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MP 5.01.01 Guidelines for Prior Authorization of Pharmacologic Therapies

Medical Policy    

Section
Prescription Drug

Original Policy Date
May 2013

Last Review Status/Date
Reviewed with literature search/1:2015

Issue
1:2015
  Return to Medical Policy Index

Disclaimer

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.

https://www.bcidaho.com/Prescription%20Drugs/special_programs/drugs_priorauthorization.asp

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 according to these standards.

Oncologic Drug Use

Oncologic drugs will be evaluated according to National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org). 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 (See Policy Guidelines)

Off-label Drug Use

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.  Off-label uses of drugs range from completely unstudied applications to thoroughly investigated applications for which FDA approval has not been sought.

Non FDA-approved therapies are considered investigational as defined below (See Policy Guidelines).

Off-label applications of FDA-approved drugs may be considered medically necessary when all of the following criteria are met:

  • The drug and indicated use meet Blue Cross of Idaho medical necessity standards:
    • The most appropriate supply or level of service, considering potential benefits and harms to the Insured. 
    • Proven to be effective in improving health outcomes; 
      • For new treatments, effectiveness is determined by scientific evidence; 
      • For existing treatments, effectiveness is determined first by scientific evidence, then by professional standards, then by expert opinion. 
    • Not primarily for the convenience of the Insured or Covered Provider. 
    • Cost-effective for this condition, compared to alternative treatments, including no treatment. Cost-effectiveness does not necessarily mean lowest price.
  • The drug is recognized as appropriate for the stated indication:
    • By one of the following sources:
      • The National Comprehensive Cancer Network (see Oncologic Drug Use above)
      • The American Hospital Formulary Service Drug Information
      • Facts & Comparisons documentation level 1 (good) or 2 (fair)
    • In the absence of inclusion in one of the above resources (eg. very rare diseases or newly identified treatments), at least two scientific studies from major peer-reviewed journals supporting the efficacy and safety of the treatment must be submitted for review.  These articles will be evaluated on their strength of evidence.

If the off-label drug use is determined to be medically necessary, its use shall also be determined to be "non-investigational" for the purposes of benefit determination.

This policy shall not be construed to require coverage for any drug when the FDA has determined its use to be contraindicated.

 

Policy Guidelines

All requested therapies, supplies and services will be evaluated in accordance with the following criteria:

Medically Necessary —the Covered Services or supplies required to identify or treat an Insured’s condition, Disease, Illness or Accidental Injury and which, as recommended by the treating Physician or other Covered Provider and as determined by Blue Cross of Idaho, are:  

  1. The most appropriate supply or level of service, considering potential benefits and harms to the Insured. 
  2. Proven to be effective in improving health outcomes; 
    1. For new treatments, effectiveness is determined by scientific evidence; 
    2. For existing treatments, effectiveness is determined first by scientific evidence, then by professional standards, then by expert opinion. 
  3. Not primarily for the convenience of the Insured or Covered Provider. 
  4. Cost-effective for this condition, compared to alternative treatments, including no treatment. Cost-effectiveness does not necessarily mean lowest price.

Investigational—any technology (service, supply, procedure, treatment, drug, device, facility, equipment or biological product), which is in a developmental stage or has not been proven to improve health outcomes such as length of life, quality of life, and functional ability. A technology is considered investigational if, as determined by Blue Cross of Idaho, it fails to meet any one of the following criteria:

  1. The technology must have final approval from the appropriate government regulatory body. This applies to drugs, biological products, devices, and other products/procedures that must have approval from the U.S. Food and Drug Administration (FDA) or another federal authority before they can be marketed. Interim approval is not sufficient. The condition for which the technology is approved must be the same as that BCI is evaluating. 
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence should consist of current published medical literature and investigations published in peer-reviewed journals. The quality of the studies and consistency of results will be considered. The evidence should demonstrate that the technology can measure or alter physiological changes related to a Disease, injury, Illness, or condition. In addition, there should be evidence that such measurement or alteration affects health outcomes.
  3. The technology must improve the net health outcome. The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. 
  4. The technology must be as beneficial as any established alternatives. 
  5. The technology must show improvement that is attainable outside the investigational setting. Improvements must be demonstrated when used under the usual conditions of medical practice.

These definitions may not apply to some health plans, such as Federal Employee Program (FEP), Medicare Advantage and some self-funded group plans. Blue Cross of Idaho reserves the right to periodically update its definitions.


Policy History

Date Action Reason
05/14/13 Add to Prescription section New policy
1/19/15 Replace policy updated with literature review