Cytomegalovirus (CMV) — Pharmacy Management Drug Policy
Customize your policy alerts
Sign up for univerahealthcare Policy PHARMACY-136 alerts
Get alerted when Policy PHARMACY-136 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, clinical criteria, and utilization management for drugs used to prevent or treat CMV in Univera Healthcare members across applicable lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Livtencity (maribavir) Initial Therapy
Covered when ALL of the following are met:
Refractory CMV infection/end‑organ disease definitions and documentation requirements are specified in policy.
inv-02: Prevymis (letermovir) Prophylaxis
Covered when ONE of the following pathways is met:
Risk factors for late CMV are listed in policy (see Pathway A risk factor list).
Prescriber must attest member is not taking medications contraindicated with Prevymis; IV Prevymis requires clinical justification why oral formulation cannot be used.
Requests for Livtencity (maribavir) will not be authorized for CMV disease involving the central nervous system or the retina, and the agent is not approved for non‑FDA indications such as prophylaxis. Livtencity must not be used in combination with ganciclovir or valganciclovir; requests that propose concurrent use with these agents will be denied. Initial approval for Livtencity is limited to 8 weeks and the standard quantity limit is 120 tablets per 30 days (an increase may be allowed per prescribing information if co‑administered with certain anticonvulsants).
Intravenous Prevymis (letermovir) will be considered only with clinical justification demonstrating why the oral formulation cannot be used. Prevymis prophylaxis approvals follow the specific transplant‑timing and serostatus criteria in the policy (e.g., HSCT recipients R+ initiating Day 0–28; D+/R- kidney recipients initiating Day 0–7) and durations are limited to the windows specified in the policy (initial authorization and recertification rules apply).
Eligibility for reimbursement and coverage of listed codes depend on the member’s subscriber contract and the policy’s clinical criteria. Codes may not be covered under all circumstances, and coding lists in this policy may not be exhaustive due to updates from AMA or CMS; providers should verify coverage and applicable codes for each request.
Some agents historically used for CMV prophylaxis — including foscarnet, acyclovir, and valacyclovir — are not FDA‑approved for prophylaxis and are identified in the policy as not FDA‑approved for that indication. Likewise, Livtencity is not authorized for prophylaxis or other non‑FDA approved uses. When alternative or off‑label antiviral strategies are proposed, supporting clinical documentation must clearly justify the choice and demonstrate alignment with the policy’s covered indications (for example, use of letermovir for prophylaxis in specified transplant populations per its labeled indications).
Initial Therapy Criteria
inv-22: Livtencity initial therapy
Initial approval for maribavir is provided when ALL of the following are satisfied:
Refer to prescribing information for dosing; documentation of prior antiviral therapy and refractory status required.
inv-23: Prevymis initial therapy
Initial prophylaxis authorization for Prevymis is provided when ONE of the following pathways is met:
Prescriber must attest member is not taking medications contraindicated with Prevymis; IV Prevymis requires justification why oral cannot be used.
Refer to Prevymis prescribing information for dosing and quantity limits (tablet and pellet packet limits apply).
Continuation and Recertification Criteria
inv-24: Prevymis continuation
Recertification for Prevymis in allogeneic HSCT recipients:
Documentation of transplant date and risk‑factor evidence required for recertification.
Provider Actions and Requirements
Livtencity (maribavir): prior authorization and prescriber requirements
Prior authorization required. Livtencity must be prescribed by, or in consultation with, a hematologist, infectious disease specialist, oncologist, or a physician affiliated with a transplant center, and member must be ≥12 years and ≥35 kg. Requests must document post‑transplant CMV infection/disease refractory to at least one listed antiviral and exclude CNS/retinal disease.
- Age/weight: must be ≥12 years and weigh ≥35 kg.
- Specialist prescriber or documented consultation required (hematologist, infectious disease, oncologist, or transplant‑affiliated physician).
- Must document post‑transplant CMV infection/disease refractory to ≥1 of: ganciclovir, valganciclovir, cidofovir, or foscarnet.
- Must not have CNS or retinal CMV disease.
Prevymis (letermovir): prior authorization for prophylaxis
Prevymis (letermovir) prophylaxis requires prior authorization. Approvals follow one of two pathways: allogeneic HSCT recipients (R+, age ≥6 months/≥6 kg, initiate Day 0–28 post‑transplant) or D+/R‑ kidney transplant recipients (age ≥12 years/≥40 kg, initiate Day 0–7 post‑transplant). Prescriber must attest to contraindicated medications and IV use requires justification.
- HSCT pathway: CMV‑seropositive (R+), age ≥6 months and ≥6 kg, initiation Day 0–28; initial authorization 4 months (100 days).
- Kidney D+/R‑ pathway: age ≥12 years and ≥40 kg, initiation Day 0–7; authorization provided for 7 months (200 days); reauthorization not permitted for kidney recipients.
- Prescriber attestation required that member is not using contraindicated medications.
- All requests for Prevymis IV require clinical justification why oral cannot be used.
Prevymis (J3490): coding and reimbursement depends on contract
Prevymis intravenous administration is listed under HCPCS J3490. Inclusion in coding does not guarantee reimbursement; eligibility and payment depend on the member's subscriber contract and policy criteria.
- HCPCS code: J3490 — Prevymis injection (for intravenous use).
- Reimbursement and eligibility are determined by the member's subscriber contract and policy criteria; codes may not be covered under all circumstances.
Step therapy and recertification may require trials of alternatives
Step therapy and recertification requirements may be imposed; recertification reviews may require trials of more cost‑effective alternatives as they become available (e.g., generics, biosimilars, or other guideline‑supported options).
- Recertification must demonstrate ongoing benefit (improvement or stability) and medical necessity.
- Plan may require trial of more cost‑effective alternatives at recertification.
Provide required clinical documentation for all requests and recertifications
Submit clinical documentation with each initial request and recertification unless otherwise specified; documentation should include progress notes, prior treatments, diagnostic testing, laboratory results, genetic/biomarker testing, imaging, and objective or subjective measures of benefit.
- Progress notes documenting previous treatments and treatment history.
- Diagnostic testing and laboratory test results (including measures demonstrating response or stability).
- Imaging, genetic testing/biomarkers, and other objective/subjective measures of clinical benefit.
Document transplant date to confirm eligibility window
For transplant prophylaxis requests, document the date of transplant to confirm initiation within the permitted post‑transplant window (e.g., Day 0–28 for HSCT pathway; Day 0–7 for kidney D+/R‑ pathway).
- HSCT prophylaxis: therapy must be initiated between Day 0 and Day 28 post‑transplant and transplant date must be documented.
- Kidney D+/R‑ prophylaxis: therapy must be initiated between Day 0 and Day 7 post‑transplant and transplant date must be documented.
Confirm coding and coverage against the member's contract and current coding updates
Read the policy and guideline statements carefully; coding lists in the policy may not be exhaustive due to AMA and CMS updates and coverage is subject to the member's contract.
- Codes may not be covered under all circumstances; check the member's subscriber contract for benefit coverage.
- Policy guidelines note that code lists may not be all‑inclusive because AMA/CMS updates can occur more frequently than policy updates.
Livtencity: common denial triggers
Livtencity will be denied if requested in combination with ganciclovir or valganciclovir, for CMV disease involving the central nervous system or retina, or for non‑FDA‑approved indications (such as prophylaxis).
- Denied if used concurrently with ganciclovir or valganciclovir.
- Denied for CNS or retinal CMV disease.
- Denied for non‑FDA approved indications (e.g., prophylaxis).
Prevymis IV: provide justification why oral cannot be used
IV Prevymis requests must include clinical justification explaining why the oral formulation cannot be used; absence of such justification may result in denial.
- All requests for Prevymis IV require clinical justification why oral formulation is not appropriate.
- Lack of adequate justification may lead to denial of IV administration.
Eligibility for reimbursement is conditional on subscriber contract
Coverage and reimbursement for requested codes and services depend on the benefits set forth in the member's subscriber contract; codes listed in the policy may not be covered in all circumstances.
- Verify benefit coverage in the member's subscriber contract before submitting requests.
- Policy coding lists may not be all‑inclusive and coverage can vary by contract.
Coding
| J3490 | Prevymis injection - for intravenous use |
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Trial and failure or refractory CMV infection/disease to at least one of the following prior to maribavir: ganciclovir, valganciclovir, cidofovir, or foscarnet. Refractory infection defined as CMV viremia that increases (>1 log10) or persists (<1 log10 change) after ≥2 weeks of antiviral therapy; refractory end‑organ disease defined as worsening or lack of improvement after ≥2 weeks of appropriately dosed antiviral therapy. |
| 2 | No CMV disease involving the central nervous system or retina (maribavir will not be authorized for CNS/retinal CMV disease). |
| 3 | Not to be used in combination with ganciclovir or valganciclovir—requests will be denied if used concurrently with these agents. |
| 4 | Indication must be post‑transplant CMV infection/disease (following HSCT or SOT); maribavir will not be approved for non‑FDA approved indications such as prophylaxis. |
| 5 | Patient must meet age/weight requirements: ≥12 years of age and ≥35 kg, and therapy must be prescribed by or in consultation with a hematologist, infectious disease specialist, oncologist, or physician affiliated with a transplant center. |
| 6 | Initial approval duration: up to 8 weeks; recertification beyond 8 weeks will not be authorized. |
| 7 | Quantity limit: 120 tablets per 30 days (may be increased per prescribing information if co‑administered with specified anticonvulsants with documentation). |
Step therapy and recertification: documentation and possible trial of alternatives
Step therapy and recertification requirements may be applied; recertification reviews can require documentation of ongoing benefit and may mandate trials of cost‑effective alternatives when available.
- Recertification requires evidence of improvement or stability and that continued use remains medically necessary.
- Plans may require trying generics, biosimilars, or other guideline‑supported, more cost‑effective options.
Quantity Limits
Site of Care Considerations
Infusion‑center Prevymis IV requests require oral‑formulation justification
For infusion‑center (IV) Prevymis requests, include clinical justification that the oral formulation is not appropriate for this member to avoid denial.
- All requests for Prevymis IV must state why oral Prevymis cannot be used.
- Site‑of‑care requests for IV administration will be reviewed and require clinical justification.
Definitions
Background
Cytomegalovirus (CMV) is a common herpesvirus that is often asymptomatic in immunocompetent individuals but can cause severe disease in neonates and immunocompromised patients, including transplant recipients and people with HIV. First‑line antivirals for treatment and prophylaxis include ganciclovir and valganciclovir, with agents such as foscarnet, cidofovir, and maribavir (Livtencity) used for resistant or refractory infections. Refractory CMV infection is defined as CMV viremia that increases (> 1 log10) or persists (< 1 log10 change) after at least two weeks of antiviral therapy; refractory end‑organ disease is lack of improvement or worsening of signs/symptoms after at least two weeks of appropriately dosed antiviral therapy.
Revision History
Policy last reviewed and updated with current coverage criteria, coding, and references (includes updates to Livtencity and Prevymis sections).
Policy effective date set for updated coverage criteria and utilization management provisions for CMV drugs.
References and source literature updated/verified (multiple package inserts and guideline references cited).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.