Original Title: Pembrolizumab en carcinoma urotelial avanzado o metastásico

Authors' recommendations: Very low-quality evidence does not allow us to draw conclusions about the effectiveness/safety of pembrolizumab as the first therapeutic choice for patients with advanced or metastatic urothelial carcinoma who are not eligible for a platinum-based chemotherapy regimen. High-quality evidence shows that pembrolizumab as second line therapy for patients with advanced or metastatic urothelial carcinoma who experienced disease progression after chemotherapy, has a significant net benefit because it showed improvement in overall survival at long-term, with fewer adverse effects, when compared with chemotherapy. Additionally, it has been documented that patients who received pembrolizumab experienced longer periods of quality of life impairment, although results might be marginal. All the clinical practice guidelines analyzed consider pembrolizumab as first line therapy for patients with advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy or as second line therapy when disease has progressed after chemotherapy. This is due to the benefits achieved in overall survival for both settings. Regarding the coverage policies analyzed in Latin America, none of the countries mentions using pembrolizumab for these patients, except for Mexico, which covers it for patients with advanced urothelial carcinoma as second line therapy. In Argentina, it is not covered by the Mandatory Medical plan, and it is not reimbursed by the Unique Reimbursement System of the Superintendence of Health Services either. Among the United States private health funders, only Aetna covers pembrolizumab as first and second line therapy, both for patients who are not eligible for platinum-based chemotherapy, as well as for those who experienced disease progression after chemotherapy, respectively. Among the high-income countries surveyed Germany, Austria, France and Canada cover pembrolizumab as second line therapy, while Germany covers it as first line therapy for patients who are ineligible for chemotherapy. Regarding cost-effectiveness, pembrolizumab was cost-effective as the second line for the two indications mentioned in this report for high-income countries such as the United States and Sweden. For Argentina, its cost-effectiveness is uncertain since no studies have been found in the country as a second line. Cost-effectiveness could not be determined as the first therapeutic choice since the evidence was considered to be of very low quality.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iecs.org.ar/publicacion/?id=23028

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: <p>Institute for Clinical Effectiveness and Health Policy (IECS)</p>