In Portugal, public funding of health technologies by the National Health Service (SNS) depends on a health technology assessment (HTA) carried out by INFARMED, within the National Health Technology Assessment System (SiNATS).
SiNATS was created in 2015 by Decree-Law 97/2015 and revised in 2026. Decree-Law 118/2026, of 17 June, establishes the new SiNATS framework and came into force on 1 July 2026.
This guide summarises how HTA works in Portugal and what changes with the new framework.
What is assessed?
HTA in Portugal looks at two dimensions.
- Pharmacotherapeutic assessment. It analyses the added therapeutic value of the technology against the relevant comparators, for a defined population and outcomes. In practice, it is organised around a PICO (Population, Intervention, Comparators and Outcomes).
- Economic assessment. It analyses the relationship between costs and health outcomes (cost-effectiveness) and the financial consequences for the SNS (budget impact).
Under the new framework, funding decisions are based on criteria of clinical evidence, cost-effectiveness and added therapeutic value.
What changes with Decree-Law 118/2026?
Wider scope. The framework covers medicines, medical devices, in vitro diagnostic medical devices and other relevant health technologies. Medical devices now have their own rules, instead of following the criteria used for medicines.
Link with Europe. INFARMED is the coordinating body and articulates the national process with the European joint clinical assessments (JCA) and joint scientific consultations under Regulation (EU) 2021/2282. We explain the JCA in detail in this article.
Defined deadlines. The decree-law sets submission, assessment and decision procedures with legal deadlines for each phase, which gives applicants more predictability.
Participation. The structured participation of patient associations, consumers and health professionals in the assessment is strengthened.
Real-world data. Companies must make real-world data available whenever it has an impact on the assessment or when INFARMED requests it.
Prioritisation and advice. There are prioritisation mechanisms for innovative technologies and unmet therapeutic needs, and the possibility of early scientific advice.
Confidentiality. The possibility of keeping the agreed funding conditions confidential is now expressly provided for.
Supply. Funding lapses if the technology is not marketed for a set period, and it cannot be requested again for two years.
Which procedures does it apply to?
The new framework does not apply to assessment procedures that were already pending on 1 July 2026. The previous regulations remain in place until the new implementing ordinances (portarias) are published, so it is worth following the guidance that INFARMED publishes.
How does the economic assessment work in Portugal?
Economic evaluation studies follow INFARMED’s Methodological Guidelines for Economic Evaluation Studies of Health Technologies, published in 2019 and mandatory for submissions from 1 May 2020.
Some rules carry particular weight when preparing a dossier:
- The budget impact analysis adopts the SNS perspective, includes current patients (prevalence) and new cases (incidence), and has a short time horizon, as a rule around two years. Read more in our article on budget impact analysis in Portugal.
- The comparators in the budget impact analysis must be the same as in the economic evaluation.
- When there is no empirical data for the Portuguese context, structured expert elicitation can be used, with the experts identified and their conflicts of interest declared.
- Uncertainty must be analysed explicitly and can support requests for additional evidence at the reassessment stage.
How to prepare a submission
- Anticipate the PICO. Forecast the population, comparators and outcomes that the assessment will focus on, taking Portuguese clinical practice into account.
- Review the evidence. Run a gap analysis and update the systematic literature review for the relevant comparators.
- Generate comparative evidence. When there are no head-to-head trials, plan appropriate indirect comparisons or network meta-analyses.
- Adapt the economic models. Align the cost-effectiveness and budget impact models with SNS data and practice.
- Prepare real-world data. Under the new framework, real-world data carries more weight and can be requested.
- Look at Europe. If the technology falls within the scope of the JCA, align the European dossier with the national submission from the start.
Frequently asked questions
What is SiNATS?
It is the National Health Technology Assessment System, coordinated by INFARMED, which assesses health technologies to support funding decisions by the SNS.
When did the new SiNATS framework come into force?
On 1 July 2026, with Decree-Law 118/2026 of 17 June. It does not apply to procedures that were already pending on that date.
Are medical devices also assessed?
Yes. The new framework covers medical devices and in vitro diagnostic medical devices, with their own rules, different from those for medicines.
Does the European joint clinical assessment replace INFARMED’s assessment?
No. INFARMED must take the European report into account, but the economic assessment and the funding decision remain national.
Final thoughts
The new SiNATS widens the scope of HTA in Portugal, links it to the European assessment, gives more weight to real-world data and sets deadlines for each phase. For companies, this means preparing clinical and economic evidence earlier and more consistently.
At Clevidence, we support companies through every stage of HTA and reimbursement in Portugal, from PICO anticipation to the economic evaluation. See our case study on integrated support for the HTA process in Portugal and learn more about our HTA and market access services.
This article is for information only and does not replace reading the decree-law as published in the Portuguese Official Journal (Diário da República).