Health Technology Assessment: Evidence Evaluation

• The lecture discusses the evaluation of evidences for Health Technology Assessment (HTA), including key topics from gathering evidences to ethical considerations.

Assessment in Health Technology

• Applies scientific methods to assess the impact of health technologies in the Philippine context

Assessment in Health Technology (Scopes)

• Encompasses medicines, vaccines, medical devices, procedures, and interventions

Usual Process of Assessment

• Involves critical appraisal of dossiers
• May include clinical and cost analyses

Gathering of HTA Evidences (Background)

• Requires literature searching and evidence retrieval
• Efficiency and timeliness are crucial

Notion of Evidence in HTA

• Relies on research and data analysis
• Considers research design and execution quality

Executive Summary vs. Scientific Summary Report

• Executive Summaries target decision-makers with recommendations
• Scientific Summary Reports target the HTA and scientific community and stress context and methodology
• An Executive level summary has to quickly inform decisions
• A Scientific level summary has to enable critical appraisal

Aggregation and Appraisal of HTA

• Critical appraisal is necessary when there's an urgency for evidence or limited synthesized evidence
• Rapid reviews are for public health emergencies only
• The Health Technology Assessment Council (HTAC) evaluates health technology based on marketing approval by the FDA, better intervention availability, and use during health emergencies

Sources and Uses of Data to Conduct an HTA

• In HTA, a variety of data sources are used to compile and analyze information
• This includes randomized controlled trials (RCTs), single opinions, safety data, cost data, quality of life information, and epidemiological data
• Data can be collected prospectively in pragmatic trials

Things to Consider

• Direct links between interventions and health effects should be established through studies
• Directness relates to the parameters used to measure intervention effect

Systematic Reviews and Reporting of Evidences

• Systematic reviews summarize research
• Evidence strength is judged by research design, directness, homogeneity and the study number
• Addressing research and policy questions in decision making and assessment.

Evidence as Source for Recommendation

• Factors like illness perception and financial consequences influence decisions more than clinical effectiveness

Economic Evaluation, Budget and Health Systems Impact

• HTA assesses economic outcomes, cost-effectiveness, and budget impact

Cost-Effectiveness

• Refers to cost-effectiveness analysis and cost-utility analysis

Incremental Cost-Effectiveness Ratio (ICER)

• The formula for ICER is (C1-C2) / (E1-E2),
• C = cost, E = effect
• Costs include direct medical expenses

Health-Related Quality of Life (HRQOL)

• Generic scales are validated to measure how the general population values different health states

Resource Utilization and Costs

• Costs are evaluated by identifying resource utilization and applying unit costs

Decision Analytic Model

• It is presented as a decision tree to increase transparency
• The costs of the probability and value of each outcome must be assigned

Rare Diseases

• Well-powered RCT may not be feasible for one jurisdiction

Cost of Illness

• Includes all resource utilization costs for a disease or health state

Epidemiology

• Rates of incidence and prevalence are essential for estimating budget impact and potential cost savings

Assessment of Social, Ethical and Legal Considerations of HTA

• Includes equitable access, efficiency and value, patient privacy and confidentiality, and informed consent

Equitable Access

• Assuring access to health care is society's responsibility

Efficiency and Value

• Efficiency is important when resource scarcity leads society to overlook some populations
• Value is created when there is greater quality for the same cost or the same quality for lower price

Patient Privacy and Confidentiality

• Patient records offer potential learning about disease processes and care outcomes

Informed Consent

• Subjects should be informed that the study involves research, the purpose, and any potential risks

Personal Responsibility

• Cost of health care can be attributed to lifestyle choices

Professional Ethics

• Includes confidentiality, truthfulness, informed consent, and respect for autonomy

Consumer Sovereignty

• Patients or consumers make decisions rather than the government

Social Welfare

• There are economic models that base policy decisions on benefit-cost or cost-effectiveness criteria

Rationing

• Intended to reduce overall costs to a targeted level

Process Equity

• Policy itself should be perceived as fair by all involved parties

Formulation of Health-Related Policy Based on the Cost-Effectiveness of Drug Products and Health Services

• CEA compares costs and outcomes of health programs or treatments

Health Programs or Treatments

• Health outcomes are measured in life years saved or changes in functional status

Medicines

• CEA compares medicines that are not equivalent in dose or therapeutic effect but treat the same condition

Decision Framework of the Philippine HTAC

• These criteria include responsiveness to disease burden, safety and effectiveness, household financial impact, and affordability and viability
• The intervention must address the top medical conditions and reduce out-of-pocket expenses

Health programs or treatments

• CEA is a type of economic evaluation that compares the costs and outcomes of interventions with a common health outcome but differ in effectivenes