Compounded Prescription Drug products

Criteria for Approval:

1. The total prescription ingredient cost is ≥ $200; OR 
   1. At least one prescription ingredient in the compounded product is on BCBSNC’s prior review list; AND
2. The compounded product contains at least one prescription ingredient; AND 
3. Costs associated with prescription drug ingredients in the compounded product will be covered if approved by the Food & Drug Administration (FDA) for medical use in the United States; AND 
4. Costs associated with ingredients which are non-FDA approved will not be covered; AND
5. The active prescription medication component(s) are in therapeutic amounts, based on scientific literature or national compendia*; AND 
6. The compounded product is not a copy of any commercially available FDA-approved drug product; AND 
7. The use for which the compounded product is being prescribed is supported by FDA approval of the active ingredient(s), or is supported by adequate medical and scientific evidence in the medical literature* for that diagnosis and for the method or route of delivery; OR
8. If any prescription ingredient in the compounded product is on BCBSNC’s prior review list, the patient must meet the criteria designated for that prescription ingredient; AND
9. Costs associated with ingredients which are over the counter (OTC) medications will not be covered; AND 
10. The compound will not be used for cosmetic purposes; AND 
11. The compound does not contain investigational or experimental drugs as defined in the BCBSNC Corporate Medical Policy Investigational (Experimental) Services; AND 
12. The compound does not contain medications which have been withdrawn or removed from the market for safety purposes; AND 
13. The compound is not being created for convenience only.
    1. Exceptions include: 
       1. Patients that cannot swallow or have trouble swallowing and require administration with an oral liquid, or administration by topical, rectal or other appropriate non-oral routes; OR 
       2. Patients who have sensitivity to dyes, preservatives, or fillers in commercial products and require allergy-free medications as documented in the medical record; OR 
       3. Children who require prescription medications for which there are no liquid formulations available.

 Duration of Approval: 1095 days (3 years) 

* Please note: Medical and scientific evidence is defined as any ONE of the following:

1. Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff; OR
2. Peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institute of Health’s Nations Library of Medicine for indexing in index Medicus, Excerpta Medicus (EMBASE), Medline, or MEDLARS database Health Services Technology Assessment Research (STAR).; OR 
3. Medical journals recognized by the Secretary of Health and Human Services, under Section 1861(t)(2) of the Social Security Act (42 U.S.C. 1395x).; OR 
4. The following standard reference compendia; OR
   1. The American Hospital Formulary Service Drug Information (AHFS-DI) 
   2. Micromedex’s DrugDex 
   3. National Comprehensive Cancer Network (NCCN) Drug & Biological Compendia; OR 
5. Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes including the; 
   1. Agency for Healthcare Research and Quality,
   2. National Institutes of Health,
   3. National Cancer Institute,
   4. National Academy of Sciences,
   5. Center for Medicare and Medicaid Services, 
   6. Any national board recognized by the National Institutes of Health for evaluating the medical value of health services. 

BCBSNC “Off-Label” Requirements

The FDA is responsible for approving medications for use based on clinical data proving the medication is safe and effective for that specific use. BCBSNC’s prior review and quantity limitations programs follow FDA-approved uses for these drugs. However, BCBSNC recognizes that in many cases, “off-label” (non- FDA approved) uses of prescription drugs may be acceptable. In determining the acceptability of off-label uses, BCBSNC utilizes several sources of clinical information including but not limited to 1) nationally recognized clinical references including American Hospital Formulary Service Drug Information and Micromedex; 2) the results of at least two randomized controlled clinical studies that support a specific off-label use, and that are published in peer-reviewed professional medical journals; and 3) consultations with internal and external physician experts regarding community standards. Additional searches for current supporting medical literature may be performed utilizing standard electronic databases. 

Policy Implementation/Update Information:

May 2020: Criteria update: Removed section addressing compounds of chloroquine phosphate or hydroxychloroquine sulfate.

March 2020: Criteria update: Added section to address compounds of chloroquine phosphate or hydroxychloroquine sulfate utilizing bulk ingredients.

October 2019: Criteria change: Costs associated with OTC or non-FDA approved ingredients will not be covered; reformatted criteria.

February 2017: Clarification added on over the counter products. Over the counter medications are a benefit exclusion outlined in the members benefit booklet and therefore excluded from coverage in a compound.

September 2012: Policy Originated