Indications, Dosages and Administration of FDA-Approved Drugs Form

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 include AHFS Drug Information or LexiDrugs (Supportive), DrugDex (must have

Strength of Recommendation Class I or IIa

Strength of Evidence Category A or B), Clinical Pharmacology (must have

Quality of Evidence High or Moderate

Strength of Recommendation Strong), and NCCN Drugs & Biologics Compendium (Categories of Consensus I and IIa).

In the absence of a published Aetna Clinical Policy Bulletin (CPB) to the contrary, U.S. Food and Drug Administration (FDA)-approved prescription drugs are considered medically necessary for an indication if:

In the absence of a published Aetna CPB to the contrary, the medically necessary dosage of an FDA-approved presciption drug for an indication is equal to any of the following:

: 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.