Cosyntropin (Cortrosyn) Form

Cosyntropin (Cortrosyn®) is a synthetic subunit of adrenocorticotropic hormone (ACTH). FDA Approved Indication(s) Cortrosyn is indicated for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. 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 Cortrosyn is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Presumed Adrenocortical Insufficiency (must meet all):

1. Prescribed for diagnostic testing of adrenocortical insufficiency;
   2. If Cortrosyn is requested, member must use generic cosyntropin, unless contraindicated or clinically significant adverse effects are experienced;
2. Dose does not exceed one of the following (a or b):
   a. If age < 2 years: 0.125 mg per dose (1 vial); b. If age > 2 years: 0.75 mg per dose (3 vials). Approval duration: 1 dose
   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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

   2. 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 Page 1 of 5

   CLINICAL POLICY Cosyntropin of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Presumed Adrenocortical Insufficiency

4. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

   2. 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: 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 – HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ACTH: adrenocorticotropic hormone FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to Cosyntropin injection, synthetic ACTH, or to any of the excipients.
      • Boxed warning(s): none reported Page 2 of 5

   CLINICAL POLICY Cosyntropin V. Dosage and Administration
   Indication Diagnostic testing of adrenal insufficiency Dosing Regimen 0.25-0.75 mg IV or IM; in pediatric patients < 2 years, 0.125 mg will often suffice
   Maximum Dose 0.75 mg/dose VI. Product Availability
   Vial for injection: 0.25 mg VII.