By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Aetna (CVS Health) in Michigan: Complete Guide to Forms, Appeals, and Approval

Answer Box: Get Juxtapid (lomitapide) Covered by Aetna (CVS Health) in Michigan

Fast Track to Approval: Aetna (CVS Health) requires prior authorization for Juxtapid (lomitapide) with documented homozygous familial hypercholesterolemia (HoFH), genetic testing, and failed trials of high-intensity statin + ezetimibe + PCSK9 inhibitor. First step today: Have your doctor gather genetic test results and prior therapy records, then submit the PA form via fax (1-888-267-3277) or Availity portal. If denied, you have 180 days to appeal internally, then 127 days for Michigan DIFS external review.

Table of Contents

  1. Verify Your Plan and Find the Right Forms
  2. Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Forms and Submission Methods
  5. Common Denial Reasons and Solutions
  6. Appeals Process in Michigan
  7. Specialty Pharmacy Enrollment
  8. Cost Support Programs
  9. When to Contact Michigan DIFS
  10. FAQ

Verify Your Plan and Find the Right Forms

Before starting, confirm your specific Aetna (CVS Health) plan type, as requirements vary between commercial, Medicare, and Medicaid plans in Michigan. Log into your Aetna member portal or call member services to verify:

  • Plan name and ID number
  • Formulary tier for Juxtapid (lomitapide)
  • Whether prior authorization is required
  • Your current deductible and specialty tier copay
Tip: Aetna processes most specialty drugs through CVS Caremark. Your member portal will show if Juxtapid requires "precertification" or "prior authorization."

Prior Authorization Requirements

Aetna (CVS Health) requires comprehensive documentation for Juxtapid (lomitapide) approval. Based on current Aetna formulary guidelines, you must meet these criteria:

Coverage at a Glance

Requirement What It Means Where to Find It Documentation Needed
HoFH Diagnosis Homozygous familial hypercholesterolemia confirmed Genetic testing lab report LDLR, APOB, PCSK9, or LDLRAP1 mutations
Untreated LDL-C Baseline cholesterol > 400 mg/dL Lab results before treatment Lipid panel from cardiology/endocrinology
Prior Therapy Failure Failed statin + ezetimibe + PCSK9 inhibitor Medical records Treatment duration, doses, LDL-C response
Liver Function Normal baseline liver enzymes Recent lab work ALT/AST < 3x upper limit of normal
Contraindications Screen No heart failure, recent cancer, substance abuse Clinical notes Provider attestation in PA form

Step Therapy Requirements

Aetna typically requires documented trial and failure of preferred alternatives before approving Juxtapid:

  1. High-intensity statin (atorvastatin 40-80mg or rosuvastatin 20-40mg)
  2. Ezetimibe 10mg daily
  3. PCSK9 inhibitor (evolocumab or alirocumab)

Exception: Patients with homozygous null mutations in both LDL receptor alleles may bypass PCSK9 inhibitor requirement with genetic documentation.

Step-by-Step: Fastest Path to Approval

Step 1: Gather Required Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete family history of heart disease and cholesterol
  • List of all cholesterol medications tried with dates and outcomes
  • Recent lab results (lipid panel, liver function tests)

Step 2: Schedule Genetic Testing (If Not Done)

Your doctor will order genetic testing for familial hypercholesterolemia mutations. This typically takes 2-3 weeks for results and is essential for approval.

Step 3: Provider Submits Prior Authorization (Clinic Staff)

Download the Aetna Medical Exception/Prior Authorization form and submit via:

  • Fax: 1-888-267-3277 (specialty drugs)
  • Online: Availity provider portal
  • Timeline: Submit at least 2 weeks before planned start date

Step 4: Enroll in Juxtapid REMS Program (Required)

While waiting for PA approval, complete REMS enrollment at juxtapidREMSprogram.com or call 1-855-JUXTAPID (1-855-898-2743).

Step 5: Await Decision (15-30 days)

Aetna typically responds within 15-30 days for standard requests, 72 hours for urgent/expedited requests.

Step 6: If Approved, Coordinate with CVS Specialty

CVS Specialty Pharmacy will contact you to arrange delivery and provide adherence support.

Step 7: If Denied, File Internal Appeal Immediately

You have 180 days from the denial notice to file an internal appeal with supporting documentation.

Forms and Submission Methods

Required Forms

Primary Form: Aetna Medical Exception/Prior Authorization/Precertification Request for Prescription Medications

Supporting Documents:

  • Genetic testing report showing HoFH mutations
  • Baseline and follow-up lipid panels
  • Documentation of prior therapy trials and failures
  • Recent liver function tests
  • Clinical notes supporting medical necessity

Submission Options

Method Contact Information Processing Time Best For
Online Portal Availity Provider Portal 24-48 hours Fastest processing
Specialty Drug Fax 1-888-267-3277 2-3 business days When portal unavailable
Phone (urgent only) 1-855-240-0535 Same day Expedited requests
Mail Check current provider manual 7-10 business days Not recommended
Note: Always include a cover sheet with patient name, member ID, prescriber NPI, and "JUXTAPID PRIOR AUTHORIZATION" clearly marked.

Common Denial Reasons and Solutions

Denial Reason How to Fix It Required Documentation
"Genetic testing not provided" Submit HoFH genetic test results Lab report showing specific mutations
"Step therapy not completed" Document prior therapy failures Prescription records, progress notes, LDL-C levels
"Not medically necessary" Provide clinical rationale Letter from specialist explaining why Juxtapid is essential
"Experimental/investigational" Cite FDA approval for HoFH FDA label, clinical guidelines
"Liver monitoring plan absent" Submit monitoring protocol Provider letter outlining LFT schedule

Medical Necessity Letter Template

Your doctor should include these elements in the medical necessity letter:

  • Patient's specific HoFH genotype and baseline LDL-C level
  • Failed prior therapies with specific drugs, doses, and durations
  • Current cardiovascular risk factors
  • Clinical rationale for Juxtapid based on FDA labeling
  • Monitoring plan for hepatotoxicity per REMS requirements

Appeals Process in Michigan

Internal Appeals with Aetna (CVS Health)

Timeline: 180 days from denial notice Process:

  1. Call Aetna member services to request appeal forms
  2. Submit written appeal with additional clinical documentation
  3. Request peer-to-peer review if initial appeal denied
  4. Decision within 30 days (72 hours for expedited)

External Review through Michigan DIFS

If Aetna's internal appeal is denied, you can request external review through Michigan's Department of Insurance and Financial Services (DIFS).

Key Michigan Details:

  • Timeline: 127 days after final internal denial (Michigan's specific requirement)
  • Contact: 877-999-6442 or michigan.gov/difs
  • Forms: Available online or by phone
  • Decision Time: 60 days standard, 72 hours expedited
  • Binding: If DIFS approves, Aetna must cover the medication

Required for External Review:

  • Copy of Aetna's final denial letter
  • All supporting medical documentation
  • Written explanation of why you believe coverage should be approved
Michigan Advantage: DIFS has strong consumer protections and frequently overturns denials for FDA-approved rare disease treatments when medical necessity is documented.

Specialty Pharmacy Enrollment

Juxtapid requires enrollment in both the REMS program and a certified specialty pharmacy. CVS Specialty is Aetna's preferred provider.

REMS Program Requirements

  • Prescriber certification and training
  • Pharmacy certification
  • Patient enrollment and education
  • Ongoing liver function monitoring

CVS Specialty Onboarding

  1. Enrollment: CVS will contact you after PA approval
  2. Insurance Verification: Confirm coverage and copay
  3. Clinical Assessment: Review drug interactions and monitoring
  4. Delivery Setup: Schedule monthly shipments
  5. Support Services: 24/7 pharmacist access, adherence monitoring

Counterforce Health can help streamline this process by ensuring all REMS documentation is complete before submission, reducing delays in specialty pharmacy enrollment.

Cost Support Programs

Manufacturer Support

  • Chiesi Patient Support Program: May provide copay assistance for eligible patients
  • Contact: Check Juxtapid.com for current programs

Financial Assistance Options

  • Patient Advocate Foundation
  • HealthWell Foundation (rare disease fund)
  • Michigan Department of Health and Human Services (for Medicaid patients)

Insurance Optimization

If your current Aetna plan has high specialty drug costs, consider switching during open enrollment to a plan with better specialty coverage.

When to Contact Michigan DIFS

Contact Michigan's Department of Insurance and Financial Services if:

  • Aetna delays processing beyond stated timeframes
  • You believe the denial violates Michigan insurance law
  • You need help understanding your appeal rights
  • Aetna fails to comply with an approved external review decision

Michigan DIFS Contact:

FAQ

Q: How long does Aetna prior authorization take for Juxtapid in Michigan? A: Standard PA decisions take 15-30 days. Expedited requests (when medically urgent) are decided within 72 hours.

Q: What if Juxtapid isn't on my Aetna formulary? A: You can request a formulary exception with medical necessity documentation. This follows the same PA process but may require additional clinical justification.

Q: Can I appeal if I've tried these medications outside Michigan? A: Yes, prior therapy trials from any state count toward step therapy requirements. Provide complete medical records from your previous providers.

Q: Does Aetna cover genetic testing for HoFH? A: Most Aetna plans cover genetic testing when ordered by a specialist for suspected familial hypercholesterolemia. Check your specific plan's coverage.

Q: What happens if I miss the 127-day deadline for Michigan external review? A: The deadline is strict, but you may have other options like filing a complaint with DIFS or consulting with a healthcare attorney about potential legal remedies.

Q: Can someone else file appeals for me? A: Yes, you can authorize your doctor, family member, or patient advocate to file appeals on your behalf with signed consent.

From our advocates: We've seen several Michigan patients successfully overturn Juxtapid denials by ensuring genetic testing clearly showed HoFH mutations and documenting specific LDL-C levels before and after each prior therapy. The key is comprehensive documentation rather than rushing the initial submission.

For patients and providers navigating complex prior authorization requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps identify denial reasons and drafts point-by-point rebuttals aligned with Aetna's specific policies, incorporating the right clinical evidence and procedural requirements for Michigan appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with your plan. Coverage policies and forms may change without notice.

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