By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by Aetna (CVS Health) in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Brineura Covered by Aetna (CVS Health) in Texas

Aetna requires prior authorization for Brineura (cerliponase alfa) in Texas with strict clinical criteria. You'll need confirmed CLN2 disease diagnosis, CLN2 Clinical Rating Scale scores ≥1 in motor and language domains, prescription by a pediatric neurologist or specialist, and administration at a qualified intraventricular infusion center. Start today: Call Aetna Member Services (number on your ID card) to request the Brineura Medication Precertification Request form. If denied, Texas law gives you 65 days for internal appeals and binding external review through the Texas Department of Insurance.

Table of Contents

  1. Understanding Aetna's Brineura Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Medical Necessity Letter Requirements
  5. Appeals Process in Texas
  6. Scripts & Templates for Success
  7. Costs & Financial Assistance
  8. When to Escalate & Get Help
  9. FAQ: Your Top Questions Answered

Understanding Aetna's Brineura Coverage Requirements

Brineura (cerliponase alfa) is the only FDA-approved treatment to slow loss of ambulation in pediatric patients with CLN2 disease (late infantile neuronal ceroid lipofuscinosis type 2). At approximately $702,000 annually, Aetna requires prior authorization for all lines of business under Clinical Policy 0442.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Diagnosis TPP1 deficiency via enzyme assay or genetic testing Lab results, genetic reports Aetna Policy CPB 0442
Age All ages (FDA expanded July 2024) Birth certificate if needed FDA Approval
Functional Status CLN2 Scale motor score ≥1 Scale assessments, neurologist notes Aetna Precert Form
Prescriber Pediatric neurologist or specialist Physician credentials Aetna Policy CPB 0442
Site of Care Qualified intraventricular infusion center Center verification Aetna Policy CPB 0442
Dosing 300 mg every 2 weeks maximum Treatment plan Aetna Policy CPB 0442

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete medical records from the past 6 months
  • TPP1 enzyme assay and genetic testing results
  • CLN2 Clinical Rating Scale scores
  • Timeline: 1-2 weeks to collect

2. Schedule Specialist Consultation (If Needed)

  • Ensure care from pediatric neurologist, epileptologist, or geneticist
  • Request detailed letter of medical necessity
  • Timeline: 2-4 weeks for appointment

3. Submit Prior Authorization Request (Prescriber)

4. Track Your Request (Patient)

  • Call Aetna Member Services (ID card number) after 5 business days
  • Use member portal to check status
  • Timeline: Standard decisions in 30-45 days; expedited in 72 hours

5. Verify Infusion Site Coverage (Patient/Prescriber)

  • Confirm center is in Aetna network
  • Verify intraventricular administration capability
  • Timeline: 1-2 weeks for verification

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing CLN2 Scale Scores Submit complete motor/language assessments CLN2 Clinical Rating Scale with scores ≥1
Non-Qualified Prescriber Provide specialist credentials Board certification in pediatric neurology, epilepsy, or genetics
Unverified Infusion Site Document center capabilities Letter confirming intraventricular expertise
Age/Diagnosis Mismatch Clarify FDA expansion** Reference July 2024 approval for all ages
Device Complications Update medical status Recent imaging showing clear insertion site
From Our Advocates: We've seen families successfully overturn "experimental/investigational" denials by submitting the FDA approval letter alongside the specialist's medical necessity letter. The key is addressing each denial reason point-by-point with specific documentation.

Medical Necessity Letter Requirements

Your pediatric neurologist's letter should address these critical elements:

Essential Components Checklist

  • Diagnosis confirmation: TPP1 deficiency with enzyme levels and genetic mutations
  • Clinical presentation: Current CLN2 Scale scores and functional status
  • FDA indication match: Slowing loss of ambulation in CLN2 disease
  • Prior treatments: Document supportive care limitations
  • Device status: Confirm intraventricular access without complications
  • Prognosis without treatment: Reference natural history data
  • Monitoring plan: Ongoing assessments and safety monitoring

Sample Medical Necessity Template

[Letterhead]

Dear Aetna Medical Director,

I am requesting prior authorization for Brineura (cerliponase alfa) for [Patient Name], a [age]-year-old with confirmed CLN2 disease meeting all Aetna Policy CPB 0442 criteria:

1. DIAGNOSIS: TPP1 deficiency confirmed by enzyme assay ([attach results]) and biallelic TPP1 mutations ([attach genetic report])

2. FUNCTIONAL STATUS: Current CLN2 Scale scores - Motor: [score]/Language: [score] (total [score]), demonstrating ambulatory function

3. SPECIALIST CARE: Board-certified pediatric neurologist with CLN2 expertise

4. DEVICE: Ommaya reservoir placed [date] with no complications ([attach imaging])

5. MEDICAL NECESSITY: FDA-approved indication to slow ambulation loss; no alternative therapies exist for CLN2

Without treatment, [Patient] faces rapid neurologic decline and loss of ambulation by age 6. Brineura is medically necessary and appropriate.

Sincerely,
[Signature and credentials]

Appeals Process in Texas

Counterforce Health helps patients navigate complex insurance denials by turning denial letters into targeted, evidence-backed appeals. Their platform identifies the specific denial basis and drafts point-by-point rebuttals aligned to each payer's own rules.

Texas Appeal Timeline

Process Filing Deadline Aetna Response Time Notes
Level 1 Internal Appeal 65 days from denial 30 days standard / 72 hours expedited Submit via member portal or written request
Level 2 Internal Appeal 65 days from Level 1 denial 30 days standard / 72 hours expedited Include additional documentation
Texas IRO External Review 45 days from final internal denial 20 days standard / 5 days urgent Binding decision through Texas Department of Insurance

How to File Your Appeal

  1. Internal Appeal Submission
    • Use Aetna member portal or call Member Services
    • Include original denial letter with reference number
    • Attach updated medical records and specialist letter
    • Request expedited review if clinically urgent
  2. Texas External Review
    • Contact Texas Department of Insurance: 1-800-252-3439
    • Submit IRO request form with all records
    • TDI oversees process; insurer pays fees
    • Decision is binding on Aetna

Scripts & Templates for Success

Patient Phone Script for Aetna Member Services

"Hi, I'm calling about prior authorization for Brineura for my child with CLN2 disease. My member ID is [number]. I need to:

  • Request the Brineura precertification form
  • Verify our pediatric neurologist is in-network
  • Confirm which infusion centers are covered
  • Check the status of our current request [if applicable]

Can you help me with these items and provide the correct fax number for submissions?"

Peer-to-Peer Request Script (for Clinicians)

"I'm requesting a peer-to-peer review for [Patient Name]'s Brineura prior authorization. This is a pediatric patient with confirmed CLN2 disease meeting all Aetna policy criteria. I have the TPP1 enzyme results, genetic testing, and current CLN2 Scale scores showing ambulatory function. When can we schedule the clinical review?"

Costs & Financial Assistance

Manufacturer Support Programs

  • BioMarin RareConnections: Patient support services and potential financial assistance
  • Contact: Visit BioMarin's website or call their patient services team

Foundation Resources

  • National Organization for Rare Disorders (NORD): Medication assistance programs
  • HealthWell Foundation: Copay assistance for eligible patients
  • Patient Advocate Foundation: Insurance appeals support

Texas-Specific Resources

  • Texas Department of Insurance: Consumer assistance at 1-800-252-3439
  • Office of Public Insurance Counsel: Help line at 1-877-611-6742

When to Escalate & Get Help

File a Complaint When:

  • Aetna misses response deadlines (30 days standard, 72 hours expedited)
  • Denial reasons don't match policy criteria
  • Appeals process violations occur

Texas Department of Insurance Complaint Process

  • Online: TDI Consumer Complaint Portal
  • Phone: 1-800-252-3439
  • Required documents: Denial letters, appeal responses, medical records
  • Timeline: TDI investigates within 30 days

Professional Advocacy Services

Organizations like Counterforce Health specialize in turning insurance denials into successful appeals by ingesting denial letters, plan policies, and clinical notes to draft targeted rebuttals with the right evidence and citations.

FAQ: Your Top Questions Answered

How long does Aetna prior authorization take for Brineura in Texas? Standard decisions take 30-45 days; expedited requests are decided within 72 hours if clinical urgency is documented.

What if Brineura isn't on Aetna's formulary? You can request a formulary exception with medical necessity documentation showing no covered alternatives exist for CLN2 disease.

Can I get expedited review if my child is declining rapidly? Yes, Texas allows expedited appeals when delays would jeopardize health. Your neurologist must certify the urgency.

Does step therapy apply to Brineura? No, there are no alternative disease-modifying treatments for CLN2 disease, so step therapy requirements don't apply.

What happens if both internal appeals are denied? Texas provides binding external review through an Independent Review Organization (IRO) that can overturn Aetna's denial.

Are there age restrictions for coverage? The FDA expanded Brineura approval to all ages in July 2024, so age restrictions should not apply.

Can home infusion be covered? Aetna's policy requires qualified intraventricular administration sites. Home infusion coverage depends on provider capabilities and network status.

How much will I pay out-of-pocket? Costs depend on your specific plan's specialty drug tier and deductible. Contact Aetna Member Services for your exact copay/coinsurance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by plan type and can change. Always verify current requirements with Aetna and consult your healthcare team for medical decisions. For plan-specific questions, contact Aetna Member Services directly.

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