Comparative Efficacy and Safety of Lorlatinib Versus Alectinib and Lorlatinib Versus Brigatinib for ALK-Positive Advanced/Metastatic NSCLC: Matching-Adjusted Indirect Comparisons.

Introduction: The comparative efficacy and safety of lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), versus second-generation ALK TKIs as a first-line treatment for ALK+ advanced/metastatic nonsmall cell lung cancer (NSCLC) remains uncertain as there are no head-to-head clinical trials.

Methods: Matching-adjusted indirect comparisons (MAICs) were conducted using phase III trial data demonstrating superior efficacy over crizotinib, a first-generation ALK TKI. MAICs were conducted to compare lorlatinib (CROWN) versus alectinib (ALEX and ALESIA) and brigatinib (ALTA-1L) with matching based on prespecified effect modifiers.

The Impact of Biosimilar Use on Total Cost of Care and Provider Financial Performance in the Medicare Oncology Care Model: A Population-Based Simulation Study.

Introduction: Payment for oncology care is increasingly moving from fee-for-service to value-based payment (VBP). VBPs are agreements in which providers are held accountable for total cost of care (TCOC) through risk-sharing arrangements with payers that tie reimbursement levels to TCOC benchmarks. Oncology biosimilars may play an important role in managing financial risk in the VBPs like Medicare's Oncology Care Model (OCM), but there has been limited research in this area.

Biomarker Testing Trends in Patients With Metastatic Colorectal Cancer Who Live in Rural Areas and Urban Clusters in the US.

Background: There is a paucity of data on biomarker testing rates in rural populations with metastatic colorectal cancer (mCRC). To assess biomarker testing practices, oncologists in rural areas and urban clusters in the US were surveyed.

Materials And Methods: A web-based survey was administered to oncologists spending ≥40% of their time practicing in rural areas or urban clusters and who had treated ≥2 patients with stage IV mCRC in the prior month.

Practical Strategies for Advanced Practitioners Streamlining the Integration of Oncology Biosimilar Therapies Into Practice.

In oncology practices across the United States, biosimilars-highly similar versions of licensed, innovator (reference) biological medicines-are currently emerging as more affordable therapeutic options. Only after a rigorous product development program, during which a proposed biosimilar is analyzed and compared with its reference biologic to demonstrate comparable clinical efficacy, safety, and tolerability, is biosimilarity supported and licensure granted by the US Food and Drug Administration. Coincidentally, many advanced practitioners (APs) are finding themselves at the forefront of introducing monoclonal antibody (mAb) biosimilars in their oncology practice.

Real-world usage of bevacizumab-bvzr biosimilar in US oncology practice.

Objectives: Bevacizumab is commonly used to treat solid tumors. However, little is known about the manner and the extent to which bevacizumab biosimilars are utilized in real-world oncology practice in the United States. The objective of this study was to describe patient and provider characteristics and treatment patterns associated with the recently introduced bevacizumab-bvzr biosimilar.

Real-world use and acceptance of biosimilar monoclonal antibodies of rituximab in oncology practice in the USA.

To describe treatment patterns and patient and provider characteristics associated with the recently introduced biosimilar rituximab-pvvr. This retrospective analysis included adult patients with one or more claims for rituximab-pvvr, with an index date of 23 January 2020 and a study period covering 1 January 2019-31 July 2020. Of 249 patients included, the most common rituximab-pvvr indications were non-Hodgkin's lymphoma (77.

Sowing confusion in the field: the interchangeable use of biosimilar terminology.

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)-licensed reference product. FDA released the draft guidance for industry on Demonstrating Interchangeability with a Reference Product (hereafter referred to as the Draft Interchangeability Guidance) in January 2017. Despite FDA's efforts, there continues to be a great deal of confusion and misinformation surrounding the topic of interchangeability.