Abstract

We aimed to assess which new treatments for advanced melanoma (AM) are adopted by the Brazilian Private Health Care Sector (PHCS) and describe the profile of patients receiving those therapies. Anonymized, clinical data were retrieved on patients treated for AM during 2016, from a proprietary database of claims (Auditron® - Evidências-Kantar Health) encompassing 20% of people covered by PHCS in Brazil. Evaluated drugs had at least ten months of registry in the National Agency of Sanitary Vigilance (ANVISA): vemurafenib, nivolumab, ipilimumab, dabrafenib, trametinib and cobimetinib. Volume of disease was defined as high (visceral or bone lesions, > one site) or low (single visceral lesion or soft tissue lesions only). Eighty-four patients were included for analysis. Ipilimumab was prescribed for 62% of cases (35% in 1st line; 54% 2nd line and 11% 3rd plus lines). Half these patients had high volume of disease (HVD) and 9.5% had controlled lesions in central nervous system (CNS). Ipilimumab was preceded by 1st line chemotherapy in 92% of cases. Vemurafenib was the second most prescribed new drug (24%) with 50% in 1st line; 35% in 2nd line and 15% in 3rd plus lines. Among these patients, 65% had HVD and 10% had controlled CNS lesions. BRAF status was informed for only 50% of cases. Finally, 13% of patients received nivolumab (73% in 1st line and 27% 2nd line); all had HVD. We retrieved one prescription of cobimetinib for 2nd line in a BRAF+ patient progressing after vemurafenib. No prescriptions for dabrafenib or trametinib were retrieved. Older therapies, like ipilimumab and vemurafenib are already adopted to treat advanced melanoma in clinical practice in Brazil. Prescriptions for more recently approved therapies remain scarce maybe because some are oral medications still unlisted in the regulatory organs’ directory or because they have very specific indications.

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