HTA Decision Analysis Framework
Cuatrecasas / Portugal
Join industry executives in staying informed on the market access and HTA process in Portugal.
1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?
The CATS and the DATS are responsible for SiNATS.
2. Do regulators require HTA studies in your country?
Yes, regulators may require HTA studies. Moreover, the information contained in SiNATS and the studies that support HTA decisions are published in accordance with the conditions to be defined by Infarmed.
3. Do payers require HTA studies in your country?
Thought not mandatory, payers are allowed to require HTA studies in Portugal.
4. How are HTA assessments translated into pricing conditions in your country?
HTA assessment is the basis for (i) deciding on the price, reimbursement, acquisition, or installation of health technologies and (ii) deciding on the maintenance of reimbursement or acquisition, through prior evaluation of health technologies.
5. How are HTA assessments translated into reimbursement conditions in your country?
For the purposes of prior evaluation agreements and reimbursement matters, medicinal products must be subject to a pharmacoeconomic and pharmacotherapeutic evaluation.
6. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?
The assessment or re-evaluation is subject to a pharmacotherapeutic and/or economic evaluation. The technical-scientific criteria for assessing the different health technologies are established in a regulation approved by Infarmed.
7. What is the methodology used in your country for HTA assessment?
HTA assessment aims to support the decision to use and finance health technologies in the NHS. This decision is based not only on the criteria of quality, safety, and efficacy but also on criteria of comparative economic effectiveness and efficiency, to optimize the use of available resources.
Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment, as referred below.
8. Which are the other decisions impacted by the assessed outcome in your country?
HTA assessment constitutes grounds to:
- Decide on the price, reimbursement, acquisition or installation of health technologies;
- Issue recommendations or decisions on the use of any health technology;
- Decide on the maintenance of the reimbursement or the acquisition, after prior evaluation of health technologies.
9. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?
Infarmed may enter into protocols or contract health technology assessment experts, whether legal or natural persons, national or foreign, to conduct health technology assessments.
