Recent clinical trials have shown that immune checkpoint inhibitors are active against several neoplasms, including lung cancer. Tumor PD-L1 receptor expression is being studied as a predictive biomarker. The objective of our study is to assess the cost-effectiveness and economical impact of nivolumab and pembrolizumab with or without the use of PD-L1 as a biomarker.
We developed a decision-analytic model to determine the cost-effectiveness of PD-L1 assessment and second-line treatment with NIVO or PEMBRO versus docetaxel. The model used outcomes data from randomized clinical trials and drug acquisition costs from the United States. We also included the costs of adverse events and post-progression therapies. Published utility values were used. Health effects were expressed as quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) were calculated. Thereafter, we used US and Brazilian epidemiologic data to estimate the economical impact of the treatment with or without the use of PD-L1 as a biomarker.
We included 3 RCTs (2 with NIVO and 1 with PEMBRO). Among all patients with squamous histology, the incremental QALY of NIVO was 0.23. The ICER was US$ 128 K. PD-L1 expression improved incremental QALY only for patients with PD-L1 > 5% and > 10% (by 15% and 18% respectively). Among all patients with non-squamous histology, the incremental QALY of NIVO was 0.12. The ICER was US$ 121 K. PD-L1 expression improved incremental QALY for patients with PD-L1 > 1%, > 5% and > 10% (by 67%, 157% and 137%, respectively). All patients treated with PEMBRO had at least 1% of PD-L1 expression; the incremental QALY was 0.13. The ICER was US$ 116 K. PD-L1 expression above 50% improved QALY by 18%. The estimated cost of treating all American patients with NIVO in the second-line was $ 1.57 billion yearly. The estimate of expenses treating only patients with PD-L1 > 1% with PEMBRO was $ 0.97 billion yearly. In Brazilian, these values were $ 251 million and $ 155 million, respectively.
The use of PD-L1 expression as a biomarker increases cost-effectiveness and decreases the economical treatment burden with immune checkpoint inhibitors.
Clinical trial identification
Legal entity responsible for the study
Universidade Federal de São Paulo
All authors have declared no conflicts of interest.