Advanced Therapies for Inflammatory Bowel Disease: Navigating Payor and Financial Challenges.

PURPOSE OF REVIEW: In the United Sates the cost of managing Crohn's disease and ulcerative colitis, the two most common inflammatory bowel diseases, is a major factor that can alter the course of treatment. The increasing use of advanced therapies such as biologics and oral small molecules is a driver of these costs. Many IBD providers find navigating the payor and non-insurance cost assistance processes to be a significant challenge in care management. We aim to clarify these processes and provide an outline for success. RECENT FINDINGS: Insurance companies use various processes to manage medication costs and while they may not ultimately be cost-effective, the processes have continued and are increasingly complex. This complexity has led to measurable delays in care and negative outcomes. With a deeper understanding of payor and non-insurance cost-assistance processes we have developed a workflow for navigating the use of advanced therapies in the treatment of IBD.

Baseline Clearance of Infliximab Is Associated With Requirement for Colectomy in Patients With Acute Severe Ulcerative Colitis.

BACKGROUND & AIMS: Hospitalized patients with acute severe ulcerative colitis (ASUC) often require surgery. Although the tumor necrosis factor antagonist infliximab is an effective salvage therapy to prevent colectomy in patients with ASUC, optimal dosing is unclear. Calculated infliximab clearance has been associated with important outcomes in patients with ulcerative colitis, but its utility in patients with ASUC has not been established. We assessed the relationship between calculated the baseline infliximab clearance before infliximab salvage therapy and the requirement for colectomy in patients hospitalized for ASUC. METHODS: We obtained data from hospitalized patients with ASUC who initiated infliximab therapy. We then calculated the baseline infliximab drug clearance in these patients based on an existing formula. The primary aim was to compare clearance between patients who required colectomy 6 months later and patients who did not require colectomy. Receiver operating characteristic curve analyses evaluated clearance thresholds for colectomy. Multivariable logistic regression analysis evaluated factors associated with colectomy. RESULTS: In 39 patients with ASUC, the median baseline calculated clearance was higher in patients requiring colectomy at 6 months than in patients without colectomy (0.733 vs 0.569 L/d; P = .005). An infliximab clearance threshold of 0.627 L/d identified patients who required colectomy with 80.0% sensitivity and 82.8% specificity (area under the curve, 0.80). A higher proportion of patients with infliximab clearance of 0.627 L/d or more underwent colectomy within 6 months (61.5%) than patients with lower infliximab clearance values (7.7%) (P = .001). Multivariable analysis identified baseline infliximab clearance as the only factor associated with colectomy. The infliximab dose in the hospital was higher in patients who required colectomy. Results were similar at 30 days and 1 year. CONCLUSIONS: In patients hospitalized with ASUC, higher values of calculated infliximab clearance before infliximab administration is associated with higher rates of colectomy. Although patients who required colectomies received higher doses, data on infliximab concentrations are lacking. Infliximab pharmacokinetic models are needed for patients with ASUC to allow comparative trials on clearance-based vs standard dosing.

Physician experiences with clinical pharmacists in primary care teams.

BACKGROUND: Improving medication management is an important component of comprehensive care coordination for health systems. The Managing Your Medication for Education and Daily Support (MyMeds) medication management program at the University of California Los Angeles addresses medication management issues by embedding trained clinical pharmacists in primary care practice teams. OBJECTIVES: The aim of this work was to examine and explore physician opinions about the clinical pharmacist program and identify common themes among physician experiences as well as barriers to integration of clinical pharmacists into primary care practice teams. METHODS: We conducted a mixed quantitative-qualitative methods study consisting of a cross-sectional physician survey (n = 69) as well as semistructured one-on-one physician interviews (n = 13). Descriptive statistics were used to summarize survey responses, and standard qualitative content-analysis methods were used to identify major themes from the interviews. RESULTS: The survey response rate was 61%; 13 interviews were conducted. Ninety percent of survey respondents agreed or strongly agreed that having the pharmacist in the office makes management of the patient's medication more efficient, 93% agreed or strongly agreed that pharmacist recommendations are clinically helpful, 71% agreed or strongly agreed that having access to a pharmacist has increased their knowledge about medications they prescribe, and 75% agreed or strongly agreed that having a pharmacist as part of the primary care team has made their job easier. Qualitative interviews corroborated survey findings, and physicians highlighted the value of the clinical pharmacist's communication, team care and expanded roles, and medication management. CONCLUSION: Primary care physicians valued the integrated pharmacy program highly, particularly its features of strong communication, expanded roles, and medication management. Pharmacists were viewed as integral members of the health care team.

Analysis of Evusheld safety and efficacy in multiple sclerosis patients.

BACKGROUND: In December 2021, the U.S. Food and Drug Administration issued emergency use authorization for the combination monoclonal antibodies tixagevimab and cilgavimab (Evusheld - AstraZeneca) for COVID-19 pre-exposure prophylaxis. While COVID-19 vaccination is recommended for multiple sclerosis (MS) patients, there is concern for insufficient antibody response in patients receiving B-cell depleting therapies. The literature is sparse regarding the safety and efficacy of Evusheld use in MS patients. OBJECTIVE: We sought to investigate the administration, safety, and efficacy of Evusheld in MS patients. METHODS: Participants were consecutively recruited from the UCSD MS Center from July 2022 to October 2022. We conducted both a review of medical records and a prospective cohort study. Inclusion criteria included prior diagnosis of MS and eligibility for Evusheld injection due to use of B-cell depleting disease modifying therapy (DMT). All eligible patients were evaluated to determine uptake of Evusheld use. Participant surveys were distributed to Evusheld recipients that evaluated for potential Evusheld side effects and COVID-19 vaccination and infection history. The proportion of COVID-19 infections among participants with or without Evusheld use were compared using Fisher's exact test, and a negative binomial regression analysis was used to evaluate risk for COVID-19 infection after Evusheld administration. RESULTS: A review of medical records showed that 79 MS patients were offered Evusheld by their clinicians during the recruitment period; 48 patients ultimately received the injection. Forty-two participants consented to the prospective cross-sectional study (mean age 46.4 years, 71.8 % female), of which 33 individuals received Evusheld. All participants received at least one COVID-19 vaccination dose, with 92.3 % receiving the initial series and at least one booster dose. One-third (30.8 %) of participants had a previous COVID-19 infection. DMTs included ocrelizumab, rituximab, and ofatumumab. Of the 33 participants who received Evusheld, 10 (30.3 %) reported experiencing at least one side effect. Injection site reactions included pain (most common), itchiness, and redness. General side effects included fatigue (most common), headache, muscle pain, and weakness. Of the 33 participants who received Evusheld, seven participants (21.2 %) tested positive for COVID-19 within 6 months of Evusheld injection. In an unadjusted binomial regression analysis, Evusheld administration was associated with a reduction in COVID-19 infection risk (OR 0.22, 95 % CI 0.05 - 1.02, p = 0.05). After adjusting for age and sex, Evusheld administration was still associated with a lower COVID-19 infection risk though it did not achieve nominal significance (OR 0.21, 95 % CI 0.04 - 1.09, p = 0.06). Of the 9 participants who were offered but did not receive Evusheld, five (55.6 %) tested positive for COVID-19 (p = 0.04 with Pearson's chi square test and p = 0.09 on Fisher's exact test). CONCLUSIONS: Our medical records data demonstrated that only 61 % of MS patients offered Evusheld received the injection. Evusheld seems to be largely well-tolerated. No serious adverse effects were reported. The use of Evusheld was associated with fewer COVID-19 infections, but this did not reach nominal statistical significance in the modest sample size. The lessons learned from the initial Evusheld experience may be applied to future interventions directed at infection prevention in MS patients on immunomodulatory therapies.

Therapeutic Advances in Multiple Sclerosis.

Multiple sclerosis (MS) is an autoimmune disease affecting the central nervous system that causes significant disability and healthcare burden. The treatment of MS has evolved over the past three decades with development of new, high efficacy disease modifying therapies targeting various mechanisms including immune modulation, immune cell suppression or depletion and enhanced immune cell sequestration. Emerging therapies include CNS-penetrant Bruton's tyrosine kinase inhibitors and autologous hematopoietic stem cell transplantation as well as therapies aimed at remyelination or neuroprotection. Therapy development for progressive MS has been more challenging with limited efficacy of current approved agents for inactive disease and older patients with MS. The aim of this review is to provide a broad overview of the current therapeutic landscape for MS.

A Collaboration Among Primary Care-Based Clinical Pharmacists and Community-Based Health Coaches.

BACKGROUND/OBJECTIVES: Medication discrepancies and adverse drug events are common following hospital discharge. This study evaluates whether a collaboration between community-based health coaches and primary care-based pharmacists was associated with a reduction in inpatient utilization following hospitalization. DESIGN: Retrospective cohort study using propensity score matching. SETTING: Urban academic medical center and surrounding community. PARTICIPANTS: Intervention patients (n = 494) were adults aged 65 and older admitted to the University of California, Los Angeles (UCLA) Ronald Reagan Medical Center during the study period and who met study inclusion criteria. A matched-control group was composed of patients with similar demographic and clinical characteristics who were admitted to the study site during the study period but who received usual care (n = 2,470). A greedy algorithm approach was used to conduct the propensity score match. INTERVENTION: Following acute hospitalization, a health coach conducted a home visit and transmitted all medication-related information to a pharmacist based in a primary care practice. The pharmacist compared this information with the patient's electronic medical record medication list and consulted with the patient's primary care provider to optimize medication management. MEASUREMENTS: Thirty-day readmissions (primary outcome), 60- and 90-day readmissions, and 30-day emergency department (ED) visits (secondary outcomes) to UCLA Health. RESULTS: Among 494 patients who received the intervention, 307 (62.1%) were female with a mean age of 83.0 years (interquartile range [IQR] = 76-90 years). Among 2,470 matched-control patients, 1,541 (62.4%) were female with a mean age of 82.7 years (IQR = 74.9-89.5 years). For the propensity score match, standardized mean differences were below .1 for 23 of 25 variables, indicating good balance. Patients who received this intervention had a significantly lower predicted probability of being readmitted within 30 days compared with matched-control patients (10.6%; 95% confidence interval [CI] = 7.9-13.2) vs 21.4%; 95% CI = 19.8-23.0; P value < .001). CONCLUSION: A home visit conducted by a health coach combined with a medication review by a primary care-based pharmacist may prevent subsequent inpatient utilization.

Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease.

BACKGROUND: Biologic therapies in patients with Crohn's disease often yield low clinical and endoscopic remission rates. After multiple failed therapies, combining two biologic therapies is possibly the sole medical alternative to recurrent surgery. However, data on this approach are limited. AIMS: To assess the efficacy and safety of concomitant use of two biologic therapies in the largest cohort to date of refractory Crohn's disease patients. METHODS: Data were extracted from Crohn's disease patients started on dual biologic therapy at two referral centres. Biologics utilised include infliximab, adalimumab, vedolizumab, ustekinumab, certolizumab and golimumab. The primary outcome was endoscopic improvement (>50% reduction in Simplified Endoscopic Score-Crohn's disease [SES-CD] or explicitly stated). Endoscopic remission (SES-CD < 3 or stated), clinical response (Crohn's disease-patient-reported outcome-2 score [PRO2] reduced by 8), clinical remission (PRO2 < 8), and C-reactive protein (CRP) were also assessed. RESULTS: A total of 22 patients with 24 therapeutic trials of dual biologic therapy were identified. The majority of patients had prior surgical resections (91%), stricturing (59%) or penetrating (36%) phenotype, and perianal fistulas (50%). Median number of prior failed biologics was 4. Endoscopic improvement occurred in 43% of trials and 26% achieved endoscopic remission. Fifty per cent had clinical response and 41% achieved clinical remission. There were significant post-treatment reductions in median SES-CD (14.0 [12.0-17.5] to 6.0 [2.5-8.0], P = 0.0005], PRO-2 (24.1 [20.3-27.0] to 13.4 [4.6-21.8], P = 0.002] and CRP (17.0 [11.0-24.0] to 9.0 [4.0-14.0], P = 0.02). Presence of perianal fistulas decreased from 50% to 33%. Adverse events occurred in 13% of trials. CONCLUSION: Dual biologic therapy was associated with clinical, biomarker and endoscopic improvements in selected patients with refractory Crohn's disease who failed multiple biologics. Further studies are needed to validate this approach.

Improving medication management competency of clinical trainees in geriatrics.

The authors hypothesized that an interprofessional workshop would improve geriatrics trainees' medication management. The workshop was based on a needs assessment and comprised an interactive session with pharmacists on managing medications in elderly adults. Participants were trainees in their geriatrics rotation at a tertiary care medical center. Trainees completed a medication appropriateness survey for three patients, one of which was their own. After the workshop, trainees reviewed medications of the three patients. Trainees completed online surveys after their rotation and 3 months later. Of 95 trainees rotating through geriatrics, 76 (80%) attended the workshop and completed the worksheet. Trainees' scores on reviewing medication lists improved significantly, from 6.7±2.3 to 7.7±2.0 out of 11 for standardized patient 1 (P<.001) and from 5.7±1.8 to 6.4±1.5 out of 11 for standardized patient 2 (P=.009). Trainees' scores on their own patients' lists also improved significantly, from 5.6±1.5 to 6.6±1.5 out of 10 (P<.001). After the workshop, 95% (71/75) planned to change the medication regimen of the patient they presented, and 93% (68/73) planned to change other patients' medications based on information learned during the workshop. Three months later, 35% (12/34) had made changes to the regimen of the patient they discussed during the workshop, and 71% (15/21) had made changes to other patients' regimens. Seventy-eight percent (18/23) rated the workshop as the top nonclinical experience of their geriatrics rotation. In conclusion, this interprofessional medication management workshop improved trainees' ability to perform medication reviews accurately and led to change in self-reported prescribing behavior.