More topics

Limited coverage criteria – tenofovir alafenamide

Last updated on December 4, 2025

 

Return to Special Authority drug list

Generic name

tenofovir alafenamide

Strength & form

25 mg tablet

Special Authority criteria

Approval period

For the treatment of adults (≥ 18 years of age) with chronic hepatitis B who are treatment-naive, when:

  • Patient has a confirmed diagnosis of chronic hepatitis B1

AND

  • Patient meets at least ONE of the following criteria:
    • HBV DNA > 2000 IU/mL AND ALT level >1x ULN, or
    • Fibrosis stage F2 or greater2

Indefinite

For the treatment of chronic hepatitis B in treatment-experienced patients, when:

  • Patient demonstrates lamivudine resistance (previous use of lamivudine for a minimum of 3 months)

OR

  • Patient is adefovir-experienced with persistent viremia and has a history of lamivudine resistance

AND

  • Patient is medication-compliant
 Indefinite

Practitioner exemptions

  • None

Special notes

  • 1Hepatitis B surface antigen (HBsAg) positive for at least 6 months
  • 2Supporting evidence must be attached. Accepted methods of evaluation include liver biopsy/Fibroscan (preferred) or APRI (AST to Platelet Ratio Index)
  • Patients who have Special Authority coverage for tenofovir disoproxil fumarate are automatically covered for tenofovir alafenamide, and vice versa
  • In exceptional cases, PharmaCare may consider requests for coverage of patients who do not meet the established criteria, if the physician provides additional documentation supporting the patient's specific clinical need. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews exceptional requests

Special Authority requests