Formulary Medications Without Specific Guidelines, Form

This policy is to be used for formulary drugs that:
• Require prior authorization where there are no specific guidelines or coverage criteria. • Have drug specific clinical policies that are pending updates as a result of recent (within the last 6 months) label changes (e.g., newly approved indications, age expansions, new dosing regimens). _ All requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against HIM.PA.103 – Brand Name Override and Non-Formulary Medications or medication specific prior authorization criteria when available 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 all medical necessity determinations for formulary drug therapy without Centene® coverage criteria or pending clinical policy updates as a result of recent label changes be considered on a case-by-case basis by a physician, pharmacist or ad hoc committee, using the guidance provided within this policy.
_ All requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against HIM.PA.103 – Brand Name Override and Non-Formulary Medications or medication specific prior authorization criteria when available I. Initial Approval Criteria A. Pharmacy Benefit: Labeled Use without Drug-specific Coverage Criteria or Pending Clinical Policy Updates as a Result of Recent Label Changes (must meet all):

1. Request is for a drug on the formulary; Requests for formulary contraceptives should be reviewed against HIM.PA.100 Non-formulary and Formulary contraceptives *Requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against medication-specific prior authorization criteria when available; if there are no medication-specific criteria, refer to HIM.PA.103 – Brand Name Override and Non-Formulary Medications Page 1 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

   2. One of the following (a or b): a. Requested drug does not have a drug-specific clinical policy or custom coverage criteria; b. Requested drug has a drug-specific clinical policy that is pending clinical policy updates as a result of recent (within the last 6 months) label changes (e.g., newly approved indications, age expansions, new dosing regimens);
   3. Diagnosis of one of the following (a or b): a. A condition for which the product is FDA-indicated and -approved; b. A condition supported by the National Comprehensive Cancer Network (NCCN) Drug Information and Biologics Compendium level of evidence 1, 2A, or 2B;
2. Failure of an adequate trial of at least two preferred FDA-approved drugs for the indication and/or drugs that are considered the standard of care, when such agents exist, at maximum indicated doses, unless contraindicated, clinically significant adverse effect are experienced, or request is for a product for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Generic is preferred, if available generically
   5. 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), unless request is for a product for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Use of a copay card or discount card does not constitute medical necessity
   6. Member has no contraindications to the prescribed agent per the prescribing information;
   7. If applicable, prescriber has taken necessary measures to minimize any risk associated with a boxed warning in the product information label;
   8. Request meets one of the following (a or b): a. Dose does not exceed the FDA-approved maximum recommended dose for the relevant product and indication; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval duration: Duration of request or 12 months, whichever is less
      B. Medical Benefit: Labeled Use without Drug-specific Coverage Criteria or Pending Clinical Policy Updates as a Result of Recent Label Changes (must meet all):

3. One of the following (a or b): a. Requested drug does not have a drug-specific clinical policy or custom coverage criteria; b. Requested drug has a drug-specific clinical policy that is pending clinical policy updates as a result of recent (within the last 6 months) label changes (e.g., newly approved indications, age expansions, new dosing regimens);
   Page 2 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

   2. Diagnosis of one of the following (a or b): a. A condition for which the product is FDA-indicated and -approved; b. A condition supported by the National Comprehensive Cancer Network (NCCN) Drug Information and Biologics Compendium level of evidence 1, 2A, or 2B;
4. Failure of an adequate trial of at least two FDA-approved drugs for the indication and/or drugs that are considered the standard of care, when such agents exist, at maximum indicated doses, unless clinically significant adverse effect are experienced, all are contraindicated, or request is for a product for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
   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), unless request is for a product for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Use of a copay card or discount card does not constitute medical necessity
   5. Member has no contraindications to the prescribed agent per the prescribing information;
   6. If applicable, prescriber has taken necessary measures to minimize any risk associated with a boxed warning in the product information label;
   7. Request meets one of the following (a or b): a. Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval duration: Duration of request or 12 months, whichever is less II. Continued Therapy A. Pharmacy or Medical Benefit: Labeled Use without Drug-specific Coverage Criteria or Pending Clinical Policy Updates as a Result of Recent Label Changes (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);
   
   2. Member is responding positively to therapy;

6. 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; Page 3 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update
   b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval duration: Duration of request or 12 months, whichever is less 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 – HIM.PA.154 for health insurance marketplace or evidence of coverage documents; B. Indications or diagnoses in which the drug has been shown to be unsafe or ineffective.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives
   Not applicable
   Appendix C: Contraindications/Boxed Warnings Varies by drug product. Appendix D: General Information
   These criteria are to be used only when specific prior authorization criteria do not exist. Appendix E: States with Regulations against Redirections in Cancer State Step Therapy Prohibited? Yes Yes FL GA IA LA NV OH PA TN TX Yes Yes Yes Yes Yes Yes Yes Notes For stage 4 metastatic cancer and associated conditions. For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness. For standard of care stage 4 cancer drug use, supported by peer- reviewed, evidence-based literature, and approved by FDA. For stage 4 advanced, metastatic cancer or associated conditions. Exception if “clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy. Stage 3 and stage 4 cancer patients for a prescription drug to treat
   the cancer or any symptom thereof of the covered person For stage 4 metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer and associated conditions V. Dosage and Administration Varies by drug product. Page 4 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update
   VI. Product Availability Varies by drug product. VII.