8.1 Health technology assessment (HTA) processes
3 min read•august 16, 2024
is a crucial process in modern healthcare systems. It systematically evaluates new medical technologies, from drugs to devices, to determine their effectiveness, safety, and value for money.
HTAs help decision-makers allocate resources wisely and ensure patient access to beneficial innovations. The process involves evidence gathering, economic evaluation, and stakeholder input to inform policy choices about adopting and funding new health technologies.
Health technology assessment: Definition and role
Systematic evaluation of health technologies
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- Health technology assessment (HTA) systematically evaluates properties, effects, and impacts of health technologies and interventions
- Encompasses wide range of health technologies (drugs, , diagnostic tests, surgical procedures, public health interventions)
- Utilizes multidisciplinary teams of experts (clinicians, health economists, epidemiologists, policy analysts)
- Aims to inform policy-making and decision-making in healthcare systems with evidence-based information
- Evaluates clinical effectiveness, cost-effectiveness, and broader societal impacts of health technologies
HTA's impact on healthcare systems
- Promotes evidence-based healthcare practices
- Ensures efficient allocation of limited healthcare resources
- Influences decisions on reimbursement, pricing, and adoption of new health technologies
- Supports healthcare systems in making informed choices about which technologies to implement or fund
- Helps balance innovation with affordability and sustainability in healthcare delivery (new cancer treatments, robotic surgery systems)
HTA process: Components and stages
Initial assessment and evidence gathering
- Problem identification and scoping defines research question and assessment scope
- Evidence gathering involves of relevant studies (clinical trials, observational studies, economic evaluations)
- Critical appraisal evaluates quality and relevance of collected evidence using standardized tools and methodologies (GRADE system, PRISMA guidelines)
- Stakeholder engagement involves , , industry representatives, and other relevant parties in assessment process
Economic evaluation and synthesis
- Economic evaluation conducts various analyses to determine value for money of technology
- Cost-effectiveness analyses compare costs and of different interventions
- Budget impact analyses estimate financial consequences of adopting new technology
- Other economic assessments may include cost-utility analysis or cost-benefit analysis
- Synthesis integrates all findings into comprehensive report with recommendations for decision-makers
- Report preparation summarizes evidence, analyses, and stakeholder input
- Dissemination communicates results to relevant parties (policymakers, healthcare providers, patient groups)
- Implementation supports integration of findings into policy and practice
HTA impact: Resource allocation and patient access
Influence on healthcare spending and reimbursement
- HTA provides evidence on cost-effectiveness of new technologies, leading to more efficient resource allocation
- Outcomes affect reimbursement decisions, determining covered technologies by public or private healthcare payers
- Impacts pricing of new technologies as manufacturers demonstrate value for money to secure favorable reimbursement terms
- Promotes adoption of high-value technologies while discouraging use of low-value or harmful interventions (proton beam therapy, routine vitamin D screening)
Effects on patient access and healthcare delivery
- Patient access to new technologies enhanced or restricted based on HTA recommendations
- Potential creation of disparities in healthcare delivery due to varying HTA outcomes across regions or countries
- Influences innovation in healthcare industry, affecting research and development investments by pharmaceutical and medical device companies
- Balances need for timely access to potentially life-saving technologies with ensuring safety and cost-effectiveness (CAR-T cell therapy, gene therapies)
Challenges and limitations of HTA
Methodological and evidence-related challenges
- Variability in HTA methodologies and decision-making criteria across countries leads to inconsistent assessments and recommendations
- Limited availability of high-quality evidence, particularly for novel technologies or rare diseases, poses challenges in conducting robust HTAs
- Time constraints in HTA process may conflict with need for timely access to potentially life-saving technologies
- Challenges in assessing long-term impacts and real-world effectiveness based on short-term clinical trial data (long-term effects of immunotherapies, real-world performance of artificial intelligence in diagnostics)
Ethical and practical considerations
- Ethical considerations in HTA include concerns and valuation of health outcomes across different patient populations
- Influence of political, social, and cultural factors on HTA processes and decision-making in different healthcare systems
- Resource constraints in conducting comprehensive HTAs, particularly in low- and middle-income countries with limited technical capacity and funding
- Balancing standardization of HTA processes with need for flexibility to address unique healthcare system contexts and priorities (adapting HTA for traditional medicine in some Asian countries)
Key Terms to Review (19)
Burden of disease framework: The burden of disease framework is a systematic approach used to assess and quantify the impact of diseases and injuries on populations, focusing on both mortality and morbidity. This framework allows for a comprehensive understanding of the health status of different populations by measuring years of life lost due to premature death and years lived with disability, ultimately guiding healthcare resource allocation and prioritization of interventions.
Clinical efficacy: Clinical efficacy refers to the ability of a healthcare intervention or treatment to provide the desired beneficial effect under ideal and controlled conditions. It encompasses not only the effectiveness of the intervention in treating or preventing a specific condition but also considers factors like dosage, timing, and the population being studied. Understanding clinical efficacy is crucial for assessing new health technologies and making informed decisions in healthcare policy and practice.
Cost-effectiveness analysis: Cost-effectiveness analysis (CEA) is a method used to compare the relative costs and outcomes of different healthcare interventions. It helps decision-makers allocate resources efficiently by evaluating the cost per unit of health outcome, often expressed as cost per quality-adjusted life year (QALY). This analysis is crucial for understanding how various sources of healthcare financing can impact access to and the adoption of new technologies, as well as guiding health technology assessments.
Equity: Equity refers to the principle of fairness and justice in the distribution of resources and opportunities, particularly in healthcare. It emphasizes the need to address disparities that exist due to socio-economic status, geography, or other factors that affect individuals' access to health services and outcomes. By focusing on equity, healthcare systems aim to ensure that everyone receives the care they need, regardless of their circumstances.
European Medicines Agency (EMA): The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for evaluating and supervising medicinal products across Europe. It plays a crucial role in ensuring that medicines are safe and effective, thereby facilitating access to innovative therapies for patients while supporting pharmaceutical research and development.
Evidence-based medicine: Evidence-based medicine is an approach to medical practice that emphasizes the use of the best available evidence from scientific research in making clinical decisions. This method integrates individual clinical expertise with the most relevant and up-to-date external clinical evidence, ensuring that patient care is grounded in scientifically validated practices. By prioritizing data and proven outcomes, this approach enhances the quality of care provided to patients.
Health outcomes: Health outcomes refer to the changes in health status or quality of life that result from healthcare interventions, policies, or systems. These outcomes can include metrics like morbidity rates, mortality rates, patient satisfaction, and overall population health indicators, which help to assess the effectiveness of healthcare systems and inform improvements.
Health technology assessment (HTA): Health technology assessment (HTA) is a systematic process that evaluates the properties, effects, and impacts of health technologies. This includes analyzing the clinical effectiveness, cost-effectiveness, and broader implications of medical devices, procedures, and interventions to inform decision-making in healthcare policy and practice.
Health technology assessment framework: A health technology assessment (HTA) framework is a structured approach used to evaluate the clinical, economic, social, and ethical implications of health technologies. This framework helps policymakers and stakeholders make informed decisions about the adoption, use, and reimbursement of new health interventions by systematically analyzing evidence related to their effectiveness, cost-effectiveness, and impact on healthcare systems.
Healthcare Providers: Healthcare providers are individuals or organizations that deliver medical services, care, or treatment to patients. This term encompasses a wide range of roles, from primary care physicians and specialists to hospitals and clinics, all of which play crucial roles in the overall healthcare system. Their functions include diagnosing, treating, and managing health conditions, making them integral to patient care and outcomes.
Incremental cost-effectiveness ratio (ICER): The incremental cost-effectiveness ratio (ICER) is a statistic used to compare the relative costs and outcomes of different healthcare interventions. It measures the additional cost associated with an intervention relative to the additional health benefits it provides, often expressed as cost per quality-adjusted life year (QALY). This concept is essential for evaluating healthcare technologies, assessing system performance, and ensuring value for money in healthcare spending.
Medical devices: Medical devices are instruments, machines, or implants used in the diagnosis, treatment, or prevention of medical conditions. These devices range from simple tools like tongue depressors to complex technologies like MRI machines, playing a crucial role in healthcare delivery and patient management.
National Institute for Health and Care Excellence (NICE): The National Institute for Health and Care Excellence (NICE) is a public organization in the United Kingdom responsible for providing national guidance and advice to improve health and social care. It plays a critical role in health technology assessment (HTA) processes by evaluating new medical treatments, devices, and procedures to determine their efficacy, safety, and cost-effectiveness, helping to ensure that patients receive appropriate and high-quality care.
Patient-centeredness: Patient-centeredness refers to an approach in healthcare that prioritizes the needs, preferences, and values of patients in the decision-making process regarding their care. It emphasizes communication, shared decision-making, and respect for patient autonomy, ensuring that patients are actively involved in their treatment options and care plans. This concept is increasingly important in evaluating health technologies and services to ensure they align with what patients truly need and want.
Patients: Patients are individuals who seek or receive medical care, treatment, or health services from healthcare professionals. They are central to the healthcare system, influencing its dynamics through their needs, preferences, and interactions with providers. Understanding patients' roles helps in recognizing the key components of healthcare systems and the processes used to assess health technologies that directly affect their care.
Pharmaceuticals: Pharmaceuticals are chemical substances used in the diagnosis, treatment, and prevention of diseases and medical conditions. These products play a crucial role in healthcare by improving patient outcomes and enabling effective treatment options, contributing to the overall quality of life. Pharmaceuticals can include prescription medications, over-the-counter drugs, vaccines, and biologics, each of which undergoes rigorous testing and approval processes to ensure safety and efficacy.
Quality-adjusted life year (QALY): Quality-adjusted life year (QALY) is a measure used to evaluate the value of medical interventions by quantifying the quality and quantity of life gained from those interventions. It combines both the duration of life and the quality of health into a single index, allowing for comparisons across different health conditions and treatments. By assessing how many years of life a person can expect to live in full health, QALYs help in making informed decisions about resource allocation in healthcare.
Safety Profile: A safety profile refers to the comprehensive assessment of the potential risks, side effects, and overall safety of a healthcare intervention, including medical devices, drugs, or technologies. This profile is crucial for understanding how a particular treatment may affect patients, allowing healthcare providers to make informed decisions and ensure patient safety while maximizing therapeutic benefits.
Systematic review: A systematic review is a rigorous, structured approach to evaluating and synthesizing all available research evidence on a specific question or topic. This method aims to minimize bias by following a predefined protocol for identifying, selecting, and analyzing studies, leading to a comprehensive understanding of the current state of knowledge. The findings from systematic reviews can significantly influence clinical guidelines, healthcare policies, and decision-making processes in various contexts.