Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease.

OBJECTIVES: The safety, efficacy, and cost savings associated with biosimilar medications are well established. However, a lack of pediatric data exists surrounding clinical outcomes when switching from an originator to a biosimilar. Our primary aim is to evaluate clinical outcomes following a nonmedical switch from the infliximab originator to a biosimilar in children and young adults with inflammatory bowel disease (IBD). Our secondary aim is to estimate cost savings associated with this switch. METHODS: A quality improvement project was implemented to establish safe switching protocols, then those patients who underwent a nonmedical switch from the infliximab originator to the biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGAs), and laboratory values were recorded 1 year pre- and post-switch. Continuation rates on the biosimilar were reported at 6 and 12 months. Cost savings were estimated using two different pricing models. RESULTS: Fifty-three patients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGA scores remained similar when assessed pre- and post-switch. No infusion reactions or antidrug antibody development occurred. Two patients reported psoriasis-like rashes. Five patients switched back to the originator during the study period. There were 379 biosimilar infusions completed with an estimated total cost savings of $11,260 (average sales price) and $566,223 (wholesale acquisition cost). CONCLUSIONS: Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after a one-time nonmedical switch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease.

OBJECTIVES: Therapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure-response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52-week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD). METHODS: A QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12-month clinical outcomes were recorded. For this study, we defined therapeutic target levels (>20 µg/mL at Week 6 and >12 µg/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes. RESULTS: Fifty-nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]/indeterminate colitis [IC]) were included in the study. In total, 68% (40/59) of patients had vedolizumab levels at Week 6 and 90% (53/59) had levels drawn at Week 6 or 14. Thirty-five percent of Week 6 trough levels were below our defined target of 20 µg/mL. Fifty-two of 59 patients had available data at 52 weeks. Over 80% (42/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23/29], UC/IC 83% [19/23]). Sixty-two percent (26/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of <8 weeks. Thirty-one of these 42 (74%) were in clinical remission (CR) rate at 52 weeks with 29/42 (69%) in corticosteroid-free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31/52). CONCLUSION: Proactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.

Similar Growth Outcomes in Children with Inflammatory Bowel Disease Initiated on Infliximab Originator or Biosimilar.

BACKGROUND: Growth is an important clinical outcome, especially in childhood-onset inflammatory bowel disease (IBD). Prior research has demonstrated growth improvements with infliximab therapy. There are limited studies evaluating whether clinical and growth outcomes in children initiated on the infliximab originator and infliximab biosimilar are similar. METHODS: This was a single-center retrospective review of patients with IBD, younger than 17 years old, and initiated on the infliximab originator or biosimilar for at least 12 months between April 2016 and February 2021. Propensity score matching was utilized. Laboratory values, disease activity scores, and growth values were collected at baseline (prior to infliximab initiation), 6 months, and 12 months post initiation. Linear mixed models with random intercepts were used to test differences in measures over time and between study groups. RESULTS: There were 113 patients on the originator and 39 patients on a biosimilar who met eligibility criteria. Propensity score methodology identified 37 dyads (1:1 match). Weight, height, and body mass index z scores increased over time (from baseline to 12 months) for both groups ( P < 0.05) and there was a similar rate of change between study groups. Clinical outcomes of lab values (albumin, C-reactive protein, and hemoglobin) and disease activity scoring were similar from baseline to 12 months between study groups. CONCLUSIONS: There were similar improvements in growth and clinical outcomes in patients initiated on the infliximab originator compared to an infliximab biosimilar agent. This study adds to the limited research evaluating whether infliximab biosimilars have similar growth outcomes in children with IBD.

Impact of pharmacist alternative therapy interventions in a pediatric Medicaid population.

BACKGROUND: Ambulatory clinical pharmacists are viewed as the medication experts on the health care team and frequently assist with medication access concerns. However, medication access and insurance navigation are difficult because of wide variations in insurance formularies. Accountable care organizations (ACOs) incorporate pharmacists as members of their population health teams to assist with these efforts. These ACO pharmacists are uniquely positioned to assist pediatric ambulatory care pharmacists with medication access concerns. This collaboration has the potential to not only improve patient care but also provide cost savings. OBJECTIVE: To estimate cost savings to an ACO derived from alternative therapy interventions made by pharmacists embedded in pediatric ambulatory clinics, using resources created by ACO pharmacists, within a pediatric Medicaid population. The secondary objectives were to quantify the frequency of alternative therapy interventions provided by these pharmacists, evaluate the impact on medication access through the avoidance of prior authorizations (PAs), and assess the frequency and cost savings of alternative therapy interventions per treatment category. METHODS: This was a retrospective review of alternative therapy interventions provided by pediatric ambulatory care pharmacists within a health-system in central Ohio. Interventions were collected within an electronic health record from January 1, 2020, to December 31, 2020. Cost savings were calculated using average wholesale pricing, and PA avoidance was quantified. RESULTS: A total of 278 alternative therapy interventions were made with an estimated cost savings of $133,191.43. Primary care clinics (n = 181, 65%) had the most documented interventions. A total of 174 (63%) interventions resulted in the avoidance of a PA. The antiallergen (28%) treatment category had the most documented interventions. CONCLUSIONS: Alternative therapy interventions were provided by pediatric ambulatory care pharmacists in collaboration with pharmacists working for an ACO. The use of ACO prescribing resources can result in cost savings to an ACO and PA avoidance within a pediatric Medicaid population. DISCLOSURES: The statistical analysis of this work was supported by the National Center for Advancing Translational Sciences (CTSA Grant UL1TR002733). Dr Sebastian discloses her role as a pharmacy consultant for Molina Healthcare Pharmacy and Therapeutics Committee. All other authors declare no relevant conflicts of interest or financial relationships.

Biosimilars for Pediatric Patients With Inflammatory Bowel Disease: Pediatric Gastroenterology Clinical Practice Survey.

BACKGROUND: Biosimilars are biological agents that have been demonstrated to have similar safety and efficacy profiles as the originator. The objective of this study was to evaluate the perspectives of pediatric gastroenterologists in the United States (U.S.) toward biosimilar use and to explore factors that impact their comfort level with prescribing infliximab biosimilars. METHODS: A cross-sectional survey was developed and distributed to pediatric gastroenterology physicians from the U.S. via a listserv (Pediatric gastroenterology Bulletin Board). Respondent's demographics were recorded. Using a 6-point Likert scale, the survey assessed the respondent's perceptions toward biosimilars and initiating switches from the originator to biosimilar agent along with factors impacting provider's comfort level. Fischer exact tests were used to detect statistically significant differences in responses for hypotheses of interest. RESULTS: One hundred thirty-nine pediatric gastroenterologists completed the online survey (response rate 5.4%). Eighty-seven percent of respondents reported being comfortable prescribing infliximab biosimilars to anti-tumor necrosis factor naive patients, and 69% reported being comfortable doing a one-time switch if the patient was in clinical remission. Factors that negatively impacted a respondent's comfort level included respondents not practicing at an ImproveCareNow (ICN) center and managing less than 50 patients with inflammatory bowel diseases (IBD). CONCLUSIONS: Nearly 90% of pediatric gastroenterologists felt comfortable prescribing an infliximab biosimilar, and 70% felt comfortable with a one-time switch to the biosimilar if the patient was in clinical remission. Involvement in ICN a learning health system and caring for higher numbers of patients with IBD was associated with increased provider comfort with biosimilar use.

Improving Hepatitis B Vaccination Rates among At-risk Children and Adolescents with Inflammatory Bowel Disease.

Patients with inflammatory bowel disease (IBD) receiving tumor necrosis factor alpha inhibitors (TNFai) may be at higher risk for hepatitis B virus (HBV) infection. We conducted a quality improvement (QI) initiative to improve HBV vaccination rates in seronegative children with IBD. Methods: This QI initiative implemented an HBV vaccination strategy from September 2018 to March 2020 in patients with newly diagnosed IBD with hepatitis B surface antibody (HBsAb) <10 mIU/mL. The project aimed to (1) increase HBV vaccination rates in seronegative patients and (2) document immunogenicity after completing a three-dose vaccine series. Outcome measures included the percentage of seronegative patients who received HBV vaccines (dose 1 and three-dose series). Interventions included applying a standardized vaccination protocol, and creating a vaccine workflow in two clinical areas, previsit planning and stakeholder engagement. Results: One hundred seventy-four children and adolescents with IBD were evaluated during the study period, and 132 (76%) were HBsAb negative. After plan-do-study-act (PDSA) 1, the proportion of eligible patients who received HBV vaccine dose 1 increased from a baseline of 7% to 100% and was sustained for over 12 months. During PDSA 2, the proportion of patients completing the three-dose vaccine series improved from a baseline of 0% to 82% (n = 100); among 93 children in this subgroup who had repeat serology performed, 86 (92%) demonstrated serologic evidence of HBV protection. Conclusions: A multidisciplinary approach applying QI methodology allowed for improved and sustained HBV vaccination rates in at-risk seronegative children and adolescents with IBD. A three-dose HBV vaccine series proved immunogenic in 92% of eligible patients.

Patient and Caregivers' Perspectives on Biosimilar Use in Pediatric Inflammatory Bowel Disease.

BACKGROUND: Studies assessing adult inflammatory bowel disease (IBD) patient perspectives on biosimilar use revealed that most were unfamiliar with biosimilars and had a negative perception. The objective of this study was to evaluate the perspectives of pediatric patients with IBD and their caregivers regarding biosimilar use and non-medical switches. METHODS: A survey was given to a cross section of patients with IBD ages 11-21 years receiving the intravenous anti-tumor necrosis factor originator and caregivers of patients with IBD ages 3-21 years receiving the originator. Recruitment occurred via mail, during clinic visits, and infusions. Fisher exact tests were used to test for statistically significant differences. RESULTS: Response rate amongst caregivers was 49% (n = 98) and among patients was 35% (n = 67). Sixty-four percent of caregivers and 79% of patients had never heard of biosimilars. There was increased discomfort surrounding the use of biosimilars and switching to a biosimilar amongst caregivers who had previously heard of biosimilars compared to caregivers who had not previously heard of biosimilars ( P < 0.05). Similar concerns were not seen in patient respondents. The length of time on the originator had no effect on patient or caregiver concerns related to biosimilar efficacy, adverse effects, or switches. CONCLUSION: The majority of pediatric patients and caregivers had never heard of biosimilars. Caregivers that had heard of biosimilars before the study were more likely to have a negative perception of them. This study highlights the importance of providing thorough and accurate education to pediatric patients and families regarding the safety and efficacy of biosimilars.

Evaluation of a remote hybrid staffing model for ambulatory clinical pharmacists in a pediatric health system during the COVID-19 pandemic.

PURPOSE: To describe and quantify patient care activities performed by ambulatory clinical pharmacists supporting medical specialty clinics in a pediatric health system utilizing a hybrid staffing model during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Five ambulatory clinical pharmacists, integrated within a health-system specialty pharmacy (HSSP), utilized a web-based data collection tool to record time spent performing patient care activities over a 2-week period. Work location (onsite or offsite) of the pharmacist was reported for each activity. Activities were classified as direct or indirect patient care. Direct patient care activities were subcategorized as telemedicine appointments, in-person clinic appointments, HSSP call center work, medication access support, electronic medical record consults, and previsit planning/postvisit documentation. Administrative tasks and precepting were considered indirect patient care activities. RESULTS: A total of 1,190 activities were completed, with 77% of all activities performed offsite. Direct and indirect patient care activities accounted for 871 (73.2%) and 319 (26.8%) of total activities, respectively. No activity took longer for the pharmacists to complete offsite versus onsite. CONCLUSION: Using a hybrid staffing model employed by a pediatric health system, ambulatory clinical pharmacists were able to efficiently provide a high volume of direct patient care activities even when working offsite. Rapid adaptation and implementation of telemedicine services was critical for pharmacists to continue to provide essential services within pediatric medical specialty clinics.

Increasing Biosimilar Utilization at a Pediatric Inflammatory Bowel Disease Center and Associated Cost Savings: Show Me the Money.

BACKGROUND: Tumor necrosis factor-alpha inhibitors (anti-TNFs) are a primary treatment for inflammatory bowel disease. Pharmaceutical expenditures and usage of specialty drugs are increasing. In the United States, biosimilars continue to be underutilized, despite opportunities for health care cost savings. Through quality improvement (QI) methodology, we aimed to increase biosimilar utilization among eligible patients initiating intravenous (IV) anti-TNF therapy and describe patient outcomes and associated cost savings. METHODS: Beginning in July 2019, all patients initiating IV anti-TNF therapy were identified and tracked. Using the Institute of Healthcare Improvement Plan-Do-Study-Act cycle, a four-stage problem-solving model used for carrying out change, we trialed interventions to increase biosimilar utilization, including provider, staff, and family education, and utilization of a clinical pharmacist and insurance specialist. Statistical process control charts were used to show improvement over time. Patients' clinical outcome and cost savings were reviewed. RESULTS: Using QI methodology, we increased biosimilar utilization from a baseline of 1% in June 2019 to 96% by February 2021, with sustained improvement. The originator (infliximab) was the insurance company's preferred product for 20 patients (20%). Patient outcomes (IV anti-TNF levels, absence of antidrug antibodies, and physician global assessment) between biosimilars and originators were similar. Estimated cost savings over the project duration were nearly $381,000 (average sales price) and $651,000 (wholesale acquisition cost). CONCLUSIONS: Through QI methodology, we increased biosimilar utilization from 1% to 96% with sustained improvement, without compromising patient outcomes or safety. Estimated cost savings were substantial. Similar methodology could be implemented at other institutions to increase biosimilar utilization and potentially decrease health care costs.

The Pediatric Inflammatory Bowel Disease Medical Home: A Proposed Model.

Care for patients with inflammatory bowel disease (IBD) can be complex and costly. Care delivery models to address these challenges and improve care quality are essential. The patient-centered medical home (PCMH), which was developed in the primary care setting, has recently been applied successfully to the adult IBD population. Following the tenets of the PCMH, this specialty medical home (SMH) emphasizes team-based care that is accessible, comprehensive, patient/family-centered, coordinated, compassionate, and continuous and has demonstrated improved patient outcomes. Children and young adults with IBD have equally complex care needs, with additional challenges not faced by the adult population such as growth, physical and psychosocial development, and transition of care from pediatric to adult providers. Thus, we advocate that the components of the PCMH are equally-if not more-important in caring for the pediatric patient population. In this article, we review what is known about the application of the PCMH model in adult IBD care, describe care delivery within the Center for Pediatric and Adolescent IBD at Nationwide Children's Hospital as an example of a pediatric IBD medical home, and propose a research agenda to further the development and dissemination of comprehensive care delivery for children and adolescents with IBD.

This article summarizes the literature regarding the adult inflammatory bowel disease medical home, highlights the need for similar models in pediatrics using the Nationwide Children's Hospital program as an example, and outlines next steps to support research and development of the pediatric IBD medical home.

Economic impact of pharmacist interventions in pediatric ambulatory care clinics.

OBJECTIVES: Ambulatory care pharmacists have a unique opportunity to identify and prevent adverse drug events (ADEs) throughout a patient's treatment course. These interventions can reduce unexpected clinic visits or hospitalizations, which may lead to decreased health care costs. However, research on this topic has not been conducted in the pediatric population. This study explored the economic impact of pharmacist interventions related to ADEs in pediatric ambulatory care clinics. The primary objective was to determine the total cost avoidance of pharmacist interventions associated with the prevention or management of ADEs in pediatric ambulatory care clinics. The secondary objectives were to describe and quantify pharmacist interventions related to the prevention and management of ADEs in pediatric ambulatory care clinics. METHODS: Pharmacist interventions from pediatric ambulatory care clinics were collected from an electronic health record. These interventions were categorized into 1 of 4 categories: Drug interaction, drug not indicated, prevent or manage ADE, or prevent or manage drug allergy. A review panel consisting of ambulatory care pharmacists reviewed the interventions. The expected probability of the event occurring was classified according to the Nesbit method (0-0.6), and the level of care necessary to treat the potential ADE was determined. The levels of care included hospitalization, ambulatory care, and self-care. The cost avoidance associated with each prevented ADE was calculated by multiplying the probability of the ADE occurring by the average charge of the expected level of care. RESULTS: Of the 8755 interventions documented, 212 were included, leading to a total cost avoidance of $307,210 (range $76,802-$1,071,053). The estimated cost avoidance from each ADE subtype was $128,283 from drug interaction, $20,727 from drug not indicated, $157,993 from prevent or manage ADE, and $207 from prevent or manage drug allergy. CONCLUSION: Pediatric ambulatory care pharmacists optimize health care cost savings through the prevention and management of ADEs as integrated members of the health care team.

Standardized documentation workflow within an electronic health record to track pharmacists' interventions in pediatric ambulatory care clinics.

OBJECTIVES: To describe the implementation of a standardized documentation workflow within an electronic health record (EHR) and to track pharmacists' interventions in pediatric ambulatory care clinics. SETTING: Ambulatory care clinics and a transitions-of-care (TOC) service within a pediatric health care system in central Ohio. PRACTICE DESCRIPTION: Ambulatory clinical pharmacists work as integrated members of the health care team in 7 pediatric ambulatory care clinics and a TOC service to achieve the best medication-related outcomes for patients. PRACTICE INNOVATION: A standardized documentation workflow was established among ambulatory clinical pharmacists to document the interventions made in their practice settings with the use of a tool in the EHR. A weekly report from the EHR was run by a technician to gather intervention data, identify reimbursable opportunities, and document and bill via a separate Internet-based medication therapy management platform. EVALUATION: The success of the new documentation workflow was evaluated, and continuous feedback was gathered from the pharmacists and the billing technician. Updates were provided to the ambulatory clinical pharmacist at monthly staff meetings and workflow changes implemented as needed. RESULTS: A total of 5210 interventions were documented by the pharmacists in various intervention categories. The 3 most common intervention categories included patient and medication education (1765), medication reconciliations (1170), and compliance assessments (795). CONCLUSION: A standardized documentation workflow allowed for consistent tracking of interventions across ambulatory care clinics and a TOC service. Key elements to the successful implementation of this new documentation workflow included proper training and continuous feedback to the ambulatory clinical pharmacists, assistance from a billing technician, and consistent documentation by the ambulatory clinical pharmacists.