Health economic outcomes of a minimal monitoring approach to providing HCV therapy

Abstract

Background: The ACTG A5360 trial demonstrated that HCV treatment without planned on-treatment monitoring is safe and effective. We report the health economic outcomes of MINMON.

Methods: A5360 was a 5-country, single-arm trial providing sofosbuvir/velpatasvir to people with HCV infection with no planned clinic visits between treatment initiation and week 24 sustained virologic response (SVR) evaluation. Trial records included planned/and most unplanned lab tests and visits. Participants completed a 4-week recall questionnaire at weeks 0, 24, 48, and 72 reporting hospital nights, emergency department visits, and ambulatory visits. We tabulated consumption and multiplied units of consumption by country-specific cost. We report the cost and cost per SVR of MINMON (2020 US$) from program and health sector perspectives. Sensitivity analyses compared MINMON costs to the standard of care (SoC). We consulted in-country experts to develop country-specific SoC treatment protocols and used micro-costing to estimate their costs. We compare the cost/SVR in MINMON with that of the simulated SoC, varying the expected SVR with the SoC.

Results: MINMON cost/SVR (program perspective) varied by country from $1692/SVR (Thailand) to $27,632/SVR (United States). The cost/SVR (health sector perspective) ranged from $6273/SVR (South Africa) to $123,974/SVR (United States) MINMON had a lower cost/SVR than SoC across broad assumptions about SVR proportions, especially in low- and middle-income countries. In the United States-, MINMON had an appealing cost per cure compared to the SoC, unless retention on treatment fell below the SoC.

Conclusions: MINMON is a cost-saving strategy for HCV treatment, particularly in low- and middle-income country settings.

Keywords: HCV therapy; health care economics; hepatitis C virus.

FIGURE 1

The figure visualizes the relative savings, on a cost per cure basis, of MINMON compared to the standard of care. Upward bars represent cost savings for MINMON versus standard of care. Downward bars represent MINMON having a higher cost per cure obtained. Each bar represents a different country. The legend includes the empirically observed MINMON SVR rate and 95% CI for each country. Each cluster of bars represents a different assumption about the cure rate in the standard of care. Generally, outside of the United States, MINMON had a lower cost per cure than the standard of care across all assumptions about cure rates. In the United States, where lab and visit costs make up a smaller proportion of treatment costs, poor cure rates can lead to situations in which the MINMON protocol has paradoxically higher cost per cure than standard of care.