Introducing standardized medical procedure and dynamic decision support program in precision oncology for the community of practice

Abstract

Background: While increasing number of diagnostic laboratories perform new generation sequencing on tumor DNA at a rapidly decreasing cost, beyond companion diagnostics, multi-gene panels are still underutilized due to lack of reimbursement and value based technical assessment. Besides financial reasons, prioritizing between diagnostic tests, multiple genetic alterations and multiple on-label or off-label targeted treatment options linked to these alterations can be a major challenge without having a reproducible, standardized and effective information service systemin hand that a molecular tumor board could safely rely on. Here, we present an easily clinically adaptable, dynamic treatment decision support program (Protocol), that makes tumor molecular profile-based oncology care feasible and potentially reimbursed by public insurance funds. Method(s): Our Protocol was developed based on 4868 cancer cases with 429 different histology, 2367 genes with 36492 variants. Our program utilizes multidisciplinary molecular tumor board (MTB) supported by Realtime Oncology Treatment CalculatorTM (Calculator) with the idea of integrating molecular and clinical data to provide genomics-driven treatment strategy plan. MTB mobilizes multiple sub-specialties for managing patients and tumor samples. The Calculator under constant upgrade is currently operating based on 24000 rules, 4000+ curated evidence, 101 registered and 618 targeted drugs under development. Result(s): This medical procedure (protocol) was endorsed by the Hungarian National Health Insurance Fund based on QUALY gain calculation and value-based technology assessment. Conclusion(s): It is crucial to have an established protocol in the community of practice to indicate effective and eliminate ineffective genomics-driven treatments based on molecular profiling. The technology assessment provided evidence that standardized decision support of the molecular tumor board (MTB) to select diagnostic tests and treatments can assure clinical utility and cost effectiveness of multigene testing (NGS).