No Coverage Criteria Form

This policy is to be used for PDL 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-PDL drugs, under the pharmacy benefit, should be reviewed against CP.PMN.16 Request for Medically Necessary Drug Not on the PDL 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 PDL 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-PDL drugs, under the pharmacy benefit, should be reviewed against CP.PMN.16 Request for Medically Necessary Drug Not on the PDL 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 PDL drug;All requests for non-PDL drugs, under the pharmacy benefit, should be reviewed against CP.PMN.16

   • Request for Medically Necessary Drug Not on the PDL.
     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);
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   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

   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 one of the following (a, b, or c):
   Generic is preferred, if available generically a. Clinically significant adverse effect are experienced or all are contraindicated; b. 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); c. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix F);
   5. For combination product or alternative dosage form or strength of existing drugs, one of the following (a, b, or c):
      a. 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
      b. 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);
      c. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix F);
   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 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 6 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);

   2. Diagnosis of one of the following (a or b): a. A condition for which the product is FDA-indicated and -approved; Page 2 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update 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 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 one of the following (a, b, or c):
   a. Clinically significant adverse effect are experienced or all are contraindicated; b. 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); c. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix F); Generic is preferred, if available generically
   4. For combination product or alternative dosage form or strength of existing drugs, one of the following (a, b, or c):
      a. 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 b. 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); c. Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix F);
   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 6 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); Page 3 of 7

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

   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; 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 policies – CP.PMN.53 for Medicaid 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 HIV: human immunodeficiency virus PDL: preferred drug list Appendix B: Therapeutic Alternatives
   Varies by drug product 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 PA TN TX 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 advanced, metastatic cancer For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer and associated conditions Page 4 of 7

   CLINICAL POLICY No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update Appendix F: States with Limitations against Redirections in Certain Mental Health Settings State Step Therapy Notes Prohibited? Yes No AR NV For the treatment of psychosis and serious mental illness through antipsychotic prescription drugs, no step therapies allowed. For typical or atypical antipsychotic or anticonvulsant medications, step therapy is limited to one PDL drug. V. Dosage and Administration
   Varies by drug product VI. Product Availability
   Varies by drug product VII.