By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (Imiglucerase) Covered by Aetna CVS Health in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Cerezyme Covered by Aetna CVS Health in Washington

Cerezyme (imiglucerase) requires prior authorization from Aetna CVS Health in Washington, with many plans requiring step therapy (trying Elelyso first). The fastest path to approval: Have your Gaucher specialist complete Aetna's Cerezyme precertification form with confirmed Type 1 Gaucher diagnosis (enzyme assay/genetics), document any Elelyso trial failures or contraindications, and submit via CVS Caremark portal. If denied, Washington's external review process has an 82% overturn rate for specialty drug denials with binding decisions on Aetna.

First step today: Call Aetna member services at the number on your card to confirm your plan's exact PA requirements and step therapy status for Cerezyme.

Table of Contents

  1. Why Washington State Rules Matter for Your Aetna Coverage
  2. Aetna CVS Health PA Requirements for Cerezyme
  3. Washington Step Therapy Protections
  4. Fastest Path to Approval: 7-Step Process
  5. Common Denial Reasons & How to Fix Them
  6. Washington Appeals Process: 82% Success Rate
  7. When to Escalate to Washington's Insurance Commissioner
  8. Costs and Financial Assistance
  9. FAQ: Cerezyme Coverage in Washington

Why Washington State Rules Matter for Your Aetna Coverage

Washington has some of the strongest patient protections in the country for specialty drug coverage. Under RCW 48.43.535, Aetna must follow specific timelines and procedures that often favor patients more than federal minimums.

Key Washington protections that apply to Aetna plans:

  • External review decisions are binding on Aetna when overturned
  • 120-day deadline to request external review (vs. shorter periods in some states)
  • 72-hour expedited reviews for urgent situations
  • Specialist Care Access Act (effective March 2025) requires specialist-to-specialist review for denials
Note: Self-funded employer plans (ERISA) may follow federal rules instead of Washington state law, but many still use Washington's external review process voluntarily.

Aetna CVS Health PA Requirements for Cerezyme

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Cerezyme prescriptions Aetna 2025 Precertification List
Step Therapy Must try Elelyso first (most plans) Plan-specific formulary
Specialist Prescriber Gaucher specialist, hematologist, or geneticist PA form requirements
Diagnosis Confirmation Enzyme assay and/or genetic testing Aetna Medical Policy
Site of Care PA May require separate approval for infusion location CVS Caremark specialty

Core Documentation Requirements

Every Cerezyme PA must include:

  1. Confirmed Type 1 Gaucher diagnosis via β-glucocerebrosidase enzyme deficiency test and/or genetic testing
  2. Baseline clinical data: hemoglobin, platelet count, liver/spleen size, bone involvement
  3. Weight-based dosing justification (typically 2.5-60 U/kg based on severity)
  4. Specialist credentials and treatment plan
  5. Completed Aetna Cerezyme precertification form

Washington Step Therapy Protections

While Washington doesn't have a comprehensive step therapy override law, patients have several paths to exceptions:

Medical Exception Criteria

Aetna typically approves step therapy exceptions when:

  • Prior trial of Elelyso caused adverse reactions
  • Elelyso is contraindicated due to allergies or medical conditions
  • Patient has been stable on Cerezyme and switching would be medically inadvisable
  • Clinical factors suggest Elelyso would be ineffective

Documentation for Step Therapy Override

Include in your exception request:

  • Detailed allergy/intolerance history with specific symptoms and dates
  • Prior therapy timeline showing Elelyso trial duration and outcomes
  • Specialist letter explaining why Cerezyme is medically necessary over alternatives
  • Supporting literature if applicable (rare but can help in complex cases)
From our advocates: We've seen step therapy exceptions approved within 48 hours when the prescriber clearly documented a severe infusion reaction to Elelyso with specific symptoms and dates. The key was providing concrete clinical details rather than general statements about "intolerance."

Fastest Path to Approval: 7-Step Process

Step 1: Verify Your Plan Details

Who: You or your clinic
What: Call Aetna member services (number on your insurance card)
Ask for: Exact PA requirements, formulary tier, and step therapy status for Cerezyme
Timeline: 15-30 minutes

Step 2: Gather Diagnostic Documentation

Who: Your Gaucher specialist
What: Compile enzyme assay results, genetic testing, baseline labs
Submit to: Clinic for PA preparation
Timeline: 1-2 business days

Step 3: Address Step Therapy Requirements

Who: Your prescriber
What: Document Elelyso trial/failure OR medical contraindication
Include: Specific dates, doses, adverse events, clinical rationale
Timeline: Same day if records available

Step 4: Complete Aetna PA Form

Who: Prescriber's office
What: Aetna Cerezyme precertification form with all sections
Submit via: CVS Caremark provider portal or fax
Timeline: 2-3 business days to complete

Step 5: Submit and Track

Who: Clinic staff
What: Submit complete PA package
Track via: Provider portal or phone follow-up
Timeline: Aetna has up to 15 business days for standard review

Step 6: Request Expedited Review if Urgent

Who: You or your prescriber
What: Call Aetna if treatment delay threatens health
Criteria: Severe symptoms, organ damage progression, hospitalization risk
Timeline: 72-hour decision required

Step 7: Prepare for Potential Appeal

Who: You and your care team
What: Gather additional documentation while waiting
Include: Treatment urgency letter, peer-reviewed studies, specialist opinion
Timeline: Concurrent with PA review

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Diagnosis not confirmed" Provide enzyme assay and/or genetic testing Lab results with reference ranges
"Step therapy not met" Document Elelyso trial/failure or contraindication Treatment timeline, adverse events
"Not medically necessary" Submit specialist letter with clinical justification Baseline labs, symptom severity, treatment goals
"Experimental/investigational" Cite FDA approval for Type 1 Gaucher disease FDA Orange Book entry
"Dosing outside guidelines" Provide weight-based calculation and specialist rationale Patient weight, dosing formula, treatment plan

Washington Appeals Process: 82% Success Rate

Internal Appeals with Aetna

Level 1 Internal Appeal:

  • Deadline: 180 days from denial
  • Decision timeline: 30 days standard, 72 hours expedited
  • Submit to: Aetna appeals department via member portal or mail
  • Include: Denial letter, medical records, specialist letter

Level 2 Internal Appeal (if available):

  • Deadline: Per plan documents (typically 60 days)
  • Decision timeline: 30 days standard
  • Enhancement: Request peer-to-peer review with Aetna medical director

External Review: Washington's Powerful Tool

Washington's Independent Review Organization (IRO) process has an 82% overturn rate for specialty drug denials. This means 4 out of 5 specialty drug denials that reach external review are overturned and coverage is required.

External Review Process:

  • Eligibility: After internal appeals exhausted or delayed beyond timelines
  • Deadline: 120 days from final internal denial
  • Timeline: 30 days standard, 72 hours expedited
  • Cost: Free to patients
  • Decision: Legally binding on Aetna

To request external review:

  1. Contact Washington Office of Insurance Commissioner at 1-800-562-6900
  2. Submit request through Aetna or directly to OIC
  3. Provide all documentation from internal appeals
  4. Include additional medical evidence supporting necessity
Tip: Washington's high overturn rate for specialty drugs makes external review particularly powerful for Cerezyme denials. The binding nature means Aetna must provide coverage if the IRO overturns the denial.

When to Escalate to Washington's Insurance Commissioner

Contact the Washington Office of Insurance Commissioner if:

  • Aetna exceeds appeal timelines without good cause
  • You need help navigating the external review process
  • You suspect unfair claims practices
  • Your case involves potential discrimination

OIC Consumer Advocacy: 1-800-562-6900 (8am-5pm, M-F)
Online complaint: insurance.wa.gov/complaints

What to include in your complaint:

  • Timeline of denials and appeals
  • All correspondence with Aetna
  • Medical documentation supporting necessity
  • Specific Washington law violations (if applicable)

Costs and Financial Assistance

Cerezyme Pricing

  • List price: Approximately $1,700+ per 400-unit vial
  • Typical dose: 2-4 vials per infusion, 2-4 times monthly
  • Annual cost: $200,000-$400,000+ without insurance

Financial Assistance Options

Sanofi Patient Assistance:

Copay Assistance:

  • Commercial insurance patients may qualify for copay cards
  • Reduces out-of-pocket costs to as low as $10-$25 per month

Foundation Support:

FAQ: Cerezyme Coverage in Washington

Q: How long does Aetna PA take for Cerezyme in Washington? A: Standard PA decisions take up to 15 business days. Expedited reviews (for urgent cases) must be completed within 72 hours per Washington law.

Q: What if Cerezyme is non-formulary on my Aetna plan? A: You can request a formulary exception with medical justification. Washington's external review process applies to formulary exception denials and has high success rates.

Q: Can I get expedited appeal if I'm already on Cerezyme? A: Yes, if stopping treatment would threaten your health. Document symptom progression or organ involvement to support urgency.

Q: Does step therapy apply if I was stable on Cerezyme before switching to Aetna? A: You may qualify for a continuity of care exception. Provide documentation of stable treatment and request continuation without step therapy.

Q: What happens if my employer plan is self-funded? A: Self-funded ERISA plans may use federal appeal processes instead of Washington state rules, but many voluntarily follow Washington's external review system.

Q: How do I know if my external review decision is binding? A: Under Washington law (RCW 48.43.535), all IRO decisions are binding on carriers. If overturned, Aetna must provide coverage as directed.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies the specific denial basis, and creates targeted, evidence-backed appeals that align with each plan's own policies. For complex cases like Cerezyme coverage, we help ensure appeals include the right clinical evidence, regulatory citations, and procedural requirements to maximize approval chances.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance professional. Coverage policies and state regulations may change. Always verify current requirements with your insurer and consult the Washington Office of Insurance Commissioner for the most up-to-date appeals guidance.

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