Product Details

Hepsera

Adefovir Dipivoxil
10 mg
Tablet


DIN/PIN/NPN

02247823

Manufacturer

Gilead Sciences Canada, Inc.

Formulary Listing Date

2014-04-30  

Unit Price

NA

Amount MOH Pays

NA

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J05AF08

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02247823 Hepsera NA NA
02420333 AA-Adefovir 20.9130 NA
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Hepatology Drugs

Adefovir

  • Brand(s): Hepsera
  • Dosage Form/Strength: 10 mg tablet

For the treatment of chronic hepatitis B in patients with objective evidence of lamivudine virologic* breakthrough where failure is not due to poor adherence to therapy; AND 

  • Liver biopsy showing Metavir stage 3 fibrosis or greater; OR 

  • Documented evidence of cirrhosis OR 

  • Patients with the presence of a lamivudine resistance mutation*****; AND 

  • Liver Biopsy showing Metavir stage 3 fibrosis or greater; OR

  • Documented evidence of cirrhosis 

Duration of Approval: 1 year (If Cirrhotic: Lifetime)

Duration of Approval for Renewal: 5 years 

Note: Effective February 28, 2018, Entecavir, Lamivudine, and Tenofovir became a Limited Use Benefit on the Ontario Drug Benefit Formulary – Please refer to the formulary for the Limited Use Criteria.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph