and regional levels. The Agencia de Evaluación de Tecnologías Sanitarias (AETS), part of the Instituto de Salud Carlos III, coordinates HTA activities nationally, while regional HTA agencies address local healthcare needs.
The Spanish HTA process involves:
- Clinical and Economic Evaluation: Assessing the clinical effectiveness and cost-effectiveness of health technologies.
- Stakeholder Engagement: Consulting with healthcare professionals, patients, and policymakers.
- Decision Making: Recommendations are made to inform national and regional healthcare policies.
Spain emphasizes the integration of HTA into clinical practice guidelines and decision-making processes to ensure the efficient use of healthcare resources.
HTA in Italy
Italy’s HTA system is decentralized, with both national and regional bodies involved. The Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS) coordinates HTA activities at the national level, while regional health authorities conduct assessments tailored to local needs.
The Italian HTA process includes:
- Horizon Scanning: Identifying emerging health technologies for assessment.
- Comprehensive Evaluation: Reviewing clinical effectiveness, safety, cost-effectiveness, and organizational impact.
- Stakeholder Involvement: Engaging healthcare providers, patients, and industry representatives in the assessment process.
Italy focuses on integrating HTA findings into the regional healthcare systems to optimize the allocation of healthcare resources and improve patient outcomes.
Comparative Insights
While each of these five countries has developed its own approach to HTA, several common themes emerge:
- Evidence-Based Decision Making: All countries emphasize the importance of robust clinical and economic evidence in informing healthcare decisions.
- Stakeholder Engagement: Involving a wide range of stakeholders, including patients, healthcare providers, and industry representatives, is a key feature of HTA processes.
- Cost-Effectiveness: Evaluating the economic value of health technologies is a central component of HTA, although the methods and thresholds vary.
- Integration into Healthcare Policy: HTA findings are used to shape healthcare policies and ensure the efficient use of resources.
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