By Counterforce Health Team in Amondys 45 (casimersen) —

How to Get Amondys 45 (casimersen) Covered by Aetna (CVS Health) in California: Complete Requirements Guide 2025

Answer Box: Getting Amondys 45 Covered by Aetna (CVS Health) in California

Fastest path to approval: Submit Aetna's precertification form with genetic test results confirming exon 45 amenable mutation, 6-minute walk test showing ≥300 meters, and specialist documentation before age 14. First step today: Call Aetna at 1-866-752-7021 to verify your plan's current prior authorization requirements and confirm CVS Specialty as your designated pharmacy. If denied, California's Independent Medical Review (IMR) provides binding external appeal through DMHC with no patient cost and 45-day resolution.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Billing Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. CVS Specialty Pharmacy Coordination
  8. After Submission: Tracking and Follow-up
  9. Common Denial Reasons & How to Fix Them
  10. California Appeals Process
  11. Costs and Financial Assistance
  12. FAQ

Who Should Use This Guide

This guide helps patients with Duchenne muscular dystrophy (DMD) and their healthcare teams navigate Aetna (CVS Health) prior authorization for Amondys 45 (casimersen) in California. You'll need this if:

  • Your child has DMD with a confirmed genetic mutation amenable to exon 45 skipping
  • You have Aetna coverage (including Medicare Advantage) in California
  • Your doctor wants to prescribe Amondys 45 but needs insurance approval first
  • You've received a denial and need to appeal

Expected outcome: With complete documentation, most approvals take 30-45 days. If denied, California's robust appeal system gives you strong options for reversal.

Member & Plan Basics

Coverage Requirements

  • Active Aetna coverage with prescription benefits through CVS Caremark
  • Prior authorization required for all Amondys 45 prescriptions
  • Most plans classify Amondys 45 as specialty tier with higher cost-sharing
  • Age requirement: Treatment must begin before the patient's 14th birthday

Plan Type Considerations

  • HMO plans: May require specialist referral before prior authorization
  • PPO plans: Can typically submit PA directly from any qualified specialist
  • Medicare Advantage: Uses separate forms and may have additional documentation requirements
Tip: Call Aetna member services at 1-866-752-7021 to confirm your specific plan's requirements and verify CVS Specialty as your designated pharmacy.

Clinical Criteria for Approval

Aetna requires strict adherence to these clinical criteria based on FDA approval parameters:

Core Requirements

  1. Genetic confirmation: DMD gene mutation specifically amenable to exon 45 skipping
  2. Age limit: Treatment initiation before 14th birthday
  3. Functional status: Ability to walk independently ≥300 meters on 6-minute walk test
  4. Specialist care: Prescription from neurologist or neuromuscular specialist with documented DMD experience

Clinical Documentation Needed

  • Current genetic test report stating "exon 45 skipping amenable"
  • Birth certificate and treatment timeline showing age compliance
  • Most recent 6-minute walk test results
  • Baseline kidney function tests
  • Documentation of stable corticosteroid therapy (if applicable)

Coding and Billing Requirements

Primary Codes

Code Type Code Description Source
HCPCS J-code J1426 Casimersen, 10 mg units CMS HCPCS
NDC 20277-0655-11 Amondys 45, 100 mg/2 mL vial Verified NDC database
ICD-10 G71.01 Duchenne muscular dystrophy Standard diagnosis coding
Administration 96413 IV infusion, up to 1 hour CPT for infusion billing

Dosing and Units

  • Standard dose: 30 mg/kg weekly IV infusion
  • Billing units: Submit J1426 in 10 mg increments
  • Quantity limits: Aetna typically approves based on patient weight with 30 mg/kg/week maximum

Documentation Packet Essentials

Required Documents Checklist

  • Completed Aetna precertification form (verify current version)
  • Genetic test report confirming exon 45 amenable mutation
  • Birth certificate and treatment initiation timeline
  • 6-minute walk test results (within 6 months)
  • Specialist clinical notes with DMD management experience
  • Baseline lab results (kidney function)
  • Prior therapy documentation (corticosteroids, other treatments)

Medical Necessity Letter Components

Your specialist should include:

  1. Patient diagnosis: Confirmed DMD with genetic testing details
  2. Mutation specificity: Exact genetic variant amenable to exon 45 skipping
  3. Clinical rationale: Disease progression, functional status, treatment goals
  4. FDA approval basis: Reference to accelerated approval for exon 45 skipping
  5. Monitoring plan: Infusion schedule, safety assessments, efficacy tracking
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific rules. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

Submission Process

Step-by-Step Submission

  1. Verify current forms: Download latest precertification request from Aetna's website
  2. Complete all fields: Incomplete forms are a leading cause of delays
  3. Attach documentation: Include all required clinical documents
  4. Submit via fax: Send to 1-888-267-3277 (verify current number)
  5. For Medicare Advantage: Use specific Medicare forms and submission process

Timeline Expectations

  • Standard review: 30-45 days from complete submission
  • Expedited review: Available for urgent clinical situations (≤72 hours)
  • Follow-up: Call after 2 weeks if no acknowledgment received

CVS Specialty Pharmacy Coordination

Pharmacy Requirements

Aetna typically requires CVS Specialty as the designated pharmacy for Amondys 45. Key coordination steps:

  1. Enrollment: Complete CVS Specialty enrollment forms
  2. Benefits verification: CVS Specialty handles insurance verification
  3. Infusion site coordination: Arrange approved infusion location
  4. Monitoring protocols: Ensure site meets safety and monitoring requirements

Approved Infusion Sites

  • Outpatient hospital departments
  • Physician offices with IV capabilities
  • Certified ambulatory infusion centers
  • Approved home infusion providers (where permitted)

After Submission: Tracking and Follow-up

What to Record

  • Confirmation number: From fax or portal submission
  • Submission date: Start your timeline tracking
  • Case reference: Any Aetna-assigned case numbers
  • Follow-up schedule: Plan check-ins every 2 weeks

Status Check Methods

  • Online portal: Aetna provider/member portal
  • Phone: 1-866-752-7021 for status updates
  • Fax confirmation: Request written status updates

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documents
Missing genetic proof Submit detailed genetic report Lab report stating "exon 45 amenable"
Age requirement not met Document treatment start before 14th birthday Birth certificate + treatment timeline
Insufficient functional status Provide recent walk test results 6-minute walk test ≥300 meters
Non-specialist prescriber Transfer to qualified neurologist Specialist credentials + DMD experience
Incomplete clinical notes Submit comprehensive documentation Detailed progress notes + treatment plan

Appeal Strategy

If denied, Counterforce Health's platform can help identify the specific denial basis and draft targeted rebuttals using evidence-backed arguments aligned to Aetna's own coverage policies.

California Appeals Process

California offers robust appeal rights through the Department of Managed Health Care (DMHC) for most Aetna plans.

Internal Appeal (First Level)

  • Timeline: Must file within 180 days of denial
  • Process: Submit appeal through Aetna member portal or in writing
  • Decision: 30 days for standard appeals, 72 hours for expedited

Independent Medical Review (IMR)

If internal appeal is denied, California residents can request binding external review:

  • Eligibility: Available for medical necessity denials
  • Cost: No fee to patients
  • Timeline: 45 days for standard IMR, 7 days for expedited
  • Success rates: While specialty drug appeals face challenges, strong clinical evidence improves outcomes
  • Contact: DMHC Help Center at 888-466-2219 or healthhelp.ca.gov

Required IMR Documentation

  • Copy of denial letter
  • Medical records supporting necessity
  • Physician statement of medical necessity
  • Genetic testing results
  • Published clinical evidence supporting treatment

Costs and Financial Assistance

Expected Costs

  • List price: Approximately $1,570.78 per 100mg vial (cash pricing reference)
  • Insurance cost-sharing: Varies by plan tier and deductible
  • Annual cost: Can exceed $300,000 without insurance coverage

Financial Assistance Options

  • Sarepta patient assistance: Contact manufacturer for eligibility
  • Copay assistance: May be available for commercially insured patients
  • Foundation grants: Rare disease foundations may offer support
  • California programs: State assistance programs for qualifying families

FAQ

How long does Aetna prior authorization take in California? Standard reviews take 30-45 days. Expedited reviews for urgent situations are completed within 72 hours.

What if Amondys 45 is non-formulary on my plan? Submit a formulary exception request with your prior authorization. Include clinical rationale for why formulary alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if there's an urgent medical need. Provide documentation of why standard timelines would jeopardize health.

Does step therapy apply to Amondys 45? Aetna may require documentation of prior corticosteroid therapy or other supportive treatments, but there are no other exon 45 skipping alternatives.

What happens if my child turns 14 during the approval process? Treatment must be initiated before the 14th birthday. Document the application submission date relative to the birthday.

How do I file an IMR in California? Contact DMHC at 888-466-2219 or apply online at healthhelp.ca.gov after completing internal appeals.

This guide provides educational information and should not replace medical advice. Always consult your healthcare provider and insurance plan for specific coverage details.

Sources & Further Reading

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