Product Details

Albrioza

Sodium Phenylbutyrate + Ursodoxicoltaurine
3 g + 1 g/Sachet
Powder for Oral Suspension


DIN/PIN/NPN

02527707

Manufacturer

Innomar Strategies, Inc.

Formulary Listing Date

2023-06-22  

Unit Price

306.7123

Amount MOH Pays

306.7123

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N07XX

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Central Nervous System Drugs

Sodium phenylbutyrate and Ursodoxicoltaurine

  • Brand(s): Albrioza
  • Dosage Form/Strength: 3g/1g Sachet
  • Effective Date: June 22, 2023

For the treatment of amyotrophic lateral sclerosis (ALS) in patients meeting all the following criteria:

  1. Diagnosis of definite ALS; AND 

  1. ALS symptom onset occurred within the past 18 months or less; AND 

  1. Forced vital capacity (FVC) is greater than or equal to 60% of predicted; AND 

  1. Does not require permanent non-invasive or invasive ventilation; AND 

  1. Is under the care of a specialist with experience in the diagnosis and management of ALS

Discontinuation Criteria: 

Reimbursement will be discontinued in patients who meet any one of the following criteria: 

  1. Patient becomes non-ambulatory AND is unable to cut food and feed themselves without assistance, irrespective of whether a gastrostomy is in place. 

  1. Patient requires permanent non-invasive or invasive ventilation 

Renewal Criteria: 

Renewals will be considered in patients who do not meet the discontinuation criteria.

Recommended dose:

For the first 3 weeks of treatment, take 1 sachet (3 g sodium phenylbutyrate, 1 g ursodoxicoltaurine) daily. 

After 3 weeks, dosing should be increased to 1 sachet twice a day. 

Approval duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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