Brand Name Override and Non-Formulary Medication Policy, Form

Brand name drugs and non-formulary drugs require review prior to approval. For non-formulary medications, this policy is to be used when there are no drug specific guidelines or coverage criteria. A generic drug is identical and bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generic substitution is mandatory for Centene health plans when A-rated generic equivalents are available. In addition, non-formulary drugs are generally drugs that have been reviewed by the Centene Pharmacy and Therapeutics Committee and believed to be either second-line therapy or of parity compared to formulary drugs. FDA Approved Indication(s) 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 brand name drugs and non-formulary drugs are medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Request for Brand Name or Non-Formulary Drug (must meet all):

1. Prescribed indication is FDA-approved;Requests for off-label use should also be reviewed against HIM.PA.154 – Off-Label Drug Use Requests for non-formulary contraceptives should be reviewed against HIM.PA.100 Non-formulary and Formulary contraceptives Requests for non-formulary blood glucose test strips should be reviewed against HIM.PA.34 Non- formulary Test Strips

2. Failure of 2 formulary agents as described below (a, b, or c), each used for at least 30 days unless contraindicated or clinically significant adverse effects are experienced: a. Agents must be within the same therapeutic class as the prescribed agent; b. If there is only 1 formulary agent within the same therapeutic class as the prescribed agent, member must use at least one additional agent that is recognized as a standard of care for the treatment of the relevant diagnosis, provided that such agent exists; c. If there are no formulary agents within the same therapeutic class, member must use 2 formulary alternatives that are recognized as standards of care for the treatment of the relevant diagnosis, provided that 2 such agents exist; Page 1 of 5

   CLINICAL POLICY Brand Name Override and Non-Formulary Medications

3. If request is for a brand name drug, one of the following (a or b), unless member has contraindications to the excipients in all generics/biosimilars:
   a. At least one of the previously tried agents was the generic version of the brand name drug; b. If a biosimilar is available, member has failed all preferred biosimilar(s);
   4. For combination product or alternative dosage form or strength of existing drugs, medical justification supports inability to use the individual drug products concurrently or alternative dosage forms or strengths (e.g., contraindications to the excipients of all alternative products); Use of a copay card or discount card does not constitute medical necessity
4. Request meets one of the following (a or b): a. Dose does not exceed the FDA approved maximum recommended dose for the relevant indication and health plan approved daily quantity limit; b. Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence). Approval duration: 12 months
   II. Continued Therapy A. Request for Brand Name or Non-Formulary Drug (must meet all):
5. Member meets one of the following (a, b, or c): a. Currently receiving medication via Centene benefit; b. Member has previously met initial approval criteria; c. State or Health plan continuity of care programs apply to the requested drug and indication (e.g., seizures, heart failure, human immunodeficiency virus infection, and psychotic disorders [e.g., schizophrenia, bipolar disorder], oncology) with documentation that supports that member has received this medication for at least 30 days (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

6. Member is responding positively to therapy;

   3. If request is for a dose increase, request meets one of the following (a or b):
      a. New dose does not exceed the FDA-approved maximum recommended dose for the relevant indication and health plan approved daily quantity limit; b. New dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence). Approval duration: 12 months
      III. Diagnoses/Indications for which coverage is NOT authorized: Not applicable.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      Varies by drug product Page 2 of 5

   CLINICAL POLICY Brand Name Override and Non-Formulary Medications
   Appendix C: Contraindications/Boxed Warnings Varies by drug product Appendix D: General Information • Examples of failure of a generic drug include: o Suboptimal drug plasma levels while taking the generic drug as compared to drug plasma levels while taking the brand name drug o Increase or worsening in symptoms (e.g., increase in seizure activity) when switched to a generic drug that is not attributed to progression of the disease state, increase in member age or weight, or member non-compliance V. Dosage and Administration
   Varies by drug product VI. Product Availability
   Varies by drug product VII.