Indications, Dosages and Administration of FDA-Approved Drugs

Number: 0156

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses indications, dosages and administration of FDA-approved drugs for commercial medical plans.

1. Medical Necessity

   1. Where there is no Aetna Clinical Policy Bulletin (CPB) for an FDA-approved prescription drug, the following may be used to determine the medical necessity of the drug and its dosing:
      

      1. A CVS Caremark Policy on that drug: or
      2. The FDA-approved prescribing information for that drug. In addition to the drug labeling, Aetna may consider the quality and design of the pivotal clinical studies that supported FDA approval of the drug, as well as other relevant clinical studies published in peer-reviewed medical literature; or
      3. The indications and dosages listed as safe and effective by the standard pharmacy compendia: American Society of Health-System Pharmacists Drug Information [AHFS Drug Information], Micromedex (Merative L.P.), Clinical Pharmacology (Elsevier), Lexidrug (UpToDate Inc.), or the National Comprehensive Cancer Network (NCCN) Drug and Biologics Compendium (Note: see Background section for level of evidence standards applied to the compendia in determining safety and effectiveness for the indication); or
      4. Indications and dosages of a drug that are proven as safe and effective by reliable evidence from a well-designed controlled clinical trial (i.e., a Phase III or Phase IIb [single center controlled] trial) published in a peer-reviewed medical journal indexed by the National Library of Medicine PubMed database.
         

   2. In the absence of a published Aetna CPB for an FDA-approved prescription drug, the above listed sources may be used to determine the medical necessity of continued use of that drug. In addition, continued use of a drug may be considered not medically necessary for members who have developed an absolute contraindication or intolerance to the drug, or who have failed to respond or who have lost response to the drug.

2. Policy Limitations and Exclusions

   1. Nothing in this policy should be interpreted as limiting Aetna's ability to require pre-certification of coverage of any given product. Coverage may also be subject to pharmacy benefit management programs and formulary restrictions. Please check benefit plan descriptions for details.
   2. FDA-approved gene-based, cellular, and/or innovative therapies (GCIT) that have a basis in genetic/molecular medicine may require specialty review by GCIT teams at Aetna. This includes reviews by Aetna's National Medical Excellence (NME) team, Specialty Pharmacy, Medicare Part B, and specialized Medicaid team, depending on the line of business.

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Code	Code Description

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Background

For purposes of this policy, a U.S. Food and Drug Administration (FDA)-approved prescription drug is defined as an FDA-approved drug, biological, or compounded prescription which, by State and Federal Law, may be dispensed only by prescription or administered by a person who is acting within his or her capacity as a paid health professional.

For purposes of this policy, compendia accepted indications and Level of Evidence (LOE) include the following:

• American Society of Health-System Pharmacists Drug Information (AHFS Drug Information) and/or UpToDate Lexidrug: Supportive use designation;
• Micromedex DrugDex (Merative L.P.) must have both of the following:
  
  
  • Strength of Recommendation: Class I or IIa; and
  • Strength of Evidence: Category A or B;
    
    

• Clinical Pharmacology (Elsevier) must have both of the following:

  • Strength of Recommendation: Strong; and
  • Level of Evidence Rating (Quality of Evidence): High or Moderate
    (follows the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system);
    
    

• National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium: Categories of Consensus I and IIa.

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References