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      Il ruolo degli esiti riferiti dal paziente nelle decisioni di rimborso e innovatività dei farmaci in Italia


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          The role of patient-reported outcomes in reimbursement decisions and drug innovation in Italy

          The attention paid by regulatory authorities to patient-reported outcomes (PROs) and their related measures (PROMs) has progressively increased to allow for a more complete description of the patient’s health status. This work aimed at investigating the use of PROs/PROMs in relation to reimbursement agreement and innovativeness recognition by the Italian Medicines Agency (AIFA).

          The list of European Public Assessment Reports (EPARs), downloaded from the European Medicine Agency (EMA) website, was analyzed to identify drugs authorized between 2017 and 2021. The associations between the use of PROs/PROMs in the EPARs and the reimbursement and innovativeness status in Italy were explored through Chi 2 test and logistic regression. In addition, each innovativeness report was analyzed to identify any further evidence about the consideration of PROs/PROM in the decision-making process.

          Of the 403 EPARs analyzed, 197 (48.9%) reported the use of PROs/PROMs. A subsample of 229 drugs with a reimbursement class (A, H, or C) officially assigned by AIFA was further investigated. Of them, 49.3% reported the use of PROs/PROMs. The Chi 2 test revealed a statistically significant association between the use of PROs/PROMs and innovativeness (p = 0.001) and orphan status (p = 0.012). In the logistic regression, orphan status and availability of PROs/PROMs are significant predictors of the innovativeness status. However, of the 46 innovative drugs, only 9 (19.6%) explicitly reported a consideration of a PRO/PROM in their innovativeness reports. Robust instrument’s validation, reliable data collection and growing potential’s awareness are keys to increase the consideration of PROs at every step of the drug development process.

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          Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)

          In recent years, there has been an increased focus on placing patients at the center of health care research and evaluating clinical care in order to improve their experience and ensure that research is both robust and of maximum value for the use of medicinal products, therapy, or health services. This paper provides an overview of patients’ involvement in clinical research and service evaluation along with its benefits and limitations. We describe and discuss patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), including the trends in current research. Both the patient-reported experiences measures (PREMs) and patient and public involvement (PPI) initiative for including patients in the research processes are also outlined. PROs provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received. PROMs are tools and/or instruments used to report PROs. Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety. This reflects the ongoing health service commitment of involving patients and the public within the wider context of the development and evaluation of health care service delivery and quality improvement.
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            A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)

            To compare US Food and Drug Administration (FDA) and European Medicines Agency (EMA) labeling for evidence based on patient-reported outcomes (PROs) of new oncology treatments approved by both agencies.
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              Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples


                Author and article information

                Glob Reg Health Technol Assess
                Glob Reg Health Technol Assess
                Global & Regional Health Technology Assessment
                9 February 2023
                Jan-Dec 2023
                : 10 ,2023
                : 12-17
                [1 ] Centro di Ricerche sulla Gestione dell’Assistenza Sanitaria e Sociale (CERGAS), SDA Bocconi School of Management, Milano - Italy
                [2 ] Dipartimento di Scienze Del Farmaco, Università Degli Studi Del Piemonte Orientale, Novara - Italy
                [3 ] Agenzia Italiana del Farmaco, Roma - Italy
                Author notes
                Indirizzo per la corrispondenza: Centro di Ricerche sulla Gestione dell’Assistenza Sanitaria e Sociale (CERGAS), SDA Bocconi School of Management Via Sarfatti 10 20141 Milano - Italy oriana.ciani@ 123456unibocconi.it

                Global & Regional Health Technology Assessment - www.aboutscience.eu/grhta

                © 2023 The Authors. This article is published by AboutScience and licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Commercial use is not permitted and is subject to Publisher’s permissions. Full information is available at www.aboutscience.eu

                : 2 November 2022
                : 26 January 2023
                Original Research Article

                european public assessment reports,innovativeness,italian drug agency,patient-reported outcomes,patient-reported outcome measures,reimbursement


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