Specialty Pharmacy and Specialty Clinic Collaboration in Treatment of Hepatitis C
Jacob Lenzmeier, PharmD, CentraCare Health-Saint Cloud
Background: An estimated 2.7 to 3.9 million people in the United States are living with chronic Hepatitis C virus (HCV) infection, per the Center for Disease Control and Prevention, many of whom are asymptomatic and unaware. Additionally, HCV is the leading cause of liver transplant and liver cancer in the United States. FDA approval of various second generation direct-acting antivirals (DAAs) for the treatment of HCV and their incorporation into current infectious disease and hepatic disease guidelines have changed the landscape of treating this disease. Minimal toxicities and high rates of achieved sustained virologic responses (SVRs) make this class of agents optimal for clinical use. Pharmacists, as one of the most accessible healthcare professionals, have a great opportunity to identify patients for screening. Furthermore, pharmacists can help navigate prescription coverage issues, drug-drug interactions, and offer close monitoring of patients who are subsequently treated for HCV.
Methods: A recent descriptive, retrospective study analyzed 364 patients in a single-center hepatology clinic who used the therapy management program at a local specialty pharmacy (LSP) and assessed the time to therapy (TtT) and rates of achieved SVRs. The definition of TtT is the number of days between the initial prescribing of the DAA and when the patient took his/her first dose. The review also evaluated the effects of the LSP’s financial assistance intervention on the out-of-pocket costs to the patients filling at the LSP. In this model, the LSP obtained a thorough medication history from the patient and developed a plan for managing pharmacist identified drug-interactions with the prescribed DAA, prior to initiating the medication. The LSP managed the prior authorization process and appeals as well as explored other financial assistance programs available for patients with copays greater than $20. Additionally, they recorded the start date of the medications, called with refill reminders seven days prior to the due date, and screened for adverse effects monthly while the patient was on the therapy. If any concerning adverse effects were identified, the LSP contacted the hepatology clinic to determine the appropriate course of action. Lastly, the LSP verified when a full treatment course was completed and helped determine when viral loads should be obtained. As dictated by insurance requirements, some patients were required to fill their DAAs outside of this LSP and copay assistance was not performed for these patients.
Outcomes: Using intention-to-treat analysis, the rates of SVR among all patients was 86.8%. However, 27 (7.4%) patients did not complete a full course of therapy; 15 of whom were lost to follow up and 12 of whom died prior to completion. Excluding the patients who did not complete a full course of DAA therapy, the rates of achieved SVR increased to 93.8%. The average TtT was 12 ± 18 days with a maximum of 86 days. Among the subgroup whose prior authorizations were approved upon first submission, the average TtT was seven days. Copay assistance was conducted by the LSP for 42.8% of patients. Among this group, 95.5% were able to reach a copay of $5 or less after the pharmacy intervention.
Discussion: The results of this study showed comparable rates of achieved SVR to DAA clinical trials data among a “real-world” patient population in a hepatology clinic. However, this study decreased TtT significantly from prior reviews where average TtT ranged from 18 to 31 days. Prior studies had varying rates of pharmacy intervention, some of which had none at all. Therefore, this study demonstrates that collaborating with a specialty pharmacy can impact the clinical outcomes of patients with HCV infection by achieving high rates of SVR with decreased TtT. Secondarily, this study was able to quantify the effects of copay assistance among patients who were able to use this benefit. Analyzing the outcomes of copay assistance is unique to this study as compared to prior reviews. Further analysis would be warranted in terms of a similar program based out of a primary care clinic setting as well as the impact a non-specialty pharmacy team could make on these outcomes.
Centers for Disease Control and Prevention. Hepatitis C FAQs for health professionals. Available at: https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1. Accessed February 1, 2018. Accessed February 2, 2018.
Briggs A. Pharmacists’ increasing involvement in hepatitis C management and prevention. JAPhA. 2018;58:5-6. doi:10.1016/j.japh.2017.10.013.
Zhu J, Hazen R, Joyce C, et al. Local specialty pharmacy and specialty clinic collaboration assists access to hepatitis C direct-acting antivirals. JAPhA. 2018;58:89-93. doi:10.1016/j.japh.2017.10.011.