By Counterforce Health Team in Brineura (cerliponase alfa) —

Getting Brineura (Cerliponase Alfa) Covered by Cigna in New York: Complete PA Guide and Appeals Process

Answer Box: Getting Started Today

To get Brineura (cerliponase alfa) covered by Cigna in New York, you need: 1) Confirmed CLN2 diagnosis with genetic/enzyme testing, 2) Prescription from a pediatric neurologist or specialist, and 3) Prior authorization through Cigna's specialty pharmacy (Express Scripts/Accredo). Start by gathering diagnostic documentation and contacting your child's neurologist. If denied, New York's external appeal process through the Department of Financial Services gives you strong rights to challenge the decision within 4 months.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all Brineura prescriptions PA form through Cigna portal/Express Scripts Cigna Specialty Drug List
Age Requirement Patient must be 3 years or older Birth certificate, medical records Cigna Coverage Policy
Diagnosis Confirmed CLN2 (TPP1 deficiency) Genetic testing + enzyme assay results Cigna Coverage Policy
Specialist Requirement Prescribed by pediatric neurologist or similar Board certification, specialist referral Cigna Coverage Policy
Baseline Function CLN2 Clinical Rating Scale score 3-6 Recent neurological assessment BioMarin Coverage Guide
Site of Care Approved infusion center with ICV capability Provider network verification Brineura Treatment Info

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who: Patient/caregiver with neurologist
Timeline: 1-2 weeks
Documents needed:

  • Genetic testing showing TPP1/CLN2 mutations
  • TPP1 enzyme activity results (deficient levels)
  • Recent CLN2 Clinical Rating Scale assessment

2. Verify Specialist Qualifications

Who: Neurologist's office
Timeline: 1-3 days
Action: Ensure prescribing physician is a board-certified pediatric neurologist, geneticist, or metabolic specialist. Cigna requires specialist involvement for approval.

3. Check Network Status for Treatment Center

Who: Patient/caregiver
Timeline: 1 week
Action: Contact Cigna member services to verify University of Rochester Medical Center or other NY treatment centers are in-network. Get written confirmation.

4. Submit Prior Authorization

Who: Neurologist's office
Timeline: Submit 2-3 weeks before needed
Portal: Cigna provider portal or Express Scripts specialty pharmacy
Response time: 5 business days for routine requests

5. Prepare for Device Placement Authorization

Who: Neurologist + neurosurgeon
Timeline: Concurrent with drug PA
Action: Submit separate authorization for intraventricular device placement surgery (required for Brineura administration).

6. Monitor Authorization Status

Who: Patient/caregiver
Timeline: Check every 2-3 days
Action: Track through Cigna member portal or call member services for updates.

7. Plan for Ongoing Renewals

Who: Care team
Timeline: Start 30-60 days before expiration
Documentation: Updated clinical assessments showing continued benefit or stability.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documents
Insufficient diagnostic evidence Submit complete genetic + enzyme testing Lab reports showing TPP1 deficiency, genetic analysis
Prescriber not qualified Provide specialist credentials Board certification, fellowship documentation
Age criteria not met Verify patient is ≥3 years old Birth certificate, recent medical records
Baseline function unclear Submit CLN2 rating scale Recent neurological assessment with scale scores
Site of care not approved Verify network status, get authorization Provider network confirmation, facility credentials
Medical necessity questioned Strengthen clinical rationale Detailed physician letter, treatment goals, prognosis

Appeals Playbook for Cigna in New York

Internal Appeal (Required First Step)

  • Deadline: 180 days from denial
  • How to file: Cigna member portal or mail
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Required: Denial letter, medical records, physician support letter

New York External Appeal

If Cigna denies your internal appeal, New York law gives you powerful rights:

  • Deadline: 4 months after final internal denial
  • Filing: New York Department of Financial Services (DFS)
  • Cost: $25 (waived for Medicaid or financial hardship)
  • Timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on Cigna

How to file external appeal:

  1. Complete DFS External Appeal Application online
  2. Attach all documentation (denial letters, medical records, specialist letters)
  3. Submit via DFS portal or mail

Free help available: Community Health Advocates helpline at 888-614-5400 can assist with appeal preparation and documentation.

From our advocates: "We've seen several successful Brineura appeals in New York where families initially received denials for 'insufficient documentation.' The key was working with the neurologist to submit a comprehensive packet including both genetic testing results and detailed functional assessments. Most of these cases were approved on external appeal when the full clinical picture was presented clearly."

Medical Necessity Letter Essentials

Your neurologist's letter should include:

Diagnosis Section:

  • Confirmed CLN2 disease (late infantile neuronal ceroid lipofuscinosis type 2)
  • TPP1 enzyme deficiency results
  • Genetic testing showing pathogenic mutations

Clinical Rationale:

  • Patient's current functional status using CLN2 Clinical Rating Scale
  • Disease progression without treatment
  • Treatment goals (slowing neurodegeneration, preserving function)

Prior Treatments:

  • Supportive care measures tried
  • Why alternative treatments are insufficient

Dosing and Administration:

  • 300 mg every 2 weeks via intraventricular infusion
  • Site of care requirements and safety monitoring

Supporting Evidence:

  • FDA labeling for Brineura
  • Published clinical trial data
  • Professional society guidelines

Treatment Centers and Site of Care

Brineura requires specialized administration at approved centers. In New York:

University of Rochester Medical Center (URMC)

  • Designated Center of Excellence for Batten disease
  • Experienced with intraventricular infusions
  • Action: Verify Cigna network status before scheduling

Requirements for any treatment center:

  • Capability for intraventricular device placement
  • Sterile infusion environment
  • Multidisciplinary team (neurology, neurosurgery, nursing)
  • Emergency response capabilities

Insurance considerations:

  • Confirm center is Cigna in-network
  • Verify both facility and provider coverage
  • Get pre-authorization for all services (drug, device, infusion, monitoring)

Costs and Financial Support

List Price: Approximately $27,000 per biweekly infusion ($702,000 annually)

Financial assistance options:

  • BioMarin RareConnections: Patient support program with insurance navigation and potential financial assistance
  • Manufacturer copay assistance: May reduce out-of-pocket costs for eligible patients
  • State programs: New York Medicaid may cover for eligible families

Insurance cost-sharing:

  • Specialty tier medications often have high coinsurance (20-40%)
  • Annual out-of-pocket maximums apply
  • Consider supplemental insurance if available

At Counterforce Health, we help families navigate complex insurance approvals for specialty medications like Brineura. Our platform analyzes denial letters and creates targeted appeals using evidence-based arguments tailored to each payer's specific requirements.

FAQ: Common Questions

How long does Cigna prior authorization take in New York? Standard reviews typically take 5 business days. Expedited reviews (for urgent medical needs) are completed within 72 hours.

What if Brineura is not on Cigna's formulary? You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. This requires additional documentation but is often successful for rare disease medications.

Can I appeal if my child tried treatments outside New York? Yes, prior treatment failures documented anywhere count toward step therapy requirements if properly documented.

What happens if I miss an appeal deadline? New York's external appeal deadline is firm (4 months), but you may have other options through state regulatory complaints or legal advocacy.

Does Cigna cover the surgical device placement? Device placement typically requires separate authorization but is usually covered when Brineura is approved, as it's medically necessary for drug administration.

How often do I need to renew authorization? Most initial authorizations are for 6-12 months. Start renewal process 30-60 days before expiration with updated clinical assessments.

What if my preferred treatment center is out-of-network? You can request a network gap exception, especially if no in-network providers offer the specialized care needed for Brineura administration.

Can I get expedited review for my child's case? Yes, if delay in treatment could seriously harm your child's health. Your neurologist must document the urgency in the request.

When facing insurance challenges with complex treatments like Brineura, Counterforce Health provides specialized support to turn denials into approvals through evidence-based appeals and comprehensive documentation strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare providers and insurance company for specific guidance about your situation. For questions about New York insurance laws and appeal rights, contact the New York Department of Financial Services or Community Health Advocates.

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