By Counterforce Health Team in Kanuma (sebelipase alfa) —

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

Answer Box: Getting Kanuma Approved by Aetna CVS Health in Florida

Kanuma (sebelipase alfa) requires prior authorization from Aetna CVS Health in Florida. To get approval: (1) Confirm LAL-D diagnosis with enzyme testing and genetic results, (2) Document ALT ≥1.5× upper limit normal on two measurements one week apart, (3) Submit Aetna's Kanuma-specific precertification form with supporting labs via Availity portal. Start today: Verify your plan covers Kanuma under specialty pharmacy benefit and gather enzyme/genetic test results. Appeals follow Florida's 180-day internal timeline plus 4-month external review option.

Table of Contents

What This Guide Covers

This 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 Florida. You'll learn the specific documentation requirements, submission procedures, and appeal strategies that work with Aetna's policies.

Who this helps: Patients diagnosed with LAL-D, prescribing physicians, specialty pharmacies, and patient advocates working with Aetna CVS Health plans in Florida.

Expected outcomes: With proper documentation, most medically appropriate Kanuma requests are approved. When initial requests are denied, well-documented appeals have meaningful success rates, particularly for FDA-approved indications with strong clinical evidence.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Kanuma. Our platform analyzes denial letters, identifies specific coverage gaps, and creates targeted, evidence-backed appeals that align with each insurer's policies. We help patients, clinicians, and pharmacies navigate complex prior authorization requirements and improve approval rates for life-changing therapies.

Before You Start: Verify Your Coverage

Step 1: Confirm Your Plan Type

Check your Aetna ID card to identify whether you have:

  • Aetna Better Health of Florida (Medicaid)
  • Aetna Medicare Advantage
  • Commercial/employer plan administered by Aetna CVS Health

Different plan types have varying timelines and appeal processes.

Step 2: Verify Kanuma Coverage

Call the member services number on your ID card and ask:

  • "Is Kanuma (sebelipase alfa) covered under my plan?"
  • "What is the formulary tier and my estimated cost-sharing?"
  • "Is prior authorization required for both the drug and infusion site?"

Step 3: Check Network Status

Confirm your prescribing physician and intended infusion center are in-network. Aetna requires prior authorization for both drug and site of care for Kanuma.

Gather Required Documentation

Diagnostic Requirements

LAL-D Confirmation (both required by Aetna):

  • Enzyme testing: LAL enzyme activity assay showing deficiency
  • Genetic testing: LIPA gene sequencing confirming pathogenic variants

Clinical Documentation

Laboratory Evidence:

  • Two ALT measurements ≥1.5× upper limit normal, taken at least one week apart
  • Complete metabolic panel including AST, GGT, bilirubin
  • Fasting lipid panel (LDL-C, HDL-C, triglycerides, total cholesterol)
  • Platelet count and other liver function indicators

Imaging and Additional Studies:

  • Liver ultrasound, CT, or MRI showing hepatomegaly or steatosis
  • FibroScan results (if available)
  • Any liver biopsy reports

Treatment History

Document previous therapies and outcomes:

  • Lipid-lowering medications tried (statins, ezetimibe, etc.)
  • Dosages, duration, and reasons for discontinuation
  • Current lipid levels despite treatment

Submit Your Prior Authorization Request

Use Aetna's Kanuma-Specific Form

Download and complete Aetna's Kanuma Medication Precertification Request form. This form includes specific clinical questions about:

  • Outpatient hospital infusion requirements
  • Infusion reaction history
  • Venous access issues
  • ALT elevation documentation

Submission Methods

Preferred: Electronic Submission

  • Submit via Availity provider portal
  • Attach completed form and all supporting documentation
  • Submit at least 2 weeks before planned treatment start

Alternative: Fax Submission

  • Fax completed form to the precertification number listed on the form
  • Include cover sheet with member ID and "URGENT" if expedited review needed

Required Attachments

  • Completed Kanuma precertification form
  • LAL enzyme assay results
  • LIPA genetic testing report
  • Two ALT lab reports with dates
  • Baseline lipid panel
  • Specialist consultation notes
  • Prior medication history and failures

Follow-Up and Timeline Expectations

Standard Processing Times

  • Standard review: 14-30 business days
  • Expedited review: 72 hours (when medically urgent)
  • Aetna's goal: >95% of complete requests processed within 24 hours

Follow-Up Schedule

Week 1: Confirm receipt via provider portal or phone Week 2: Check status if no response received Week 3: Escalate to expedited review if clinically appropriate

Sample Follow-Up Script

"I'm calling to check the status of prior authorization request [reference number] for Kanuma (sebelipase alfa) for patient [name], member ID [number]. This was submitted on [date]. Can you provide an update on the review timeline?"

If Asked for More Information

Aetna may request additional documentation. Common requests include:

Medical Necessity Clarification

  • More detailed specialist notes explaining disease severity
  • Additional lab trends showing progression
  • Justification for infusion site selection

Literature Support

Provide peer-reviewed evidence supporting Kanuma use:

Response Strategy

  • Respond within 48-72 hours of request
  • Provide exactly what was requested, clearly labeled
  • Include brief cover letter summarizing how new information supports approval

If Your Request Is Denied

Common Denial Reasons

Denial Reason How to Address
"Not medically necessary" Provide detailed disease progression data and specialist letter
"Insufficient documentation" Submit missing enzyme/genetic tests and ALT measurements
"Experimental/investigational" Reference FDA approval and published clinical data
"Non-formulary" Request formulary exception with medical necessity letter

First-Level Internal Appeal

Timeline: 180 days from denial notice Process: Submit written appeal with additional documentation Decision time: 30-45 days standard; 72 hours expedited

Tip: Request expedited review if delay would seriously jeopardize your health. Include physician statement supporting urgency.

Peer-to-Peer Review Strategy

When Aetna offers peer-to-peer review:

  • Ensure your metabolic specialist participates
  • Prepare key talking points about LAL-D pathophysiology
  • Have recent labs and imaging results readily available
  • Emphasize Kanuma as only FDA-approved enzyme replacement therapy

Appeals Process in Florida

Internal Appeals (All Plan Types)

Commercial Plans:

  • Deadline: 180 days from denial
  • Standard decision: 30-45 days
  • Expedited decision: 72 hours

Medicaid (Aetna Better Health):

External Review (After Internal Appeal)

Commercial/ACA Plans:

  • Request within 4 months of final denial
  • Decision timeline: 45 days standard; 72 hours expedited
  • File through Florida Office of Insurance Regulation

Medicaid:

When to Request External Review

  • Internal appeal upheld despite meeting medical criteria
  • Denial appears inconsistent with FDA labeling
  • Plan failed to follow proper review procedures

For assistance with appeals in Florida, contact the Florida Insurance Consumer Helpline at 1-877-MY-FL-CFO.

Renewal and Re-Authorization

Aetna typically approves Kanuma for 12-month periods. For continuation:

Required Documentation

  • Evidence of treatment response:
    • Improved or stabilized ALT/AST levels
    • Better lipid profile (LDL-C, HDL-C, triglycerides)
    • Growth improvement (pediatric patients)
  • Updated labs and imaging
  • Specialist assessment of ongoing medical necessity

Timing

Submit renewal request 30-45 days before current authorization expires to avoid treatment interruption.

Costs and Patient Assistance

Manufacturer Support

  • Alexion Access Navigator provides coverage verification and appeals assistance
  • Patient assistance programs may be available for eligible patients

Estimated Costs

Kanuma costs approximately $0.89M-$4.9M annually depending on patient weight and dosing requirements. Actual patient costs depend on insurance coverage and cost-sharing structure.

Common Questions

How long does Aetna CVS Health prior authorization take in Florida? Standard review takes 14-30 business days. Expedited review for urgent cases is completed within 72 hours.

What if Kanuma is non-formulary on my plan? Request a formulary exception by demonstrating medical necessity and lack of effective alternatives. Include detailed clinical documentation.

Can I request expedited review? Yes, if delay would seriously jeopardize your health. Your physician must provide written support for urgency.

Does step therapy apply to Kanuma? Generally no, since Kanuma is the only FDA-approved enzyme replacement for LAL-D. However, document any prior lipid-lowering therapy attempts.

What happens if I move between Florida and another state? Aetna's Kanuma policy is national, but state appeal processes differ. Verify new state requirements if you relocate.

How often do Kanuma appeals succeed? While specific statistics aren't published, well-documented appeals for FDA-approved rare disease treatments have meaningful success rates, especially when clinical criteria are clearly met.

Counterforce Health helps patients and providers navigate complex insurance approvals for specialty medications. Our evidence-based approach has helped secure coverage for thousands of patients across the country. Learn more about our services.

Sources & Further Reading

Disclaimer: This guide is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. Appeals processes and timelines may vary by plan type and can change. Verify current requirements with your insurer and state regulatory agencies.

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