By Counterforce Health Team in Zolgensma (onasemnogene abeparvovec) —

If Zolgensma Isn't Approved by Aetna CVS Health in Washington: Spinraza, Evrysdi & Exception Paths

Answer Box: When Aetna Denies Zolgensma in Washington

If Aetna CVS Health denies Zolgensma (onasemnogene abeparvovec) for your child with SMA, you have two main paths: formulary alternatives (Spinraza, Evrysdi) or formulary exception appeals. Both Spinraza and Evrysdi require prior authorization but have broader age eligibility than Zolgensma's under-24-month limit. For exceptions, file within 180 days through Aetna's specialty unit (1-866-814-5506) with comprehensive genetic testing and medical necessity documentation. If denied, Washington's external review through an Independent Review Organization provides binding decisions within 30 days. Start by calling your neurologist to discuss alternatives and gather clinical documentation for your chosen path.

Table of Contents

  1. When Alternatives Make Sense
  2. Formulary Alternatives: Spinraza vs Evrysdi
  3. Coverage Requirements Comparison
  4. Exception Strategy for Zolgensma
  5. Switching Between SMA Treatments
  6. Re-Trying for Zolgensma Later
  7. Washington Appeals Process
  8. FAQ

When Alternatives Make Sense

Aetna CVS Health typically denies Zolgensma for several reasons: age over 24 months, anti-AAV9 antibody titers above 1:50, lack of genetic confirmation, or missing specialized center documentation. When these barriers exist, Spinraza and Evrysdi offer viable treatment paths with their own coverage criteria.

Consider alternatives when:

  • Your child is over 24 months old (Zolgensma's FDA age limit)
  • Anti-AAV9 antibody testing shows titers >1:50
  • You need treatment while appealing Zolgensma denial
  • Your family prefers avoiding one-time gene therapy risks

Contraindications for all SMA treatments:

  • Invasive ventilation dependency
  • Tracheostomy dependence
  • Active severe infections
From our advocates: One family in Washington successfully transitioned from a denied Zolgensma request to Evrysdi approval within six weeks by working with their neurologist to document prior therapy failures and submitting complete genetic testing results. The oral medication allowed them to start treatment immediately while continuing their Zolgensma appeal process.

Formulary Alternatives: Spinraza vs Evrysdi

Both medications are covered options on Aetna formularies but differ significantly in administration and monitoring requirements.

Spinraza (nusinersen)

  • Administration: Intrathecal injection every 4 months after loading doses
  • Age range: FDA-approved for all ages with SMA
  • Monitoring: Regular neurological assessments, kidney function tests
  • Advantages: Established track record, works for all SMA types
  • Considerations: Requires lumbar punctures, hospital visits

Evrysdi (risdiplam)

  • Administration: Daily oral medication at home
  • Age range: 2 months and older
  • Monitoring: Regular blood tests, developmental assessments
  • Advantages: Convenient oral dosing, home administration
  • Considerations: Daily compliance required, potential drug interactions

Counterforce Health helps families navigate the complex prior authorization requirements for both alternatives, turning insurance denials into targeted appeals with the right clinical documentation.

Coverage Requirements Comparison

Requirement Spinraza Evrysdi Zolgensma
Prior Authorization Required Required Required
Genetic Testing SMN1 mutation confirmed Bi-allelic SMN1 mutations Bi-allelic SMN1 mutations
Age Limits All ages 2+ months Under 24 months
Specialist Required Neurologist Neurologist Neurologist + Gene therapy center
Baseline Testing Motor function scores Motor function scores Anti-AAV9 antibodies + motor scores
Ventilation Status No invasive ventilation No invasive ventilation No invasive ventilation
Concurrent Therapy Cannot use with Evrysdi/Zolgensma Cannot use with Spinraza/Zolgensma Cannot use with other SMA meds

Exception Strategy for Zolgensma

When Zolgensma is denied but clinically appropriate, request a formulary exception through Aetna's specialty precertification process.

Required Documentation

  • Medical necessity letter from treating neurologist explaining why alternatives are inappropriate
  • Genetic testing results confirming bi-allelic SMN1 mutations from CLIA-certified lab
  • Anti-AAV9 antibody titers showing levels ≤1:50
  • Motor function assessments (CHOP-INTEND, HFMSE, or HINE-2 scores)
  • Treatment history documenting any prior SMA therapy trials and outcomes
  • Peer-reviewed literature supporting gene therapy for your child's specific SMA type

Submission Process

Contact: Aetna Specialty Precertification Unit

  • Phone: 1-866-814-5506 (TTY: 711)
  • Fax: 1-866-249-6155
  • Timeline: Standard review up to 72 hours; expedited review within 24 hours for urgent cases
Tip: Request expedited review if your child's condition is rapidly deteriorating or if they're approaching the 24-month age cutoff.

Switching Between SMA Treatments

Coordinating treatment switches requires careful planning with your medical team and specialty pharmacy.

From Spinraza/Evrysdi to Zolgensma

  • Washout period: 6-12 months of monitoring on current therapy recommended
  • Eligibility screening: Confirm age under 24 months and negative AAV9 antibodies
  • Pre-infusion requirements: Baseline labs (CBC, liver function, troponin)
  • Steroid prophylaxis: Must start before Zolgensma infusion and continue 30+ days

Logistics Coordination

  1. Specialty pharmacy enrollment for the new medication
  2. Insurance authorization for the switch (separate PA required)
  3. Infusion center scheduling (for Spinraza or Zolgensma)
  4. Monitoring protocol setup with your neurologist
  5. Supply management to avoid treatment gaps

The specialized appeals platform from Counterforce Health can help coordinate these complex switches by managing the insurance approvals and ensuring proper documentation flows between your medical team and Aetna.

Re-Trying for Zolgensma Later

If you start with Spinraza or Evrysdi, you may still pursue Zolgensma approval later, but timing is critical due to the 24-month age limit.

Documentation During Alternative Treatment

  • Monthly motor assessments to track progression or stability
  • Detailed treatment response notes from each neurologist visit
  • Side effect documentation if alternatives cause problems
  • Quality of life measures showing treatment burden
  • Anti-AAV9 antibody monitoring if planning future Zolgensma request

Timing Considerations

  • File new Zolgensma PA at least 3-4 months before 24-month birthday
  • Allow time for potential appeals process
  • Consider expedited review if approaching age cutoff

Washington Appeals Process

Washington provides strong consumer protections for insurance denials through a structured appeals process.

Internal Appeals

  • Deadline: 180 days from denial notice
  • Timeline: Aetna has 45 business days to respond
  • Submission: Same specialty contacts as initial PA request

External Review (IRO)

  • Deadline: 120 days after final internal denial
  • Timeline: 30 days for standard review; 72 hours for expedited
  • Cost: Free to members
  • Decision: Binding on Aetna

Washington Office of Insurance Commissioner

  • Consumer helpline: 800-562-6900
  • Services: Free appeal assistance, complaint filing, IRO coordination
  • Website: insurance.wa.gov
Note: External review decisions by Independent Review Organizations are binding on Aetna and have helped many Washington families access denied gene therapies and specialty medications.

FAQ

How long does Aetna prior authorization take for SMA medications in Washington? Standard reviews take up to 72 hours after complete documentation submission. Expedited reviews for urgent cases are completed within 24 hours.

What if my child is over 24 months and Zolgensma is denied? Focus on Spinraza or Evrysdi alternatives, which have no upper age limits and are typically covered with proper documentation.

Can I request an expedited appeal if my child's condition is worsening? Yes, Washington allows expedited external reviews within 72 hours when a physician certifies that delays could seriously jeopardize your child's health.

Does step therapy apply if we've tried treatments outside Washington? Prior treatment history from any state counts toward step therapy requirements, but you must provide complete documentation of trials and outcomes.

What counts as medical necessity for SMA gene therapy? Confirmed genetic diagnosis, appropriate age/weight, negative AAV9 antibodies, and clinical rationale why alternatives are insufficient or inappropriate.

How much does external review cost in Washington? External review through an Independent Review Organization is free to members. Washington covers all costs.

Can I switch from Evrysdi back to Spinraza if needed? Yes, but requires new prior authorization and coordination with your specialty pharmacy and infusion center for logistics.

What if my Aetna plan is through my employer (self-funded)? Self-funded employer plans may not follow Washington state appeal rules. Contact the U.S. Department of Labor for ERISA plan appeals guidance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for the most current coverage criteria and medical recommendations specific to your situation.

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