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Limited coverage criteria – tenofovir disoproxil fumarate

Last updated on December 4, 2025

 

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Generic name

 tenofovir disoproxil fumarate                                    

Strength & form

 300 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 alafenamide are automatically covered for tenofovir disoproxil fumarate, 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

Additional information

Special Authority request form(s)