By Counterforce Health Team in Kanuma (sebelipase alfa) —

Do You Qualify for Kanuma (Sebelipase Alfa) Coverage by Aetna (CVS Health) in Michigan? Decision Tree & Next Steps

Quick Answer: Kanuma (Sebelipase Alfa) Coverage Eligibility

You likely qualify for Kanuma coverage by Aetna (CVS Health) in Michigan if you have: confirmed LAL-D diagnosis with both reduced enzyme activity (<10% normal) AND pathogenic LIPA gene variants, plus elevated liver enzymes (ALT ≥1.5x upper normal limit). First step: Gather diagnostic test results and submit prior authorization through your prescriber via Aetna's provider portal at least 2 weeks before planned treatment start. If denied: You have 60 days for internal appeal, then 127 days for Michigan DIFS external review.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Your Action Plan
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternative Approaches
  6. If Denied - Michigan Appeal Process
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. Frequently Asked Questions

How to Use This Guide

This decision tree helps you determine whether you qualify for Kanuma (sebelipase alfa) coverage through Aetna (CVS Health) in Michigan and provides your next steps. Work through the eligibility questions below with your healthcare team, then follow the corresponding action plan.

Kanuma is a high-cost enzyme replacement therapy for lysosomal acid lipase deficiency (LAL-D), with annual costs ranging from $890,000 to $4.9 million depending on weight and dosing. Aetna requires prior authorization for all plans, making proper documentation essential for approval.

Note: This guide focuses on commercial Aetna plans in Michigan. Medicaid and Medicare Part D may have different requirements.

Eligibility Triage: Do You Qualify?

Step 1: Confirmed LAL-D Diagnosis?

Check both boxes for "Likely Eligible":

□ LAL enzyme activity testing showing less than 10% of normal activity
□ LIPA gene sequencing confirming pathogenic or likely pathogenic variants per ACMG criteria

Important: Aetna typically requires BOTH tests. Submitting only one often results in denials for "insufficient diagnostic evidence."

Step 2: Clinical Disease Markers?

Check at least one for "Likely Eligible":

□ ALT elevated ≥1.5 times upper limit of normal (documented on two separate occasions)
□ Hepatomegaly confirmed by imaging or physical examination
□ Dyslipidemia with elevated LDL cholesterol or triglycerides
□ Growth delays (pediatric patients)

Step 3: Prescriber Requirements?

□ Prescribed by or in consultation with hepatologist, endocrinologist, gastroenterologist, metabolic specialist, or geneticist

Step 4: Infusion Site Requirements?

□ Treatment planned at in-network hospital outpatient facility or certified infusion center

If "Likely Eligible" - Your Action Plan

Document Checklist

Gather these items before prior authorization submission:

Diagnostic Documentation:

  • LAL enzyme activity test results with reference ranges
  • Complete LIPA gene sequencing report showing pathogenic variants
  • Clinical notes confirming LAL-D diagnosis

Clinical Evidence (within 30 days of submission):

  • Liver function panel with ALT ≥1.5x ULN
  • Complete lipid profile (LDL, HDL, triglycerides)
  • Growth parameters (pediatric patients)
  • Imaging studies documenting hepatomegaly (if available)

Medical Necessity Letter should include:

  • Specific LAL enzyme activity values
  • LIPA gene variant classification per ACMG criteria
  • Documentation of hepatomegaly and disease progression
  • Evidence that supportive therapies are inadequate
  • Treatment goals and monitoring plan

Submission Process

  1. Provider submits prior authorization through Aetna's Availity provider portal at least 2 weeks before treatment start
  2. Standard review: 14-30 business days
  3. Expedited review: 72 hours (requires urgent medical need documentation)
  4. Follow up if no response within 14 business days

If "Possibly Eligible" - Tests to Request

Missing Diagnostic Tests

If you only have enzyme testing: Request LIPA gene sequencing from a certified genetic testing laboratory. Most insurers cover this for suspected LAL-D.

If you only have genetic testing: Request LAL enzyme activity testing via dried blood spot (DBS) or leukocyte testing.

Additional Clinical Documentation

  • Liver biopsy results (if performed) showing lipid accumulation
  • Serial liver function tests demonstrating disease progression
  • Lipid management history showing inadequate response to conventional therapy
  • Growth charts (pediatric patients) documenting failure to thrive

Timeline to Re-apply

Once you have complete diagnostic confirmation, submit prior authorization immediately. Aetna's review clock starts fresh with each new submission.

If "Not Yet" - Alternative Approaches

Formulary Exception Request

If Kanuma is non-formulary on your specific Aetna plan, request a formulary exception by:

  1. Having your prescriber submit medical necessity documentation
  2. Providing evidence that no formulary alternatives exist for LAL-D
  3. Including FDA prescribing information confirming approved indication

Contact: 1-866-316-3784 (Michigan Aetna Better Health) or CVS Caremark Pharmacy Help Desk: 1-855-432-6843

Step Therapy Override

Step therapy doesn't apply if you've received Kanuma within the past 365 days. For new patients, document why other treatments are inappropriate due to LAL-D's unique pathophysiology.

Compassionate Use Programs

While awaiting approval, explore:

  • Alexion Access Navigator patient assistance programs
  • Manufacturer copay assistance (verify with the source linked below)
  • State pharmaceutical assistance programs

If Denied - Michigan Appeal Process

Level 1: Internal Appeal (Required First Step)

Timeline: 60 days from denial date
Process: Submit through Aetna member services with additional medical evidence
Decision time: 30-45 business days (72 hours for expedited)

Level 2: Peer-to-Peer Review

Request your prescriber speak directly with Aetna's medical director to discuss clinical necessity.

Level 3: Michigan DIFS External Review

Timeline: 127 days from final internal denial
Process: Submit Health Care Request for External Review form (FIS 0018) to Michigan Department of Insurance and Financial Services
Decision time: 60 days maximum (72 hours for expedited)

Contact DIFS: 877-999-6442 or www.michigan.gov/difs

Key: Michigan's external review decisions are binding. If approved, Aetna must cover the treatment.

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all Aetna plans Aetna Precertification List
Diagnosis Confirmation LAL enzyme <10% normal + pathogenic LIPA variants Research findings
Clinical Markers ALT ≥1.5x ULN + hepatomegaly/dyslipidemia Research findings
Prescriber Specialist (hepatologist, endocrinologist, etc.) Research findings
Site of Care In-network hospital/certified infusion center Research findings
Age Limits None (approved from 1 month+) Research findings
Appeals Deadline (Internal) 60 days from denial Research findings
Appeals Deadline (External) 127 days from final denial Michigan DIFS

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnostic evidence Submit both enzyme and genetic testing together Complete LIPA gene sequencing + LAL activity results
Not medically necessary Provide clinical progression evidence Serial liver function tests, growth charts, specialist notes
Experimental/investigational Cite FDA approval FDA prescribing information showing approved indication
Non-formulary status Request formulary exception Medical necessity letter + prior therapy documentation
Wrong site of care Confirm in-network infusion center Provider network verification

Frequently Asked Questions

How long does Aetna prior authorization take in Michigan?
Standard reviews take 14-30 business days. Expedited reviews (for urgent medical needs) are completed within 72 hours. Submit at least 2 weeks before planned treatment start.

What if Kanuma is non-formulary on my plan?
Request a formulary exception through your prescriber. Since no alternative LAL-D treatments exist, exceptions are often approved with proper medical necessity documentation.

Can I request an expedited appeal?
Yes, if delay would seriously jeopardize your health. Requires a physician letter confirming urgency. Michigan DIFS completes expedited external reviews within 72 hours.

Does step therapy apply if I've used Kanuma before?
No. Step therapy doesn't apply if you've received the medication within the past 365 days, regardless of where you previously lived.

What happens if I move from another state?
Your medical history travels with you. Provide previous treatment records and current diagnostic tests to establish continuity of care.

How much does Kanuma cost without insurance?
Approximately $9,981 per 10mL vial, with annual costs ranging from $890,000 to $4.9 million depending on weight-based dosing.

Clinician Corner: Medical Necessity Letter Checklist

When drafting medical necessity letters for Kanuma, include these evidence-based elements:

Diagnostic Confirmation:

  • Specific LAL enzyme activity values with reference ranges
  • LIPA gene variant classification per ACMG criteria
  • Clinical correlation with hepatic and lipid abnormalities

Disease Progression Documentation:

  • Serial ALT/AST trends showing hepatic involvement
  • Lipid profile abnormalities (elevated LDL-C, triglycerides)
  • Growth velocity concerns (pediatric patients)
  • Imaging findings (hepatomegaly, splenomegaly)

Treatment Rationale:

  • FDA-approved indication for LAL-D enzyme replacement
  • Absence of alternative LAL-specific therapies
  • Expected clinical endpoints (hepatic improvement, lipid normalization)
  • Monitoring plan for efficacy and safety
From our advocates: We've seen strongest approval rates when prescribers include both the numeric enzyme activity results AND the genetic testing in the initial submission, rather than submitting them separately. This comprehensive approach demonstrates definitive diagnosis from the start.

Getting expert help with complex prior authorizations can save time and improve approval rates. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's requirements.

For Kanuma appeals specifically, having specialists who understand LAL-D diagnostic criteria and can pull the right evidence—from FDA labeling to specialty guidelines—makes a significant difference in appeal success rates. The platform tracks payer-specific deadlines and procedural requirements while providing templates that meet Michigan's external review standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult with your healthcare provider and insurance company for specific coverage determinations. For additional help with Michigan insurance appeals, contact the Department of Insurance and Financial Services at 877-999-6442.

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