ArticleBritish journal of clinical pharmacology2020
Using GRADE methodology to assess innovation of new medicinal products in Italy.
Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Institutional Priority-Setting for Novel Drugs and Therapeutics: A Qualitative Systematic Review.International journal of health policy and management · 2024Pooled it
- Methods for Assessing Therapeutic Innovation of Drugs: Changes at the Italian Medicine Agency.Therapeutic innovation & regulatory science · 2026Article
- The Pharmaceutical Innovativeness Index: Supporting Value-Based Economic Regulation of Innovative Medicines.Journal of market access & health policy · 2025Article
- Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries.Frontiers in pharmacology · 2023Article
- Reporting reimbursement price decisions for onco-hematology drugs in Spain.Frontiers in public health · 2023Article
- How innovation can be defined, evaluated and rewarded in health technology assessment.Health economics review · 2022Review
- A Proposal for Value-Based Managed Entry Agreements in an Environment of Technological Change and Economic Challenge for Publicly Funded Healthcare Systems.Frontiers in medical technology · 2022Article
- 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
- Non-Price-Related Determinants of Value and Access for Novel Non-small Cell Lung Cancer Treatments: A Cross-Country Review of HTA Decision Making.PharmacoEconomics - open · 2021Article
- Variables affecting pricing of orphan drugs: the Italian case.Orphanet journal of rare diseases · 2021Article
- Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system.BMJ open · 2021Article
- The Assessment of the Innovativeness of a New Medicine in Italy.Frontiers in medicine · 2021Article
- The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy.Frontiers in pharmacology · 2021Article
- Using GRADE methodology to assess innovation of new medicinal products in Italy.British journal of clinical pharmacology · 2020Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimIn April 2017 the Italian Medicine Agency (AIFA) developed new criteria to grant any new medicinal product with an innovative designation. The aim of this study is to describe this new model and how it works.
methodsA retrospective descriptive analysis was performed on the results of the assessment process of innovativeness of new medicinal products (or therapeutic indications) based on the AIFA's new innovation criteria (therapeutic need, added therapeutic value and quality of clinical evidence through GRADE methodology) carried out between April 2017 and February 2019 and made publicly available on the AIFA website starting from January 2018.
resultsA total of 37 full reports (22 for oncological indications) explaining the rationale for the AIFA's decision is made publicly available on the agency's website. A total of 12 therapeutic indications (5 oncological) were evaluated as fully innovative, 13 indications (11 oncological) were evaluated as conditionally innovative, while 12 indications (6 oncological) as non-innovative.
conclusionThe new AIFA innovation criteria resulted in a much more flexible and transparent model to define and assess what constitutes a therapeutic innovation. In particular, the choice of AIFA to use the GRADE methodology to evaluate the quality of clinical evidence within a process of drug innovativeness assessment is essential for the early identification of the discrepancy between the need for patients of a rapid access to innovative therapies and the available clinical data needed to make decisions on drug innovativeness.
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