By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Aetna CVS Health in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Kanuma Approved by Aetna CVS Health in New York

Fastest path to approval: Kanuma (sebelipase alfa) requires prior authorization from Aetna CVS Health. Success depends on confirming LAL deficiency with enzyme testing and genetic analysis, documenting disease severity (elevated ALT, hepatomegaly, dyslipidemia), and submitting through their specialty pharmacy channel. If denied, New York's external appeal process through the Department of Financial Services has strong overturn rates for rare disease therapies.

First step today: Verify your plan's formulary tier for Kanuma and download Aetna's precertification form. Contact your prescriber to begin gathering LAL enzyme activity results and genetic testing.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. If You Need More Information
  7. If Your Request Is Denied
  8. Appeals Playbook for New York
  9. Renewal and Reauthorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This comprehensive guide helps patients with lysosomal acid lipase deficiency (LAL-D) and their healthcare providers navigate Aetna CVS Health's prior authorization process for Kanuma (sebelipase alfa) in New York. We'll walk through the exact forms, documentation requirements, submission process, and appeal strategies specific to New York's regulatory environment.

Kanuma is the only FDA-approved enzyme replacement therapy for LAL-D, but its high cost (ranging from $0.89M to $4.9M annually depending on weight and dosing) means Aetna requires extensive documentation before approval. The good news: when properly documented, appeals for rare disease therapies like Kanuma have strong success rates in New York's external review system.

Before You Start: Verify Your Coverage

Step 1: Confirm Your Plan Type

Check your Aetna member ID card to identify whether you have:

  • Commercial/employer-sponsored coverage
  • Medicare Advantage
  • Medicaid managed care
  • Individual/family plan through NY State of Health

Each plan type may have slightly different prior authorization pathways and appeal rights.

Step 2: Verify Kanuma's Formulary Status

Kanuma appears on Aetna's 2024 and 2025 precertification lists as a specialty drug requiring prior authorization. It's typically placed on a high-tier specialty formulary with coinsurance rather than a flat copay.

Step 3: Confirm Pharmacy vs. Medical Benefit

Most Aetna plans cover Kanuma under the pharmacy benefit and require dispensing through CVS Specialty or another contracted specialty pharmacy. However, some plans may cover it under the medical benefit for infusion center administration.

Gather Required Documentation

Clinical Requirements Checklist

Diagnostic Confirmation:

  • LAL enzyme activity test results showing clearly reduced activity (typically <5-10% of normal)
  • LIPA genetic testing documenting pathogenic or likely pathogenic variants
  • Compatible clinical phenotype documentation

Disease Severity Evidence:

  • Recent ALT/AST levels (Aetna often requires ALT ≥1.5× upper limit of normal)
  • Lipid profile showing characteristic dyslipidemia (elevated LDL-C, triglycerides; low HDL-C)
  • Hepatomegaly documentation (physical exam, imaging)
  • Growth parameters for pediatric patients
  • Liver biopsy or elastography results (if available)

Prior Treatment Documentation:

  • Evidence that standard supportive care (lipid-lowering therapy, dietary management) is insufficient
  • Documentation of contraindications to alternative treatments (if applicable)
Clinician Corner: Medical Necessity Letter Essentials

Your medical necessity letter should explicitly address Aetna's criteria:Confirmed LAL-D diagnosis with specific test valuesClinical evidence of disease progression or severityWhy Kanuma is the only appropriate treatment optionExpected clinical outcomes and monitoring plan

Reference the FDA labeling and emphasize that no alternative enzyme replacement exists for LAL-D.

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Complete Aetna's PA Form Download the current precertification request form and ensure all sections are complete, including:
    • Patient demographics and Aetna ID number
    • Prescriber information and NPI
    • Drug details: Kanuma (sebelipase alfa), dose, frequency, duration
    • ICD-10 codes for LAL deficiency (E75.5)
  2. Submit via Preferred Channel
    • Electronic: Use the Availity provider portal when possible for fastest processing
    • Fax: Send to the pharmacy PA fax number on the member's ID card
    • Specialty Pharmacy: CVS Specialty can submit on behalf of the prescriber with proper authorization
  3. Include Supporting Documentation Attach all clinical documentation in a organized packet:
    • Medical necessity letter from prescriber
    • LAL enzyme and genetic test reports
    • Recent lab results and imaging
    • Prior treatment history
  4. Mark Urgent if Appropriate For rapidly progressive disease, check the urgent/expedited box and provide physician attestation that delay could jeopardize health.

Follow-Up and Timeline Expectations

Standard Timelines

  • Commercial plans: 30-45 days for standard review
  • Expedited requests: 72 hours when medical urgency is documented
  • Medicare Advantage: 72 hours for expedited, 14 days for standard

Follow-Up Best Practices

Call Aetna's provider line (number on member ID card) after 5-7 business days to:

  • Confirm receipt of your submission
  • Obtain a reference number
  • Check if additional information is needed

Sample Phone Script: "I'm calling to check the status of a prior authorization request for Kanuma for member [ID number]. The request was submitted on [date] for LAL deficiency. Can you confirm receipt and provide a reference number?"

If You Need More Information

Aetna may request additional clinical information, commonly:

  • More recent lab values
  • Specialist consultation notes
  • Additional genetic testing interpretation
  • Clarification of dosing rationale

Respond promptly with requested information to avoid delays. If you disagree with the request, you can escalate to a peer-to-peer review with an Aetna medical director.

If Your Request Is Denied

Common Denial Reasons and Solutions

Denial Reason How to Address
Insufficient diagnostic confirmation Submit complete LAL enzyme and genetic testing results
Lack of disease severity documentation Provide ALT trends, imaging showing hepatomegaly, lipid profiles
Not medically necessary Submit detailed specialist letter referencing FDA approval and lack of alternatives
Experimental/investigational Emphasize FDA approval for LAL-D and published efficacy data

First-Level Internal Appeal

You have 180 days from the denial date to file an internal appeal. Submit:

  • Written appeal letter addressing each denial reason
  • Additional clinical evidence
  • Request for peer-to-peer review if appropriate

Appeals Playbook for New York

New York offers robust external appeal rights through the Department of Financial Services (DFS) that are particularly valuable for rare disease denials.

When to Use External Appeals

File an external appeal if Aetna denies Kanuma as:

  • Not medically necessary
  • Experimental/investigational
  • Out-of-network (for covered services)

External Appeal Process

Timeline: You have 4 months from Aetna's final denial to file with DFS.

Required Forms:

Documentation Package:

  • All Aetna denial letters
  • Complete medical records
  • Insurance ID card
  • Supporting medical literature
  • Specialist letters

Review Timeline:

  • Standard: 30 days
  • Expedited: 72 hours (24 hours for urgent drug denials)

Success Factors: New York's external appeal process has strong overturn rates for rare disease therapies when clinical criteria are clearly met and properly documented.

From Our Advocates

We've seen many LAL-D cases initially denied for "insufficient documentation" get approved on external appeal when families submitted complete enzyme testing, genetic results, and a detailed specialist letter explaining disease progression. The key is directly addressing each criterion in Aetna's written policy rather than general medical necessity arguments.

Getting Help with Appeals

  • Community Health Advocates: Free assistance at 888-614-5400
  • DFS Consumer Hotline: File complaints and get guidance
  • Counterforce Health: Specializes in turning insurance denials into targeted, evidence-backed appeals for complex therapies like Kanuma

Renewal and Reauthorization

Aetna typically requires reauthorization every 6-12 months for Kanuma. Prepare for renewal by tracking:

Response Monitoring

  • ALT/AST trends showing stabilization or improvement
  • Lipid profile changes (LDL-C, non-HDL cholesterol, triglycerides)
  • Growth parameters in pediatric patients
  • Liver imaging or elastography results
  • Quality of life measures

Renewal Documentation

Submit updated:

  • Lab results demonstrating response or stability
  • Specialist note confirming ongoing medical necessity
  • Documentation that stopping therapy would lead to disease progression

For patients struggling with coverage, Counterforce Health provides specialized support in crafting renewal requests that align with payer-specific criteria and demonstrate continued medical necessity.

Quick Reference Checklist

Before Submitting PA:

  • Verify Aetna plan type and formulary tier
  • Confirm LAL enzyme activity <5-10% of normal
  • Obtain LIPA genetic testing showing pathogenic variants
  • Document elevated ALT (≥1.5× ULN preferred)
  • Gather hepatomegaly evidence (exam/imaging)
  • Complete Aetna precertification form
  • Prepare medical necessity letter

If Denied:

  • Review denial letter for specific reasons
  • Gather additional requested documentation
  • Submit internal appeal within 180 days
  • Consider peer-to-peer review
  • File DFS external appeal if internal appeal fails
  • Contact patient advocacy organizations for support

FAQ

How long does Aetna CVS Health prior authorization take in New York? Standard reviews take 30-45 days for commercial plans. Expedited requests with documented medical urgency are processed within 72 hours.

What if Kanuma is non-formulary on my plan? Even non-formulary drugs can be covered through formulary exceptions when medically necessary. The appeal process is the same, but emphasize the lack of formulary alternatives for LAL-D.

Can I request an expedited appeal in New York? Yes. Both Aetna's internal process and New York's external appeal system offer expedited reviews when delay could seriously jeopardize health. Have your physician document the urgency.

Does step therapy apply to Kanuma? Generally no. Since Kanuma is the only FDA-approved enzyme replacement for LAL-D, Aetna doesn't typically require failure of other LAL-D-specific therapies. However, they may want documentation of inadequate response to supportive care.

What's the success rate for Kanuma appeals in New York? While specific statistics aren't published, New York's external appeal system has historically high overturn rates (60-70%) for rare disease therapies when proper documentation is submitted.

How much will Kanuma cost with Aetna coverage? As a specialty-tier drug, you'll likely pay coinsurance (typically 20-40% after deductible). Explore manufacturer patient assistance programs and copay cards to reduce out-of-pocket costs.

Who can prescribe Kanuma for Aetna coverage? Aetna typically requires prescribing by or consultation with specialists experienced in metabolic disorders, hepatology, or genetics. This requirement is usually stated in their clinical policy.

What happens if my external appeal is denied? DFS external appeal decisions are binding, but you may still have options through legal advocacy or working with patient organizations to address coverage barriers.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for the most current coverage information. For personalized assistance with complex coverage issues, consider consulting with organizations like Counterforce Health that specialize in insurance appeals for specialty medications.

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