CurrentmhnPolicy CP.PMN.271

Maribavir (Livtencity)

Defines medical necessity criteria and authorization requirements for maribavir (Livtencity) for treatment of post-transplant CMV infection in eligible members across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyMaribavir (Livtencity)

Policy CodePolicy CP.PMN.271

Change TypeCriteria added

Effective DateMar 1, 2022

Next Review Date

Key ActionPrior authorization requires meeting the listed initial or continuation criteria, including age, weight, prior antiviral failure, absence of CNS/retinal disease, no concurrent ganciclovir/valganciclovir, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Added requirement that Livtencity is not prescribed concurrently with ganciclovir or valganciclovir.

≥12 yrsminimum covered patient age

≥35 kgminimum covered patient weight

8 wksinitial approval duration

400 mg BIDstandard dosing regimen

200 mg tabproduct strength

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Coverage Criteria for Maribavir (Livtencity)

inv-01: Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of CMV infection following hematopoietic stem cell transplant or solid organ transplant (e.g., kidney, lung, heart, liver, pancreas, intestine)
Age ≥ 12 years>= 12 years
Weight ≥ 35 kg>= 35 kg
Prior antiviral failure: Failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a ≥ 14-day trial of ganciclovir, valganciclovir, cidofovir, or foscarnet>= 14 days trial
No CNS/retinal disease: Member does not have CMV disease involving the central nervous system (including the retina)
No concurrent ganciclovir/valganciclovir: Livtencity is not prescribed concurrently with ganciclovir or valganciclovir
Added in 1Q 2024 review
Dose limits: Dose does not exceed: 800 mg/day; or 1,600 mg/day if co-administered with carbamazepine; or 2,400 mg/day if co-administered with phenytoin or phenobarbitalsee dosing
Approval duration: 8 weeks

inv-02: Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Current therapy: Currently receiving medication via Centene benefit, or documentation supports member is currently receiving Livtencity for a covered indication and has received this medication for at least 30 days>= 30 days
Clinical response: Member is responding positively to therapy
Duration cap: Member has not received ≥ 8 weeks of therapy< 8 weeks

Requests for indications that are not FDA‑approved and not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Off‑label requests for maribavir (Livtencity) must follow the referenced off‑label use policies. If documentation per those off‑label policies is not provided, the request is considered not authorized. Providers should include clinical evidence and rationale consistent with CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable to the member’s line of business.

Initial Therapy

inv-11: Initial Therapy

Initial approval requires all of the following

ALL of the following

Diagnosis: Post-transplant CMV infection after hematopoietic stem cell transplant or solid organ transplant
Age ≥ 12 years>= 12 years
Weight ≥ 35 kg>= 35 kg
Prior antiviral failure:

Continuation Therapy

inv-12: Continuation Therapy

Continuation approval requires all listed conditions be met

ALL of the following

Current therapy: Member currently receiving Livtencity via Centene benefit or has documentation of current use for covered indication for ≥30 days>= 30 days
Response: Member is responding positively to therapy
Total duration: Member has not received ≥ 8 weeks of therapy< 8 weeks

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. PA will be approved only if the request meets the listed initial or continuation criteria (age, weight, prior antiviral failure, dosing limits, and other clinical requirements).

Approval duration (initial): 8 weeks
Do not co‑administer with ganciclovir or valganciclovir

Step Therapy

Step Requirement — Prior Antiviral Failure / Continuation Rules

Continuation/step requirement: member must have failed prior antiviral therapy as specified — failure to achieve >1 log10 decrease in CMV DNA in whole blood or plasma after at least 14 days of ganciclovir, valganciclovir, cidofovir, or foscarnet. For continuation, member must be currently receiving Livtencity, have received it ≥30 days, be responding to therapy, and not have completed ≥8 weeks of therapy.

Initial failure criterion: >1 log10 decrease not achieved after ≥14 days of listed antivirals

Step Therapy Requirements

Step	Requirement	Details
1	Required prior to coverage of Livtencity	Failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a ≥14-day trial of ganciclovir, valganciclovir, cidofovir, or foscarnet

Quantity Limits and Dosing

Dosage limits for Livtencity (maribavir)

Standard maximum daily dose800 mg/day (4 tablets)

Maximum with carbamazepine1,600 mg/day (8 tablets)

Maximum with phenytoin or phenobarbital2,400 mg/day (12 tablets)

Definitions

Definition — Maribavir (Livtencity)

Drug class / mechanismCytomegalovirus (CMV) pUL97 kinase inhibitor

Brand and generic namesLivtencity (maribavir)

Primary indication contextUsed for treatment of post-transplant CMV infection/disease refractory to prior antivirals (per policy)

Background

Maribavir (Livtencity) is an antiviral agent that acts as a CMV pUL97 kinase inhibitor and is indicated for treatment of post‑transplant cytomegalovirus (CMV) infection or disease refractory to prior antivirals. Approval criteria apply to patients who are ≥ 12 years of age and weigh ≥ 35 kg. The standard dosing regimen is 400 mg orally twice daily (800 mg/day); tablet strength is 200 mg. Higher maximum daily doses are permitted when co‑administered with enzyme‑inducing anticonvulsants (up to 1,600 mg/day with carbamazepine, or up to 2,400 mg/day with phenytoin or phenobarbital).

Policy Summary

Payermhn

PolicyMaribavir (Livtencity)

Policy CodePolicy CP.PMN.271

Change TypeCriteria added

Effective DateMar 1, 2022

Next Review Date

SourceLink

On This Page

No concurrent ganciclovir/valganciclovir:

Livtencity is not prescribed concurrently with ganciclovir or valganciclovir

Consistent with initial criteria

Dose limits: If request is for a dose increase, new dose does not exceed: 800 mg/day; or 1,600 mg/day if co-administered with carbamazepine; or 2,400 mg/day if co-administered with phenytoin or phenobarbitalsee dosing

Failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a ≥ 14-day trial of ganciclovir, valganciclovir, cidofovir, or foscarnet

No CNS/retinal disease: Member does not have CMV disease involving the central nervous system (including the retina)

No concurrent ganciclovir/valganciclovir: Livtencity is not prescribed concurrently with ganciclovir or valganciclovir

Added in 1Q 2024 review

Dose limits: Dose does not exceed: 800 mg/day; or 1,600 mg/day if co-administered with carbamazepine; or 2,400 mg/day if co-administered with phenytoin or phenobarbitalsee dosing

Approval duration: 8 weeks

No concurrent ganciclovir/valganciclovir: Livtencity not prescribed concurrently with ganciclovir or valganciclovir

Dose limits: If request is for a dose increase, new dose must not exceed: 800 mg/day; or 1,600 mg/day with carbamazepine; or 2,400 mg/day with phenytoin or phenobarbitalsee dosing

Continuation: currently receiving Livtencity ≥30 days and responding to therapy, and <8 weeks total received

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the PA request. Provider must include office chart notes, lab results (including CMV DNA values and dates showing lack of required viral load decline or response to therapy), transplant records, current weight and age, medication history (including prior antivirals and dates), and documentation of current Livtencity dosing and duration.

Office chart notes and transplant documentation
Laboratory results showing CMV DNA levels and trends (dates and values)
Medication history including prior antivirals and dates, current Livtencity dose and duration

Denial Risk

Documentation Insufficiency / Non‑approved Use — Not Authorized

Requests lacking the required documentation or requesting non‑FDA or off‑label indications without sufficient supporting evidence will not be authorized. Specifically, indications not addressed by this policy require supporting evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Incomplete documentation or off‑label use without adequate evidence = authorization denied
Refer to off‑label use policies: CP.CPA.09, HIM.PA.154, CP.PMN.53