HTA is one of the main processes for pharmaceutical and medical device market access. This type of research is used to generate and summarize data that allow clinical and cost-effectiveness characteristics of a medical technology (drug, equipment, treatment protocol, procedure, or surgery) to be evaluated.

Goals and features of HTA

Health technology assessment is a comprehensive analysis of the effects of a particular medical technology. It assesses not only the direct effects of its use but also the indirect effects:

• whether the use of the technology brings the expected therapeutic effect;
• what side effects exist;
• how treatment using the technology affects the patient’s quality of life;
• the financial implications for taxpayers;
• the value for money and opportunity cost of an investment and a medical technology

In other words, HTA allows a new drug or procedure to be evaluated against those already on the market on medical and economic parameters.

HTA studies are commissioned by pharmaceutical companies, medical device manufacturers, governments, and other companies that provide healthcare services. The results of this work are usually used to demonstrate the product’s value to potential customers and decision-makers in the healthcare industry.

The peculiarity of conducting HTA in different countries is the lack of a single unified international standard for its organization and methodology. This is due to differences in markets, legislation, requirements for the safety of medical technology, purchasing power, and the very structure of health care systems in these countries. However, major consulting companies are trying to standardize HTA processes to make their results more adaptable to other healthcare settings.

Basic Health Technology Assessment Processes

Regardless of the level of detail of the assessment, the HTA process includes:

• collection, analysis, and evaluation of epidemiology cost and clinical data;
• summarizing and making a recommendation by a competent panel.
• Implementation of the recommendation into clinical practice and tracking the real-world effectiveness

Before beginning a study, it is necessary to find out what type of data about the healthcare technology and its implications will be critical to the decision-making bodies. The entire research process depends on this, from the choice of methods for collecting and evaluating information, to results reporting and evaluation.

Any HTA study involves several steps:

• defining the drug of interest and available data;
• collecting additional data to refine the results already available;
• summarizing and evaluating the results;
• forming conclusions and recommendations;
• using the information obtained to bring the product to market.

Also, some companies (like https://digitalho.com/) that offer HTA services monitor the results of the work done in this process.

How HTA results affect government decision-making

HTA results are often used to demonstrate to health care decision-makers the value of new technology. In essence, it is the evidence base for new technology’s safety, efficacy, and cost-effectiveness. In addition, such studies help authorities decide whether a product should be allowed to enter a country’s market, as well as government reimbursement for the cost of its use.