Dojolvi (triheptanoin) prior authorization
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Prior authorization and medical necessity criteria for Dojolvi (triheptanoin) for treatment of long-chain fatty acid oxidation disorders (LC-FAOD) for UnitedHealthcare members; affects prescribers requesting coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Dojolvi (triheptanoin)
Initial Therapy
Covered when ALL of the following are met:
Authorization issued for 12 months.
Continuation/Reauthorization
Reauthorization covered when ALL of the following are met:
Authorization issued for 12 months.
Use of Dojolvi in combination with any other medium-chain triglyceride (MCT) products is not permitted. Concurrent therapy with other MCT products will preclude coverage and may be considered a basis for denial of prior authorization.
Dosing and Coding Notes
Provider Requirements, Authorization, and Documentation
Prior Authorization required; initial approval = 12 months
Prior authorization is required for Dojolvi; initial approvals will be issued for 12 months when all diagnostic and treatment criteria are met, including documentation confirming LC-FAOD by at least two diagnostic methods, prescriber specialty, dosing limits, and disease-related dietary management.
- Submission of medical records confirming LC-FAOD with at least two of: disease‑specific elevation of acylcarnitines, low enzyme activity in cultured fibroblasts, or pathogenic genetic testing (e.g., CPT2, ACADVL, HADHA, HADHB).
- Prescribed by a board‑certified medical geneticist experienced in LC‑FAOD.
- Target recommended daily dosage does not exceed 35% of total prescribed daily caloric intake (DCI).
- Patient is receiving disease‑related dietary management.
- If not diagnosed by newborn screening, provide history of clinical manifestations (e.g., rhabdomyolysis).
Combination product restriction — no other MCT products
Do not combine Dojolvi with any other medium‑chain triglyceride (MCT) products; ongoing therapy is contingent on continued disease‑related dietary management and prescriber specialty requirements.
- Combination use with other MCT products is explicitly not permitted for both initial authorization and reauthorization.
- Continuation requires documentation of dietary management alongside non‑use of other MCT products.
Required documentation to support prior authorization
Submit medical records that confirm the LC‑FAOD diagnosis using at least two diagnostic criteria and document dietary management, prescriber specialty, and dosing at or below the DCI limit.
- Diagnostic evidence: (1) disease‑specific elevation of acylcarnitines on newborn blood spot or plasma, (2) low enzyme activity in cultured fibroblasts, or (3) genetic testing showing one or more pathogenic mutations associated with LC‑FAOD (e.g., CPT2, ACADVL, HADHA, HADHB).
- Documentation that prescribed dose does not exceed 35% of total prescribed daily caloric intake (DCI).
- Evidence patient is receiving disease‑related dietary management.
- Prescriber is a board‑certified medical geneticist experienced in LC‑FAOD.
Triggers for denial
Denials may be issued if submitted records do not confirm LC‑FAOD with at least two diagnostic criteria, if the member is receiving other MCT products, or if the prescriber does not meet the required specialty.
- Missing diagnostic documentation meeting the two‑criteria standard (acylcarnitines, enzyme activity, or genetic testing) can trigger denial.
- Concurrent use of other medium‑chain triglyceride (MCT) products is a disqualifying factor.
- Absence of a board‑certified medical geneticist as the prescriber may result in denial.
Key Definitions
Background
Dojolvi (triheptanoin) is indicated as a source of calories and fatty acids for pediatric and adult patients with molecularly confirmed long‑chain fatty acid oxidation disorders (LC‑FAOD). Management of LC‑FAOD includes disease‑related dietary management, and Dojolvi dosing must be targeted so that the recommended daily dosage does not exceed 35% of the patient’s total prescribed daily caloric intake (DCI). Prescribing should be by a board‑certified medical geneticist experienced in LC‑FAOD.
Initial Therapy Criteria (Detailed)
Initial Therapy — Initial authorization requirements
Initial authorization requirements:
12-month initial approval.
Continuation / Reauthorization Criteria (Detailed)
Reauthorization — Reauthorization requirements
Reauthorization requirements:
12-month reauthorization.
Step Therapy and Automated Approvals
| Step | Description |
|---|---|
| 1 | UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Automated approval and re-approval processes may be used depending on program or therapeutic class. |
Quantity Limits
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