Dojolvi (triheptanoin) — Blue Cross Blue Shield of Montana

Initial criteria

• ALL of the following:
• 1. The patient has ONE of the following:
• A. Diagnosis of long-chain fatty acid oxidation disorder (LCFAOD) AND ALL of the following:
• • Diagnosis confirmed by at least TWO of the following:
• – Disease-specific elevations of acylcarnitines on newborn blood spot or in plasma
• – Enzyme activity assay demonstrating deficiency of enzyme associated with LCFAODs
• – Genetic testing showing pathogenic mutation in gene associated with LCFAODs
• • Patient had symptomatic LCFAOD prior to therapy
• • Patient will not be concurrently using another medium chain triglyceride product
• • Requested agent will not be used for more than 35% of total prescribed daily caloric intake
• OR
• B. Patient has another FDA labeled indication for the requested agent and route of administration
• OR
• C. Patient has another indication supported in compendia for the requested agent and route of administration
• 2. Prescriber is a specialist in or has consulted with a specialist in the area of diagnosis (e.g., endocrinologist)
• 3. Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of approval: 12 months
• Compendia allowed: AHFS or DrugDex 1, 2A, or 2B
• Additional approval scenarios:
• – For BCBS NM Fully Insured or NM HIM member: ALL of
• A. No FDA labeled contraindications
• B. Requested indication is a rare disease
• C. ONE of:
• 1. Another FDA labeled indication for requested agent and route
• 2. Another compendia-supported indication for requested agent and route
• – For member in Ohio (Fully Insured or HIM Shop): ALL of
• A. Member resides in Ohio
• B. Plan is Fully Insured or HIM Shop (SG)
• C. No FDA labeled contraindications
• D. ONE of:
• 1. Another FDA labeled indication
• 2. Another compendia-supported indication
• 3. Prescriber submits TWO articles from major peer-reviewed medical journals supporting use as generally safe and effective (case studies not acceptable)

Reauthorization criteria

• ALL of the following:
• 1. Patient previously approved for requested agent through plan’s Prior Authorization process
• 2. Patient has had clinical benefit with requested agent
• 3. If diagnosis is LCFAOD, BOTH:
• A. Patient will not be concurrently using another medium chain triglyceride product
• B. Requested agent will not be used for more than 35% of total prescribed daily caloric intake
• 4. Prescriber is a specialist in or has consulted with a specialist in area of diagnosis (e.g., endocrinologist)
• 5. Patient does NOT have any FDA labeled contraindications to requested agent
• Length of approval: 12 months

Approval duration

12 months