P2 Estimation of Metastatic Colorectal Cancer Patients Carrying BRAF Mutation Potentially Eligible to Targeted Therapy: A Real-World Evidence Study in Italy


      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.


      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+).


      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+.


      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.