By Counterforce Health Team in Aldurazyme (laronidase) —

Do You Qualify for Aldurazyme (laronidase) Coverage by Aetna (CVS Health) in Washington? Decision Tree & Next Steps

Answer Box: Qualifying for Aldurazyme Coverage

Yes, you likely qualify for Aldurazyme (laronidase) coverage by Aetna (CVS Health) in Washington if you have confirmed MPS I via enzyme assay or genetic testing. Aetna covers Aldurazyme as a specialty tier drug requiring prior authorization for Hurler, Hurler-Scheie, or moderate-to-severe Scheie forms.

Fastest path: Call CVS Specialty at 1-866-814-5506 to initiate prior authorization while your prescriber gathers enzyme/genetic test results. If denied, Washington allows internal appeals (180 days) followed by external review through the Office of the Insurance Commissioner (60 days from final denial).

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives to Discuss
  6. If Denied: Appeal Path Chooser
  7. Coverage at a Glance
  8. Costs & Savings Options
  9. FAQ
  10. Sources & Further Reading

How to Use This Decision Tree

This guide helps patients and clinicians navigate Aetna (CVS Health) coverage for Aldurazyme (laronidase) in Washington state. Start with the eligibility triage below, then follow the recommended path based on your situation.

Before you begin, gather:

  • Insurance card with member ID
  • MPS I diagnostic test results (enzyme assay, genetic testing, urine GAGs)
  • Prior treatment history and outcomes
  • Current clinical notes documenting symptoms and severity

Eligibility Triage: Do You Qualify?

✅ Likely Eligible

You meet these criteria per Aetna's 2024 Specialty Pharmacy Clinical Policy:

  • Confirmed MPS I diagnosis via alpha-L-iduronidase enzyme assay showing deficiency AND/OR genetic testing
  • Disease subtype is one of:
    • Hurler form (severe MPS I)
    • Hurler-Scheie form (attenuated MPS I)
    • Scheie form with moderate to severe symptoms (corneal clouding, joint stiffness, valvular heart disease)

🔄 Possibly Eligible

  • You have clinical suspicion of MPS I but lack definitive testing
  • Scheie form with mild symptoms (may require exception request)
  • Previous enzyme replacement therapy with documented benefit

❌ Not Yet Eligible

  • No confirmed MPS I diagnosis
  • Mild Scheie form without moderate/severe manifestations
  • Seeking coverage for CNS manifestations (not established per FDA labeling)

If "Likely Eligible": Document Checklist

Required Documentation

✅ Enzyme assay results showing IDUA deficiency
✅ Genetic testing confirming biallelic IDUA variants (if available)
✅ Baseline disease assessments (cardiac echo, pulmonary function, urinary GAGs)
✅ Clinical notes documenting MPS I symptoms and severity
✅ Prior authorization form completed by prescriber

Submission Path

  1. Call CVS Specialty at 1-866-814-5506 to initiate prior authorization
  2. Prescriber submits documentation via Aetna's specialty pharmacy portal
  3. Timeline: Standard decision within 30-45 days; expedited (urgent) within 72 hours
  4. Authorization period: 12 months with annual reauthorization required
Tip: Submit all documentation together to avoid delays. Aetna requires both enzymatic confirmation AND clinical severity documentation for approval.

If "Possibly Eligible": Tests to Request

Diagnostic Tests to Order

  • MPS Enzyme Panel (dried blood spot) - measures IDUA activity
  • Urine glycosaminoglycans (GAGs) - elevated levels support diagnosis
  • IDUA gene sequencing - confirms genetic variants and disease subtype
  • Baseline assessments - echocardiogram, pulmonary function tests, ophthalmologic exam

Timeline to Re-apply

  • 2-4 weeks for enzyme assay results
  • 4-6 weeks for genetic testing
  • Resubmit PA once diagnostic confirmation is available

Contact labs like Greenwood Genetic Center or Nationwide Children's Hospital for testing options.

If "Not Yet": Alternatives to Discuss

Clinical Alternatives

  • Hematopoietic stem cell transplant (HSCT) - for severe MPS I cases
  • Supportive care - physical therapy, orthopedic interventions, cardiac monitoring
  • Clinical trials - check ClinicalTrials.gov for investigational therapies

Exception Request Strategy

  • Document all clinical manifestations even if mild
  • Obtain specialist consultation from geneticist or metabolic specialist
  • Request compassionate use consideration if standard criteria not met
  • Consider off-label use documentation if applicable

If Denied: Appeal Path Chooser

Internal Appeals (Required First)

Level 1 Appeal

  • Deadline: 180 days from denial notice
  • Submit to: Aetna Appeals Department
  • Timeline: 30 days for pre-service, 60 days for post-service decisions
  • Include: Medical necessity letter, additional clinical documentation, peer-reviewed literature

Level 2 Appeal (if available)

  • Deadline: 60 days from Level 1 decision
  • Timeline: 30 days for decision
  • May include: Peer-to-peer review with Aetna medical director

External Review (Washington State)

After exhausting internal appeals, Washington residents can request external review through the Office of the Insurance Commissioner.

  • Eligibility: Medical necessity denial, member cost >$500
  • Deadline: 60 days from final internal denial
  • Contact: 1-800-562-6900
  • Timeline: 30 days standard, 72 hours expedited
  • Outcome: Binding decision on Aetna

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to the plan's own rules.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage CVS Specialty: 1-866-814-5506
Formulary Tier Specialty Tier 4/5 Aetna 2024 Formulary
Diagnosis Requirement Confirmed MPS I Enzyme assay + genetic testing
Site of Care Outpatient infusion Specialty pharmacy coordination
Appeals Deadline (WA) 180 days internal, 60 days external Washington OIC

Costs & Savings Options

Manufacturer Support

Sanofi CareConnect

  • Free drug program for eligible patients
  • Copay reduction (potentially $0)
  • Auto-enrollment through CVS Specialty
  • Contact: Same number as CVS Specialty (1-866-814-5506)

Foundation Assistance

National MPS Society

  • Grants $500-$2,000 for non-drug expenses
  • Travel, equipment, family support
  • Apply online with MPS I diagnosis

HealthWell Foundation

Cost Context

  • Wholesale cost: ~$1,113 per 2.9 mg vial (January 2025)
  • Typical copays: $500-$1,000+ monthly before assistance
  • Annual out-of-pocket maximums: $8,000-$18,000 depending on plan

FAQ

Q: How long does Aetna prior authorization take in Washington? A: Standard decisions take 30-45 days. Request expedited review (72 hours) if health is in jeopardy.

Q: What if Aldurazyme is non-formulary on my plan? A: Submit a formulary exception request with medical necessity documentation. Aetna covers Aldurazyme as specialty tier, not excluded.

Q: Can I request an expedited appeal in Washington? A: Yes, for both internal appeals (if health jeopardized) and external review (72-hour timeline available).

Q: Does step therapy apply to Aldurazyme? A: No other FDA-approved treatments exist for MPS I, so step therapy typically doesn't apply. However, document any prior supportive therapies tried.

Q: What counts as medical necessity for Aldurazyme? A: Confirmed MPS I diagnosis with moderate-to-severe symptoms requiring enzyme replacement therapy per FDA labeling.

Clinician Corner: Medical Necessity Letter Checklist

Required Elements

  • Diagnosis: MPS I with ICD-10 code E76.01 (Hurler's syndrome) or E76.02 (Hurler-Scheie syndrome)
  • Diagnostic confirmation: Enzyme assay results, genetic testing, urinary GAGs
  • Disease severity: Baseline cardiac, pulmonary, and developmental assessments
  • Treatment rationale: Why enzyme replacement therapy is medically necessary
  • Monitoring plan: Infusion protocols, safety monitoring, efficacy tracking

Supporting Guidelines

From our advocates: We've seen denials overturned when families included comprehensive baseline assessments showing disease progression. One effective approach is documenting specific functional limitations (mobility, cardiac function, respiratory capacity) that enzyme replacement therapy could address. While outcomes vary, thorough documentation of disease severity often strengthens the medical necessity case.

When insurance challenges feel overwhelming, Counterforce Health specializes in transforming denials into successful appeals by identifying the specific denial basis and crafting evidence-backed responses that speak directly to payer policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan details and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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