A real-world study helped show how pegfilgrastim biosimilar can improve savings in the Oncology Care Model and its successor, the Oncology Care First Model, according to findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
A real-world study of patients with breast cancer who received febrile neutropenia prophylaxis with biosimilar pegfilgrastim (Udenyca) or reference pegfilgrastim (Neulasta) has not only demonstrated comparable efficacy between the 2 products but also shown that large-scale comparisons of this nature can be done, according to a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
Investigators said the study was driven in part by the ongoing efforts by CMS to spur advances in value-based care, particularly through the Oncology Care Model (OCM) and its follow-on, the Oncology Care First Model.
“We have learned through the [OCM] that there are savings to be found by reducing inpatient admissions and emergency department visits and controlling for things such as duplicate [laboratory tests]. However, it has become increasingly clear that further savings will require practices to evaluate their use of both cancer-directed therapy and supportive therapy,” they wrote.
Pegfilgrastim is typically used to stem the incidence of neutropenia, which is a common adverse event for patients undergoing chemotherapy. Pegfilgrastim expense amounts to 5.3% of the total cost of cancer care in the OCM, so trimming this expense via use of biosimilars has great potential for savings.
Study Design
Investigators used the Integra Connect Value Monitor to perform the comparative effectiveness research at scale. This enabled them to perform a matched cohort analysis of patients with breast cancer receiving biosimilar vs reference forms of pegfilgrastim between January 1, 2017, and August 31, 2019. Patients were matched according to age, gender, OCM participation status, and date of treatment. Each biosimilar patient (n = 496) was matched to 5 Neulasta patients.
The rate of neutropenia was the efficacy end point, and neutropenia was defined as patients having an absolute neutrophil count (ANC) less than 1500 or the presence of an ICD-10 code to classify neutropenia in the patient’s medical record.
The rates of neutropenia demonstrated by the biosimilar and reference product were similar at 28.6% and 29.1%, respectively (P = .82).
“These rates are likely higher than those reported in the literature due to the very broad definition of neutropenia used in this study. Follow up will include neutropenia rates by grade,” including grade IV neutropenia (ANC < 500), investigators said.
In an additional study presented at this year’s ASCO meeting, investigators said that use of biosimilar pegfilgrastim in the OCM enabled them to reverse the upward trend in the cost of pegfilgrastim use. The rate was increasing at $292 per year and the biosimilar use from mid-2018 until mid-2019 contributed to a cost decline of $93 over the first year.
For more biosimilar news from ASCO20 Virtual, click here.
Reference
Webster J, Scott JA, Smith H. Udenyca has equivalent efficacy to the pegfilgrastim originator in breast cancer patients receiving highly myelosuppressive chemotherapy. Presented at: ASCO20 Virtual; May 30-31, 2020. Abstract e19273. meetinglibrary.asco.org/record/190539/abstract
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.