By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Aetna (CVS Health) in Ohio: Complete Guide with Forms and Appeal Scripts

Answer Box: Getting Kanuma Covered by Aetna in Ohio

Kanuma (sebelipase alfa) requires prior authorization from Aetna (CVS Health) for LAL-D patients. The fastest path: your doctor submits a prior authorization request through Aetna's Availity portal with LAL enzyme activity test results, genetic confirmation, and documented hepatic/lipid abnormalities. If denied, you have 180 days for internal appeals and Ohio's external review process. Start today: Ask your doctor to check if Kanuma is on your plan's formulary and gather your LAL-D diagnostic documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Doctor must get approval before prescribing Aetna Precertification Lists
LAL-D Diagnosis Confirmed enzyme deficiency + genetic testing LabCorp LAL Testing
Weight-Based Dosing 1 mg/kg every 2 weeks (adults/children >6mo) FDA Label
Site of Care IV infusion in medical facility Aetna Infusion Policy
Appeals Deadline 180 days from denial Ohio Department of Insurance

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Documentation

Who does it: You and your doctor
What's needed: LAL enzyme activity test results showing deficiency, genetic testing confirming LIPA gene variants
Timeline: If not done, allow 1-2 weeks for testing
Source: LAL-D diagnostic testing

2. Gather Treatment History

Who does it: You
What's needed: List of all previous treatments tried, side effects experienced, current symptoms
Timeline: 1-2 days to compile
Source: Your medical records and pharmacy history

3. Check Formulary Status

Who does it: Your doctor's office
What's needed: Call Aetna or check online formulary for your specific plan
Timeline: Same day
Source: Aetna formulary lookup

4. Submit Prior Authorization

Who does it: Your doctor
What's needed: PA request via Availity portal with clinical documentation
Timeline: 2 weeks advance submission recommended
Source: Aetna PA process

5. Follow Up on Decision

Who does it: You and your doctor's office
What's needed: Check status after 30-45 days for standard review
Timeline: Standard decisions within 30-45 days
Source: Aetna member services

6. Appeal if Denied

Who does it: You with doctor's support
What's needed: Internal appeal first, then Ohio external review if needed
Timeline: 180 days from denial date
Source: Ohio appeals process

Working with Your Doctor: Visit Preparation

Before your appointment, prepare a comprehensive overview of your LAL-D journey. Your doctor needs specific details to build a strong prior authorization case.

Bring This Documentation:

  • Complete symptom timeline (when symptoms started, how they've progressed)
  • All previous treatments attempted and their outcomes
  • Current medications and dosages
  • Recent lab results showing liver enzymes (ALT/AST) and lipid levels
  • Any hospitalizations or emergency visits related to LAL-D
  • Insurance card and policy information
Tip: Create a one-page summary of your medical history. This helps your doctor quickly understand your case and saves appointment time for discussing the prior authorization strategy.

Questions to Ask Your Doctor:

  • "What specific documentation does Aetna typically require for Kanuma approval?"
  • "Can you help me understand the weight-based dosing for my case?"
  • "What's your experience with Aetna prior authorizations for rare disease medications?"
  • "If we get denied, will you support a peer-to-peer review?"

Building Your Evidence Kit

Strong documentation significantly improves approval chances. Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by identifying specific denial reasons and crafting point-by-point rebuttals aligned with each plan's own rules.

Essential Clinical Evidence:

  • LAL enzyme activity test results showing deficiency (typically <10% of normal)
  • Genetic testing confirming LIPA gene mutations
  • Liver function tests demonstrating hepatic abnormalities
  • Lipid panels showing elevated cholesterol/triglycerides
  • Imaging studies (ultrasound, CT) if showing hepatic changes

Treatment History Documentation:

  • Previous medications tried for lipid management
  • Dietary interventions attempted
  • Any adverse reactions to other treatments
  • Documentation of disease progression despite standard care

Supporting Literature: Your doctor should reference these in the medical necessity letter:

Medical Necessity Letter Essentials

A well-crafted medical necessity letter is crucial for approval. Here's what your doctor should include:

Required Components:

  1. Patient identification (name, DOB, insurance ID, ICD-10 codes)
  2. Clear LAL-D diagnosis with supporting test results
  3. Clinical rationale for Kanuma specifically
  4. Previous treatment failures or contraindications
  5. Weight-based dosing justification per FDA guidelines
  6. Risk of disease progression without treatment
  7. Supporting literature and guideline references

Sample Letter Structure:

[Patient Name] has confirmed LAL-D based on:
- LAL enzyme activity: [X]% of normal (reference: >20%)
- Genetic testing: [specific LIPA mutations]
- Clinical presentation: [hepatomegaly, elevated ALT/AST, dyslipidemia]

Standard lipid-lowering therapies have been inadequate because [specific reasons]. 
Sebelipase alfa at 1 mg/kg every 2 weeks is FDA-approved for this indication 
and represents the only enzyme replacement therapy for LAL-D.

Without treatment, [patient] faces risk of progressive liver disease and 
cardiovascular complications.
Clinician Corner: Include specific lab values, imaging findings, and cite the FDA label for dosing rationale. Reference published studies showing clinical benefit in LAL-D patients.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Not medically necessary" Submit detailed clinical documentation showing LAL-D confirmation and disease severity
"Experimental/investigational" Cite FDA approval for LAL-D and include FDA label
"Step therapy required" Document inadequacy of standard lipid therapies for enzyme deficiency
"Non-formulary medication" Request formulary exception with medical necessity documentation
"Incorrect dosing" Provide weight-based calculation per FDA guidelines
"Site of care issues" Confirm infusion center meets Aetna network requirements

If You Receive a Denial: Don't panic. Many initial denials are overturned on appeal with proper documentation. Contact Counterforce Health for assistance turning your denial into a targeted appeal that addresses Aetna's specific concerns.

Appeals Process in Ohio

Ohio residents have strong appeal rights through both Aetna's internal process and the state's external review system.

Internal Appeals with Aetna:

  • Timeline: Must file within 180 days of denial
  • Process: Submit through member portal or written request
  • Decision timeframe: 30-45 days for standard, 72 hours for expedited
  • Required: Copy of denial letter, additional medical documentation

Ohio External Review:

  • When to use: After exhausting Aetna's internal appeals
  • Timeline: 180 days from final internal denial
  • Process: File through Ohio Department of Insurance
  • Decision timeframe: 30 days standard, 72 hours expedited
  • Cost: Free to consumers

Contact Information:

  • Ohio Department of Insurance External Review: 614-644-0188
  • Email: [email protected]
  • Consumer Hotline: 1-800-686-1526
Note: Self-funded employer plans follow federal ERISA rules, but many voluntarily use Ohio's external review process.

Cost Assistance Programs

Kanuma's high cost ($0.89M-$4.9M annually depending on weight) makes financial assistance crucial.

Manufacturer Support:

  • Alexion Access Navigator: Provides coverage support and patient assistance
  • Website: alexionaccessnavigator.com (verify current link)
  • Services: Prior authorization assistance, appeals support, financial aid programs

Additional Resources:

  • Patient advocacy organizations for LAL-D
  • State pharmaceutical assistance programs
  • Hospital charity care programs
  • Specialty pharmacy patient assistance

Frequently Asked Questions

How long does Aetna prior authorization take for Kanuma in Ohio? Standard reviews take 30-45 days. Expedited reviews (for urgent medical situations) are completed within 72 hours. Submit requests at least 2 weeks before needed treatment.

What if Kanuma isn't on my Aetna formulary? You can request a formulary exception with medical necessity documentation. Your doctor must demonstrate that formulary alternatives are inappropriate for LAL-D enzyme replacement.

Can I request an expedited appeal in Ohio? Yes, if delay would seriously jeopardize your health. Both Aetna and Ohio's external review process offer expedited timelines (72 hours) for urgent cases.

Does step therapy apply to rare disease medications? Aetna may require documentation that standard treatments are inappropriate. For LAL-D, enzyme replacement is first-line therapy, but you may need to document inadequacy of lipid-lowering medications.

What happens if Ohio external review upholds the denial? The IRO decision is binding on Aetna. However, you retain rights to seek other remedies, including regulatory complaints or legal action if appropriate.

How do I find LAL-D testing in Ohio? LabCorp offers LAL testing with locations throughout Ohio. Dried blood spot testing is the preferred method.

From Our Advocates A composite example: One Ohio family faced initial denial for their child's Kanuma therapy despite clear LAL-D diagnosis. By working with their pediatric metabolic specialist to document enzyme deficiency levels, genetic testing results, and progressive hepatic changes, they successfully appealed the decision within 60 days. The key was providing complete diagnostic documentation and citing FDA approval for pediatric LAL-D treatment.

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes for medications like Kanuma. Their platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer concerns, significantly improving approval rates for rare disease therapies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage policies vary by plan and may change. For official Ohio insurance information, visit insurance.ohio.gov or call the consumer hotline at 1-800-686-1526.

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