As common—and costly—as off-label prescribing is in oncology, it is poorly understood. It is, by nature, hard to study.
Yet it is clear that the practice is changing. Skyrocketing drug costs, tightening reimbursement, and a growing awareness of the financial toxicity of oncology drugs are curbing traditional off-label drug use.
In the other direction, oncologists are pushing boundaries with new immunotherapies, prescribing off-label on the basis of a drug’s activity in a different setting and, experts worry, supported with little high-quality data.
There are few studies quantifying this trend, but a recent analysis of 168 oncology practices in the United States, including more than 2000 oncologists, found that 18% of prescriptions for nivolumab or pembrolizumab were off-label. And this off-label use is pulling patients away from clinical trials, according to investigators.
Reimbursement, Payers Becoming More Restrictive
According to Robin Zon, MD, vice president and senior partner of Michiana Hematology Oncology, in Mishawaka, Indiana, reimbursement models are affecting off-label use, and payers are becoming more restrictive. Most reimbursement models, said Zon, are based on clinical pathways or guidelines from the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO)…