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Utilization, reimbursement, and price trends for Hepatitis C virus medications in the US Medicaid programs: 2001-2021

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.

 

Comments:

Your study provides a comprehensive overview of the utilization, reimbursement, and price trends of HCV treatments in the US over a significant period. The transition from conventional therapy (CT) to Direct Acting Antiviral (DAA) agents is evident, with DAAs commanding higher reimbursements despite lower total utilization compared to CT.

The findings highlight a rapid increase in DAA utilization post their introduction, with sofosbuvir and ledipasvir/sofosbuvir dominating prescriptions and reimbursements in their respective years. However, the high average price per prescription for DAAs, notably sofosbuvir and ledipasvir/sofosbuvir, indicates their significant cost compared to CT medications like ribavirin and pegINF.

The market dynamics show a shift from CT to DAA agents, introducing competition among various DAAs. This shift is crucial in understanding the market landscape and the impact of new treatment guidelines and policies on prescription trends.

Despite the efficacy of DAAs in treating HCV, the study implies challenges in accessibility due to their high costs. The rise in HCV incidence despite curative treatments suggests barriers to accessing these expensive yet effective medications. It underscores the importance of evaluating policies and guidelines in ensuring broader access to these treatments.

Your study's focus on the interplay between market dynamics, treatment guidelines, and policy implications provides valuable insights for healthcare stakeholders, policymakers, and researchers in understanding the HCV treatment landscape and identifying areas for improving accessibility and affordability of these crucial medications.

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