By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by Humana in Washington: Prior Authorization Guide and Appeals Process

Answer Box: Getting Brineura Covered by Humana in Washington

Brineura (cerliponase alfa) requires prior authorization from Humana for CLN2 disease patients ≥3 years old. Submit a formulary exception request with medical necessity documentation including TPP1 enzyme deficiency confirmation, specialized center capability, and neurosurgical device placement plans. If denied, you have 65 days to appeal internally, then can request external review through Washington's Independent Review Organization (IRO) process. First step today: Contact your prescribing specialist to initiate the prior authorization request through Humana's provider portal or call 1-800-833-6917.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Documentation
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Washington
  6. Specialized Infusion Centers
  7. Cost Considerations & Financial Support
  8. When to Escalate to State Regulators
  9. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Brineura requests Humana provider portal or member services Humana PA Process
Age Criteria Patient must be ≥3 years old FDA prescribing information FDA Brineura Label
Diagnosis Confirmation TPP1 enzyme deficiency documented Laboratory testing results CLN2 Diagnostic Guidelines
Specialized Center Must be administered at qualified facility Provider network verification Verify with Humana network status
Appeal Deadline 65 days from denial notification Medicare Advantage appeal rights Humana Appeals Process
External Review 180 days to request IRO review Washington state law WA Insurance Commissioner

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Eligibility

Who does it: Prescribing physician
Document needed: TPP1 enzyme activity test results and genetic confirmation
Timeline: 1-2 weeks for lab results
Source: Mayo Clinic NCL Testing

2. Identify Qualified Administration Site

Who does it: Healthcare team
Document needed: Verification of neurosurgical capability and intraventricular device placement
Timeline: Immediate verification
Note: Contact centers like AmeriPharma Kirkland (425-320-5063) for rare disease infusion capabilities

3. Submit Prior Authorization Request

Who does it: Prescribing physician or clinic staff
Document needed: Completed PA form with medical necessity statement
How to submit: Humana provider portal or fax
Timeline: 30 days for standard review, 72 hours for expedited

4. Prepare Comprehensive Medical Necessity Letter

Who does it: Prescribing physician
Document needed: Detailed clinical rationale (see checklist below)
Timeline: Allow 3-5 business days for preparation

5. Monitor Decision and Prepare for Appeals

Who does it: Patient/family and healthcare team
Timeline: Track 30-day decision deadline
Next step: If denied, immediately begin internal appeal process

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

Clinical Problem Statement

  • Patient age and confirmed CLN2 disease diagnosis
  • Current functional status using CLN2 Clinical Rating Scale
  • Rate of neurological decline without treatment

Prior Treatments and Outcomes

  • Supportive care measures attempted
  • Seizure management history
  • Any contraindications to alternative approaches

Clinical Rationale for Brineura

  • Only FDA-approved disease-modifying treatment for CLN2
  • Expected slowing of motor and language decline
  • Specialized administration requirements met

Supporting Evidence

  • FDA approval documentation
  • Clinical trial data showing 95% of patients had no motor decline at 96 weeks
  • Appropriate ICD-10 codes (E75.4 for neuronal ceroid lipofuscinosis)

Monitoring Plan

  • Regular CLN2 Clinical Rating Scale assessments
  • Infection monitoring protocols
  • Device maintenance schedule

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Age/diagnosis mismatch Submit complete diagnostic workup TPP1 enzyme results, genetic testing, clinical assessment
Lack of specialized center Identify qualified facility Network verification, neurosurgical capability confirmation
"Experimental" designation Cite FDA approval FDA approval letter and prescribing information
Out-of-network provider Request network exception Medical necessity for specific center, lack of in-network alternatives
Device/procedure not covered Separate authorization for device placement Surgical necessity documentation, CPT codes for procedures

Appeals Process in Washington

Internal Appeals (First Level)

  • Deadline: 65 days from denial notification
  • How to file: Written request to Humana member services
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Copy of denial letter, additional medical documentation

External Review (Independent Review Organization)

If internal appeals are unsuccessful, Washington residents can request external review:

  • Deadline: 180 days from final internal denial
  • How to request: Submit to Washington Insurance Commissioner or directly to Humana
  • Process: IRO assigns independent medical experts to review case
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Cost: Free to patients
  • Decision: Binding on Humana if overturned
Note: Washington's external review process is particularly effective for rare disease medications, with medical experts from research institutions often serving as reviewers.

Getting Help with Appeals

Specialized Infusion Centers

Brineura requires intraventricular administration through a surgically implanted device. While no Washington centers were specifically identified for Brineura in our research, these facilities handle complex pediatric infusions and may coordinate care:

Potential Coordination Centers:

  • AmeriPharma Kirkland: 13107 121st Way NE, 425-320-5063 (specializes in rare disease therapies)
  • Infusion Solutions: Multiple WA locations, home infusion capabilities statewide
  • Seattle Children's Hospital: Likely neurosurgical capability (verify directly)
Important: Brineura administration requires specialized neurosurgical expertise. Your healthcare team will need to identify and coordinate with an appropriately equipped facility.

Cost Considerations & Financial Support

Annual Cost: Approximately $702,000 per year for medication alone, plus administration and monitoring costs.

Financial Support Options:

  • BioMarin RareConnections: Free patient support program including financial assistance
  • Humana Coverage: After PA approval, standard plan copays/coinsurance apply
  • 2026 Medicare Part D: Out-of-pocket cap of $2,100 annually
  • State Programs: Contact Washington Department of Social and Health Services for additional resources

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Brineura. Their platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that address specific coverage criteria and procedural requirements.

When to Escalate to State Regulators

Contact the Washington Insurance Commissioner if:

  • Humana fails to respond within required timeframes
  • Appeal process appears unfair or biased
  • You need help understanding your rights
  • External review decision is not honored

Contact Information:

  • Phone: 1-800-562-6900
  • Website: insurance.wa.gov
  • Online Complaint: Available through OIC website

Frequently Asked Questions

How long does Humana prior authorization take for Brineura? Standard PA decisions take up to 30 days. Expedited reviews (for urgent medical situations) are completed within 72 hours. Request expedited review if delay could harm the patient.

What if Brineura is not on Humana's formulary? Submit a formulary exception request along with medical necessity documentation. The prescriber must demonstrate that formulary alternatives are ineffective or cause adverse effects.

Can I request an expedited appeal in Washington? Yes, both internal appeals and external reviews can be expedited if standard timeframes could seriously jeopardize your health. Contact Humana or the Washington Insurance Commissioner for expedited processing.

Does step therapy apply to Brineura? Step therapy typically doesn't apply since Brineura is the only approved disease-modifying treatment for CLN2. However, Humana may require documentation of supportive care attempts.

What happens if my child ages out of pediatric coverage? Work with your healthcare team to ensure continuity of care during insurance transitions. Document ongoing medical necessity and coordinate with adult specialists as needed.

How do I find the right infusion center in Washington? Start with your prescribing physician's recommendations. Contact potential centers directly to verify Brineura administration capabilities and Humana network status.

From Our Advocates

We've seen families successfully overturn Brineura denials by emphasizing the time-sensitive nature of CLN2 disease progression and the lack of alternative treatments. The key is comprehensive documentation of the diagnosis, the specialized care requirements, and the medical necessity for immediate treatment to prevent irreversible neurological decline.

Important Notice: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific guidance about your situation. Coverage policies and procedures may change.

For complex prior authorization challenges like Brineura, Counterforce Health provides specialized support in navigating insurance denials and creating compelling appeals that meet payer-specific requirements and deadlines.

Sources & Further Reading

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