Health Technology Assessment (HTA)

What is health technology assessment (HTA)?

Health Technology Assessment (HTA) is a multidisciplinary process that uses systematic methods to evaluate the properties, effects, and/or impacts of health technology. The primary purpose of HTA is to inform decision-making in health care policy and practice, ensuring that health technologies are used appropriately, effectively, and efficiently. HTA encompasses the assessment of medical, social, economic, and ethical issues related to the use of a health technology.

The WHO defines HTA as:

“A multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner”.

HTA uses explicit methods to determine the value of a health technology at different points in its lifecycle. HTA evaluates the efficacy, safety, cost and value of health technologies, considering factors such as clinical evidence, regulatory approvals, and compatibility with existing infrastructure and processes.

What is the purpose of HTAs?

HTA aims to inform healthcare policy and decision-making by providing evidence about the benefits, risks, and costs of health technologies, such as medications, medical devices, diagnostic tools, and health interventions. This process ensures healthcare decisions are based on the best available evidence, improving the quality, efficiency, and equity of healthcare services.

The primary objectives of HTA are to:

• Provide evidence-based information to policymakers, healthcare providers, and patients.
• Ensure the optimal use of health technologies.
• Promote the efficient allocation of healthcare resources.
• Enhance the quality and accessibility of healthcare services.

Components of HTA

An HTA examines both clinical and non-clinical aspects of health technologies to draw conclusions on the benefits, risks, costs and value:

• Clinical Effectiveness: Evaluates whether the device improves health outcomes compared to existing treatments or the standard of care. This involves systematic reviews of clinical trials and other studies.
• Safety: Assesses the risks associated with the device, including potential side effects, complications, and long-term safety concerns.
• Economic Evaluation: Analyses the economic implications of adopting the device, including costs related to purchase, implementation, maintenance, and any savings from improved health outcomes. This often involves cost-utility or cost-benefit analyses.
• Ethical, Legal, and Social Implications: Considers the broader impact of the device, including issues of equity, accessibility, patient consent, and data privacy.
• Organisational Aspects: Examines how the device will fit into existing healthcare infrastructure, including necessary training for healthcare providers, changes to clinical workflows, and potential impacts on healthcare delivery.
• Patient and Public Perspectives: Involves understanding the views and experiences of patients and the public regarding the device, including acceptability, quality of life impacts, and patient preferences.

The HTA process for medical device evaluations

HTAs follow a comprehensive, systematic evaluation process including the following key steps:

• Scoping: Defining the technology to be assessed, the purpose of the assessment, and the key questions to be addressed.
• Evidence Gathering: Collecting data from various sources, including clinical trials, observational studies, economic models, and expert opinions.
• Evidence Synthesis: Analyzing and synthesising the gathered evidence to form conclusions about the device’s effectiveness, safety, cost-effectiveness, and broader implications.
• Reporting: Compiling the findings into a comprehensive report that includes recommendations for policymakers, healthcare providers, and other stakeholders.
• Dissemination: Sharing the HTA report with relevant stakeholders to inform decision-making processes.

Who conducts HTAs for medical devices?

The assessment is typically conducted by specialised HTA agencies or organisations, which use a structured and transparent process to gather, analyse, and interpret data. High-quality data sources, such as peer-reviewed or nationally certified assessments, ensure that technology assessments can support evidence-based decision-making.

HTAs can be conducted at different organisational levels within a health system:

• Global: HTAs conducted by international organisations
• National: HTAs conducted by national HTA organisations at a national or regional level
• Healthcare provider: HTAs conducted by an individual healthcare provider at the organisation or facility level.

Collaborative efforts between procurement specialists, clinicians, biomedical engineers, and administrators are essential to ensure a holistic evaluation aligned with the organisation’s strategic objectives and budgetary constraints.

Challenges and future directions in HTA

Challenges in performing HTAs include:

• Rapid Technological Advancements: Keeping pace with the rapid development and innovation in health technologies.
• Data Quality and Availability: Ensuring the availability and quality of data for robust assessments.
• Methodological Complexity: Addressing the complexity and variability of HTA methodologies.
• Stakeholder Engagement: Effectively engaging and balancing the perspectives of diverse stakeholders.

Future directions for HTA include:

• Enhanced Methods and Tools: Developing advanced methods and tools for more accurate and efficient assessments.
• Real-World Evidence: Increasing the use of real-world evidence from electronic health records, registries, and other sources.
• Global Collaboration: Promoting international collaboration and harmonisation of HTA practices.
• Patient-Centred HTA: Enhancing the focus on patient-centred outcomes and preferences.

Resources