Work With Your Doctor to Get Exondys 51 (Eteplirsen) Covered by Cigna in Washington: Complete Guide
Answer Box: Getting Exondys 51 Covered by Cigna in Washington
What you need: Genetic testing confirming DMD with exon 51-amenable mutation, neurologist prescription, functional assessments (6-minute walk test), and cardiac/pulmonary baseline testing.
Fastest path: 1) Schedule visit with neuromuscular specialist, 2) Gather genetic reports and functional testing, 3) Submit comprehensive prior authorization with medical necessity letter. If denied, Washington's external review process has an ~82% overturn rate for specialty drugs.
Start today: Contact your neurologist to request genetic testing results and schedule functional assessments. Call Cigna at the member services number on your card to confirm current prior authorization requirements.
Table of Contents
- Set Your Goal: Understanding Cigna's Exondys 51 Requirements
- Prepare for Your Doctor Visit
- Build Your Evidence Kit
- Medical Necessity Letter Structure
- Supporting Your Doctor Through Peer-to-Peer Review
- After Your Visit: Documentation and Follow-up
- Respectful Persistence: When and How to Follow Up
- Washington Appeals Process
- FAQ
Set Your Goal: Understanding Cigna's Exondys 51 Requirements
Getting Exondys 51 (eteplirsen) covered by Cigna requires meeting specific clinical criteria and working closely with your healthcare team. Here's what approval requires and how you'll partner with your provider.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Prior Authorization | Cigna must approve before dispensing | Cigna Provider Portal |
| Genetic Testing | DMD mutation amenable to exon 51 skipping | Laboratory genetic report |
| Specialist Prescriber | Neurologist or neuromuscular specialist | Provider credentials documentation |
| Functional Status | 6-minute walk test ≥180 meters | Clinical assessment records |
| Age Requirement | Typically ≤13 years at therapy start | Medical records |
| Cardiac Function | Baseline cardiac assessment | Echocardiogram or MUGA scan |
| Pulmonary Function | FVC ≥50% predicted if applicable | Pulmonary function tests |
Note: Requirements may vary based on your specific Cigna plan. Always verify current criteria with your plan documents or member services.
Your Partnership Role
You're not just a passive recipient of care—you're an active partner in building the strongest possible case for approval. Your role includes:
- Gathering historical records of treatments tried and their outcomes
- Tracking functional changes and documenting how DMD affects daily activities
- Organizing insurance documentation and understanding your specific plan's requirements
- Advocating respectfully when additional information or clarification is needed
Prepare for Your Doctor Visit
Thorough preparation helps your doctor write the most compelling medical necessity letter possible. Come to your appointment with organized information about your medical history and current status.
Symptom Timeline Documentation
Create a detailed timeline of your or your child's DMD progression:
Motor Function Changes:
- When did walking difficulties first appear?
- Changes in ability to climb stairs, get up from the floor, or run
- Frequency of falls or near-falls
- Use of assistive devices (braces, wheelchair, walker)
Functional Impact Notes:
- Activities that have become more difficult (school, play, self-care)
- Energy levels and fatigue patterns
- Sleep disturbances or breathing difficulties
- Social or emotional impacts of the condition
Treatment History Summary
Prepare a comprehensive list of:
Previous Therapies:
- Corticosteroids (prednisone, deflazacort) - doses, duration, effectiveness
- Physical therapy frequency and specific interventions
- Occupational therapy services
- Respiratory treatments or devices
Treatment Outcomes:
- Which therapies helped and for how long
- Side effects experienced
- Reasons for discontinuing treatments
- Current medication regimen and adherence
Insurance Information Checklist
Bring to your appointment:
- Insurance card with member ID and group number
- Summary of benefits (if available)
- Any previous denial letters or correspondence about Exondys 51
- Documentation of any step therapy requirements completed
Build Your Evidence Kit
Strong evidence supporting medical necessity significantly improves approval chances. Work with your healthcare team to compile comprehensive documentation.
Essential Laboratory and Imaging
Genetic Testing Results:
- Complete genetic analysis report confirming DMD diagnosis
- Specific documentation that the mutation is amenable to exon 51 skipping
- Laboratory letterhead and certified results
Functional Assessments:
- Recent 6-minute walk test results (within 6 months)
- North Star Ambulatory Assessment (NSAA) if available
- Motor Function Measure (MFM) scores
- Brooke Upper Extremity Function scores
Cardiac and Pulmonary Testing:
- Echocardiogram showing left ventricular ejection fraction
- Pulmonary function tests including forced vital capacity (FVC)
- Any additional cardiac monitoring (Holter monitor, ECG)
Published Guidelines and Evidence
Your doctor will reference established medical literature, but you can help by understanding the evidence base:
FDA Approval Information:
- Exondys 51 received accelerated approval in September 2016
- Approved for DMD patients with confirmed mutations amenable to exon 51 skipping
- Approximately 13% of DMD patients are eligible for exon 51 skipping therapy
Clinical Guidelines:
- Care considerations from the DMD Care Network
- Recommendations from neuromuscular specialty societies
- Published treatment algorithms for DMD management
Medication History Summary
Organize your complete treatment history:
- Current medications with exact doses and frequency
- Previous DMD treatments and their effectiveness
- Contraindications to other therapies
- Adherence patterns and any barriers to compliance
Medical Necessity Letter Structure
The medical necessity letter is the cornerstone of your prior authorization request. Understanding its key components helps you ensure your doctor includes all critical information.
Essential Components
Patient and Insurance Information:
- Complete demographic details
- Insurance policy numbers and group information
- Prescribing physician credentials and NPI number
Diagnosis and Clinical Rationale:
- DMD diagnosis with ICD-10 code G71.01
- Genetic testing confirmation of exon 51-amenable mutation
- Clinical progression and functional status documentation
Treatment Justification:
- Why Exondys 51 is medically necessary for this specific patient
- Evidence of functional decline without treatment
- Risks of delaying therapy
- Expected clinical benefits
Supporting References:
- FDA approval documentation
- Peer-reviewed literature supporting efficacy
- Clinical guidelines recommending exon skipping therapy
- Specialist society position statements
Key Clinical Points to Address
Your doctor's letter should specifically address:
- Genetic Eligibility: Clear documentation that genetic testing confirms a DMD mutation amenable to exon 51 skipping
- Functional Status: Current ambulatory ability and recent changes in motor function
- Specialist Care: Confirmation that care is provided by or in consultation with a neuromuscular specialist
- Alternative Treatments: Discussion of other therapies tried and their outcomes
- Prognosis: Expected disease progression without Exondys 51 treatment
Tip: Ask your doctor to reference specific sections of Cigna's coverage policy to demonstrate how your case meets their stated criteria.
Supporting Your Doctor Through Peer-to-Peer Review
If Cigna requests a peer-to-peer review, you can help your doctor prepare for this important conversation with Cigna's medical reviewer.
Offering Availability Support
Scheduling Assistance:
- Help coordinate between your doctor's office and Cigna's review team
- Offer flexible windows when your doctor is available
- Ensure all parties have correct contact information
Information Organization:
- Prepare a concise case summary your doctor can reference during the call
- Organize key documents in order of importance
- Highlight the most compelling evidence points
Concise Case Summary for Your Provider
Help your doctor prepare a brief but comprehensive case summary:
Patient Overview (30 seconds):
- Age, DMD diagnosis confirmation, current functional status
- Genetic testing results confirming exon 51 amenability
Clinical Rationale (60 seconds):
- Current symptoms and functional decline
- Treatments tried and their outcomes
- Why Exondys 51 is the appropriate next step
Supporting Evidence (30 seconds):
- Key test results and specialist recommendations
- Relevant literature or guidelines
- Patient/family treatment goals
Preparation Questions
Before the peer-to-peer call, ensure your doctor can address:
- Specific genetic mutation details and exon 51 amenability
- Current functional assessments and recent changes
- Why alternative treatments are not appropriate
- Expected benefits and monitoring plan for Exondys 51
After Your Visit: Documentation and Follow-up
Proper documentation and organized follow-up increase your chances of approval and help prepare for potential appeals.
What to Save
Clinical Documentation:
- Copy of the medical necessity letter
- All test results and reports submitted
- Prescription and dosing information
- Provider notes from your visit
Insurance Communications:
- Prior authorization submission confirmation
- Any correspondence from Cigna
- Reference numbers and case tracking information
- Names and contact information for representatives you speak with
Patient Portal Communication
Use your healthcare provider's patient portal effectively:
Message Templates:
- "Could you please send me a copy of the prior authorization request submitted to Cigna?"
- "I'd like to track the status of my Exondys 51 prior authorization. Do you have any updates?"
- "Cigna requested additional information. Can we schedule a time to discuss what they need?"
Follow-up Timing:
- Check portal messages daily during the review period
- Respond promptly to any requests for additional information
- Keep a log of all communications with dates and content
Respectful Persistence: When and How to Follow Up
Appropriate follow-up demonstrates your commitment to treatment while maintaining positive relationships with your healthcare team.
Follow-up Cadence
Week 1-2: Allow time for initial processing
- Check with your doctor's office once for submission confirmation
- Verify Cigna received the prior authorization request
Week 3-4: Gentle status inquiries
- Contact your doctor's office for any updates
- Call Cigna member services to check status (have your reference number ready)
After 30 Days: More active follow-up
- Request peer-to-peer review if not already scheduled
- Ask about expedited review options if medically appropriate
Escalation Guidelines
When to Escalate Politely:
- No response after 30 days (standard review timeline)
- Request for information that was already provided
- Denial without clear clinical rationale
How to Escalate:
- Ask to speak with a supervisor or case manager
- Request written explanation of denial reasons
- Inquire about expedited appeal options
Professional Communication:
- Always remain courteous and professional
- Document names, dates, and reference numbers
- Focus on medical necessity rather than emotional appeals
Washington Appeals Process
If Cigna denies your Exondys 51 prior authorization, Washington state provides strong consumer protections through its appeals process.
Internal Appeals with Cigna
Timeline: 180 days from denial to file internal appeal Process: Submit written appeal with additional clinical documentation Decision Time: 30 days for standard appeals, 72 hours for expedited
External Review Through Washington OIC
Washington's external review process has shown high success rates for specialty drug appeals.
Eligibility: After completing Cigna's internal appeal process Timeline: 60 days from final internal denial to request external review Success Rate: Approximately 82% overturn rate for specialty drug appeals
How to Request External Review:
- Contact Washington Office of the Insurance Commissioner at 1-800-562-6900
- Submit external review request (automatically assigned to certified IRO)
- Provide additional evidence within 5 business days
- IRO reviews within 20-30 days (expedited: 72 hours)
- Decision is binding on Cigna
Important: This process applies to fully insured plans. If your Cigna plan is self-insured through your employer, different rules may apply.
Support Resources
Washington Office of the Insurance Commissioner:
- Phone: 1-800-562-6900
- Provides guidance on appeals process
- Offers template appeal letters
- Can investigate insurer compliance issues
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific requirements.
FAQ
How long does Cigna prior authorization take for Exondys 51 in Washington? Standard prior authorization decisions are made within 30 days. Expedited reviews for urgent medical situations are completed within 72 hours.
What if Exondys 51 is not on Cigna's formulary? You can request a formulary exception by demonstrating medical necessity and providing clinical rationale for why preferred alternatives are not appropriate.
Can I request an expedited appeal if my initial request is denied? Yes, if you can demonstrate that delays in treatment could seriously jeopardize your health, you can request expedited review at both internal and external appeal levels.
Do I need to complete step therapy before getting Exondys 51 approved? Step therapy requirements vary by plan, but many Cigna policies recognize that Exondys 51 is appropriate first-line therapy for eligible patients with confirmed genetic mutations.
What happens if my employer plan is self-insured? Self-insured plans may not be subject to Washington state external review requirements. Check your Summary Plan Description or contact your plan administrator to understand your appeal rights.
How much does Exondys 51 cost without insurance? The typical U.S. cash price is approximately $7,822 for a 10 mL vial, though actual costs vary. Sarepta Therapeutics offers patient assistance programs that may help with costs.
Can I get help with the appeals process? Yes, the Washington Office of the Insurance Commissioner provides free consumer assistance. Counterforce Health also offers specialized support for complex drug appeals, helping to identify denial bases and craft targeted rebuttals using the right clinical evidence and payer-specific workflows.
What if I'm on Washington Apple Health (Medicaid)? Apple Health has its own appeals process through managed care plans and fair hearings. The OIC can help direct you to the appropriate process for Medicaid appeals.
Sources & Further Reading
- Cigna Eteplirsen Coverage Policy (PDF)
- Washington Insurance Commissioner Appeals Guide
- Parent Project Muscular Dystrophy Medical Necessity Template
- FDA Exondys 51 Prescribing Information
- Washington Office of the Insurance Commissioner
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company to understand your specific coverage requirements. Coverage policies and requirements may change, so verify current information with official sources.
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