By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) —

Do You Qualify for Elevidys Coverage by Cigna in Michigan? Complete Decision Tree & Appeal Guide

Quick Answer: Cigna requires prior authorization for Elevidys (delandistrogene moxeparvovec-rokl) with strict DMD genetic testing, anti-AAVrh74 antibody screening, and steroid protocol documentation. Most eligible patients need complete medical records, specialist letter, and submission through Cigna's specialty pharmacy network. If denied, Michigan patients have 180 days for internal appeals, then 127 days for binding external review through Michigan DIFS. First step: Verify your DMD genetic testing excludes exons 8/9 deletions and confirm anti-AAVrh74 antibodies are below 1:400.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives and Exceptions
  6. If Denied: Michigan Appeal Path
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. FAQ: Elevidys Coverage in Michigan

How to Use This Decision Tree

This guide helps you determine if you qualify for Cigna coverage of Elevidys gene therapy in Michigan and provides your next steps. Work through the eligibility triage first, then follow the appropriate path based on your results.

Before you start, gather:

  • Insurance card and policy details
  • DMD genetic testing results
  • Anti-AAVrh74 antibody test results
  • Current medication list (especially steroids)
  • Recent clinic notes from your neuromuscular specialist

Eligibility Triage: Do You Qualify?

Step 1: Diagnosis Confirmation

✅ YES if: You have confirmed DMD with genetic testing showing a pathogenic mutation in the DMD gene
❌ NO if: No genetic confirmation or non-DMD muscular dystrophy diagnosis

Step 2: Age and Mutation Check

✅ YES if: Age 4 years or older AND genetic testing confirms NO deletions in exons 8 or 9
⚠️ CAUTION if: Deletions in exons 8/9 present (typically excluded per Cigna policy)

Step 3: Antibody Screening

✅ YES if: Anti-AAVrh74 antibody titers below 1:400
❌ NO if: Antibody titers at or above 1:400
❓ UNKNOWN if: No antibody testing completed yet

Step 4: Previous Therapies

✅ YES if: No prior gene therapy for DMD
✅ YES if: Not currently on exon-skipping therapies (eteplirsen, golodirsen, viltolarsen)
❌ NO if: Previous gene therapy or concurrent exon-skipping treatment

Step 5: Specialist Care

✅ YES if: Under care of neuromuscular or DMD specialist
⚠️ CAUTION if: Primary care only (may need specialist referral)

If "Likely Eligible": Document Checklist

You answered YES to all triage questions. Here's your submission pathway:

Required Documentation

  • DMD genetic testing report showing pathogenic mutation and confirming no exons 8/9 deletions
  • Anti-AAVrh74 antibody results with titers below 1:400
  • Specialist letter documenting medical necessity, current functional status, and treatment goals
  • Steroid protocol plan detailing pre- and post-infusion corticosteroid regimen
  • Hepatic monitoring plan including baseline labs and follow-up schedule
  • Current medication list and prior therapy history
  • Insurance verification confirming Elevidys coverage and approved center-of-excellence requirements

Submission Process

  1. Contact Accredo Specialty Pharmacy (Cigna's partner) at 1-800-803-2523
  2. Provider submits PA through Cigna's electronic portal or via fax
  3. Standard turnaround: 72 hours for complete submissions; up to 15 days for complex cases
  4. Track status via myCigna portal or Accredo's patient portal
Tip: Submit complete documentation upfront to avoid delays. Incomplete submissions often result in automatic denials that require appeals.

If "Possibly Eligible": Tests to Request

You have some qualifying factors but need additional testing or documentation.

Missing Antibody Testing

Request: Anti-AAVrh74 antibody titer test from your specialist
Timeline: Results typically available in 1-2 weeks
Resubmit when: Titers confirmed below 1:400

Unclear Genetic Testing

Request: Comprehensive DMD genetic analysis including exon deletion/duplication analysis
Timeline: 2-4 weeks for complete results
What to verify: Specific mutation type and confirmation that exons 8/9 are intact

Steroid Management Questions

Discuss with specialist: Optimal timing for steroid initiation or modification
Document: Current steroid regimen and planned peri-infusion protocol
Timeline: Can often be addressed at next appointment

If "Not Yet": Alternatives and Exceptions

High Antibody Titers (≥1:400)

Current options:

  • Discuss immunosuppression protocols with specialist (emerging research)
  • Consider clinical trials for alternative gene therapies
  • Continue standard DMD care (steroids, supportive therapies)

Exception request strategy:

  • Request coverage determination review citing evolving protocols
  • Provide literature on immunosuppression approaches
  • Consider second opinion from major DMD center

Exons 8/9 Deletions Present

Cigna typically excludes these patients based on clinical trial data
Exception path: Request individual case review with detailed specialist rationale
Alternative: Explore clinical trials or other gene therapy approaches

Age Under 4 Years

Standard approach: Wait until FDA-labeled age
Exception consideration: Individual case review for severe, rapidly progressive disease

If Denied: Michigan Appeal Path

Michigan provides strong consumer protections with specific timelines and binding external review.

Level 1: Internal Appeal with Cigna

Timeline: 180 days from denial letter to file
Cigna response time: 30 days (pre-service) or 60 days (post-service)
How to file: Cigna appeals portal or written request
Include: Additional medical records, specialist letter addressing denial reasons, updated clinical data

Level 2: Michigan External Review

Timeline: 127 days from Cigna's final internal denial
Decision time: 30-60 days (standard) or 72 hours (expedited)
How to file: Michigan DIFS External Review portal or Form FIS 0018
Contact: Michigan DIFS at 877-999-6442
Result: Binding decision—if you win, Cigna must cover

Expedited Appeals

When to request: Delay would seriously jeopardize health
Required: Physician letter stating medical urgency
Timeline: 72 hours for both internal and external expedited reviews

From our advocates: We've seen Michigan families successfully overturn Elevidys denials by submitting comprehensive genetic testing documentation and specialist letters that directly address Cigna's specific coverage criteria. The key is ensuring your appeal responds point-by-point to the denial reasons rather than simply restating medical necessity.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Cigna provider portal Cigna PA Policy
DMD Genetic Testing Confirmed pathogenic mutation, no exons 8/9 deletions Specialist or genetic counselor Cigna Coverage Policy
Anti-AAVrh74 Antibodies Titers must be <1:400 Specialty lab via neuromuscular specialist FDA Label
Steroid Protocol Pre/post-infusion corticosteroid plan Specialist documentation Treatment Guide
Specialist Care Neuromuscular or DMD specialist oversight Provider credentials verification Cigna Coverage Policy
Center of Excellence Treatment at approved facility Cigna provider directory Cigna COE Program

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Experimental/Investigational" Cite Michigan regulatory determinations that Elevidys is standard of care; reference FDA approval and clinical guidelines
"Missing genetic confirmation" Submit comprehensive DMD genetic testing report with specific mutation details and exon analysis
"Elevated antibody titers" Provide recent anti-AAVrh74 results <1:400; if elevated, discuss immunosuppression protocols with specialist
"Inadequate steroid plan" Include detailed pre/post-infusion corticosteroid protocol with dosing, duration, and monitoring plan
"Not medically necessary" Specialist letter addressing functional decline, treatment goals, and why Elevidys is appropriate at this disease stage
"Site of care not approved" Verify treatment facility is Cigna-approved center of excellence; if not, request network exception

FAQ: Elevidys Coverage in Michigan

How long does Cigna prior authorization take in Michigan?
Standard PA decisions are made within 72 hours for complete submissions, up to 15 days for complex cases requiring medical review.

What if Elevidys is non-formulary on my plan?
Request a formulary exception with medical necessity documentation. Michigan law requires payers to have a formulary exception process.

Can I request an expedited appeal if my child's condition is worsening?
Yes. Both Cigna internal appeals and Michigan external reviews offer expedited pathways (72 hours) with physician documentation of urgency.

Does step therapy apply to Elevidys in Michigan?
Cigna may require documentation of previous DMD treatments, but gene therapy typically doesn't have direct step therapy alternatives.

What's the cost if Cigna approves coverage?
Your out-of-pocket costs depend on your plan's specialty drug benefits. Sarepta offers patient assistance programs—contact them at 1-888-SAREPTA.

How do I find a Cigna-approved center for Elevidys in Michigan?
Contact Cigna customer service or check their provider directory for centers of excellence with gene therapy capabilities.

What if I'm on Medicaid in addition to Cigna?
Coordinate with both payers. Michigan Medicaid may have different appeal processes—contact Michigan DHHS for dual coverage guidance.

Can my doctor help with the appeal process?
Yes. Michigan law allows healthcare providers to file appeals on your behalf with written consent. Many specialists are experienced with gene therapy appeals.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Elevidys. Our platform analyzes denial letters, identifies the specific coverage criteria, and generates evidence-backed appeals that address each payer's requirements. For families navigating Cigna's prior authorization process in Michigan, we provide the clinical documentation and procedural expertise needed to maximize approval chances and minimize delays.

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 plan terms, medical circumstances, and payer policies. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals or coverage questions, contact Michigan DIFS at 877-999-6442.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.