Non-medical Switching Research Articles

Retrospective analysis of the safety and efficacy of Pembroria® during non-medical switching from the original drug Keytruda® in patients with advanced malignancies of various localizations in real clinical practice

Introduction. The emergence of genetically engineered biological drugs is rightly considered a revolutionary event in medicine. In 2022, the first biosimilar of pembrolizumab, the Russian drug Pembroria®, was approved. One of the study types that can convincingly demonstrate the safety and efficacy of biosimilar is its use for switching from the original drug for non-medical indications (NMS, or non-medical switching) according to standard approaches of real clinical practice and the drug label. Aim. To assess the safety of NMS switching in patients with advanced malignancies of various localizations from the original drug Keytruda® to the biosimilar Pembroria® and to evaluate its effectiveness in real clinical practice. Materials and methods. We analyzed the data of 114 patients with advanced malignancies of various localizations and the last line of treatment with Keytruda® as monotherapy or in combination with other agents within the approved indications and switched to Pembroria® for NMS. After switching to Pemboria®, patients did not change treatment for another checkpoint inhibitor within this line of therapy. Results. The incidence of immune-mediated adverse reactions (imARs) of any severity during treatment with comparators differed slightly: 57% with Keytruda® and 54% with Pembroria®. The majority of imARs with both Keytruda® and Pembroria® were Grade 1 in severity (69% and 86%, respectively). All serious ARs were resolved and did not result in drug discontinuation. When analyzing the best objective response to treatment with Keytruda®, complete response, partial response, and stabilization were observed in 9 (7.9%), 28 (24.6%), and 61 (53.5%) cases, respectively, during treatment with Pemboria® – in 8 (7%), 24 (21%), 52 (45.6%) cases, respectively. Conclusion. The safety profile of Keytruda® and Pembroria® is acceptable and comparable: the imAR rate with Pembroria® when switching from Keytrada® did not exceed that with the original drug Keytruda®; in most patients, switching from Keytruda® to Pembroria® was not associated with an increase in the imAR rate or severity. The majority of patients maintained disease control when switched to Pembroria®.

Utilization management and physician burnout.

This study was designed to assess physician experiences with utilization management and burnout and investigate whether they are linked. We conducted an electronic survey with items related to demographics, profession, utilization management, burnout, and potential policy solutions. The survey was sent to 7222 physicians working in outpatient settings who were recruited from a large, opt-in database. Outcome measures were responses to categorical and Likert-style survey items related to demographics, utilization management, burnout, and potential policy solutions. Of 7222 requests sent, 501 physicians completed the survey and were included in the final data set (77% men; mean [SD] age, 57 [9.8] years; mean [SD] years in practice, 24 [8.9]). Of these, 200 were general practitioners and 301 were nonhospital specialists. Physicians indicated that utilization management procedures for prior authorization (81%), step therapy (79%), and nonmedical switching (69%) were major or significant barriers to their clinical and patient care. More than half (52%) reported spending 6 to 21 or more hours per week on paperwork related to health insurance utilization management, 67% had experienced burnout at some point in their careers, and 64% indicated that utilization management had been a contributing factor to feelings of burnout, with an additional 8% citing it as the main factor. Physicians favored streamlining prior authorization practice (77%), requiring step therapy to be based on science (73%), and ensuring that peer-to-peer reviews are done by qualified medical experts (67%). These findings indicate that utilization management has a detrimental impact on physicians and patient care and contributes to physician burnout.

Downstream Effects of Market Changes on Inhalers: Impacts on Individuals With Chronic Lung Disease.

COPD and asthma are two of the most common chronic lung diseases, affecting over 545 million people globally and 34 million in the United States. Annual health care costs related to chronic lung disease are estimated at €380 billion in the European Union, and $24-$50 billion in the United States averaging to $4,000 in out-of-pocket costs per person in the U.S. A full-text literature search was conducted for English publications between January 1, 2005-March 18, 2024. It returned over 5,000 publications that were further narrowed using key search words, resulting in 172 peer-reviewed articles. Using their experience and subject expertise, the authors further narrowed the peer-reviewed articles to 55 that were in their opinion relevant. Also, 38 recently published industry reports and news articles specific to downstream effects of inhaler market changes and the future impact were included. The literature suggests that individuals with chronic lung disease face increased challenges with access to inhaled medication due to rising medication costs, discontinuation of branded medications, introduction of generic medications not covered by insurance, exclusionary preferred drug list tactics that force health care providers into non-medical switching of medication or devices, and ongoing medication shortages. Providers experience ongoing hurdles in prescribing appropriate inhaled medications for individuals with chronic lung disease, including increased time and costs spent on administrative tasks due to inhaler denials, a loss of patient trust, and limits on their ability to prescribe appropriate inhaled medication for individuals with chronic lung disease.

2022 CVS Caremark DOAC non-medical switch: Patient ramifications and physician advocacy

2022 CVS Caremark DOAC non-medical switch: Patient ramifications and physician advocacy

The Efficacy, Safety, and Persistence of Therapy after Non-Medical Switching from an Originator Adalimumab in Inflammatory Bowel Disease: Real-Life Experience from Two Tertiary Centres.

During the last two decades, an increased number of molecules with multiple mechanisms of action have been approved for the treatment of inflammatory bowel disease (IBD), with a substantial increase in the costs related to therapy, which has become a concern for payers, regulators, and healthcare professionals. Biosimilars are biologic medical products that are highly structurally similar to their reference products; have no clinically meaningful differences in terms of immunogenicity, safety, or effectiveness; and are available at a lower price. Materials and Methods: This was an observational prospective study conducted in two IBD centres in Bucharest and included 53 patients, 27 male (M) and 26 female (F), diagnosed with IBD according to standard clinical, endoscopic, radiological, and histological criteria, who were non-medically switched at the indication of the National Insurance House to a biosimilar of Adalimumab. Aims: The aim was to determine the rates of clinical remission, adverse effects, and treatment persistence at one year. Results: No significant differences were found in terms of the faecal calprotectin (FC) and C-reactive protein (CRP) levels 6 and 12 months after changing from the originator biologic treatment to a biosimilar. Only one patient required a change in their biological treatment following the clinical and biological loss of response. The main adverse effect reported by the patients was pain at the injection site. Of the 53 patients, only 2 reported pain at the injection site, and 1 patient reported experiencing abdominal pain and rectal bleeding immediately after the switch, but no recurrence was observed clinically or endoscopically. Conclusions: This observational study is the first to be carried out in Romania that shows that, after a non-medical switch, biosimilars of Adalimumab are as efficient and safe as the originator Adalimumab in the clinical treatment of patients with IBD.

A Bayesian model to analyse the association of comorbidities with biosimilar treatment retention in a non-medical switch scenario in patients with inflammatory rheumatic musculoskeletal diseases

ObjectivesTo analyse clinical outcomes of a non-medical switch from originator adalimumab (ADA) to its ABP501 biosimilar (ABP) over 6 months in patients with inflammatory rheumatic musculoskeletal diseases (RMD) in relation to comorbidity as a risk factor for therapy discontinuation.MethodsRMD patients switching from originator ADA to ABP were identified from a large routine database from October 2018 onwards. Documented clinical data at the time of non-medical switching (baseline), and at 3 and 6 months were collected. Comorbidities were represented by the Charlson Comorbidity Index (CCI) at baseline and patients were categorized based on CCI > 0. Differences in the ABP retention rate over 6 months between patients with CCI = 0 and patients with CCI > 0 were analysed using Bayesian exponential regression.ResultsA total of 111 patients with axial spondyloarthritis (n = 68), rheumatoid arthritis (n = 23) and psoriatic arthritis (n = 15), were identified, 74.8% of whom had continued treatment with ABP after 6 months, while a smaller proportion had either switched to another ADA biosimilar (10.8%), switched back to originator ADA (7.2%), switched to a different biologic (3.6%), or dropped out (3.6%). At baseline, a CCI > 0 was found in 38% of patients. Cardiovascular comorbidities (40%) were most prevalent followed by diseases of the skin (33%), the gastrointestinal tract (20%) and the eye (20%). ABP treatment was continued after 6 months in 74% of patients with CCI = 0 and in 76% with CCI > 0. Bayesian analysis showed only a small difference (months) in the APB continuation rate between groups (estimate 0.0012, 95% credible interval (CrI) -0.0337 to 0.0361). Adjusting for age, sex, and disease subtype revealed somewhat shorter retention rates for patients with CCI > 0, but the distribution of the difference included 0 (estimate -0.0689, 95% CrI -0.2246 to 0.0234).ConclusionIn a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups.

Non-Medical Switching or Discontinuation Patterns among Patients with Non-Valvular Atrial Fibrillation Treated with Direct Oral Anticoagulants in the United States: A Claims-Based Analysis.

This study assessed direct-acting oral anticoagulant (DOAC) switching/discontinuation patterns in patients with non-valvular atrial fibrillation (NVAF) in 2019, by quarter (Q1-Q4), and associated socioeconomic risk factors. Adults with NVAF initiating stable DOAC treatment (July 2018-December 2018) were selected from Symphony Health Solutions' Patient Transactional Datasets (April 2017-January 2021). Switching/discontinuation rates were reported in 2019 Q1-Q4, separately. Non-medical switching/discontinuation (NMSD) was defined as the difference between switching/discontinuation rates in Q1 and mean rates across Q2-Q4. The associations of socioeconomic factors with switching/discontinuation were assessed. Of 46,793 patients (78.7% ≥ 65 years; 52.6% male; 7.7% Black), 18.0% switched/discontinued their initial DOAC in Q1 vs. 8.8% on average in Q2-Q4, corresponding to an NMSD of 9.2%. During the quarter following the switch/discontinuation, more patients who switched/discontinued in Q1 remained untreated (Q1: 77.0%; Q2: 74.3%; Q3: 71.2%) and fewer reinitiated initial DOAC (Q1: 17.6%; Q2: 20.8%; Q3: 24.0%). Factors associated with the risk of switching/discontinuation in Q1 were race, age, gender, insurance type, and household income (all p < 0.05). More patients with NVAF switched/discontinued DOACs in Q1 vs. Q2-Q4, and more of them tended to remain untreated relative to those who switched/discontinued later in the year, suggesting a potential long-term impact of NMSD. Findings on factors associated with switching/discontinuation highlight potential socioeconomic discrepancies in treatment continuity.

Safety of Pembroria® during non-medical switching from Keytruda® in patients with advanced malignant neoplasms of various localizations: the REFLECTION real-world study

Background. Post-registration observational studies with switching therapy from the original drug to a biosimilar for non-medical indications allow us to assess the safety and effectiveness of this type of switching in real clinical practice. Aim. Evaluation of the safety and effectiveness of non-medical switching from the original drug Keytruda® to the biosimilar drug Pembroria® in patients with various oncological pathologies in real clinical practice (REFLECTION). Materials and methods. A retrospective analysis of data from electronic medical records from 21 medical institutions of the Russian Federation for the period 2020–2023 was carried out. Data were included from patients with cancer of various locations who received at least 2 injections of Keytruda® followed by switching to Pembroria® for non-medical indications (at least 2 injections). Primary criteria: incidence of immune-mediated adverse reactions (ImARs) of any severity. Secondary indicators: incidence of ImARs of various degrees of severity and infusion reactions, frequency of objective response rate (according to RECIST 1.1 criteria). Results. The analysis included data from 382 patients (male/female 200/182, median age 62 years) with NSCLC (24.1%), RCC (23.3%), melanoma (20.4%) and cancer of other localization. Patients received Keytruda® on 1st and 2nd lines (54.2 and 25.4% of patients, respectively), on 3 or 4 lines (14.1%), or as part of adjuvant therapy (6.3%). 50.5% of patients received pembrolizumab as monotherapy. The median number of administrations was 7.0 and 5.0 for Keytruda® and Pembroria®, respectively. ImARs were registered in 44 (11.5%) patients (60 ImARs), including 40 ImARs in 35 (9.2%) patients while using Keytruda® and 20 ImARs in 17 (2.4%) patients with Pembroria®. The most common ImARs were hypothyroidism, hyperthyroidism, and hepatitis; the frequency of these ImARs was higher with Keytruda® (EAER for hypothyroidism 0.00422 and 0.00144, for hepatitis – 0.00124 and 0.00096, respectively). All 5 reported cases of hyperthyroidism in patients on Keytruda® (EAER 0.00124), were resolved before switching to Pembroria®. No infusion-related reactions or deaths due to ImARs have been reported. The objective response rate was comparable – 104 (32.6%) and 90 (29.2%) patients оn Keytruda® and Pembroria® therapy, respectively. Most patients maintained disease control after switching to Pembroria® [progression was recorded in 29 (9.4%) patients after switching to a biosimilar]. Conclusion. The safety profiles of Keytruda® and Pembroria® were satisfactory and comparable in this study. Switching from therapy with Keytruda® to Pembroria® is not accompanied by an increase in the frequency or severity of ImARs. Switching from Keytruda® to Pembroria® maintains disease control in most patients.

Outcomes after anti-tumour necrosis factor originator to biosimilar switching in children and young people with juvenile idiopathic arthritis in the UK: a national cohort study.

For cost-saving purposes, children and young people with juvenile idiopathic arthritis (JIA) are being switched (for non-medical reasons) from biological originators to biosimilars. Here, we aimed to investigate those who switched from an anti-tumour necrosis factor (TNF) originator to a biosimilar, regarding drug survival and disease activity, compared with a matched cohort who continued the originator. This analysis included all patients in the UK JIA Biologics Register switching directly from an anti-TNF originator to a biosimilar of the same product. All patients were matched (age, sex, disease duration, calendar year of when patients started originator therapy, line of therapy, and International League of Associations for Rheumatology [ILAR] category) to patients continuing the originator. For those matched successfully, a Cox proportional hazard model assessed whether drug persistence differed between those who switched compared with those who continued the originator. Overall change in the 71-joint juvenile arthritis disease activity score and the proportion of patients with a clinically important worsening score (by ≥1·7 units) after 6 months was compared between cohorts. This analysis was designed to address a priority research area set by our patient partners. There were 224 children and young people with non-systemic JIA (139 [62%] were female, and 85 [38%] were male) identified as switching from a biological originator to a biosimilar of the same product from Jan 1, 2017, to July 7, 2023. 143 (64%) patients were originally on adalimumab, 56 (25%) on etanercept, and 25 (11%) on infliximab. Of these, 164 patients were matched successfully to those continuing the originator. There was no evidence that patients switching were more likely to stop treatment compared with those continuing the originator, with a hazard ratio of 1·46 (95% CI 0·93-2·30). Of the 51 patients in the biosimilar group who stopped treatment, 18 (35%) switched back to the originator (14 in the first year), 28 (55%) started a different biological drug, and five (10%) discontinued all treatment by the last follow-up. Of the 87 matched patients with available disease activity, there was no evidence that JADAS-71 worsened more after 6 months, with an odds ratio of 0·71 (95% CI 0·34-1·51; p=0·38). In this matched comparative effectiveness analysis, children and young people with JIA switched from originators to biosimilars. Disease activity was similar between patients switching compared with those continuing the originator. Three quarters of patients were still receiving their biosimilar after 1 year, with switching back to originator uncommon, at only 9% after 1 year, suggesting good tolerability of non-medical switching in this patient population. This information is reassuring to clinicians and patients regarding the effect of non-medical biological switching. British Society for Rheumatology, Versus Arthritis, and National Institutes for Health Research Manchester Biomedical Research Centre.

HSD3 Implications of Non-Medical Switching in Medicare Part D: An Updated Review of the Literature

HSD3 Implications of Non-Medical Switching in Medicare Part D: An Updated Review of the Literature

Results of a 24-week open-label, non-interventional study on the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

In the context of the new coronavirus infection (NCI) COVID-19 pandemic, the rheumatological community is facing new challenges in the treatment of immune-inflammatory rheumatic diseases (IIRDs). It has been shown that rheumatological patients have an increased risk of infections and a severe course of NCI and that IIRD therapy also influences the disease outcomes. In particular, the use of the anti-B-cell medication rituximab (RTM) is associated with a higher risk of severe NCI and increased mortality. The COVID-19 pandemic has highlighted the need to find alternative and safe treatment options for these patients. This work is the continuation of a 12-week study on the efficacy and safety of olok-izumab (OKZ) therapy in patients with rheumatoid arthritis (RA) after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic. Objective: to evaluate the efficacy and safety of OKZ (Artlegia®; solution for subcutaneous administration, 160 mg/ml – 0.4 ml) for the treatment of patients with RA in real-life clinical practice after switching from RTM during the COVID-19 pandemic. Material and methods. The study included 19 patients with a confirmed diagnosis of RA who had received RTM at a dose of 500–1000 mg twice every 14 days at least 6 months ago. As disease activity increased, RTM was replaced with OKZ while therapy with synthetic disease-modifying anti-rheumatic drugs (DMARDs) was continued. At weeks 0, 4, 8, 12 and 24 after switching the biologic DMARD, the number of tender (TJN) and swollen (SJN) joints out of 28, pain intensity on a visual analogue scale, ESR, CRP level, disease activity indices CDAI, DAS28-ESR, DAS28-CRP, HAQ index and the safety profile of the therapy were assessed at each visit. Results and discussion. After 4, 8, 12 and 24 weeks of OKZ administration, there was a statistically significant decrease in mean TJN (from 10 to 6.0, 3.0, 5.0 and 4.0, respectively; p &lt; 0.05) and SJN (from 7.0 to 3.0 by week 4 and to 2.0 by weeks 8, 12 and 24; p &lt; 0.05). At the same time, a decrease in CRP and ESR values was also observed: median CRP decreased from 18 to 0.6 mg/l by week 4 and to 0.5 mg/l by weeks 8, 12 and 24 (p &lt; 0.05), ESR from 30 to 5 mm/h in each study period (p &lt; 0.05). CRP levels normalized by week 4, regardless of baseline values. All RA activity indices showed a positive dynamic compared to baseline values from week 4 onwards in each assessment period. After weeks 4, 8, 12 and 24, the median DAS28-ESR decreased from 5.50 to 3.57; 3.30; 3.08 and 3.01 (p &lt; 0.05); DAS28-CRP – from 5.30 to 3.46; 3.23; 3.26 and 3.12 (p &lt; 0.05); CDAI – from 27.0 to 17.0; 12.0; 15.0 and 12.0 (p &lt; 0.05), respectively. All patients showed a decrease in pain by the 4th week of observation. A statistically significant improvement in functional status was observed after the 4th week of therapy and was maintained until week 24. The median HAQ index decreased from 1.62 to 1.50 at weeks 4, 8 and 12 and to 1.12 at week 24 (p &lt; 0.05). Conclusion. The study showed that the non-medical switch from RTM to OKZ during the COVID-19 pandemic was effective and safe.

Long-Term Survival of Subcutaneous Biosimilar Tumor Necrosis Factor Inhibitors Compared to Originators: Results From a Multicenter Prospective Registry.

To analyze the long-term survival of subcutaneous biosimilar tumor necrosis factor inhibitors compared to the originator molecules in patients with rheumatic diseases, as well as the factors associated with drug discontinuation. Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of patients with rheumatic disease receiving biologic and targeted disease-modifying antirheumatic drugs. Patients who started etanercept (ETN) or adalimumab (ADA) from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific causes (inefficacy or adverse events [AEs]) of discontinuation. A total of 4162 patients received 4723 treatment courses (2991 courses of ADA and 1732 courses of ETN), of which 722 (15.29%) were with originator molecules and 4001 (84.71%) were with biosimilars. The originators were more frequently discontinued than biosimilars (53.32% vs 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI 0.75-0.95). Female sex, obesity, and second or later treatment lines increased the risk of discontinuation, whereas disease duration and the use of concomitant methotrexate were associated with a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. No significant differences were found between treatments in long-term survival due to inefficacy or AEs.

Comparative Effectiveness and Persistence of SB4 and Reference Etanercept in Patients With Psoriatic Arthritis in Norway.

We aim to compare drug effectiveness and persistence between the reference etanercept (ETN) and ETN biosimilar SB4 in patients with psoriatic arthritis (PsA) naive to ETN and to investigate drug effectiveness and persistence in those undergoing a mandatory nonmedical switch from ETN to SB4. We used a retrospective comparative database study including 1,138 patients with PsA treated with ETN or SB4 (years 1999-2021) in Norway. Disease activity score in 28 joints (DAS28) and drug persistence were compared between unmatched ETN (n = 644) and SB4 (n = 252) cohorts and in matched analyses (n = 144, both cohorts) at baseline using a propensity score (PS) to adjust for confounders. Drug persistence was analyzed with the Kaplan-Meier method. In unmatched analyses, difference in change from baseline between ETN (n = 140) and SB4 (n = 132) for DAS28 at one year was mean 0.67 (95% confidence interval [CI] 0.38-0.96) in favor of ETN. In PS-matched analyses, the difference in change from baseline between ETN (n = 54) and SB4 (n = 54) was mean 0.09 (95% CI -0.33 to 0.50), and the mean difference assessed with an analysis of covariance model was 0.01 (95% CI -0.38 to 0.40), both within predefined equivalence margin (±0.6). Drug persistence at one year was mean 0.75 (95% CI 0.71-0.78) for ETN, mean 0.58 (95% CI 0.51-0.63) for SB4, hazard ratio (HR) 2.45 (95% CI 2.02-2.97) in unmatched analysis, and mean 0.55 (95% CI 0.46-0.63) for ETN, mean 0.60 (95% CI 0.51-0.67) for SB4, HR 1.29 (95%CI 0.94-1.76) in PS-matched cohorts. At one year, outcomes for PsA disease activity and drug persistence were comparable for patients treated with either ETN or SB4. In patients undergoing a mandatory nonmedical switch from ETN to SB4, drug effectiveness was maintained during a two-year period.

Does the introduction of an infliximab biosimilar always result in savings for hospitals? A descriptive study using real-world data

BackgroundBiosimilars are biologic drugs that have the potential to increase the efficiency of healthcare spending and curb drug-related cost increases. However, their introduction into hospital formularies through initiatives such as non-medical switching must be carefully orchestrated so as not to cause treatment discontinuation or result in increased health resource utilization, such as additional visits or laboratory tests, among others. This retrospective cohort study aims to assess the impact of the introduction of CT-P13 on the healthcare expenditures of patients who were treated with originator infliximab or CT-P13.MethodsGastroenterology, immunoallergology and rheumatology patients treated between September 2017 and December 2020 at a university hospital in Western Switzerland were included and divided into seven cohorts, based on their treatment pathway (i.e., use and discontinuation of CT-P13 and/or originator infliximab). Costs in Swiss francs were obtained from the hospital's cost accounting department and length of stay was extracted from inpatient records. Comparisons of costs and length of stay between cohorts were calculated by bootstrapping.ResultsSixty immunoallergology, 84 rheumatology and 114 gastroenterology patients were included. Inpatient and outpatient costs averaged (sd) CHF 1,611 (1,020) per hospital day and CHF 4,991 (6,931) per infusion, respectively. The mean (sd) length of stay was 20 (28) days. Although immunoallergology and rheumatology patients had higher average costs than gastroenterology patients, differences in costs and length of stay were not formally explained by treatment pathway. Differences in health resource utilization were marginal.ConclusionsThe introduction of CT-P13 and the disruption of patient treatment management were not associated with differences in average outpatient and inpatient costs and length of stay, in contrast to the results reported in the rest of the literature. Future research should focus on the cost-effectiveness of non-medical switching policies and the potential benefits for patients.

Outcomes of a mandatory non-medical switch of infliximab to a biosimilar for inflammatory bowel disease in British Columbia, Canada.

Despite infliximab biosimilars becoming widely used in inflammatory bowel disease (IBD) patients, real-world non-medical switching is sparse. A biosimilar non-medical switch was launched in British Columbia in 2019, the first Canadian province to do so, from Remicade to an approved biosimilar (CT-P13 or SB2). This study aims to obtain real-world evidence evaluating the clinical outcomes of non-medical switching from Remicade to the infliximab biosimilars. This is a retrospective observational study of stable IBD patients from the IBD Centre of BC who underwent the non-medical infliximab switch. The primary outcome is treatment continuation at 12 ± 2 months post-switch. Secondary outcomes include frequency of loss of response, adverse events, and immunogenicity within the first 12 months post-switch. A control group of patients maintained on the originator served as a comparison. Patients in the biosimilar switch group (n = 264) and originator group (n = 99), show similar demographics and disease characteristics. There was no difference in infliximab continuation between the biosimilar group (94.9%) and the originator group (90.1%) (P = 0.18). Reasons for discontinuation of infliximab included loss of response (4.04% vs 4.91%), immunogenicity (1.01% vs 0.75%), or adverse effect (1.01% vs 2.3%) in the infliximab originator vs biosimilar switch group, respectively. Similarly, no differences in safety or efficacy were observed between patients switched to CT-P13 or SB2. Non-medical biosimilar switch of infliximab demonstrates similar clinical outcomes compared to originator molecule continuation for therapy of IBD. These data support the safety and efficacy of non-medical infliximab switching in IBD patients.

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

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. 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. Fifty-threepatients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGAscores 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). Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after aone-time nonmedicalswitch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

P938 Effectiveness and safety of switching from original infliximab to GP1111 biosimilar in inflammatory bowel diseases – prospective, cohort study

Abstract Background Biosimilars are highly similar to the already approved reference biological medication, and are potentially more accessible widespread due to the better cost-effectiveness. However, both the effectiveness and immunogenicity may differ due to structure characteristics. In 2020, non-medical switch was obligated from originator infliximab (IFX) to biosimilar GP1111 amongst inflammatory bowel disease (IBD, Crohns’s disease [CD], ulcerative colitis [UC]) patients in Hungary. As data regarding GP1111 are lacking in IBD, thus we aimed to assess the pharmacokinetics, effectiveness and safety of biosimilar GP1111 following the financial switch. Methods This was a real-world, prospective, single-center cohort study enrolling IBD patients who were switched from original IFX to GP1111 biosimilar. Baseline was defined as the day of the switch, and 52 weeks of follow-up was set. Demographic and clinical data were recorded at w0, w8, w16, w24, and w52, while infliximab serum levels were measured at baseline and at w52. Primary outcome was change in serum trough level of IFX, while sustained steroid-free remission, loss of response rates and adverse events were secondary outcomes. Results Overall, data of 142 patients were analyzed (median age: 43.1 years [IQR: 32.3 - 49.6]; male/female ratio: 77/65; CD: 97, UC: 42). Mean follow-up period was 46.2 ± 10.3 weeks. Change in serum IFX level was not observed (baseline 3.2 ± 2.3, µg/mL; w24: 3.7 ± 2.7 µg/mL; p = 0.106). Sustained steroid-free remission rates did not alter at w52 (99/142) from baseline (86/142) (p = 0.11). Overall, treatment was ceased in 24 patients. Following dose escalation and intensification, 9/18 patients discontinued treatment due to loss of response. Further treatments were ceased in 15 patients due to allergy (8), paradoxical reactions (3), malaise (1), pregnancy (1), and non-compliance (2). At w52 83.1% of the patients were on drug, and treatment persistence was not associated with the length of prior IFX treatment period. Conclusion Our study revealed convincing effectiveness with reassuring safety profile of switching to GP1111 in long-term, with sustained IFX levels. The usage of this particular biosimilar in daily practice may be suggested.

Communication skills-based training about medication switch encounters: pharmacy staff and patients' experiences.

Non-medical medication switches can lead to difficult conversations. To support pharmacy staff, a communication training has been developed based on two strategies: 'positive message framing' to emphasize positive elements of the message and 'breaking bad news model' to break the news immediately and address emotions. To assess how patients and trained pharmacy staff experience the application of communication strategies for non-medical medication switch conversations and which are barriers and facilitators for the application. The Kirkpatrick training evaluation model, level 3 'behavior', including barriers and facilitators and 4 'results' was used. Trained pharmacy staff registered switch conversation characteristics and asked patients to complete a questionnaire. Semi-structured interviews with trained pharmacy staff members were conducted. Quantitative data were analyzed descriptively and interview data were analyzed thematically. Of the 39 trained pharmacy staff members, 21 registered characteristics of 71 conversations and 13 were interviewed; 31 patients completed questionnaires. Level 3: trained pharmacy staff self-reported they applied aspects of the strategies, though indicated this was not yet a standard process. Interviewees indicated signs of increased patient contact and job satisfaction. Time, face-to-face conversations and colleague support were facilitators. Level 4: pharmacy staff members were satisfied with most switch conversations (89%), particularly with addressing emotions (74%). Patients were (very) positive (77%) about the communication, particularly about clear explanations about the switch. Pharmacy staff's learned behavior includes being able to apply aspects of the strategies. The training results show first signs of better patient-pharmacy staff relationships and increased job satisfaction.

S38 Efficacy and Safety of Nonmedical Switching From Infliximab Originator to Infliximab Biosimilar CT-P13 in Patients With Inflammatory Bowel Disease, A Single-Center Prospective Study in Japan

S38 Efficacy and Safety of Nonmedical Switching From Infliximab Originator to Infliximab Biosimilar CT-P13 in Patients With Inflammatory Bowel Disease, A Single-Center Prospective Study in Japan

SAT109 Diabetic Ketoacidosis Due To Non-medical Switching

Abstract Disclosure: A.S. Can: None. Z. Zhang: None. F. Yeakley: None. Background/Objective: Non-medical switching is a change in treatment regimen for reasons other than efficacy, side effects, or adherence. Non-medical switching aims to decrease health care costs and is initiated by patient’s health insurance company. Case Report: A 20-year-old female with type 1 diabetes mellitus presented with diabetic ketoacidosis (DKA). She was having issues between her health insurance and pharmacy in filling her prescriptions. Both her standing prescription for long-acting (Basaglar, Eli Lilly and Company, Indianapolis, IN, USA) and rapid-acting (Admelog, sanofi-aventis U.S. LLC, Bridgewater, NJ, USA) insulin were no longer covered. The insulin treatment was switched as requested by her health insurance and Semglee (Mylan Pharmaceuticals Inc., a Viatris Company, Morgantown, WV, USA) as long-acting and Humalog (Eli Lilly and Company, Indianapolis, IN, USA) as rapid-acting insulin prescriptions were transmitted to the pharmacy electronically. The patient was confused on what she should be taking. This led to her thinking that her new long-acting insulin (Semglee) was her rapid-acting due to a name that she did not recognize from her past diabetes self-management education. The patient endorsed taking long-acting insulin Semglee three times daily before meals in place of rapid-acting insulin along with previously prescribed long-acting insulin Basaglar twice daily before breakfast and at bedtime. To make things worse, she could not fill her prescription for Semglee due to a Semglee shortage in the preceding three weeks before her admission. Patients with similar health plan were switched to the same insulin at the same time, causing a shortage in our service area. Even if Admelog was prescribed, she was under the impression that she was getting her rapid-acting insulin needs from Semglee. She did not fill her prescription for Admelog. After her discharge, her insurance covered her original regimen (Basaglar and Admelog) that she was on before her non-medical switching. Around the time of admission, wholesale acquisition cost of 5-pack of 3 ml (1500 Units) of Basaglar was $326.36 and unbranded Semglee $147.98 allowing a saving of $0.12 for one unit of insulin. Our patient takes 40 units of long-acting insulin daily, totaling 14600 units per year. Non-medical switching would achieve $1736 savings per year. But inpatient bill for this DKA was $17078. Discussion: In our case, non-medical switching defeated its purpose and increased health care spending. With the switches, patient became confused about her medical regimen. Non-medical switching did not only place additional financial burden but jeopardized patient safety by significantly contributing to an acute complication of diabetes. Further studies that compare health care utilization, not just drug prices are needed to find out if non-medical switching really saves money and is cost-effective. Presentation: Saturday, June 17, 2023