CurrentCignaPolicy N/A

Livtencity (maribavir) prior authorization for CMV

Defines Cigna's prior authorization requirements and medical necessity criteria for Livtencity (maribavir tablets) for treatment of cytomegalovirus (CMV) in post-transplant patients, and who may prescribe it.

Policy Summary

PayerCigna

PolicyLivtencity (maribavir) prior authorization for CMV

Policy CodePolicy N/A

Change TypeApproval duration added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prescriber-confirmed response by CMV PCR within the past 4 weeks to approve continuation for 2 months.

SourceLink

POLICY UPDATE CHANGES

Approval for 2 months was added for a patient currently receiving Livtencity if the prescriber documents response by CMV PCR within the past 4 weeks.

2 monthsinitial/continuation approval duration

≥12minimum age for coverage

≥35 kgminimum weight for coverage

post-transplantrequired clinical context

5–14%drug-resistant CMV incidence

Policy Summary

PayerCigna

PolicyLivtencity (maribavir) prior authorization for CMV

Policy CodePolicy N/A

Change TypeApproval duration added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prescriber-confirmed response by CMV PCR within the past 4 weeks to approve continuation for 2 months.

SourceLink

On This Page

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Coverage Criteria for Livtencity (maribavir)

FDA-Approved Indication - Cytomegalovirus Infection - Treatment

Covered when ALL of the following are met for FDA-approved indication (approve for 2 months):

Initial Therapy (A)

i: Patient is ≥ 12 years of age
chunk 8
ii: Patient weighs ≥ 35 kg
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iii: Patient is post-transplant
This includes patients who are post-hematopoietic stem cell transplant or solid organ transplant; chunk 8
iv
- a: Patient has cytomegalovirus infection/disease that is refractory to treatment with at least one of the following: cidofovir, foscarnet, ganciclovir, or valganciclovir
  chunk 8
- b: Patient has significant intolerance to ganciclovir or valganciclovir
  chunk 8
v: Medication is not prescribed in conjunction with ganciclovir or valganciclovir
chunk 8
vi: Medication is prescribed by or in consultation with a hematologist, infectious diseases specialist, oncologist, or a physician affiliated with a transplant center
chunk 8

Currently Receiving Livtencity (B): Patient is currently receiving Livtencity and, according to the prescriber, has responded as demonstrated by CMV PCR laboratory results within the past 4 weeks showing improvement in CMV levels

Approve for 2 months when met; chunk 8

Livtencity (maribavir) is not medically necessary for any uses not specified in the coverage criteria. Uses outside the approved and enumerated indications and criteria in this policy are excluded from coverage.

Any use of Livtencity outside the specified coverage criteria is considered not medically necessary and will not be approved under this policy unless and until the criteria are revised to include additional indications.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Livtencity (maribavir) prescription benefit coverage. Approvals are provided for the duration specified by the clinical criteria (e.g., 2 months for initial/continuation treatment as noted). When approvals are expressed in months, 1 month = 30 days.

Approval durations correspond to the clinical criteria (example: FDA‑Approved indication — approve for 2 months when criteria met).

Step Therapy

Prior Treatment Requirement (Step Therapy)

Prior treatment (step therapy-like) requirement: for initial therapy, the patient must have cytomegalovirus infection/disease that is refractory to treatment with at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir, OR have significant intolerance to ganciclovir or valganciclovir.

This prior treatment requirement applies to Initial Therapy criteria (see clinical criteria A.iv.a/b).

Background

Cytomegalovirus (CMV) is a frequent and important complication following hematopoietic-cell and solid-organ transplantation, contributing to increased morbidity and mortality in these patients. Available antiviral options such as ganciclovir/valganciclovir, cidofovir, and foscarnet are associated with significant toxicities, and an estimated 5–14% of transplant recipients develop drug-resistant CMV. Livtencity (maribavir), a protein kinase inhibitor, is indicated for treatment of refractory CMV in patients aged ≥ 12 years and weighing ≥ 35 kg, and coadministration with ganciclovir or valganciclovir is not recommended.

Definitions

Refractory CMV — definition

DefinitionRefractory CMV is characterized by persistent signs and symptoms of CMV disease or persistent CMV DNAemia.

Clinical contextMay occur after hematopoietic-cell or solid-organ transplantation; treatment sometimes continues beyond 8 weeks until resolution on 1 or 2 consecutive weekly CMV PCRs.

Implication for coverageMeeting refractory criteria to at least one alternative antiviral supports use under the FDA‑approved indication when other coverage criteria are met.

Resistant CMV — definition

DefinitionResistant CMV infection is defined as detection of a known viral genetic mutation(s) that decrease susceptibility to one or more anti‑CMV medications.

IncidenceApproximately 5–14% of transplant recipients may develop drug‑resistant CMV (context from clinical background).

MonitoringCMV viral load monitoring (weekly PCRs) is important for identifying emergence of resistance.

OpenPayer

Livtencity (maribavir) prior authorization for CMV

Coverage Criteria for Livtencity (maribavir)

Coding and Eligibility

Provider Actions and Authorization Requirements

Background

Definitions