By Counterforce Health Team in Juxtapid (lomitapide) —

Complete Guide to Getting Juxtapid (Lomitapide) Covered by Cigna in California: Forms, Appeals, and Step Therapy Overrides

Answer Box: Getting Juxtapid (Lomitapide) Covered by Cigna in California

Eligibility: Patients with confirmed homozygous familial hypercholesterolemia (HoFH) who've failed maximum statins, ezetimibe, and PCSK9 inhibitors can get Juxtapid covered through Cigna's Express Scripts pharmacy benefit. Fastest path: Submit prior authorization with genetic testing, step therapy documentation, and REMS enrollment through Cigna's provider portal. First step today: Gather HoFH diagnosis confirmation and prior therapy failure records, then contact your prescriber to initiate the PA process. If denied, California's Independent Medical Review has a 68-73% success rate for specialty drug appeals.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation
  5. Step-by-Step: Fastest Path to Approval
  6. Common Denial Reasons & Fixes
  7. Appeals Playbook for California
  8. Costs & Savings Options
  9. FAQ
  10. Printable Checklist

Who Should Use This Guide

This guide helps California patients and their clinicians navigate Cigna's prior authorization process for Juxtapid (lomitapide), a specialty oral medication for homozygous familial hypercholesterolemia (HoFH). You'll need this if:

  • Your doctor has prescribed Juxtapid for confirmed HoFH
  • You have Cigna insurance (commercial, Medicare Advantage, or employer-sponsored plans)
  • You're facing prior authorization requirements or have received a denial
  • You need to understand step therapy requirements and appeal options

Expected outcome: With proper documentation, most patients can get Juxtapid approved within 72 hours for standard reviews or 24 hours for urgent cases. If initially denied, California's robust appeal system offers strong patient protections.

Member & Plan Basics

Coverage Verification

Before starting the PA process, confirm your Cigna plan details:

  • Active coverage: Verify your plan is current and includes prescription benefits
  • Specialty pharmacy: Juxtapid must be dispensed through Express Scripts/Accredo specialty pharmacy due to REMS requirements
  • Formulary status: Check if Juxtapid is on your plan's formulary (typically Tier 4-5 specialty)
  • Prior authorization: Required for all Cigna plans covering Juxtapid
Note: Cigna manages specialty drugs through Express Scripts. Your regular pharmacy cannot dispense Juxtapid due to FDA REMS program requirements.

Plan Types and Requirements

Plan Type PA Required Step Therapy Specialty Pharmacy
Cigna Commercial Yes Yes Express Scripts/Accredo
Cigna Medicare Advantage Yes Yes Express Scripts/Accredo
Employer Plans Yes* Yes* Express Scripts/Accredo

*Requirements may vary by employer; verify with your specific plan documents.

Clinical Criteria Requirements

HoFH Diagnosis Confirmation

Cigna requires documented proof of homozygous familial hypercholesterolemia through:

Genetic Testing (preferred):

  • LDLR, APOB, or PCSK9 gene mutations
  • Two pathogenic variants (homozygous or compound heterozygous)
  • Submit genetic test reports with your PA

Clinical Criteria (if genetic testing unavailable):

  • LDL-C ≥400 mg/dL despite treatment
  • Family history of premature cardiovascular disease
  • Physical findings (tendon xanthomas)
  • Both parents with clinically diagnosed FH

Step Therapy Requirements

Before Juxtapid approval, you must have tried and failed:

  1. Maximum tolerated statin therapy (≥90 days)
    • Atorvastatin 80mg or rosuvastatin 40mg preferred
    • Document dose, duration, and reason for discontinuation
  2. Ezetimibe (typically with statin)
    • Standard trial period varies by plan
    • Include combination therapy attempts
  3. PCSK9 inhibitor (≥8 weeks)
    • Evolocumab (Repatha) or alirocumab (Praluent)
    • Document LDL-C response and any adverse effects
  4. Evkeeza (evinacumab) (increasingly required)
    • Some Cigna plans now require this before Juxtapid
    • Verify current step therapy requirements

REMS Program Compliance

Juxtapid requires REMS enrollment due to hepatotoxicity risk:

  • Prescriber certification: Must complete REMS training
  • Patient enrollment: Required before first prescription
  • Liver monitoring plan: Baseline and ongoing LFTs mandatory
  • Pharmacy certification: Only REMS-certified pharmacies can dispense

Coding & Documentation

ICD-10 Diagnosis Codes

  • E78.01: Familial hypercholesterolemia (primary code for HoFH)

Required Documentation Elements

Your prior authorization packet must include:

Medical Records:

  • Complete history and physical
  • Genetic testing results (if available)
  • Lipid panel results showing LDL-C levels
  • Documentation of cardiovascular risk factors

Prior Therapy Documentation:

  • Medication names, doses, and durations
  • Reasons for discontinuation or failure
  • LDL-C response to each therapy
  • Adverse event reports

Liver Function Assessment:

  • Baseline ALT, AST, alkaline phosphatase, total bilirubin
  • Confirmation of no moderate/severe hepatic impairment
  • Ongoing monitoring plan

Letter of Medical Necessity should address:

  • HoFH diagnosis with supporting evidence
  • Inadequate response to standard therapies
  • Clinical rationale for Juxtapid
  • Monitoring and safety plan
  • Treatment goals and expected outcomes

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Clinic)

Timeline: 1-3 days

  • Insurance card and member ID
  • Complete medical records for HoFH
  • Genetic testing results
  • Prior therapy failure documentation
  • Recent liver function tests

2. Complete REMS Enrollment (Prescriber)

Timeline: Same day

3. Submit Prior Authorization (Prescriber)

Timeline: Same day

  • Use Cigna provider portal (preferred method)
  • Alternative: Fax to Express Scripts PA department (verify current fax number)
  • Include all required documentation
  • Request expedited review if urgent (24-hour turnaround)

4. Verify Submission (Clinic Staff)

Timeline: Within 24 hours

  • Obtain confirmation number
  • Document submission date and method
  • Set follow-up reminder for review deadline

5. Monitor Review Status (Patient/Clinic)

Timeline: 72 hours standard, 24 hours expedited

  • Check status via Cigna provider portal
  • Contact Express Scripts if no response within deadline
  • Note: Automatic approval if Cigna fails to respond within timeframe

6. Coordinate Specialty Pharmacy (If Approved)

Timeline: 1-2 days

  • Transfer prescription to Express Scripts/Accredo
  • Verify patient contact information
  • Schedule delivery and patient education

7. Appeal if Denied (Patient/Prescriber)

Timeline: Within 180 days of denial

  • File internal appeal with additional documentation
  • Consider peer-to-peer review
  • Escalate to California Independent Medical Review if needed

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
Insufficient HoFH documentation Submit genetic testing or complete clinical criteria Genetic test results or comprehensive lipid/family history
Missing step therapy Document prior failures or contraindications Detailed medication history with doses, durations, outcomes
Incomplete liver assessment Provide baseline LFTs and monitoring plan Recent liver function tests, hepatic impairment assessment
REMS non-compliance Complete enrollment and training REMS confirmation numbers, prescriber certification
Non-formulary status Request formulary exception Medical necessity letter, lack of alternatives documentation
From our advocates: "We've seen many Juxtapid denials overturned by providing comprehensive step therapy documentation. Include specific drug names, exact doses, treatment duration, and detailed reasons for discontinuation. Plans often initially deny based on incomplete prior therapy records, but thorough documentation usually resolves this quickly."

Appeals Playbook for California

Internal Appeals (Cigna)

Timeline: 180 days from denial to file

  • Standard review: 30 days for determination
  • Expedited review: 72 hours for urgent cases
  • How to file: Cigna member portal or written request
  • Required: Denial letter, additional medical records, prescriber support

California Independent Medical Review (IMR)

Success rate: 68-73% of specialty drug denials overturned Timeline: 45 days standard, 7 days expedited Cost: Free to patients Eligibility: After internal appeal or for experimental/investigational denials

How to file IMR:

  1. Complete internal Cigna appeal first (unless experimental denial)
  2. Submit DMHC IMR application within 6 months
  3. Include all medical records and prescriber statement
  4. DMHC assigns independent physician reviewers
  5. Decision is binding on Cigna

Contact for help:

When to Escalate

Consider state regulator involvement if:

  • Cigna violates appeal timelines
  • Multiple inappropriate denials
  • Pattern of delay tactics
  • Urgent medical needs not addressed

Costs & Savings Options

Manufacturer Support

Additional Resources

  • National Organization for Rare Disorders (NORD): Medication assistance programs
  • HealthWell Foundation: Potential copay assistance for rare diseases
  • State programs: California may have additional rare disease support

FAQ

How long does Cigna prior authorization take for Juxtapid in California? Standard reviews take 72 hours; expedited reviews for urgent cases take 24 hours. If Cigna doesn't respond within these timeframes, the request is automatically approved.

What if Juxtapid is not on my Cigna formulary? You can request a formulary exception by providing medical necessity documentation and evidence that formulary alternatives are inappropriate for HoFH treatment.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California IMR offer expedited processes for urgent medical situations, typically decided within 72 hours to 7 days.

Does step therapy apply if I failed these drugs outside California? Yes, step therapy documentation from any state is acceptable. Provide complete records of prior therapy trials regardless of where treatment occurred.

What happens if my prescriber isn't REMS certified? Juxtapid cannot be prescribed without REMS certification. Your prescriber must complete the training at the Juxtapid REMS website before submitting any prior authorization.

How often do California IMR appeals succeed for specialty drugs? Approximately 68-73% of IMR requests for specialty drug denials result in approval for the patient, making it a highly effective appeal option.

Printable Checklist

Before Starting PA Process

  • Confirmed HoFH diagnosis (genetic testing or clinical criteria)
  • Documented failure of maximum statin therapy
  • Documented failure of ezetimibe
  • Documented failure of PCSK9 inhibitor
  • Recent liver function tests (normal)
  • Prescriber completed REMS training
  • Patient enrolled in REMS program

PA Submission Requirements

  • Complete medical records
  • Genetic testing results (if available)
  • Prior therapy documentation with doses/durations
  • Letter of medical necessity
  • Baseline liver function tests
  • REMS enrollment confirmation
  • ICD-10 code E78.01 documented

After Submission

  • Confirmation number obtained
  • Follow-up date scheduled
  • Specialty pharmacy contact information ready
  • Appeal timeline noted (if needed)

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-backed, payer-specific strategies for prescription drug approvals. Our platform analyzes denial letters and creates targeted rebuttals aligned with each plan's specific requirements.

When facing complex prior authorization requirements like those for Juxtapid, having expert guidance can significantly improve approval rates. Counterforce Health's platform specializes in rare disease medications and understands the intricate documentation requirements that specialty drugs demand.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Coverage policies and requirements may change. Always verify current requirements with your specific insurance plan and consult official sources for the most up-to-date information. For personalized assistance with insurance appeals and coverage issues, contact the California Department of Managed Health Care at 888-466-2219.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.