How to Get Dojolvi (Triheptanoin) Covered by Aetna CVS Health in California: Complete Timeline, Appeals Guide, and Required Documentation

Answer Box: Getting Dojolvi (Triheptanoin) Covered by Aetna CVS Health in California

Fastest path to approval: Submit complete prior authorization through Aetna's provider portal with genetic confirmation of long-chain fatty acid oxidation disorder (LC-FAOD), specialist consultation notes, and medical necessity letter. Standard review takes 30 days; expedited review 72 hours if urgent. If denied, California's Independent Medical Review (IMR) has a 68% success rate for specialty drug appeals.

First step today: Contact your metabolic specialist to gather genetic testing results and enroll with CVS Specialty Pharmacy while initiating the PA request.

Table of Contents

  1. What Affects Dojolvi Approval Timeline
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Decision Window and Outcomes
  5. If Denied: California Appeal Process
  6. Coverage Requirements at a Glance
  7. Common Denial Reasons and Solutions
  8. Timeline Milestones
  9. Costs and Patient Support
  10. FAQ

What Affects Dojolvi Approval Timeline

Several factors influence how quickly Aetna CVS Health processes your Dojolvi (triheptanoin) prior authorization in California:

Benefit Type and Formulary Status Dojolvi typically requires both prior authorization and a formulary exception since it's not on most standard formularies. This dual requirement can extend review times but is standard for rare disease therapies.

Documentation Completeness The most critical factor affecting timeline is having complete documentation upfront. Missing genetic confirmation or incomplete specialist notes will trigger additional information requests, adding 7-14 days to the process.

Clinical Urgency For patients with acute metabolic crises or those currently stable on Dojolvi, expedited review can reduce approval time to 72 hours with proper clinical justification.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist:

  • Genetic testing results showing pathogenic mutations in LC-FAOD genes (CPT2, ACADVL, HADHA, HADHB)
  • Specialist consultation notes from endocrinologist, geneticist, or metabolic disease specialist
  • Medical necessity letter linking patient's LC-FAOD to FDA-approved Dojolvi indications
  • Prior treatment documentation including MCT oil trials and outcomes
  • Dosing calculations based on patient's daily caloric intake (up to 35% DCI)
  • CVS Specialty Pharmacy enrollment (initiated alongside PA)

Verification Steps:

  1. Confirm patient's Aetna plan requires CVS Specialty dispensing
  2. Verify current PA forms on Aetna's provider portal
  3. Gather ICD-10 codes (E71.310 or E71.318 for LC-FAOD)
  4. Document discontinuation of other MCT products

Submission to Initial Review (1-5 Days)

California Processing Requirements California law requires insurers to acknowledge receipt of PA requests within 5 business days and provide estimated review timelines. Aetna typically confirms receipt within 24-48 hours through their provider portal.

What Reviewers Check First:

  1. Genetic confirmation - Primary screening criterion
  2. Specialist credentials - Must be qualified metabolic specialist
  3. FDA indication alignment - Diagnosis must match approved uses
  4. CVS Specialty enrollment status - Required for dispensing
Tip: Submit through Aetna's provider portal for fastest processing and real-time tracking. Fax submissions may take 2-3 additional days for initial review.

Decision Window and Outcomes

Standard Review Timeline:

  • Initial review: 30 days from complete submission
  • Additional information requests: 7-14 days if incomplete
  • Final determination: Within 45 days total

Expedited Review (72 Hours): Available for urgent clinical situations with provider attestation of medical necessity. Common qualifying scenarios include:

  • Current patient experiencing metabolic decompensation
  • Patient stable on Dojolvi with coverage interruption
  • Acute clinical deterioration without treatment

Approval Outcomes:

  • Full approval: 12-month authorization typical
  • Partial approval: May include quantity limits or step therapy requirements
  • Denial: Requires specific reason code and appeal rights notice

If Denied: California Appeal Process

California offers exceptionally strong patient protections for specialty drug appeals, with 68% of specialty drug denials overturned through the Independent Medical Review (IMR) process.

Internal Appeal (First Level):

  • Deadline: 180 days from denial notice
  • Timeline: Aetna has 30 days to respond
  • Required: Must exhaust internal appeal before IMR

Independent Medical Review (External Appeal):

  • Success rate: 68% for specialty drugs, 60% for oncology drugs
  • Timeline: 30 days standard, 7 days expedited
  • Cost: Free to patients
  • Decision: Binding on Aetna

How to File IMR:

  1. Complete internal appeal with Aetna first
  2. File IMR application with California DMHC within 6 months
  3. Submit supporting documentation and medical records
  4. DMHC assigns independent specialty physician reviewers
From our advocates: We've seen several Dojolvi denials overturned in California when families submitted comprehensive genetic testing results alongside detailed specialist letters explaining prior MCT failures. The key was demonstrating that Dojolvi was the only FDA-approved option after conventional dietary therapy proved insufficient.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before dispensing Aetna PA List
Formulary Exception Non-formulary drug needs exception Provider portal
Genetic Confirmation Molecular testing for LC-FAOD Lab reports with pathogenic variants
Specialist Prescription Must be prescribed by qualified specialist Endocrinologist/geneticist notes
CVS Specialty Dispensing Must use CVS Specialty Pharmacy CVS Specialty enrollment
MCT Discontinuation Stop other MCT products Provider attestation

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing genetic confirmation Submit molecular testing results Pathogenic variant report
Concurrent MCT therapy Provide discontinuation proof Specialist attestation
Non-formulary status Request formulary exception Medical necessity letter
Lack of specialist oversight Confirm prescriber credentials Board certification documentation
Insufficient medical necessity Strengthen clinical justification Prior therapy failures, outcomes

Timeline Milestones

Complete Process Timeline:

  • Days 0-2: Preparation and documentation gathering
  • Days 1-5: Submission and initial review acknowledgment
  • Days 5-30: Standard PA review period
  • Days 30-45: Additional information requests (if needed)
  • Days 45-60: Internal appeal (if denied)
  • Days 60-105: Independent Medical Review (if needed)

Expedited Timeline (Urgent Cases):

  • Day 0: Submit with urgency attestation
  • Days 1-3: Expedited review and decision
  • Days 3-10: Expedited appeal if denied

Costs and Patient Support

Dojolvi Pricing: Cash prices range from $5,857-$6,365 per 500-mL bottle, making insurance coverage essential for most patients.

Patient Support Options:

  • Ultragenyx Patient Support Program: Copay assistance and prior authorization support
  • California Prescription Drug Discount Program: State-sponsored savings for eligible residents
  • Rare Disease Foundation Grants: Various organizations offer financial assistance

FAQ

How long does Aetna CVS Health PA take in California? Standard review is 30 days from complete submission. Expedited review for urgent cases takes up to 72 hours with proper clinical justification.

What if Dojolvi is non-formulary on my plan? Request a formulary exception alongside your PA. Provide medical necessity documentation showing why formulary alternatives aren't appropriate for LC-FAOD.

Can I request an expedited appeal in California? Yes, both Aetna internal appeals and California IMR offer expedited processes for urgent medical situations, typically decided within 7 days.

Does step therapy apply to Dojolvi? Some plans may require trying dietary MCT therapy first. However, documented failures or contraindications to step therapy drugs can qualify for an override.

What genetic testing is required? Molecular testing confirming pathogenic mutations in LC-FAOD-related genes (CPT2, ACADVL, HADHA, HADHB) is mandatory for approval.

How often do I need reauthorization? Initial approvals are typically for 12 months. Renewals require documentation of positive clinical response and continued medical necessity.


About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed rebuttal letters. The platform identifies denial reasons and drafts point-by-point responses using FDA labeling, peer-reviewed studies, and payer-specific requirements to improve approval rates for complex therapies like Dojolvi.

For additional support with your Dojolvi appeal, Counterforce Health provides specialized assistance in preparing comprehensive documentation packages that address Aetna's specific approval criteria while leveraging California's strong patient protection laws.

Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with insurance complaints in California, contact the DMHC Help Center at 888-466-2219.

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