By Counterforce Health Team in Brineura (cerliponase alfa) —

Do You Qualify for Brineura (cerliponase alfa) Coverage by Humana in Texas? Decision Tree & Next Steps

Answer Box: Getting Brineura Covered by Humana in Texas

If your child has confirmed CLN2 disease and is 3+ years old, you likely qualify for Brineura coverage through Humana Medicare Advantage. The fastest path: have your pediatric neurologist submit prior authorization through Humana's provider portal with TPP1 enzyme/genetic test results, current CLN2 functional scores, and a medical necessity letter. Standard decisions take 30 days; expedited requests get 72-hour turnaround. If denied, you have 65 days to appeal through Medicare's 5-level process, starting with Humana's internal review.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Your Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives and Exception Requests
  6. If Denied: Your Texas Appeal Path
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & How to Fix Them
  9. Medical Necessity Letter: Clinician Checklist
  10. Frequently Asked Questions

How to Use This Decision Tree

This guide helps families and clinicians navigate Humana's prior authorization process for Brineura (cerliponase alfa) in Texas. Start with the eligibility triage below to determine your likelihood of approval, then follow the corresponding action steps.

Important: This covers Humana Medicare Advantage plans in Texas. If you have traditional Medicare with a separate Part D plan, or employer-sponsored coverage through Humana, some details may differ.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if your child has:

  • Confirmed CLN2 diagnosis via TPP1 enzyme deficiency AND/OR biallelic TPP1 gene mutations
  • Age 3 years or older (updated FDA labeling includes birth+, but some policies still specify 3+)
  • Documented functional decline with measurable motor/language function remaining
  • Pediatric neurologist as prescriber
  • Treatment planned at a qualified neurosurgical/infusion center

⚠️ Possibly Eligible if your child has:

  • Suspected CLN2 but incomplete diagnostic testing
  • Age under 3 (may need updated policy interpretation)
  • Advanced disease but some preserved function
  • Non-specialist prescriber willing to refer to pediatric neurology

❌ Not Yet Eligible if:

  • No CLN2 diagnosis confirmed
  • End-stage disease with complete loss of motor/language function
  • Active contraindications (device infection, severe complications)

If "Likely Eligible": Your Document Checklist

Before submitting your prior authorization, gather these required documents:

Diagnostic Evidence

  • TPP1 enzyme assay results showing deficiency (typically <10-20% of normal)
  • Genetic testing report confirming biallelic TPP1 pathogenic variants
  • Lab reports clearly labeled from CLIA-certified laboratories

Clinical Documentation

  • Recent pediatric neurology consultation with CLN2 diagnosis
  • Baseline functional assessment using CLN2 Clinical Rating Scale or Hamburg Scale
  • Current ambulation status (independent, assisted, non-ambulatory)
  • Documentation of progression over time (lost milestones, increased falls, seizure changes)

Treatment Planning

  • Neurosurgical consultation for intraventricular reservoir placement
  • Treatment center confirmation experienced with intraventricular infusions
  • Dosing plan aligned with FDA labeling (300 mg every 2 weeks)

Administrative Requirements

  • Completed PA form through Humana's Medicare PAL process
  • Correct coding (HCPCS J0567 for cerliponase alfa)
  • Medical necessity letter from pediatric neurologist

If "Possibly Eligible": Tests to Request

If your diagnostic workup is incomplete, ask your neurologist to order:

  1. TPP1 enzyme activity assay (blood or skin fibroblast sample)
  2. TPP1 gene sequencing to identify pathogenic variants
  3. Baseline CLN2 functional assessment to document current abilities
  4. Brain MRI to assess disease progression (supportive evidence)

Timeline to reapply: Most test results are available within 2-4 weeks. Schedule follow-up with pediatric neurology once results are complete.

Tip: Some labs offer combined NCL panels that test multiple genes simultaneously, which can be helpful for differential diagnosis.

If "Not Yet": Alternatives and Exception Requests

If standard criteria aren't met, consider:

Clinical Trial Options

Compassionate Use

  • Discuss expanded access programs with BioMarin (Brineura's manufacturer)
  • Your neurologist can submit requests through FDA's expanded access pathway

Exception Request Strategies

  • Age exceptions: Cite updated FDA labeling for birth+ indication
  • Off-label use: Provide compelling clinical rationale with literature support
  • Advanced disease: Document any preserved function that could benefit

If Denied: Your Texas Appeal Path

Humana Medicare follows federal Medicare appeal rules, not Texas state insurance law. Here's your 5-level appeal process:

Level 1: Humana Internal Appeal (Redetermination)

  • Deadline: 65 days from denial notice
  • Decision time: 30 days (standard) or 72 hours (expedited)
  • How to file: Humana member portal or mail/fax
  • Include: Updated medical necessity letter addressing specific denial reasons

Level 2: Independent Review Entity (IRE)

  • Who: Medicare-contracted external reviewer (not Humana)
  • Deadline: Follow instructions in Level 1 decision letter
  • Cost: Free to patient
  • Decision: Binding on Humana if overturned

Levels 3-5: Administrative Law Judge, Medicare Appeals Council, Federal Court

  • Available for high-dollar amounts (thresholds adjust annually)
  • Consider legal representation for complex cases
Texas-Specific Help: Contact the State Health Insurance Assistance Program (SHIP) at 1-800-252-9240 for free Medicare counseling.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before first dose Medicare PAL Humana PAL 2025
Age Criteria 3 years+ (some policies updating to birth+) PA policy documents FDA label, payer policies
Diagnosis Confirmed CLN2 via enzyme/genetic testing Lab reports, genetic testing Clinical guidelines
Prescriber Pediatric neurologist or qualified specialist Provider credentials PA requirements
Site of Care Hospital outpatient or specialized center Treatment facility documentation Medicare coverage rules
Dosing 300 mg every 2 weeks intraventricular FDA labeling Brineura prescribing information

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Diagnosis not confirmed" Submit complete diagnostic workup TPP1 enzyme assay, genetic testing
"Age criteria not met" Cite updated FDA labeling Birth certificate, current FDA label
"Not medically necessary" Stronger clinical rationale Updated neurologist letter, functional assessments
"Experimental/investigational" Emphasize FDA approval FDA approval documentation, clinical guidelines
"Wrong site of care" Confirm qualified facility Hospital/center credentials, neurosurgery availability

Medical Necessity Letter: Clinician Checklist

For pediatric neurologists writing PA or appeal letters:

Essential Elements

  • Patient age and confirmed CLN2 diagnosis (enzyme + genetic results)
  • Current functional status with specific CLN2 or Hamburg scale scores
  • Documented progression over time with specific examples
  • FDA approval statement for slowing loss of ambulation in CLN2
  • No alternative therapies available for disease modification
  • Time-sensitive nature of neurologic decline
  • Treatment plan with dosing, site, and monitoring details

Supporting Evidence

  • Natural history data showing untreated CLN2 progression
  • Clinical trial results demonstrating efficacy
  • Guideline recommendations from relevant medical societies
  • Irreversibility statement emphasizing permanent nature of decline
From our advocates: We've seen the strongest approvals when neurologists include specific before-and-after functional scores and emphasize that "days and weeks matter" in preventing irreversible decline. One compelling approach is showing how the child's current abilities align with the treatment window where Brineura has proven most effective.

Frequently Asked Questions

How long does Humana prior authorization take in Texas? Standard PA decisions take up to 30 days for Medicare Advantage plans. Expedited requests (when delay could harm health) get 72-hour decisions. Submit expedited requests when functional decline is rapid.

What if Brineura is non-formulary on my plan? Brineura is typically covered as a medical benefit (Part B) rather than pharmacy benefit, so formulary status may not apply. Verify with Humana whether it's covered under your medical or pharmacy benefit.

Can I request peer-to-peer review? Yes, your neurologist can request to speak directly with a Humana medical director. This is often helpful for rare diseases like CLN2 where clinical context matters significantly.

Does step therapy apply to Brineura? Generally no, since there are no alternative disease-modifying therapies for CLN2. However, plans may require documentation of supportive care attempts (seizure management, physical therapy).

What if my child is under 3 years old? The FDA updated Brineura's indication in July 2024 to include patients from birth. If denied based on age, appeal with the updated FDA labeling and emphasize early intervention benefits.

How much does Brineura cost with Humana coverage? Costs vary by specific plan. List price is approximately $702,000 annually, but your out-of-pocket costs depend on your plan's coverage terms and any applicable copay assistance programs.

What happens if Humana still denies after internal appeal? You can request Level 2 review by an Independent Review Entity (IRE), which is free and binding on Humana if they overturn the denial. This external review is often more favorable for rare disease cases.

Where can I get help with the appeal process in Texas? Contact Texas SHIP (State Health Insurance Assistance Program) at 1-800-252-9240 for free Medicare counseling, or the Texas Department of Insurance consumer hotline at 1-800-252-3439.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful approvals. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with each payer's specific requirements. For complex cases like Brineura approvals, we provide the clinical documentation and procedural expertise needed to navigate prior authorization and appeals processes effectively.

When facing a Humana denial for Brineura, Counterforce Health can help identify the specific denial reasons and craft appeals that address Humana's medical necessity criteria while incorporating the latest clinical evidence for CLN2 treatment. Our approach has helped families across Texas secure coverage for critical specialty medications through strategic appeal processes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan details. Always verify current policy terms with Humana and consult with your healthcare providers regarding treatment decisions. For official Texas insurance regulations and consumer rights, visit the Texas Department of Insurance website.

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