HTA processes for medicines and devices typically begin with a company submitting a dossier of relevant information to an HTA body.

ℹ️ Click on the Information buttons on the figure below to learn more about the three key phases
 
 
 

The clinical section of the dossier typically includes:

  • Safety and efficacy data of the new technology
  • Added therapeutic benefit – a comparison of its clinical effectiveness with existing standard treatments (the comparator)

Some HTA systems in Europe also evaluate:

  • Budget impact – estimating costs within the healthcare system
  • Cost-effectiveness analysis – assessing the value of the medicine compared to its cost

While not all European HTA systems emphasize cost-effectiveness, all focus on the added therapeutic benefit.

Key components of an HTA Submission

HTA dossiers contain both quantitative and qualitative components note that some of these components are more quantitative than others. Equity, legal, and public health factors are often addressed in the appraisal phase rather than the evaluation phase.

Specification of the population covered (full approved indication or a subgroup).
Number of affected patients, inadequacies of current treatments, and societal impact.
💊 Medicine description
How the medicine works, method of delivery, treatment setting (hospital, primary care, self-administered).
Measures how well a treatment works in clinical trials.
Compares the intervention’s benefits and harms under ideal conditions against alternative treatments.
Assesses real-world performance based on research, clinical experience, and patient preferences.
Compares how well an intervention works against alternatives in routine healthcare settings.
💰 Economic evaluation
Assesses cost per therapeutic unit of effectiveness to determine value for money. Other factors include equity, needs, work-life impact, and patient priorities.
Estimates financial costs based on epidemiology, treatment uptake, and replacement of existing treatments.
Examines advantages beyond clinical benefits, such as easier administration or improved patient adherence.
Identifies existing treatment options, which may include non-medicinal approaches.
Evaluates how the new therapy affects health system fairness (e.g., benefits for disadvantaged populations).
Assesses broader effects on society, such as reduced transmission of infectious diseases.

 

HTA Guidelines and evaluation

Most HTA bodies provide guidelines to ensure consistency and fair comparisons. These guidelines vary by country and are often available on HTA body websites.

Dossiers are assessed either directly or outsourced. Some HTA bodies conduct independent reviews of clinical and economic evidence to minimise conflicts of interest, while others focus on evaluating company submissions in detail.

📌Interactive activity

Time to test your knowledge! Drag and drop the different tasks depending on whether they are part of the HTA bodies' or the Regulatory Agency's responsibilities.

This is not the assessment, it is just an interactive activity to help you with your learning.