AIM: In 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: The 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.
AIM: In 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: The 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.
Authors: Gordon H Guyatt; Andrew D Oxman; Gunn E Vist; Regina Kunz; Yngve Falck-Ytter; Pablo Alonso-Coello; Holger J Schünemann Journal: BMJ Date: 2008-04-26
Authors: Philipp Dahm; Andrew D Oxman; Benjamin Djulbegovic; Gordon H Guyatt; M Hassan Murad; Laura Amato; Elena Parmelli; Marina Davoli; Rebecca L Morgan; Reem A Mustafa; Shahnaz Sultan; Yngve Falck-Ytter; Elie A Akl; Holger J Schünemann Journal: J Clin Epidemiol Date: 2017-04-01 Impact factor: 6.437
Authors: Elena Parmelli; Laura Amato; Andrew D Oxman; Pablo Alonso-Coello; Massimo Brunetti; Jenny Moberg; Francesco Nonino; Silvia Pregno; Carlo Saitto; Holger J Schünemann; Marina Davoli Journal: Int J Technol Assess Health Care Date: 2017-06-28 Impact factor: 2.188
Authors: Pablo Alonso-Coello; Holger J Schünemann; Jenny Moberg; Romina Brignardello-Petersen; Elie A Akl; Marina Davoli; Shaun Treweek; Reem A Mustafa; Gabriel Rada; Sarah Rosenbaum; Angela Morelli; Gordon H Guyatt; Andrew D Oxman Journal: BMJ Date: 2016-06-28