By Counterforce Health Team in Amondys 45 (casimersen) —

How to Get Amondys 45 (Casimersen) Covered by Cigna in Pennsylvania: Complete Appeals Guide with Forms and Timelines

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

Fastest path to approval: Submit prior authorization through Cigna's provider portal or call 1-800-882-4462 with genetic testing confirming exon 45-amenable DMD mutation, specialist prescription, and infusion plan. If denied, file internal appeal within 60 days, then Pennsylvania external review within 4 months through pa.gov. First step today: Contact your neuromuscular specialist to order comprehensive DMD genetic testing if not already completed.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all specialty drugs Cigna provider portal or call 1-800-882-4462 Cigna PA Requirements
Genetic Testing DMD mutation amenable to exon 45 skipping Lab report from certified genetics lab FDA Amondys 45 Label
Specialist Prescription Neuromuscular or genetics specialist Provider credentials in Cigna network Cigna Provider Directory
Infusion Plan Weekly IV protocol with monitoring Clinic or home infusion documentation Sarepta Dosing Guide
Internal Appeal Deadline 60 days from denial Cigna member portal or mail Cigna Appeals Process
PA External Review 4 months from final denial Pennsylvania Insurance Department PA External Review

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Eligibility (Patient/Family + Specialist)

What you need: Comprehensive DMD genetic testing showing exon 45-amenable mutation. Approximately 9% of DMD patients worldwide have mutations suitable for exon 45 skipping. Timeline: 2-4 weeks for genetic testing results Action: Request full DMD gene sequencing and deletion/duplication analysis from a certified lab

2. Gather Clinical Documentation (Specialist)

Required documents:

  • DMD diagnosis confirmation with ICD-10 code
  • Genetic test report showing exon 45-amenable mutation
  • Previous therapy trials and outcomes (steroids, other DMD treatments)
  • Current functional assessments and treatment goals Timeline: 1-2 weeks to compile records

3. Submit Prior Authorization (Specialist Office)

How to submit:

  • Electronic: CoverMyMeds, ExpressPAth, or Cigna provider portal
  • Phone: 1-800-882-4462
  • Include all documentation from Step 2 Timeline: 72 hours for standard review, 24 hours for expedited

4. Monitor Authorization Status (Patient + Specialist)

Check status: Cigna member portal or call customer service number on your ID card If approved: Coordinate with specialty pharmacy (typically Accredo) for drug delivery and infusion scheduling If denied: Proceed immediately to Step 5

5. File Internal Appeal if Denied (Patient or Specialist)

Deadline: 60 days from denial notice Submit via: Cigna appeals portal or mail with additional clinical evidence Timeline: 30 days for decision (15 days for expedited)

6. Request Pennsylvania External Review (Patient)

Eligibility: After final internal denial from Cigna Deadline: 4 months from final denial letter Submit: PA Insurance Department online portal Timeline: 45 days for standard review, 72 hours for expedited

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Genetic testing not provided" Submit comprehensive DMD gene analysis Lab report showing specific exon 45-amenable mutation
"Not medically necessary" Provide specialist letter with clinical rationale Treatment history, functional decline, specialist attestation
"Experimental/investigational" Cite FDA accelerated approval status FDA approval letter, peer-reviewed studies
"Site of care restriction" Document medical necessity for requested setting Infusion center capacity, patient access limitations
"Quantity limits exceeded" Justify weight-based dosing (30 mg/kg weekly) Patient weight, dosing calculations, prescribing information

Appeals Playbook for Pennsylvania

Internal Appeals with Cigna

First Level Appeal:

  • Deadline: 60 days from denial
  • Submit: Cigna member portal, mail, or fax
  • Timeline: 30 days for decision (15 days expedited)
  • Required: Denial letter, additional clinical evidence, specialist support letter

Second Level Appeal (if available):

  • Deadline: 60 days from first appeal denial
  • Process: Same as first level with new evidence
  • Timeline: 30 days for decision

Pennsylvania External Review

Pennsylvania's Independent External Review Program has shown strong results for patients, with approximately 50% of appeals overturning initial denials in its first year.

Process:

  1. Eligibility Check: Must have final adverse determination from Cigna
  2. Submit Request: PA Insurance Department portal within 4 months
  3. IRO Assignment: Independent Review Organization assigned within 1 business day
  4. Additional Evidence: 15 days to submit supporting materials
  5. Decision: 45 days for standard, 72 hours for expedited
  6. Binding Result: Cigna must comply with favorable decisions immediately

Contact for Help: Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 or [email protected]

Medical Necessity Letter Checklist

Essential Elements for Specialists

Patient Information:

  • Confirmed DMD diagnosis with ICD-10 code
  • Age, weight, and functional status
  • Genetic testing results showing exon 45-amenable mutation

Clinical Rationale:

  • Previous DMD therapies tried and outcomes
  • Current disease progression and functional decline
  • Expected benefits from exon 45 skipping therapy
  • Contraindications to alternative treatments

Treatment Plan:

  • Weekly IV infusion protocol (30 mg/kg)
  • Monitoring plan for renal function and hypersensitivity
  • Site of care justification (clinic vs. home infusion)

Supporting Evidence:

  • FDA prescribing information for Amondys 45
  • Relevant clinical studies on exon 45 skipping
  • DMD treatment guidelines from neuromuscular societies
From our advocates: We've seen the strongest approvals when specialists include a clear timeline showing the patient's functional decline alongside genetic confirmation of exon 45 eligibility. One effective approach is creating a simple table showing motor milestones lost over time, paired with the genetic report highlighting the specific mutation that makes exon 45 skipping appropriate.

Patient and Family Support Resources

Financial Assistance:

  • Sarepta Therapeutics Patient Access - copay assistance and foundation grants
  • Counterforce Health - helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific rules

Pennsylvania-Specific Help:

DMD Community Resources:

  • Parent Project Muscular Dystrophy - advocacy and support
  • CureDuchenne - research updates and family connections
  • Muscular Dystrophy Association - local support groups in Pennsylvania

FAQ: Cigna and Amondys 45 in Pennsylvania

Q: How long does Cigna prior authorization take for Amondys 45? A: Standard reviews take 72 hours, expedited reviews take 24 hours. Cigna processes these through Express Scripts/Accredo specialty pharmacy networks.

Q: What if Amondys 45 is not on Cigna's formulary? A: Request a formulary exception through your specialist. Cigna reviews these within 72 hours and may approve based on medical necessity and lack of formulary alternatives.

Q: Can I get an expedited appeal if my child is declining rapidly? A: Yes. Both Cigna internal appeals and Pennsylvania external reviews offer expedited timelines (15 days internal, 72 hours external) for urgent medical situations.

Q: Does step therapy apply if we've already tried other DMD treatments? A: Document all previous therapies with your specialist. Cigna may waive step therapy requirements if you've already tried and failed standard DMD treatments under any health plan.

Q: What genetic testing labs does Cigna typically accept? A: Cigna generally accepts results from any CLIA-certified laboratory. Ensure the report specifically identifies the DMD mutation and confirms amenability to exon 45 skipping.

Q: How much does Amondys 45 cost if not covered? A: Cash prices can exceed $300,000 annually. Always pursue insurance coverage and manufacturer assistance programs rather than paying out-of-pocket.

Q: Can Counterforce Health help with my Cigna appeal? A: Yes. Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing your specific denial letter, Cigna's policy requirements, and clinical notes to create evidence-backed rebuttals that address each payer's unique criteria.

Q: What happens if Pennsylvania's external review rules in my favor? A: Cigna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Pennsylvania insurance regulations and Cigna policies may change; verify current requirements through official sources linked above.

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