By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (cerliponase alfa) Covered by Humana in California: PA Forms, Appeals, and Exception Paths

Quick Answer: Getting Brineura Covered by Humana in California

Brineura (cerliponase alfa) requires prior authorization from Humana for pediatric CLN2 patients ≥3 years. Submit Humana's "Request for Medicare Prescription Drug Coverage Determination" with prescriber documentation proving CLN2 diagnosis, specialized center capability, and medical necessity. Standard decisions take 72 hours; expedited reviews complete in 24 hours for urgent cases. If denied, appeal within 65 days using California's Independent Medical Review (IMR) process through the DMHC. First step: Have your neurologist check Humana's formulary and gather CLN2 diagnostic records.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. When Brineura Isn't Initially Approved: Exception Strategies
  4. Common Denial Reasons & How to Fix Them
  5. California Appeals Process
  6. Clinician Corner: Medical Necessity Documentation
  7. Cost Support Options
  8. FAQ

Coverage Requirements at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all Humana plans Humana PA Portal
Age Requirement ≥3 years with CLN2 disease FDA Label
Diagnosis Confirmed CLN2 (TPP1 deficiency) Medical records with enzyme/genetic testing
Prescriber Pediatric neurologist or geneticist Humana clinical criteria
Administration Site Specialized center with ICV capability BioMarin Resources
Appeal Deadline 65 days from denial notice CMS Guidelines

Step-by-Step: Fastest Path to Approval

1. Verify Formulary Status (Patient/Family) Check if Brineura is on your specific Humana plan's formulary using the Humana Drug List. Most plans require PA regardless of formulary placement.

2. Gather Diagnostic Documentation (Clinic Staff) Collect CLN2 confirmation via TPP1 enzyme activity testing and/or genetic analysis showing TPP1 mutations. Include Motor Language Scale scores documenting current function.

3. Submit PA Request (Prescriber) Complete Humana's "Request for Medicare Prescription Drug Coverage Determination" form. Include supporting statement detailing CLN2 diagnosis, patient age ≥3 years, and specialized center availability for intraventricular administration.

4. Await Decision (72 hours standard, 24 hours expedited) Humana will review clinical documentation. For urgent cases where delay risks immediate health deterioration, request expedited review through Humana Customer Care.

5. If Approved (Coordinate Care) Work with specialty pharmacy and neurosurgery team for device placement and infusion scheduling. Brineura requires surgical reservoir placement before first infusion.

6. If Denied (Appeal Immediately) File redetermination request within 65 days. In California, you can simultaneously prepare for Independent Medical Review (IMR) through the DMHC.

When Brineura Isn't Initially Approved: Exception Strategies

Formulary Exception Path

If Brineura is non-formulary on your Humana plan, request a formulary exception rather than standard PA. This requires stronger documentation that no formulary alternatives exist for CLN2 disease.

Key Point: Brineura is the only FDA-approved enzyme replacement therapy for CLN2. No formulary alternatives provide disease-modifying treatment—only supportive care for seizures and symptoms.

Medical Necessity Arguments

Strengthen your case by emphasizing:

  • Unique mechanism: Intracerebroventricular TPP1 enzyme replacement directly addresses CLN2's underlying pathophysiology
  • No alternatives: Unlike other rare diseases, CLN2 has no approved therapeutic alternatives
  • Progressive nature: Untreated CLN2 leads to rapid neurologic decline and death in childhood
  • Time sensitivity: Earlier treatment initiation preserves more neurologic function

Specialized Center Documentation

Humana often requires proof that your treatment center can safely administer intraventricular infusions. Include:

  • Hospital credentials for neurosurgery and pediatric neurology
  • Experience with intraventricular access devices
  • Infection control protocols and monitoring capabilities
  • Emergency response capabilities for hypersensitivity reactions

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
"Not medically necessary" Provide CLN2 natural history data showing rapid decline without treatment FDA approval letter, Motor Language Scale scores
"Experimental/investigational" Cite FDA approval and established safety profile FDA label, clinical trial data from approval
"Age restriction" Confirm patient ≥3 years with birth certificate Birth certificate, current clinical assessment
"Lack of specialized facility" Document center capabilities and experience Hospital credentials, physician qualifications
"Cost concerns" Emphasize cost-effectiveness vs. intensive supportive care Economic analyses, projected care costs

California Appeals Process

California offers robust appeal rights through two regulatory agencies depending on your plan type:

DMHC-Regulated Plans (Most HMOs and Managed Care)

Internal Appeal (Grievance)

  • Timeline: 30 days for standard, expedited available for urgent cases
  • Submit to: Your Humana plan's grievance department
  • Required: Written request with medical records and prescriber statement

Independent Medical Review (IMR)

  • When: After internal appeal denial or 30 days without response
  • Timeline: 45 days for standard, 7 days for expedited
  • Cost: Free to patients
  • Contact: DMHC Help Center at 888-466-2219

CDI-Regulated Plans (Some PPOs)

Similar external review process through the California Department of Insurance at 800-927-4357.

California Advantage: The state's IMR success rate is notably high for rare disease treatments when medical necessity is well-documented. Independent physician experts review cases without insurer bias.

Clinician Corner: Medical Necessity Documentation

Essential Elements for PA Requests

Patient History

  • CLN2 diagnosis confirmation (enzyme activity <10% normal, genetic testing)
  • Current Motor Language Scale score and trajectory
  • Seizure history and current management
  • Previous supportive treatments attempted

Clinical Rationale

  • Reference FDA approval criteria for symptomatic pediatric patients ≥3 years
  • Cite clinical trial data showing slowed ambulation loss
  • Document absence of therapeutic alternatives for CLN2

Treatment Plan

  • Confirm surgical reservoir placement capability
  • Outline infusion schedule (300 mg every 2 weeks)
  • Address monitoring for device complications and hypersensitivity

Supporting Literature Include references to:

  • FDA prescribing information
  • CLN2 natural history studies
  • Clinical trial efficacy data (NCT01907087)

Counterforce Health helps clinicians navigate complex prior authorization requirements by analyzing denial patterns and crafting evidence-based appeals that align with payer-specific criteria. Their platform streamlines the documentation process for rare disease treatments like Brineura, reducing approval timelines and improving success rates.

Cost Support Options

Manufacturer Programs

  • BioMarin RareConnections: Patient support program offering copay assistance and care coordination
  • Access: Available regardless of insurance status
  • Contact: Visit BioMarin patient support or call patient services

Foundation Grants

  • National Organization for Rare Disorders (NORD): Emergency financial assistance
  • HealthWell Foundation: Copay assistance for eligible rare diseases
  • Patient Advocate Foundation: Copay relief and appeals support

California-Specific Resources

  • Medi-Cal: Expanded Medicaid coverage for eligible families
  • Covered California: Marketplace plans with essential health benefits including specialty drugs

FAQ

How long does Humana PA take in California? Standard decisions: 72 hours after receiving complete documentation. Expedited reviews: 24 hours for urgent medical situations.

What if Brineura is non-formulary on my Humana plan? Request a formulary exception emphasizing that no formulary alternatives exist for CLN2 disease. This may require additional documentation but follows the same timeline.

Can I request an expedited appeal in California? Yes, for both internal appeals and IMR. Expedited reviews are available when standard timelines could seriously jeopardize health.

Does step therapy apply to Brineura? Rarely, since no therapeutic alternatives exist for CLN2. If step therapy is required, document that supportive treatments (anticonvulsants, etc.) don't address underlying disease progression.

What happens if my child is under 3 years? FDA approval is for ages 3+, but off-label use may be covered with compelling medical necessity documentation. Expect additional scrutiny and potential need for appeals.

How do I find a qualified treatment center in California? Contact BioMarin for a list of certified centers with intraventricular infusion capability. Major children's hospitals with neurosurgery programs typically qualify.

Can I appeal while continuing current supportive treatments? Yes, continue seizure medications and other supportive care during the appeals process. Document any progression to strengthen your case.

What if Humana requires peer-to-peer review? Your neurologist can request a peer-to-peer discussion with Humana's medical director. Prepare with clinical data, FDA approval information, and patient-specific medical necessity arguments.

This information is for educational purposes only and does not constitute medical or legal advice. Consult your healthcare provider and insurance plan for specific guidance. For additional help with California insurance appeals, contact the DMHC Help Center at 888-466-2219.

Sources & Further Reading

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