How to Get Juxtapid (lomitapide) Covered by Cigna in Ohio: Complete Guide to Prior Authorization and Appeals
Answer Box: Getting Juxtapid (lomitapide) Covered by Cigna in Ohio
Juxtapid requires prior authorization from Cigna and is only covered for homozygous familial hypercholesterolemia (HoFH). Your fastest path to approval: (1) Confirm HoFH diagnosis with genetic/clinical documentation, (2) Document failure or intolerance to PCSK9 inhibitors like Repatha, and (3) Submit complete prior authorization through Express Scripts with liver function tests. If denied, you have 180 days to file an external review through the Ohio Department of Insurance. Start by calling Cigna at the number on your insurance card to request the PA form.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Understanding Your Costs and Assistance Options
- Common Denial Reasons and How to Fix Them
- Appeals Process in Ohio
- Working with Accredo Specialty Pharmacy
- When to Request a Formulary Exception
- FAQ: Juxtapid Coverage with Cigna
- Sources and Further Reading
Coverage Requirements at a Glance
Requirement | What It Means | Where to Find It |
---|---|---|
Prior Authorization | Required before coverage | Cigna PA Policy |
Diagnosis | HoFH only (not HeFH) | Genetic testing or clinical criteria |
Step Therapy | Must fail PCSK9 inhibitor first | Document Repatha/Praluent trial |
Specialty Tier | Higher copay/coinsurance | Check your plan's formulary |
Liver Monitoring | Required before and during treatment | LFTs within normal limits |
Specialty Pharmacy | Accredo only (REMS requirement) | Cannot use retail pharmacy |
Step-by-Step: Fastest Path to Approval
1. Confirm Your Diagnosis Documentation
Who does it: Your cardiologist or lipid specialist
What's needed: Genetic testing results showing HoFH mutations OR clinical criteria (LDL-C >500 mg/dL, family history, physical findings)
Timeline: Allow 2-4 weeks for genetic testing if not already done
2. Document Previous Therapy Failures
Who does it: Your doctor's office
What's needed: Records showing inadequate response, contraindication, or intolerance to a PCSK9 inhibitor (evolocumab/Repatha or alirocumab/Praluent)
Key detail: You cannot be on a PCSK9 inhibitor while taking Juxtapid
3. Complete Liver Function Assessment
Who does it: Your doctor
What's needed: Recent liver function tests showing no moderate/severe hepatic impairment
Source: Cigna PA criteria
4. Submit Prior Authorization
Who does it: Your doctor's office
How to submit: Through Express Scripts or Cigna provider portal
Timeline: Standard review within 72 hours; expedited within 24 hours if urgent
Source: Cigna formulary exception process
5. Enroll in REMS Program
Who does it: Your doctor
What's needed: Complete Juxtapid REMS Patient Authorization Form
Submit to: Chiesi Total Care at 1-855-898-2743
6. Set Up Specialty Pharmacy
Who does it: Patient with help from Chiesi Total Care
Pharmacy: Accredo (required for REMS compliance)
What to expect: Coordination of insurance billing and delivery
Understanding Your Costs and Assistance Options
Insurance Coverage Structure
Juxtapid is on Cigna's specialty tier, which typically means:
- Higher copayment or coinsurance (often 25-40% of drug cost)
- May require meeting deductible first
- Count toward out-of-pocket maximum
Manufacturer Assistance Programs
Juxtapid Copay Card: Available for patients with commercial insurance
- Eligibility: Commercial insurance holders (not Medicare, Medicaid, or other government programs)
- Benefit: Can cover 100% of copay/coinsurance up to program maximum
- How to apply: Call Chiesi Total Care at 1-855-898-2743 or visit Juxtapid support page
Additional Financial Resources
- Patient advocacy foundations may offer grants for rare disease medications
- Chiesi Total Care provides case management to help navigate financial assistance options
Common Denial Reasons and How to Fix Them
Denial Reason | How to Overturn |
---|---|
"Not HoFH diagnosis" | Submit genetic testing results or detailed clinical criteria documentation |
"No PCSK9 inhibitor trial" | Provide records of Repatha/Praluent use with inadequate response or intolerance |
"Experimental/investigational" | Cite FDA approval for HoFH and include FDA label |
"Liver concerns" | Submit current LFTs showing normal function and monitoring plan |
"Concurrent PCSK9 use" | Confirm discontinuation of other PCSK9 inhibitors |
From our advocates: We've seen cases where patients were initially denied because their genetic testing was done years ago. Resubmitting recent genetic counselor interpretation alongside current lipid levels often resolves this issue, especially when the clinical picture clearly supports HoFH diagnosis.
Appeals Process in Ohio
Internal Appeals with Cigna
- First level: Submit written appeal within 180 days of denial
- Timeline: Decision within 30 days (expedited within 72 hours if urgent)
- How to file: Call Cigna customer service or submit through member portal
External Review Through Ohio Department of Insurance
If Cigna upholds the denial, Ohio residents can request an external review:
Timeline: Must request within 180 days of Cigna's final denial
Process: Independent Review Organization (IRO) reviews your case
Decision timeline: 30 days for standard review, 72 hours for expedited
Cost: Free to you (Cigna pays the IRO fees)
How to file: Ohio Department of Insurance external review process
Contact Ohio Department of Insurance:
- Consumer hotline: 1-800-686-1526
- External review request form
When to Request Expedited Review
Request expedited review if delay could seriously jeopardize your health, such as:
- Severely elevated cholesterol levels despite maximum therapy
- History of cardiovascular events
- Physician recommendation for urgent treatment
Working with Accredo Specialty Pharmacy
Juxtapid can only be dispensed through specialty pharmacies enrolled in the REMS program, with Accredo serving as the primary provider.
What to Expect
- Coordination: Accredo handles insurance verification and prior authorization support
- Delivery: Medication ships directly to your home with temperature control
- Support: Dedicated pharmacists available for questions about your medication
Cost Management Through Accredo
- Accredo coordinates with Chiesi Total Care to apply manufacturer copay assistance
- They'll contact you before dispensing to discuss expected costs
- Can help coordinate foundation grants if you qualify
When to Request a Formulary Exception
If Juxtapid isn't covered at all (non-formulary), your physician can request a formulary exception by certifying in writing that:
- You've tried formulary alternatives that were detrimental to your health or ineffective
- In their medical opinion, formulary drugs are likely to be detrimental or ineffective again
Timeline: Cigna reviews formulary exceptions within 72 hours (24 hours if expedited)
Source: Cigna formulary exception policy
Clinician Corner: Medical Necessity Letter Checklist
When submitting prior authorization or appeals, include:
✓ Diagnosis: HoFH with genetic testing or clinical criteria
✓ Previous treatments: Specific PCSK9 inhibitors tried, doses, duration, and outcomes
✓ Current therapy: Other lipid-lowering medications and their effectiveness
✓ Clinical rationale: Why Juxtapid is medically necessary for this patient
✓ Monitoring plan: Liver function testing schedule and safety protocols
✓ Guidelines: Reference FDA labeling and relevant clinical guidelines
Key citation: FDA-approved indication for HoFH as adjunct to lipid-lowering therapies
FAQ: Juxtapid Coverage with Cigna
Q: How long does Cigna prior authorization take?
A: Standard review within 72 hours; expedited review within 24 hours if urgent medical need is documented.
Q: What if Juxtapid isn't on my Cigna formulary?
A: Your doctor can request a formulary exception if you've failed or can't tolerate formulary alternatives.
Q: Can I get Juxtapid from my local pharmacy?
A: No, Juxtapid requires specialty pharmacy dispensing through REMS-certified pharmacies like Accredo.
Q: Does step therapy apply if I failed PCSK9 inhibitors in another state?
A: Yes, documented failure or intolerance from any provider should meet Cigna's step therapy requirements.
Q: What if I'm on Medicare with Cigna?
A: Medicare patients aren't eligible for manufacturer copay cards but may qualify for foundation grants or Medicare Extra Help programs.
Q: How often do I need reauthorization?
A: Initial authorization is typically for 6 months, with reauthorization for up to 12 months if showing clinical benefit.
Q: Can I appeal if Cigna says external review isn't available?
A: Yes, contact the Ohio Department of Insurance at 1-800-686-1526 if Cigna incorrectly denies external review eligibility.
Q: What counts as "inadequate response" to previous therapy?
A: Typically failure to achieve target LDL-C levels despite maximum tolerated doses, or continued cardiovascular events.
About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for specialty medications like Juxtapid.
When dealing with specialty drug coverage challenges, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health's platform streamlines this process by identifying specific denial reasons and crafting responses that align with each payer's own rules and requirements.
Sources and Further Reading
- Cigna Juxtapid Prior Authorization Policy
- Cigna Formulary Exception Process
- Ohio Department of Insurance External Review
- Juxtapid Patient Support Resources
- FDA Juxtapid Prescribing Information
- Chiesi Total Care Program
Disclaimer: This information is for educational purposes only and is not medical advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.
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