Author(s)
Degli Espositi L1, Sangiorgi D2, Andretta M3, Bacca M4, Barbieri A5, Bartolini F6, Cavaliere A7, Chinellato A8, Ciaccia A9, Cillo MR10, Citraro R11, Costantini A12, De Francesco A11, Enieri N8, Ferrante F13, Gentile S14, Lavalle A14, Mancini D4, Mensurati M15, Moscogiuri R16, Pastorello M17, Procacci C18, Re D19, Santoleri F12, Serao Creazzola S20, Tegon M8, Ubertazzo L21, Vercellone A22, Perrone V23
1CliCon S.r.l. Health, Economics & Outcomes Research, Bologna, Italy, 2CliCon S.r.l. Health, Economics & Outcomes Research, Bologna, BO, Italy, 3Azienda ULSS 8 Berica, Vicenza, Italy, 4ASL Brindisi, Brindisi, Italy, 5ASL Vercelli, Vercelli, Italy, 6USL Umbria 2, Terni, Italy, 7ASL Viterbo, Viterbo, Italy, 8Azienda ULSS 3 Serenissima, Mestre (VE), Italy, 9ASL Foggia, Foggia, Italy, 10ASL Salerno, Salerno, Italy, 11Azienda ospedaliero-universitaria Mater Domini, Catanzaro, Italy, 12ASL Pescara, Pescara, Italy, 13ASL Frosinone, Frosinone, Italy, 14Direzione Generale per la Salute Regione Molise, Campobasso, Italy, 15ASL Roma 3, Roma, Italy, 16ASL Taranto, Taranto, Italy, 17ASP Palermo, Palermo, Italy, 18ASL BAT, Trani, Italy, 19ASL Teramo, Teramo, Italy, 20ASL Napoli 1, Napoli, Italy, 21ASL Roma 4, Civitavecchia (RM), Italy, 22ASL Napoli 3 SUD, Torre del Greco, Italy, 23CliCon S.r.l. Health, Economics & Outcomes Research, Ravenna, RA, Italy
OBJECTIVES: Cancer treatments represent one of the most expensive items for the National Health System. In a limited-resource system, the introduction of costly and innovative oncological therapies makes it necessary to balance the innovation and the access to treatments based on patient eligibility. The study aimed to evaluate the possibility of identifying metastatic colorectal cancer (mCRC) patients carrying BRAF-gene mutation, potentially eligible to targeted therapy, by linking administrative and pathological anatomy (PA) databases. METHODS: A retrospective study was conducted across 2013-2019 in a sample of Italian Entities, using the data-linkage between administrative and PA databases. Data were reported per million of health-assisted individuals. CRC and mCRC patients [diagnosed by at least one hospitalization for CRC or mCRC (ICD-9-CM codes 153-154 and 196-197-198, respectively)], were screened. Mutational status of mCRC patients was identified by BRAF genetic test (procedure codes: 91.30.3/91.36.5/91.29.3/91.29.4). Data-linkage of these data with those from the administrative databases allowed the identification of mCRC patients carrying BRAF mutation (BRAF+). RESULTS: Overall, 4,666 CRC patients were identified, with an incidence (2019) estimated of 0.7/1,000 of health-assisted individuals. Among them, mCRC accounted for the 39% (N=1,818) of patients. The 50% (N=915) of mCRC patients had an outpatient test for BRAF. After the data-linkage between administrative and PA databases, 83% (N=765) of them performed the BRAF test, and 107 patients (14% of patients with BRAF test reported) were BRAF+. CONCLUSIONS: These results reported an epidemiological scenario of CRC and mCRC-BRAF+ Italian patients in line with published data, showing that our methodology could be a supportive tool to identify eligible patients for targeted therapy. Furthermore, the use of PA database would allow to quantify patients with a specific genetic profile required to access to innovative therapies, thus enabling to estimate health-costs and to plan the pharmaceutical expenditure in a perspective of economic sustainability.
