By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (eteplirsen) Covered by Aetna (CVS Health) in Washington: Appeals, Timelines & Templates

Answer Box: Your Fastest Path to Approval

Getting Exondys 51 (eteplirsen) covered by Aetna (CVS Health) in Washington requires genetic testing proving exon 51-amenable DMD mutation, specialist prescriber, and functional documentation. Submit prior authorization with complete genetic report, 6-minute walk test results, and neuromuscular specialist letter. If denied, Washington law provides strong appeal protections including external review by Independent Review Organizations. Start today: Contact your DMD clinic to gather genetic testing and functional assessments, then submit PA through Aetna's provider portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Aetna Precert List Aetna 2025
Genetic Testing Confirmed exon 51-amenable DMD mutation Lab report from CLIA-certified lab Aetna DMD Policy
Specialist Prescriber Neuromuscular neurologist required DMD clinic letterhead Aetna CPB 0911
Functional Status 6-minute walk test ≥180 meters Physical therapy assessment Aetna CPB 0911
Age Limits Typically before age 14 for initiation Check current policy Aetna CPB 0911
Appeals Timeline 180 days for external review Washington law RCW 48.43.535

Step-by-Step: Fastest Path to Approval

1. Confirm Your Plan Type (Day 1)

Who: Patient/caregiver
Action: Check if you have Aetna commercial, Medicare Advantage, or employer plan
Why it matters: Washington state protections apply only to fully insured plans, not self-funded ERISA plans
Timeline: 15 minutes

2. Gather Genetic Documentation (Days 1-3)

Who: DMD clinic coordinator
Documents needed:

  • Complete DMD genetic testing report from CLIA-certified lab
  • Report must explicitly state mutation is "amenable to exon 51 skipping"
  • If unclear, request geneticist interpretation letter
    Submit via: Secure patient portal or fax
    Timeline: 1-3 days to obtain records

3. Obtain Functional Assessment (Days 1-7)

Who: Physical therapist or neuromuscular specialist
Required test: 6-minute walk test showing ≥180 meters distance
Alternative: North Star Ambulatory Assessment or timed function tests if 6MWT not feasible
Documentation: Signed, dated report within past 6 months
Timeline: 1 week if scheduling needed

4. Submit Prior Authorization (Day 7-10)

Who: Prescribing clinic
Forms: Aetna specialty drug PA form
Include: Genetic report, functional testing, specialist letter, treatment plan
Submit via: Aetna provider portal or designated fax
Timeline: Standard review 5-15 business days, expedited 72 hours

5. Monitor Decision (Days 10-25)

Who: Patient and clinic
Track: PA status through provider portal
Prepare: Appeal documents if denied
Timeline: Aetna typically responds within 15 calendar days

6. File Appeal if Denied (Within 180 days)

Who: Patient with clinic support
Process: Internal appeal first, then external review if needed
Support: Washington OIC Consumer Advocacy at 1-800-562-6900
Timeline: Internal appeal 30-45 days, external review 30 days

7. Escalate to External Review (If needed)

Who: Patient
Process: Request Independent Review Organization through Washington OIC
Binding: IRO decision is final and binding on Aetna
Timeline: 30 days for standard, 72 hours for expedited

Washington State Protections for DMD Patients

Washington provides exceptional protection for patients facing insurance denials, especially for rare disease medications like Exondys 51.

Step Therapy Override Rights

Under RCW 48.43.420, Washington requires insurers to grant step therapy exceptions when:

  • Previous failure: Patient tried required step drug and it failed or caused intolerance
  • Contraindication: Step drug would cause harm or adverse reaction
  • Clinical inappropriateness: Step drug not suitable for patient's specific condition
  • Stable on current therapy: Patient already controlled on requested medication
Tip: For DMD patients, emphasize that corticosteroids (typical step therapy) may be insufficient alone and that exon-skipping therapy addresses the underlying genetic defect.

External Review Rights

Washington's Independent Review Organization process provides binding external review:

  • Timeline: 180 days from final internal denial to request external review
  • Cost: Free to patients; insurer pays IRO fees
  • Scope: Medical necessity, plan interpretation, experimental treatment disputes
  • Decision: Binding on insurer; must provide coverage if overturned

Prior Authorization Requirements

Essential Documentation Checklist

Genetic Testing Requirements:

  • Complete DMD sequencing/deletion-duplication report
  • Explicit confirmation of exon 51-amenable mutation
  • CLIA-certified laboratory interpretation
  • If ambiguous, geneticist clarification letter

Clinical Documentation:

  • Neuromuscular specialist consultation note
  • Current DMD diagnosis with ICD-10 code
  • Functional assessment (6MWT ≥180m or equivalent)
  • Cardiac and pulmonary baseline studies
  • Prior therapy history and outcomes

Prescriber Qualifications:

  • Board-certified neurologist specializing in neuromuscular disorders
  • DMD clinic affiliation clearly stated
  • Experience with dystrophinopathy management

Clinician Corner: Medical Necessity Letter Elements

Your specialist's letter should address each Aetna policy criterion:

  1. Diagnosis confirmation: "Patient has genetically confirmed Duchenne muscular dystrophy with [specific mutation] amenable to exon 51 skipping"
  2. Functional status: "Current 6-minute walk distance of [X] meters demonstrates ambulatory status appropriate for therapy"
  3. Treatment rationale: "Eteplirsen targets the underlying genetic defect and represents standard of care for exon 51-amenable patients"
  4. Monitoring plan: "Patient will be monitored with serial functional assessments and safety laboratories per FDA labeling"

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Genetic testing insufficient" Submit complete lab report + geneticist interpretation Full CLIA report showing exon 51 amenability
"Not medically necessary" Emphasize FDA approval + standard of care Specialist letter + guideline references
"Experimental/investigational" Cite FDA accelerated approval FDA label + dystrophin expression data
"Non-specialist prescriber" Transfer care to DMD center Neuromuscular neurologist consultation
"Functional status unclear" Provide objective testing 6MWT or validated motor assessment
"Prior therapy not documented" Detail steroid trial outcomes Chart notes showing steroid use/limitations

Appeals Process in Washington

Internal Appeals (Required First Step)

Timeline: 30-45 days for standard, 72 hours for expedited
Submit to: Aetna member services or provider appeals department
Include:

  • Original denial letter
  • Additional medical documentation
  • Updated specialist letter addressing denial reasons
  • Patient/family impact statement

External Review (Independent Review Organization)

Eligibility: After internal appeal denial for fully insured plans
Process:

  1. Request IRO review through Washington OIC portal
  2. Submit within 180 days of final internal denial
  3. Provide 5 business days for additional documentation
  4. IRO panel reviews within 30 days (72 hours if expedited)

Decision: Binding on Aetna; must provide coverage if overturned

Note: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals that align with insurers' own rules.

Scripts & Templates

Patient Phone Script for Aetna

"Hello, I'm calling about prior authorization for Exondys 51 for my child with Duchenne muscular dystrophy. We have genetic testing confirming an exon 51-amenable mutation and functional testing meeting your policy requirements. I need to submit a PA request - can you provide the current form and submission process?"

Clinic Staff Peer-to-Peer Request

"I'm requesting a peer-to-peer review for [patient name] regarding denial of Exondys 51. This patient has genetically confirmed DMD with exon 51-amenable mutation, meets all Aetna policy criteria in CPB 0911, and eteplirsen represents FDA-approved standard of care. When can we schedule with a neuromuscular specialist reviewer?"

Appeal Letter Opening

"I am formally appealing the denial dated [date] for Exondys 51 (eteplirsen) for [patient name] with Duchenne muscular dystrophy. This patient meets all criteria in Aetna Clinical Policy Bulletin 0911, and the denial appears inconsistent with your published coverage standards. Under Washington law RCW 48.43.535, I request expedited review as delay risks irreversible disease progression."

When to Contact Washington's Insurance Commissioner

Contact the Washington Office of the Insurance Commissioner Consumer Advocacy at 1-800-562-6900 when:

  • Aetna violates appeal timelines or procedures
  • You need help understanding your appeal rights
  • Internal appeals are repeatedly denied without clear rationale
  • You want template language for appeal letters
  • Aetna refuses to provide required step therapy exceptions

The OIC maintains a searchable database of IRO decisions that can help identify successful appeals for similar cases.

Costs & Patient Support

Manufacturer Support

  • Sarepta Therapeutics Patient Services: Financial assistance and copay support programs
  • Eligibility: Varies by insurance type and income
  • Application: Through prescribing clinic or manufacturer website

State and Foundation Resources

  • Washington State Prescription Drug Program: Limited eligibility
  • Parent Project Muscular Dystrophy: Insurance resources and advocacy
  • National Organization for Rare Disorders: Financial assistance programs

When working with insurance appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals that identify the denial basis and draft point-by-point rebuttals aligned to the plan's own rules.

FAQ

How long does Aetna prior authorization take in Washington?
Standard PA decisions typically take 5-15 business days. Expedited requests (when delay risks serious harm) must be decided within 72 hours per Aetna policy.

What if Exondys 51 is non-formulary on my plan?
You can request a formulary exception based on medical necessity. Washington's step therapy law supports exceptions when formulary alternatives are inappropriate for your specific genetic mutation.

Can I request an expedited appeal?
Yes, if delay would seriously jeopardize health or cause severe pain. Your DMD specialist should document that postponing treatment risks irreversible disease progression.

Does step therapy apply if I've failed steroids outside Washington?
Prior therapy failures from other states count toward step therapy requirements. Document the trial, duration, and reason for discontinuation or inadequate response.

What happens if Aetna denies my external review request?
For fully insured plans, you have the right to IRO external review under Washington law. Aetna cannot block this process for eligible denials.

How much does Exondys 51 cost without insurance?
Typical U.S. cash price is approximately $7,822 for a 10 mL vial (50 mg/mL), though actual costs vary. Most patients require multiple vials per infusion based on weight.

Can I switch from another exon-skipping therapy to Exondys 51?
Aetna's policy generally prohibits concurrent exon-skipping therapies but may allow switches with appropriate documentation of medical necessity.

What if my employer plan is self-funded?
Self-funded ERISA plans aren't bound by Washington state insurance laws, but many voluntarily follow similar appeal procedures. Contact your HR department for specific appeal rights.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeal processes. It is not medical advice or legal counsel. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare team and insurance plan for specific guidance. For personalized help with appeals, contact the Washington Office of the Insurance Commissioner Consumer Advocacy at 1-800-562-6900.

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