Warren Emma, Castles Belinda J C, Sharratt Gillian C, Arteaga Aitor
HERA Consulting Australia Pty Ltd., Balmain, Sydney, NSW, Australia.
AbbVie PTY LTD., Mascot, Sydney, NSW, Australia.
Infect Dis Ther. 2024 Mar;13(3):549-564. doi: 10.1007/s40121-024-00926-1. Epub 2024 Mar 1.
The first direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection were reimbursed via Australia's Pharmaceutical Benefits Scheme (PBS) in March 2016. This was based on the recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) that the regimens would be acceptably cost-effective at an incremental cost-effectiveness ratio (ICER) no greater than $15,000/quality-adjusted life-year (QALY). Since the initial PBS listings for DAA therapies and subsequent listings of newer DAA treatments such as glecaprevir/pibrentasvir (Maviret), the demographics and some of the disease characteristics of currently treated patients have markedly changed. This analysis aims to reassess the cost-effectiveness of glecaprevir/pibrentasvir, accounting for the changes to the HCV population currently seeking treatment and incorporating retreatment in first-line failures and the treatment of new infections in previously treated individuals.
To assess the cost-effectiveness 7 years after initial listing of DAAs, an update was made to the Markov model used to achieve PBS reimbursement for Viekira-Pak in May 2016. Amendments to the Viekira-Pak model include: changes to baseline age and fibrosis distribution of treated patients, and inclusion of retreatment of first-line failures [those not achieving a sustained virologic response (SVR12)] and reinfected individuals. Treatment-related inputs including SVR12 response rates, adverse events, treatment-related disutility, and discontinuations were sourced from pivotal glecaprevir/pibrentasvir clinical trials.
Using the published price of glecaprevir/pibrentasvir, the ICER is below $15,000/QALY.
Despite changes in demographics and disease characteristics of treated patients, and changes to the model structure to reflect retreatment in clinical practice in Australia, DAAs remain cost-effective in 2023.
2016年3月，澳大利亚药品福利计划（PBS）开始报销首批用于慢性丙型肝炎病毒（HCV）感染的直接抗病毒（DAA）疗法。这是基于药品福利咨询委员会（PBAC）的建议，即这些治疗方案的成本效益在增量成本效益比（ICER）不超过15,000澳元/质量调整生命年（QALY）时是可以接受的。自DAA疗法最初被列入PBS清单以及随后更新的DAA治疗药物（如glecaprevir/pibrentasvir，商品名Maviret）被列入清单以来，目前接受治疗患者的人口统计学特征和一些疾病特征发生了显著变化。本分析旨在重新评估glecaprevir/pibrentasvir的成本效益，考虑到目前寻求治疗的HCV患者群体的变化，并纳入一线治疗失败后的再治疗以及既往治疗个体中新感染的治疗情况。
为评估DAA首次上市7年后的成本效益，对2016年5月用于使Viekira - Pak获得PBS报销的马尔可夫模型进行了更新。对Viekira - Pak模型的修订包括：改变接受治疗患者的基线年龄和纤维化分布，纳入一线治疗失败患者（未实现持续病毒学应答[SVR12]的患者）和再感染个体的再治疗情况。与治疗相关的输入数据，包括SVR12应答率、不良事件、治疗相关的效用降低和停药情况，均来自glecaprevir/pibrentasvir的关键临床试验。
按照glecaprevir/pibrentasvir的公布价格，ICER低于15,000澳元/QALY。
尽管接受治疗患者的人口统计学特征和疾病特征发生了变化，且模型结构也进行了调整以反映澳大利亚临床实践中的再治疗情况，但在2023年DAA疗法仍然具有成本效益。
