VEMLIDY (tenofovir alafenamide)

VEMLIDY (tenofovir alafenamide)

Self-Administration – Oral

Indications for Prior Authorization:

• Hepatitis B - indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

Coverage Criteria:

For treatment of chronic hepatitis B virus (HBV):

• Dose does not exceed 25mg once daily; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with a gastroenterologist, hematologist, or infectious disease specialist; AND
• One of the following:
  • Documented inadequate response, intolerable side effects, or contraindication to tenofovir disoproxil fumarate (Viread).
  • Documented medically appropriate reason why tenofovir disoproxil fumarate (Viread) cannot be used.

 Reauthorization Criteria:

 For treatment of chronic HBV:

• Dose does not exceed 25 mg tablet once daily; AND
• Documentation of positive clinical response to therapy.

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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:

• The European Association for the Study of the Liver (EASL) HBV infection management guidelines recommend using Vemlidy over Viread for the following indications:
  • Greater than age 60.
  • Bone disease (chronic steroid or other drug use that worsens bone density, history of bone fragility fractures, osteoporosis).
  • Renal disease (eGFR less than 60 ml/min/1.73m2, albuminuria less than 30 mg/day or moderate dipstick proteinuria, low phosphate [less than 2.5 mg/dl], hemodialysis).
• Vemlidy is not recommended in patients with estimated creatinine clearance below 15 ml/min who are not receiving chronic hemodialysis. In patients on chronic hemodialysis, on hemodialysis days, administer Vemlidy after hemodialysis.
• When co-administered with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. Coadministration of VEMLIDY with oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin rifapentine, or St. John’s wort is not recommended.

Policy Updates:

• 03/22/2017 – policy reviewed and published
• 10/19/2021 – updated list of appropriate specialists, updated language for determining medical necessity of Vemlidy in place of Viread.

References:

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. Journal of hepatology. 2017 Aug 1;67(2):370-98
• Terrault NA, Lok AS, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown Jr RS, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99
• Vemlidy [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2021