Brogan AP, DeMuro C, Barrett AM, D’Alessio D, Bal V, Hogue SL. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: oncology Examples. J Manag Care Spec Pharm. 2017;23(2):125-134. https://doi.org/10.18553/jmcp.2017.23.2.125 PMID:28125369 DOI: https://doi.org/10.18553/jmcp.2017.23.2.125

Brettschneider C, Lühmann D, Raspe H. Informative Value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA). https://doi.org/10.3205/hta000092.

EUnetHTA. Joint Action on HTA 2012-2015, HTA Core Model User Guide. 2016. https://www.eunethta.eu/wp-content/uploads/2018/06/HTACoreModel_UserGuide_Version1.1-1.pdf. Online (Accessed November 2022)

FDA. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009. https://www.fda.gov/media/77832/download Online (Accessed November 2022)

EMA. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-healthrelated-quality-life-hrql-measures-evaluation_en.pdf Online (Accessed November 2022)

EMA. Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies. 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-patient-reported-outcome-pro-measures-oncology-studies_en.pdf Online (Accessed November 2022)

Weldring T, Smith SMS. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-68. https://doi.org/10.4137/HSI.S11093PMID:25114561 DOI: https://doi.org/10.4137/HSI.S11093

EMA. Marketing Authorization. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation Online (Accessed November 2022)

EMA. European public assessment reports: background and context. https://www.ema.europa.eu/en/medicines/what-we-publish-when/european-public-assessment-reports-background-context Online (Accessed November 2022)

AIFA. Procedura di autorizzazione centralizzata. https://www.aifa.gov.it/procedura-di-autorizzazione-centralizzata Online (Accessed November 2022)

Ministero della Salute. Decreto 2 agosto 2019. Criteri e modalità con cui l'Agenzia italiana del farmaco determina, mediante negoziazione, i prezzi dei farmaci rimborsati dal Servizio sanitario nazionale. (20A03810). (GU Serie Generale n.185 del 24-07-2020) https://www.gazzettaufficiale.it/eli/id/2020/07/24/20A03810/sg Online (Accessed November 2022)

AIFA. Criteri per la valutazione dell’innovatività. Allegato 1. https://www.aifa.gov.it/documents/20142/241044/Allegato_1_1.pdf Online (Accessed November 2022)

AIFA. Valutazioni economiche. https://www.aifa.gov.it/web/guest/valutazioni-economiche Online (Accessed November 2022)

AIFA. Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale. 2019. https://www.aifa.gov.it/documents/20142/1283800/Linee_guida_dossier_domanda_rimborsabilita.pdf/8249e3d6-b2fc-915d-a211-02abafb8aa6d Online (Accessed November 2022)

AIFA. Melazzini M. Esiti riferiti dal paziente: fonte di dati preziosi per la valutazione dei medicinali. 2018. https://www.aifa.gov.it/en/-/esiti-riferiti-dal-paziente-fonte-di-dati-preziosi-per-la-valutazione-dei-medicinali Online (Accessed November 2022)

EMA. European Public Assessment Reports (EPAR). Table of all EPARs for human and veterinary medicines. https://www.ema.europa.eu/en/medicines/download-medicine-data#european-public-assessment-reports-(epar)-section Online (Accessed November 2022)

Gnanasakthy A, Barrett A, Evans E, D’Alessio D, Romano CD. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016). Value Health. 2019;22(2):203-209. https://doi.org/10.1016/j.jval.2018.09.2842 PMID:30711065 DOI: https://doi.org/10.1016/j.jval.2018.09.2842

AIFA. Elenchi Farmaci di Classe A e H AIFA (15-12-2021). https://www.aifa.gov.it/liste-farmaci-a-h Online (Accessed November 2022)

AIFA. Elenco Farmaci Innovativi (gennaio 2022). https://www.aifa.gov.it/farmaci-innovativi Online (Accessed November 2022)

AIFA. Storico Farmaci Innovativi (30-09-2021) https://www.aifa.gov.it/storico-farmaci-innovativi Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività DUPIXENT (gennaio 2018). https://www.aifa.gov.it/sites/default/files/DUPIXENT.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività ALUNBRIG (luglio 2020). https://www.aifa.gov.it/documents/20142/1308577/96_Alunbrig_15255_scheda_innovativita_GRADE.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività HEMLIBRA (giugno 2018). https://www.aifa.gov.it/sites/default/files/HEMLIBRA_v1.0.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività ZEJULA (gennaio 2018). https://www.aifa.gov.it/sites/default/files/ZEJULA_12934_v1.0.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività Poteligeo (aprile 2020). https://www.aifa.gov.it/documents/20142/1308577/98_Poteligeo_14935_scheda_innovativita_GRADE.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività KAFTRIO (gennaio 2021) https://www.aifa.gov.it/documents/20142/1540069/126_KAFTRIO_KALYDECO_genotipo_F_F_scheda_innovativita_GRADE.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività ONPATTRO (novembre 2018) https://www.aifa.gov.it/documents/20142/1184740/ONPATTRO_13833_INNOV._v.1.0.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività Waylivra (settembre 2020) https://www.aifa.gov.it/documents/20142/1504529/112_Waylivra_scheda_innovatività_GRADE.pdf Online (Accessed November 2022)

AIFA. Valutazione dell’innovatività Braftovi (maggio 2021) https://www.aifa.gov.it/documents/20142/1690663/5_Braftovi_scheda_innovativita-GRADE.pdf Online (Accessed November 2022)

EMA. Regulatory Science to 2025. https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-strategy#regulatory-science-strategy-to-2025-section Online (Accessed November 2022)