As new and exciting advancements in cancer drugs and care are made, updated guidance and regulations must follow. Oncologists and other stakeholders must keep up with the latest rules and regulations in order to utilize these advancements to their and patients’ advantage, however, translating guidance into real-world practice and procedures is difficult, to say the least. New guidance creates many questions that may not have ready answers.
The Centers for Medicare and Medicaid Services (CMS) recently announced their reimbursement level for the new chimeric antigen receptor T-cell (CAR-T) products. While it is in line with their standard reimbursement methodology for medications on an outpatient basis, it creates a dilemma for the institution and the patient. Depending on the site of service, financial implications are significant, impacting the feasibility of providing access to this breakthrough medication. I explore this question of the site-of-service setting in my Viewpoint article, examining the key differences between CMS Part A and Part B coverage, as this is critical to fully comprehend the dilemma (page 37).
In their Counterpoint piece, Chadi Nabhan, MD, MBA, FACP, and Bruce A Feinberg, DO, address some of the questions I raise related to CAR-T therapy infusion settings (page 38). They contend that, while there are financial implications to the decision of therapy setting, it is critical to ensure that patients receive CAR-T therapy safely in a monitored environment where timely interventions to mitigate potential adverse events are available. They underscore that the decision on site of service should first and foremost consider patient safety.
The Food and Drug Administration (FDA) recently published guidance that clarifies how pharmaceutical manufacturers can share product information with payers while remaining compliant with FDA rules on communication. The FDA aims to promote value-based contracting through increased sharing of information, including off-label use of a pharmaceutical treatment. In his column, Richard G Stefanacci, DO, MGH, MBA, AGSF, CMD, discusses how pathway developers could incorporate this information concerning use beyond the label into clinical pathways to achieve greater clinical and financial value (page 34).
Also included in this issue is a Research Report utilizing real-world claims data of patients with metastatic colorectal cancer (mCRC). As guidelines continue to evolve based on new evidence, it is important to understand the characteristics of patients with mCRC who are tested for biomarkers and the potential impact of testing on treatment. Alexandra Christodoulopoulou, MSc, and colleagues present findings from an observational retrospective cohort study of selected participants from a payer claims database to evaluate KRAS/RAS testing patterns in patients with mCRC (page 40). They found that KRAS/RAS testing significantly reduced the risk of discontinuation in first-line, second-line, and overall treatment.
