By Counterforce Health Team in Translarna (ataluren) —

How to Get Translarna (Ataluren) Covered by Cigna in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Translarna Coverage

Translarna (ataluren) requires prior authorization from Cigna and is non-formulary, needing a formulary exception for nonsense mutation Duchenne muscular dystrophy (DMD). Your neuromuscular specialist must submit comprehensive documentation via the EviCore portal, including genetic confirmation of nonsense mutation and proof of ambulatory status. If denied, New York residents can file an external appeal through the Department of Financial Services within 4 months, with 24-hour expedited review available for urgent cases.

First step today: Verify your Cigna plan includes specialty pharmacy benefits and schedule an appointment with a neuromuscular specialist to begin gathering required documentation.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Medical Necessity Criteria
  4. Timeline and Status Tracking
  5. Common Denial Reasons
  6. Appeals Process in New York
  7. Specialty Pharmacy Requirements
  8. Costs and Financial Assistance
  9. Frequently Asked Questions
  10. Troubleshooting Common Issues

Coverage Basics

Is Translarna Covered by Cigna?

Translarna (ataluren) is non-formulary on most Cigna plans managed by Express Scripts, meaning it requires both prior authorization and a formulary exception. The drug lacks FDA approval in the U.S. (though an NDA was resubmitted in October 2024), making coverage challenging but not impossible for patients with nonsense mutation DMD.

Which Cigna Plans Cover Translarna?

All Cigna plans with prescription and specialty pharmacy benefits can potentially cover Translarna through the prior authorization process. Coverage is managed through Express Scripts, and approved medications are typically dispensed through Accredo Specialty Pharmacy.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Family)
    • Confirm active Cigna prescription and specialty pharmacy benefits
    • Note your member ID and group number
    • Timeline: Same day
  2. Schedule Specialist Consultation (Patient/Family)
    • Book appointment with neuromuscular specialist or pediatric neurologist
    • Request genetic testing if not already completed
    • Timeline: 1-2 weeks
  3. Gather Required Documentation (Specialist)
    • CLIA-certified genetic test confirming nonsense mutation
    • Recent functional assessments (6-minute walk test, timed function tests)
    • Complete medical history and prior therapy documentation
    • Timeline: 1-2 weeks
  4. Submit Prior Authorization (Specialist)
    • Complete submission via EviCore ePA portal (select "Pharmacy Drugs - Express Scripts Coverage")
    • Include comprehensive medical necessity letter
    • Timeline: Same day submission
  5. Track Status (Clinic Staff)
    • Monitor portal for updates
    • Prepare for potential peer-to-peer review request
    • Timeline: Check after 5 business days
  6. Enroll in Specialty Pharmacy (If Approved)
    • Accredo will contact patient within 24-48 hours
    • Complete enrollment and coordinate first shipment
    • Timeline: 2-3 days post-approval
  7. Appeal if Denied (Specialist/Patient)
    • File internal appeal within 180 days
    • Gather additional supporting evidence
    • Timeline: Start immediately upon denial

Medical Necessity Criteria

Cigna requires all of the following criteria to be met for Translarna approval:

Coverage at a Glance

Requirement What It Means Where to Find It Documentation Needed
Genetic Confirmation Pathogenic nonsense mutation in DMD gene CLIA-certified lab report Full genetic test with HGVS notation
Ambulatory Status Independent walking or minimal assistance Recent functional tests 6MWD, timed tests within 6 months
DMD Diagnosis Confirmed Duchenne muscular dystrophy Medical records ICD-10 G71.0, elevated CK levels
Standard Care Optimized corticosteroid therapy Treatment history Documentation of prednisone/deflazacort trial
Specialist Oversight Neuromuscular or pediatric neurologist Provider credentials Board certification verification

Required Documentation Package

Your specialist must submit a comprehensive medical necessity letter including:

  • Patient demographics and Cigna member ID
  • Diagnosis confirmation with ICD-10 code G71.0
  • Specific nonsense mutation details from genetic testing
  • Clinical rationale explaining Translarna's read-through mechanism
  • Prior therapy history including corticosteroid outcomes and any intolerances
  • Current functional status with recent assessments

Timeline and Status Tracking

How Long Does Cigna Prior Authorization Take?

  • Standard review: 3-5 business days
  • Complex cases: Up to 14 days
  • Expedited review: 72 hours (requires physician attestation that delay could seriously jeopardize health)

Checking Your Status

Track your prior authorization through the EviCore portal or by calling Cigna at 1-800-882-4462. Have your member ID and prior authorization reference number ready.

Common Denial Reasons

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
Insufficient genetic evidence Submit complete CLIA-certified genetic report Full lab report with variant interpretation
Non-ambulatory status Demonstrate current walking ability 6MWD, physical therapy evaluation, video documentation
Lack of medical necessity Provide comprehensive clinical rationale Literature citations, treatment history
Missing specialist oversight Confirm neuromuscular specialist involvement Provider credentials and consultation notes

When to Request Peer-to-Peer Review

If your initial submission is pending or denied, your specialist can request a peer-to-peer review with Cigna's medical director. This allows direct physician-to-physician discussion of the case and often leads to approval when clinical rationale is strong.

Appeals Process in New York

New York offers robust appeal rights for insurance denials, particularly valuable for rare disease medications like Translarna.

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • Filing deadline: 180 days from denial notice (commercial plans)
  • Decision timeline: 30 days for pre-service, 60 days for post-service
  • Expedited option: 72 hours if urgent (call 1-800-882-4462)
  • Submission: Via Cigna provider portal or mail to National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422

Level 2 Internal Appeal:

  • Filing deadline: 60 days from Level 1 decision
  • Review process: New medical director or appeals committee
  • Decision timeline: 30-60 days

New York External Appeal

If Cigna denies your internal appeals, New York residents have the right to an independent external review through the Department of Financial Services (DFS).

Key Features:

  • Filing deadline: 4 months from final adverse determination
  • Cost: Maximum $25 (waived for financial hardship or Medicaid enrollees)
  • Decision timeline: Standard review varies; expedited review within 24 hours for urgent cases
  • Binding decision: If external reviewer approves coverage, Cigna must comply

How to File:

  • Submit online at dfs.ny.gov or call the DFS Consumer Assistance Unit at 1-800-342-3736
  • Include all denial letters, medical records, and physician attestation for urgent cases
  • New York's external appeal program has strong success rates for rare disease cases with proper documentation

Consumer Assistance Resources

Community Health Advocates (CHA) offers free counseling on insurance denials and appeals. Call their helpline at 888-614-5400 for assistance with filing appeals or understanding your rights in New York.

Specialty Pharmacy Requirements

Why Specialty Pharmacy?

Translarna requires special handling due to its temperature-controlled storage requirements and complex dosing regimen. Cigna contracts with Accredo Specialty Pharmacy for these services.

Enrollment Process

Once your prior authorization is approved:

  1. Accredo will contact you within 24-48 hours
  2. Complete enrollment call with dedicated pharmacist
  3. Coordinate first shipment with temperature monitoring
  4. Set up refill management and copay assistance coordination

Costs and Financial Assistance

Understanding Your Coverage

Translarna's investigational status in the U.S. means traditional copay structures may not apply. Your out-of-pocket costs will depend on:

  • Your specific Cigna plan's investigational drug coverage
  • Whether the drug is obtained through expanded access programs
  • Available manufacturer assistance programs

Financial Support Options

PTC Therapeutics Support: Contact PTC Therapeutics directly at ptcbio.com to inquire about:

  • Expanded access programs
  • Compassionate use protocols
  • Patient assistance programs (availability varies by region)

Foundation Grants: Organizations like Parent Project Muscular Dystrophy may offer assistance for DMD-related expenses.

From our advocates: We've seen families successfully obtain Translarna coverage by working closely with their neuromuscular specialist to build a comprehensive case file that includes not just the required medical documentation, but also detailed functional assessments showing the patient's current ambulatory status and risk of decline. The key is demonstrating both medical necessity and the time-sensitive nature of maintaining walking ability in nonsense mutation DMD.

Frequently Asked Questions

Q: How long does Cigna prior authorization take in New York? A: Standard review takes 3-5 business days, with complex cases taking up to 14 days. Expedited review (72 hours) is available when delay could seriously jeopardize health.

Q: What if Translarna is non-formulary on my plan? A: You'll need both prior authorization and a formulary exception. Your specialist should request both simultaneously, explaining why no formulary alternatives are appropriate for nonsense mutation DMD.

Q: Can I request an expedited appeal in New York? A: Yes. Both Cigna internal appeals and New York external appeals offer expedited timelines (72 hours for Cigna, 24 hours for DFS) when your physician attests that delay poses serious health risks.

Q: Does step therapy apply to Translarna? A: Typically no, as there are no FDA-approved alternatives specifically for nonsense mutation DMD. However, you must document prior corticosteroid therapy as standard of care.

Q: What happens if I move from New York to another state? A: Your Cigna coverage continues, but appeal rights change based on your new state's laws. Contact your new state's insurance department for external appeal options.

Q: How often do I need to renew prior authorization? A: Authorization periods vary, but typically require annual renewal with updated functional assessments and continued medical necessity documentation.

Troubleshooting Common Issues

Portal Problems

If the EviCore portal is down or you're having technical issues:

  • Call Cigna provider services at 1-800-882-4462
  • Request manual submission via fax (get confirmation number)
  • Ask for expedited processing due to technical delays

Missing Forms or Documentation

  • Contact your neuromuscular specialist's office immediately
  • Request expedited processing of any missing genetic tests
  • Use Cigna's provider portal to track exactly which documents are needed

Communication Gaps

  • Ensure all parties (patient, specialist, Cigna, Accredo) have current contact information
  • Set up a three-way call between specialist and Cigna if needed
  • Document all conversations with reference numbers and representative names

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for specialty medications like Translarna. Our platform analyzes denial letters and insurance policies to create targeted, evidence-backed appeals that align with each payer's specific requirements. Learn more about our services at www.counterforcehealth.org.

For additional support with your Translarna coverage journey, consider working with advocacy organizations or platforms like Counterforce Health that specialize in turning insurance denials into successful approvals through systematic, evidence-based approaches.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for personalized guidance regarding your specific situation. Coverage policies and procedures may change; verify current requirements with Cigna and applicable New York state agencies.

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