CurrentUnitedHealthcarePolicy 2025 P 1330-6

Pa Notification Dojolvi

UnitedHealthcare prior authorization/notification program for Dojolvi (triheptanoin) covering initial authorization and reauthorization criteria for treatment of molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). Governs approval duration, combination product exclusions, and notes on automated approvals and supply limits.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Dojolvi

Policy CodePolicy 2025 P 1330-6

Change TypeRevised (authorization duration); Annual reviews

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Dojolvi; initial and reauthorization approvals are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Initial authorization changed to 12 months (5/2024).

Annual reviews (10/2021,10/2022,10/2023,5/2025) noted with no change to clinical coverage criteria.

12 monthsAuthorization Duration

2Authorization types

YesMolecular confirmation required

Coverage Summary

UnitedHealthcare covers Dojolvi (triheptanoin) with prior authorization under a covered_with_criteria stance. Approval is contingent on meeting the program's clinical criteria for molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) and other policy requirements. Initial authorizations and reauthorizations are issued for 12 months. Automated approvals may occur based on prior claims/medication history, diagnosis codes, and/or claim logic per the program's automated approval possibility.

Initial Authorization Criteria

Initial Authorization

Dojolvi will be approved based on ALL of the following criteria:

Initial Authorization criteria

Diagnosis of long-chain fatty acid oxidation disorders (LC-FAOD)
Molecular confirmation: Disease has been molecularly confirmed (i.e., genetic testing)
Operational note: 'Molecularly confirmed' is defined as confirmation of disease diagnosis via genetic testing.
Combination product exclusion: Patient is not receiving Dojolvi in combination with any other medium-chain triglyceride (MCT) products

Reauthorization / Continuation Criteria

Reauthorization

Dojolvi will be approved based on all the following criteria:

Reauthorization criteria

Clinical response: Documentation of positive clinical response to Dojolvi therapy
Reauthorizations are issued for 12 months per provider requirements and program changes.
Combination product exclusion: Patient is not receiving Dojolvi in combination with any other medium-chain triglyceride (MCT) products

Exclusions and Combination Product Restrictions

Do not approve Dojolvi when the patient is receiving it in combination with any other medium-chain triglyceride (MCT) products. This combination product exclusion is a firm criterion for both initial authorization and reauthorization and will result in denial if concurrent MCT products are present. Medium-chain triglyceride (MCT) products are defined in the policy as MCT.

Provider Actions & Requirements

Prior Authorization

Prior authorization/notification required

Prior authorization/notification is required for Dojolvi. When the policy clinical criteria are met, initial and reauthorization approvals are issued for 12 months.

Documentation Required

Molecular confirmation required

For initial authorization, clinical documentation must show molecular confirmation of LC-FAOD (genetic testing) as defined by the policy.

Documentation Required

Clinical response documentation for reauthorization

For reauthorization, documentation demonstrating a positive clinical response to Dojolvi therapy is required.

Billing Rule

Combination product exclusion

Do not approve Dojolvi if the patient is receiving it in combination with any other medium-chain triglyceride (MCT) products.

Billing Rule

Automated approval possibility

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claims or medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval processes.

Billing Rule

Supply limits/medical necessity

Supply limits and/or additional medical necessity review may apply to Dojolvi requests.

Background

Dojolvi (triheptanoin) is indicated as a source of calories and fatty acids for treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). Coverage is contingent on genetic (molecular) confirmation of LC-FAOD and approval requires avoidance of concurrent medium-chain triglyceride (MCT) products.

Definitions

Molecularly confirmedConfirmation of disease diagnosis via genetic testing.

MCTMedium-chain triglyceride products.

Revision History

10/2020policy_creation

Program created (Prior Authorization/Notification for Dojolvi).

10/2021annual_review

Annual review with no change to clinical coverage criteria.

10/2022annual_review

Annual review with no change to clinical coverage criteria.

10/2023annual_review

Annual review with no change to clinical coverage criteria.

5/2024revisedLatest

Initial authorization changed to 12 months; updated reference.

5/2025annual_review

Annual review with no change to clinical coverage criteria.

2025-05-01last_review_date

Last review recorded (policy last review date).

2025-08-01effective_date

Policy effective date.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Dojolvi

Policy CodePolicy 2025 P 1330-6

Change TypeRevised (authorization duration); Annual reviews

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Dojolvi; initial and reauthorization approvals are issued for 12 months when criteria are met.

SourceLink

On This Page

OpenPayer

Pa Notification Dojolvi

Coverage Summary

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Exclusions and Combination Product Restrictions

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History