By Counterforce Health Team in Amondys 45 (casimersen) —

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

Answer Box: Getting Amondys 45 Covered by Cigna in New York

Eligibility: Amondys 45 (casimersen) requires Cigna prior authorization for patients with DMD and genetic confirmation of exon 45 skipping amenability. Fastest path: Submit complete PA with CLIA-certified genetic testing, specialist prescription, and current weight-based dosing plan through Cigna provider portal. First step today: Contact your neuromuscular specialist to order comprehensive DMD genetic testing if not already available. New York patients have strong appeal rights through the state's external review system if initially denied.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Checklist
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Common Denial Reasons & Solutions
  10. Appeals Process for New York Patients
  11. Quick Reference Checklist
  12. FAQ

Who Should Use This Guide

This guide is designed for:

  • Patients with Duchenne muscular dystrophy (DMD) who need Amondys 45 and have Cigna coverage in New York
  • Clinicians preparing prior authorization requests for casimersen
  • Families navigating insurance denials and appeals

Expected outcome: With complete documentation meeting Cigna's clinical criteria, most prior authorizations are approved within 72 hours. If denied, New York's external appeal system has a 50-70% success rate for well-documented rare disease appeals.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage with medical benefits (not pharmacy-only plans)
  • Prior authorization required for all Amondys 45 prescriptions
  • Specialty pharmacy routing through Accredo (Express Scripts network)
  • Medical benefit billing only (never pharmacy benefit)
Note: Verify your specific plan's formulary status and any quantity limits by calling Cigna member services at 1-800-244-6224.

Clinical Criteria Checklist

Essential Requirements

Requirement Details Source
Genetic Testing CLIA-certified lab report confirming DMD mutation amenable to exon 45 skipping Cigna Policy
Specialist Prescription Neuromuscular specialist, neurologist, or MDA clinic provider Cigna Policy
Ambulatory Status Patient must be ambulatory at treatment initiation Cigna Policy
Baseline Labs Renal function (serum cystatin C, urinalysis, protein/creatinine ratio) FDA Label
Weight Documentation Current weight in kg for dosing calculation (30 mg/kg weekly) Cigna Policy

Step Therapy Considerations

Cigna may require documentation of prior DMD therapies, including:

  • Corticosteroids (prednisone, deflazacort)
  • Previous exon-skipping agents (if applicable)
  • Rationale for therapy selection

Coding Requirements

Diagnosis Code

  • ICD-10: G71.01 (Duchenne or Becker muscular dystrophy)

Procedure Code

  • HCPCS: J1426 (Injection, casimersen, 10 mg)
  • Unit calculation: (Patient weight in kg × 30 mg/kg) ÷ 10 = units per dose

NDC Information

Verify current 11-digit NDC with Accredo for accurate billing submission.

Documentation Packet

Provider Letter of Medical Necessity Must Include:

  1. Patient identification with member ID and ICD-10 code G71.01
  2. Genetic testing results with specific exon 45 amenability confirmation
  3. Clinical assessment including:
    • DMD diagnosis confirmation
    • Current ambulatory status
    • Recent 6-minute walk test results
    • Pulmonary function tests (FVC%)
    • Current weight and vital signs
  4. Treatment history documenting prior DMD therapies and outcomes
  5. Dosing plan with weight-based calculation and infusion schedule
  6. Safety monitoring plan including renal function surveillance

Required Attachments:

  • Complete genetic testing report from CLIA-certified laboratory
  • Recent clinic notes (within 30 days)
  • Baseline laboratory results
  • Functional assessment documentation
  • Prior therapy records
Clinician Corner: Reference Cigna's specific policy language in your letter. Include peer-reviewed literature supporting exon 45 skipping therapy and cite FDA labeling requirements for safety monitoring.

Submission Process

Step-by-Step Submission

  1. Gather documentation (allow 1-2 weeks for genetic testing if needed)
  2. Complete Cigna PA form via provider portal or call 1-800-882-4462
  3. Submit complete packet with all required attachments
  4. Coordinate with Accredo for medication fulfillment
  5. Track submission with confirmation number
  6. Follow up within 72 hours if no response received

Submission Methods:

  • Primary: Cigna provider portal (fastest processing)
  • Alternative: Fax to designated PA number (verify current fax with Cigna)
  • Phone: 1-800-882-4462 for urgent submissions

Specialty Pharmacy Coordination

Accredo Requirements

Counterforce Health helps streamline the complex process of getting specialty medications like Amondys 45 approved by turning insurance denials into targeted, evidence-backed appeals that align with each plan's specific requirements.

  • Enrollment: Patient must be enrolled with Accredo before first shipment
  • Home infusion: Available for qualified patients with nursing support
  • Site of care: Must justify medical necessity if requiring hospital outpatient setting
  • Coordination: Accredo handles PA submission and ongoing refill management

After Submission: What to Expect

Timeline Expectations

  • Standard review: 72 hours
  • Expedited review: 24 hours (with medical urgency justification)
  • Additional information requests: 5-10 business days for response

Status Monitoring

  • Check portal daily for updates
  • Document all communication with reference numbers
  • Maintain contact with Accredo case manager

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Insufficient genetic documentation Submit complete CLIA lab report Genetic test explicitly stating exon 45 amenability
Medical necessity not established Provide detailed clinical rationale Specialist letter with disease progression data
Missing baseline assessments Complete required testing Recent labs, functional tests, weight documentation
Site of care issues Justify infusion location Medical necessity for specific infusion setting
Step therapy not met Document prior treatments Records of previous DMD therapies and outcomes

Appeals Process for New York Patients

New York provides robust patient protections for insurance appeals, with one of the most comprehensive external review systems in the nation.

Internal Appeals (First Level)

  • Timeline: 60 days from denial notice
  • Process: Submit through Cigna member portal or mail
  • Documentation: Include all supporting clinical evidence
  • Response time: 30 days (15 days for expedited)

External Review (New York DFS)

If internal appeal is denied, New York patients can request external review through the Department of Financial Services.

  • Timeline: 4 months from final internal denial
  • Cost: Maximum $25 (waived for financial hardship)
  • Process: Independent medical expert review
  • Success rate: 50-70% for well-documented rare disease appeals
  • Expedited option: 72 hours for urgent cases
From our advocates: We've seen cases where initial Cigna denials for Amondys 45 were overturned on external review when families provided comprehensive genetic documentation and detailed specialist letters addressing each coverage criterion. The key is ensuring every piece of clinical evidence directly supports the medical necessity argument.

Filing External Appeal

  1. Complete DFS form available at NY DFS Portal
  2. Attach all documentation including denial letters and medical records
  3. Submit within deadline (4 months from final internal denial)
  4. Free assistance available through Community Health Advocates: 888-614-5400

When dealing with complex prior authorization requirements, Counterforce Health specializes in creating comprehensive appeals that address each payer's specific criteria while incorporating the latest clinical evidence and regulatory requirements.

Quick Reference Checklist

Before Submitting PA:

  • Genetic testing confirms exon 45 skipping amenability
  • Specialist prescription from neuromuscular provider
  • Current weight documented for dosing calculation
  • Baseline renal function labs completed
  • Patient ambulatory status confirmed
  • Prior DMD therapy history documented
  • Accredo enrollment initiated

After Denial:

  • Internal appeal filed within 60 days
  • All supporting documentation included
  • External review option preserved (4-month deadline)
  • Patient advocacy resources contacted if needed

FAQ

How long does Cigna prior authorization take for Amondys 45 in New York? Standard review is 72 hours; expedited review is 24 hours with medical urgency justification. Complex cases may require additional information, extending the timeline.

What if Amondys 45 is not on my Cigna formulary? Request a formulary exception with detailed medical necessity documentation. Cigna typically reviews these requests within 72 hours.

Can I appeal if my child loses ambulatory function during treatment? Yes. Continued medical necessity can be established based on slowing disease progression, maintaining respiratory function, or other clinical benefits documented by your specialist.

Does step therapy apply to Amondys 45? Cigna may require documentation of prior corticosteroid therapy or other DMD treatments, but specific step therapy requirements vary by plan.

How do I request an expedited appeal in New York? Contact Cigna member services and provide medical documentation of urgency. New York also offers expedited external appeals for urgent medical needs.

What genetic testing is acceptable to Cigna? CLIA-certified laboratory reports that specifically identify DMD mutations amenable to exon 45 skipping. Generic DMD diagnosis statements are insufficient.

Can I use a different specialty pharmacy besides Accredo? Most Cigna plans require Accredo for specialty medications like Amondys 45. Contact member services to confirm your plan's requirements.

What happens if I move to another state during treatment? Coverage continues under the same Cigna plan, but state-specific appeal rights may change. Contact member services about maintaining continuity of care.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and is not medical advice. Coverage decisions depend on individual plan benefits and medical circumstances. Consult your healthcare provider for medical guidance and contact Cigna member services for plan-specific information. For free assistance with appeals in New York, contact Community Health Advocates at 888-614-5400.

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