In 2019, the nonprofit Utilization Review Accreditation Commission (URAC) implemented a new pharmacy measure, PH2018-07. This measure, which is in the safety domain, defines the treatment of chronic hepatitis C virus (HCV) completion of therapy (COT). It measures the percentage of individuals aged 18 years and older who initiated antiviral therapy during the measurement year for treatment of chronic HCV and who completed the minimum intended duration of therapy without significant gaps in therapy.

This measure is calculated by dividing the number of individuals with >1 prescription claims for a direct-acting antiviral medication (DAA) during the measurement year who received the cumulative days’ supply required to complete the minimum duration of therapy as indicated for the DAA within the treatment period and who did not have a cumulative gap of >15 days between the first and last fill of the DAA by the number of individuals with >1 prescription claims for a DAA during the measurement year.

A recent observational, retrospective, cohort study set out to compare URAC-defined HCV COT to a modified version of the HCV COT measure that took into account additional adjustments to make this measure more closely reflect what actually had occurred in clinical practice. Patients who received their first fill of a DAA from a specialty pharmacy between January 1, 2018 to December 31, 2018 and January 1, 2019 to December 31, 2019 were included in the study. The minimum length of therapy for the DAAs was defined as 12 weeks for sofosbuvir/velpatasvir and 8 weeks for glecaprevir/pibrentasvir and ledipasvir/sofosbuvir.

Investigators manually calculated the cumulative gap for each patient based on the days of the paid claims for each fill of the DAA. Electronic health records of patients who failed to meet the minimum duration of therapy according to the URAC definition were reviewed to identify the reason why this lapse in therapy occurred. The HCV COT was calculated for 2018 and 2019. If a gap of therapy of >15 days was observed, a second calculation was performed to adjust the gap based on documented DAA start dates. Patients were included in the numerator for the HCV COT measure only if their adjusted calculation based upon review of the medical record resulted in a treatment gap of <15 days.

A total of 1,485 patients, 602 patients from 2018 and 883 patients from 2019, met the inclusion criteria. The average age of the two cohorts were 51 years and 49 years, respectively; over 55% of patients were male. Glecaprevir/pibrentasvir was the most frequently prescribed DAA in both years. In 2018, ledipasvir/sofosburvir and sofosbuvir/velpatasvir were the next most commonly prescribed DAAs, while in 2019 the next most frequently prescribed DAAs were sofosbuvir/velpatasvir and ledipasvir/sofosbuvir.  

Based on the URAC criteria for HCV COT, 502 of the 602 patients (83.4%) in 2018 and 764 of the 833 patients (86.5%) in 2019 met the definition for COT. This left 100 patients in 2018 and 119 patients in 2019 who were excluded from the numerator in URAC’s definition of HCV COT.  

Of the 100 patients excluded in 2018, 47 patients were transferred to another pharmacy and 19 patients were lost to follow-up, never began treatment, or were unable to finish treatment, making them unable to be serviced during this time period. Only 34 patients had a cumulative gap of >15 days when these other factors were considered. Of these 34 patients, further analysis revealed that the first DAA prescription was more often delivered to the prescriber’s office than to the patient’s home (79.4% vs. 17.6%, respectively), which contributed to the delay in treatment.

Of the 119 patients excluded in 2019, 40 were transferred to another pharmacy and 46 were unable to be serviced. Only 33 patients had a cumulative gap of >15 days. In these 33 patients, additional review showed that just as in 2018, the first DAA prescription was also more often delivered to the prescriber’s office than to the patient’s home (69.7% vs. 24.2%, respectively).

The investigators found that the only statistically significant factor that contributed to the cumulative gap of >15 days during both timeframes was if the first prescription was delivered to the prescriber’s office instead of the patient’s home. A chart review conducted on these outlying patients determined that only one patient out of the 34 patients in 2018 and three patients out of the 33 patients in 2019 actually had a gap in therapy of >15 days. Therefore, 33 patients in 2018 and 30 patients in 2019 were inappropriately excluded from the numerator in the URAC measure. Adding these patients back to the URAC pharmacy-measure numerator increased the rates of HCV COT in 2018 from 83.4% to 88.9% and in 2019 from 86.5% to 89.9%.

This study addresses limitations in URAC’s current definition of HCV COT. While pharmacists need to meet the URAC definition, the mechanism used to calculate HCV COT in this study allows pharmacists to more adequately assess a patient’s adherence to HCV treatment.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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