By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Aetna CVS Health in Virginia: Complete Guide with Forms and Appeal Scripts

Answer Box: Quick Path to Approval

Aldurazyme (laronidase) is covered by Aetna CVS Health but requires prior authorization with genetic/enzyme confirmation of MPS I diagnosis. Here's your fastest path:

  1. Gather documentation: Genetic test results (IDUA gene mutation) or enzyme assay, baseline clinical assessments, and complete medical records
  2. Submit PA request: Your doctor submits via Availity portal at least 2 weeks before treatment start
  3. If denied: Request peer-to-peer review immediately, then file internal appeal within 180 days, followed by Virginia external review if needed

Start today: Contact your MPS specialist to begin PA documentation and review Aetna's precertification requirements.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Coverage Tiers
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Virginia External Review Rights
  10. Common Questions Answered

Coverage Basics

Is Aldurazyme covered by Aetna CVS Health?

Yes, Aldurazyme (laronidase) is listed on Aetna's formulary as a specialty medication for mucopolysaccharidosis I (MPS I). However, coverage requires:

  • Prior authorization for both the drug and infusion site
  • Specialty tier copay or coinsurance
  • Dispensing through CVS Specialty Pharmacy
  • Ongoing monitoring and reauthorization

Which Aetna plans cover it?

All major Aetna CVS Health products include Aldurazyme coverage:

  • Commercial plans (employer-sponsored and individual)
  • Medicare Advantage plans
  • Aetna Better Health (Medicaid managed care)

Coverage details vary by specific plan design, but the core requirements remain consistent across products.

Prior Authorization Process

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before dispensing Aetna Precert List
Genetic Confirmation IDUA gene mutation or enzyme assay Aetna Clinical Policy
Specialist Prescriber Metabolic/lysosomal disorder specialist FDA Label Requirements
Baseline Assessments Clinical status, organ involvement Aetna Policy Bulletin
CVS Specialty Must use designated specialty pharmacy CVS Specialty Services

Step-by-Step: Fastest Path to Approval

  1. Confirm diagnosis (Patient/Specialist): Ensure genetic testing (IDUA gene mutation) or enzyme assay confirming MPS I is complete and documented
  2. Gather baseline data (Specialist): Complete clinical assessments including pulmonary function, cardiac status, hepatosplenomegaly, and mobility measures
  3. Submit PA request (Specialist): File via Availity portal with all supporting documentation at least 2 weeks before planned start
  4. Include monitoring plan (Specialist): Document infusion protocols, safety measures, and ongoing assessment schedule per FDA requirements
  5. Await decision (Patient): Standard review takes 30-45 days; expedited available for urgent cases within 72 hours
  6. If approved (Patient): Contact CVS Specialty at 1-800-237-2767 to coordinate infusion scheduling
  7. If denied (Patient/Specialist): Request peer-to-peer review immediately, then prepare appeal documentation

Timing and Deadlines

Standard Timeline:

  • PA submission to decision: 30-45 business days
  • Expedited review (urgent): 72 hours with physician certification
  • Appeal deadlines: 180 days from denial notice
  • External review filing: 120 days from final internal denial

Virginia-Specific Timelines:

  • External review decision: 45 days (standard) or 72 hours (expedited)
  • Insurer compliance after overturn: 1-3 days depending on urgency
Tip: Submit PA requests at least 2 weeks before your planned treatment start date to allow for potential appeals or additional documentation requests.

Medical Necessity Criteria

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's medical necessity letter should include:

Diagnosis Confirmation:

  • Genetic testing results showing IDUA gene mutations
  • Enzyme assay demonstrating alpha-L-iduronidase deficiency
  • Clinical phenotype classification (Hurler, Hurler-Scheie, or Scheie syndrome)

Clinical Rationale:

  • Current symptom severity and organ involvement
  • Baseline assessments: pulmonary function, cardiac status, hepatosplenomegaly
  • Functional limitations and quality of life impacts
  • Treatment goals and expected outcomes

Supporting Evidence:

  • FDA-approved indication for MPS I
  • Dosing rationale (0.58 mg/kg weekly)
  • Monitoring plan for infusion reactions and clinical response

Prior Therapies:

  • Document any previous treatments or explain why alternatives aren't appropriate
  • Note that no other FDA-approved enzyme replacement exists for MPS I

Costs and Coverage Tiers

Aldurazyme falls under Aetna's specialty tier, which typically means:

  • Commercial plans: 10-30% coinsurance or set copay ($50-200+ per infusion)
  • Medicare Advantage: Varies by plan; may have monthly caps
  • Medicaid managed care: Minimal or no patient cost-sharing

Cost-Saving Resources:

  • Sanofi Patient Support Program - copay assistance and free drug programs
  • National Organization for Rare Disorders (NORD) assistance programs
  • State pharmaceutical assistance programs in Virginia
Note: Actual costs vary significantly by plan. Contact Aetna member services at the number on your ID card for specific benefit details.

Denials and Appeals

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic confirmation Submit complete diagnostic workup IDUA gene test or enzyme assay results
Insufficient baseline data Provide comprehensive clinical assessment Pulmonary, cardiac, hepatic function tests
Non-specialist prescriber Transfer to metabolic specialist Specialist consultation notes
Experimental/investigational Cite FDA approval and guidelines FDA label, clinical policy
Quantity over limits Justify weight-based dosing Patient weight, dosing calculations

Appeals Playbook for Aetna CVS Health in Virginia

Level 1: Internal Appeal

  • Deadline: 180 days from denial notice
  • How to file: Aetna provider portal or written request
  • Timeline: Up to 45 business days (expedited available)
  • Required: Original denial letter, additional clinical evidence, specialist letter

Level 2: Peer-to-Peer Review

  • When: Can request during or after initial denial
  • Process: Specialist speaks directly with Aetna medical director
  • Timeline: Usually scheduled within 5-10 business days
  • Outcome: May overturn denial without formal appeal

Level 3: External Review (Virginia)

  • Eligibility: After exhausting internal appeals, for medical necessity denials
  • Deadline: 120 days from final internal denial
  • How to file: Virginia SCC Form 216-A
  • Timeline: 45 days (standard) or 72 hours (expedited)
  • Decision: Binding on Aetna

At Counterforce Health, we help patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and payer policies to draft point-by-point rebuttals that align with each plan's specific requirements, pulling the right clinical evidence and procedural details that payers expect to see.

Renewal Requirements

Aldurazyme typically requires reauthorization every 6-12 months. Your specialist must document:

Clinical Response Monitoring:

  • Improvement or stabilization in pulmonary function tests
  • Changes in hepatosplenomegaly (liver/spleen size)
  • Mobility and functional status assessments
  • Urinary GAG (glycosaminoglycan) levels

Safety Monitoring:

  • Infusion reaction history and management
  • Development of anti-drug antibodies
  • Any adverse events or hospitalizations

Continued Medical Necessity:

  • Ongoing symptoms requiring treatment
  • Lack of disease progression on therapy
  • Patient/family adherence to treatment plan

Specialty Pharmacy Requirements

Why CVS Specialty?

Aetna requires specialty medications like Aldurazyme to be dispensed through CVS Specialty Pharmacy because:

  • Complex storage and handling requirements
  • Patient education and monitoring programs
  • Coordination with infusion centers
  • Insurance and copay assistance management

What to Expect:

  • Dedicated pharmacist and care team
  • Home or clinic delivery coordination
  • Insurance benefit verification
  • Patient support services and education

Contact Information:

  • CVS Specialty: 1-800-237-2767
  • Specialty pharmacy transfer requests handled automatically after PA approval

Virginia External Review Rights

If Aetna denies your appeal, Virginia law provides strong consumer protections through the State Corporation Commission Bureau of Insurance.

Your Rights in Virginia:

  • Independent medical review by board-certified specialists
  • No cost to you for the external review process
  • Binding decision that Aetna must follow
  • Expedited review available for urgent medical needs

How to File:

  1. Complete Form 216-A (External Review Request)
  2. Include final denial letter from Aetna
  3. Submit within 120 days to: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  4. Fax: (804) 371-9915 or email: [email protected]

Virginia-Specific Advantages:

  • Consumer Services staff will guide you through the process (1-877-310-6560)
  • Managed Care Ombudsman available for additional support
  • Special provisions for cancer and urgent care (expedited without exhausting appeals)

For complex denials involving rare disease treatments like Aldurazyme, Virginia's external review process has helped many patients secure coverage when insurers initially denied medically necessary care.

Common Questions Answered

How long does Aetna prior authorization take for Aldurazyme in Virginia? Standard PA decisions take 30-45 business days. Expedited reviews (with physician certification of urgent need) are decided within 72 hours. Submit at least 2 weeks before planned treatment start.

What if Aldurazyme is non-formulary on my specific plan? Even if listed as non-formulary, you can request a formulary exception with documentation that no covered alternatives exist for MPS I.

Can I request an expedited appeal if my condition is worsening? Yes. Your specialist must certify that delay would seriously jeopardize your health. Both Aetna internal expedited appeals and Virginia external expedited reviews are available.

Does step therapy apply if I've never tried other treatments? No step therapy alternatives exist for MPS I, as Aldurazyme is the only FDA-approved enzyme replacement therapy for this condition.

What happens if I move from Virginia to another state? Your Aetna coverage continues, but external review rights may differ by state. Contact the new state's insurance department for local appeal processes.

How much will I pay out-of-pocket for Aldurazyme? Costs vary by plan but typically range from 10-30% coinsurance for specialty tier medications. Contact member services and explore manufacturer copay assistance programs.

Can my general practitioner prescribe Aldurazyme? Aetna requires prescribing by specialists experienced in metabolic or lysosomal storage disorders, typically found at academic medical centers or specialized clinics.

What if CVS Specialty can't deliver to my infusion center? CVS Specialty coordinates with most infusion centers. If issues arise, contact both CVS Specialty and Aetna to resolve delivery logistics.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For official Virginia insurance regulations and consumer rights, visit the State Corporation Commission Bureau of Insurance.

Sources & Further Reading

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