INFARMED Methodology for Pharmacotherapeutic Assessment of Health Technologies (METOD-AFT)
This is Portugal's official guide for assessing the added clinical and pharmacotherapeutic value of medicines to support decisions on whether they should be reimbursed nationally. It outlines how evidence is reviewed and compared to existing treatments.
At a glance
Use when
Assessing new medicines for reimbursement in Portugal, particularly when comparing therapeutic value to existing options
Avoid when
Evaluating non-pharmacological technologies or in contexts outside Portugal's reimbursement system
Inputs
Clinical trial data, real-world evidence, comparative effectiveness studies, safety profiles, patient-reported outcomes, and health-related quality of life data
Outputs
Assessment of added therapeutic value, classification of benefit level, recommendation for reimbursement eligibility
How it works
The METOD-AFT guideline, developed by INFARMED I.P. under the SiNATS framework, provides a structured methodology for evaluating the pharmacotherapeutic assessment of health technologies, focusing on comparative clinical effectiveness, safety, and patient-relevant outcomes. Version 3.0 (February 2023) defines criteria for determining the magnitude of added therapeutic value, incorporating both quantitative and qualitative evidence, and supports reimbursement decision-making within the Portuguese healthcare system.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Assumptions
- The comparator is appropriately selected (current standard of care); submitted evidence is robust and relevant to the Portuguese population; therapeutic value can be meaningfully graded on a scale
- Strengths
- Transparent, standardized framework aligned with national health priorities; integrates multiple evidence types; clearly defined grading system for added value
- Limitations
- May be less adaptable to very rare diseases or ultra-orphan indications; reliance on head-to-head trials which may not always be available
- Also known as
- METOD-AFT, SiNATS Methodology, INFARMED Methodology v3.0
Questions this answers
- › How is the clinical added value of a medicine assessed in Portugal?
- › What evidence is required to demonstrate therapeutic improvement over existing treatments?
- › How are patient-relevant outcomes integrated into reimbursement decisions?
- › What criteria define different levels of pharmacotherapeutic benefit?
- › How is comparative effectiveness evaluated against standard of care?
- › What role does safety and tolerability play in the assessment?
References & sources
- websiteinfarmed.pt ↗
Similar by meaning
- Revised methods guide for economic evaluation studies of health technologies in Portugal
- Polish HTA Methodological Guidelines (AOTMiT)
- Guideline for the economic evaluation of medicines (CAPF / Spanish NHS Advisory Committee for Pharmaceutical Financing)
- Danish Medicines Council Methods Guide for assessing new pharmaceuticals (Medicinrådet)
- AIFA Guidelines for the economic evaluation of health technologies (P&R dossier, Chapter 9)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.