By Counterforce Health Team in Cerezyme (imiglucerase) —

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

Answer Box: Fastest Path to Approval

Cerezyme (imiglucerase) requires prior authorization from Aetna CVS Health in North Carolina. To get approved, you'll need: (1) confirmed Type 1 Gaucher disease diagnosis with enzyme testing and genetic confirmation, (2) completed Aetna Cerezyme Precertification Request Form, and (3) prescription from a Gaucher disease specialist. If denied, North Carolina's Smart NC external review process provides binding decisions within 45 days. Start today: Contact your specialist to gather diagnostic testing results and complete the PA form—fax to 1-888-267-3277.

Table of Contents

What This Guide Covers

This guide helps patients with Type 1 Gaucher disease and their healthcare teams navigate Aetna CVS Health's prior authorization process for Cerezyme (imiglucerase) in North Carolina. We'll walk through every step from initial submission to appeals, including North Carolina's powerful external review rights through Smart NC.

Who this helps: Patients diagnosed with Type 1 Gaucher disease, their families, prescribing physicians, and specialty pharmacy teams working with Aetna CVS Health plans in North Carolina.

Quick outcome preview: With proper documentation, initial approvals typically take 30-45 days. If denied, North Carolina's external review process overturns roughly 40-60% of specialty drug denials when strong clinical evidence is provided.

At Counterforce Health, we help patients turn insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules, pulling the right medical citations and procedural requirements for your case.

Before You Start: Verify Your Coverage

Check Your Plan Type

Not all Aetna plans work the same way. Verify whether you have:

  • Commercial Aetna plan (through employer or individual purchase)
  • Aetna Medicare Advantage
  • Aetna Medicaid (through North Carolina's managed care)
Tip: Call the member services number on your insurance card to confirm your specific plan type and formulary.

Confirm Formulary Status

Cerezyme is typically covered by Aetna but requires prior authorization and may be subject to step therapy requirements. Check your plan's 2025 formulary to confirm:

  • Formulary tier (usually specialty tier)
  • Prior authorization requirements (yes, required)
  • Step therapy protocols (may need to try Elelyso first)

Verify Network Status

Ensure your prescribing physician and infusion site are in-network with your Aetna plan. Cerezyme is administered via IV infusion, typically at:

  • Hospital outpatient infusion centers
  • Specialty infusion clinics
  • Home infusion services (if covered)

Gather What You Need

Diagnosis Documentation

Required for approval:

  • Beta-glucosidase enzyme assay results showing deficient activity
  • GBA gene testing confirming pathogenic mutations
  • ICD-10 diagnosis code for Type 1 Gaucher disease (E75.22)
  • Clinical evidence of disease burden (anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly)

Clinical Documentation

Your specialist will need to provide:

  • Detailed clinical notes documenting Gaucher disease symptoms
  • Laboratory results (CBC, comprehensive metabolic panel, liver function tests)
  • Imaging studies if bone disease is present
  • Treatment goals and monitoring plan
  • Dosing rationale (FDA-approved range: 2.5-60 units/kg)

Prior Authorization Form

Download and complete the Aetna Cerezyme Medication Precertification Request Form. This form requires:

  • Patient demographics and insurance information
  • Prescriber credentials (must be Gaucher disease specialist)
  • Diagnosis confirmation
  • Dosing and administration details
  • Prior therapy history (if applicable)

Submit the Request

Submission Methods

Primary method: Fax completed form and supporting documents to 1-888-267-3277

Alternative methods:

  • Aetna provider portal (verify current link with your provider)
  • Mail to address specified on the PA form

Clean Request Packet Checklist

✓ Completed Cerezyme PA form (all fields legible)
✓ Enzyme assay results
✓ Genetic testing report
✓ Prescriber's clinical notes
✓ Laboratory results supporting disease burden
✓ Prior therapy documentation (if step therapy applies)
✓ Prescriber attestation/signature

Specialty Pharmacy Routing

Aetna typically routes Cerezyme through:

  • CVS Specialty Pharmacy (preferred)
  • Other Aetna-contracted specialty pharmacies

Confirm your specialty pharmacy is in-network before submission.

Follow-Up Cadence

When to Call

  • Day 3-5: Confirm receipt of PA request
  • Day 15: Check processing status
  • Day 25: Follow up if no decision received

Sample Call Script

"Hi, I'm calling to check the status of a prior authorization request for Cerezyme submitted on [date]. The patient name is [name], member ID [number], and the reference number is [if available]. Can you tell me the current status and expected decision date?"

Document Everything

Keep records of:

  • Reference numbers from each call
  • Names of representatives spoken with
  • Dates and times of all communications
  • Any additional information requested

Typical Timelines

North Carolina Requirements

Standard decisions: Aetna must respond within 30-45 days for non-urgent requests
Expedited decisions: 72 hours for urgent medical situations
Appeal decisions: 30 days for standard appeals, 72 hours for expedited appeals

Note: These timelines are regulated by North Carolina insurance law and apply to fully insured plans.

What Speeds Decisions

  • Complete PA form with all required attachments
  • Clear documentation of Gaucher disease diagnosis
  • Specialist prescriber credentials
  • Prior authorization submitted by in-network specialty pharmacy

What Slows Decisions

  • Missing diagnostic test results
  • Incomplete PA forms
  • Non-specialist prescriber
  • Step therapy requirements not addressed

If You're Asked for More Info

Common Information Requests

Medical necessity clarification: Provide additional clinical notes documenting disease severity and treatment goals

Dosing justification: Reference FDA labeling showing approved dosing range of 2.5-60 units/kg

Step therapy documentation: If Elelyso is preferred, document contraindications, prior failures, or intolerance

Responding Quickly

  • Submit additional information within 10 business days of request
  • Include original PA reference number on all correspondence
  • Fax to the same number used for initial submission (1-888-267-3277)

If Denied: Appeals Process

First-Level Internal Appeal

Timeline: File within 180 days of denial
Decision timeframe: 30 days (standard) or 72 hours (expedited)
Required: Written appeal letter addressing specific denial reasons

Peer-to-Peer Review

Request a clinical discussion between your prescriber and Aetna's medical director:

  • Call Aetna provider services to schedule
  • Have prescriber prepare clinical rationale
  • Document outcomes of the discussion

Sample Appeal Points

Address common denial reasons:

  • "Not medically necessary": Reference FDA approval for Type 1 Gaucher disease with documented clinical manifestations
  • "Step therapy not met": Document contraindications or failures with preferred alternatives
  • "Experimental/investigational": Cite FDA approval and established treatment guidelines

North Carolina External Review with Smart NC

If Aetna denies your internal appeals, North Carolina residents have powerful external review rights through Smart NC.

Eligibility

  • Fully insured Aetna plan (not self-funded employer plans)
  • Completed Aetna's internal appeal process
  • Denial based on medical necessity or experimental/investigational determination

Timeline and Process

File within: 120 days of final internal appeal denial
Decision timeframe: 45 days (standard) or 72 hours (expedited for urgent cases)
Contact: 855-408-1212 for forms and assistance

Required Documentation

  • Copy of Aetna's denial letter
  • Completed internal appeal records
  • Supporting medical documentation
  • Smart NC external review request form

Success Rates

External reviews through Smart NC overturn approximately 40-60% of specialty drug denials when comprehensive clinical evidence is provided.

Important: Smart NC's decision is binding—if they approve coverage, Aetna must provide it within 3 business days.

Renewal & Re-Authorization

When to Resubmit

Most Cerezyme approvals are granted for 6-12 months. Calendar renewal requests 60 days before expiration to avoid treatment interruptions.

Renewal Documentation

  • Updated clinical notes showing treatment response
  • Current laboratory values
  • Continued medical necessity statement
  • Any dosing adjustments with rationale

Evidence of Benefit

Document clinical improvements such as:

  • Hemoglobin and platelet count improvements
  • Reduced organomegaly
  • Bone pain reduction
  • Improved quality of life measures

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Diagnosis not confirmed Submit enzyme assay and genetic testing results
Step therapy not met Document Elelyso contraindications/failures
Not medically necessary Provide clinical evidence of disease burden
Non-specialist prescriber Transfer prescription to Gaucher disease specialist
Dosing outside guidelines Reference FDA labeling for approved dose range
Missing clinical documentation Submit comprehensive progress notes and labs

FAQ

How long does Aetna CVS Health PA take in North Carolina?
Standard decisions take 30-45 days. Expedited requests for urgent medical situations receive decisions within 72 hours.

What if Cerezyme is non-formulary on my plan?
Request a formulary exception with medical necessity documentation. If denied, appeal through Aetna's internal process, then Smart NC external review.

Can I request an expedited appeal?
Yes, if delaying treatment would seriously jeopardize your health. Your physician must document the urgent medical need.

Does step therapy apply if I've tried alternatives outside North Carolina?
Yes, document prior therapy trials with medical records from previous providers. Aetna should accept out-of-state documentation.

What's the difference between medical and pharmacy benefit coverage?
Cerezyme administered via IV infusion typically falls under medical benefit. Confirm with Aetna which benefit applies to your specific situation.

Can I appeal to Smart NC while still going through Aetna's internal appeals?
No, you must complete Aetna's internal appeal process first, except in urgent situations where Smart NC may waive this requirement.

Quick Checklist

Before Starting:

  • Confirm Type 1 Gaucher disease diagnosis
  • Verify Aetna plan type and formulary status
  • Ensure specialist prescriber is in-network

Documentation Needed:

  • Enzyme assay results
  • Genetic testing confirmation
  • Clinical notes from specialist
  • Laboratory results showing disease burden
  • Completed Aetna PA form

Submission:

  • Fax complete packet to 1-888-267-3277
  • Confirm specialty pharmacy is in-network
  • Document submission date and reference number

Follow-Up:

  • Call Day 3-5 to confirm receipt
  • Check status at Day 15 and Day 25
  • Prepare appeal documentation if denied

If Denied:

  • File internal appeal within 180 days
  • Consider peer-to-peer review
  • Contact Smart NC at 855-408-1212 for external review

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with Aetna CVS Health and consult with your healthcare provider for medical decisions.

For additional support navigating insurance appeals, Counterforce Health provides specialized assistance turning denials into targeted, evidence-backed appeals with the right medical citations and procedural requirements for your specific case.

Sources & Further Reading

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