By Counterforce Health Team in Vyondys 53 (golodirsen) —

How to Get Vyondys 53 (Golodirsen) Covered by Cigna in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Vyondys 53 Covered by Cigna in Virginia

To get Vyondys 53 (golodirsen) covered by Cigna in Virginia, you need genetic testing confirming a DMD mutation amenable to exon 53 skipping, prescription from a neurologist, and documented ambulatory function (6-minute walk test ≥250 meters). Submit prior authorization through Accredo specialty pharmacy at 877-848-6953 or via your prescriber's Cigna portal. If denied, Virginia allows external review through the State Corporation Commission within 120 days. Start today: Confirm genetic testing results and contact your neuromuscular specialist to initiate the prior authorization process.

Table of Contents

What This Guide Covers

This comprehensive guide helps patients with Duchenne muscular dystrophy (DMD) and their healthcare teams navigate Cigna's prior authorization process for Vyondys 53 (golodirsen) in Virginia. Whether you're facing an initial request or appealing a denial, you'll find step-by-step instructions, required documentation, and Virginia-specific appeal rights.

Vyondys 53 is an FDA-approved antisense oligonucleotide for DMD patients with mutations amenable to exon 53 skipping. At approximately $1,571 for a 2 mL vial, prior authorization is typically required by most insurers, including Cigna.

Before You Start: Plan Verification

Confirm Your Cigna Plan Details

  1. Check if Vyondys 53 is covered: Log into your myCigna portal or call member services at 1-800-244-6224
  2. Verify specialty pharmacy requirement: Cigna typically requires specialty medications like Vyondys 53 to be dispensed through Accredo specialty pharmacy
  3. Confirm in-network status: Ensure your prescribing neurologist is in Cigna's network
  4. Review your benefits: Check for any step therapy requirements or quantity limits
Note: Self-funded employer plans may have different requirements than standard Cigna policies. Verify your specific plan documents.

Gather What You Need

Required Documentation Checklist

Clinical Documentation:

  • Confirmed DMD diagnosis with ICD-10 code (G71.01)
  • Genetic testing report from CLIA-certified lab confirming mutation amenable to exon 53 skipping
  • Current neurologist or neuromuscular specialist consultation notes
  • Baseline functional assessments (6-minute walk test, North Star Ambulatory Assessment)
  • Documentation of stable corticosteroid therapy for ≥6 months
  • Baseline kidney function tests (cystatin C, urine protein/creatinine ratio)

Insurance Information:

  • Cigna member ID card
  • Prior authorization form (obtain from Cigna provider portal)
  • Previous therapy trials and outcomes (if applicable)
  • Current medication list

Key Eligibility Criteria

According to Cigna's medical policy, Vyondys 53 approval requires:

Requirement Details
Age Typically <16 years for initial therapy
Diagnosis Confirmed DMD with genetic mutation amenable to exon 53 skipping
Functional Status Ambulatory (6MWT ≥250 meters, Gower's sign <7 seconds)
Prescriber Neurologist or neuromuscular specialist
Corticosteroids Stable dose for ≥6 months
Exclusions No concurrent exon-skipping therapies or recent gene therapy

Submit the Prior Authorization Request

Step-by-Step Submission Process

1. Prescriber Initiates Request

  • Your neurologist submits the prior authorization through Cigna's provider portal
  • Alternative: Fax completed PA form to 1-866-873-8279
  • Include all required documentation from checklist above

2. Specialty Pharmacy Coordination

  • Cigna will route approved prescriptions to Accredo
  • Contact Accredo directly at 877-848-6953 for neuromuscular medications
  • Accredo provides 24/7 clinical support and home delivery

3. Medical Necessity Letter Your prescriber should include a comprehensive letter addressing:

  • DMD diagnosis and genetic confirmation
  • Prior therapies attempted and outcomes
  • Clinical rationale for Vyondys 53
  • Expected treatment goals and monitoring plan
  • References to FDA approval and clinical guidelines
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to payer policies.

Follow-Up and Tracking

Monitoring Your Request Status

Week 1-2: Initial review period

  • Track status through myCigna portal or call 1-800-882-4462
  • Document all reference numbers and representative names
  • Accredo will contact you if prescription is approved

If Additional Information Requested:

  • Respond within timeframes specified (typically 14 days)
  • Submit through same channel as original request
  • Follow up within 48 hours to confirm receipt

Sample Phone Script for Status Checks

"Hello, I'm calling to check the status of a prior authorization request for Vyondys 53 for [patient name], member ID [number]. The request was submitted on [date] with reference number [if available]. Can you provide an update on the review status and expected decision timeline?"

Typical Timelines

Virginia-Specific Requirements

Request Type Cigna Timeline Virginia Standard
Standard PA 5-7 business days 30 days (pre-service)
Urgent/Expedited 24-48 hours 72 hours
Appeal Decision 30 days 30 days (internal)
External Review N/A 45 days (standard)

Virginia regulations require expedited review when delays could seriously jeopardize health or ability to regain function.

If You're Asked for More Information

Common Information Requests

Genetic Testing Clarification:

  • Provide detailed lab report with specific mutation identified
  • Include geneticist interpretation if available
  • Ensure testing was performed by CLIA-certified laboratory

Functional Assessment Updates:

  • Submit current 6-minute walk test results
  • Provide North Star Ambulatory Assessment scores
  • Document any functional decline or stability

Prior Therapy Documentation:

  • Detail previous DMD treatments and outcomes
  • Include reasons for discontinuation or inadequate response
  • Provide timeline of corticosteroid therapy

If Your Request Is Denied

Understanding Denial Reasons

Common denial codes and meanings:

  • Medical necessity: Insufficient clinical justification
  • Experimental/investigational: Plan doesn't recognize FDA approval
  • Age restriction: Patient outside approved age range
  • Genetic criteria: Inadequate documentation of exon 53 mutation

First-Level Internal Appeal

Submit within 180 days of denial notice to:

  • Cigna Appeals Department
  • Address provided in denial letter
  • Include all original documentation plus additional supporting evidence

Appeal Letter Should Address:

  • Specific reason for denial
  • Additional clinical evidence
  • Peer-reviewed literature supporting treatment
  • FDA approval status and labeling
From our advocates: "We've seen success when families include a detailed timeline showing disease progression and how Vyondys 53 fits into the comprehensive DMD care plan. The key is demonstrating medical necessity with objective functional measures and genetic confirmation."

Virginia External Review Process

If Cigna upholds the denial after internal appeals, Virginia residents have strong external review rights through the State Corporation Commission Bureau of Insurance.

External Review Eligibility

  • Must complete Cigna's internal appeal process first
  • Submit Form 216-A within 120 days of final denial
  • Applies to medical necessity and experimental treatment denials

How to File External Review

Contact Information:

  • Fax: (804) 371-9915
  • Email: [email protected]
  • Phone: 1-877-831-4900 (consumer helpline)

Required Documents:

  • Completed Form 216-A
  • Copy of denial notice
  • All medical records and supporting documentation
  • Signed authorization for records release

Timeline and Process

  1. Initial Review: Bureau confirms eligibility within 5 business days
  2. IRO Assignment: Independent Review Organization assigned within 1 business day
  3. Decision Timeline: 45 days for standard review, 72 hours for expedited
  4. Final Decision: Binding on Cigna; coverage must be provided if overturned

Expedited Review Available When:

  • Waiting could seriously jeopardize life or health
  • Delay could impair ability to regain function
  • Certified by treating physician

Virginia's external review is free to patients and has helped many families obtain coverage for necessary treatments.

Renewal and Re-Authorization

Planning for Continued Coverage

Timeline: Submit renewal 30-60 days before current authorization expires

Required Documentation for Renewal:

  • Updated functional assessments
  • Current lab values (kidney function monitoring)
  • Treatment response documentation
  • Continued medical necessity letter
  • Any adverse events or tolerability issues

Monitoring Requirements:

  • Regular kidney function tests (urine protein pre-infusion)
  • Functional assessments (6MWT, NSAA scores)
  • Growth and development monitoring
  • Corticosteroid management

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient genetic testing Submit detailed CLIA lab report with mutation analysis
Age restriction Provide literature supporting use in specific age group
Functional criteria not met Include recent 6MWT and NSAA assessments
Missing specialist consultation Ensure neurologist/neuromuscular specialist is prescriber
Experimental designation Reference FDA accelerated approval and clinical data
Step therapy requirement Document trials of required therapies and outcomes

Costs and Patient Support

Financial Assistance Options

SareptAssist Program:

  • Patient support services for Sarepta medications
  • Insurance navigation and prior authorization assistance
  • Contact through Vyondys 53 website

Copay Assistance:

  • Commercial insurance patients may be eligible for copay support
  • Not available for government insurance (Medicare, Medicaid)

Foundation Support:

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • Muscular Dystrophy Association (MDA)

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals, particularly valuable for complex cases involving specialty medications like Vyondys 53.

FAQ

How long does Cigna prior authorization take for Vyondys 53 in Virginia? Standard requests: 5-7 business days. Urgent requests: 24-48 hours. Virginia law requires decisions within 30 days for pre-service requests.

What if Vyondys 53 is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. Include prescriber letter explaining why formulary alternatives are inappropriate.

Can I request an expedited prior authorization? Yes, if delays could jeopardize health or function. Your physician must certify the urgent need in writing.

What genetic testing is required? CLIA-certified lab testing confirming DMD mutation amenable to exon 53 skipping. Include detailed report with specific mutation identified.

Does step therapy apply to Vyondys 53? Some Cigna plans may require trials of corticosteroids or other DMD therapies first. Document previous treatments and outcomes.

How do I contact Accredo for Vyondys 53? Call 877-848-6953 for neuromuscular medications. They provide 24/7 support and coordinate with your healthcare team.

What happens if I move from Virginia during treatment? Contact Cigna member services to understand how coverage may change. External review rights vary by state.

Can I appeal if my child ages out during treatment? Yes, document continued medical necessity and functional benefit. Include literature supporting continued treatment in older patients.

Quick Reference Checklist

Before Submitting:

  • Genetic testing confirming exon 53 mutation
  • Neurologist consultation and prescription
  • 6-minute walk test ≥250 meters
  • Stable corticosteroids ≥6 months
  • Baseline kidney function tests
  • Cigna prior authorization form completed

If Denied:

  • Review denial reason carefully
  • Gather additional supporting documentation
  • Submit internal appeal within 180 days
  • Consider external review if internal appeal fails
  • Contact Virginia Bureau of Insurance for guidance

Key Contacts:

  • Cigna PA: 1-800-882-4462
  • Accredo: 877-848-6953
  • Virginia BOI: 1-877-831-4900
  • SareptAssist: Via Vyondys53.com

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and requirements may vary by plan and change over time.

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