By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Humana in New Jersey: Requirements Checklist and Appeals Guide

Answer Box: Fastest Path to Approval

Getting Kanuma (sebelipase alfa) covered by Humana in New Jersey requires prior authorization with confirmed LAL-D diagnosis through enzyme testing and genetic analysis. Submit your PA request through Humana's provider portal with complete diagnostic documentation, medical necessity letter, and evidence of supportive therapy failure. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review within 180 days. Most approvals occur within 72 hours with proper documentation. Start today: Gather your LAL enzyme activity results and LIPA gene test, then contact your prescriber to initiate the PA process.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & Solutions
  10. Appeals Process in New Jersey
  11. Costs and Patient Support
  12. FAQ

Who Should Use This Guide

This comprehensive checklist is designed for patients with lysosomal acid lipase deficiency (LAL-D) and their healthcare providers seeking Kanuma (sebelipase alfa) coverage through Humana plans in New Jersey. You'll find this guide most helpful if you:

  • Have a confirmed LAL-D diagnosis and need enzyme replacement therapy
  • Are facing a Humana prior authorization requirement or denial
  • Need to understand New Jersey's specific appeal rights and timelines
  • Want to avoid common documentation mistakes that delay approval

Expected outcome: With proper preparation using this guide, most medically appropriate Kanuma requests receive approval within 72 hours. If initially denied, New Jersey's robust external review process has helped many patients secure coverage.

Member & Plan Basics

Active Coverage Verification

Before starting your prior authorization request, confirm your current Humana coverage status:

  • Medicare Advantage members: Kanuma falls under Part B coverage as a physician-administered injectable
  • Commercial plan members: Coverage varies by formulary tier and requires PA
  • Dual Medicare-Medicaid plans: Follow Medicare guidelines with additional state protections
Tip: Call the member services number on your insurance card to verify your plan's specific formulary status for Kanuma before beginning the PA process.

Plan Type Considerations

Humana's 2024 Medicare Advantage plans list Kanuma as requiring prior authorization across all tiers. The medication is not subject to step therapy requirements specifically, but payers expect documentation of supportive therapy attempts before approving enzyme replacement.

Clinical Criteria Requirements

Diagnosis Confirmation

Humana requires definitive LAL-D diagnosis through both:

  1. LAL enzyme activity testing - Fluorometric assay showing significantly reduced activity (<5-10% of normal mean)
  2. LIPA gene variant analysis - Molecular testing confirming pathogenic mutations
Note: Genetic testing alone is insufficient. Both biochemical and molecular confirmation are required for most insurance approvals.

Medical Necessity Standards

Your clinical documentation must demonstrate:

  • Disease severity: Evidence of hepatic lipid abnormalities, hepatomegaly, or other LAL-D manifestations
  • Failure of supportive management: Documented trials of lipid-lowering therapy, dietary modifications, or other conventional treatments with inadequate response
  • Appropriate dosing: Weight-based dosing per FDA labeling (1 mg/kg every other week for most patients)
  • Monitoring plan: Baseline and follow-up labs including ALT/AST, lipid panels, and clinical assessments

Coding and Billing Information

Essential Codes

Code Type Code Description
HCPCS J-Code J2840 Injection, sebelipase alfa, 1 mg
NDC 25682-0007-01 Kanuma 20 mg/10 mL vial
ICD-10 E75.5 Other lipid storage disorders (Wolman disease)
ICD-10 Alternative E75.6 Lipid storage disorder, unspecified

Billing Units

Each billable unit equals 1 mg of sebelipase alfa. Calculate total mg based on patient weight and prescribed dose, then bill accordingly. Since Kanuma comes in 20 mg/10 mL vials, round up to the nearest full vial as needed.

Documentation Packet Essentials

Provider Note Elements

Your prescriber's clinical note should include:

  • Complete medical history and physical examination findings
  • Specific LAL-D symptoms and severity
  • Previous treatment attempts and outcomes
  • Current weight and calculated dose
  • Treatment goals and monitoring plan

Medical Necessity Letter Components

A strong medical necessity letter should address:

  1. Patient identification and confirmed LAL-D diagnosis
  2. Clinical presentation with specific lab values and symptoms
  3. Treatment history documenting failure of supportive therapies
  4. Rationale for Kanuma as the only FDA-approved enzyme replacement therapy
  5. Dosing justification based on current weight and disease severity

Counterforce Health specializes in crafting evidence-backed appeals that align with payer-specific requirements, helping patients navigate complex prior authorization processes for specialty medications like Kanuma.

Required Attachments

  • LAL enzyme activity test results
  • LIPA genetic testing report
  • Recent liver function tests and lipid panels
  • Clinical notes documenting disease progression
  • Records of previous therapy attempts
  • FDA prescribing information for Kanuma

Submission Process

Correct Forms and Portals

Submit your prior authorization request through:

  • Humana Provider Portal: Primary submission method for most plans
  • Fax submission: Use current PA fax number (verify with provider services)
  • Phone requests: Available for urgent/expedited reviews
Important: Always use the most current PA form version. Outdated forms commonly cause processing delays.

Required Fields That Prevent Rejections

Ensure these critical fields are complete:

  • Patient demographics exactly matching insurance card
  • Prescriber NPI and contact information
  • Specific diagnosis codes (E75.5 or E75.6)
  • Precise dosing and frequency
  • Complete prior therapy documentation
  • Attachment confirmation checkboxes

Specialty Pharmacy Requirements

Preferred Vendors

Humana requires Kanuma dispensing through CenterWell Specialty Pharmacy for most plans. This ensures proper handling, patient education, and coordination with infusion centers.

Transfer Steps

If switching from another specialty pharmacy:

  1. Contact CenterWell at their provider line
  2. Provide current prescription details and patient information
  3. Coordinate timing to prevent therapy gaps
  4. Confirm infusion center arrangements
  5. Verify insurance authorization transfer

After Submission: What to Expect

Timeline Expectations

  • Standard review: 72 hours for complete submissions
  • Expedited review: 24 hours for urgent medical situations
  • Additional information requests: 5-7 business days for response

Status Tracking

Record these details after submission:

  • Confirmation number or reference ID
  • Submission date and method
  • Contact person (if applicable)
  • Expected decision timeline
  • Follow-up schedule

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient diagnostic evidence Submit both enzyme activity and genetic test results with interpretation
Lack of supportive therapy documentation Provide detailed records of lipid-lowering drugs, dietary interventions, and outcomes
Dosing not per FDA label Recalculate dose based on current weight; provide prescriber rationale if exceeding standard dosing
Missing clinical severity markers Include recent ALT/AST, lipid panels, imaging showing hepatomegaly/splenomegaly
Incomplete prior authorization form Review all required fields; resubmit with complete information

Appeals Process in New Jersey

Internal Appeals

If Humana denies your initial request:

  1. Request peer-to-peer review within 30 days
  2. Submit additional clinical evidence addressing denial reasons
  3. Consider expedited appeal if delay would cause serious harm

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program provides robust patient protections:

  • Eligibility: Available after completing Humana's internal appeal process
  • Timeline: 180 days from final internal denial to file external appeal
  • Process: Submit directly to Maximus Federal Services (contracted IURO)
  • Cost: Free to patients; insurers pay all review costs
  • Decision timeline: 45 days for standard review, expedited options available

IHCAP Contact Information:

  • Phone: 1-888-393-1062
  • NJ Department of Banking and Insurance: 1-800-446-7467

When preparing your external appeal, Counterforce Health can help identify the specific denial basis and craft targeted rebuttals that address Humana's coverage criteria while incorporating New Jersey's patient protection standards.

Binding Decisions

External review decisions are legally binding on insurers. If the independent medical reviewers determine Kanuma is medically necessary, Humana must provide coverage.

Costs and Patient Support

Manufacturer Support Programs

Alexion offers patient assistance through:

  • Alexion Access Navigator: Comprehensive support for PA assistance and appeals
  • Financial assistance programs: For eligible patients meeting income criteria
  • Copay support: May be available for commercial insurance patients

Foundation Resources

Consider these additional support options:

  • Patient advocacy organizations for rare diseases
  • State pharmaceutical assistance programs
  • Hospital charity care programs for infusion costs

FAQ

How long does Humana prior authorization take for Kanuma in New Jersey? Standard PA reviews take up to 72 hours with complete documentation. Expedited reviews are available within 24 hours for urgent medical situations.

What if Kanuma is non-formulary on my Humana plan? Request a formulary exception with medical necessity documentation. Emphasize that Kanuma is the only FDA-approved treatment for LAL-D with no therapeutic alternatives.

Can I request an expedited appeal if Humana denies coverage? Yes, expedited appeals are available if delay would cause serious harm to your health. Provide clinical documentation supporting urgency.

Does step therapy apply to Kanuma for LAL-D? Humana doesn't specifically require step therapy for Kanuma, but expects documentation of supportive therapy attempts before approving enzyme replacement.

What happens if I move from another state to New Jersey during treatment? New Jersey's appeal rights apply to NJ-regulated plans. For Medicare Advantage, federal appeal rules apply regardless of state. Contact the NJ Department of Banking and Insurance for guidance on plan transitions.

How often does Humana require reauthorization for Kanuma? Typically every 6-12 months, with updated clinical data showing therapeutic response through liver function tests and lipid improvements.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company for plan-specific requirements. Coverage policies may change, and individual circumstances vary.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements, incorporating the right clinical evidence and procedural details to maximize approval success.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.