Blue Cross Blue Shield of North Dakota recognizes the following drug compendia as authoritative sources for use in the determination of a medically-accepted indication of drugs and biologicals used off-label. New uses for approved products that are not reflected in a product’s labeling are often discovered after marketing. Before a pharmaceutical manufacturer may include any new indications in the labeling for a particular drug it must obtain the government’s approval for the uses. Such approval requires the completion of adequate and well-controlled clinical trials to document the drug’s safety and efficacy for the new uses. Manufacturers, in some cases, may not seek or obtain approval of new uses since there may not be sufficient economic incentive for the product sponsor to perform the necessary research or to make application to the regulatory agency.
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
If a medical policy specific to a drug does not exist:
IBM Watson HealthMicromedex® or the National Comprehensive Cancer Network (NCCN) Guidelines can be used as a reference to determine FDA approval of a drug or accepted, off-label indications. Benefits will be allowed for either Accepted FDA approved indications or Accepted off-label indications from either of these sources. The Micromedex Strength of Recommendation Class I or Class IIa will be considered an allowable indication for off-label indications. NCCN Guidelines with a Category 2A level of evidence and consensus or above will be considered an allowable indication for off-label use.