LIVTENCITY (maribavir)
Self-Administration – oral
Diagnosis considered for coverage:
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
Coverage Criteria:
For diagnosis of post-transplant cytomegalovirus (CMV):
- Dose does not exceed the Food and Drug Administration (FDA) labeled maximum dosing:
- 400 mg twice daily
- If co-administered with carbamazepine: 800 mg twice daily
- If co-administered with phenytoin or phenobarbital: 1,200 mg twice daily; AND
- Patient is 12 years of age or older; AND
- Patient weighs 35 kg or more; AND
- Prescribed by or in consultation with a transplant or Infectious Disease specialist; AND
- Patient has a diagnosis of cytomegalovirus (CMV) infection/disease as confirmed by one of the following methods:
- 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
- Chart note documentation confirms 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
Coverage Duration:
- 8 weeks
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Recommended dose (adults and pediatric patients [12 years of age and older and weighing at least 35 kg]): 400 mg twice daily
- If co-administered with carbamazepine: 800 mg twice daily
- If co-administered with phenytoin or phenobarbital: 1,200 mg twice daily
- Warnings: risk of reduced antiviral activity when coadministered with ganciclovir and valganciclovir, virologic failure during treatment and relapse post-treatment, risk of adverse reactions or loss of virologic response due to drug interactions
- Livtencity is not recommended to be coadministered with valganciclovir/ganciclovir
- Coadministration of Livtencity with strong inducers of CYP3A4 is not recommended, except for selected anticonvulsants
Policy Updates:
- 5/17/2022 – New policy approved by P&T.
References:
- Livtencity Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. November 2021.
- 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).
- 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.
Last review date: May 17, 2022