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Dojolvi (triheptanoin) — Blue Cross Blue Shield of New Mexico

long-chain fatty acid oxidation disorder (LCFAOD)

Initial criteria

  • The patient has ONE of the following:
  • A. The patient has a diagnosis of long-chain fatty acid oxidation disorder (LCFAOD) AND ALL of the following:
  • 1. The diagnosis has been confirmed by at least TWO of the following:
  • A. Disease-specific elevations of acylcarnitines on a newborn blood spot or in plasma
  • B. Enzyme activity assay (in cultured fibroblasts or lymphocytes) demonstrating deficiency of an enzyme associated with LCFAODs
  • C. Genetic testing demonstrating pathogenic mutation in a gene associated with LCFAODs
  • 2. The patient had symptomatic LCFAOD prior to therapy with the requested agent
  • 3. The patient will not be concurrently using another medium chain triglyceride product
  • 4. The patient will not be using the requested agent for more than 35% of the patient’s total prescribed daily caloric intake
  • OR B. The patient has another FDA labeled indication for the requested agent and route of administration
  • OR C. The patient has another indication that is supported in compendia for the requested agent and route of administration
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the patient’s diagnosis
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate approval when ONE of the following is met:
  • 1. For a BCBS NM Fully Insured or NM HIM member: ALL of the following:
  • A. The patient does NOT have any FDA labeled contraindications to the requested agent
  • B. The requested indication is a rare disease
  • C. ONE of the following:
  • 1. The patient has another FDA labeled indication for the requested agent and route of administration
  • 2. The patient has another indication that is supported in compendia for the requested agent and route of administration
  • OR 2. ALL of the following:
  • A. The member resides in Ohio
  • B. The plan is Fully Insured or HIM Shop (SG)
  • C. The patient does NOT have any FDA labeled contraindications to the requested agent
  • D. ONE of the following:
  • 1. The patient has another FDA labeled indication for the requested agent and route of administration
  • 2. The patient has another indication that is supported in compendia for the requested agent and route of administration
  • 3. The prescriber has submitted TWO peer-reviewed journal articles supporting the proposed use(s) as generally safe and effective

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had clinical benefit with the requested agent
  • If the patient has a diagnosis of LCFAOD, BOTH of the following:
  • A. The patient will not be concurrently using another medium chain triglyceride product
  • B. The patient will not be using the requested agent for more than 35% of the patient’s total prescribed daily caloric intake
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the patient’s diagnosis
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months