CurrentCignaPolicy IP0394

Livtencity

Defines coverage criteria for Livtencity (maribavir) for treatment of post-transplant cytomegalovirus (CMV) infection/disease refractory to or intolerant of standard antivirals in patients ≥12 years and ≥35 kg, including initial and continuation approval rules, duration, exclusions, and prescribing specialist requirement for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyLivtencity

Policy CodePolicy IP0394

Change TypeAnnual revision with material updates (weight threshold, intolerance language, co-administration prohibition, continuation rule)

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must obtain coverage authorization and document the patient meets the specified criteria, ensure specialist prescribing/consultation, include recent CMV PCR results for continuation, and avoid co-administration with ganciclovir/valganciclovir.

SourceLink

POLICY UPDATE CHANGES

Policy now applies to Individual and family plans.

Added a weight restriction (≥ 35 kg) aligned to the FDA labeled indication.

Updated the ganciclovir resistance statement to intolerance to ganciclovir or valganciclovir.

Added a restriction prohibiting concurrent use of Livtencity with ganciclovir or valganciclovir.

Approval for 2 months was added for a patient currently receiving Livtencity if prescriber documents recent laboratory improvement.

Annual Revision dated 03/15/2025 noted 'No criteria changes.'

1Covered Indications (CMV treatment post-transplant)

2Approval Pathways (Initial or Currently Receiving)

2 monthsStandard Initial Authorization Duration

≥35 kgWeight Threshold

Coverage Summary

Coverage stance: covered_with_criteria for Livtencity (maribavir) for treatment of post-transplant cytomegalovirus (CMV) infection/disease that is refractory to prior antivirals or in patients with intolerance to ganciclovir/valganciclovir. Scope: defines coverage criteria for use in patients ≥ 12 years and weighing ≥ 35 kg, includes initial and continuation approval pathways, a standard initial authorization duration of 2 months, exclusions for concurrent ganciclovir/valganciclovir use, and a prescribing specialist requirement for Cigna-administered health plans.

FDA-Approved Indication / Coverage Criteria

Approve for 2 months if the patient meets ONE of the following (A or B):

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Duration and Usage Notes

Policy Summary

PayerCigna

PolicyLivtencity

Policy CodePolicy IP0394

Change TypeAnnual revision with material updates (weight threshold, intolerance language, co-administration prohibition, continuation rule)

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

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Duration and Usage Notes

When coverage is available and medically necessary:

ALL of the following

Approve for 2 months (initial authorization duration)2 months
Dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy
Receipt of sample product does not satisfy any criteria requirements for coverage

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Surface Thresholds

Age>= 12 years

Weight>= 35 kg

Response proof windowCMV PCR DNA laboratory results within the past 4 weeks showing improvement

Exclusions / Not Medically Necessary

Not Medically Necessary

ALL of the following

Livtencity for any other use is considered not medically necessary

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Co-administration of Livtencity with ganciclovir or valganciclovir is not recommended and is prohibited by policy due to evidence that Livtencity may antagonize the antiviral activity of these agents; concurrent prescribing may result in claim denial and is explicitly disallowed in the coverage criteria.

Provider Actions

Prior Authorization

Authorization required with clinical criteria

Providers must obtain coverage authorization prior to treatment and document that the patient meets the policy clinical criteria: age ≥ 12 years, weight ≥ 35 kg, post-transplant status (hematopoietic stem cell or solid organ transplant), and either refractory CMV infection to at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir OR significant intolerance to ganciclovir or valganciclovir. For patients currently receiving therapy, document response with CMV PCR DNA laboratory results within the past 4 weeks showing improvement. Also document that Livtencity is not co-administered with ganciclovir or valganciclovir (co-administration is not recommended/prohibited).

Patient age (≥ 12 years)
Patient weight (≥ 35 kg)
Post-transplant status (hematopoietic stem cell or solid organ transplant)
Evidence of refractory infection to ≥1 listed antiviral OR documented significant intolerance to ganciclovir/valganciclovir
Recent CMV PCR DNA results (within past 4 weeks) showing improvement if requesting continuation
Statement that Livtencity is not prescribed concomitantly with ganciclovir or valganciclovir

Documentation Required

Specialist prescribing or consultation

Medication must be prescribed by or in consultation with a hematologist, infectious diseases specialist, oncologist, or a physician affiliated with a transplant center. When requesting continuation for a patient currently receiving Livtencity, include recent CMV PCR DNA laboratory results (within the past 4 weeks) demonstrating improvement in CMV levels.

Billing Rule

Authorization duration

Initial authorization is for 2 months. Authorization beyond the initial 2-month period requires documented clinical evidence of response (for patients currently receiving therapy, CMV PCR DNA laboratory results within the past 4 weeks demonstrating improvement) to support continued coverage.

Denial Risk

Concurrent antiviral co-prescription prohibition

Claims may be denied if Livtencity is prescribed concurrently with ganciclovir or valganciclovir; co-administration is not recommended and may antagonize antiviral activity.

Applicable Codes

Drug / Product (NDC)NDCCovered

No codes listed

Clinical Evidence & Metrics

up to 8 wksSOLSTICE trial used up to 8 weeks of treatment

5-14%Approximate prevalence of drug‑resistant CMV in transplant recipients

Livtencity is indicated for post-transplant CMV infection/disease that is refractory to or in patients intolerant of standard antivirals. In clinical practice, treatment is usually continued until CMV DNAemia resolves on 1–2 consecutive weekly PCRs. The pivotal SOLSTICE trial evaluated up to 8 weeks of therapy, but resistant and refractory infections and disease relapses may require treatment beyond 8 weeks. Monitoring CMV viral load at weekly intervals is important for assessing response and detecting resistance. Additionally, Livtencity may antagonize ganciclovir/valganciclovir, so co-administration is contraindicated by the policy.

Definitions

Refractory CMV infection: Persistent signs and symptoms of CMV disease or persistent CMV DNAemia despite therapy.

Resistant CMV infection: Detection of a known viral genetic mutation(s) that decrease susceptibility to one or more anti-CMV medications.

Revision History

2024-07-01administrative_scope_expansion

Policy now applies to Individual and family plans (administrative scope expansion).

2024-07-01weight_restriction_added

Added a weight restriction (≥ 35 kg) aligned to the FDA labeled indication for patients ≥ 12 years and ≥ 35 kg.

2024-07-01criteria_language_revised

Replaced language about ganciclovir resistance with wording specifying significant intolerance to ganciclovir or valganciclovir in the coverage criteria.

2024-07-01coadministration_prohibited

Added a restriction prohibiting concurrent use of Livtencity with ganciclovir or valganciclovir; co-administration is not recommended due to potential antagonism.

2025-07-01continuation_authorization_rule_addedLatest

Approved continuation pathway: authorization for 2 months for a patient currently receiving Livtencity if the prescriber documents response with CMV PCR DNA laboratory results within the past 4 weeks showing improvement.

2025-03-15annual_revision

Annual Revision dated 03/15/2025 noted 'No criteria changes.'