By Counterforce Health Team in Amondys 45 (casimersen) —

How to Get Amondys 45 (Casimersen) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Amondys 45 (Casimersen) Covered by Cigna in Michigan

Cigna requires prior authorization for Amondys 45 with genetic confirmation of exon 45 skipping amenability, specialist prescription, and ambulatory status documentation. Submit through CoverMyMeds or Cigna's provider portal with complete genetic testing from a CLIA-certified lab. Standard approval takes 72 hours; expedited review is 24 hours. If denied, file internal appeal within 180 days, then Michigan DIFS external review within 127 days. First step today: Have your neuromuscular specialist gather genetic testing, recent 6-minute walk test, and weight-based dosing plan for PA submission.

Table of Contents

  1. Cigna's Coverage Policy for Amondys 45
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Quantity Limits and Dosing Rules
  5. Required Diagnostic Documentation
  6. Specialty Pharmacy and Site of Care
  7. Evidence to Support Medical Necessity
  8. Prior Authorization Step-by-Step
  9. Appeals Process in Michigan
  10. Common Denial Reasons and Solutions
  11. Cost Assistance Options
  12. FAQ

Cigna's Coverage Policy for Amondys 45

Cigna classifies Amondys 45 (casimersen) as a specialty medication requiring prior authorization across all plan types—commercial, Medicare Advantage, and Medicaid managed care plans in Michigan. The drug is typically managed through Express Scripts/Accredo specialty pharmacy for distribution and infusion coordination.

Plan Type Coverage Differences:

  • Commercial/ACA Plans: Follow Cigna's standard prior authorization criteria with 72-hour standard review
  • Medicare Part D: Use Medicare's 72-hour timeline for drug exceptions with 24-hour expedited review
  • Medicaid: May have additional state-specific requirements through Michigan's Medicaid program

All Cigna plans in Michigan require the same core medical necessity criteria, but appeal processes vary by plan type.

Medical Necessity Requirements

FDA-Approved Indication

Amondys 45 received FDA accelerated approval for treating Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 45 skipping. Cigna's medical policy aligns with this narrow indication.

Required Elements:

  • Diagnosis: Confirmed DMD with ICD-10 code G71.01
  • Genetic Testing: CLIA-certified laboratory report explicitly documenting exon 45 skipping amenability
  • Age Requirement: Patient must be ambulatory at treatment initiation
  • Specialist Care: Prescription from neuromuscular or genetics specialist

Off-Label Use Considerations

Cigna rarely approves off-label use of Amondys 45. Any off-label request requires extensive peer-reviewed literature demonstrating efficacy and safety for the specific genetic mutation or clinical scenario.

Step Therapy and Exceptions

Cigna may require documentation of standard DMD therapies before approving Amondys 45, including:

  • Corticosteroids (prednisone, deflazacort)
  • Other exon-skipping therapies if applicable to the patient's mutation
  • Supportive care documentation (physical therapy, cardiac monitoring)

Medical Exception Pathways

Step therapy can be bypassed if your specialist documents:

  • Contraindications to required step therapies
  • Previous failure or intolerance with specific dates and adverse events
  • Clinical urgency where delay would cause irreversible progression

Quantity Limits and Dosing Rules

Standard Dosing: 30 mg/kg IV once weekly over 35-60 minutes

Quantity Limits: Cigna calculates weekly dose based on current weight in kilograms. Claims exceeding this calculation require additional authorization.

Renewal Requirements:

  • Every 6 months: Updated weight and functional assessments
  • Annual review: Complete reassessment including 6-minute walk test and specialist evaluation

Required Diagnostic Documentation

Genetic Testing Requirements

The most critical requirement is genetic confirmation from a CLIA-certified laboratory. The report must explicitly state the patient's mutation is "amenable to exon 45 skipping therapy."

Baseline Laboratory Values

Required Tests:

  • Serum cystatin C and creatinine (renal function)
  • Urinalysis with protein/creatinine ratio
  • Current weight in kilograms
  • Pulmonary function tests (FVC%)

Timing: All labs must be within 30 days of PA submission.

Functional Assessments

  • 6-Minute Walk Test: Recent results demonstrating ambulatory status
  • North Star Ambulatory Assessment (if available)
  • Rise time from floor measurements

Specialty Pharmacy and Site of Care

Accredo Specialty Pharmacy

Cigna typically requires Amondys 45 to be dispensed through Accredo, their contracted specialty pharmacy. Accredo coordinates:

  • Drug shipment to infusion site
  • Nursing services for home infusion
  • Prior authorization management
  • Renal monitoring coordination

Site of Care Requirements

Preferred Sites (in order of preference):

  1. Home infusion with nursing support
  2. Physician office infusion center
  3. Free-standing ambulatory infusion center

Hospital Outpatient: Generally requires medical necessity documentation such as:

  • First 4 infusions (initiation period)
  • History of severe infusion reactions
  • Clinical instability requiring higher-level monitoring
  • Complex comorbidities

Evidence to Support Medical Necessity

Key Clinical Guidelines

Reference these authoritative sources in your medical necessity letter:

  • FDA Label: Approved indication and dosing
  • Muscular Dystrophy Association Care Guidelines: Standard of care recommendations
  • Parent Project Muscular Dystrophy: Treatment pathway guidance

Peer-Reviewed Literature

Include citations demonstrating:

  • Dystrophin upregulation in patients with exon 45 mutations
  • Functional improvements in ambulatory DMD patients
  • Safety profile in the target population
Clinician Corner: Medical Necessity Letter Checklist

✓ DMD diagnosis with ICD-10 G71.01
✓ Genetic testing report with explicit exon 45 amenability
✓ Current ambulatory status with functional testing
✓ Prior therapy history (corticosteroids, other treatments)
✓ Weight-based dosing calculation (30 mg/kg weekly)
✓ Renal monitoring plan
✓ Infusion site preference with clinical justification

Prior Authorization Step-by-Step Process

Step 1: Gather Required Documentation

Who: Clinic staff and specialist
Timeline: 1-2 weeks before PA submission
Documents needed:

  • Genetic testing report (CLIA-certified)
  • Recent clinic notes (within 30 days)
  • Functional assessments (6MWT, NSAA)
  • Laboratory results (renal function, urinalysis)
  • Prior therapy documentation

Step 2: Submit Prior Authorization

Who: Prescribing specialist or clinic
How: CoverMyMeds, ExpressPAth, or Cigna provider portal
Include: Complete documentation packet with weight-based dosing plan

Step 3: Track Submission

Timeline: 72 hours for standard review, 24 hours for expedited
Action: Follow up if no response within expected timeframe
Contact: Cigna provider services at 1-800-882-4462

Step 4: Coordinate with Accredo

When: After PA approval
Action: Confirm specialty pharmacy enrollment and infusion site coordination

Appeals Process in Michigan

Internal Appeal (Level 1)

Deadline: 180 days from denial notice
Timeline: Cigna responds within 30 days (72 hours for expedited)
Required: Additional clinical evidence addressing denial reasons

Michigan External Review

If internal appeal is denied, Michigan residents can file for external review through the Michigan Department of Insurance and Financial Services (DIFS).

Key Details:

  • Deadline: 127 days after final internal denial
  • Timeline: 60 days for standard review, 72 hours for expedited
  • Cost: Free for consumers
  • Decision: Binding on Cigna

How to File:

  • Online: DIFS External Review Request form
  • Phone: 877-999-6442
  • Email/Fax: Submit paper form with supporting documentation
From Our Advocates

We've seen Michigan families successfully overturn Cigna denials for rare disease medications by submitting comprehensive genetic testing documentation and specialist letters emphasizing irreversible disease progression risks. The key is addressing every denial reason with specific clinical evidence and peer-reviewed support.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing genetic confirmation Submit CLIA-certified genetic testing Laboratory report stating "exon 45 skipping amenable"
Not ambulatory Provide recent functional testing 6-minute walk test, NSAA scores, rise time
Insufficient prior therapy Document step therapy trials Medication history with dates, doses, outcomes
Wrong site of care Justify infusion location Clinical letter explaining medical necessity
Dosing exceeds policy Recalculate based on current weight Updated weight with 30 mg/kg calculation

Cost Assistance Options

Manufacturer Support

  • Sarepta Cares: Patient assistance program for eligible families
  • Copay assistance: May reduce out-of-pocket costs for commercial insurance

Foundation Grants

  • Patient Advocate Foundation: Copay relief program
  • HealthWell Foundation: Rare disease medication assistance
  • National Organization for Rare Disorders (NORD): Patient assistance programs

Michigan State Programs

Contact Michigan Medicaid for potential coverage if eligible for state programs.

FAQ

How long does Cigna prior authorization take for Amondys 45 in Michigan? Standard review is 72 hours; expedited review is 24 hours when medical urgency is documented.

What if Amondys 45 is not on my Cigna formulary? Request a formulary exception with your specialist documenting medical necessity and why covered alternatives are inappropriate.

Can I get expedited review for my appeal? Yes, if your doctor certifies that delay would seriously jeopardize your health or cause irreversible harm.

Does Michigan have special protections for rare disease appeals? Michigan's 127-day external review deadline is longer than the federal 120-day standard, providing extra time to file.

What happens if Cigna misses the 72-hour deadline? File a complaint with Michigan DIFS for procedural violations and timeline enforcement.

How much does Amondys 45 cost without insurance? Cash prices show approximately $1,570.78 for a 2 mL vial (100 mg), though actual costs vary by pharmacy and patient weight.

When to Contact Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. If your Amondys 45 prior authorization is denied by Cigna, our platform can help draft a point-by-point rebuttal aligned to Cigna's specific coverage criteria, pulling the right clinical evidence and weaving it into a compelling appeal that meets Michigan's procedural requirements.

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 plan for specific coverage decisions. Coverage policies may vary by plan and change over time.

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