Product Details
Ocaliva
Obeticholic Acid5 mg
Tablet
DIN/PIN/NPN
02463121
Manufacturer
Advanz Pharma Canada Inc.
Formulary Listing Date
2023-04-28
Unit Price
108.4110
Amount MOH Pays
108.4110
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
A05AA04
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Hepatology Drugs | Obeticholic Acid
Obeticholic Acid (Ocaliva) will be funded for the treatment of primary biliary cholangitis (PBC) in adult patients who meet the following criteria:
1Note that an inadequate response is defined as a patient who has used UDCA to treat PBC for a minimum of twelve (12) months and demonstrates ANY ONE or more of the following:
(Documentation of lab work to be submitted with the request application.) Renewals will be considered in patients who continue to benefit from treatment as evidenced by any one of the following:
AND the patient has not developed unacceptable toxicity from treatment with obeticholic acid. Patients not meeting the above renewal criteria may be considered on a case-by-case basis. Exclusion Criteria (applies to both initial and renewal requests): Duration of funding approval for initials: 1 year Duration of funding approval for renewals: 1 year EAP Drug Request Form: |