Amirah AzzerMaznah DahluiRosmawati MohamedScott Alexander McDonaldHafiz JaafarFatiha Hana Shabaruddin2024-06-162024-06-1620232024-1-29Amirah Azzeri, Maznah Dahlui, Rosmawati Mohamed McDonald SA,Hafiz Jaafar & Fatiha Hana Shabaruddin H (2023) Budget impact analysis of two treatment approaches for hepatitis C in Malaysia through the use of voluntary and compulsory licensing options. Front. Public Health 11:1114560. doi: 10.3389/fpubh.2023.11145602296-25652446-1510.3389/fpubh.2023.1114560https://oarep.usim.edu.my/handle/123456789/19809Front. Public Health Volume 11 Page (1-9)Introduction: A scaled-up treatment cascade with direct-acting antiviral (DAA therapy is necessary to achieve global WHO targets for hepatitis C virus (HCV) elimination in Malaysia. Recently, limited access to sofosbuvir/daclatasvir (SOF/DAC) is available through compulsory licensing, with access to sofosbuvir/velpatasvir (SOF/VEL) expected through voluntary licensing due to recent agreements. SOF/VEL has superior clinical outcomes but has higher drug acquisition costs compared to SOF/DAC. A stratified treatment cascade might be the most cost-e cient approach for Malaysia whereby all HCV patients are treated with SOF/DAC except for patients with cirrhosis who are treated with SOF/VEL. Methods: This study aimed to conduct a 5-year budget impact analysis of the proposed stratified treatment cascade for HCV treatment in Malaysia. A disease progression model that was developed based on model-predicted HCV epidemiology data was used for the analysis, where all HCV patients in scenario A were treated with SOF/DAC for all disease stages while in scenario B, SOF/DAC was used only for non-cirrhotic patients and SOF/VEL was used for the cirrhotic patients. Healthcare costs associated with DAA therapy and disease stage monitoring were included to estimate the downstream cost implications. Results: The stratified treatment cascade with 109 in Scenario B was found to be cost-saving compared to Scenario A. The cumulative savings for the stratified treatment cascade was USD 1.4 million over 5 years. Discussion: A stratified treatment cascade with SOF/VEL was expected to be cost-saving and can result in a budget impact reduction in overall healthcare expenditure in Malaysia.en-UShepatitis Cdirect acting antiviraleconomic burdenbudget impact analysisMalaysiatext::journal::journal article19111114560