By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Blue Cross Blue Shield in Ohio: Complete Appeals Guide and Financial Assistance

Answer Box: Getting Kanuma Covered by Blue Cross Blue Shield in Ohio

Blue Cross Blue Shield (Anthem) in Ohio requires prior authorization for Kanuma (sebelipase alfa) under medical benefits, governed by Clinical Criteria document CC-0037. To get approved: (1) Confirm LAL-D diagnosis with both reduced LAL enzyme activity and biallelic LIPA gene variants, (2) Submit PA through Anthem's provider portal with complete diagnostic documentation, and (3) Use Alexion OneSource financial assistance to minimize out-of-pocket costs. If denied, Ohio residents have 180 days to request external review through an Independent Review Organization. Start with Anthem's Clinical Documentation Lookup Tool.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Monitoring
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Kanuma Covered by Blue Cross Blue Shield in Ohio?

Yes, Anthem Blue Cross Blue Shield (operating as BCBS in Ohio) covers Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) under medical benefits, but prior authorization is required under Clinical Criteria document CC-0037.

Kanuma is classified as a specialty drug requiring:

  • Prior authorization through Anthem's provider portal
  • Dispensing through approved in-network specialty pharmacies
  • Confirmed LAL-D diagnosis with both biochemical and genetic testing

Which Plans Cover Kanuma?

All Anthem Blue Cross Blue Shield plans in Ohio follow the same clinical criteria for Kanuma, but coverage details vary by specific contract. This includes:

  • Individual and family plans
  • Employer-sponsored plans (fully insured)
  • Medicare Advantage plans (follow Medicare guidelines)
Note: Self-funded employer plans may have different policies, though many adopt Anthem's standard criteria.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis Requirements (Patient/Clinician)
    • Obtain LAL enzyme activity test showing deficient activity
    • Complete LIPA gene sequencing with deletion/duplication analysis
    • Document biallelic pathogenic/likely pathogenic variants
    • Timeline: 2-4 weeks for testing
  2. Gather Clinical Documentation (Clinician)
    • Medical necessity letter with diagnosis confirmation
    • Lab results (lipid panel, liver enzymes, genetic report)
    • Prior treatment history and failures
    • Timeline: 1-2 days
  3. Submit Prior Authorization (Clinician)
  4. Anthem Review Process
    • Standard review: 15 business days
    • Urgent review: 72 hours (with physician certification)
    • Timeline: 3 weeks maximum
  5. If Approved, Coordinate Specialty Pharmacy (Patient/Clinician)
    • Route prescription to approved specialty pharmacy
    • Enroll in financial assistance programs
    • Timeline: 1-2 weeks

Timing and Urgency

Standard Timelines

Process Timeline Notes
Prior Authorization 15 business days Standard review
Urgent PA 72 hours Requires physician certification
Appeal (Internal) 30 days Two levels available
External Review 30-45 days Through Ohio IRO
Expedited External Review 72 hours For urgent medical conditions

When to Request Urgent Review

Request expedited review if delay would:

  • Seriously jeopardize life or health
  • Impair ability to regain maximum function
  • Worsen progressive liver disease or metabolic complications

Your LAL-D specialist must certify the urgency in writing.

Medical Necessity Criteria

Core Requirements for Kanuma Approval

Diagnostic Criteria:

  • Reduced LAL enzyme activity on validated assay (typically <10% of normal)
  • Biallelic pathogenic LIPA variants confirmed by CLIA-certified lab
  • Clinical evidence of LAL-D (hepatomegaly, elevated liver enzymes, dyslipidemia)

Treatment Criteria:

  • Age-appropriate dosing per FDA label
  • Prescriber specialization in metabolic disorders or hepatology
  • Documentation of disease progression or severity

Clinician Corner: Medical Necessity Letter Checklist

Your LAL-D specialist should include:

✓ Confirmed diagnosis with enzyme and genetic test results
✓ Clinical presentation (hepatosplenomegaly, liver enzymes, lipid abnormalities)
✓ Disease progression or failure to respond to supportive care
✓ Dosing rationale consistent with FDA labeling
✓ Monitoring plan for treatment response and safety
✓ References to peer-reviewed literature supporting efficacy

From our advocates: We've seen the strongest approvals when specialists include specific enzyme activity numbers (e.g., "2% of normal control") and cite the pivotal New England Journal of Medicine studies showing sustained improvements in liver and lipid parameters. Concrete data points help medical reviewers understand disease severity.

Costs and Financial Assistance

Understanding Your Costs

Kanuma is an extremely high-cost therapy (estimated $0.89M-$4.9M annually). With Anthem Blue Cross Blue Shield:

  • Medical benefit coverage (infusion in facility)
  • Coinsurance typically 20-40% until out-of-pocket maximum
  • Prior authorization required before coverage begins

Financial Assistance Options

Alexion OneSource (Primary Option)

  • Commercial insurance: Potential $0 copay through manufacturer program
  • Free drug program: For uninsured/underinsured patients meeting criteria
  • Contact: Through your prescriber or Alexion OneSource

PAN Foundation LAL-D Fund

  • Up to $11,500/year toward copays and deductibles
  • Available for Medicare patients (manufacturer copay cards not allowed)
  • Income-based eligibility requirements
  • Apply at: PAN Foundation LAL-D Fund
Tip: Enroll in Alexion OneSource immediately after PA approval. The program can significantly reduce or eliminate your out-of-pocket costs.

Denials and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
Insufficient diagnosis Submit complete enzyme and genetic testing LAL activity <10% normal + biallelic LIPA variants
Off-label dosing Provide FDA dosing rationale Dose calculation based on weight/age per label
Lack of specialist Transfer to metabolic/hepatology specialist Specialist consultation notes
Missing prior therapy documentation Document supportive care attempts Records of lipid management, nutritional support

Appeals Process for Blue Cross Blue Shield in Ohio

Internal Appeals (2 Levels)

  1. First Level: 30 days to file, 30 days for decision
  2. Second Level: 30 days to file, 30 days for decision
  3. Submit through: Anthem member portal or appeals address on denial letter

External Review (Ohio IRO)

  • Deadline: 180 days from final internal denial
  • Process: File through Anthem, reviewed by Independent Review Organization
  • Timeline: 30-45 days (72 hours if expedited)
  • Binding: Decision is binding on Anthem

Contact Ohio Department of Insurance:

When to Request Expedited External Review

For urgent cases where delay would seriously jeopardize health, your physician can certify need for expedited review. This is common with progressive LAL-D where liver function is declining.

Renewals and Monitoring

Re-authorization Requirements

Anthem typically requires annual re-authorization for Kanuma with:

  • Updated clinical assessment
  • Laboratory monitoring (ALT/AST, lipid panel)
  • Documentation of treatment response
  • Continued medical necessity

Response Monitoring

Your specialist should document:

  • Liver enzyme improvements (ALT, AST reduction)
  • Lipid parameter changes (LDL-C, triglycerides)
  • Growth parameters (in pediatric patients)
  • Quality of life measures

Specialty Pharmacy Requirements

Approved Specialty Pharmacies

Anthem requires Kanuma dispensing through in-network specialty pharmacies only:

  • BioPlus Specialty Pharmacy (Primary network option)
  • CarelonRx (Anthem's designated specialty pharmacy)
  • CVS Specialty (In-network option)
  • Accredo (Verify network status)
Important: Using out-of-network pharmacies may result in no coverage and full out-of-pocket costs.

Coordination Steps

  1. Prescription routing: Doctor sends Rx directly to specialty pharmacy
  2. Benefits verification: Pharmacy confirms coverage and PA status
  3. Financial assistance: Pharmacy coordinates with OneSource program
  4. Delivery/infusion: Arrange home delivery or infusion center administration

Troubleshooting Common Issues

Portal and Form Issues

If Anthem Provider Portal is Down:

  • Use backup fax submission (verify current fax with customer service)
  • Call provider services for alternative submission methods
  • Document submission attempts for appeal purposes

Missing Forms or Criteria:

  • Access Clinical Criteria CC-0037
  • Use Clinical Documentation Lookup Tool for real-time requirements
  • Contact Anthem provider services: (verify with member services)

Prior Authorization Delays

If PA is Taking Too Long:

  1. Call Anthem to check status and required documents
  2. Request peer-to-peer review with medical director
  3. Submit additional clinical documentation if requested
  4. Consider urgent review if clinically appropriate

Counterforce Health specializes in turning insurance denials into successful appeals for complex rare disease therapies like Kanuma. Our platform analyzes denial letters and plan policies to create targeted, evidence-based appeals that align with Blue Cross Blue Shield's specific criteria, potentially saving months in the approval process.

FAQ

How long does Blue Cross Blue Shield PA take in Ohio? Standard prior authorization takes up to 15 business days. Urgent cases with physician certification are decided within 72 hours.

What if Kanuma is non-formulary on my plan? Kanuma is typically covered under medical benefits, not pharmacy formulary. If denied, request formulary exception with medical necessity documentation.

Can I request an expedited appeal? Yes, if your physician certifies that delay would seriously jeopardize your health or ability to regain function. This applies to both internal appeals and external review.

Does step therapy apply to Kanuma? Step therapy requirements vary by plan. Since Kanuma is the only FDA-approved ERT for LAL-D, step therapy typically involves documenting failure of supportive therapies (lipid management, nutritional support).

What if I move to another state? Coverage policies may differ if you switch to a different Blue Cross Blue Shield plan. Contact your new plan to confirm Kanuma coverage and transfer medical records.

How do I get help with appeals in Ohio? Contact Ohio Department of Insurance Consumer Services at 1-800-686-1526 for external review assistance, or consider working with patient advocacy organizations.

What happens if external review denies coverage? External review decisions are binding, but you retain rights to legal remedies or regulatory complaints. Consider consulting with healthcare attorneys specializing in insurance coverage.

Can I use manufacturer copay assistance with Medicare Advantage? No, federal anti-kickback rules prohibit manufacturer copay cards for government insurance. Use independent foundations like PAN Foundation instead.

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 are subject to change. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with your healthcare provider regarding medical decisions. For personalized assistance with insurance appeals and coverage optimization, Counterforce Health provides specialized support for rare disease therapies.

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