By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by Aetna (CVS Health) in New York: Complete Appeals Guide

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

Aetna requires prior authorization for Brineura (cerliponase alfa) under the medical benefit for pediatric CLN2 patients ≥3 years with confirmed TPP1 deficiency and motor function scores ≥1. Submit via neurologist with diagnosis confirmation, CLN2 Clinical Rating Scale scores, and site-of-care verification. If denied, New York offers binding external appeals through the Department of Financial Services within 4 months. First step today: Call Aetna at 1-800-872-3862 to verify benefits and request the Brineura precertification form.

Table of Contents

  1. Understanding Aetna's Coverage Requirements
  2. Prior Authorization: Step-by-Step Process
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for New York Patients
  5. Medical Necessity Documentation
  6. New York External Review Rights
  7. Cost Assistance and Support Resources
  8. FAQ: Brineura Coverage with Aetna

Understanding Aetna's Coverage Requirements

Brineura (cerliponase alfa) is covered under Aetna's medical benefit, not the CVS Caremark pharmacy benefit, because it requires specialized intraventricular infusion via surgically implanted device. Aetna's Clinical Policy Bulletin 0442 outlines strict medical necessity criteria for this $27,000 per infusion therapy.

Coverage at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all plans Brineura precert form
Age Eligibility ≥3 years (FDA indication) Birth records, medical history
Diagnosis Confirmed CLN2 (TPP1 deficiency) Enzyme assay or genetic testing
Motor Function CLN2 Scale motor score ≥1 Current assessment scores
Prescriber Neurologist experienced in CLN2 Provider credentials, treatment history
Administration Site Approved infusion center Site verification, neurosurgery clearance

Prior Authorization: Step-by-Step Process

Step 1: Verify Benefits and Gather Documentation

Call Aetna member services at 1-800-872-3862 with your member ID to confirm:

  • Current plan status and medical benefit coverage
  • Network status of prescribing neurologist and infusion site
  • Any existing prior authorizations

Step 2: Complete Medical Documentation

Your neurologist must provide:

  • Diagnosis confirmation: TPP1 enzyme deficiency results or genetic testing showing pathogenic TPP1 variants
  • CLN2 Clinical Rating Scale: Current motor domain score (must be ≥1)
  • Treatment history: Documentation of symptomatic CLN2 with slowed ambulation loss
  • Safety clearance: No acute device complications, infections, or contraindications

Step 3: Submit Prior Authorization Request

Submit the Aetna Brineura precertification form via:

  • Aetna provider portal (fastest processing)
  • Fax to number listed on form
  • Mail to address specified in form instructions

Timeline: Standard review takes 30-45 days; expedited review available within 72 hours for urgent cases.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Age/diagnosis mismatch Submit birth certificate + genetic/enzyme testing Birth records, lab reports
Insufficient motor function Provide current CLN2 Scale assessment Recent neurological evaluation
Lack of specialist care Confirm neurologist credentials and experience Provider CV, treatment protocols
Site-of-care issues Verify approved infusion center Facility certification, safety protocols
"Not medically necessary" Submit medical necessity letter with guidelines FDA labeling, peer-reviewed studies
From our advocates: We've seen families successfully overturn denials by working closely with their CLN2 specialist to document the progression timeline and emphasize that Brineura is the only FDA-approved therapy for this rare disease. The key is showing clear motor decline without treatment and the specialized infusion requirements.

Appeals Process for New York Patients

Internal Appeals with Aetna

First-level appeal must be filed within 180 days of the denial notice:

  1. Submit appeal letter addressing specific denial reasons
  2. Include supporting documentation: Updated CLN2 scores, medical necessity letter, peer-reviewed literature
  3. Request expedited review if delay could jeopardize health
  4. Timeline: Standard appeals decided within 30 days; expedited within 72 hours

Medical Necessity Letter Checklist

Your neurologist's appeal should include:

  • Problem statement: CLN2 diagnosis with progressive neurodegeneration
  • Prior treatments: Document that no alternative therapies exist for CLN2
  • Clinical rationale: FDA approval for slowing motor decline in symptomatic patients
  • Guideline citations: FDA labeling, clinical trial data
  • Monitoring plan: Regular CLN2 Scale assessments, safety monitoring

When appeals fail with Aetna, New York patients have powerful external review rights that can override the insurer's decision.

New York External Review Rights

New York's Department of Financial Services provides binding external appeals for specialty drug denials. This is one of the strongest patient protection systems in the country.

External Appeal Process

Eligibility: Must complete internal appeal or have insurer waive requirement Timeline: File within 4 months of final denial Decision: Binding on both patient and insurer

Appeal Type Decision Timeline Best For
Standard External Appeal 30 days Non-urgent denials
Expedited External Appeal 72 hours Health at serious risk
Expedited Formulary Exception 24 hours Non-formulary drug, urgent need

How to File External Appeal

  1. Download forms from NY DFS website
  2. Complete application with physician attestation
  3. Submit via:
    • Mail: NY DFS, 99 Washington Avenue, Box 177, Albany, NY 12210
    • Fax: (800) 332-2729
    • For expedited: Call 888-990-3991

Cost: Maximum $25 filing fee (waived for financial hardship or Medicaid)

Tip: New York's external appeal database shows successful overturns for rare disease therapies when medical necessity is well-documented. Search previous decisions at Community Health Advocates.

Cost Assistance and Support Resources

Patient Support Programs

  • BioMarin RareConnections: Financial assistance and case management
  • Verify current programs: Contact manufacturer directly as programs change

Free Help with Appeals

Community Health Advocates: Call 888-614-5400 for free insurance appeal assistance. CHA helps New York patients navigate internal appeals and external review processes, including specialty drug denials.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to payer requirements.

FAQ: Brineura Coverage with Aetna

Q: How long does Aetna prior authorization take for Brineura in New York? A: Standard review takes 30-45 days; expedited review within 72 hours for urgent cases. Submit via provider portal for fastest processing.

Q: What if Brineura is denied as "experimental"? A: Emphasize FDA approval since 2017 for CLN2 patients ≥3 years. Include FDA labeling and clinical trial data showing efficacy in slowing motor decline.

Q: Can I get expedited review if my child is declining rapidly? A: Yes. Request expedited prior authorization or appeal if delay could worsen your child's condition. Provide documentation of rapid progression.

Q: What happens if Aetna denies the appeal? A: File external appeal with NY Department of Financial Services within 4 months. Their decision is binding and can override Aetna's denial.

Q: Does step therapy apply to Brineura? A: No alternative therapies exist for CLN2, so step therapy typically doesn't apply. Emphasize Brineura's unique FDA indication.

Q: How do I find an approved infusion site? A: Contact Aetna provider services to verify network status of CLN2 treatment centers. Sites must have experience with intraventricular infusion.

When to Escalate

Contact the New York Department of Financial Services at 800-342-3736 if:

  • Aetna fails to meet review timelines
  • Appeals process seems unfair or incomplete
  • You need help understanding your external review rights

For complex cases involving multiple denials or procedural issues, consider consulting with Counterforce Health, which helps patients and clinicians build stronger appeals by identifying specific denial reasons and crafting targeted rebuttals with the right medical evidence.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for the most current requirements. Coverage policies may vary by plan type and can change.

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