Comparison of time to treatment initiation of specialty medications between an integrated health system specialty pharmacy and external specialty pharmacies.

BACKGROUND: Specialty medications are commonly dispensed through specialty pharmacies equipped to meet unique monitoring and dispensing requirements. Integrated health system specialty pharmacies (HSSPs) coordinate with health system providers to deliver specialty medications to patients and ameliorate barriers to care. However, payors may restrict specialty medication fills to specialty pharmacies external to the health system, potentially leading to delayed treatment. OBJECTIVE: To compare time to treatment initiation among patients whose specialty medications were transferred to external pharmacies and patients whose medications were filled at an internal HSSP. METHODS: This was a retrospective, propensity-matched cohort study examining time to treatment initiation in patients with a specialty medication referral to the University of Kentucky HealthCare Specialty Pharmacy between July 1, 2021, and July 1, 2022. Patients were classified into cohorts by receipt of dispensing services from the internal HSSP or an external specialty pharmacy. Data collected via chart review included insurance type, reason for prescription transfer, dates of service (including prescription order, transfer, and receipt of medication), and whether a prior authorization or clinical intervention was performed. Subgroup analyses were performed for patients requiring a prior authorization or clinical intervention. The Wilcoxon signed-rank test was used to assess for statistically significant differences in time to treatment initiation between cohorts. RESULTS: A total of 560 patients with external transfers were identified for inclusion into the study, and after exclusion criteria were applied, 408 external transfer patients were propensity matched 1:1 to 408 patients with internal fills (total n = 816). Time to treatment initiation was significantly longer in the external transfer cohort as compared with the internal fill cohort, (18 days vs 12 days; P < 0.0001). The internal fill cohort had a greater mean days from provider order to the medication being ready to fill compared with the external transfer cohort (10 days vs 6 days; P < 0.0001). The internal fill cohort had fewer mean days from the medication being ready to fill to patient receipt of the medication as compared with the external transfer cohort (2 days vs 12 days; P < 0.0001). Similar findings were observed in the subgroup analyses. CONCLUSIONS: Average time to treatment initiation was 6 days shorter for patients whose specialty medications were filled at this HSSP compared with externally transferred patients. Delays in therapy can cause a negative impact on patient care and disease state management, with increased concern for specialty populations. The results of this study highlight the need for continued discussion about policies that limit patient choice to in-network pharmacies.

Low rates of primary medication nonadherence in patients prescribed oral oncology agents across health system specialty pharmacies.

BACKGROUND: New oral oncology medications bring novel challenges when patients are initiating treatment. Rates of primary medication nonadherence (PMN), the rate at which a medication is prescribed but not obtained, of up to 30% have been reported for oral oncology medications. More research is needed to identify causes and develop strategies for health system specialty pharmacies (HSSPs) to improve cancer treatment initiation rates. OBJECTIVE: To evaluate the rate and reasons for PMN to specialty oral oncology medications in an HSSP setting. METHODS: We performed a multisite retrospective cohort study across 7 HSSP sites. Patients were included if they had an orally self-administered oncology medication referral generated by the health system of the affiliated specialty pharmacy between May 1, 2020, and July 31, 2020. Data collected at each site using pharmacy software and the electronic health record were deidentified and aggregated for analysis. After identifying unfilled referrals within a 60-day fill window, a retrospective chart review was performed to identify final referral outcomes and reasons for unfilled referrals. Referral outcomes were categorized as unknown fill outcomes (because of being referred to another fulfillment method or if received for benefits investigation only), filled by the HSSP, or not filled. The primary outcome was PMN for each PMN-eligible referral and secondary outcomes included reason for PMN and time to fill. The final PMN rate was calculated by dividing the number of unfilled referrals by total referrals with a known fill outcome. RESULTS: Of 3,891 referrals, 947 were PMN eligible, representing patients with a median age of 65 years (interquartile range = 55-73), near equal distribution between male and female (53% vs 47%), and most commonly with Medicare pharmacy coverage (48%). The most referred medication was capecitabine (14%), and the most common diagnosis was prostate cancer (14%). Among PMN-eligible referrals, 346 (37%) had an unknown fill outcome. Of the 601 referrals with known fill outcome, 69 referrals were true instances of PMN, yielding the final PMN rate of 11%. Most referrals were filled by the HSSP (56%). Patient decision was the most common reason for not filling (25%; 17/69 PMN cases). The median time to fill after initial referral was 5 days (interquartile range = 2-10). CONCLUSIONS: HSSPs have a high percentage of patient initiation of new oral oncology medication treatments in a timely manner. More research is needed to understand patient reasons for deciding not to start therapy and to improve patient-centered cancer treatment planning decisions. DISCLOSURES: Dr Crumb was a planning committee member with Horizon CME for the Nashville APPOS 2022 Conference. Dr Patel received funding and support for attending meetings and/or travel from the University of Illinois Chicago College of Pharmacy.

Effect on medication adherence of applying a specialty pharmacy care model to nonspecialty medications: A quasi-experimental cohort study.

PURPOSE: Medication nonadherence is a multifactorial healthcare problem that contributes to increased healthcare costs and morbidity. To improve medication adherence, specialty pharmacies offer services not typically provided by retail pharmacies such as benefits investigation, financial assistance, medication synchronization, and proactive refill reminders. This study assessed the impact of the specialty pharmacy care model on medication adherence for patients on nonspecialty medications. METHODS: This study was a quasi-experimental cohort comparison of patients who were transferred from a health-system retail pharmacy to a health-system specialty pharmacy between April 1, 2020, and June 30, 2021. The primary endpoint in this study was the difference in mean medication adherence proportion of days covered (PDC) between the post-transfer and pretransfer periods. Secondary outcomes included the proportion of patients with PDC of greater than 80%, medication adherence by drug group, shipment volumes, number of medications per shipment, and the mean copay per medication. RESULTS: In this study of 163 patients, use of a specialty pharmacy care model led to a significant increase of 7.0% in mean PDC, a significant increase in the percentage of patients with PDC of greater than 80%, a significant decrease in the number of shipments per 30 days per patient, a significant increase in the number of medications included per shipment, and a significant reduction in the mean copay per medication. CONCLUSION: The findings in this study suggest that the application of the specialty pharmacy care model to nonspecialty pharmacy patients may improve medication adherence, decrease the number of shipments per patient sent from the pharmacy, and reduce patient copays.

Impact of a subcutaneous casirivimab and imdevimab clinic in outpatients with symptomatic COVID-19: A single-center, propensity-matched cohort study.

PURPOSE: To evaluate the success of a clinic for subcutaneous administration of casirivmab and imdevimab (REGEN-COV; Regeneron) for treatment of patients with symptomatic mild to moderate coronavirus disease 2019 (COVID-19) in terms of preventing disease progression and healthcare utilization. METHODS: This retrospective single-center, propensity-matched cohort study examined healthcare utilization outcomes for patients who received subcutaneous casirivimab and imdevimab at a pharmacist-led clinic of an academic health system. Eligible patients were treated between August 1, 2021, and January 5, 2022, and were at high risk for COVID-19 disease progression. Treatment patients were propensity matched with high-risk control patients with a diagnosis of COVID-19 in the same timeframe who did not receive casirivimab and imdevimab. Patients were followed for 30 days for collection of data on inpatient admissions, emergency department visits, and mortality. Risk of a 30-day healthcare utilization event was assessed and tested for statistical significance utilizing McNemar's test. RESULTS: A total of 585 patients who received treatment with subcutaneous casirivimab and imdevimab were matched with 585 patients who did not receive casirivimab and imdevimab therapy. Patients who received casirivimab and imdevimab had significantly lower risk of a 30-day all-cause inpatient admission event than untreated patients (relative risk reduction, 62.4%; P < 0.0001). Treated patients also had a significantly lower risk of 30-day all-cause emergency department visit than untreated subjects (relative risk reduction, 36.5%; P = 0.0021). There were 6 mortality events in the untreated group and no mortality events in the treatment group. CONCLUSION: This study provides evidence for the effectiveness of a subcutaneous casirivimab and imdevimab clinic in preventing progression of symptomatic mild to moderate COVID-19.

Utility of an integrated health system specialty pharmacy in provision of extended-release buprenorphine for patients with opioid use disorder.

PURPOSE: Extended-release (ER) monthly injectable buprenorphine offers an alternative to daily sublingual (SL) dosing for treatment of opioid use disorder (OUD) that may be attractive to several patient populations, including those with barriers to adherence and the frequent follow-up that are necessary for traditional SL buprenorphine. Despite the potential benefits of ER-buprenorphine, there are significant barriers to healthcare provider adoption that may prevent utilization in the populations that would benefit. SUMMARY: Our health system began providing clinic-administered ER-buprenorphine as treatment for OUD in May 2018 at a single clinic. Expansion was limited due to difficulties with delayed and inaccurate medication delivery and heavy administrative burden. To facilitate uptake of ER-buprenorphine for patients who could benefit, our integrated health-system specialty pharmacy (HSSP) assumed responsibility for medication distribution and administrative management beginning in October 2019. The HSSP provided accurate medication delivery, alleviated administrative burdens of benefits investigation and Risk Evaluation and Mitigation Strategy compliance, and decreased medication wastage by implementing a medication return process. Subsequently, ER-buprenorphine services were expanded to 4 additional sites, allowing 244 more patients to receive treatment. CONCLUSION: HSSP support can provide significant benefit to patients and the health system through coordinating ER-buprenorphine dispensing and delivery.

Impact of the COVID-19 pandemic on hepatitis C outcomes at a health-system specialty pharmacy.

BACKGROUND: The goal of hepatitis C virus (HCV) treatment is to cure the patient of the infection, defined as a nondetectable HCV RNA at least 12 weeks after treatment completion, or sustained virologic response (SVR). The COVID-19 pandemic has presented new barriers to care in the treatment of patients with HCV that resulted in a transition to tele-health services at many health systems to overcome these barriers. OBJECTIVE: To assess the real-world impact of the COVID-19 pandemic and the subsequent shift to a telehealth model on collection of SVR data and other HCV treatment outcomes in a health-system setting. METHODS: Subjects who received a referral for an HCV direct-acting antiviral agent between January 1, 2018, and November 30, 2020, and were aged 18 years or older at time of enrollment were placed in either "pre-COVID-19" or "COVID-19" cohorts based on enrollment date. The primary endpoint of this study evaluated confirmed SVR to treatment determined by the absence of HCV RNA by polymerase chain reaction testing at least 12 weeks after completion of drug therapy. Secondary endpoints evaluated completion of medication therapy and adherence to laboratory appointments. RESULTS: 1,504 patients met study inclusion criteria (pre-COVID-19 cohort, n = 1,230; COVID-19 cohort, n = 274). The COVID-19 cohort demonstrated significantly lower therapy completion rates (P = 0.001), were less likely to obtain SVR laboratory tests (P < 0.001), and had a significantly lower confirmed SVR rate (P < 0.001) compared with the pre-COVID-19 cohort. In a subset of patients who completed therapy and had SVR laboratory tests collected, there were no significant differences observed in the rate of patients who achieved SVR (P = 0.959). CONCLUSIONS: During the COVID-19 pandemic, patients with HCV were significantly less likely to complete therapy or participate in SVR laboratory work. Further studies are needed to determine if offering a telehealth option for our patients in a post-COVID-19 environment would offer any additional advantage in increasing access to care for patients with HCV. DISCLOSURES: No outside funding supported this study. Dr Cooper is an employee of the University of Kentucky whose position was partially funded by Gilead Sciences, Inc.