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The evolution of the medical sector and the scarcity of resources

Seeking to meet an ever-growing demand, healthcare systems around the world have been investing heavily in the development of procedures, approaches and drugs with greater diagnostic and therapeutic resolution capabilities.

This scenario has raised the costs of the sector. Increasing access to more effective therapies in a scenario of recession and an aging population is one of the greatest challenges facing healthcare systems.This has caused greater concern among area managers in evaluating the costs and benefits of a technology before incorporating it.

In order to make better use of available resources to be incorporated, a new technology needs to present good results in the real world: efficiency, ease of implementation, patient safety and compatible price, all compared to the technologies already present in the Marketplace.

The National Commission for the Incorporation of Technologies in the Brazilian Unified Health System (SUS)

In order to institutionalize a legal process for the incorporation of new technologies in healthcare in Brazil, the CONITEC (National Commission for the Incorporation of Technologies in the Brazilian Unified Health System (SUS) – Law No. 12401/2011) was created, a permanent collegiate body whose objective is to advise the Ministry of Health in the areas of technological incorporation and clinical protocol.

This body is responsible for recommending relevant, safe, effective and cost-effective technologies for Brazilian health and thus guaranteeing the supply of updated and qualified procedures, medicines and products, consistent with the best of medical practice.

To be approved by CONITEC, the incorporation of a new procedure or technology undergoes an evaluation based on aspects such as efficacy, accuracy, effectiveness and safety, in addition to a comparative economic evaluation of the benefits and costs in relation to existing technologies.

Steps in the process of incorporating health technologies

To request the evaluation of a technology, the applicant must go through the following steps:

• Registration with ANVISA (National Health Surveillance Agency)
• Price definition with CMED – Medicine Market Regulation Chamber (here it is already recommended to start the production of value dossiers on the product to reach a compatible price).
• Documentation filing with SCTIE/MS (Ministry of Health Science, Technology and Strategic Inputs
• Presentation of studies to CONITEC – which will receive, study (and if necessary request additional data), submit to public consultation, evaluate contributions and recommend, or not, the incorporation of the technology.
• Holding a public hearing (if the Secretary of the SCTIE deems it necessary)
• Evaluation of the report by the Secretary of the SCTIE
• Publication in the Federal Official Gazette
• Market launch

From this point on, applicants can present their technology to paying institutions through their Market Access team (which we will cover in the next Article), armed with the value data collected by HEOR.

The request for technology assessment can be made by any institution or individual, for example, by a technology manufacturing company, a medical or patient society, technical areas of the Ministry of Health, State and Municipal Health Secretariats.

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The medical section evolution and the scarcity of resources

Seeking to meet an increasingly demand, the health systems all over the world have heavily invested in the development of procedures, approaches and drugs with bigger capacity of diagnostic and therapeutic resolution.

This scenario has been increasing the cost of the sector. Increasing the access to more efficient therapies in a scenario of recession and of ageing population is a big challenge of health systems. This has been aggravated a bigger concern of the managers of the area when evaluating the costs and benefits of a technology before incorporating it.

Having the goal of making a better use of the available resources, to be incorporated, a new technology needs to present good results in the real world: efficiency, ease of implementation, security to the patients and compatible price, everything comparing to the technologies in the market.

The National Commission for the Incorporation of Technologies in SUS

In order to institutionalize a legal process to incorporate new health technologies in Brazil, CONITEC (Comissão Nacional de Incorporação de Tecnologias no SUS – National Commission for the Incorporation of Technologies in SUS – Law number 12401/2011) was created. It’s a permanent collegiate agency that has the goal of advice the Brazilian Health Ministry in the subject of incorporating new technology and clinical protocol.

This agency is responsible for recommending relevant, safe, efficient and cost-effective technologies to the Brazilian health and then be sure that the proceeding offer, medicines and updated and qualified products, are consistent with the best of medical practice.

To be aproved by the CONITEC, the incorporation of a new proceedment or technology goes through an assessment based on aspects such as efficiency, accuracy, effectiveness and security, besides the economic assessment comparing the benefits and costs related to technologies that already exist.

Stages of the incorporation process

To request the assessment of a technology, the applicant must go through the following stages:

• Record in ANVISA
• Defining the price with the CMED (Câmara de Regulação do Mercado de Medicamentos) – Market of Regulation of the Market of Medicines (in this point it’s recommended to start the production of value dossiers about the product to get to a compatible price).
• Documentation protocol with SCTIE/MS (Science Secretary, Technology and Strategic Inputs of the Health Ministry – Secretaria de Ciência, Tecnologia e Insumos Estratégicos do Ministério da Saúde)
• Presenting the studies to CONITEC – which will receive, study (and, if it’s necessary it will ask for complementary data), submit to public consultation, evaluate the contribution and recommend, or not, the incorporation of the technology.
• Holding a public hearing (if the SCTIE secretary thinks it’s necessary).
• Evaluation of the report by the Secretary of the SCTIE.
• Publication in Diário Oficial da União
• Market Launch

After this the applicant can already present his technology to the payer institution through his Market Access team (which we will  be the subject of our next article), provided with value data collected by HEOR.

The technology assessment request can be made by any institution or person, for example, by a company that makes technology, a medical or patient society, technical areas of the Health Ministry, State secretaries and Town Health areas.

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