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Medical Policy: 05.01.09
Original Effective Date: July 2005
Reviewed: September 2011
Revised: September 2008
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Off-label drug use is the use of a drug approved by the U.S. Food and Drug Administration (FDA) for other uses or in treatment regimens or patient populations that are not included in approved labeling.
The FDA approves drugs or specific indications that are included in the drug's labeling. When a drug is used for an indication other than those specifically included in the labeling, it is referred to as an off-label use. Many off-label uses are effective, well-documented in the literature, and widely used.
Unapproved uses of drugs include a variety of situations ranging from completely unstudied to thoroughly investigated drug uses where the FDA has not been asked for approval, whereas approved uses of drugs have been proved to be safe and effective by the FDA after the review of adequate and controlled clinical trials that have documented their use.
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Prior Approval:
Not applicable
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Policy:
Off-label, or unlabeled, uses of drugs may be considered medically necessary for use if the indication is supported by one of the following drug compendia:
- American Hospital Formulary Service Drug Information (AFHS-DI)
- Drug Facts and Comparison
- National Comprehensive Cancer Network (NCCN) Drugs and Biologics CompendiumTM
- Gold Standard's Clinical PharmacologyTM
OR
The scientific evidence indicates the drug is effective for the off-label indication. The evidence must:
- Consist of an adequate number of well-designed studies with sufficient numbers of patients in relation to the incidence of the disease.
- Be published in major peer-reviewed journals that publish original manuscripts only after the manuscripts have been critically reviewed by unbiased independent experts for scientific accuracy, validity, and reliability.
- Demonstrate consistent results across all studies.
- Document positive health outcomes and demonstrate that the drug is as effective as or more effective than established alternatives.
- Document improvements that are attainable outside the investigational setting.
Off-label uses in cases where established alternatives have failed or there is a lack of alternative treatment(s) for a rare condition may be considered medically necessary if:
AND
Internal publications or promotional material from pharmaceutical manufacturers are not peer-reviewed literature.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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Selected References:
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Policy History:
Date Reason Action
September 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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