By Counterforce Health Team in Translarna (ataluren) —

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

Answer Box: Getting Translarna (Ataluren) Covered by Cigna in Texas

Translarna (ataluren) requires prior authorization from Cigna/Express Scripts and is typically non-formulary, requiring a formulary exception for nonsense mutation Duchenne muscular dystrophy (DMD). The fastest path: 1) Confirm genetic testing shows nonsense mutation, 2) Have your neuromuscular specialist submit a comprehensive PA packet via the EviCore portal, and 3) If denied, file an internal appeal within 180 days followed by Texas Independent Review Organization (IRO) external review if needed.

First step today: Contact your DMD specialist to gather genetic confirmation and recent functional assessments (6-minute walk test, timed function tests) needed for the PA submission.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Documentation Requirements
  5. Submission Process
  6. Specialty Pharmacy Enrollment
  7. Common Denial Reasons & Solutions
  8. Texas Appeals Process
  9. Costs & Patient Assistance
  10. Printable Checklist

Who Should Use This Guide

This guide is for Texas residents with Cigna insurance seeking coverage for Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy. You'll need this if:

  • Your child has DMD with confirmed nonsense mutation
  • Your neurologist has recommended Translarna
  • You've received a Cigna denial or need to submit a prior authorization
  • You're preparing for the appeals process

Expected outcome: With proper documentation and genetic confirmation, many families successfully obtain coverage through the appeals process, though initial denials are common due to the drug's investigational status in the U.S.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage with prescription benefits
  • Specialty pharmacy benefits (typically through Express Scripts/Accredo)
  • Prior authorization required for all Translarna requests
  • Formulary exception needed (drug is non-formulary)
Note: Translarna lacks FDA approval in the U.S. as of 2024, with a new drug application (NDA) resubmitted in October 2024. Coverage requires demonstrating medical necessity for investigational use.

Plan Types That May Cover

  • Commercial employer plans
  • Individual marketplace plans
  • Some Medicare Advantage plans (verify coverage)

Clinical Criteria for Approval

Essential Requirements

Requirement Details Documentation Needed
Genetic Confirmation Pathogenic nonsense mutation in DMD gene CLIA-certified genetic test report with HGVS notation
Ambulatory Status Patient must be walking independently or with minimal assistance Recent 6-minute walk distance (6MWD), timed function tests
DMD Diagnosis Confirmed Duchenne (not Becker) muscular dystrophy ICD-10 code G71.0, clinical history, elevated CK levels
Standard Care Optimized corticosteroid therapy unless contraindicated Documentation of prednisone/deflazacort trial or contraindications
Specialist Oversight Neuromuscular neurologist or pediatric neurologist Prescriber credentials and specialty confirmation

Age and Functional Criteria

  • Typically prescribed for ambulatory patients aged 2+ years
  • Must demonstrate preserved walking ability
  • Recent functional assessments required (within 6 months)

Documentation Requirements

Core Medical Records

  • Genetic testing report from CLIA-certified laboratory
  • Neurologist consultation notes with DMD diagnosis
  • Laboratory results: Elevated creatine kinase (CK), dystrophin analysis if available
  • Functional assessments: 6MWD, North Star Ambulatory Assessment (NSAA), timed tests
  • Cardiac evaluation: Echocardiogram, ECG (DMD cardiac involvement)
  • Pulmonary function tests if applicable

Medical Necessity Letter Components

Your specialist should include:

  1. Patient demographics and Cigna member ID
  2. Diagnosis confirmation with ICD-10 code G71.0
  3. Genetic mutation details (specific nonsense mutation)
  4. Clinical rationale for Translarna's read-through mechanism
  5. Prior therapy history (corticosteroids, outcomes, intolerances)
  6. Functional status with recent test results
  7. Treatment goals and monitoring plan
  8. Literature support (FDA guidance, clinical trials, guidelines)
Clinician Corner: The medical necessity letter should emphasize that nonsense mutations require specific read-through therapy, distinguishing this from other DMD treatments like exon-skipping therapies (eteplirsen, golodirsen) that target different genetic subtypes.

Submission Process

Step-by-Step Submission

  1. Gather Documentation (Patient/Family)
    • Collect all medical records and genetic testing
    • Verify Cigna member ID and plan details
    • Timeline: 1-2 weeks
  2. Specialist Consultation (Physician)
    • Review genetic testing and functional status
    • Complete medical necessity letter
    • Timeline: 1-2 weeks for appointment and documentation
  3. Prior Authorization Submission (Physician Office)
    • Submit via EviCore by Evernorth ePA portal
    • Select "Pharmacy Drugs (Express Scripts Coverage)"
    • Include all required documentation
    • Timeline: Same day submission
  4. Cigna Review (Cigna/Express Scripts)
    • Standard review: 3-5 business days
    • Complex cases: Up to 14 days
    • Expedited (if urgent): 72 hours

Alternative Submission Methods

  • Phone: 1-800-882-4462
  • Fax: (verify current number with provider services)
  • Provider portal: CignaForHCP.com (login required)

Specialty Pharmacy Enrollment

Accredo Specialty Pharmacy Process

Since Translarna requires specialty handling, Cigna typically routes approvals through Accredo:

  1. Physician referral to Accredo upon PA approval
  2. Benefit verification by Accredo pharmacists
  3. Patient enrollment with dedicated support team
  4. Shipment coordination with temperature-controlled delivery
  5. Ongoing monitoring and refill management

What to Expect

  • Enrollment call from Accredo within 24-48 hours of approval
  • Dedicated pharmacist for questions and monitoring
  • Shipment tracking with signature required delivery
  • Copay assistance coordination if available

Common Denial Reasons & Solutions

Denial Reason Required Action Key Documents
Insufficient genetic evidence Provide complete CLIA-certified genetic report Full lab report with variant interpretation and clinical significance
Non-ambulatory status Demonstrate current walking ability Recent 6MWD, physical therapy evaluation, video documentation
Alternative therapies available Explain mutation-specific treatment need Geneticist letter distinguishing nonsense vs. other mutations
Experimental/investigational Provide clinical evidence and compassionate use rationale Published studies, FDA guidance, medical necessity for individual case
Step therapy not completed Document standard care optimization Corticosteroid trial records or contraindication documentation

Common Fixes That Work

  • Address specific criteria: Review Cigna's PA policy PH_1407 and address each requirement
  • Peer-to-peer review: Request physician-to-physician discussion
  • Additional literature: Include recent clinical trial data and FDA communications
  • Functional decline documentation: Show progression despite standard care

Texas Appeals Process

Internal Appeals (Required First Step)

Timeline: File within 180 days of denial date

Process:

  1. Level 1 Appeal
    • Submit via Cigna member portal or call 1-800-882-4462
    • Include denial letter, additional medical evidence
    • Decision timeline: 30 days (standard), 72 hours (expedited)
  2. Level 2 Appeal (Automatic if Level 1 denied)
    • Reviewed by different Cigna clinician
    • Same timeline as Level 1

External Review (Texas IRO)

When to use: After internal appeals exhausted, for medical necessity disputes

Timeline: File within 4 months of final internal denial

Process:

  1. Request review via Texas Department of Insurance
  2. Submit documentation (free to patient, Cigna pays IRO)
  3. Independent review by medical experts
  4. Decision timeline: 20 days (standard), 72 hours (expedited)
  5. Binding decision: Cigna must comply if overturned

Expedited Appeals

Request expedited review if delay would:

  • Seriously jeopardize health or ability to regain maximum function
  • Subject patient to severe pain
  • Risk permanent disability progression
From Our Advocates: Families often succeed on external review when the initial denial cited "experimental" status. The key is demonstrating that while Translarna lacks FDA approval, the specific genetic mutation creates a medical necessity that standard DMD therapies cannot address. Include genetic counselor letters explaining why exon-skipping therapies won't work for nonsense mutations.

Costs & Patient Assistance

Insurance Coverage Expectations

  • Copay: Varies by plan, typically $100-500+ per month for specialty tier
  • Deductible: May apply before coverage begins
  • Annual out-of-pocket maximum: Provides cost ceiling protection

Patient Assistance Options

  • Manufacturer support: Contact PTC Therapeutics for patient assistance programs
  • Foundation grants: Research rare disease foundations offering DMD support
  • State programs: Texas may have additional resources for rare diseases
Note: Given Translarna's investigational status in the U.S., traditional copay cards may not be available. Focus on compassionate use programs and foundation support.

Printable Checklist

Before Submission

  • Active Cigna coverage verified
  • CLIA-certified genetic test report (nonsense mutation confirmed)
  • Recent functional assessments (6MWD, timed tests within 6 months)
  • Neuromuscular specialist consultation notes
  • Medical necessity letter completed
  • Prior therapy documentation (corticosteroids)
  • Cardiac and pulmonary evaluations if applicable

During Process

  • PA submitted via EviCore portal
  • Confirmation number obtained and recorded
  • Status checked within 5 business days
  • Peer-to-peer requested if initial review pending

If Denied

  • Internal appeal filed within 180 days
  • Additional evidence gathered and submitted
  • External IRO review requested if internal appeals fail
  • All deadlines tracked and documented

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific submissions. Our platform helps families navigate complex prior authorization requirements for rare disease treatments like Translarna, ensuring that genetic testing, functional assessments, and medical necessity documentation align with each insurer's specific criteria.

For additional support with your Translarna appeal, visit www.counterforcehealth.org to access resources designed specifically for rare disease coverage challenges.

Frequently Asked Questions

How long does Cigna prior authorization take for Translarna in Texas? Standard review takes 3-5 business days, with complex cases taking up to 14 days. Expedited review (72 hours) is available if delay would jeopardize health.

What if Translarna is non-formulary on my Cigna plan? Submit a formulary exception request along with your PA, providing medical necessity documentation that explains why formulary alternatives aren't suitable for nonsense mutations.

Can I request expedited appeal if my child is declining? Yes, Texas allows expedited appeals when delays would seriously jeopardize health or ability to regain function. Document functional decline and request expedited internal and external review.

Does step therapy apply to Translarna? Typically no, since there are no FDA-approved treatments specifically for nonsense mutation DMD. However, document optimization of standard care (corticosteroids) to strengthen your case.

What happens after Texas IRO approves coverage? The decision is binding—Cigna must provide coverage and cannot appeal the IRO decision. Coverage typically begins within days of the favorable decision.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan terms. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with Texas insurance complaints or appeals, contact the Texas Department of Insurance at 1-800-252-3439.

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