By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Cigna in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Juxtapid (lomitapide) Covered by Cigna in Georgia

Eligibility: Cigna covers Juxtapid (lomitapide) for adults with homozygous familial hypercholesterolemia (HoFH) who've failed maximally tolerated statin + ezetimibe + PCSK9 inhibitor therapy, with LDL-C >70 mg/dL (ASCVD) or >100 mg/dL (no ASCVD).

Fastest path: (1) Gather HoFH genetic testing and step therapy failure documentation, (2) Complete REMS enrollment at 1-855-898-2743, (3) Submit Cigna's Juxtapid PA form via provider portal or CoverMyMeds.

Start today: Call Cigna at the number on your insurance card to verify coverage and request the current PA form. If denied, you have 180 days for internal appeal and 60 days for Georgia external review.

Table of Contents

Policy Overview

Cigna manages Juxtapid (lomitapide) through its specialty pharmacy benefit via Express Scripts/Accredo. The drug requires prior authorization across all Cigna plan types—HMO, PPO, and Medicare Advantage—due to its specialty status and FDA REMS requirements.

Key policy details:

  • Formulary status: Specialty tier with quantity limits
  • Site of care: Accredo specialty pharmacy only (REMS requirement)
  • Age restriction: Adults ≥18 years
  • Coverage duration: Initial 6 months, reauthorization up to 12 months

In Georgia, where roughly 11-13% of residents are uninsured and many rely on employer-sponsored plans, understanding Cigna's specific requirements can mean the difference between approval and a lengthy appeals process.

Note: Georgia has limited Medicaid expansion, so most patients access Juxtapid through commercial insurance or Medicare Advantage plans.

Medical Necessity Requirements

Cigna's policy PH-1507 defines strict medical necessity criteria for Juxtapid coverage:

Diagnosis Requirements

  • Documented HoFH via genetic testing showing biallelic pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • OR clinical criteria: untreated LDL-C ≥300 mg/dL + signs like tendon xanthomas before age 10 + parental heterozygous FH
  • OR untreated LDL-C >500 mg/dL with consistent family history

Laboratory Criteria

  • Current LDL-C levels: >70 mg/dL (with ASCVD) or >100 mg/dL (without ASCVD) despite maximally tolerated therapy
  • Recent liver function tests: Normal ALT/AST, bilirubin (within 6 months)
  • No moderate/severe hepatic impairment (Child-Pugh B/C)

Step Therapy & Required Trials

Before Cigna approves Juxtapid, patients must demonstrate inadequate response to standard HoFH therapy:

Required First-Line Therapy

  1. High-intensity statin (atorvastatin 80mg or rosuvastatin 40mg) for ≥3 months
  2. Ezetimibe 10mg daily added to statin
  3. PCSK9 inhibitor (evolocumab/Repatha or alirocumab/Praluent) for ≥3 months

Documenting Treatment Failure

Your doctor must provide:

  • Specific medications, doses, and duration of each trial
  • LDL-C values before and after each intervention
  • Reasons for discontinuation if due to intolerance or contraindications
  • Percentage LDL-C reduction achieved (if <30% on PCSK9 inhibitor, this supports Juxtapid need)
Clinician Corner: Include a timeline showing "Patient started atorvastatin 80mg (date) → LDL-C remained 280 mg/dL → added ezetimibe (date) → LDL-C 240 mg/dL → added evolocumab (date) → LDL-C 190 mg/dL, still above target of <70 mg/dL."

REMS Program Requirements

The FDA mandates a Risk Evaluation and Mitigation Strategy (REMS) for Juxtapid due to hepatotoxicity risk. You cannot get the medication without REMS enrollment.

Patient Steps

  1. Call Chiesi Total Care: 1-855-898-2743 to begin enrollment
  2. Complete acknowledgment form confirming understanding of liver risks
  3. Provide recent liver function tests (ALT, AST, bilirubin)
  4. Commit to monitoring schedule and low-fat diet (<20% calories from fat)

Prescriber Requirements

  • Complete online training module on hepatotoxicity risks
  • Submit signed enrollment form to REMS program
  • Use special Prescription Authorization Form (PAF) for all prescriptions
  • Fax PAF to 1-855-898-2498 (not regular pharmacy)

Timeline tip: REMS enrollment can take 3-5 business days, so start this process while your PA is under review.

Prior Authorization Process

Step-by-Step Submission

Step 1: Gather Documentation

  • HoFH genetic testing report or clinical diagnostic criteria
  • Complete lipid panels showing step therapy failures
  • Liver function tests (within 6 months)
  • REMS enrollment confirmation

Step 2: Submit PA Request

Step 3: Track Timeline

  • Standard review: 72 hours
  • Expedited review: 24 hours (requires attestation of serious jeopardy)
  • Approval duration: Up to 6 months initially

Medical Necessity Letter Template

Your prescriber should include:

  • "Patient has genetically confirmed HoFH with biallelic LDLR mutations"
  • "Despite maximally tolerated atorvastatin 80mg + ezetimibe 10mg + evolocumab, LDL-C remains 185 mg/dL, above target of <70 mg/dL"
  • "Juxtapid's LDLR-independent mechanism is medically necessary for this patient"
  • "Patient enrolled in REMS program with liver monitoring plan"

Appeals Process in Georgia

If Cigna denies your Juxtapid request, Georgia law provides robust appeal rights through the Georgia Department of Insurance.

Internal Appeals with Cigna

  • Timeline: 180 days from denial date
  • Process: Submit additional clinical evidence, request peer-to-peer review
  • Expedited option: Available if delay poses serious health risk

Georgia External Review

After internal appeal denial, you can request external review:

  • Deadline: 60 days from final internal denial (verify with the Georgia DOI)
  • Cost: Free to consumers
  • Process: Independent medical reviewers evaluate your case
  • Timeline: 30 business days (72 hours for urgent cases)
  • Contact: Georgia Consumer Services at 1-800-656-2298
Important: Georgia's external review is binding on Cigna—if you win, they must cover the medication.

Common Denial Reasons & Solutions

Denial Reason Solution
"Missing HoFH documentation" Submit genetic testing report or detailed clinical criteria with LDL-C >300 mg/dL + family history
"Step therapy not completed" Provide pharmacy records showing ≥3 months each of statin, ezetimibe, PCSK9 inhibitor with outcomes
"Liver function concerns" Submit recent normal LFTs and hepatologist clearance if needed
"Not medically necessary" Appeal with EAS HoFH guidelines showing Juxtapid as standard adjunct therapy

Appeals often succeed: In Medicare Advantage, Cigna members appeal PA denials at ~18% rate, suggesting many initial denials are overturned with proper evidence.

Costs & Financial Assistance

Juxtapid typically costs mid-five figures per month, making financial assistance crucial:

Manufacturer Support

  • Chiesi Total Care: Copay assistance for commercially insured patients
  • Patient support services: Help with PA submissions and appeals
  • Free drug program: For uninsured patients meeting income criteria

Other Options

  • State pharmaceutical assistance programs (verify current Georgia programs)
  • Foundation grants: Patient Access Network, HealthWell Foundation
  • Hospital charity care if receiving care at qualifying facilities

When to Escalate

Contact these resources if standard appeals aren't working:

Georgia Department of Insurance

  • Consumer Services: 1-800-656-2298
  • Online complaint form: Available on Georgia DOI website (verify with the source linked)
  • Services: External review assistance, insurer complaint investigation

Additional Support

  • Georgians for a Healthy Future: Nonprofit providing consumer assistance with insurance appeals
  • Georgia Legal Services Program: For low-income patients needing legal help with Medicaid/PeachCare appeals

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into evidence-backed appeals. The platform analyzes denial letters and plan policies to draft targeted rebuttals with the right clinical evidence and procedural requirements. For complex cases like Juxtapid appeals, having expert support can significantly improve approval odds.

FAQ

How long does Cigna PA take in Georgia? Standard review is 72 hours; expedited is 24 hours if your doctor attests to serious health jeopardy.

What if Juxtapid is non-formulary on my plan? Request a formulary exception with documentation that covered alternatives (PCSK9 inhibitors, ezetimibe) have failed.

Can I get expedited review? Yes, if your doctor confirms that delay in treatment poses serious risk to your health or ability to regain maximum function.

Does step therapy apply if I failed these drugs in another state? Yes, Cigna accepts documented treatment failures from other providers/states with proper medical records.

What's the success rate for Juxtapid appeals? While specific data isn't available, rare disease appeals with proper genetic documentation and guideline citations have higher success rates than average.

Can I use external review for non-medical necessity denials? Georgia's external review covers "not medically necessary" denials but may not apply to purely contractual exclusions.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and is not medical advice. Always consult your healthcare provider about treatment decisions and work with them on prior authorization submissions. For personalized help with Georgia insurance appeals, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

For patients facing complex insurance denials, Counterforce Health specializes in turning denials into successful appeals by identifying specific denial reasons and crafting evidence-backed responses aligned to each payer's own rules and requirements.

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