By Counterforce Health Team in Amondys 45 (casimersen) —

How to Get Amondys 45 (casimersen) Covered by Cigna in California: Complete Prior Authorization, Appeals, and Forms Guide

Answer Box: Getting Amondys 45 Covered by Cigna in California

Cigna covers Amondys 45 (casimersen) for Duchenne muscular dystrophy patients under 14 years old with confirmed exon 45-amenable gene mutations, but requires prior authorization via Coverage Policy IP0137. Fastest path: Have your neuromuscular specialist submit genetic test results showing "exon 45 skipping amenable" mutation, recent 6-minute walk test (≥300 meters), and forced vital capacity ≥50% through Cigna's provider portal or CoverMyMeds. Standard approval takes 5-10 business days; expedited reviews complete in 24-72 hours. If denied, California residents can appeal internally within 180 days, then request Independent Medical Review through the DMHC—which is free and binding on Cigna.

Table of Contents

  1. Plan Types & Network Requirements
  2. Formulary Status & Coverage Criteria
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup
  5. Cost-Share Basics
  6. Submission Process
  7. Appeals Process in California
  8. Common Denial Reasons & Solutions
  9. FAQ

Plan Types & Network Requirements

Cigna HMO vs PPO Coverage Differences

In California, Cigna offers both HMO and PPO plans with different network requirements that can impact your access to Amondys 45:

Cigna HMO (Cigna HealthCare of California, Inc.):

  • Must use in-network providers and assigned medical group
  • Requires PCP referrals for specialist care
  • Prior authorization flows through your medical group
  • No out-of-network coverage except emergencies

Cigna PPO (Cigna Health and Life Insurance Company):

  • Can see any in-network provider without referrals
  • Out-of-network options available at higher cost
  • Direct specialist access for prior authorization
  • More flexibility but higher premiums
Note: Both plan types require prior authorization for Amondys 45, but the coordination process differs. HMO members work through their assigned medical group, while PPO members can have any contracted specialist submit the request.

Network Provider Requirements

For Amondys 45 infusions, you'll need access to:

  • Neuromuscular specialist (required for prescribing and monitoring)
  • Infusion center (home infusion preferred; outpatient hospital acceptable)
  • Accredo specialty pharmacy (Cigna's contracted partner)

Verify your providers are in-network before starting treatment by calling Cigna member services or checking the online provider directory.

Formulary Status & Coverage Criteria

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all patients Cigna Policy IP0137
Age Limit Under 14 years at therapy start Policy IP0137
Genetic Testing Confirmed exon 45-amenable DMD mutation Policy IP0137
Ambulatory Status ≥300 meters on 6-minute walk test Policy IP0137
Pulmonary Function Forced vital capacity ≥50% Policy IP0137
Specialist Care Neurologist or neuromuscular specialist Policy IP0137
Specialty Pharmacy Accredo required Cigna Specialty Pharmacy

Formulary Tier Placement

Amondys 45 is typically placed on Cigna's highest specialty tier, requiring:

  • Prior authorization approval
  • Specialty pharmacy dispensing
  • Higher coinsurance (usually 20-40% after deductible)

The drug is covered under the medical benefit for infusions rather than the pharmacy benefit, which may affect your out-of-pocket costs.

Prior Authorization Requirements

Required Documentation Checklist

Genetic Testing (Critical):

  • CLIA-certified lab report explicitly stating "amenable to exon 45 skipping therapy"
  • Comprehensive DMD gene analysis showing deletions/duplications
  • Report must confirm mutation restores reading frame with exon 45 skipping

Clinical Assessments (Within 30 Days):

  • 6-minute walk test results (must show ≥300 meters)
  • North Star Ambulatory Assessment (NSAA) scores
  • Forced vital capacity percentage
  • Current weight in kilograms for dosing calculations

Laboratory Results:

  • Serum cystatin C and creatinine levels
  • Urinalysis with protein/creatinine ratio
  • Any other relevant monitoring labs

Clinical Documentation:

  • Neuromuscular specialist consultation notes
  • Prior therapy history and outcomes
  • Current disease stage and functional status
  • Treatment goals and monitoring plan

Clinician Corner: Medical Necessity Letter

For Healthcare Providers: Your medical necessity letter should address:Problem Statement: Patient's specific DMD mutation and current functional declinePrior Treatments: Corticosteroids, physical therapy, other supportive care attemptedClinical Rationale: Why exon 45 skipping is appropriate based on genetic profileEvidence Base: Reference FDA approval and clinical trial data supporting efficacyMonitoring Plan: Regular assessments of ambulation, pulmonary function, and safety labsDosing Justification: 30 mg/kg weekly based on patient's current weight

Specialty Pharmacy Setup

Accredo Enrollment Process

Once prior authorization is approved, Cigna requires use of Accredo specialty pharmacy:

  1. Prescription Submission: Your doctor sends the prescription to Accredo via fax, phone (800-803-2523), or electronic prescribing
  2. Benefits Verification: Accredo confirms coverage and calculates your out-of-pocket costs
  3. Patient Enrollment: Complete intake forms and provide insurance information
  4. Infusion Coordination: Accredo arranges home infusion services or coordinates with your preferred outpatient center
  5. Delivery Setup: Medication ships free with temperature monitoring and tracking

Home Infusion Benefits

Accredo's home infusion program offers several advantages:

  • Nurse-administered infusions in your home
  • 24/7 pharmacist and nurse support
  • Automatic refill coordination
  • Cost savings of 40-60% compared to hospital outpatient
  • Patient satisfaction rates above 97%

The first infusion typically takes 1-2 hours with safety monitoring, while subsequent infusions are usually completed in 35-60 minutes.

Cost-Share Basics

Understanding Your Out-of-Pocket Costs

Amondys 45 costs vary significantly based on your specific Cigna plan:

Typical Cost Structure:

  • Deductible: May apply before coverage begins
  • Coinsurance: Usually 20-40% of the negotiated rate
  • Out-of-pocket maximum: Annual cap on your total costs

Financial Assistance Options:

  • Sarepta Patient Support Program: May help with copays and deductibles
  • Chronic Disease Fund: Grants for eligible patients
  • State pharmaceutical assistance programs: California-specific options
Important: These are educational examples only. Your actual costs depend on your specific plan design and cannot be determined without reviewing your individual benefits.

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Family): Call Cigna member services to confirm Amondys 45 coverage and Accredo requirement
  2. Gather Documentation (Specialist Office): Collect genetic testing, recent functional assessments, and clinical notes
  3. Submit Prior Authorization (Specialist): Use CoverMyMeds, Cigna provider portal, or fax with complete documentation packet
  4. Track Status (Office Staff): Monitor submission through online portal or by calling Cigna
  5. Coordinate Accredo (Post-Approval): Contact Accredo at 800-803-2523 to initiate specialty pharmacy services
  6. Schedule Infusion (Patient/Family): Work with Accredo to arrange home infusion or outpatient center
  7. Begin Treatment (All): First infusion with nurse monitoring and safety protocols

Forms and Portals

Primary Submission Methods:

  • CoverMyMeds: Electronic prior authorization platform (preferred)
  • Cigna Provider Portal: Direct submission through Cigna's online system
  • Fax Submission: Use plan-specific fax number on prior authorization form

Required Forms:

  • Cigna Pharmacy Prior Authorization Form
  • Accredo Prescription/Enrollment Form (post-approval)

Download current forms from Cigna's provider resource library to ensure you have the latest version.

Appeals Process in California

Internal Appeals with Cigna

If your initial prior authorization is denied, you have strong appeal rights in California:

Timeline: File within 1 year of denial notice Decision: Cigna must respond within 30 calendar days (72 hours for expedited) Requirements: Submit new evidence, medical records, and physician narrative

How to File:

Recent Development: In October 2025, the California Department of Managed Health Care fined Cigna $500,000 for denying claims without proper physician clinical reviews, strengthening your position in appeals for complex cases like DMD.

Independent Medical Review (IMR)

California residents have access to free, binding external review through the Department of Managed Health Care:

Eligibility: Available after final internal denial for medical necessity determinations Timeline: Request within 6 months of final Cigna denial Decision: Independent medical experts decide within 60-90 days Cost: Free to patients; binding on Cigna

How to Request IMR:

  1. Receive final denial letter from Cigna with IMR instructions
  2. Complete IMR application at dmhc.ca.gov
  3. Submit medical records and physician support letter
  4. DMHC assigns independent expert for review

Success Factors for DMD Cases:

  • Emphasize rare disease status under California's AB 2251 (Kate's Law)
  • Include genetic confirmation and FDA approval documentation
  • Provide specialist letter explaining medical necessity
  • Reference clinical trial data and treatment guidelines

When to Escalate

Contact the DMHC Help Center at 1-888-466-2219 if:

  • Cigna fails to meet appeal deadlines
  • You need assistance filing an IMR
  • Your health plan isn't following proper procedures

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Missing genetic testing Submit CLIA-certified report with exact "exon 45 skipping amenable" language
Incomplete functional data Provide recent 6-minute walk test and NSAA scores showing ambulatory status
Age criteria not met Confirm patient was under 14 at therapy initiation; submit birth certificate if needed
Insufficient specialist involvement Include consultation notes from neurologist or neuromuscular specialist
Dosing concerns Recalculate 30 mg/kg weekly dose based on current weight; justify any variations
Site of care issues Document why home infusion or specific outpatient center is medically appropriate

Scripts for Common Situations

Patient Phone Script for Cigna: "I'm calling about prior authorization for Amondys 45 for my child with Duchenne muscular dystrophy. Can you confirm this medication is covered under our plan and provide the current prior authorization form? I also need to verify that Accredo is our required specialty pharmacy."

Peer-to-Peer Request Script: "I'm requesting a peer-to-peer review for a denied Amondys 45 prior authorization. The patient has confirmed exon 45-amenable DMD with documented functional decline. I have additional clinical data that supports medical necessity under your Coverage Policy IP0137."

FAQ

How long does Cigna prior authorization take for Amondys 45? Standard reviews take 5-10 business days, while expedited requests for urgent cases are decided within 24-72 hours. Submit complete documentation to avoid delays.

What if Amondys 45 is not on my Cigna formulary? The drug should be covered under Cigna's specialty formulary per Policy IP0137. If it appears non-formulary, request a formulary exception with medical necessity documentation.

Can I get an expedited appeal in California? Yes, if the delay could seriously jeopardize your health. Cigna must decide expedited appeals within 72 hours, and expedited IMR decisions come within 72 hours to 7 days.

Does step therapy apply to Amondys 45? Step therapy requirements are not specified in current Cigna policies for exon 45 skipping therapy, as no alternative exon 45-specific treatments exist.

What happens if I move from California to another state? Appeal rights and timelines may change based on your new state's insurance regulations. Contact your new state insurance department for specific external review processes.

How much will Amondys 45 cost with Cigna coverage? Costs vary by plan design but typically include deductible and coinsurance of 20-40%. Contact Cigna member services and explore Sarepta's patient assistance programs for specific estimates.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies, then creates point-by-point rebuttals aligned to each payer's specific rules and requirements.

When navigating complex prior authorizations like Amondys 45, having expert support can make the difference between approval and denial. Counterforce Health's system pulls the right clinical evidence and weaves it into appeals that meet procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with California insurance issues, contact the DMHC Help Center at 1-888-466-2219.

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