By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (imiglucerase) Covered by Aetna in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Cerezyme Covered by Aetna in New Jersey

Aetna covers Cerezyme (imiglucerase) for confirmed Gaucher disease Types 1-3 with prior authorization. You'll need enzyme deficiency test results or genetic testing, plus documentation that Elelyso was ineffective or contraindicated. If denied, you have 180 days for internal appeals, then 4 months for New Jersey's external review through IHCAP. Start by requesting the prior authorization form from your doctor or Aetna's provider portal.

Table of Contents

  1. Understanding Aetna's Cerezyme Coverage
  2. Reading Your Denial Letter
  3. Common Denial Reasons and How to Fix Them
  4. Step-by-Step: Fastest Path to Approval
  5. First-Level Appeal Process
  6. Peer-to-Peer Review Strategy
  7. New Jersey External Appeals (IHCAP)
  8. Appeal Letter Templates
  9. Costs and Financial Assistance
  10. When to Escalate to State Regulators
  11. FAQ

Understanding Aetna's Cerezyme Coverage

Aetna covers Cerezyme for Gaucher disease types 1, 2, and 3 when specific criteria are met. The medication is available through both pharmacy and medical benefits, depending on your plan design.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
Confirmed Diagnosis Gaucher disease proven by testing Enzyme assay showing glucocerebrosidase deficiency OR genetic testing
Step Therapy Must try Elelyso first Records showing Elelyso failure, contraindication, or intolerance
Prior Authorization Pre-approval required Complete PA form with clinical documentation
Specialist Care Treatment oversight Prescription from qualified specialist

The FDA-approved dosing ranges from 2.5 units/kg three times weekly to 60 units/kg every two weeks, with most patients receiving 60 units/kg every two weeks.

Reading Your Denial Letter

When Aetna denies Cerezyme coverage, the letter will specify the exact reason. Common denial codes include:

  • Medical necessity not established: Missing diagnostic tests or clinical documentation
  • Step therapy required: Need to try Elelyso first
  • Non-formulary: Drug not on preferred list (requires exception)
  • Quantity limits exceeded: Requesting more than standard allowance
Tip: Look for the appeal deadline in your denial letter. You typically have 180 days to file an internal appeal, but this can vary by plan type.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documents
No enzyme testing Submit lab results Beta-glucosidase leukocyte test showing <30% normal activity
Elelyso not tried Document contraindication Medical records showing allergy, intolerance, or clinical failure
Dosing outside guidelines Justify medical necessity Specialist letter explaining weight-based dosing rationale
Missing specialist Get proper referral Prescription from hematologist or geneticist

Step-by-Step: Fastest Path to Approval

  1. Gather diagnostic proof (Patient/Clinic): Obtain enzyme deficiency test results showing glucocerebrosidase activity below 30% of normal range.
  2. Document Elelyso trial (Clinic): If applicable, compile records showing Elelyso failure, contraindication, or intolerance from previous treatment attempts.
  3. Submit prior authorization (Clinic): Complete Aetna's Cerezyme PA form at least 2 weeks before treatment start.
  4. Follow up within 5-7 days (Patient): Call Aetna member services to confirm receipt and processing status.
  5. Request peer-to-peer if denied (Clinic): Schedule medical director review within 24-48 hours of denial notification.
  6. File formal appeal if needed (Patient/Clinic): Submit within 180 days with comprehensive medical necessity documentation.
  7. Pursue external review (Patient): If internal appeals fail, file with New Jersey IHCAP within 4 months of final denial.

First-Level Appeal Process

Your internal appeal should include a detailed medical necessity letter addressing Aetna's specific denial reasons. Key components include:

Medical Necessity Letter Checklist

  • Confirmed Gaucher disease diagnosis with enzyme or genetic testing results
  • Clinical manifestations requiring treatment (anemia, thrombocytopenia, bone disease, organomegaly)
  • Prior therapy documentation showing Elelyso failure or contraindication
  • Dosing rationale based on patient weight and disease severity
  • Treatment goals and monitoring plan
Clinician Corner: Include references to FDA labeling for approved indications and dosing guidelines. Cite specific sections that support your patient's treatment plan.

Peer-to-Peer Review Strategy

When Aetna offers a peer-to-peer review, prepare these talking points:

Pre-Call Preparation

  • Review patient's complete medical history
  • Have lab results and imaging readily available
  • Prepare 2-3 key clinical points supporting medical necessity
  • Know exact dosing rationale and administration plan

Key Discussion Points

  1. Confirmed Gaucher disease with specific test results
  2. Clinical symptoms requiring immediate treatment
  3. Contraindications or failures with alternative therapies
  4. Expected treatment outcomes and monitoring plan

New Jersey External Appeals (IHCAP)

If Aetna's internal appeals fail, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review through Maximus Federal Services.

IHCAP Timeline and Process

Stage Timeline Requirements
Filing Deadline 4 months from final denial Complete internal appeals first
Preliminary Review 5 business days Eligibility verification
Additional Information 5 business days after acceptance Submit supporting documents
Final Decision 45 days (standard) / 48 hours (urgent) Binding determination

The external review is free to patients, and approximately 50% of appeals are decided in favor of consumers.

From Our Advocates

"We've seen several Gaucher disease cases where the initial denial was based on missing enzyme testing documentation. Once families obtained the specific glucocerebrosidase activity results and resubmitted with a clear medical necessity letter, approval typically followed within 2-3 weeks. The key is ensuring all diagnostic criteria are explicitly documented rather than assumed."

Appeal Letter Templates

Initial Appeal Opening

"I am writing to formally appeal Aetna's denial of coverage for Cerezyme (imiglucerase) for [Patient Name], Member ID [number]. The denial dated [date] cited [specific reason]. This treatment is medically necessary for my confirmed Type 1 Gaucher disease, as evidenced by the following clinical documentation..."

Medical Necessity Paragraph

"My diagnosis was confirmed by [enzyme assay/genetic testing] showing [specific results]. Current symptoms include [list manifestations]. Previous treatment with [alternative therapy] resulted in [outcome], necessitating Cerezyme therapy per FDA-approved indications."

Dosing Justification

"The requested dosing of [X units/kg every X weeks] aligns with FDA labeling recommendations for patients with [specific clinical characteristics]. This regimen is supported by [cite specific guideline or study] and is appropriate for my weight of [X kg] and disease severity."

Costs and Financial Assistance

Cerezyme can cost over $1,700 per 400-unit vial. If coverage is delayed or denied:

  • Sanofi Patient Assistance: Contact manufacturer for potential support programs
  • CVS Specialty Pharmacy: May offer payment plans for covered prescriptions
  • State Programs: New Jersey residents may qualify for additional assistance through state pharmaceutical programs

For current assistance options, verify eligibility directly with Sanofi's patient support (verify with the source linked below).

When to Escalate to State Regulators

If Aetna fails to follow proper appeal procedures or timelines, contact the New Jersey Department of Banking and Insurance at 1-800-446-7467. File a complaint if:

  • Appeals exceed stated timelines without explanation
  • Required forms or processes are not provided
  • Coverage decisions appear to violate state insurance laws

FAQ

How long does Aetna prior authorization take for Cerezyme in New Jersey? Standard decisions typically take 30-45 days. Expedited reviews for urgent cases may be completed within 72 hours.

What if Cerezyme is not on my Aetna formulary? Request a formulary exception with medical necessity documentation. Aetna must review non-formulary requests when medically appropriate alternatives are unavailable.

Can I get expedited appeals for Cerezyme? Yes, if treatment delay would seriously jeopardize your health. Both Aetna and New Jersey IHCAP offer expedited review processes.

Do I need to try Elelyso before Cerezyme? Aetna requires documentation of Elelyso failure, contraindication, or intolerance before approving Cerezyme as first-line therapy.

What happens if my appeal is approved? Aetna must authorize coverage and reimburse claims within 10 business days of the decision, including any retroactive coverage for medically necessary care.

How much does the New Jersey external appeal cost? External appeals through IHCAP are free to patients. The insurance company pays all review costs.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and citations to support medical necessity arguments.

For complex prior authorization cases like Cerezyme, having the right documentation and appeal strategy can make the difference between approval and denial. Counterforce Health's approach of matching clinical evidence to specific payer criteria has helped numerous patients access essential specialty medications through the appeals process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Appeal processes and requirements may change; verify current procedures with official sources.

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