Real-world trends in biosimilar prescribing among oncology providers, 2019-2021.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18701-e18701
Author(s):  
Kelly A. McGlynn ◽  
Jacqueline McGarry ◽  
Kashyap B. Patel ◽  
Natasha Clinton

e18701 Background: The number of approved biosimilars in the United States has increased exponentially in recent years. Within the oncology market, there are currently 14 approved biosimilars, with 11 launched since the start of 2019. The emergence of new oncology biosimilars provides a tool for success in value-based care, and has the potential to lower costs to patients and providers and expand access to care. Methods: Analysis of biosimilar prescribing behavior was performed using 2020 prescription data (Wolters Kluwer, n = 130,836), sales data (IQVIA), and dosage data for patients taking bevacizumab, trastuzumab, rituximab, or an FDA-approved biosimilar for these products (FDA Purple Book), between 2019-2021 (ION Solutions, n = 69,884). Drugs not directly interchangeable with the bevacizumab, trastuzumab or rituximab reference products according to NCCN guidelines were excluded. Results: Biosimilar products are currently available for bevacizumab (2 biosimilars), rituximab (3 biosimilars), and trastuzumab (5 biosimilars). We found that in 2020, 8.2% of new prescriptions for any of these three reference products were for a biosimilar. An analysis of real-world drug administration data revealed that in the 3 months following the 2019 launch of trastuzumab’s first biosimilar (trastuzumab-anns), 7.3% of initiating line 1 patients were prescribed the biosimilar over the reference product. During the same period in 2020, when a total of 5 trastuzumab biosimilars were available, 80.5% of initiating line 1 trastuzumab patients began treatment on a biosimilar, suggesting rapid uptake by providers. However, this differed by product, with the initial uptake for the first rituximab biosimilar (rituximab-pvvr), at only 2.3%. Uptake also occurred within treatment lines, with 11.1% of all patients (bevacizumab: 11.3%, trastuzumab: 14.1%, rituximab: 7.9%) switching from a reference product to a biosimilar during treatment. Uptake was particularly rapid for trastuzumab biosimilars: among patients on trastuzumab at the time of its first biosimilar launch, 18.2% switched to trastuzumab-anns in the first 90 days post-launch. Biosimilars launched at significantly lower prices than their reference products, with cost per prescription at -42.0%, -29.9% and -89.5% relative to the reference product for trastuzumab, rituximab and bevacizumab, respectively. However, biosimilar launches had little impact on reference product pricing, with 2019-2020 year-over-year (YOY) differences in price per prescription close to the YOY averages in previous years (2015-2019) for all three reference products. Conclusions: We conclude that uptake of biosimilars among oncology providers between 2019-2020 was rapid, although the extent of biosimilar prescribing varied among products. Biosimilars offered greatly reduced costs to providers, although reference product prices remained stable despite increased biosimilar competition.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 81-81
Author(s):  
Ran Jin ◽  
Neil A Accortt ◽  
Darcie Sandschafer ◽  
Tatiana Lawrence ◽  
Arturo Loaiza-Bonilla

81 Background: Bevacizumab-awwb is the first anti-cancer biosimilar and the first biosimilar to bevacizumab approved by the FDA. It was launched in the United States on July 19, 2019. Bevacizumab-awwb approval was based on a phase 3 study in a pre-determined sensitive population of non-squamous non-small cell lung cancer (NSCLC) patients. This study investigated initial use of bevacizumab-awwb, across its approved indications for advanced cancer management, in real-world US community and academic oncology practices. Methods: This retrospective observational study described demographic and clinical characteristics of patients who received bevacizumab-awwb using structured patient-level data from the nationwide de-identified Oncology Services Comprehensive Electronic Records (OSCER), a Flatiron Health EHR-derived database. The database is longitudinal, demographically and geographically diverse, and includes more than 2.2 million US cancer patients from >280 cancer clinics. This analysis included adult patients who received ≥1 bevacizumab-awwb infusion between July 30, 2019 and April 30, 2020 and focused on describing initial biosimilar uptake in cancer patient populations beyond NSCLC. Results: First use of bevacizumab-awwb was in mCRC and occurred within 10 days of product launch. All bevacizumab-awwb approved cancer indications were represented among 2,422 patients treated with bevacizumab-awwb. Initial use of bevacizumab-awwb across indications: mCRC (68%), NSCLC (14%), brain cancer (11%), cervical cancer (5%), metastatic renal cell carcinoma (1%). Among 1657 mCRC patients treated with bevacizumab-awwb, 55% were male with a median age of 65 years (y). Most patients were white (60%), with ECOG scores of 0/1 (84%), and median body weight was 78 kg. Among mCRC patients, 59% had received the reference product before receiving the biosimilar. Among patients with other tumor types, 42-50% had prior bevacizumab exposure. Among mCRC patients with prior exposure to bevacizumab, 67% received bevacizumab-awwb within 28 days of last infusion of reference product (Table). Demographic and clinical characteristics were comparable between patients with and without prior bevacizumab use. Conclusions: Early evidence suggests physicians are comfortable initiating or transitioning patients to the first FDA-approved biosimilar to bevacizumab, with little evidence that demographic characteristics differ between patients with and without previous treatment with bevacizumab. Future analyses will determine whether these patterns persist across all indications. [Table: see text]


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 24-25
Author(s):  
David L. Grinblatt ◽  
Bhavik J. Pandya ◽  
Wei Han ◽  
Loretta Sullivan ◽  
Qi Feng ◽  
...  

Background: Targeted inhibition of the FLT3 tyrosine kinase is a treatment strategy for patients with relapsed or refractory, FLT3 mutation-positive acute myeloid leukemia (R/R FLT3mut+ AML). While the multikinase inhibitors, sorafenib and midostaurin, were not approved specifically for R/R AML, they are used off-label as treatment. Since FDA approval on 11/28/2018, gilteritinib has become the first globally approved targeted therapy for the treatment of R/R FLT3mut+ AML in adults. This study aims to understand the treatment landscape for R/R FLT3mut+ AML patients following the introduction of a new therapeutic agent. Aim/Objective: To describe the characteristics and treatment patterns of patients initiating FLT3 tyrosine kinase inhibitors (TKIs) for R/R FLT3mut+ AML in the real-world setting. Methods: This US-based retrospective cohort study was conducted using two separate closed-claims databases (MarketScan, 1/1/2007-2/29/2020; IQVIA, 1/1/2006-4/30/2020) and a specialty-pharmacy claims database (ProMetrics, 12/6/2018-3/12/2020). Patients ≥18 years of age, with an AML diagnosis and newly initiated FLT3-TKI (ie, gilteritinib, midostaurin, or sorafenib) therapy for R/R diagnosis or episode ("R/R AML") on or after gilteritinib market availability were eligible for inclusion. Patients were indexed on the first newly initiated FLT3-TKI for R/R AML observed on or after 12/1/2018. Patients' baseline clinical and demographic characteristics, AML-related treatments preceding FLT3-TKI initiation for R/R AML, and concomitant therapies (defined as any AML-related treatment overlapping with FLT3-TKI use after R/R AML) were identified. Because individual patients could have received more than one FLT3-TKI during the study period, treatment sequencing was analyzed by FLT3-TKI-containing regimens. Given the larger sample size available within the ProMetrics Specialty Pharmacy database, gilteritinib dose patterns and treatment duration were analyzed using de-identified dispensed prescription data from a separate gilteritinib-only cohort for greater precision. Descriptive statistics were used to evaluate all study outcomes, except for treatment duration, which was estimated using Kaplan-Meier life table analysis. Results: A total of 52 and 51 patients initiating FLT3-TKIs for R/R AML were identified in the MarketScan and IQVIA databases, respectively. The mean age of patients was 53.1 (MarketScan) and 52.3 years (IQVIA); patients had a mean ± SD Quan-Charlson Comorbidity Index of 3.6 ± 2.4 (MarketScan) and 3.7 ± 2.2 (IQVIA). Most patients treated with FLT3-TKIs for R/R AML during the study period were first initiated on gilteritinib (MarketScan: n=35 [67.3%], IQVIA: n=36 [70.6%]); sorafenib was the second most common FLT3-TKI (MarketScan: n=9 [17.3%], IQVIA: n=8 [15.7%]), followed by midostaurin (MarketScan: n=8 [15.4%], IQVIA: n=7 [13.7%]). During the study period, 61 and 55 FLT3-TKI-containing regimens among 52 and 51 R/R AML patients were identified across the MarketScan and IQVIA databases, respectively. Most FLT3-TKI-containing regimens for R/R AML included gilteritinib (MarketScan: n=43 [70.5%], IQVIA: n=38 [69.1%]). Prior exposure to other FLT3-TKIs for new onset and/or R/R AML indications was observed in up to 63% of gilteritinib-, 56% of sorafenib-, and 13% of midostaurin-containing regimens (Table). Following onset of R/R AML, gilteritinib was given without concomitant chemotherapy in 47% (Marketscan: 20/43) to 55% (IQVIA: 21/38) of gilteritinib regimens; in a smaller sample of sorafenib regimens, sorafenib was given without concomitant chemotherapy in up to 56% (IQVIA: 5/9) of regimens. Of 748 patients identified in the ProMetrics database with gilteritinib claims, 714 (95%) patients were initiated on a 120-mg daily dose, with less than 5% (n=34) incurring a downward dosage titration. The median treatment duration was 150 days (95% CI: 129-172 days). Conclusions: Among FLT3-TKI-containing regimens initiated for R/R AML after gilteritinib market approval, close to 70% included gilteritinib, an agent approved for R/R FLT3mut+ AML. Sample sizes for midostaurin- and sorafenib-containing regimens limited characterization of treatment patterns. Gilteritinib was given without concomitant chemotherapy in approximately 50% of regimens prescribed; the dose and treatment durations were similar to those previously reported by the ADMIRAL trial. Disclosures Grinblatt: Astellas: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Alexion: Speakers Bureau. Pandya:Astellas Pharma, Inc.: Current Employment. Sullivan:Astellas Pharma: Current Employment. Feng:Astellas: Current Employment. Hedlund:Astellas: Current Employment.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 73-73
Author(s):  
Amit Sanyal ◽  
Michelle Schmitt ◽  
Daniel Wellner

73 Background: Biosimilar drugs, defined as biologic products with no clinically significant differences in quality, efficacy and safety compared to approved reference products have gained increasing adoption based on studies projecting significant cost savings[1]. Real world evaluation of biosimilar related cost savings and adoption is however still limited. We prospectively evaluate cost savings generated by transitioning to biosimilar monoclonal antibodies in a community based oncology practice. Methods: In July 2020, a process for transitioning patients to biosimilar equivalents of Rituximab, Trastuzumab and Bevacizumab was implemented in a community based oncology practice. Provider adoption was facilitated by monthly oncology pharmacy governance meetings that allowed provider participation and feedback followed by defaulting the preferred biosimilar product in oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI). The treatment templates allowed for care personalization by listing reference products that could be chosen if desired. Cost savings achieved by switching to biosimilars was calculated by subtracting the actual spending on the biosimilar product from projected acquisition cost of the branded reference product (Table). Biosimilar adoption, defined as amount of biosimilar drug used over total amount of the drug ordered was also calculated. Results: Between July 2020 and April 2021, transitioning to biosimilar products for Rituximab, Bevacizumab and Trastuzumab resulted in net savings of $268,194.64, $285,251.89 and $274,359.51 respectively. Actual spending on Rituximab biosimilar product was $726,476.10 against a projected spending of $994,670.74 on the branded reference product. Actual spending on Bevacizumab biosimilar product was $1,254,977.30 against a projected spending of $1,540,229.19 on the branded reference product. Actual spending on Trastuzumab biosimilar product was $1,218,641.60 against a projected spending of $1,493,001.11 on the branded product. Average biosimilar utilization between October 2020 and April 2020 has been 92%, 100% and 98% for Rituximab, Bevacizumab and Trastuzumab respectively. Conclusions: Significant cost-savings can result from widespread utilization of biosimilar drugs in community oncology practices. References: Mulcahy, A.W., J.P. Hlavka, and S.R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Rand Health Q, 2018. 7(4): p. 3.[Table: see text]


2020 ◽  
Vol 9 (20) ◽  
Author(s):  
Akshay Pendyal ◽  
Craig Rothenberg ◽  
Jean E. Scofi ◽  
Harlan M. Krumholz ◽  
Basmah Safdar ◽  
...  

Background Despite investments to improve quality of emergency care for patients with acute myocardial infarction (AMI), few studies have described national, real‐world trends in AMI care in the emergency department (ED). We aimed to describe trends in the epidemiology and quality of AMI care in US EDs over a recent 11‐year period, from 2005 to 2015. Methods and Results We conducted an observational study of ED visits for AMI using the National Hospital Ambulatory Medical Care Survey, a nationally representative probability sample of US EDs. AMI visits were classified as ST‐segment–elevation myocardial infarction (STEMI) and non‐STEMI. Outcomes included annual incidence of AMI, median ED length of stay, ED disposition type, and ED administration of evidence‐based medications. Annual ED visits for AMI decreased from 1 493 145 in 2005 to 581 924 in 2015. Estimated yearly incidence of ED visits for STEMI decreased from 1 402 768 to 315 813. The proportion of STEMI sent for immediate, same‐hospital catheterization increased from 12% to 37%. Among patients with STEMI sent directly for catheterization, median ED length of stay decreased from 62 to 37 minutes. ED administration of antithrombotic and nonaspirin antiplatelet agents rose for STEMI (23%–31% and 10%–27%, respectively). Conclusions National, real‐world trends in the epidemiology of AMI in the ED parallel those of clinical registries, with decreases in AMI incidence and STEMI proportion. ED care processes for STEMI mirror evolving guidelines that favor high‐intensity antiplatelet therapy, early invasive strategies, and regionalization of care.


Author(s):  
Wendy Thompson ◽  
Leanne Teoh ◽  
Colin C. Hubbard ◽  
Fawziah Marra ◽  
David M. Patrick ◽  
...  

Abstract Objective: Our objective was to compare patterns of dental antibiotic prescribing in Australia, England, and North America (United States and British Columbia, Canada). Design: Population-level analysis of antibiotic prescription. Setting: Outpatient prescribing by dentists in 2017. Participants: Patients receiving an antibiotic dispensed by an outpatient pharmacy. Methods: Prescription-based rates adjusted by population were compared overall and by antibiotic class. Contingency tables assessed differences in the proportion of antibiotic class by country. Results: In 2017, dentists in the United States had the highest antibiotic prescribing rate per 1,000 population and Australia had the lowest rate. The penicillin class, particularly amoxicillin, was the most frequently prescribed for all countries. The second most common agents prescribed were clindamycin in the United States and British Columbia (Canada) and metronidazole in Australia and England. Broad-spectrum agents, amoxicillin-clavulanic acid, and azithromycin were the highest in Australia and the United States, respectively. Conclusion: Extreme differences exist in antibiotics prescribed by dentists in Australia, England, the United States, and British Columbia. The United States had twice the antibiotic prescription rate of Australia and the most frequently prescribed antibiotic in the US was clindamycin. Significant opportunities exist for the global dental community to update their prescribing behavior relating to second-line agents for penicillin allergic patients and to contribute to international efforts addressing antibiotic resistance. Patient safety improvements will result from optimizing dental antibiotic prescribing, especially for antibiotics associated with resistance (broad-spectrum agents) or C. difficile (clindamycin). Dental antibiotic stewardship programs are urgently needed worldwide.


Drug Safety ◽  
2021 ◽  
Vol 44 (4) ◽  
pp. 447-454 ◽  
Author(s):  
Yasser Albogami ◽  
Amir Sarayani ◽  
Juan M. Hincapie-Castillo ◽  
Almut G. Winterstein

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S111-S111
Author(s):  
Swetha Ramanathan ◽  
Connie H Yan ◽  
Colin Hubbard ◽  
Gregory Calip ◽  
Lisa K Sharp ◽  
...  

Abstract Background Data suggest dental antibiotic prescribing is increasing with relatively less documented about prescribing trends in adults and children. Therefore, the aim was to evaluate trends in antibiotic prescribing by US dentists from 2012–2017. Methods This was a cross-sectional study of US dental prescribing using IQVIA Longitudinal Prescription Data from 2012 to 2017. Prescribing rates (prescriptions [Rx] per 100,000 dentists), mean days’ supply, and mean quantity dispensed were calculated monthly across eight oral antibiotic groups: amoxicillin, clindamycin, cephalexin, azithromycin, penicillin, doxycycline, fluoroquinolone, and other antibiotics. Descriptive frequencies and multiple linear regressions were performed to obtain trends overall and stratified by adults (≥ 18) and children (< 18). Results 220, 325 dentists prescribed 135 million Rx (94.0% in adults). 61.0% were amoxicillin, 14.4% clindamycin, 11.7% penicillin, 4.4% azithromycin, 4.3% cephalexin, 2.0% other antibiotics, 1.4% doxycycline, and 0.7% fluoroquinolones. Prescribing increased by 33 Rx/100,000 dentists (p< 0.0001) each month for all antibiotics. Amoxicillin (p< 0.0001) and clindamycin (p=0.02) prescribing rate increased by 73 and 5 Rx/100,000 dentists, respectively. Prescribing decreased by 8, 12, and 2 Rx/100,000 dentists for cephalexin (p< 0.0001), doxycycline (p< 0.0001), and fluoroquinolones (p=0.008), respectively. Mean days’ supply increased for amoxicillin, penicillin, and clindamycin (p< 0.0001), and decreased for cephalexin (p< 0.0001).Mean quantity dispensed decreased (p< 0.0001) for all groups except azithromycin and doxycycline. Among adults, cephalexin prescribing rates (7 Rx/100,000 dentist; p< 0.0001) and other antibiotics days’ supply (p< 0.0001) decreased. Among children, azithromycin prescribing rates (1 Rx/100,000 dentists, p=0.02), and fluoroquinolone and other antibiotics days’ supply (p< 0.0001) decreased. Conclusion These findings support dental antibiotic prescribing is increasing, specifically for amoxicillin and clindamycin. Further, trends differed between adults and children. Understanding what is driving these trends is important to target dental antibiotic stewardship efforts. Disclosures All Authors: No reported disclosures


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