AIFA innovativeness assessment algorithm (therapeutic innovativeness ranking)
This method is used by the Italian Medicines Agency (AIFA) to assess whether a new medicine is innovative based on criteria like added therapeutic value, therapeutic need, and quality of clinical evidence. It helps decide which drugs are considered truly new and beneficial for patients.
At a glance
Use when
Assessing the innovation level of new medicines for reimbursement or market access in Italy; comparing therapeutic value across drugs; informing health technology assessment decisions on novelty
Avoid when
When objective quantitative metrics alone are required without expert judgment; in countries with different regulatory or HTA frameworks; for non-therapeutic health technologies
Inputs
Drug characteristics, clinical evidence, therapeutic context, unmet need, comparative effectiveness data
Outputs
Innovativeness status (fully innovative, conditionally innovative, not innovative)
How it works
The AIFA innovativeness assessment algorithm applies a multidimensional approach to evaluate the innovativeness of new medicinal products. It considers three main criteria: added therapeutic value, therapeutic need, and quality of clinical evidence. A Classification Tree (CT) model identified added therapeutic value as the most predictive factor for innovativeness, with high accuracy (89.4%). The method was validated through retrospective analysis of 109 drug reports from 2017 to 2021, showing good consistency and reproducibility in decisions.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Categories
- Appraisal
- Assumptions
- The three criteria (added therapeutic value, therapeutic need, quality of evidence) are sufficient to determine innovativeness; decisions are reproducible when criteria are consistently applied
- Strengths
- High accuracy in predicting innovativeness (89.4%), good consistency and reproducibility in decision-making, transparent and structured framework based on published reports
- Limitations
- Therapeutic need and quality of evidence show only mild association; no differentiation in outcomes between orphan/non-orphan or oncological/non-oncological drugs; reliance on subjective interpretation of criteria may affect objectivity
- Also known as
- AIFA innovativeness algorithm, Therapeutic innovativeness ranking
Questions this answers
- › Does the drug provide added therapeutic value compared to existing treatments?
- › Is there an unmet therapeutic need the drug addresses?
- › How strong is the clinical evidence supporting the drug's effectiveness?
- › Is the medicine considered fully, conditionally, or non-innovative?
- › How consistent are AIFA's innovativeness decisions across similar cases?
- › What is the relative weight of each criterion in determining innovativeness?
References & sources
Similar by meaning
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