CYTOGAM, Cytomegalovirus Immune Globulin (Human) Form

Cytomegalovirus immune globulin (CytoGam®) is an intravenous immune globulin (IVIG) containing antibody to cytomegalovirus (CMV).
FDA Approved Indication(s) CytoGam is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV- IVIG should be considered in combination with ganciclovir.
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 CytoGam is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. CMV Prophylaxis (must meet all):

1. Prescribed for prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, or heart;
2. Prescribed by or in consultation with an immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, or transplant specialist;
3. Dose does not exceed maximum dose indicated in Section V.
   Approval duration: 16 weeks B. Other diagnoses/indications (must meet 1 or 2):

4. 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: CP.CPA.190 for commercial, 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: Page 1 of 5

   CLINICAL POLICY Cytomegalovirus Immune Globulin CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

5. 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: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. CMV Prophylaxis
6. Reauthorization beyond 16 weeks is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
7. 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: CP.CPA.190 for commercial, 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: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. 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: CP.CPA.09 for commercial, 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 policies – CP.CPA.09 for commercial, 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 CMV: Cytomegalovirus FDA: Food and Drug Administration IVIG: intravenous immune globulin Page 2 of 5

   CLINICAL POLICY Cytomegalovirus Immune Globulin Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including Cytogam. • Boxed Warning(s): none reported V. Dosage and Administration
   Indication Prophylaxis of CMV disease in kidney transplant Dosing Regimen Initial dose (within 72 hrs of transplant): 150 mg/kg/dose IV Maximum Dose See regimen Prophylaxis of CMV disease in liver, lung, pancreas, or heart transplant At 2, 4, 6, and 8 weeks after transplant: 100 mg/kg/dose IV At 12 and 16 weeks after transplant: 50 mg/kg/dose IV Initial dose (within 72 hrs of transplant): 150 mg/kg/dose IV At 2, 4, 6, and 8 weeks after transplant: 150 mg/kg/dose IV At 12 and 16 weeks after transplant: 100 mg/kg/dose IV VI. Product Availability
   Vial for intravenous injection: 50 mg/mL See regimen VII.