Immunotherapy with check-point inhibitors (CPI) in adult malignancies: a protocol for the systematic review of the quality of economic analyses.

backgroundImmuno-oncology, and in particular, check-point inhibitors (CPIs), have led to a paradigm shift in the field of cancer care. The cost of new drug development is high, and many novel agents in oncology are significantly more expensive than older agents. Therefore, healthcare funders have factored measures of cost-effectiveness into decisions concerning drug reimbursement and incorporation of new agents into treatment algorithms. The methodology of cost-effectiveness evaluations, however, is less rigorously applied than those evaluating clinical efficacy and safety data. Thus, in spite of many regulatory bodies having approved CPIs based on existing economic analyses, to date, there has not been a systematic evaluation of the quality of health economic studies conducted on this new class of agents. Therefore, we propose to systematically review the methodologic and reporting quality of cost-effectiveness and cost-utility studies assessing CPIs to alternate established therapies, other immuno-oncology regimens, or placebo, in adults with malignancies. METHODS/

designThe systematic review will include all published economic evaluations of CPIs compared with at least one other treatment in adult patients with solid or hematologic malignancies. A search will be performed to identify relevant studies in Ovid MEDLINE, EMBASE, Cost-effectiveness Analysis Registry, Evidence-Based Medicine Reviews, and the NIHR-HTA database. The titles and abstracts of all identified studies will be independently reviewed by two reviewers, who will then assess the full text of all articles deemed to meet eligibility criteria. Assessed articles will be screened for compliance with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) criteria. The association, with CHEERS criteria, of the journal impact factor, publication year, funding source, tumor site, trial or model-based study, and CPIs studied, will then be assessed. DISCUSSION: The systematic review will aim to provide an overview of the quality of economic analyses evaluating CPIs for the treatment of malignancies in adult patients. Any systemic or recurrent deficiencies in methodological or reporting quality will be described and used to inform recommendations for improved reporting of economic analyses. SYSTEMATIC REVIEW REGISTRATION: This review will not be registered with PROSPERO, it does not meet the eligibility criterion of addressing an outcome of the direct patient or clinical relevance.