OBJECTIVES : Programmed Death-1 (PD-1) and Programmed Death Ligand-1 (PDL-1) inhibitors are a group of immune-checkpoint inhibitors that have proved to be beneficial for several tumor types by blocking the negative regulation of T-cell-mediated immune response by PD-1/PDL-1. The PD-1/PDL-1 inhibitors market is expected to grow at a rate of 23.4% during 2017-2025. This study aimed to review the NICE decisions and understand the challenges associated with the reimbursement of PD-1/PDL-1 inhibitors in the UK.

METHODS : NICE website was searched for the available appraisals of PD-1/PDL-1 agents for different oncology indications.

RESULTS : Ninety-six appraisals for PD-1 (nivolumab, pembrolizumab, and cemiplimab) and PDL-1 inhibitors (atezolizumab, avelumab, and durvalumab) were identified, of which 25 were published, 48 in-progress, 22 suspended, and 1 terminated. The number of NICE submissions for PD-1/PDL-1 inhibitors has witnessed a steep increase since 2016. The majority of submissions were in Non-Small-Cell Lung Cancer (n=22) followed by melanoma (n=10). Out of 25 published recommendations, 23 were positive while two were negative decisions. Interestingly, all except one positive recommendation were within the framework of restricted criteria with nine being reimbursed through Patient Access Schemes or commercial access agreements and 13 through Cancer Drugs Fund while further data are collected. Though rejection on clinical and cost-effectiveness was uncommon, the two negative recommendations were due to high uncertainties in the clinical or cost-effectiveness estimates which were not feasible to be resolved with evidence from the ongoing trials.

CONCLUSIONS : NICE recognises the unmet need in various cancer types despite the non-availability of long-term data for PD-1/PDL-1 inhibitors which is responsible for highly uncertain clinical and cost-effectiveness estimates of these therapies. As a result, majority of these therapies are reimbursed through Cancer Drugs Fund thus, necessitating the need of long-term follow-up data for full reimbursement of PD-1/PDL-1 inhibitors in the UK.