After 1945, the emphatic scientific and technological development contributed to the economic healthcare complex establishing itself as one of the sectors of greatest development; at the same time, the health of individuals and populations came to be considered a right to be preserved, contributing to the expansion of healthcare systems and the medicalization of societies.

In recent decades, in several countries, to a lesser or greater degree; and healthcare systems, although inserted in market economies, have been strongly influenced by public policies with different perspectives, as well as by the strengthening of the role of their professionals and users who, altogether, exert strong pressure for the incorporation of new technologies.

Current discussions on the impact of these policies consider that knowledge in healthcare is articulated in a population and social perspective, overcoming the limits of individual clinical practice. In a systematic and shareable way, the study of different technologies, their biomedical consequences and their social cost contributes to a better understanding of the problems identified in health services.

The continuous growth in health expenditures, the increasing production of new technologies and the changes in the epidemiological profile of populations that have taken place in recent decades have led to diversified care needs. Thus, it was necessary to develop articulation mechanisms between the sectors involved in the production/incorporation/use of technologies in healthcare systems.

The healthcare technology management process implies a reflection on the principle of equity, in which decision-making for the incorporation of technology involves several actors, with specific needs and different financial ceilings. Thus, the management of healthcare technologies is defined as the set of activities related to the processes of assessment, incorporation, dissemination, management of the use and removal of technologies from the healthcare system. This process must have as references the healthcare needs, the budget, the responsibilities of the levels of government and social control, in addition to the principles of equity, universality and integrality, which underlie health care in Brazil.

According to the World Health Organization (WHO), HTA is “the systematic assessment of the properties, effects and/or impacts of technology on healthcare. Its main objective is to generate information for decision-making, encouraging the adoption of cost-effective technologies and preventing the adoption of technologies of questionable value to healthcare systems”..

The notion of technologies, by itself, comprises a wide range of elements, ranging from knowledge concretely incorporated in vaccines and medicines to knowledge applied to new medical procedures. In general, the objective of a Healthcare Technology Assessment is to provide support for the decision on the use and financing of healthcare technologies – medicines and medical devices.

The decision, therefore, is based on safety and quality criteria, required for each technology, and on criteria of comparative effectiveness, so that there is an optimization of the use of available resources.

Carried out by a multidisciplinary team, usually composed of experts from different areas with a focus on healthcare, the Healthcare Technology Assessment (HTA) also takes into account the social and ethical impacts resulting from the diffusion and development of a technology.

As we well know, there are many challenges that involve healthcare systems in Brazil – and in the world. Given that multiple scenario, we will stick to the following topics.

Population aging and few resources: a challenge for Health Systems

Anyone who minimally follows the news can realize that there are many barriers to be overcome by healthcare. Among them we highlight the aging population and the resources that never seem to be enough.

Let’s reflect a little more on these two challenges.

1. Ageing population

The increase in life expectancy and the consequent aging of the population, added to the predominance of chronic and degenerative diseases, have required that healthcare systems update and invest more and more in diagnosis, prevention and treatment of diseases.

The inversion of the Brazilian age pyramid – which today already has the shape of an accordion, that is, it has a larger elderly population than the adult population – has forced companies to increasingly dedicate themselves to evaluating new ways of offering services.

According to surveys, in 2050 it is expected that there will be more grandparents than grandchildren in Brazilian society. But there are still obstacles for the consolidation of investments in the modernization and improvement of medicine.

2. Shortage of investment in public healthcare

In 2018, the Federal Council of Medicine made a serious complaint. And it showed that spending on public healthcare, which should be equivalent to 10% of GDP, was around 2.94% of all wealth produced in the country. High inflation and economic recession are among the main factors responsible for this scenario.

However, the reality of healthcare is one of scarcity of resources – and it is not new. Therefore, it is important that any decision about new investments is preceded by a thorough evaluation of costs and benefits to patients. Everything must be calculated with accuracy and clarity of purpose to ensure the best possible results for the public served by healthcare systems.

These two major barriers gave rise to collaboration between two sectors that were initially unconnected, as we can see in the following topic.

Health Economics

As we said before, the population’s life expectancy has been growing year after year, requiring greater expenses with care related to the physical and emotional well-being of individuals. On the other hand, the resources allocated to this area are scarce, consequently generating an imbalance.

This scenario motivated the approximation of two apparently unrelated areas: health and economics. From this junction came Health Economics – a discipline that is already part of the schedules of several courses related to the subject and the healthcare system in general.

Although technically and relatively new in Brazil, Health Economics has proven to be fundamental in helping managers to assess the best way to allocate available resources, seeking to optimize clinical and economic results.

Several economics concepts and techniques are already used to resolve impasses that affect the healthcare system on a daily basis. In a pragmatic way, to answer whether or not a new drug or equipment should be incorporated into a healthcare system, it is necessary to know whether its global cost compensates for the gains it provides – cost-benefit ratio, in other words.

And this is where the Assessment of Health Technologies comes in. Read on and discover its relationship with the economics of healthcare.

Health Economics and Technology Assessment

As we said, the Health Technology Assessment (HTA) is the process of investigating the clinical, economic and social results of the use of healthcare technologies, such as medicines, equipment, systems and procedures through which the healthcare service is provided.

It aims to analyze the clinical, social, ethical and economic implications of the development, diffusion and use of a given technology in the healthcare field.

Through the technical subsidies offered by Health Economy, HTA makes viable the analysis of clinical aspects, considering this evaluation from the economic aspects of the technology. .

There are several methods for obtaining clinical data. But it is suggested that the approach to be used has an empirical appeal and combines the rigor of clinical studies with elements obtained from observations, especially with regards to the use of resources.

Economic valuations are not just based on cost per se. They also take into account the opportunity cost, since investing in one type of economy cannot limit funding for another. And it also takes into account the application of results to clinical practice to measure the cost-benefit of the investment.

In this way, the paradigm of making health decisions based solely on costs is broken – primarily aiming at financial savings – or only on clinical aspects.

The economy as a guide for decisions

At the end of the 18th century and the beginning of the following one, we saw the first technical-scientific revolution. These advances that began to permeate the routine of human beings also reached healthcare, generating enormous benefits for all people. However, most technologies aimed at health require high investments, increasing costs.

And there is an aggravating factor: unlike other sectors, in which new technologies act to replace the old ways, in healthcare, technologies are cumulative – extra reason to optimize the cost-benefit ratio.

Magnetic resonance imaging, for example, produces images with a high level of resolution. But a healthcare space that has equipment for this type of examination must also have an X-ray machine – the obvious consequence is that the accumulation of technologies means more expenses!

It is undeniable, therefore, that economic studies are of great importance for the management of health systems – both in the public and private sectors. The data resulting from these areas of study provide indicators on the efficiency and costs of healthcare technologies, in addition to exploring financing alternatives and subsidies for market access.

But, after all, why is HTA used?

Since 1980, in countries such as the United Kingdom and Canada, any new medicine, product or health-related procedure only enters the marketplace after its efficacy is proven, compared to all other available alternatives, and at an affordable cost for the federal budget. This assessment later arrived in our country.

In Brazil

It was in the late 1990s that the Ministry of Health began to think about initiatives related to the adoption of the process. The Secretariat of Science and Technology and Strategic Inputs (SCTIE) was created in 2005 and within the Department of Science and Technology a body responsible for the dissemination of the ATS was created.

The main purpose was to maximize healthcare benefits from the population’s greater access to effective and safe technologies. HTA, in this case, subsidized the activities of analysis, evaluation and recommendation of these technologies.

In 2006 the National Healthcare Technology Management Policy was issued with a focus on developing methodological guidelines for the study of impacts and assessment of technologies.

The link between scientific research and clinical practice was made official in Brazil only in 2011. It was throughLaw No. 12401that HTA was institutionalized as an indispensable practice for the Unified Health System (SUS) when evaluating adoption and impacts of a certain technology in the public health system.

This entire structure is coordinated by the Ministry of Health and goes through some stages:

• Anvisa –  the National Health Surveillance Agency (ANVISA) is responsible for validating the drug registration;
• CMED –  the Medicines Market Regulation Chamber (CMED) is the entity that prices medicines. After carrying out a cost study regarding treatments and procedures, the agency is responsible for stipulating the maximum price of drugs on the market;
• CONITEC – the National Commission for the Incorporation of Technology (CONITEC), which acts by recommending or not the incorporation of healthcare technology based on evidence already collected and taking into account the cost/effectiveness ratio.

Created in 2011, a CONITECadvises the Ministry of Health in evaluating the incorporation, alteration or even exclusion of technologies linked to the SUS. In addition, coordinating the activities of changing clinical protocols and therapeutic approaches

For an incorporation proposal to succeed, all previous studies, impact analysis, research on efficacy, safety and economic feasibility must be presented to this Commission.

And any institution or individual has the right to make such a suggestion, such as a medical or patient society, or a technology manufacturing company, among others.

New demands for the incorporation of drugs into the healthcare system are analyzed in monthly meetings. By presidential decree, the deadline for completion of requests filed with the Commission is 180 days, with an extension for another 90 days being allowed.

What are the stages of Health Technology Assessment (HTA)?

To clarify, step by step, how health technology assessment (HTA) happens, we decided to point out which steps make up this process. See below:

1. Identify priority technologies to be studied, considering their relevance to the collective healthcare framework and specifying the problem to be evaluated;
2. Conduct research from different sources of information, synthesize them and interpret evidence creating arguments;
3. Formulate the entire proposal based on the research and results obtained;
4. Disseminate the conclusion obtained – disseminate results based on public consultations;
5. Monitor and track the impact of recommendations.

Remember: secondary studies can follow early research, giving rise to new findings and conclusions.

Collective construction of healthcare technology

The same law that regulates healthcare technology assessment (HTA) also formalizes the participation of society, and consequently of patients, in the process of incorporating technologies linked to the healthcare system.

This makes the documented process have clear evidence of the impacts of new processes and drugs on the daily lives of patients who depend on the treatment. This collective involvement contributes to more transparent decision making.

By sharing a specific experience, the patient can provide information about the condition that the disease imposes, limitations, expectations regarding innovative technologies in treatment, the social and financial impacts of technology on patients’ lives, among other issues.

But how to get involved? The main channel to participate in decisions involving the assessment of healthcare technologies are public consultations, carried out by the Ministry of Health, on the CONITEC portal, always for a pre-fixed period of 20 days. Thus, it is possible to broaden the discussion on various topics in a transparent way, involving the population in decision-making regarding the introduction of medicines on the market, for example.

Investing in HTA creates value

By analyzing impacts, feasibility and considering popular participation, a company that uses HTA methods raises its status in terms of social responsibility.

Naming and characterizing studies and processes is an essential step to build the analysis base that supports the Healthcare Technology Assessment processes.

If you think about the management of healthcare resources to improve services, you must keep in mind that the decision process can be subject to several variables. And, therefore, the analyzes need to be rigorous, impartial and reliable.

About MAPESolutions

Mapes Solutionsis an organization that provides scientific knowledge services applied to healthcare management, helping to identify the added value of products in the productive area (life sciences industries).

Our focus is to transform technical-scientific knowledge to support the development and innovation of new products in order to obtain the best price, incorporation and commercialization in healthcare systems.

Would you like know more about our HTA-based solutions? Access the link ou entre em contato or contact our experts.