CurrentCentenePolicy CP.PHAR.277

Cytomegalovirus Immune Globulin (CytoGam)

Policy governing medical necessity and coverage criteria for CytoGam (cytomegalovirus immune globulin) used for prophylaxis of CMV disease in solid organ transplant recipients; applies to members covered by Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyCytomegalovirus Immune Globulin (CytoGam)

Policy CodePolicy CP.PHAR.277

Change TypeNo material changes

Effective Date09.01.18

Next Review Date

Key ActionProvider must submit clinical documentation (chart notes, lab results, or other information) demonstrating the member meets all approval criteria for CMV prophylaxis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16approval duration (weeks)

J0850HCPCS

150 mg/kginitial dose

50 mg/mLconcentration

Coverage Criteria for CytoGam (CMV IVIG)

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CMV Prophylaxis Criteria: 1) Prescribed for prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, or heart;

Approval duration: 16 weeks

Prescriber/Consultation Requirement: 2) Prescribed by or in consultation with an immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, or transplant specialist;

Dose Limit: 3) Dose does not exceed the maximum dose indicated in Section V (dosing regimens by organ).

Requests for use of CytoGam for non‑FDA approved indications that are not specifically addressed in this policy are excluded unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Coding and Billing

HCPCS CodesHCPCS

J0850

Injection, cytomegalovirus immune globulin intravenous (human), per vial

Approval duration — 16 weeks

Initial approval duration16 weeks

Reauthorization beyond initial durationReauthorization beyond 16 weeks is not permitted; members must meet the initial approval criteria

Approval contextApproval duration applies to CMV prophylaxis following transplantation of kidney, lung, liver, pancreas, or heart

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cytogam (CMV IVIG) when used for CMV prophylaxis associated with transplantation. Requests must document the indication, the prescriber or consulting specialist, and the planned dose (not to exceed the maximum dosing in Section V). Approval duration: 16 weeks.

Indication: prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, or heart.
Dose: must not exceed maximum dose indicated in Section V; include planned dosing schedule.
Approval duration: 16 weeks.

Documentation Required

Non‑FDA Indications

Requests for non–FDA approved (off‑label) indications are not covered by this policy unless sufficient documentation of efficacy and safety is provided per the plan's off‑label use policies. Submit supporting evidence in accordance with CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) as applicable.

Non‑FDA indications require submission of clinical evidence or reference to the applicable off‑label policy.
If not addressed by this policy, approval may be granted only with adequate supporting documentation.

Documentation Required

Prescriber / Consultation Requirement

Prescriptions must be written by or in consultation with an appropriate specialist: immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, or transplant specialist. Include documentation of the specialist consultation in the request (e.g., consultation note, co‑signature, or referral documentation).

Acceptable prescribers/consultants: immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, or transplant specialist.
Include consultation documentation with the prior authorization request.

Note

Combination Therapy Consideration

For cytomegalovirus prophylaxis in transplants from CMV seropositive donors to seronegative recipients (D+/R‑), consider CMV IVIG in combination with ganciclovir per FDA‑approved prescribing information. If combination therapy is requested, document rationale and concurrent antiviral regimen.

Combination therapy consideration: CMV IVIG plus ganciclovir for D+/R‑ transplants per FDA guidance.
Provide documentation of planned concurrent ganciclovir dosing/schedule.

Candidate Criteria by Organ

inv-14: Organ-specific indications

Organ transplant indications covered:

Covered organs: Prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, or heart.

For transplants (other than kidney) from CMV-seropositive donors into seronegative recipients, CMV IVIG should be considered in combination with ganciclovir.

Dosing and Post-Transplant Administration

CytoGam IV administration per dosing schedule — Dosing regimen by organ and reauthorization limits

Kidney — initial doseInitial dose within 72 hours of transplant: 150 mg/kg IV

Kidney — maintenance dosesAt 2, 4, 6, and 8 weeks: 100 mg/kg IV; At 12 and 16 weeks: 50 mg/kg IV

Liver/Lung/Pancreas/Heart — initial doseInitial dose within 72 hours of transplant: 150 mg/kg IV

Liver/Lung/Pancreas/Heart — maintenance dosesAt 2, 4, 6, and 8 weeks: 150 mg/kg IV; At 12 and 16 weeks: 100 mg/kg IV

Reauthorization limitDosing regimen limited to maximums per Section V; reauthorization beyond 16 weeks is not permitted

Contraindications

CytoGam is contraindicated in individuals with a history of a prior severe reaction associated with administration of this or other human immunoglobulin preparations. Additionally, persons with selective IgA deficiency may develop antibodies to IgA and are at risk for anaphylactic reactions if given blood products containing IgA, including CytoGam.

Evaluation and Documentation Requirements

Documentation Required

Evaluation: submit clinical chart notes and labs

Approval is contingent on submission of clinical documentation (chart notes, laboratory results, or other clinical information) that demonstrates the member meets the policy approval criteria.

Documentation should confirm organ transplant type, timing of doses per Section V, and that dosing does not exceed maximums.
Include evidence of specialist prescribing or consultation when applicable.

Center and Prescriber Requirements

Note

Center requirement: specialist prescriber or consultation

Prescriptions should be by, or in consultation with, an appropriate specialist (immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, or transplant specialist) as required by the policy.

Record the specialist name and role (prescriber vs. consultant) in the submitted documentation.

Definitions

CytoGam / CMV IVIG — Definition of product and clinical use

Product nameCytoGam (cytomegalovirus immune globulin) — an intravenous immune globulin (IVIG) containing antibody to cytomegalovirus

FDA indicationIndicated for prophylaxis of CMV disease associated with transplantation of kidney, lung, liver, pancreas, and heart

Use with antiviral therapyFor transplants (other than kidney) from CMV-seropositive donors to seronegative recipients, CMV IVIG should be considered in combination with ganciclovir per FDA labeling

Policy Summary

PayerCentene

PolicyCytomegalovirus Immune Globulin (CytoGam)

Policy CodePolicy CP.PHAR.277

Change TypeNo material changes

Effective Date09.01.18

Next Review Date

Key ActionProvider must submit clinical documentation (chart notes, lab results, or other information) demonstrating the member meets all approval criteria for CMV prophylaxis.

SourceLink

On This Page

OpenPayer

Cytomegalovirus Immune Globulin (CytoGam)

Coverage Criteria for CytoGam (CMV IVIG)

Coding and Billing

Provider Requirements and Actions

Candidate Criteria by Organ

Dosing and Post-Transplant Administration

Contraindications

Evaluation and Documentation Requirements

Center and Prescriber Requirements

Definitions

Background