Pharmacy Prior Authorization Criteria

Livtencity (maribavir)

Indications for Prior Authorization

Livtencity (maribavir)

• For diagnosis of Cytomegalovirus (CMV) infection/disease
  Indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Criteria

Livtencity

Prior Authorization

Length of Approval: 8 Week(s) [1]
For diagnosis of CMV infection/disease

• Diagnosis of cytomegalovirus (CMV) infection/disease as confirmed by one of the following methods: [2, 3]
• quantitative polymerase chain reaction (qPCR)
• CMV pp65 antigenemia
AND
• Patient is a recipient of one of the following:
• Hematopoietic stem cell transplant
• Solid organ transplant
AND
• Trial and failure of a minimum 2 weeks duration, contraindication, or intolerance to one of the following therapies at an appropriately indicated dose:
• Intravenous (IV) ganciclovir
• Oral valganciclovir
• IV foscarnet
• IV cidofovir
AND
• Patient is 12 years of age or older
AND
• Patient weighs greater than or equal to 35kg
AND
• Prescribed by or in consultation with a provider who specializes in one of the following areas:
• Transplant
• Infectious Disease
• Oncology

P & T Revisions

2024-12-23, 2024-01-16, 2023-01-19, 2022-01-26, 2022-01-19

References

1. Livtencity Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. March 2024.
2. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients—Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clinical Transplantation. 2019;33(9).
3. ClinicalTrials.gov [Internet]. U.S. National Library of Medicine. Identifier NCT02931539. Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir; October 13, 2016. Available from: https://clinicaltrials.gov/ct2/show/NCT02931539.

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End Notes

1. A one-log decline in CMV viral load is the anticipated outcome after at least 2 weeks of appropriately dosed antiviral therapy. [2]

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Revision History

• 2024-12-23: 2025 Annual Review - Addition of Oncology as another prescriber specialty. Updated references
• 2024-01-16: 2024 Annual Review - no changes
• 2023-01-19: 2023 Annual Review
• 2022-01-26: Formulary update
• 2022-01-19: New program

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