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.

Rural disparities in emergency department utilization for migraine care.

OBJECTIVE: To evaluate differences in emergency department (ED) utilization and quality of care for migraine in patients with rural and nonrural residences. BACKGROUND: Migraine is a significant problem in the United States with direct health-care utilization cost amounting to US $4.2 billion annually. A considerable portion of this cost is attributed to more than 4 million annual ED visits for migraine and headache. Previous research has documented health disparities among rural populations in other disease states, which can be influenced by factors such as socioeconomic status and health-care access. Given these associations, it was hypothesized that patients with rural residence in a national sample would have increased ED utilization for migraine compared to patients with nonrural residence. METHODS: This was a cross-sectional epidemiologic study to evaluate rural disparities in ED utilization and quality of care for migraine in the United States in 2019. ED encounter data were collected from the Healthcare Cost and Utilization Project (HCUP) Nationwide Emergency Department Sample (NEDS) and Kentucky State Emergency Department Database (KY-SEDD). The primary outcome was crude and age-adjusted rates of ED encounters for migraine per 10,000 population. ED encounters were included if they had a primary International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code of G43.xx. ED encounters lacking sufficient data to classify into a geographic group were excluded. Secondary outcomes examined differences in quality of care, including mean ED charges and the proportion of encounters with medication administration, imaging, and nerve block service codes between groups. RESULTS: One hundred eighty-three thousand two hundred eleven national ED discharges were classified as rural patient encounters and 627,176 were classified as nonrural. The rural group had significantly higher crude and age-adjusted rates of ED utilization for migraine (crude: rural 39.8, 95% confidence interval [CI] 36.9-42.7; nonrural 22.2, 95% CI 21-23.5 and age-adjusted: rural 41.8, 95% CI 38.8-44.8; nonrural 23.4, 95% CI 22.1-24.7). Opioid utilization was higher in rural encounters (rural n = 26,764, 14.6%; nonrural n = 50,367, 8%; p < 0.001). A Kentucky sub-analysis found 5210 ED discharges were classified as Appalachian and 12,551 as non-Appalachian. The Appalachian group had significantly higher ED utilization rates for migraine compared to the non-Appalachian and national rural groups (crude: Appalachian 44.9, 95% CI 43.7-46.2; age-adjusted: Appalachian 47.4, 95% CI 46.1-48.8). The Kentucky Appalachian group also demonstrated significantly higher opioid analgesia use compared to the national rural group (Appalachian n = 1031, 19.8%; p < 0.001). CONCLUSION: This study suggests rural populations, particularly in Appalachia, may experience significantly higher ED utilization for migraine compared to nonrural patients. Moreover, rural populations were more likely to receive suboptimal migraine management with opioid analgesia. Multimodal health-care interventions should be developed to improve access to outpatient migraine care and further investigate potential risk factors in the rural population. With high ED utilization, the Appalachian population may benefit most from such an intervention.

Inflammatory Bowel Disease in Appalachian Kentucky: An Investigation of Outcomes and Health Care Utilization.

BACKGROUND: Rural residence has been associated with a lower incidence of inflammatory bowel disease (IBD) but higher health care utilization and worse outcomes. Socioeconomic status is intrinsically tied to both IBD incidence and outcomes. Inflammatory bowel disease outcomes have not been investigated in Appalachia: a rural, economically distressed region rife with risk factors for both increased incidence and unfavorable outcomes. METHODS: Hospital inpatient discharge and outpatient services databases were utilized to assess outcomes in patients diagnosed with either Crohn's disease (CD) or ulcerative colitis (UC) in Kentucky. Encounters were classified by patient residence in Appalachian or non-Appalachian counties. Data were reported as crude and age-adjusted rates of visits per 100,000 population per year collected in 2016 to 2019. National inpatient discharge data from 2019, stratified by rural and urban classification codes, were utilized to compare Kentucky to national trends. RESULTS: Crude and age-adjusted rates of inpatient, emergency department and outpatient encounters were higher in the Appalachian cohort for all 4 years observed. Appalachian inpatient encounters are more frequently associated with a surgical procedure (Appalachian, 676, 24.7% vs non-Appalachian, 1408, 22.2%; P = .0091). In 2019, the Kentucky Appalachian cohort had significantly higher crude and age-adjusted rates of inpatient discharges for all IBD diagnoses compared with national rural and nonrural populations (crude 55.2; 95% CI, 50.9-59.5; age-adjusted 56.7; 95% CI, 52.1-61.3). CONCLUSIONS: There is disproportionately higher IBD health care utilization in Appalachian Kentucky compared with all cohorts, including the national rural population. There is a need for aggressive investigation into root causes of these disparate outcomes and identification of barriers to appropriate IBD care.

The Kentucky Appalachian IBD population experiences increased health care utilization, with increased rates of inpatient admissions, emergency department, and outpatient visits compared with non-Appalachian Kentuckians. Kentucky Appalachian rates of inpatient admissions are higher compared with national rates, controlling for rural residence.

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.

Efficacy and safety of vancomycin loading doses in critically ill patients with methicillin-resistant Staphylococcus aureus infection.

BACKGROUND: While vancomycin loading doses may facilitate earlier pharmacokinetic-pharmacodynamic target attainment, the impact of loading doses on clinical outcomes remains understudied. Critically ill patients are at highest risk of morbidity and mortality from methicillin resistant Staphylococcus aureus (MRSA) infection and hypothesized to most likely benefit from a loading dose. We sought to determine the association between receipt of a vancomycin loading dose and clinical outcomes in a cohort of critically ill adults. METHODS: Four hundred and forty-nine critically ill patients with MRSA cultures isolated from blood or respiratory specimens were eligible for the study. Cohorts were established by receipt of a loading dose (⩾20 mg/kg actual body weight) or not. The primary outcome was clinical failure, a composite outcome of death within 30 days of first MRSA culture, blood cultures positive ⩾7 days, white blood cell count up to 5 days from vancomycin initiation, temperature up to 5 days from vancomycin initiation, or substitution (or addition) of another MRSA agent. RESULTS: There was no difference in the percentage of patients experiencing clinical failure between the loading dose and no loading dose groups (74.8% versus 72.8%; p = 0.698). Secondary outcomes were also similar between groups, including mortality and acute kidney injury, as was subgroup analysis based on site of infection. Exploratory analyses, including assessment of loading dose based on quartiles and a multivariable logistic regression model showed no differences. CONCLUSION: Use of vancomycin loading doses was not associated with improved clinical outcomes in critically ill patients with MRSA infection.

Chronic opioid use is associated with early biologic discontinuation in inflammatory bowel disease.

BACKGROUND: Chronic opioid use is associated with poorer clinical outcomes in inflammatory bowel disease. AIMS: To investigate an association between chronic opioid use and persistence with biologic agents in management of inflammatory bowel disease. METHODS: A total of 16 624 patients diagnosed with inflammatory bowel disease and receiving a first-time biologic prescription from 2011 to 2016 were identified retrospectively from the Truven MarketScan Database. A cohort of 1768 patients were identified as chronic opioid users utilising outpatient prescription claims. Utilisation patterns of biologic therapies were assessed from inpatient administration and outpatient claims data, including persistence calculations. Information on healthcare utilisation and common comorbidities was also collected. A Cox regression model was constructed to assess the hazard of chronic opioid use on early discontinuation of biologic therapy controlling for disease severity. RESULTS: A mean 1.5 different biologic agents were utilised by inflammatory bowel disease patients with chronic opioid use (vs 1.37 in the comparator group; P < 0.0001). A lower proportion of the chronic opioid use cohort persisted on biologic therapies to the end of the study period (16.2% vs 33.5% P < 0.0001). Inflammatory bowel disease patients with chronic opioid use utilised more healthcare resources and had a higher rate of comorbidities than the reference cohort. Patients with chronic opioid use were 23% more likely (hazard ratio 1.23; 95% CI [1.16-1.31]) to be non-persistent with biologic therapy while accounting for relevant markers of disease acuity. CONCLUSIONS: Chronic opioid use is associated with increased hazard of biologic discontinuation in inflammatory bowel disease. Symptoms of opioid withdrawal may mimic IBD flares thereby leading providers to inappropriately switch biologic therapies and compromise disease control.