Cost‐effectiveness of precision diagnostic testing for precision medicine approaches against non‐small‐cell lung cancer: A systematic review

Abstract

Precision diagnostic testing (PDT) employs appropriate biomarkers to identify cancer patients that may optimally respond to precision medicine (PM) approaches, such as treatments with targeted agents and immuno‐oncology drugs. To date, there are no published systematic appraisals evaluating the cost‐effectiveness of PDT in non‐small‐cell lung cancer (NSCLC). To address this gap, we conducted Preferred Reporting Items for Systematic Reviews and Meta‐Analyses searches for the years 2009–2019. Consolidated Health Economic Evaluation Reporting Standards were employed to screen, assess and extract data. Employing base costs, life years gained or quality‐adjusted life years, as well as willingness‐to‐pay (WTP) threshold for each country, net monetary benefit was calculated to determine cost‐effectiveness of each intervention. Thirty‐seven studies (50%) were included for analysis; a further 37 (50%) were excluded, having failed population‐, intervention‐, comparator‐, outcomes‐ and study‐design criteria. Within the 37 studies included, we defined 64 scenarios. Eleven scenarios compared PDT‐guided PM with non‐guided therapy [epidermal growth factor receptor ( EGFR ), n = 5; programmed death‐ligand 1 (PD‐L1), n = 6]. Twenty‐eight scenarios compared PDT‐guided PM with chemotherapy alone (anaplastic lymphoma kinase, n = 3; EGFR , n = 17; PD‐L1, n = 8). Twenty‐five scenarios compared PDT‐guided PM with chemotherapy alone, while varying the PDT approach. Thirty‐four scenarios (53%) were cost‐effective, 28 (44%) were not cost‐effective, and two were marginal, dependent on their country’s WTP threshold. When PDT‐guided therapy was compared with a therapy‐for‐all patients approach, all scenarios (100%) proved cost‐effective. Seven of 37 studies had been structured appropriately to assess PDT‐PM cost‐effectiveness. Within these seven studies, all evaluated scenarios were cost‐effective. However, 81% of studies had been poorly designed. Our systematic analysis implies that more robust health economic evaluation could help identify additional approaches towards PDT cost‐effectiveness, underpinning value‐based care and enhanced outcomes for patients with NSCLC.

European Groundshot—addressing Europe's cancer research challenges: a Lancet Oncology Commission

“…Our recent health economic analyses have underlined the potential for cancer biomarkers to deliver value for money. [24][25][26] However, we also found a paucity of studies employing detailed health economic analysis to inform the feasibility of incorporating cancer biomarkers/genomic testing into the clinic, highlighting the need for wider deployment of health economic evaluation to inform value-based care. Precision diagnostics can also help target interventions to the most significant areas of disease.…”

Delivering the precision oncology paradigm: reduced R&D costs and greater return on investment through a companion diagnostic informed precision oncology medicines approach

“…In seeking to reduce R&D costs through earlier patient stratification by a CDx approach, pharmaceutical companies can better manage their oncology pipelines, improve timing of phase transitions into, ultimately, marketing authorizations for CDx-oncology medicines that deliver clinically meaningful benefit, in what is becoming a complex regulatory and competitive environment. Precision medicine has been hailed as a potential breakthrough for cancer patients and a disruptive technology which will potentially lower healthcare costs [ 3 , 5 ], but studies that deploy health economic analysis to determine the value of a precision medicine approach have been scarce [ 6 , 7 ]. Reducing R&D cost is not just beneficial for industry, but also provides a better environment for fair pricing and reimbursement on a country-by-country basis.…”

State legislative trends related to biomarker testing

“…[18][19][20] In the 2020 American Cancer Society Cancer Action Network survey, 29% of patients who discussed treatment plans with their providers decided to forgo biomarker testing because of its cost. 21 Finally, although biomarker testing for cancer targeted therapy for metastatic colorectal cancer and metastatic non-small cell lung cancer is mostly cost-effective, 22,23 a recent study showed that use of upfront NGS testing in patients with metastatic non-small cell lung cancer was associated with substantial cost savings and shorter time-to-test results in comparison with sequential testing of single analytes for both the Centers for Medicare & Medicaid Services (CMS) and commercial payers. 24 Studies show that currently only half of patients with cancer in the United States for whom biomarker testing is recommended are receiving the tests.…”