Product Details
Ravicti
Glycerol Phenylbutyrate1.1 mg/mL
Oral Liquid
25-mL Glass Bottle
DIN/PIN/NPN
02453304
Manufacturer
Horizon Therapeutics Ireland DAC
Formulary Listing Date
2018-04-09
Unit Price
48.0000
Amount MOH Pays
48.0000
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
A16AX09
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Metabolic/Genetic Modifiers | Glycerol phenylbutyrate
For the management of patients with chronic urea cycle disorders (UCD) who meet all the following criteria:
1The initial request should include levels for blood ammonia and glutamine levels demonstrating inadequate effects of protein restriction or amino acid supplementation. Exclusion Criteria:
Recommended dose: 5 g/m2 to 12.4 g/m2 per day Approval duration: 1 year Renewal Criteria: Renewals will be considered in patients who demonstrate benefit from treatment2 and who have not developed unacceptable toxicities requiring discontinuation. 2At the time of renewal, please provide recent (within 3 months) blood ammonia and glutamine levels while on treatment and address the number and severity of hyperammonemic events experienced while on treatment in the previous 12 months and any treatment emergent events requiring urgent care or hospitalization. First renewal: 1 year Subsequent renewals: 2 years EAP Drug Request Form: |