Drug Evaluation Committee Cost-Effectiveness Analysis Using Patient-Level Models
December 2019
In FY2019, the DS Subcommittee’s Continuing T5 group is working to summarize the key points of the Technical Support Documents (TSD) issued by the UK’s NICE Decision Support Unit and to provide detailed information on statistical methods.
Starting in April of this year, a cost-effectiveness evaluation system was institutionalized to complement the existing drug pricing standards system.Eligible products are designated at the same time new drugs are covered by insurance. Under this system, companies conduct their own analyses following pre-analysis consultations regarding analytical methods and other matters; a specialized cost-effectiveness evaluation organization then performs a comprehensive evaluation; and adjustments are made to the utility-based surcharge portion of the drug price based on the Incremental Cost-Effectiveness Ratio (ICER).The ICER obtained through cost-effectiveness analysis is calculated by dividing the increase in public healthcare costs resulting from the new drug treatment compared to the control treatment by the difference in quality-adjusted life years (QALYs), which serves as an indicator of utility.Economic models are used to estimate healthcare costs and QALYs; these include population-level models—such as Markov models and decision-tree models—and patient-level models, which simulate each individual patient in the target population and then aggregate the results.Compared to population-level models, there are few Japanese-language explanations dealing with patient-level models. Based on Technical Support Document 15, “COST-EFFECTIVENESS MODELLING USING PATIENT-LEVEL SIMULATION,” (2014), we will introduce what patient-level models entail, including their implementation using SAS (a port of the Excel/R models from TSD 15).We hope this will serve as a useful reference for readers interested in patient-level models. Please note that any references to or citations of TSD 15 in this report represent the interpretations of this Task Force, and NICE bears no responsibility whatsoever.Furthermore, this report does not cover the entirety of TSD 15; rather, it presents selected excerpts. In presenting these excerpts, the task force has provided additional interpretations and created and presented SAS programs. Please note that these are the task force’s own findings and do not represent the views of NICE.