Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb.

BACKGROUND: In 2016, the FDA approved infliximab-dyyb (IFX-dyyb) as a biosimilar to infliximab (IFX). Deemed to have comparable efficacy and safety to IFX, IFX-dyyb is 20%-30% less expensive, allowing significant cost savings for institutions and some payers. In 2018, IFX was reported to be the drug with the highest spend since 2013, costing $3.8 billion; however, transition to IFX-dyyb would save $1.1 billion. Regardless, many institutions have not transitioned to IFX-dyyb or other IFX biosimilars (e.g., IFX-abda) because of concerns about clinical outcomes, uncertainty regarding financial impact, and barriers to operationalizing biosimilar adoption. At Boston Medical Center, a decision was made in March 2018 to adopt IFX-dyyb and transition patients who have been on IFX for ≥ 6 months for all indications to IFX-dyyb. OBJECTIVES: To (a) describe a biosimilar adoption process of IFX-dyyb in patients on IFX for ≥ 6 months; (b) characterize cost savings of transitioning patients to IFX-dyyb; and (c) evaluate real-world clinical outcomes of adult patients with inflammatory bowel disease (IBD) who transitioned to IFX-dyyb. METHODS: This is a retrospective cohort study of patients eligible for the IFX-dyyb switch from March 2018 to June 2019 at a large academic medical center. For process outcomes, we collected the proportion of patients who transitioned to IFX-dyyb and calculated the cost savings generated. To assess clinical outcomes of adult IBD patients who transitioned, we collected IFX and IFX-dyyb dosage, Harvey Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) scores, c-reactive protein (CRP) levels, and colonoscopy results. Descriptive statistics, Wilcoxon signed-rank test, and McNemar's test were used for statistical analyses. RESULTS: Of 151 eligible patients, 146 (97%) successfully transitioned to IFX-dyyb. Based on our conversion rate to IFX-dyyb, our health system is forecasted to save approximately $500,000 annually. From March to June 2018, 63 of 75 (84%) eligible IBD patients transitioned from IFX to IFX-dyyb. In this cohort, of the 40 patients with HBI or SCCAI scores before and after transition, 36 (90%) maintained remission. For 32 patients, the mean CRP (SD) before transition was 11.2 (22) and 4.1 (4.8) after transition (P = 0.09). Since the IFX-dyyb transition, 9 patients had a colonoscopy, of which 5 (56%) were in endoscopic remission. As of October 2018, 56 (89%) patients continued with IFX-dyyb after transition. Of the 46 patients who had 12-15 months posttransition data, 38 (83%) remained on IFX-dyyb. CONCLUSIONS: Implementation of a biosimilar adoption program can be successful and result in significant cost savings without compromising clinical outcomes. A model that uses actionable strategies and embraces collaboration among stakeholders is described here, with outcomes demonstrating successful IFX-dyyb uptake and no changes in clinical outcomes of transitioned adult patients with IBD. DISCLOSURES: No outside funding supported this study. Farraye reports advisory board fees from Janssen, Merck, and Pfizer. Shah reports speaker fees from Pfizer. The other authors have nothing to disclose.

Advocating for Patients With Inflammatory Bowel Disease: How to Navigate the Prior Authorization Process.

In an effort to manage health care costs and avoid improper medication use, prior authorizations (PAs) have become a standard stipulation required by payers in the determination of medication coverage. For gastroenterologists managing patients, especially those with inflammatory bowel disease (IBD), the PA process is time-consuming and further complicated by 2 additional factors: step therapy requirements and failure of payers to recognize updated IBD treatment pathways. These factors often lead to PA denials and cause treatment delays, which in turn can lead to disease progression, ongoing patient suffering, and ultimately an increase in both direct and indirect total costs. In this manuscript, the PA process, PA models, tips and available resources to navigate the PA process, and future advocacy efforts are discussed with the intent to help gastroenterology practices optimize PA outcomes and improve the care provided to patients with IBD and other gastrointestinal disorders.

Sustained Improvement in Type 2 Diabetes Mellitus is Common After Treatment of Hepatitis C Virus With Direct-acting Antiviral Therapy.

GOALS: To determine whether diabetic patients with hepatitis C virus (HCV) treated with direct-acting antiviral agents have improved diabetes, accounting for change in both hemoglobin A1c (HbA1c) and diabetes medications, and whether any improvement was sustained. BACKGROUND: HCV infection is associated with an increased risk of diabetes, with improvement in glycemic control after eradication. There remains uncertainty about the durability and magnitude of this effect. STUDY: HbA1c and diabetes medications were recorded at 6-month intervals for 1.5 years pretreatment and posttreatment for 122 patients. Subjects were classified as having improved diabetes if there was a decrease in HbA1c≥0.5% with no increase in diabetes medications or a decrease in diabetes medications with a stable HbA1c. RESULTS: HbA1c at the nearest time point before treatment was 8.4%±1.9%, compared with 7.8%±1.7% after treatment, a mean difference of 0.6% [95% CI (0.2, 0.9), P<0.01]. A linear mixed effects model incorporating each subject's repeated measurements over time also demonstrated a reduction after treatment of 0.5% [95% CI, (0.3, 0.8), P<0.001]. Accounting for both HbA1c and diabetes medications, 42 of 122 (34%) had an improvement in diabetes after HCV treatment, and 20 of 28 (71%) of these subjects sustained improvement at 1.5 years follow-up. Prescription of insulin was associated with improved diabetes. CONCLUSIONS: Treatment of HCV with direct-acting antiviral agents was associated with improved diabetes in a significant portion of patients with an average reduction in HbA1c of clinically significant magnitude. Among responders, this effect was sustained over 1.5 years of follow-up.

Intensive Pharmacy Care Improves Outcomes of Hepatitis C Treatment in a Vulnerable Patient Population at a Safety-Net Hospital.

BACKGROUND: Treatment of hepatitis C virus (HCV) with direct-acting antiviral (DAA) regimens has resulted in high rates of sustained virologic response (SVR). Treatment of vulnerable populations may be improved by incorporating an on-site intensive specialty pharmacy (ON-ISP). AIMS: To describe outcomes of HCV treatment at a safety-net hospital and proportion of subjects achieving SVR for those using the ON-ISP compared to an off-site pharmacy (OFF-SP). METHODS: A retrospective cohort study of 219 subjects treated for HCV with DAA at Boston Medical Center was conducted. Subject characteristics, virologic response, and pharmacy services used were recorded. We used multivariable logistic regression to test the association between ON-ISP and SVR after adjusting for covariates. RESULTS: SVR occurred in 71% of subjects by intention-to-treat (73% among ON-ISP users vs 57% among OFF-SP users) and 95% completing treatment per-protocol (96% among ON-ISP users vs 87% among OFF-SP users). Adjustment for age, sex, ethnicity, insurance, fibrosis, prior treatment, and MELD revealed an increased likelihood of SVR among users of ON-ISP: OR 6.0 (95% CI 1.18-31.0). No significant difference in treatment delay or adverse events was seen among users of either pharmacy type. CONCLUSIONS: HCV treatment with DAA was well tolerated, but the rate of SVR was low (71%) compared to trials. This was due to loss to follow-up, as the per-protocol rate of SVR was much higher (95%). Use of ON-ISP was associated with an increase in SVR and may be valuable for improving care for vulnerable populations.

Once-weekly exenatide as adjunct treatment of type 1 diabetes mellitus in patients receiving continuous subcutaneous insulin infusion therapy.

OBJECTIVE: The use of once-weekly exenatide in type 2 diabetes mellitus is well supported, but little is known about its effectiveness in type 1 diabetes. The objective of this study was to determine the clinical efficacy of once-weekly exenatide on glycemic control in patients with type 1 diabetes when added to basal-bolus insulin therapy. METHODS: For this retrospective study, patients with type 1 diabetes, aged 18 years and older, receiving continuous subcutaneous insulin infusion, using a continuous glucose monitoring device or regularly measuring blood glucose levels and receiving 2 mg of exenatide once weekly for at least 3 months were included. Demographic information, glycated hemoglobin (A1C), body weight, body mass index, systolic and diastolic blood pressures, total daily insulin dose, basal and bolus insulin doses, 28-day continuous subcutaneous insulin infusion glucose average and incidence of hypoglycemia were collected at baseline and 3 months after beginning therapy with once-weekly exenatide. RESULTS: An electronic medical record search identified 11 patients with type 1 diabetes who met the inclusion criteria. Comparing baseline and 3 months after initiation of once-weekly exenatide revealed reductions of 0.6% in A1C (p=0.013), 3.7% in body weight (p=0.008), 1.7 kg/m(2) in body mass index (p=0.003), 13% in total daily insulin dose (p=0.011) and 9.3 units in bolus insulin dose (p=0.015). CONCLUSIONS: This study revealed that the addition of once-weekly exenatide to insulin therapy for type 1 diabetes patients leads to significant improvements in A1C, body weight, body mass index and insulin doses.