Tenofovir Alafenamide (Vemlidy)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • Treatment of chronic hepatitis B (HBV) infection in adults with compensated liver disease

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by or in collaboration with a specialist; AND

  • Diagnosis of chronic HBV in adults with compensated liver disease; AND
  • First line agent (i.e., Viread) has been tried and failed or documented reason why it cannot be considered (documented renal or bone impairment, or those at high risk (e.g.postmenopausal women)); AND
  • Use is not recommended in those with CrCl < 15mL/minute or if Child-Pugh class B or C
  • Hepatic enzymes, ALT and AST, should be monitored during therapy
  • HIV testing: HIV antibody testing should be offered to all HBV infected patients prior to treatment initiation
  • HIV and HBV coinfection: Should not be used as a single agent for the treatment of HIV due to resistance development risk
  • For females: There have been no data reported to the antiretrovial registry related to the use of this drug in pregnancy.  The Health and Human Services (HHS) Perinatal HIV Guidelines note data are insufficient to recommend tenofovir alafenamide for initial therapy in antiretrovial-naive pregnant women 

The following conditions do not meet the criteria for use as established by WHA P&T committee:

  • all non-FDA approved uses not listed in the approved indications

Dosing:

  • 25mg orally once daily with food

Approval:

  • 1 year

Last review date: March 22, 2017