DOJOLVI (triheptanoin liquid)

DOJOLVI (triheptanoin liquid)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• Indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)

Coverage Criteria:

• Patient has a documented diagnosis of long-chain fatty acid oxidation disorder (LC-FAOD), AND
• Disease has been molecularly confirmed (i.e., genetic testing), AND
• Prescribed by or in consultation with a clinical specialist knowledgeable in appropriate disease-related dietary management (e.g., geneticist, cardiologist, gastroenterologist, etc.), AND
• Not used with any other medium-chain triglyceride (MCT) product

Reauthorization Criteria:

• Prescriber attests to continued need of therapy

Dosing:

• Initial total daily dose: 10% DCI divided into at least four times per day
• Recommended target daily dose: up to 35% of the patient’s total prescribed DCI divided into at least four doses and administered at mealtimes or with snacks
• Avoid co-administration of Dojolvi™ with pancreatic lipase inhibitors (e.g., orlistat)
• Avoid administration of Dojolvi™ in patients with pancreatic insufficiency

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Feeding Tube Dysfunction: Feeding tube performance and functionality can degrade over time depending on usage and environmental conditions. Do not administer Dojolvi™ in feeding tubes manufactured of polyvinyl chloride (PVC)
• Intestinal Malabsorption in Patients with Pancreatic Insufficiency: Avoid administration of Dojolvi™ in patients with pancreatic insufficiency
• Pregnancy: There are no available data on triheptanoin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation: There are no data on the presence of triheptanoin or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production

Review History:

• 2/16/21- Original review

References:

• Dojolvi (triheptanoin) prescribing information. Ultragenyx Pharmaceutical Inc. Novato, CA. June 2020.