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Original Articles

Analisi dei Registri AIFA nell’era dei Big Data:

l’esperienza dell’AOU Ospedali Riuniti di Foggia

DOI 10.23753/htafocus2019.01.005

Raffaele Petti, Vittorio Renzone


Introduction The availability of Big Data into the health world can provide many benefits in terms of clinical, regulatory and economic evaluations. In particular, the Drug Registries created by The Italian Agency of Medicines (AIFA) to monitoring innovative high cost therapies represent the most advanced instrument for the evaluation of the required prescriber for reimbursement.

The study aimed to carry out an in-depth analysis to select irregular individual patient records and to close them with the objective to recover economic resources.

Material and Methods The in-depth software AIFA-Extractor to analyze Drug Registries data was developed to monitoring the patient records and looking for the information from the AIFA's portal. The monitoring process lasted 12 months with monthly surveys starting on 2017, March 8th to 2018, March 1st. 

Results The first survey showed that only 40.06% of the total number of patient records in the system was correctly closed. The irregular patient records were notified to the prescribers and a progressive reduction of them was obtained to reach in one year the value of 69.53% of patients records correctly closed (from 1,198 in March 2017 to 2,471 in March 2018; +106%). Otherwise, the percentage of records closed correctly on the total number of patient records increased of 25.71%, thanks to the identification and regularization of a total of 975 irregular patient records in one year. The economic analysis focused on Hepatitis C treatments characterized by reimbursement with Industry payback (equal to 6% of the regular cards) highlighted the chance to obtain the reimbursement of € 556,702.83.

Conclusion The process of closing irregular patient records through a data extraction and analysis software has allowed to improve the quality and robustness of the data present on the AIFA Register platform and to proceed with the specific application of the Managed entry agreement (MEA), as well as to the recovery of important economic and financial resources for the National Health System.

Key words: AIFA Registries, data extraction software, patient records, Hepatitis C treatment, payback reimbursement

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