By Counterforce Health Team in Myozyme (alglucosidase alfa) —

Get Myozyme (Alglucosidase Alfa) Covered by Aetna CVS Health in Washington: Complete PA Guide and Appeal Process

Answer Box: Your Fastest Path to Myozyme Coverage

Myozyme (alglucosidase alfa) requires prior authorization from Aetna CVS Health, but is covered when medically necessary for confirmed Pompe disease. In Washington, submit your PA through CVS Specialty Pharmacy with GAA enzyme test results, genetic confirmation, and a specialist's medical necessity letter. Standard approval takes 30-45 days; expedited reviews complete within 72 hours for urgent cases. If denied, Washington's robust external review process through an Independent Review Organization (IRO) gives you a second chance with binding decisions.

Start today: Contact your metabolic or neuromuscular specialist to initiate the PA submission via CVS Specialty Pharmacy.

Table of Contents

  1. Coverage Basics: Is Myozyme Covered?
  2. Prior Authorization Process
  3. Timeline and Urgency Options
  4. Required Documentation and Criteria
  5. Understanding Costs
  6. Denial Reasons and Appeals
  7. Renewal Requirements
  8. CVS Specialty Pharmacy Transfer
  9. Troubleshooting Common Issues
  10. Washington-Specific Appeal Rights
  11. FAQ: Your Most Common Questions

Coverage Basics: Is Myozyme Covered?

Yes, Myozyme is covered by Aetna CVS Health when medically necessary for Pompe disease. According to Aetna's clinical policy, alglucosidase alfa (Myozyme/Lumizyme) is considered medically necessary for members with confirmed Pompe disease who meet specific diagnostic criteria.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans CVS Caremark PA portal
Formulary Status Preferred specialty tier (2025) Aetna specialty drug list
Step Therapy None required for Pompe disease Aetna clinical policy
Specialist Requirement Metabolic or lysosomal storage disorder expert Policy documentation
Site of Care Infusion center or home health Aetna infusion policy

The medication is dispensed exclusively through CVS Specialty Pharmacy once approved, which handles the coordination between your doctor, insurance, and delivery logistics.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Specialist Evaluation (1-2 weeks)
    • Schedule with metabolic specialist or neuromuscular neurologist
    • Complete GAA enzyme assay and genetic testing if not done
    • Document functional assessments (6-minute walk test, muscle strength, FVC)
  2. Diagnostic Confirmation (1-3 days for results)
    • GAA enzyme deficiency test (blood spot or tissue)
    • Genetic testing showing pathogenic GAA mutations
    • Clinical correlation with Pompe disease symptoms
  3. PA Submission (Same day)
    • Specialist submits via CVS Specialty portal
    • Include all required documentation (see criteria below)
    • Request expedited review if health deterioration risk exists
  4. CVS Specialty Enrollment (Day of approval)
    • Call 1-800-237-2767 to enroll
    • Provide insurance details and shipping preferences
    • Schedule first infusion delivery (3-5 business days)
Tip: Start the PA process 60 days before your current ERT expires if switching from another therapy, as gaps in treatment can lead to rapid functional decline.

Timeline and Urgency Options

Standard Processing Times

  • Prior Authorization Review: 30-45 days from complete submission
  • Expedited Review: 72 hours when health is at risk
  • CVS Specialty Processing: 1 week average after PA approval
  • First Delivery: 3-5 business days after enrollment

When to Request Expedited Review

According to Aetna policy, expedited reviews are granted when:

  • Delay would seriously jeopardize your health
  • Standard timeline could impair bodily functions
  • You're experiencing rapid disease progression
  • Current therapy has failed and immediate replacement is needed

Your specialist must provide written attestation of urgency when requesting expedited processing.

Required Documentation and Criteria

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Approval:

✅ Diagnostic Confirmation

  • GAA enzyme assay results showing deficiency
  • Genetic testing confirming pathogenic GAA mutations
  • Clinical symptoms consistent with Pompe disease

✅ Treatment Rationale

  • FDA-approved indication for Pompe disease
  • Evidence-based dosing (20 mg/kg every 2 weeks)
  • Treatment goals (stabilize/improve motor function, respiratory capacity)

✅ Clinical Assessment

  • Baseline functional measurements
  • Prior treatment history (if applicable)
  • Expected response monitoring plan

✅ Guideline Support

  • Reference to FDA labeling
  • Cite relevant medical literature
  • Include specialist society recommendations

Required Laboratory Documentation

According to the Mayo Clinic testing guidelines, proper Pompe diagnosis requires:

  1. GAA Enzyme Assay - Blood spot test measuring acid alpha-glucosidase activity
  2. Genetic Confirmation - GAA gene sequencing identifying pathogenic variants
  3. Clinical Correlation - Symptoms, family history, and physical findings
Note: Enzyme testing alone may show pseudodeficiency in some patients, making genetic confirmation essential for definitive diagnosis.

Understanding Costs

Insurance Coverage Structure

  • Specialty Tier Copay: Varies by plan (typically $50-$150 per month)
  • Coinsurance Plans: Usually 10-20% after deductible
  • Annual Out-of-Pocket Maximum: Protects against unlimited costs

Cost-Saving Resources

Manufacturer Support:

  • Sanofi Patient Assistance Program
  • Copay assistance for eligible patients
  • Free drug programs for uninsured patients

Foundation Grants:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders

Contact these organizations directly or ask your CVS Specialty case manager about enrollment assistance.

Denial Reasons and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient diagnostic proof Submit complete enzyme + genetic testing GAA testing guidelines
Not medically necessary Stronger medical necessity letter with guidelines Specialist attestation + literature
Non-formulary status Request formulary exception Prior therapy failures, contraindications
Dosing outside guidelines Justify weight-based dosing FDA labeling, specialist rationale

Internal Appeals Process

Timeline: 60-180 days from denial notice (varies by plan type) Submission: Via Aetna member portal or written request Documentation: Address specific denial reasons with additional evidence Expedited Option: Available if delay risks health deterioration

When Counterforce Health reviews Myozyme denials, we often see approvals overturned when appeals include stronger diagnostic documentation and detailed medical necessity letters that directly address the payer's specific coverage criteria.

Washington-Specific Appeal Rights

External Review Through Independent Review Organization (IRO)

Washington state provides robust consumer protections through RCW 48.43.535, giving you the right to an independent external review after exhausting internal appeals.

Key Features:

  • Free to patients - insurer pays all IRO fees
  • Binding decisions - insurers must comply with favorable rulings
  • Independent specialists - medical experts not employed by your insurer
  • Broad scope - covers denials, reductions, or terminations of coverage

Filing for External Review

Eligibility: After unfavorable internal appeal decision or if Aetna exceeds grievance timelines Deadline: 180 days from final internal denial (verify current timeline) Process: Submit request to Washington Office of Insurance Commissioner (OIC) Contact: 1-800-562-6900 for assistance

Timeline:

  • Standard Review: 15-30 days after IRO receives complete information
  • Expedited Review: 72 hours for urgent cases threatening health
From Our Advocates: We've seen Washington patients successfully overturn Myozyme denials through external review when the internal appeal included comprehensive genetic testing results and detailed functional assessments. The key was demonstrating clear medical necessity according to established clinical guidelines, not just the insurer's internal policies.

Required Documentation for External Review

Submit to the IRO (forwarded by OIC):

  • Copy of final internal denial letter
  • All medical records supporting medical necessity
  • Specialist letters explaining treatment rationale
  • Relevant medical literature or guidelines
  • Any additional evidence not considered in internal review

The OIC provides template forms and guidance on their website to help you prepare a complete submission.

Renewal Requirements

Annual Prior Authorization Renewal

Start Timeline: 60-90 days before current authorization expires Required Updates:

  • Current functional assessments showing response to therapy
  • Specialist evaluation confirming ongoing medical necessity
  • Updated laboratory values if relevant
  • Documentation of treatment compliance

Evidence of Treatment Response

Aetna considers continuation appropriate when patients demonstrate:

  • Stabilization or improvement in motor function
  • Maintained or improved walking capacity (6-minute walk test)
  • Stable or improved respiratory function (FVC measurements)
  • Slowed disease progression compared to natural history

Even stabilization without improvement qualifies as treatment response for renewal approval.

CVS Specialty Pharmacy Transfer

Why Myozyme Transfers to CVS Specialty

Network Requirements: Aetna contracts exclusively with CVS Specialty for most specialty medications Benefits: Dedicated case management, insurance coordination, and home delivery Clinical Support: Pharmacist consultations and adherence monitoring

Enrollment Process

  1. Automatic Transfer: CVS Specialty contacts you after PA approval
  2. Patient Enrollment: Call 1-800-237-2767 to complete setup
  3. Delivery Scheduling: Coordinate with infusion center or home health
  4. Ongoing Support: Dedicated case manager for refills and questions

Troubleshooting Common Issues

Portal and System Problems

CVS Specialty Portal Down:

  • Call 1-800-237-2767 for status updates by phone
  • Fax urgent requests to backup number (provided during enrollment)
  • Use Aetna member portal for general PA status

Missing Forms or Documentation:

  • Download current forms from CVS Specialty provider resources
  • Contact your specialist's office for clinical documentation
  • Request expedited processing if delays affect treatment

Prior Authorization Status Unknown:

  • Check Aetna member portal online
  • Call CVS Specialty patient services
  • Have your policy number and prescription details ready

FAQ: Your Most Common Questions

Q: How long does Aetna CVS Health prior authorization take for Myozyme in Washington? A: Standard PA review takes 30-45 days. Expedited reviews for urgent cases complete within 72 hours when your doctor attests that delay would risk your health.

Q: What if Myozyme is non-formulary on my specific plan? A: Request a formulary exception with documentation of medical necessity. Include prior therapy failures, contraindications to alternatives, and specialist support for Myozyme specifically.

Q: Can I request an expedited appeal in Washington? A: Yes, both internal appeals and external IRO reviews offer expedited processing when delay would jeopardize your health or continued care.

Q: Does step therapy apply if I've tried other treatments outside Washington? A: Aetna's policy doesn't require step therapy for Pompe disease ERTs, but document any prior therapy trials and outcomes to strengthen your case.

Q: What happens if CVS Specialty can't deliver to my location? A: CVS Specialty serves all of Washington state. For remote areas, they coordinate with local infusion centers or home health agencies for delivery and administration.

Q: How do I know if my specialist qualifies as a "metabolic expert"? A: Look for board certification in genetics, neurology with neuromuscular subspecialty, or endocrinology with metabolic disorders focus. Hospital-based specialists often have the required expertise.

Understanding your coverage options and appeal rights empowers you to advocate effectively for necessary treatments. Counterforce Health specializes in helping patients navigate these complex prior authorization and appeal processes, turning insurance denials into targeted, evidence-backed approvals through systematic documentation and payer-specific strategies.

For additional support navigating Washington's insurance landscape, contact the Office of Insurance Commissioner at 1-800-562-6900. Their consumer advocates provide free assistance with appeals and can guide you through the external review process.

Sources & Further Reading

This guide is for educational purposes and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage and policies may change; verify current requirements with your insurer and state regulators.

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