Cost-Effectiveness of Pembrolizumab for Adjuvant Treatment of Patients With Renal-Cell Carcinoma Who Have Undergone Nephrectomy in Colombia

OBJECTIVES: In Colombia, the incidence of renal-cell carcinoma (RCC) is increasing, and nearly two-thirds of the cases are diagnosed without evidence of metastatic disease. The KEYNOTE-564 (KN564) trial demonstrated that pembrolizumab as adjuvant treatment significantly improved disease-free survival compared to placebo after nephrectomy among patients with RCC who were at intermediate-high or high risk of recurrence. This study aimed to evaluate the cost-effectiveness of pembrolizumab as an adjuvant treatment compared to routine surveillance in patients with RCC who have undergone nephrectomy and have intermediate-high risk, high risk of recurrence, or M1 no evidence of disease (NED). The evaluation was conducted from the perspective of a third-party payer.

METHODS: A Markov cohort model was developed, consisting of four mutually exclusive health states: disease-free, locoregional recurrence, distant metastasis, and death. This model was used to simulate the lifetime disease course of patients based on efficacy and safety data obtained from the KN564 trial. Health outcomes and costs were discounted at an annual rate of 3%. The time-on-treatment was estimated using observed Kaplan-Meier curves from the KN564 trial. Utility inputs were derived from the EuroQoL-5D questionnaire administered in both the KN564 and KEYNOTE-426 trials. Costs related to initial and subsequent therapies, disease and adverse events management, as well as terminal care, were estimated using publicly available drug and healthcare price lists.

RESULTS: Over a 41-year time horizon, patients who received pembrolizumab as adjuvant treatment accrued an additional 0.88 life-years (LYs) and 0.81 quality-adjusted life-years (QALYs) compared to those who underwent routine surveillance. The resulting incremental cost-effectiveness ratios (ICERs) were COP 26,488,299/LY and COP 28,783,889/QALY, which were significantly lower than the willingness-to-pay threshold of COP 85,093,272 (3 GDP) in Colombia.

CONCLUSIONS: From a third-party payer perspective, pembrolizumab as adjuvant treatment is cost-effective compared to routine surveillance for patients with RCC who have undergone nephrectomy.