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. 2021 Jan 13;11(1):e041259.
doi: 10.1136/bmjopen-2020-041259.

Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system

Carlotta Galeone  1   2 , Paolo Bruzzi  3 , Claudio Jommi  4
Affiliations

Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system

Carlotta Galeone et al. BMJ Open. .

Abstract

Objective: In 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.

Design: A desk research gathered AIFA's appraisal reports on innovativeness and data analyses were conducted. No patients were directly involved in this study.

Setting and participants: We 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.

Results: Among 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.

Conclusions: Despite 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.

Keywords: health policy; health services administration & management; international health services; public health.

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Conflict of interest statement

Competing interests: CG is a senior consultant at Statinfo. CJ and PB have received a consultant fee from Celgene as scientific consultants for the project.

Figures

Figure 1
Figure 1
Criteria used to evaluate innovativeness adopted by the Italian Medicines Agency (adapted from Recchia, 2017). *For rare disease there is the following exception: the fully innovative is attributed in the presence of at least important unmet therapeutic need and added therapeutic value in presence of at least low quality of clinical evidence. **The innovativeness appraisal has to be decided on a case-by-case basis. GRADE, Grading of Recommendations Assessment, Development and Evaluation.
Figure 2
Figure 2
Innovative appraisals by the Italian Medicines Agency (2017–2020).
See this image and copyright information in PMC

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