By Counterforce Health Team in Brineura (cerliponase alfa) —

Do You Qualify for Brineura (Cerliponase Alfa) Coverage by Humana in Florida? Decision Tree & Next Steps

Answer Box: Your Path to Brineura Coverage

Likely eligible if: Your child is ≥3 years old with confirmed CLN2 disease (both enzyme deficiency and genetic testing), has mild-to-moderate symptoms with some remaining motor and language function, and can receive treatment at a specialized center with intraventricular device placement capabilities.

Fastest path: Submit prior authorization through Humana's provider portal with complete diagnostic documentation, specialist consultation notes, and Hamburg Scale or CLN2 Clinical Rating Scale scores. Standard decision timeline is 30 days, expedited available in 72 hours for urgent cases.

First step today: Contact your pediatric neurologist to confirm CLN2 diagnosis meets Humana's dual-testing requirement (TPP1 enzyme + genetic confirmation) and request referral to an experienced CLN2 treatment center in Florida.

Table of Contents

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

How to Use This Guide

This decision tree helps you determine if your child qualifies for Brineura (cerliponase alfa) coverage through Humana Medicare Advantage plans in Florida, and what steps to take based on your situation.

Brineura 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, plus surgical and monitoring costs, prior authorization is mandatory for all Humana plans.

Note: This guide focuses on Humana Medicare Advantage coverage. If you have traditional Medicare with Humana as a supplement, or Medicaid, some requirements may differ.

Eligibility Triage: Do You Qualify?

Work through these questions with your healthcare team to determine your approval likelihood:

1. Age & Diagnosis Confirmation

  • Is your child at least 3 years old? ✓ Required
  • Has CLN2 been confirmed by BOTH enzyme testing (deficient TPP1 activity) AND genetic testing (two pathogenic TPP1/CLN2 mutations)? ✓ Required
  • Are you working with a pediatric neurologist, epileptologist, or geneticist experienced in CLN2? ✓ Required

2. Disease Severity Assessment

  • Does your child have mild-to-moderate disease documented by clinical rating scale? Typically defined as Hamburg Scale or CLN2 Clinical Rating Scale with two-domain motor and language score of 3-6, with at least 1 point in both domains
  • Is your child still ambulatory (able to walk)? ✓ Required at treatment initiation

3. Treatment Setting

  • Do you have access to a specialized center capable of intraventricular device placement and ongoing infusion management? ✓ Required
  • Can the center provide the required neurosurgical expertise and infection monitoring? ✓ Required

Results:

  • All ✓ = "Likely Eligible" → Proceed to document gathering
  • Missing 1-2 items = "Possibly Eligible" → Additional testing/referrals needed
  • Missing 3+ items = "Not Yet Eligible" → Focus on alternatives and preparation

If "Likely Eligible": Document Checklist & Submission

Required Documentation

Clinical Records:

  • Complete diagnostic workup showing both TPP1 enzyme deficiency and genetic confirmation
  • Recent clinical assessment using standardized rating scale
  • Specialist consultation notes from pediatric neurologist or geneticist
  • Documentation of ambulatory status
  • Treatment history and current medications

Facility Requirements:

  • Confirmation of treatment center's experience with intraventricular device management
  • Neurosurgical consultation for device placement planning
  • Infection control protocols documentation

Submission Process

  1. Provider submits PA request through Humana provider portal with complete documentation
  2. Standard timeline: 30 days for decision
  3. Expedited option: 72 hours if medical urgency is documented
  4. Initial approval period: Typically 6-12 months
  5. Reauthorization: Required with documented clinical benefit
Clinician Corner: Medical necessity letters should emphasize the progressive nature of CLN2, document current functional status, and cite FDA labeling for the specific indication. Include recent Hamburg Scale scores and emphasize the narrow therapeutic window for intervention.

If "Possibly Eligible": Tests to Request

Missing Diagnostic Confirmation

If enzyme testing incomplete:

  • Request TPP1 enzyme assay through specialized lab
  • Ensure proper sample collection and shipping protocols
  • Results typically available within 2 weeks

If genetic testing needed:

  • Consider epilepsy gene panels that include TPP1/CLN2
  • Behind the Seizure program offers sponsored testing
  • Genetic counseling recommended for family planning

Missing Specialist Care

  • Request referral to pediatric neurologist with CLN2 experience
  • Consider consultation at major Florida children's hospitals (UF Health, Nicklaus Children's Hospital)
  • Ensure specialist can provide ongoing treatment oversight

Timeline to reapply: Allow 4-6 weeks for test results and specialist consultations before resubmitting PA request.

If "Not Yet Eligible": Alternatives & Exception Requests

If Too Young (Under 3 Years)

  • Monitor and prepare: Continue supportive care and seizure management
  • Clinical trial consideration: Research ongoing studies through ClinicalTrials.gov
  • Prepare for future approval: Establish care with CLN2 specialist, complete diagnostic workup

If Disease Too Advanced

  • Exception request rationale: Document any remaining ambulatory function or meaningful motor skills
  • Compassionate use: Consider expanded access programs through BioMarin
  • Supportive care optimization: Focus on seizure control, nutrition, and quality of life

If No Specialized Center Access

  • Travel considerations: Document willingness to travel to qualified centers
  • Hub services: Explore manufacturer support for logistics and coordination
  • Telemedicine: Some monitoring may be possible remotely between infusions

If Denied: Appeal Path Chooser

Level 1: Internal Appeal (Redetermination)

  • Timeline: Must file within 65 days of denial
  • Decision: 7 days standard, 72 hours expedited
  • Submit via: Humana member portal or phone
  • Required: Updated clinical documentation, specialist letter addressing denial reasons

Level 2: Independent Review Entity (IRE)

  • When: After internal appeal denial
  • Timeline: Must request promptly after Humana's final decision
  • Cost: No charge to patient
  • Process: Federal Medicare contractor reviews case independently

Level 3: Florida External Review

  • Timeline: Within 4 months of final internal denial
  • Submit to: Florida Department of Financial Services
  • Phone: 1-877-693-5236
  • Decision: 45 days standard, 72 hours expedited for urgent cases
  • Binding: Decision is legally binding on Humana

Peer-to-Peer Review Option

Available at any stage - provider requests direct discussion with Humana medical director to address clinical appropriateness and rare disease considerations.

From our advocates: In one composite case, a family's initial denial was overturned at the peer-to-peer level when the pediatric neurologist emphasized the narrow treatment window for CLN2 and provided detailed Hamburg Scale documentation showing the child was still within the therapeutic range. The key was having all diagnostic confirmation ready and clearly articulating the time-sensitive nature of the intervention.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory for all Humana plans Submit through provider portal Humana PAL
Age ≥3 years Child must be at least 3 years old Birth certificate, medical records FDA labeling requirement
Dual diagnostic confirmation Both enzyme AND genetic testing Lab reports showing TPP1 deficiency + genetic mutations Clinical testing guidelines
Specialist oversight Pediatric neurologist/geneticist required Consultation notes, treatment plan Humana clinical criteria
Ambulatory status Must be able to walk at initiation Clinical assessment, video documentation Hamburg Scale evaluation
Specialized center Facility with intraventricular device expertise Hospital credentials, surgeon qualifications BioMarin center requirements
Quantity limits 2 packages per 28 days (300mg q2weeks) Prescription matches approved dosing Humana formulary

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Diagnosis not confirmed" Submit both enzyme assay results AND genetic testing showing two pathogenic mutations
"Age requirement not met" Provide birth certificate; if under 3, request exception with specialist letter
"Not ambulatory" Document any remaining walking ability; provide video evidence if helpful
"Lack of specialist care" Obtain consultation from pediatric neurologist with CLN2 experience
"Facility not qualified" Confirm treatment center has neurosurgical capabilities and device management experience
"No prior therapy documentation" This doesn't apply to CLN2 - emphasize no alternative disease-modifying treatments exist

Frequently Asked Questions

How long does Humana prior authorization take in Florida? Standard decisions take up to 30 days. Expedited reviews are completed within 72 hours if medical urgency is documented by your physician.

What if Brineura is not on Humana's formulary? You can request a formulary exception with detailed medical necessity documentation. The lack of alternative CLN2 treatments strengthens exception requests.

Can I request an expedited appeal? Yes, if waiting for standard review would jeopardize your child's health. Your physician must document the medical urgency for expedited processing.

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

What if my child's symptoms worsen during the approval process? Document all changes and request expedited review. Progressive neurologic decline supports urgency arguments in appeals.

Are there financial assistance programs? Yes, BioMarin offers patient support programs including financial assistance and care coordination services.

What if I need to travel to a qualified treatment center? Document your willingness to travel and explore manufacturer hub services for logistics support. Some costs may be covered as part of the treatment protocol.

How often do I need reauthorization? Typically every 6-12 months, with requirements to document continued clinical benefit and absence of unacceptable adverse effects.

Expert Support for Complex Cases

When navigating Brineura approvals becomes challenging, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and payer policies to create point-by-point rebuttals aligned with Humana's specific requirements, incorporating the right clinical evidence and procedural documentation that payers expect for complex therapies like intraventricular enzyme replacement.

For families facing denials or complex authorization requirements, having expert support can make the difference between approval and prolonged delays in accessing this time-sensitive treatment. Counterforce Health's approach is particularly valuable for rare disease cases where standard appeal templates may not address the unique clinical and administrative complexities.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always consult with your healthcare providers and verify current requirements with Humana directly. For assistance with insurance problems in Florida, contact the Department of Financial Services Consumer Helpline at 1-877-693-5236.

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