Product Details

Ocaliva

Obeticholic Acid
10 mg
Tablet


DIN/PIN/NPN

02463148

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

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Hepatology Drugs

Obeticholic Acid

  • Brand(s): Ocaliva
  • Dosage Form/Strength: 5mg, 10mg tablet

Obeticholic Acid (Ocaliva) will be funded for the treatment of primary biliary cholangitis (PBC) in adult patients who meet the following criteria:

  1. Diagnosis of PBC is demonstrated by antimitochondrial antibodies or a liver biopsy; AND 

  1. Used in combination therapy with ursodeoxycholic acid (UDCA) in patients who have experienced an inadequate response1 to a minimum of twelve months of treatment with UDCA OR as monotherapy in patients who have experienced unmanageable intolerance to UDCA; AND 

  1. The request is prescribed by or in consultation with a prescriber who is a gastroenterologist, hepatologist or internist with experience in the treatment of PBC. (If you are a prescriber who is not one of the specialists identified above, please submit the consultation note with the request.)

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:

  1. alkaline phosphatase ≥ 1.67 x upper limit of normal 

  1. total bilirubin > 1 x upper limit of normal and below 2 x upper limit of normal 

  1. abnormal bilirubin with progressing and/or compensated cirrhosis

(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:

  1. a reduction in the alkaline phosphatase level to less than 1.67 x upper limit of normal; AND/OR 

  1. a 15% reduction in the alkaline phosphatase level compared with baseline values prior to initiation of treatment with obeticholic acid; AND/OR 

  1. a normal bilirubin level.

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):
Pre-liver transplant patients and/or patients who have complete biliary obstruction will not be funded. 

Duration of funding approval for initials: 1 year 

Duration of funding approval for renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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