By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Cigna in New Jersey: Timeline, Appeals, and Approval Guide

Answer Box: Getting Kanuma Covered by Cigna in New Jersey

Kanuma (sebelipase alfa) requires prior authorization from Cigna with documented LAL-D diagnosis via enzyme activity testing and genetic confirmation. Standard approval takes 5 business days through Cigna's EviCore portal or provider submission. If denied, New Jersey's IHCAP external review provides binding decisions within 45 days at no cost to patients. First step: Have your prescribing physician submit the Kanuma CCRD Prior Authorization Form with complete LAL-D diagnostic documentation through Cigna's provider portal or fax to (855) 840-1678.

Table of Contents

Understanding Kanuma Coverage Requirements

Kanuma (sebelipase alfa) is a specialty enzyme replacement therapy for lysosomal acid lipase deficiency (LAL-D) that requires prior authorization from Cigna. The medication costs approximately $0.89M–$4.9M annually depending on patient weight and dosing, making thorough documentation essential for approval.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Kanuma PA Form Cigna Policy
Formulary Status Specialty tier coverage Express Scripts/Accredo Cigna Specialty Pharmacy
Diagnostic Requirements LAL enzyme + genetic testing Dried blood spot test FDA Label
Age Restrictions All ages approved No age limits FDA Approval
Site of Care Infusion center/hospital IV administration required Clinical Guidelines
Appeals Deadline 180 days from denial Internal appeal first NJ IHCAP

Pre-Submission Preparation (0-2 Days)

Before submitting your Kanuma prior authorization, gather these essential documents to prevent delays:

Diagnostic Documentation Checklist

  • LAL enzyme activity test results showing deficient activity (below 1.5 nmol/h/mL)
  • LIPA gene sequencing confirming pathogenic variants
  • Clinical evidence of disease severity including:
    • Elevated liver enzymes (ALT > 1.5x upper normal)
    • Hepatomegaly documentation via imaging
    • Dyslipidemia with low HDL cholesterol (< 50 mg/dL)
    • Liver biopsy results if available

Insurance Verification

Contact Cigna member services at the number on your ID card to confirm:

  • Your specialty pharmacy benefits (typically through Express Scripts/Accredo)
  • Prior authorization requirements for your specific plan
  • Any step therapy requirements (though none exist for LAL-D)
Tip: Kanuma is the only FDA-approved enzyme replacement therapy for LAL-D, which strengthens medical necessity appeals since no therapeutic alternatives exist.

Submission to Initial Review (1-5 Days)

Primary Submission Methods

EviCore Portal (Fastest) Your physician can submit through EviCore by Evernorth by selecting "Pharmacy Drugs (Express Scripts Coverage)" from the prior authorization options. This electronic submission typically processes within 24-48 hours.

Alternative Submission Options:

  • Fax: Complete Kanuma CCRD Prior Authorization Form and fax to (855) 840-1678
  • Phone: Call 1-800-882-4462 for urgent submissions
  • Standard processing: 5 business days for non-urgent requests

New Jersey Regulatory Timeline

Under New Jersey regulations effective 2025, Cigna must respond to prior authorization requests within 9 calendar days for non-urgent requests and 72 hours for urgent requests requiring expedited review.

Additional Information Requests (1-7 Days)

If Cigna requests additional information, respond promptly to avoid approval delays:

Common Information Requests

  • Previous treatment history: Documentation of any supportive therapies tried
  • Specialist consultation notes: Hepatologist or metabolic specialist recommendations
  • Updated laboratory results: Recent liver function tests and lipid panels
  • Dosing justification: Weight-based dosing calculations per FDA labeling
Note: Many practices can respond to information requests within 24-48 hours. Contact your healthcare provider's office immediately if Cigna requests additional documentation.

Decision Window and Outcomes

Typical Approval Outcomes

When Approved:

  • Cigna typically authorizes Kanuma for a 12-month coverage period
  • Approval letter specifies quantity limits and designated specialty pharmacy
  • Coverage begins immediately upon approval notification

Reading Your Approval Letter:

  • Authorization duration and renewal requirements
  • Specialty pharmacy routing (usually Accredo)
  • Any quantity or frequency limitations
  • Required monitoring parameters

If Denied: New Jersey Appeal Process

New Jersey offers one of the most robust appeal systems in the country through the Independent Health Care Appeals Program (IHCAP).

Step-by-Step Appeals Process

1. Internal Appeal (Required First Step)

  • Timeline: 180 days from denial date to file
  • Processing: 30 days standard, 15 days expedited
  • Submit to: Cigna member services or provider portal
  • Required: Original denial letter, additional clinical documentation, specialist letter

2. External Review Through IHCAP

  • Administrator: Maximus Federal Services
  • Timeline: 45 days for standard review, 48 hours for expedited
  • Cost: Free to patients (insurers pay all costs)
  • Binding: Cigna must comply with favorable decisions

3. IHCAP Submission Requirements

  • Complete internal appeal process first
  • Submit within 4 months (180 days) of final denial
  • Include all medical records and specialist recommendations
  • Submit directly to Maximus (not NJ DOBI)

Strengthening Your Appeal

Since Kanuma is the only approved treatment for LAL-D, focus your appeal on:

  • Medical necessity: No therapeutic alternatives exist
  • Diagnostic certainty: Enzyme and genetic testing confirmation
  • Disease severity: Clinical evidence of hepatic and lipid complications
  • Standard of care: FDA approval for all ages with LAL-D
From Our Advocates: We've seen successful appeals when families include a detailed timeline showing how LAL-D symptoms progressed despite supportive care, combined with specialist letters explaining why Kanuma is the only viable treatment option. This composite approach helps external reviewers understand the urgency and lack of alternatives.

Renewal Cycles and Re-Authorization

Annual Renewal Process

  • Timing: Submit renewal 30-60 days before expiration
  • Requirements: Updated clinical response documentation
  • Monitoring: ALT/AST improvements and LDL-C reductions
  • Specialist assessment: Continued medical necessity evaluation

What Speeds Renewals

  • Documented clinical improvements in liver enzymes
  • Sustained lipid profile improvements
  • Specialist confirmation of ongoing treatment need
  • No significant adverse events requiring discontinuation

Timeline Visual and Milestones

Milestone Expected Timeline Key Actions
Preparation 0-2 days Gather diagnostic documentation, verify benefits
Submission Day 1 Submit PA through EviCore portal or fax
Initial Review 1-5 days Cigna reviews for completeness and criteria
Information Request 1-7 days Respond to any additional documentation requests
Decision 5-9 days total Approval notification or denial letter
Internal Appeal 30 days If denied, submit internal appeal
External Review 45 days IHCAP binding decision if internal appeal fails

Time-Saving Tips for Faster Approval

Portal Usage Optimization

  • Use EviCore electronic submission for fastest processing
  • Submit during business hours (Monday-Friday, 8 AM-5 PM EST)
  • Include all required documentation in initial submission

Bundled Evidence Strategy

  • Submit comprehensive diagnostic package upfront
  • Include specialist consultation notes with initial PA
  • Attach recent laboratory results and imaging

Direct Specialty Routing

  • Confirm Accredo specialty pharmacy enrollment before PA approval
  • Coordinate with specialty pharmacy for seamless fulfillment
  • Verify infusion site capabilities for IV administration

FAQ: Common Questions

How long does Cigna prior authorization take for Kanuma in New Jersey? Standard processing is 5 business days, with New Jersey regulations requiring response within 9 calendar days for non-urgent requests and 72 hours for urgent cases.

What if Kanuma is non-formulary on my Cigna plan? You can request a formulary exception with physician certification that formulary alternatives are ineffective or contraindicated.

Can I request an expedited appeal in New Jersey? Yes, both Cigna internal appeals and IHCAP external reviews offer expedited processing when delays could seriously jeopardize health.

Does step therapy apply if I've never tried other treatments? No step therapy requirements exist for LAL-D since Kanuma is the only approved enzyme replacement therapy for this condition.

What happens if IHCAP overturns Cigna's denial? The decision is binding by New Jersey statute (N.J.S.A. 26:2S-11), and Cigna must provide coverage as directed by the external review.

How much does Kanuma cost without insurance? Retail costs approximately $998 per mL, with annual costs ranging from $0.89M to $4.9M depending on patient weight and dosing frequency.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed submissions. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, pulling appropriate clinical citations and weaving them into appeals that meet procedural standards. For complex cases like Kanuma coverage, Counterforce Health provides the specialized expertise needed to navigate prior authorization and appeal processes effectively.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For assistance with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP-specific number 1-888-393-1062.

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