Compounded Medications Form

This policy applies to requests for compounded medications. FDA Approved Indication Varies by drug product. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that compounded medications are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. All FDA-Approved Indications (must meet all):

1. Active ingredient(s) in compound are FDA-approved;
   
   2. One of the following (a or b): a. Medical justification supports inability to use commercially available FDA- approved products (e.g., allergy to a certain dye and need for a medication to be made without it, elderly patient who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form); b. Prescribed for pediatric dosing in the absence of commercially available products;
   3. Acceptable compendium supports efficacy and safety for the indicated treatment (see Appendix D);
2. Prescribed dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.
   Approval duration: 1 month B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

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   Compounded Medications b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All FDA-Approved Indications (must meet all):
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose for the relevant indication. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid, or evidence of coverage documents. Page 2 of 5

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   Compounded Medications IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration
   Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings Varies by drug product Appendix D: Acceptable Compendia • American Hospital Formulary Service-Drug Information (AHFS-DI) • Truven Health Analytics Micromedex DrugDEX (DrugDEX), with strength of recommendation Class I or IIa • National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, level of evidence 1, 2A, or 2B • Elsevier/Gold Standard Clinical Pharmacology V. Dosage and Administration Varies by drug product VI. Product Availability Varies by drug product VII.