By Counterforce Health Team in Brineura (cerliponase alfa) —

Requirements Checklist to Get Brineura (cerliponase alfa) Covered by Aetna (CVS Health) in Washington

Answer Box: Getting Started

Aetna (CVS Health) requires prior authorization for Brineura (cerliponase alfa) with strict clinical criteria. Your fastest path to approval: confirm CLN2 diagnosis with genetic/enzyme testing, ensure treatment by a metabolic specialist at an approved infusion center, and submit complete documentation showing motor function assessment. Start by calling Aetna Member Services (number on your ID card) to request prior authorization forms. If denied, Washington residents can appeal through the state's Independent Review Organization process via the Office of Insurance Commissioner at 1-800-562-6900.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: Tracking Your Request
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in Washington
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is for families of children with CLN2 disease (neuronal ceroid lipofuscinosis type 2) who need Brineura (cerliponase alfa) covered by Aetna (CVS Health) in Washington state. You'll also find this useful if you're a clinician preparing prior authorization documentation or appealing a denial.

Expected outcome: With complete documentation meeting Aetna's criteria, most initial requests are approved within 2-4 weeks. If denied, Washington's strong external review process provides an additional pathway to coverage.

Member & Plan Basics

Active Coverage Requirements

  • Verify eligibility: Call the Member Services number on your Aetna ID card to confirm active coverage
  • Plan type: Brineura requires prior authorization across all Aetna plan types (commercial, Medicare Advantage, Medicaid managed care)
  • Deductible status: High-deductible plans may require meeting your deductible first; specialty tier copays typically apply after approval

Authorization Timeline

  • Standard review: 2-4 weeks after complete submission
  • Expedited review: Available for urgent cases with physician justification (typically ≤72 hours)
  • Renewal timing: Start renewal process 60-90 days before current authorization expires

Clinical Criteria Requirements

Aetna follows strict prior authorization criteria for Brineura coverage:

Mandatory Requirements

  • Confirmed CLN2 diagnosis by enzyme assay (TPP1 deficiency) or genetic testing
  • Pediatric patient (FDA indication expanded July 2024 to include all ages from birth)
  • Specialist involvement: Prescribed by or in consultation with a metabolic disease or lysosomal storage disorder specialist
  • Qualified administration: Must be given by physician skilled in intraventricular administration
  • Dosage limits: Maximum 300 mg every other week

Exclusions That Block Coverage

  • Active intraventricular device-related complications
  • Presence of ventriculoperitoneal shunt
  • Exceeding maximum dosage
  • All non-CLN2 uses (deemed investigational)

Continuation Criteria

For ongoing coverage, patients must demonstrate:

  • No loss or only slowed loss of ambulation from baseline
  • Motor function score ≥1 on CLN2 Clinical Rating Scale
  • Regular safety monitoring and adherence to biweekly schedule

Coding & Billing Information

Primary Codes

  • HCPCS J-code: J0567 (Injection, cerliponase alfa, 1 mg)
  • NDC: 68682-0520-01 (Brineura 150 mg/5 mL)
  • ICD-10: E75.249 (Other neuronal ceroid lipofuscinoses)

Billing Notes

  • Each vial contains 150 mg; bill units in milligrams
  • Prior authorization required for both drug and site of care
  • Link diagnosis code E75.249 to support medical necessity

Documentation Packet

Provider Note Elements

Your specialist's documentation must include:

  • Confirmed CLN2 diagnosis with genetic/enzyme test results
  • Current motor function using CLN2 Clinical Rating Scale
  • Treatment history and response to any prior therapies
  • Baseline ambulatory status and treatment goals
  • Administration plan including infusion center details

Medical Necessity Letter Components

Clinician Corner: Your letter should address these key points:Patient's confirmed CLN2 diagnosis and clinical presentationFDA indication for Brineura to slow loss of ambulation in pediatric CLN2 patientsCurrent motor function assessment and progression riskLack of alternative disease-modifying treatmentsTreatment plan with qualified infusion center

Required Attachments

Submission Process

Correct Forms and Portals

  • Use the current Aetna Brineura precertification form
  • Submit via Aetna provider portal or fax (verify current fax number with Member Services)
  • Include all required fields to avoid automatic rejections

Common Submission Errors

  • Incomplete motor function documentation
  • Missing specialist consultation
  • Outdated forms or incorrect patient information
  • Insufficient infusion center credentials

Specialty Pharmacy Coordination

CVS Specialty Requirements

Once approved, Brineura is typically dispensed through CVS Specialty Pharmacy with coordination to your infusion center. The process requires:

  • Infusion center verification: Must have neurosurgical capabilities for device implantation
  • Staff training: Aseptic intraventricular administration techniques
  • Equipment requirements: Compatible infusion pumps and monitoring capabilities
  • Shipment coordination: Direct delivery to approved treatment centers

BioMarin RareConnections Support

The manufacturer's patient support program provides:

  • Case management and insurance navigation
  • Prior authorization assistance
  • Coordination with CVS Specialty for timely delivery
  • Ongoing education for treatment centers

After Submission: Tracking Your Request

What to Record

  • Confirmation number from your submission
  • Case manager contact if assigned
  • Review timeline provided by Aetna
  • Required follow-up documentation or calls

Status Check Schedule

  • Week 1: Confirm receipt and completeness
  • Week 2-3: Follow up if no initial response
  • Week 4: Escalate if no decision received

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix Required Documentation
Age/diagnosis mismatch Cite July 2024 FDA expansion Updated FDA labeling, genetic confirmation
Lack of specialist involvement Add metabolic specialist consultation Specialist referral and assessment notes
Insufficient motor documentation Complete CLN2 Clinical Rating Scale Baseline and current motor function scores
Non-qualified infusion site Verify center capabilities Facility credentials and staff training verification
"Experimental" designation Reference FDA approval FDA labeling and indication documentation

Appeals Process in Washington

If Aetna denies your request, Washington residents have strong appeal rights:

Internal Appeals

  1. First level: Call Member Services to initiate formal appeal
  2. Documentation: Submit additional clinical evidence
  3. Timeline: Typically 30 days for standard review

External Review (Independent Review Organization)

If internal appeals fail, Washington offers binding external review:

  • Contact: Washington Office of Insurance Commissioner at 1-800-562-6900
  • Process: OIC assigns independent medical reviewers
  • Timeline: 180 days to request after final internal denial
  • Outcome: Binding decision on Aetna if overturned
From our advocates: We've seen families successfully overturn Brineura denials by emphasizing the July 2024 FDA indication expansion and providing comprehensive motor function documentation. The key is demonstrating that early treatment can preserve ambulatory function even in presymptomatic children.

When to Escalate

Contact the Washington OIC immediately if:

  • Aetna exceeds review timelines
  • You're not receiving clear denial reasons
  • Internal appeals aren't being processed properly

Quick Reference Checklist

Before You Start

  • Aetna member ID and active coverage confirmed
  • CLN2 diagnosis confirmed by genetic/enzyme testing
  • Metabolic specialist consultation completed
  • Infusion center identified and verified
  • Current Aetna prior authorization form obtained

Clinical Documentation

  • CLN2 Clinical Rating Scale assessment completed
  • Motor function baseline and current scores documented
  • Treatment goals and monitoring plan specified
  • Alternative treatments considered and documented

Submission Requirements

  • All form fields completed accurately
  • Required attachments included
  • Specialist letter of medical necessity attached
  • Confirmation of submission received

If Denied

  • Denial reason clearly understood
  • Additional documentation gathered
  • Internal appeal filed within deadline
  • External review option considered if needed

About Counterforce Health: Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-based rebuttals. The platform specializes in complex specialty medications like Brineura, ensuring appeals address payer-specific requirements with appropriate clinical documentation and regulatory citations.

For additional support with your Brineura coverage journey, Counterforce Health can help analyze denial letters and prepare targeted appeals that address Aetna's specific criteria while leveraging Washington's strong consumer protection framework.

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical or legal advice. Coverage decisions depend on individual circumstances and plan terms. Always verify current requirements with Aetna and consult with your healthcare team for medical decisions.

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