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Updated: Jul 7, 2025
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Utilization, reimbursement, and price trends for Hepatitis C virus medications in the US Medicaid programs: 2001-2021
Musaab H Gari1, Abdulrahman Alsuhibani1,2, Amin Alashgar1,2
1James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA.
Insights
Direct Acting Antiviral (DAA) agents for Hepatitis C Virus (HCV) treatments generated higher reimbursements than conventional therapy, despite high prices. Treatment guidelines and policies significantly influenced these trends, impacting accessibility.
Area of Science:
- Hepatology
- Pharmacoeconomics
- Public Health
Background:
- Hepatitis C Virus (HCV) remains a global health challenge with increasing incidence.
- Direct Acting Antiviral (DAA) agents offer a cure but face utilization and accessibility issues.
Purpose of the Study:
- To analyze the utilization, reimbursement, and price trends of HCV treatments in the US from 2001-2021.
- To evaluate the impact of treatment guidelines and policies on HCV drug trends.
Main Methods:
- Retrospective drug utilization study using outpatient pharmacy data (2001-2021).
- Analysis of prescription numbers, reimbursements, and prices for conventional therapy (CT) and DAA agents.
- Evaluation of HCV treatment guidelines, policies, and legislation over time.
Main Results:
- DAA agents generated significantly higher reimbursements ($19.45 billion) than CT ($4.1 billion) despite lower total utilization.
- DAA agents, such as sofosbuvir and ledipasvir/sofosbuvir, had high average prescription prices ($24,992 and $22,787, respectively).
- DAA agents replaced CT, leading to market competition, but high prices persist.
Conclusions:
- High DAA agent prices may contribute to accessibility issues, evidenced by increasing HCV incidence.
- Treatment guidelines and policies are critical factors influencing HCV treatment trends and accessibility.
- Further research into cost-effective strategies for DAA agent accessibility is warranted.
Background:
Hepatitis C Virus (HCV) remains a challenging health problem worldwide, with increasing incidence despite being curable with Direct Acting Antiviral (DAA) agents.
Objective:
This study aimed to describe the utilization, reimbursement, and price trends of HCV treatments and evaluate the influence of treatment guidelines and policies.
Methods:
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.
Results:
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.
Conclusion:
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.
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