Original Title: Pembrolizumab para el tratamiento de melanoma en adultos

Authors' recommendations: Moderate-quality evidence shows that pembrolizumab as adjuvant therapy in patients with resectable stage IIB –IIC melanoma may probably yield a higher net benefit because it improves progression-free survival when compared to placebo, nivolumab, ipilimumab, chemotherapy, dabrafenib with trametinib and interferon-alpha. On the other hand, high-quality evidence shows that pembrolizumab in patients with unresectable stage III//IV melanoma yields a higher net benefit because it increases overall survival when compared with ipilimumab. However, moderate-quality evidence shows that pembrolizumab, for that population, probably yields a higher net benefit because it reduces the estimated mortality at 1 year when compared with chemotherapy. In addition, low-quality evidence suggests that pembrolizumab would not yield any benefit, since it might not reduce estimated 1-year mortality when compared with nivolumab or nivolumab plus ipilimumab. Very low-quality evidence does not allow to draw conclusions on the effectiveness/safety of pembrolizumab in patients with disease progression after failure with anti-PD-1 therapy or in neoadjuvant setting in patients with high-risk stage IIIB and IV melanoma. Regarding cost-effectiveness, studies conducted in our country proved that pembrolizumab as adjuvant therapy after complete resection of melanoma with lymph node involvement is costeffective when compared to placebo, even in all the subgroups of disease stages assessed. In contrast, in metastatic unresectable melanoma, cost-effectiveness was not favorable when compared with chemotherapy. The budget impact analysis showed a high increase in costs when including pembrolizumab versus nivolumab as single or combination therapy and ipilimumab. In most of the clinical practice guidelines analyzed, the efficacy of pembrolizumab as first-line therapy in patients with resected or advanced melanoma is highlighted. Regarding coverage policies in Latin-American countries, only Mexico, Uruguay and Brazil mention pembrolizumab coverage for patients with unresectable melanoma, whereas most high-income countries mention it is covered for metastatic melanoma and as first line therapy for resectable melanoma.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iecs.org.ar/publicacion/?id=22853

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>