ArticleBMJ open2021
Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Closing the first wave of drug innovativeness in italy: final evidence from 2017 to 2025.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- The Italian Assessment System for Innovative Medicines: An 8-Year Retrospective Analysis of Outcomes, Criteria, Timelines and Funding Dynamics.Applied health economics and health policy · 2026Article
- From Indication-Based Pricing to Blended Approach: Evidence on the Price and Reimbursement Negotiation in Italy.PharmacoEconomics - open · 2024Article
- The impact of level of documentation on the accessibility and affordability of new drugs in Norway.Frontiers in pharmacology · 2024Article
- Do France, Germany, and Italy agree on the added therapeutic value of medicines?International journal of technology assessment in health care · 2023Article
- The Evaluation of Drug Innovativeness in Italy: Key Determinants and Internal Consistency.PharmacoEconomics - open · 2023Article
- Value assessment of medicinal products by the Italian Medicines Agency (AIFA) and French National Authority for Health (HAS): Similarities and discrepancies.Frontiers in medical technology · 2022Article
- Accelerating patient access to oncology medicines with multiple indications in Europe.Journal of market access & health policy · 2021Review
- The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy.Frontiers in pharmacology · 2021Article
- The Assessment of the Innovativeness of a New Medicine in Italy.Frontiers in medicine · 2021Article
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- Price and reimbursement for orphan medicines and managed entry agreements: does Italy need a framework?Global & regional health technology assessmentArticle
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3 authors.
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No grant is acknowledged in the PubMed record.
Abstract
objectiveIn 2017, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) introduced a standardised process to appraise innovativeness of medicines. Innovative medicines are provided speeder market access and dedicated funds. Innovativeness criteria are: unmet therapeutic need, added therapeutic value and quality of the evidence (Grading of Recommendations Assessment, Development and Evaluation method). We investigated the role played by these three criteria on the final decision aimed to understand how the new Italian innovativeness appraisal framework was implemented.
designA desk research gathered AIFA's appraisal reports on innovativeness and data analyses were conducted. No patients were directly involved in this study. SETTING AND
participantsWe scrutinised all 77 appraisal reports available on AIFA's website (2017-2020). PRIMARY AND SECONDARY OUTCOME MEASURES: The impact of the three domains on final decision was investigated through a series of univariate analyses.
resultsAmong 77 appraisal reports on innovativeness available, 49 (64%) and 28 (36%) were for oncology and non-oncology medicines, respectively. The appraisals were equally distributed among 'fully innovative' (36%), 'conditionally innovative' (30%) and 'not innovative' (34%). Added therapeutic value was the most important driver on innovativeness decision, followed by quality of the evidence. Drugs for rare diseases and with paediatric/mixed indications were appraised 'innovative' by a larger proportion, but no statistical significance was found.
conclusionsDespite some limitations, including the moderate number of appraisals, this paper provides an insight into the determinants of innovativeness appraisals for medicines in Italy and the accuracy of the appraisal process. This has important implications in terms of transparency and accountability in the prioritisation process applied to innovative medicines.
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