Livtencity™

Drug - Livtencity™ (maribavir) [Takeda Pharmaceuticals America, Inc.]

April 2022

Therapeutic area - Antivirals, General

Initial approval criteria

Patient is ≥ 12 years of age AND
Patient must weigh ≥ 35 kilogram (kg) AND
Patient is a recipient of a hematopoietic stem cell or solid organ transplant AND
Patient has documented cytomegalovirus (CMV) infection in whole blood or plasma (screening value ≥ 2,730 IU/mL in whole blood or ≥ 910 IU/mL in plasma) in 2 consecutive assessments separated by ≥ 1 day AND
Patient has current CMV infection that is refractory (documented failure to achieve > 1 log10 decrease in CMV deoxyribonucleic acid [DNA] level in whole blood or plasma after ≥ 14 days treatment) to anti-CMV treatment agents (ganciclovir, valganciclovir, cidofovir, or foscarnet), even with documented genetic mutations associated with resistance AND
Maribavir will NOT be coadministered with ganciclovir or valganciclovir AND
Patient will be monitored for clinically important drug interactions that could result in decreased therapeutic effect of maribavir
Initial approval is for 6 months

Patient must continue to meet the initial approval criteria AND
Patient must have disease improvement and/or stabilization OR improvement in the slope of decline (> 1 log10 decrease in CMV DNA level in whole blood or plasma after 14 days or longer treatment) AND
Patient has NOT experienced any treatment-restricting adverse effects (e.g., dysgeusia, diarrhea, nausea, and recurrence of underlying disease) AND
Patient is NOT a non-responder (resistant) to maribavir
Renewal approval is for 6 months

MHCP Provider Resource Center 651-431-2700 or 800-366-5411