By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Aetna (CVS Health) in Ohio: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Juxtapid (lomitapide) Covered by Aetna (CVS Health) in Ohio

Aetna (CVS Health) requires prior authorization for Juxtapid (lomitapide) with documented homozygous familial hypercholesterolemia (HoFH) diagnosis and evidence of failure or intolerance to preferred therapies. First step today: Gather genetic testing results or clinical HoFH documentation, baseline LDL-C levels, and complete treatment history. Submit PA using Aetna's Juxtapid-specific form with ICD-10 code E78.010. If denied, you have 180 days to appeal internally, then 180 days for Ohio external review through an Independent Review Organization (IRO).

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Documentation
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Ohio
  6. Cost and Financial Assistance
  7. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Juxtapid prescriptions Aetna 2025 Advanced Control Plan
Formulary Tier Specialty tier with high copay/coinsurance Member-specific drug guide
Step Therapy Must try statins, ezetimibe, PCSK9 inhibitors first Aetna PA criteria
ICD-10 Code E78.010 (Homozygous familial hypercholesterolemia) ICD-10-CM 2025 Updates
Age Requirement 18+ years (FDA labeling) FDA Access Data
Appeals Deadline 180 days from denial (internal and external) Ohio Department of Insurance

Step-by-Step: Fastest Path to Approval

1. Confirm HoFH Diagnosis and Gather Documentation

Who: Patient and prescriber
Documents needed:

  • Genetic testing report showing pathogenic variants in both alleles (LDLR, APOB, PCSK9, or LDLRAP1)
  • OR clinical diagnostic criteria documentation (untreated LDL-C ≥500 mg/dL or treated LDL-C ≥300 mg/dL with family history)
  • Baseline and current LDL-C levels with dates

2. Document Prior Therapy Failures

Who: Prescriber
Documents needed:

  • Complete treatment history with dates, doses, and outcomes for:
    • High-intensity statins (atorvastatin, rosuvastatin)
    • Ezetimibe
    • PCSK9 inhibitors (evolocumab, alirocumab)
    • Any other lipid-lowering therapies tried
  • Documentation of intolerance, contraindications, or inadequate response

3. Complete Safety Assessment

Who: Prescriber
Requirements:

  • Baseline liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
  • Assessment for hepatic steatosis or active liver disease
  • Confirmation of REMS program enrollment capability
  • Low-fat diet counseling documentation

4. Submit Prior Authorization

Who: Prescriber or office staff
How to submit: Use Aetna's Juxtapid-specific PA form via:

  • Aetna provider portal (fastest)
  • Fax to Medical Exception to Pharmacy Prior Authorization Unit
  • Mail to address on member's drug guide

Timeline: 72 hours for standard review, expedited available for urgent cases

5. Follow Up and Track Decision

Who: Patient or office staff
Action: Call Aetna member services to confirm receipt and check status Expected timeline: Decision within 30-45 days for commercial plans

Medical Necessity Documentation

Clinician Corner: Your medical necessity letter should include these key elements to strengthen approval chances.

Essential Documentation Elements

HoFH Diagnosis Confirmation:

  • ICD-10 code E78.010 (not E78.019 unspecified)
  • Genetic testing results with specific variants identified
  • If no genetic testing: detailed clinical criteria used (Simon Broome, Dutch Lipid Clinic Network)
  • Family history showing both parents with confirmed or suspected FH

Treatment History:

  • Chronological list of all lipid-lowering therapies with:
    • Drug names, doses, start/stop dates
    • LDL-C response (before and on-treatment values)
    • Reasons for discontinuation (ineffective, intolerant, contraindicated)
  • Documentation that patient is on maximally tolerated therapy

Safety and Monitoring Plan:

  • Current liver function test results
  • Plan for ongoing LFT monitoring per FDA labeling
  • Confirmation of prescriber experience with REMS programs
  • Patient counseling on low-fat diet and GI side effect management

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Diagnosis not confirmed as HoFH" Submit genetic testing report or detailed clinical diagnostic criteria documentation with ICD-10 code E78.010
"Step therapy not completed" Document trials, failures, or contraindications to statins, ezetimibe, and PCSK9 inhibitors with dates and outcomes
"Experimental/investigational" Cite FDA approval for HoFH (2012) and include FDA labeling excerpt
"Missing baseline labs" Submit liver function tests and lipid panels with dates
"Prescriber not qualified" Include CV, board certification, or consultation with lipid specialist

Appeals Process in Ohio

Internal Appeal (First Level)

Deadline: 180 days from denial letter
How to file: Written request to Aetna appeals department
Timeline: 30 days for standard, 72 hours for expedited
Required documents:

  • Copy of denial letter
  • Additional clinical documentation
  • Medical necessity letter from prescriber

External Review (Independent Review Organization)

Eligibility: After exhausting internal appeals, amount in controversy >$500
Deadline: 180 days from final internal denial
Process:

Ohio-Specific Rights:

  • Ohio Department of Insurance can help if Aetna denies external review eligibility
  • Consumer hotline: 1-800-686-1526
  • External review is free to members
Note: Self-funded employer plans follow federal ERISA rules, not Ohio state external review. Contact Aetna directly to confirm your plan type.

Cost and Financial Assistance

Manufacturer Support:

  • Chiesi Global Rare Diseases patient assistance programs
  • Copay assistance for eligible commercially insured patients
  • Contact manufacturer directly for current programs

Foundation Grants:

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Resources:

  • Ohio Patient Advocate Foundation
  • UHCAN Ohio (Universal Health Care Action Network) for consumer assistance

FAQ

Q: How long does Aetna (CVS Health) prior authorization take in Ohio?
A: Standard PA decisions typically take 30-45 days. Expedited reviews are available for urgent cases and must be completed within 72 hours.

Q: What if Juxtapid is not on my Aetna formulary?
A: Request a formulary exception with your PA submission. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Q: Can I request an expedited appeal if my LDL-C is dangerously high?
A: Yes. Document clinical urgency (recent cardiovascular event, extremely high LDL-C levels) and request expedited review at each appeal level.

Q: Does Ohio step therapy apply if I've already tried therapies in another state?
A: Yes, prior therapy trials count regardless of where they occurred. Include complete documentation with dates and outcomes.

Q: What happens if the external review denies coverage?
A: The IRO decision is binding, but you retain rights to file complaints with Ohio Department of Insurance or pursue legal remedies.

Q: How do I know if my plan is subject to Ohio external review?
A: Fully insured plans are subject to Ohio rules. Self-funded employer plans follow federal rules. Call Ohio DOI at 1-800-686-1526 to confirm.

When to Get Help

Contact Counterforce Health if you need assistance with your Juxtapid appeal. Our platform helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

For additional support:

  • Ohio Department of Insurance: 1-800-686-1526
  • Aetna Member Services: Number on your insurance card
  • UHCAN Ohio: Consumer advocacy and assistance
Tip from our advocates: When submitting genetic testing results, include a cover letter explaining how the specific variants identified meet the definition of homozygous FH. Many denials occur because reviewers don't understand the genetic complexity of HoFH diagnosis.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Aetna (CVS Health) plan and consult with your healthcare provider and insurance representative for personalized guidance.

Sources & Further Reading

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