By Counterforce Health Team in Brineura (cerliponase alfa) —

Getting Brineura (Cerliponase Alfa) Covered by Cigna in Ohio: PA Forms, Appeals, and Cost Assistance

Answer Box: Getting Brineura Covered by Cigna in Ohio

Brineura (cerliponase alfa) requires prior authorization from Cigna with confirmed CLN2 diagnosis, specialist involvement, and administration at an approved infusion center. The fastest path: (1) Gather genetic testing and TPP1 enzyme results confirming CLN2 disease, (2) Have your pediatric neurologist submit a PA request with clinical documentation, and (3) Coordinate with Cigna's specialty pharmacy network. If denied, Ohio provides two internal appeal levels plus external review through the Ohio Department of Insurance within 180 days. Start by calling Cigna at the number on your insurance card to request PA forms.

Table of Contents

  1. What Drives Brineura Costs
  2. Benefit Investigation: What to Ask Cigna
  3. Assistance Options and Cost Support
  4. Tiering Exceptions and Formulary Appeals
  5. Pharmacy Choice and Coordination
  6. Appeals Process for Coverage Denials
  7. Renewal and Annual Changes
  8. Scripts for Key Conversations
  9. FAQ

What Drives Brineura Costs

Brineura's high cost—approximately $702,000 annually at list price—stems from its classification as a specialty orphan drug requiring complex administration. With Cigna, several factors influence your out-of-pocket expenses:

Benefit Design Basics:

  • Medical vs. Pharmacy Benefit: Brineura is typically covered under your medical benefit, not pharmacy, meaning it's subject to medical deductibles and coinsurance rather than prescription copays
  • Specialty Tier Placement: When covered, it's usually placed on the highest specialty tier with 20-40% coinsurance
  • Site of Care Requirements: Must be administered at Cigna-approved infusion centers, which affects facility fees

Key Cost Drivers:

  • Annual medical deductible (often $1,000-$5,000+ for individual coverage)
  • Coinsurance percentage on specialty drugs (typically 20-30%)
  • Facility fees for intraventricular infusion procedures
  • Out-of-network penalties if using non-contracted centers

Understanding these elements helps you navigate the system more effectively and identify where cost assistance might apply.

Benefit Investigation: What to Ask Cigna

Before starting treatment, gather specific information about your Cigna coverage. Call the member services number on your insurance card and ask these targeted questions:

Essential Coverage Questions:

  1. "Is Brineura (cerliponase alfa) covered under my medical benefit or pharmacy benefit?"
  2. "What prior authorization requirements apply, and where do I get the forms?"
  3. "What's my annual deductible and coinsurance percentage for specialty drugs?"
  4. "Which infusion centers in Ohio are in-network for Brineura administration?"
  5. "What's my annual out-of-pocket maximum?"

Information to Record:

  • Reference number from your call
  • Name of the representative you spoke with
  • Specific policy language they reference
  • Any prior authorization form numbers or submission addresses
  • Deadline for PA submission after prescription is written
Tip: Ask Cigna to email you a summary of benefits specific to Brineura coverage. This creates a paper trail and helps avoid confusion later.

Keep detailed notes of all conversations, including dates and reference numbers. This documentation becomes crucial if you need to appeal a denial later.

Assistance Options and Cost Support

Multiple programs can help reduce your out-of-pocket costs for Brineura, but eligibility varies by insurance type and income.

BioMarin Co-Pay Assistance Program

Eligibility Requirements:

  • Commercial insurance (not Medicare, Medicaid, VA, or TRICARE)
  • U.S. resident in 50 states or Puerto Rico
  • FDA-approved use for CLN2 disease
  • No income limits specified

How It Works: Contact BioMarin RareConnections at 1-866-906-6100 to enroll. After each infusion, submit your Explanation of Benefits (EOB) with your copay ID for reimbursement processing.

Note: Massachusetts and Rhode Island residents can only receive assistance for the medication cost, not infusion procedure fees.

Additional Support Options

Foundation Grants:

  • National Organization for Rare Disorders (NORD)
  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)

State Programs: Ohio residents may qualify for additional assistance through state pharmaceutical assistance programs, particularly if you have Medicare coverage.

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeals processes for specialty drugs like Brineura.

Tiering Exceptions and Formulary Appeals

If Brineura is non-formulary or placed on a high-cost tier, you can request exceptions through Cigna's formulary exception process.

When to Request Exceptions

Step Therapy Override: Request when:

  • Previous required medications failed or caused adverse effects
  • Step therapy drugs are contraindicated due to CLN2 disease characteristics
  • Medical literature supports first-line use of Brineura

Non-Formulary Exception: Required when Brineura isn't on your plan's covered drug list but is medically necessary for your CLN2 diagnosis.

Required Documentation

Your physician must submit:

  • Completed Cigna formulary exception form
  • Clinical letter detailing:
    • Confirmed CLN2 diagnosis with genetic testing results
    • TPP1 enzyme deficiency documentation
    • Previous treatment attempts and outcomes
    • Medical necessity for Brineura specifically
  • Supporting literature from peer-reviewed sources

Timeline:

  • Standard review: up to 72 hours
  • Expedited review: typically 24 hours if health is at serious risk

Pharmacy Choice and Coordination

Brineura requires specialty pharmacy coordination and administration at approved infusion centers.

Specialty Pharmacy Requirements

Cigna's Network: Brineura is typically managed through Express Scripts specialty pharmacy or Accredo, depending on your specific plan. Your physician will need to:

  • Submit prescriptions to the designated specialty pharmacy
  • Coordinate delivery to the infusion center
  • Ensure proper storage and handling requirements are met

Infusion Center Coordination

Site Selection: Choose a Cigna in-network facility with:

  • Experience in intraventricular drug administration
  • Pediatric neurology oversight
  • Proper sterile procedure capabilities
  • Emergency response protocols

Contact your infusion center before your first appointment to confirm they're contracted with Cigna and can handle Brineura administration requirements.

Appeals Process for Coverage Denials

Ohio provides robust appeal rights for Cigna members, including external review through independent organizations.

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • Deadline: 180 days from denial notice
  • Process: Submit written appeal with additional clinical documentation
  • Timeline: Decision within 30 days (expedited: 72 hours)

Level 2 Internal Appeal:

  • Available if first-level appeal is denied
  • Same timeline and documentation requirements
  • Reviewed by different clinical team

External Review in Ohio

After exhausting internal appeals, Ohio residents can request external review through the Ohio Department of Insurance.

Key Features:

  • Deadline: 180 days from final internal denial
  • Process: Independent Review Organization (IRO) conducts medical review
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Binding: If IRO overturns denial, Cigna must provide coverage

Contact Information:

  • Ohio Department of Insurance Consumer Services: 1-800-686-1526
  • Submit requests through your health plan, which notifies ODI
From our advocates: We've seen Cigna coverage appeals succeed most often when families submit comprehensive genetic testing results, detailed treatment history, and specialist letters that directly address Cigna's medical policy criteria point-by-point. The key is matching your documentation to their specific requirements rather than general medical necessity arguments.

Renewal and Annual Changes

Brineura coverage requires ongoing attention to plan changes and renewal requirements.

Annual Considerations

Plan Year Changes:

  • Formulary status can change annually
  • Prior authorization requirements may be updated
  • In-network infusion centers can change
  • Cost-sharing amounts typically adjust

Renewal Documentation: Most payers require annual reauthorization with:

  • Updated CLN2 Clinical Rating Scale scores
  • Evidence of treatment response or disease stabilization
  • Continued specialist oversight
  • Absence of contraindications

Budget Planning

Cost Tracking:

  • Monitor progress toward annual deductible
  • Track out-of-pocket maximum
  • Document all EOBs for copay assistance claims
  • Plan for potential January restart of cost-sharing

Set calendar reminders 60 days before your plan year ends to review upcoming changes and prepare renewal documentation.

Scripts for Key Conversations

Calling Cigna Member Services

"Hi, I'm calling about prior authorization requirements for Brineura, generic name cerliponase alfa, for my [child/family member] with CLN2 disease. Can you tell me:

  • What forms I need for prior authorization
  • Where to submit them
  • What clinical documentation is required
  • Which infusion centers in Ohio are in-network
  • What my cost-sharing will be once approved

Can you also email me a summary of these requirements? My member ID is [number]."

Requesting Peer-to-Peer Review

"This is [clinic name] requesting a peer-to-peer review for Brineura prior authorization denial. Our patient has confirmed CLN2 disease with genetic testing and needs this FDA-approved treatment. When can our pediatric neurologist speak with your medical director? We have comprehensive documentation ready to discuss."

Pharmacy Coordination

"We need to coordinate Brineura delivery for a patient with CLN2 disease. The medication needs to be delivered to [infusion center name] on [date]. Can you confirm:

  • The delivery timeline
  • Storage requirements at the facility
  • Any special handling instructions
  • Emergency contact information"

FAQ

How long does Cigna prior authorization take for Brineura in Ohio? Standard PA reviews take up to 72 hours, but complex cases may take longer. Request expedited review if treatment delay poses health risks.

What if Brineura is non-formulary on my Cigna plan? Submit a formulary exception request with your physician. Include genetic testing, specialist recommendations, and evidence that no formulary alternatives treat CLN2 disease.

Can I appeal if my infusion center isn't in Cigna's network? Yes, you can request a network adequacy exception if no in-network facilities in Ohio can properly administer Brineura. Document the specialized requirements needed.

Does step therapy apply to Brineura for CLN2 disease? Step therapy shouldn't apply since no alternative disease-modifying treatments exist for CLN2. If required, request an immediate override with specialist documentation.

How do I access external review in Ohio? After exhausting Cigna's internal appeals, request external review within 180 days. Contact the Ohio Department of Insurance at 1-800-686-1526 for guidance.

What happens if I miss appeal deadlines? Missing deadlines can forfeit your appeal rights. If you have a valid reason for delay, contact Ohio DOI immediately—they may allow exceptions in certain circumstances.

The appeals process for specialty drugs like Brineura can be complex, but Ohio provides strong consumer protections. Counterforce Health helps families navigate these challenges by creating targeted appeals that address specific payer requirements and maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurer and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals and prior authorizations, consider consulting with coverage advocacy specialists.

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