Coverage Policy for Prescription Drug Step Therapy Protocols

This coverage policy is developed in accordance with Texas Insurance Code Section 1369.0547 regarding step therapy protocols for prescription drugs to treat serious mental illnesses. This policy applies only to requests for drugs prescribed to members 18 years of age or older for the treatment of diagnoses listed as serious mental illnesses in Section 1355.001.

Applicable Diagnoses

These include:

1. Bipolar disorders
2. Major depressive disorders
3. Obsessive-compulsive disorders
4. Paranoid and other psychotic disorders
5. Schizo-affective disorders
6. Schizophrenia

For covered outpatient prescription drugs to treat these diagnoses, the plan will provide coverage without implementing step therapy protocols that require a member to:

• Fail more than one drug for each drug prescribed, excluding generic equivalents
• Prove a history of failure of more than one drug for each drug prescribed, excluding generic equivalents

Definitions

Brand Name Drug means the first version of a particular medication to be developed or a medication that is sold under a pharmaceutical manufacturer's own registered trade name or trademark. The original manufacturer is granted a patent, which allows it to be the only company to make and sell the new drug for a certain number of years.

Compendia are summaries of drug information and medical evidence to support decision-making about the appropriate use of drugs and medical procedures. Examples include, but are not limited to:

1. American Hospital Formulary Service Drug Information
2. Elsevier Clinical Pharmacology
3. National Comprehensive Cancer Network Drugs and Biologics Compendium
4. Thomson Micromedex DrugDex
5. United States Pharmacopeia-National Formulary (USP-NF)

Documentation refers to written information, including but not limited to:

1. Up-to-date chart notes, relevant test results, and/or relevant imaging reports to support diagnoses;
2. Prescription claims records, and/or prescription receipts to support prior trials of formulary alternatives.

FDA, or the Food and Drug Administration, is an agency of the United States federal government responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, and veterinary products. The FDA's main goal is to ensure that these products are safe and effective for their intended use, and that their labeling and marketing are truthful and not misleading.

Formulary means a list of medications available to members with or without Prior Authorization.

Generic Drugs means prescription Drugs that have been determined by the Food and Drug Administration (FDA) to be equivalent to Brand Name Drugs, but are not made or sold under a registered trade name or trademark. Generic Drugs have the same active ingredients, meet the same FDA requirements for safety, purity, and potency and must be dispensed in the same dosage form (e.g., tablet, capsule, cream) as the Brand Name Drug.

Serious Mental Illness Defined

Serious mental illness is defined in accordance with the Texas Insurance Code Section 1355.001. This term refers to specific psychiatric illnesses as detailed by the American Psychiatric Association in the Diagnostic and Statistical Manual (DSM). These illnesses include:

• A. Bipolar disorders (including hypomanic, manic, depressive, and mixed episodes);
• B. Childhood and adolescent depression;
• C. Major depressive disorders (whether single episode or recurrent);
• D. Obsessive-compulsive disorders;
• E. Paranoid and other related psychotic disorders;
• F. Schizo-affective disorders (either bipolar or depressive types);
• G. Schizophrenia.

Coverage Criteria

The Plan will provide coverage for the requested drug when ALL the following criteria are met:

1. The member is 18 years of age or older; AND

The drug is being prescribed to treat ONE of the following diagnoses:

1. bipolar disorders (hypomanic, manic, depressive, and mixed); or
2. depression in childhood and adolescence; or
3. major depressive disorders (single episode or recurrent); or
4. obsessive-compulsive disorders; or
5. paranoid and other psychotic disorders; or
6. schizo-affective disorders (bipolar or depressive); or
7. schizophrenia; AND

Medical Necessity Criteria for Initial Authorization

The Plan considers the requested drug medically necessary when ALL of the following criteria are met:

1. The safety and effectiveness of the drug has been established for the member's age and disease or condition; AND
2. The drug is being used for an FDA-approved or compendia supported indication; AND
3. The member has adequately tried and failed at least ONE different FDA-approved drug for the given diagnosis, unless all alternatives are contraindicated; AND
4. IF the request is for a brand drug with a generic available - the member is unable to use, or has tried and failed the corresponding generic; AND
5. The member does NOT have ANY contraindications to the requested drug as defined in the FDA prescribing information; AND
6. The drug being requested meets BOTH of the following:
   • is being used at the dosage, frequency, duration of therapy, and site of administration that is supported by ONE of the following:
     1. FDA-approved labeling (product information); or
     2. Compendia of current literature; and
   • if the requested dosage exceeds the Plan’s quantity limit AND the prescribed dosage cannot be achieved using a different dose or formulation that is within the Plan’s limit.

If the above prior authorization criteria are met, the requested drug will be approved for 12-months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if the member has recent (within the last 6 months) clinical chart documentation indicating that the member has experienced a clinically meaningful improvement in symptoms related to their diagnosed serious mental illness. This improvement must be validated by clinical documentation showing, for example, a reduction in the frequency or severity of acute episodes, reduced need for higher levels of care, improved social/occupational functioning, or other evidence that the medication is providing significant benefit.

Experimental or Investigational / Not Medically Necessary

The use of any drug, including prescription drugs to treat a serious mental illness, for any indication that is not supported by the FDA or compendia is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. 'Texas HB1337 | 2023-2024 | 88th Legislature.' LegiScan, legiscan.com/TX/text/HB1337/2023. Accessed 31 Aug. 2023.
2. Insurance Code Chapter 1355. Benefits for Certain Mental Disorders. Statutes.capitol.texas.gov, statutes.capitol.texas.gov/Docs/IN/htm/IN.1355.htm. Accessed 31 Aug. 2023.

Clinical Guideline Revision / History Information

Original Date: 9/21/2023
Reviewed/Revised: