Involving public and patients in the process of Evaluation of Health Technologies in Brazil

September 13, 2017  

Português


Aline Silveira Silva, MS Technologist at Executive Secretariat of the National Committee for Health Technology Incorporation – CONITEC.


The Health Technology assessments (HTA) is a multidisciplinary field of policies analysis which studies the clinical, social, ethical, and economic implications of the development, diffusion, and use of health technology. It takes into account aspects such as efficacy, effectiveness, safety, costs, and cost-effectiveness, among others. However, the ethical, legal, and social impacts addressed to patients’ and society’s perspectives are, in general, behind clinical and economic attributes (efficacy, effectiveness, safety, and cost).

However, with the growing engagement of patients in their right to healthcare, as full partners respecting to the care of their own health, there is a need to establish effective means to involve the society in the evaluation and decision processes. Therefore, the participation of society in the HTA is essential and needs to be implemented.

In Brazil, the community participation is one of the guidelines of the Unified Health System (Sistema Único de Saúde – SUS) present in the Federal Constitution of 1988. It is also one of the principles described in Laws 8.080/1990 and 8.142/1990, which anticipate the community participation in the SUS.

On April 28th, 2011, Law # 12.401[1]  created the framework for the incorporation of health technologies in the ambit of SUS, creating the National Commission of Technologies Incorporation (COmissão Nacional de Incorporação de TECnologias – CONITEC) of SUS, which is composed of two forums: Plenary and Executive Office. The CONITEC has a purpose of advising the Ministry of Health in the attributions related to incorporation, exclusion, or changes of health technologies by the SUS, as well as to assist in the constitution or modifications  of Clinical Protocols and Therapeutic Guidelines (Protocolos Clínicos e Diretrizes Terapêuticas – PCDT).

The same Law has formalized the participation of Society in the technologies incorporation process at SUS, by the participation of a representative from the National Health Council (Conselho Nacional de Saúde – CNS) and a representative of the Fedearal Council of Medicine (Conselho Federal de Medicina – CFM) as members of CONITEC plenary and bythe execution of  Public Consultation (Consulta Pública – CP) within the term of 20 days, for all recommendations issued by the Plenary or from Public Audience before the final decision-making, in the cases in which its justified.

Since the CONITEC activities started in 2012, up to the month of July 2017, 220 CPs have taken place and more than 30 thousand contributions were received from the most diverse actors, including patients, caregivers, families, groups of patients, and healthcare professionals. Considering this period, we have an average of 5000 contributions per year.

In other words, besides the society representation in the plenary, by the  CFM, CNS, and councils of states and cities secretariats, there is also participation of several other actors in the public consultations: Ministry of Health, Statal Health Secretaries, healthcare professionals, patients associations, Education Institutions, Hospitals, medical societies, pharmaceutical and medical devices & diagnostics companies, individuals, among others.

Even so, assuming that the plenary representation is not enough for all evaluated themes, CONITEC has thought of other strategies for participation besides the execution of a public consultation for each evaluated theme. Some themes evaluated in 2014 and 2015 had participation in the plenaries of patient’s representatives coming from associations, as an example the use of fingolimod for treatment of multiple sclerosis and budesonide 200 µg/formoterol 6 µg in aerosol suspension for the treatment of asthma. Those stakeholders provided to the CONITEC plenary information about the unique experience of patients regarding the discussed themes. However, it is necessary to improve such mechanisms and have a better definition of methods for their participation.

A Brazilian study published in 2013[2] has identified proposals to improve the public’s involvement and the consideration of patients and public preferences in the HTA processes and the incorporation of new health technologies within the current Brazilian context. Such proposals were done under the SUS perspective and many of them, among others, are being implemented by the Executive Office of CONITEC.

In any case, the CP is considered the main strategy of CONITEC for the involvement of the public and patients in the process of Evaluation of Health Technologies. Because of that, manners to improve such instruments have been sought in order to qualify this participation. Therefore, in 2014, a new CP form has been created to report the patients’ and caregivers’ perspectives respecting the new technologies evaluated. Besides, the CPs divulgence has been improved by means of social networks (Twitter, LinkedIn), sites, and e-mail listings, aiming to reach out the interested public and assure a better participation.

In 2015, some reports focused in lay people have started to be produced, those docuements are abreviattions of CONITEC’s technical reports, elaborated in simplified language, aiming to improve the participants understanding about the public consultations and stimulating their participation in the HTA process that antecedes the incorporation, exclusion, or modifications of drugs, devices and procedures utilized at SUS. As of July 2017, 57 reports have already been published at CONITEC website.

In some cases, the considerations from the public received during the public consultations acts have influenced the commission’s decision-making process, as an example: Rituximab for the treatment of B-cells non-Hodgkin lymphoma; Gefitinib and erlotinib for the treatment of advanced non-small cells lung cancer or metastatic mutation of EGFR; Ambrisentan and Bosentan for the treatment of Pulmonary Arterial Hypertension (PAH) in primary or secondary failure or sildenafil contraindication ; Fingolimod for the treatment of multiple sclerosis.

In the same year with the aim to investigate the public and patients preferences, it has been started the execution of surveys related to Clinical Protocols and Therapeutic Guidelines (Protocolos Clínicos e Diretrizes Terapêuticas – PCDT). Patients provides information and suggestions about their disease, improvements in the healthcare, appeal for new technologies among other aspects that should be approached. As this participation takes place before the document elaboration, the society contributes for the scope elaboration of the protocol of the referred disease. Up to 2017 July, 15 surveys have been developed about the most varied themes.

The popular education should be thought, having as reference the participation of everybody in a society organized in democratic shape. Because of that, in 2016 it was launched the guide “Understanding the Incorporation of Health Technologies at SUS: How to Get Involved” (Entendendo a Incorporação de Tecnologias em Saúde no SUS: Como se Envolver)[3] addressed to lay audience, in order to disseminate the knowledge and facilitate the society involvement. Following this same line, it is planned for the end of 2017, an event addressed to patients representatives, who will have the opportunity to discuss the process of incorporation of health technologies to SUS, together with members of the CONITEC Executive Office.

The CONITEC web portal was elected as the base of initiatives for communication and transparence. It is possible to access all the complete technical reports, as well as the contributions received during already developed public consultations, and the agendas and minutes of CONITEC plenary meetings. Besides this, in the specific session “Social Participation” (Participação Social), it is possible to access the surveys, ongoing and finished public consultations, the reports for the society, monthly clippings about the CONITEC activities, and the guide about how to participate in the evaluation process and incorporation of health technologies.

In addition, CONITEC performs fortnightly, since August 2016, videoconferences by a program named “CONITEC in evidence” (CONITEC em evidência), which has as purpose to debate and deepen relevant themes of the management and technology evaluation areas, with the most diverse actors in the field, besides to disseminate the contents produced by CONITEC and Technology Evaluation Cores (Núcleos de Avaliação de Tecnologias – NATs). Besides the participation of several institutions by videoconferences, any citizen could follow such transmission from his own computer and in real time, even asking questions using e-mail. The content of such meetings remains available for further access at CONITEC website.

Finally, it is possible to observe that Public Consultations, as a tool for society inclusion into HTA, are something valid and innovative. Their improvement will increase the patient and public involvement in HTA processes and incorporation of new technologies in Brazil.

However the contexts of participation still presents large challenges to be solved with practice in the upcoming years, understanding more and more the importance of defending and qualifying such spaces and actors implied in the participation. For the gradual involvement of public and patients in the HTA process in Brazil, it is important that the policymakers and those who support them effectively plan and evaluate carefully the strategies to be used, because the participation is a policy learning to be improved and understood in its different contexts, such as that of HTA.


[1] Brazil. Law # 12401, dated April 28th, 2011. It changes Law # 8080, dated September 19th, 1990, to decide about the therapeutic assistance and the health technology incorporation in the ambit of Single Health System (Sistema Único de Saúde – SUS). Union Official Daily Newspaper, Brasília, DF, April 29th, 2011.

[2] Silva, Aline Silveira. O envolvimento do público no processo de Avaliação de Tecnologias em Saúde: experiências mundiais e proposições para sua ampliação no Brasil. 172 f. Dissertation (master’s degree) – Escola Nacional de Saúde Pública Sergio Arouca, Rio de Janeiro, 2013.

 

[3] Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Gestão e Incorporação de Tecnologias em Saúde. Entendendo a Incorporação de Tecnologias em Saúde no SUS: como se envolver. Brasília: Ministério da Saúde, 2016.