LIVTENCITY (maribavir)

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.