Gari Musaab H, Alsuhibani Abdulrahman, Alashgar Amin, Guo Jeff J
James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA.
Department of Pharmacy Practice, Unaizah College of Pharmacy, Qassim University, Saudi Arabia.
Explor Res Clin Soc Pharm. 2023 Nov 28;12:100383. doi: 10.1016/j.rcsop.2023.100383. eCollection 2023 Dec.
Hepatitis C Virus (HCV) remains a challenging health problem worldwide, with increasing incidence despite being curable with Direct Acting Antiviral (DAA) agents.
This study aimed to describe the utilization, reimbursement, and price trends of HCV treatments and evaluate the influence of treatment guidelines and policies.
A retrospective, descriptive drug utilization study conducted using the outpatient pharmacy data extracted from the Centers for Medicaid and Medicare Services State Drug Utilization Data between 2001 and 2021. All HCV treatments approved in the US were included, conventional therapy (CT), and DAA agents. The annual secular trends were calculated for each medication's total number of prescriptions, reimbursements, and prices. The average reimbursement per prescription was calculated and utilized as a proxy of prices. The HCV treatment guideline and policies and legislation were evaluated overtime to measure the impact on the trends.
Despite CT having a higher total utilization, DAA agents commanded significantly greater reimbursements, with 4.1 billion USD for CT and 19.45 billion USD for DAA agents. CT utilization increased rapidly and dominated the market until 2011, peaking at 379,696 prescriptions in 2003 but declining afterward. DAA agents' utilization increased rapidly in their first year: i.e., sofosbuvir reached 50,377 prescriptions with 1.3 billion USD in 2014, while ledipasvir/sofosbuvir reached 79,387 prescriptions with 2 billion USD in 2015. The average price per prescription was high for the DAA agents, like 24,992 USD for sofosbuvir and 22,787 USD for ledipasvir/sofosbuvir, compared to CT medications ribavirin, around 500 USD, and pegINF, around 3000 USD. The new DAA agents replaced CT, and initiating market competition among DAA agents.
The introduction of multiple DAA agents slightly changed their prescription prices but remained high during the study period. The recent increase in HCV incidence cases indicates accessibility issues for costly and effective DAA agents, with treatment guidelines and policies playing a critical role in shaping these trends.
丙型肝炎病毒（HCV）在全球范围内仍是一个具有挑战性的健康问题，尽管直接抗病毒药物（DAA）可治愈丙型肝炎，但发病率仍在上升。
本研究旨在描述HCV治疗的使用情况、报销情况和价格趋势，并评估治疗指南和政策的影响。
使用从医疗补助和医疗照顾服务中心（Centers for Medicaid and Medicare Services）的州药物使用数据中提取的门诊药房数据，进行了一项回顾性描述性药物使用研究，研究时间为2001年至2021年。纳入了美国批准的所有HCV治疗药物，包括传统疗法（CT）和DAA药物。计算了每种药物的处方总数、报销金额和价格的年度长期趋势。计算了每张处方的平均报销金额，并将其用作价格的代理指标。对HCV治疗指南、政策和立法进行了长期评估，以衡量其对趋势的影响。
尽管CT的总使用量较高，但DAA药物的报销金额显著更高，CT为41亿美元，DAA药物为194.5亿美元。CT的使用量迅速增加，并在2011年之前主导市场，2003年达到379,696张处方的峰值，但随后下降。DAA药物在上市的第一年使用量迅速增加：例如，索磷布韦在2014年达到50,377张处方，报销金额为13亿美元，而来迪派韦/索磷布韦在2015年达到79,387张处方，报销金额为20亿美元。与CT药物利巴韦林（约500美元）和聚乙二醇干扰素（约3000美元）相比，DAA药物的每张处方平均价格较高，如索磷布韦为24,992美元，来迪派韦/索磷布韦为22,787美元。新型DAA药物取代了CT，并引发了DAA药物之间的市场竞争。
多种DAA药物的推出略微改变了它们的处方价格，但在研究期间价格仍然很高。最近HCV发病率的上升表明，昂贵且有效的DAA药物存在可及性问题，治疗指南和政策在塑造这些趋势方面发挥了关键作用。
