By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (cerliponase alfa) Covered by Aetna (CVS Health) in New Jersey: Complete PA Guide and Appeal Process

Answer Box: Getting Brineura Covered by Aetna in New Jersey

Aetna requires prior authorization for Brineura (cerliponase alfa) in New Jersey. To get coverage, you need: (1) confirmed CLN2 disease diagnosis via enzyme assay or genetic testing, (2) treatment by a neurologist experienced in intraventricular administration, and (3) no acute device complications or ventriculoperitoneal shunt. First step: Have your specialist complete Aetna's Brineura Medication Precertification Request form and submit via fax to 1-866-329-2779. If denied, New Jersey's step therapy override law (A1825) and external review through Maximus Federal Services provide strong appeal options.

Table of Contents

Why New Jersey State Rules Matter

New Jersey has some of the strongest patient protection laws in the country, which work alongside Aetna's national policies to create additional safeguards for patients needing specialty drugs like Brineura.

Key New Jersey protections that help:

  • Step therapy override law (A1825): Requires insurers to grant exceptions when step therapy drugs are contraindicated, ineffective, or harmful—with mandatory 24-72 hour response times
  • External review through IHCAP: Independent medical review by Maximus Federal Services with binding decisions
  • Continuity of care protections: Stronger than most states, including requirements to continue coverage through facility discharge

These state rules apply to Aetna commercial plans, Medicaid (NJ FamilyCare), and state employee health benefits in New Jersey. However, self-funded employer plans follow federal ERISA rules and may have different appeal processes.

Aetna Prior Authorization Requirements

Aetna requires prior authorization for both the drug and site of care for Brineura in all lines of business, including New Jersey commercial plans. The approval is based on Aetna's Clinical Policy 0442 for lysosomal storage disorder treatments.

Initial approval requirements:

  • Confirmed CLN2 diagnosis via enzyme assay showing TPP1 deficiency OR genetic testing showing pathogenic TPP1 variants
  • Dose does not exceed 300 mg every other week
  • No acute intraventricular device complications and no ventriculoperitoneal shunt
  • Administration by physician knowledgeable in intraventricular administration

Continuation requirements:

  • Same administration requirements as above
  • Documentation of no loss of ambulation or slowed loss of ambulation from baseline
Note: Aetna considers patients not eligible if they exceed the 300mg dose limit or have active device complications.

New Jersey Step Therapy Protections

New Jersey's step therapy override law (A1825) took effect January 1, 2026, and provides mandatory exceptions when your doctor determines that required step therapy drugs would be harmful or ineffective.

Automatic override required if:

  1. Step therapy drug is contraindicated or likely to cause adverse reaction/harm
  2. Expected to be ineffective or less effective based on clinical characteristics
  3. Patient is currently stable on the requested drug
  4. Required drug is not in the best interest of the patient based on medical necessity

Response timeframes:

  • 24 hours for urgent requests (risk of hospitalization, severe symptoms, rapidly progressing disease)
  • 72 hours for non-urgent requests
  • If Aetna doesn't respond within the timeframe, the exception is automatically granted

For CLN2 patients, step therapy exceptions are often appropriate because alternative treatments are extremely limited, and delays can cause irreversible neurological decline.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for drug and site of care 2024 Aetna Precertification List
Diagnosis Confirmed CLN2 via enzyme assay or genetics Aetna Policy 0442
Prescriber Neurologist experienced in IV administration Brineura PA Form
Dose Limit 300 mg every other week maximum Aetna Policy 0442
Device Status No acute complications or VP shunt Aetna Policy 0442
Site of Care Hospital outpatient, infusion center, or home Aetna Site of Care Policy

Step-by-Step: Fastest Path to Approval

  1. Gather diagnostic documentation (Patient/Family)
    • Enzyme assay results showing TPP1 deficiency
    • Genetic test results confirming CLN2 mutations
    • Neurologist notes documenting CLN2 phenotype
  2. Complete Aetna's Brineura PA form (Prescriber)
  3. Submit via specialty pharmacy channel (Clinic Staff)
    • Fax to Aetna Specialty Pharmacy: 1-866-329-2779
    • Include supporting documentation (lab results, clinic notes)
    • Request expedited review if clinically urgent
  4. Verify network status (Patient/Family)
    • Confirm prescriber and infusion site are Aetna-contracted
    • Check if Caremark Specialty Pharmacy is required for dispensing
  5. Follow up within 5 business days (Clinic Staff)
    • Standard PA decisions typically take 30-45 days
    • Expedited reviews often completed within 72 hours
    • Call Aetna if no response received
  6. Prepare for potential appeal (All)
    • Keep copies of all submitted documentation
    • Note any clinical urgency factors
    • Identify supporting medical literature
  7. Coordinate ongoing care (Prescriber)
    • Plan for PA renewals (typically 6-12 months)
    • Document continued benefit/slowed decline
    • Monitor for device complications

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Emphasize irreversible nature of CLN2, lack of alternatives Updated neurologist assessment, CLN2 rating scales, peer-reviewed literature
"Experimental/investigational" Cite FDA approval for CLN2 indication FDA label, Aetna's own policy recognizing approval
"Insufficient documentation" Submit complete diagnostic workup Enzyme assay, genetic testing, MRI/imaging, clinical rating scales
"Device complications" Provide current neurosurgery clearance Recent imaging, neurosurgeon notes confirming device integrity
"Out-of-network provider" Request continuity of care or find in-network alternative Use Aetna's COC process

Appeals Playbook for New Jersey

Internal Appeals (Aetna):

  • Timeline: 180 days from denial to file
  • Standard review: 30-45 days for decision
  • Expedited review: 72 hours for urgent cases
  • How to file: Aetna member portal, phone, or written request

External Review (New Jersey IHCAP):

  • Administered by: Maximus Federal Services
  • Timeline: 4 months from final internal denial to file
  • Standard review: 45 days for decision
  • Expedited review: 48 hours for urgent cases
  • Cost: Free to patients (insurer pays all fees)

Required for external review:

  • Completed internal appeals process
  • Medical necessity denial (not just coverage exclusion)
  • Fully-insured plan regulated by New Jersey

What to include in appeals:

  • Detailed letter from neurologist explaining medical necessity
  • CLN2 disease progression documentation
  • Evidence that alternatives are inappropriate or unavailable
  • Published guidelines supporting enzyme replacement therapy
Tip: For urgent appeals, document specific risks from treatment delays (e.g., "risk of irreversible neurological decline" or "loss of ambulation").

Continuity of Care Protections

New Jersey has stronger continuity protections than most states. If you're already receiving Brineura and face a coverage change, you may be eligible for continued coverage.

When continuity of care applies:

  • Provider or facility leaves Aetna's network
  • Plan formulary changes affecting ongoing treatment
  • Specialty pharmacy or vendor changes
  • Plan termination (coverage continues through facility discharge in NJ)

How to request:

  1. Use Aetna's Transition/Continuity of Care Coverage Request
  2. Emphasize "serious and complex condition" requiring ongoing treatment
  3. Document clinical consequences of interruption
  4. Include treatment start date and current response

New Jersey advantage: Unlike most states, NJ allows continuity of care for primary care providers and has specific regulations requiring coverage continuation through facility discharge.

When to Escalate to State Regulators

Contact the New Jersey Department of Banking and Insurance (DOBI) if:

  • Aetna fails to respond to step therapy override requests within required timeframes
  • Internal appeals are denied without adequate medical review
  • External review through IHCAP is needed

Contact information:

  • IHCAP Hotline: 1-888-393-1062
  • DOBI Consumer Hotline: 1-800-446-7467
  • Website: nj.gov/dobi

What to include in complaints:

  • Timeline of PA requests and denials
  • Medical documentation supporting necessity
  • Evidence of compliance with Aetna's stated criteria
  • Documentation of clinical urgency or harm from delays

FAQ

How long does Aetna prior authorization take in New Jersey? Standard PA decisions typically take 30-45 days, while expedited reviews are often completed within 72 hours. Under New Jersey's step therapy law, override requests must be answered within 24-72 hours depending on urgency.

What if Brineura is non-formulary on my Aetna plan? You can request a formulary exception by demonstrating medical necessity and lack of appropriate alternatives. Use the same PA process but emphasize the orphan drug status and absence of therapeutic substitutes for CLN2.

Can I request an expedited appeal? Yes, if delays would seriously jeopardize health or ability to regain function. For CLN2 patients, document risk of irreversible neurological decline, loss of skills, or other urgent clinical factors.

Does step therapy apply if I've already tried other treatments? Document any prior treatment failures or intolerances thoroughly. New Jersey's A1825 law requires automatic overrides when step therapy drugs are expected to be ineffective based on your clinical characteristics.

What if my CLN2 treatment center is out-of-network? Request continuity of care coverage, especially if you're already established in treatment. New Jersey has stronger continuity protections, and CLN2 treatment requires specialized centers that may have limited network participation.

How do I get help navigating this process? Counterforce Health specializes in turning insurance denials into successful appeals by identifying denial reasons and crafting evidence-backed rebuttals. Their platform helps patients, clinicians, and pharmacies streamline the approval process for complex specialty drugs like Brineura.

From our advocates: "We've seen CLN2 families succeed by emphasizing the urgent, progressive nature of the disease in every communication with insurers. One family's neurologist included specific CLN2 rating scale scores showing decline, which helped demonstrate both medical necessity and the time-sensitive nature of treatment. The key was treating every delay as potentially harmful to the child's development."

Understanding your rights under New Jersey law can make the difference between a quick approval and months of delays. The state's step therapy protections and external review process provide powerful tools for families facing coverage challenges.

For additional support navigating complex prior authorization requirements, Counterforce Health offers specialized assistance in building compelling cases for specialty drug approvals, helping transform denials into approvals through targeted, evidence-based appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with appeals and denials, contact the New Jersey Department of Banking and Insurance or consult with qualified patient advocacy services.

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