Review of Medicare Part B Avastin and Lucentis Treatments for Aged-Related Macular Degeneration

摘要

Medicare Part B provides limited coverage for drugs and biologicals that are furnished incident to a physician's service and that are not usually self-administered. Biologicals are medications that are made from living organisms or their products. In general, to meet coverage requirements, drugs and biologicals must be safe and effective and otherwise reasonable and necessary. Medicare considers drugs and biologicals that the Food and Drug Administration (FDA) has approved for marketing to be safe and effective when used for indications specified on the labeling. Physicians sometimes prescribe drugs and biologicals for indications not specified on their labels. Such uses are referred to commonly as off-label. Medicare may cover off-label use of FDA-approved drugs and biologicals if it determines the use to be medically accepted. While off-label prescribing by physicians is not prohibited, manufacturers may not promote drugs and biologicals for uses that have not been approved by FDA. Wet age-related macular degeneration (wet AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States. Avastin and Lucentis are currently the most commonly administered Part B biologicals used to treat wet AMD.