Introduction The combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies.This study protocol of a systematic review is aimed to describe available literature evidences about BSS Hats the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysis A systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines.PubMed and Embase will be queried from June 2010 to June 2021.The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit.
The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and dissemination This systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice.This research is 5 HTP exempt from ethics approval because the work is carried out on published documents.We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration number CRD42020201549.