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MP 5.01.01 Guidelines for Prior Authorization of Pharmacologic Therapies

Medical Policy    

Prescription Drug

Original Policy Date
May 2013

Last Review Status/Date
Created with literature search/5:2013

  Return to Medical Policy Index


Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 

All drugs on the Blue Cross of Idaho prior authorization list must go through the prior authorization process.

FDA indication alone does not establish the medical necessity (See Policy Guidelines) of a particular drug for a particular patient.  We reserve the right to review all treatments for their clinical appropriateness. 

Oncologic Drug Use                                                                                                                                                                        

Oncologic drugs will be evaluated according to National Cancer Care Network (NCCN) guidelines (  Additional scientific data may be reviewed as appropriate.

NCCN grade 1 and 2A recommendations may be considered medically necessary (See Policy Guidelines) when appropriately applied to the patient in question.

2B and lower recommendations are considered investigational.

All drugs requiring prior authorization will still need to be evaluated for medical necessity through the standard process.  NCCN guidelines will then be reviewed by Blue Cross of Idaho in the context of the particular patient. 

Off-label Drug Use                                                                                                                                                                         

Off-label or "unlabeled" 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 for 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 or unlabeled 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 uses.

Off-label drug uses should be viewed as potentially medically necessary pending evaluation of their efficacy to determine whether the off-label use improves health outcomes. (See Policy Guidelines).

This policy shall not be construed to require coverage for any drug when the FDA has determined its use to be contraindicated. It is suggested that each unlabeled use of any drug be individually evaluated. 

Policy Guidelines                                                                                                                                                                          

Medical Necessity will be evaluated using the following criteria:

A. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

  • The evidence should consist of well-designed and well-conducted investigations published in peer-review journals. The quality of the body of studies and the consistency of the results are considered in evaluating the evidence.
  • The evidence should demonstrate that the technology can measure or alter the physiological changes related to a disease, injury, illness, or condition. In addition, there should be evidence or a convincing argument based on established medical facts that such measurement or alteration affects the health outcomes.
  • Opinions and evaluations by national medical associations, consensus panels, or other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence and rationale.

B. The technology must improve the net health outcome.

  • The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.

C. The technology must be as beneficial as any established alternatives.

  • The technology should improve the net health outcome as much as, or more than, established alternatives.

D. The improvement must be attainable outside the investigational settings.

  • When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy criteria B and C.

Policy History

Date Action Reason
05/14/13 Add to Prescription section New policy