In August 2024, the Centers for Medicare & Medicaid Services (CMS) announced a negotiated price for the Bruton’s tyrosine kinase inhibitor ibrutinib that is 38% lower than the manufacturer’s list price. This new price will go into effect in January 2026. Negotiations began following passage...
Decisions regarding the rationing of chemotherapy are commonplace in many countries around the world—including those where patients must pay for chemotherapy out of pocket—and increasingly so in cancer settings that treat both well-off and socioeconomically disadvantaged patients. However, these...
Regulations that are developed by the U.S. Food and Drug Administration (FDA) must have some shelf-life before revisions are considered. The FDA has several mechanisms to provide patients with more rapid access to medicines. One such pathway is accelerated approval. Backward Glance at Accelerated...
In an article in The Lancet Oncology, Y. Tony Yang, ScD, of George Mason University, Charles L. Bennett, MD, PhD, MPP, of the University of South Carolina and colleagues from the United States, Europe, and Japan examined clinical, policy, safety, and regulatory considerations for generic oncology...
Charles L. Bennett, MD, PhD, MPP of the University of South Carolina College of Pharmacy, and James O. Armitage, MD, of the University of Nebraska Medical Center, discuss the emerging and future benefits of biosimilars.
As introduced in our report on page 1 of this issue, counterfeit pharmaceuticals are an increasingly important safety concern, and three of the most prominent drug-counterfeiting episodes in recent years have involved hematology/oncology products. Counterfeit Erythropoietin Helen B., a 61-year-old...
In 2002, Tim F., a 17-year-old liver transplant patient, received 40,000 units of erythropoietin weekly, beginning immediately after his transplantation procedure.1 His family had purchased the product from the local CVS Pharmacy, upon his discharge from a Manhattan hospital. After each injection,...
Twenty years ago, the National Comprehensive Cancer Network (NCCN) began as a cooperative effort of 12 prestigious cancer centers, working to define and promote national guidelines for the care of patients with cancer. A major goal was to encourage uniformity in the management of malignant...
A study among patients with advanced non–small cell lung cancer (NSCLC) treated with carboplatin-paclitaxel or carboplatin-paclitaxel-bevacizumab (Avastin) found that those receiving the bevacizumab combination were more likely to experience a toxicity event but were less likely to be...