By Counterforce Health Team in Dojolvi (triheptanoin) —

How to Get Dojolvi (Triheptanoin) Covered by Aetna in Michigan: Complete Prior Authorization and Appeals Guide 2025

Answer Box: Getting Dojolvi Covered by Aetna in Michigan

Dojolvi (triheptanoin) is not on Aetna's formulary, requiring a formulary exception and prior authorization. You'll need genetic confirmation of LC-FAOD, specialist documentation, and proof you're not using other MCT products. If denied, Michigan gives you 127 days to file an external review with DIFS. Start today: Have your metabolic specialist gather genetic test results and submit a prior authorization through Aetna's provider portal while enrolling with CVS Specialty.

Table of Contents

Policy Overview: How Aetna Handles Non-Formulary Specialty Drugs

Dojolvi (triheptanoin) is classified as a non-formulary specialty medication across Aetna's 2024-2025 formularies, meaning it requires both a formulary exception and prior authorization regardless of your plan type (HMO, PPO, or EPO). This applies to all Aetna commercial plans in Michigan.

Key Policy Facts:

  • Specialty tier status: Must be dispensed through CVS Specialty Pharmacy
  • Prior authorization required: No exceptions for any plan type
  • Medical necessity standard: Must meet FDA indication and demonstrate clinical need
  • Concurrent enrollment: CVS Specialty enrollment must be completed alongside PA submission
Note: Aetna Medicaid plans in Michigan may have different requirements. Check with Michigan DIFS for Medicaid-specific policies.

Medical Necessity Requirements for Dojolvi

Based on Aetna's prior authorization criteria and FDA labeling, your request must include:

Core Documentation Requirements

Requirement What You Need Where to Get It
Genetic Confirmation Pathogenic mutations in LC-FAOD genes (CPT2, ACADVL, HADHA, HADHB) Genetic testing lab report
Biochemical Evidence Elevated acylcarnitines or reduced enzyme activity Newborn screening or plasma testing
Specialist Involvement Prescription from metabolic specialist, geneticist, or endocrinologist Board-certified specialist
Dosing Documentation Patient weight, daily caloric intake, dose ≤35% of calories Clinical notes
MCT Discontinuation Confirmation no other MCT products are being used Provider attestation

FDA Indication Alignment

Dojolvi is FDA-approved as "a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)." Your request must demonstrate molecular confirmation through genetic testing or biochemical assays.

Step-by-Step: Fastest Path to Approval

Step 1: Gather Required Documentation (Patient & Clinic)

Timeline: 1-2 weeks

  • Obtain genetic test results confirming LC-FAOD diagnosis
  • Collect previous treatment records (dietary management, MCT trials)
  • Document current weight and daily caloric needs
  • Ensure specialist consultation notes are current

Step 2: Submit Prior Authorization (Clinic)

Timeline: Submit immediately

  • Access Aetna's provider portal
  • Complete formulary exception request with all supporting documents
  • Include detailed medical necessity letter (see Clinician Corner below)
  • Submit CVS Specialty enrollment forms simultaneously

Step 3: CVS Specialty Enrollment (Patient & Clinic)

Timeline: Concurrent with PA

  • Complete enrollment through CVS Specialty
  • Provide insurance information and prescription details
  • Set up delivery preferences and financial assistance if needed

Step 4: Aetna Review Process

Timeline: 30-45 days standard, 72 hours expedited

  • Standard review for stable patients
  • Request expedited review if medical urgency exists
  • Aetna may request additional documentation or peer-to-peer review

Step 5: If Approved - Begin Treatment

Timeline: 5-7 days for delivery

  • CVS Specialty will coordinate delivery
  • Begin dosing per specialist's instructions
  • Schedule follow-up monitoring as required

Step 6: If Denied - File Internal Appeal

Timeline: Within 65 days of denial

  • Submit appeal through Aetna's member portal or by phone
  • Include additional clinical evidence and specialist support
  • Request expedited appeal if medically urgent

Step 7: Michigan External Review (If Still Denied)

Timeline: Within 127 days of final denial

  • File with Michigan DIFS
  • Include all documentation and final denial letter
  • DIFS decision within 60 days (72 hours if expedited)

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
"Molecular confirmation missing" Submit genetic test results Lab report showing pathogenic LC-FAOD mutations
"Not medically necessary" Strengthen clinical justification Specialist letter detailing disease severity, prior treatments
"Concurrent MCT use" Document MCT discontinuation Provider attestation confirming no other MCT products
"Insufficient prior therapy" Document dietary management attempts Records of previous dietary interventions, outcomes
"Experimental/investigational" Emphasize FDA approval FDA label, approval letter, clinical trial data

Appeals Process: Internal to Michigan DIFS External Review

Aetna Internal Appeals

Standard Appeal:

  • Deadline: 65 days from denial date
  • Timeline: 30-45 business days for decision
  • How to file: Aetna member portal, phone (800-872-3862), or mail
  • Required: Original denial letter, additional medical evidence

Expedited Appeal:

  • When to use: Medical urgency, risk to health
  • Timeline: 72 hours for decision
  • Required: Physician certification of urgency

Michigan DIFS External Review

After exhausting Aetna's internal appeals, Michigan residents can file for independent external review.

Key Facts:

  • Deadline: 127 days from Aetna's final denial
  • Cost: Free to patients
  • Timeline: 60 days for standard review, 72 hours if expedited
  • Decision: Binding on Aetna if overturned

How to File:

  1. Complete DIFS External Review form
  2. Include Aetna's final denial letter and all medical records
  3. Submit online, by email, fax, or mail
  4. For expedited review, include physician letter certifying urgency

Contact Michigan DIFS: 877-999-6442

From our advocates: We've seen several LC-FAOD cases where initial denials were overturned at the Michigan external review level when families provided comprehensive genetic testing results and detailed specialist letters explaining why dietary management alone was insufficient. The key was documenting the specific gene mutations and connecting them to clinical symptoms.

Costs & Patient Assistance Programs

Typical Costs:

  • Cash price: $5,857-$6,365 per 500mL bottle
  • With insurance: Varies by plan (specialty tier copay/coinsurance)

Financial Assistance:

  • Ultragenyx Patient Support: Contact manufacturer for copay assistance and patient support programs
  • CVS Specialty Financial Assistance: Available for eligible patients
  • State Programs: Michigan residents may qualify for additional assistance through state pharmaceutical programs

Counterforce Health helps patients navigate the complex prior authorization and appeals process, turning denials into targeted, evidence-backed appeals that align with payer requirements and maximize approval chances.

Clinician Corner: Medical Necessity Letter Essentials

Required Elements for Strong Medical Necessity Documentation

Patient Background:

  • Confirmed LC-FAOD diagnosis with specific gene mutation
  • Age, weight, and current clinical status
  • Previous hospitalizations or metabolic crises

Prior Treatments & Outcomes:

  • Dietary management attempts and effectiveness
  • Previous MCT supplementation (document discontinuation)
  • Any adverse events or treatment failures

Clinical Rationale:

  • Why Dojolvi is medically necessary for this patient
  • Expected clinical benefits and monitoring plan
  • Dosing rationale (percentage of daily caloric intake)

Supporting Evidence:

Sample Medical Necessity Statement

"This [age]-year-old patient has molecularly confirmed LC-FAOD with [specific mutation] documented by genetic testing. Despite dietary management including MCT supplementation, the patient has experienced [specific clinical issues]. Dojolvi (triheptanoin) is the only FDA-approved therapy for LC-FAOD and is medically necessary to provide anaplerotic substrates that standard MCT therapy cannot provide. All other MCT products have been discontinued per FDA labeling requirements."

FAQ: Your Top Questions Answered

How long does Aetna prior authorization take in Michigan? Standard PA decisions take 30-45 business days. Expedited reviews (for urgent medical need) are completed within 72 hours. Michigan law doesn't change Aetna's internal timelines, but provides additional external review rights.

What if Dojolvi is non-formulary on my Aetna plan? Dojolvi is non-formulary across Aetna plans, requiring a formulary exception. This doesn't prevent coverage—it just requires additional documentation of medical necessity and specialist involvement.

Can I request an expedited appeal in Michigan? Yes, both Aetna and Michigan DIFS offer expedited appeals. You'll need physician certification that delay would jeopardize your health. Expedited reviews are completed in 72 hours.

Does step therapy apply to Dojolvi? Aetna doesn't have specific step therapy requirements for Dojolvi, but you must document prior dietary management attempts and explain why standard MCT therapy is insufficient.

What happens if Michigan DIFS overturns Aetna's denial? DIFS external review decisions are binding. If overturned, Aetna must provide coverage as directed. The insurer cannot appeal a favorable external review decision.

How much will Dojolvi cost with Aetna coverage? Costs depend on your specific plan's specialty tier structure. With prior authorization approval, you'll pay your plan's specialty medication copay or coinsurance. Contact Aetna member services for your specific cost-sharing details.

Can my doctor file appeals for me? Yes, Michigan law allows authorized representatives (including physicians) to file appeals on your behalf with written consent. This can streamline the process and ensure medical expertise in the appeal submission.

What if I need Dojolvi urgently while the PA is pending? Request expedited review from Aetna with physician certification of urgency. You can also explore manufacturer patient assistance programs or discuss temporary alternative management with your specialist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Coverage policies and requirements may change. Always verify current requirements with Aetna directly and consult with your healthcare provider about treatment decisions. For personalized assistance with prior authorizations and appeals, Counterforce Health specializes in turning insurance denials into successful, evidence-backed appeals.

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