Role of HTA (Health Technology Assessment) in Portugal Reimbursement
National HTA Organisations & Stakeholders
National HTA Organization
In 1998 Portugal released guidelines for economic medicine evaluation studies to help MAH developing cost-effectiveness studies to support reimbursement, laying down the first steps of HTA, unfortunately only for medicines.0.
At a European level, the development of Health Technology Assessment (HTA) systems led the Portuguese government to design and implement its HTA system, and integrate the EUnetHTA – European network for Health Technology Assessment.
On June 1, 2015, Portuguese Decree-Law n.o 97/2015 was published laying down the legal framework of the National System for the Evaluation of Health Technologies (SiNATS).
SiNATS is comprised of all entities and means that are involved in health technology assessment and managed by INFARMED. All entities, public or private, that produce, commercialize or use health technologies are covered by SiNATS and all health technologies are under its evaluation. HTA process is performed by experts in the pharmaceutical, clinical and economic areas from the HTA Directorate (DATS – Direção de Avaliação de Tecnologias de Saúde) and HTA Commission (CATS – Comissão de Avaliação de Tecnologias de Saúde) 0,0.
SiNATS aims to provide the National Health Service (NHS) with an instrument for 0, 0:
a) Maximizing health gains and citizens’ quality of life;
b) Contributing to the sustainability of the NHS;
c) Guarantee the efficient use of health public resources;
d) Monitoring the use and effectiveness of technologies;
e) Reducing waste and inefficiencies;
f) Promoting and awarding relevant innovation development;
g) Promoting equal access to technologies.
SiNATS is supported by an Information System for Health Technologies Assessments (SIATS – Sistema de Informação para a Avaliação de Tecnologias da Saúde). SIATS contains all the information necessary for the evaluation of health technologies, in compliance with legal standards. Data contained in SIATS may be obtained from other information systems of public or private entities or by its own records 0, 0.
Types of guidance for Medical Technologies
In Portugal, the type of guidance for Medical Technologies is through the decrees-laws and the INFARMED website. Additionally, there are documents produced to better understand the laws in force, for example, can find through this link 0 on the document prepared by INFARMED.
The Portuguese Decree-Law n.o 97/2015 and the Portuguese Decree-Law n.o 115/2017 including the medicines, medical devices, and other health technologies.
Impact of guidance
With the implementation of SiNATS, Portugal was able to adopt an HTA system that also aims to monitor medicines’ effectiveness in the real context of use, helping at the same time in the investigation and promotion of knowledge in sectors under assessment.
The collection of information necessary for SiNATS will be carried out in a number of ways, including the actual holders of the technology within the framework of their contractual obligations, but also through national or regional registers of patients, information generated by providers, databases national and international data and bodies cooperating in this area at European level.
In the diagram below you can find the structure of SiNATS:
The Process of evaluation of Health Technologies in Portugal, according to the current Decree-Law, is described in the following scheme:
DATS – Health Technology Assessment Directorate CATS – Health Technology Assessment Commission
CD – Board of Directors
SEAS – Assistant Secretary of State for Health
MS – Ministry of Health
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Question 1 of 3: Complete the sentence: “The national HTA Portuguese organization is…”CorrectIncorrect
Question 2 of 3: One of the objectives of SiNATS is contributing to the sustainability of the National Service of Health (SNS).CorrectIncorrect
Question 3 of 3: The Portuguese Decree-Law n.o 97/2015 and the Portuguese Decree-Law n.o 115/2017 including the medicines, medical devices, and other health technologies.CorrectIncorrect