10 October 2018 - In accordance with federal law, CMS must reimburse cancer drugs used off-label if one of five authorised drug compendia consider such treatment medically appropriate.
Private insurers often refer to the compendia and make similar reimbursement decisions. Here, off-label refers to prescription of pharmaceuticals for an unapproved indication, age group, dose, or form of administration. Off-label use is widely practiced in oncology; for example, with the drug Tarceva (erlotinib). The National Comprehensive Cancer Network (NCCN) estimates that 50% to 75% of all uses of cancer therapy are off-label.
Recently, concerns have been raised regarding the five reference guides that CMS utilises to justify reimbursement of drugs used off-label for cancer: