By Counterforce Health Team in Raxone (idebenone) —

How to Get Raxone (idebenone) Covered by Cigna in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Raxone (idebenone) Covered by Cigna in New Jersey

Raxone (idebenone) requires prior authorization from Cigna and faces coverage challenges as a non-FDA approved medication. Your physician must submit a formulary exception request demonstrating medical necessity for LHON treatment. If denied, New Jersey's IHCAP external review program through Maximus provides binding appeals within 45 days. Start today: Have your doctor call Cigna at the number on your card to initiate the prior authorization process while gathering genetic testing results and LHON documentation.

Table of Contents

Coverage Basics: Is Raxone Covered?

Raxone (idebenone) appears on Cigna's Performance 4-Tier formulary with prior authorization requirements, but coverage is complicated by its lack of FDA approval in the United States. While idebenone is approved in Europe for Leber hereditary optic neuropathy (LHON), U.S. insurers typically require formulary exceptions for non-FDA approved medications.

Coverage at a Glance:

Requirement Status What This Means Source
Prior Authorization Required Doctor must get approval before filling Cigna PA Policy
Formulary Exception Likely needed Non-FDA status requires special request Cigna Exception Process
Step Therapy Not specified May need to try alternatives first Verify with plan
Specialty Pharmacy Probable Through Express Scripts/Accredo Contact member services
Note: Coverage varies by specific Cigna plan. Log into myCigna.com or call member services to verify your plan's formulary status.

Prior Authorization Process

Your physician initiates the prior authorization through multiple channels, but given Raxone's non-FDA status, expect this to require a formulary exception request.

Step-by-Step: Fastest Path to Approval

  1. Physician contacts Cigna via CignaforHCP.com or calls the provider line on your insurance card
  2. Submit formulary exception request using Cigna's exception form with clinical justification
  3. Include required documentation: LHON genetic testing, ophthalmology records, failed alternative treatments
  4. Request expedited review if vision loss is progressing (24-hour turnaround available)
  5. Track status through provider portal or by calling Cigna
  6. If approved: Coverage typically lasts 12 months before renewal needed
  7. If denied: Proceed immediately to internal appeal process

Timeline and Urgency Options

Standard prior authorization decisions take 15 business days, but Cigna offers expedited review for urgent cases.

Timeline Options:

  • Standard Review: 15 business days
  • Expedited Review: 24 hours (if delay would cause serious health risks)
  • Peer-to-Peer: Available if initial review is unfavorable

For LHON patients, the acute phase represents a critical treatment window, making expedited review appropriate in many cases.

Medical Necessity Criteria

Since Cigna doesn't publish specific criteria for idebenone, your physician must build a compelling medical necessity case for the formulary exception.

Clinician Corner: Medical Necessity Documentation

Essential Elements for LHON/Idebenone Requests:

  • Confirmed LHON diagnosis: Genetic testing showing primary mutations (m.11778G>A, m.3460G>A, or m.14484T>C)
  • Clinical documentation: Ophthalmology records showing characteristic findings
  • Treatment timeline: Document acute/subacute phase for optimal intervention window
  • Alternative therapies: Evidence that standard supportive care is insufficient
  • European approval: Reference EMA approval and clinical trial data
  • Dosing rationale: Standard 300mg three times daily per European guidelines

The strongest applications reference peer-reviewed studies and emphasize the lack of FDA-approved alternatives for LHON.

Understanding Costs

Raxone's cost varies significantly, with European pricing around £6,364 per 180-tablet pack. In the U.S., expect substantial out-of-pocket costs if coverage is denied.

Cost-Saving Options:

  • Manufacturer support: Contact Santhera Pharmaceuticals for patient assistance programs
  • Foundation grants: Organizations like NORD may provide financial assistance for rare diseases
  • Clinical trials: Check ClinicalTrials.gov for ongoing LHON studies

Denials and Appeals Process

If your initial request is denied, New Jersey residents have robust appeal rights through both Cigna's internal process and the state's external review program.

Common Denial Reasons & Solutions

Denial Reason How to Address Documentation Needed
"Not FDA approved" Cite medical necessity and lack of alternatives European approval data, clinical studies
"Experimental/investigational" Demonstrate established use in Europe Published treatment guidelines
"Not medically necessary" Strengthen clinical justification Genetic testing, ophthalmology records
"Step therapy not completed" Document contraindications to alternatives Medical records showing unsuitability

Cigna Internal Appeals Process

  1. First-level internal appeal: Submit written request within 180 days of denial
  2. Second-level review: If first appeal denied, automatic second review by different reviewers
  3. Expedited appeals: Available if standard timeline would jeopardize health

Submit appeals through your myCigna member portal or by mail to the address on your denial letter.

New Jersey External Review (IHCAP)

New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review after completing Cigna's internal appeals.

IHCAP Process Through Maximus

Eligibility Requirements:

  • Completed Cigna's internal appeal process (both levels)
  • Denial based on medical necessity or experimental/investigational status
  • File within 4 months of final internal denial
  • NJ-regulated plan (not self-funded employer plans)

How to File:

  1. Submit online: njihcap.maximus.com
  2. By mail: NJ DOBI Office of Managed Care, PO Box 329, Trenton, NJ 08625-0329
  3. Include: Consent form, medical records, denial letters, physician support letter

Timeline:

  • Preliminary review: 5 business days for acceptance
  • Full review: 45 calendar days (standard) or 48 hours (expedited)
  • Decision: Binding on Cigna if favorable
Important: The external review is free to you—Cigna pays all costs. If Maximus overturns the denial, Cigna must provide coverage.

For questions about IHCAP, call 1-888-393-1062 or contact NJ Department of Banking and Insurance.

Specialty Pharmacy Requirements

If approved, Raxone will likely require filling through Cigna's specialty pharmacy network, typically Express Scripts Accredo.

What to Expect:

  • Transfer required: Prescription moves from retail to specialty pharmacy
  • Overnight delivery: Standard for specialty medications
  • Accredo contact: 877-882-3324 for questions
  • 90-day supplies: Typical for specialty drugs

Contact Express Scripts to verify network pharmacies and confirm coverage details for your specific plan.

Troubleshooting Common Issues

Portal Access Problems:

  • Clear browser cache and try incognito mode
  • Contact Cigna IT support at number on your member card
  • Use phone/fax submission as backup

Missing Documentation:

  • Request records from all treating physicians
  • Obtain genetic testing reports from lab
  • Gather ophthalmology imaging and visual field tests

Communication Delays:

  • Follow up weekly on pending requests
  • Document all phone calls with reference numbers
  • Consider peer-to-peer review if facing delays

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed rebuttals. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeals processes, particularly for specialty medications like Raxone where coverage can be challenging due to regulatory status. Visit www.counterforcehealth.org to learn more about their comprehensive coverage support services.

FAQ: Most Common Questions

Q: How long does Cigna prior authorization take for Raxone in New Jersey? A: Standard review takes 15 business days, but expedited review (24 hours) is available for urgent cases where vision loss is progressing.

Q: What if Raxone is completely non-formulary on my plan? A: You'll need a formulary exception request demonstrating medical necessity. Your physician must show that formulary alternatives are ineffective or contraindicated.

Q: Can I request an expedited appeal in New Jersey? A: Yes, both Cigna's internal appeals and New Jersey's IHCAP external review offer expedited options when delays would jeopardize health or function.

Q: Does step therapy apply if I've tried treatments outside New Jersey? A: Medical records from any licensed physician should count toward step therapy requirements. Ensure all prior treatments are documented and submitted.

Q: What genetic testing do I need for LHON coverage? A: Confirmatory mtDNA testing for the three primary LHON mutations (m.11778G>A, m.3460G>A, m.14484T>C) is essential. Full mtDNA sequencing may be needed if initial panel is negative.

Q: How much will Raxone cost with Cigna coverage? A: This depends on your plan's specialty drug tier and whether you meet deductible requirements. Contact member services for specific cost-sharing details.

Q: Can my doctor file the external review appeal for me? A: Yes, New Jersey allows providers to file IHCAP appeals on behalf of patients with proper consent forms completed.

Q: What happens if IHCAP overturns Cigna's denial? A: The decision is binding—Cigna must provide coverage for the approved treatment. This is mandated by New Jersey statute.

Sources & Further Reading

This guide provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations. For additional help with insurance appeals in New Jersey, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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