By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (Sebelipase Alfa) Covered by Aetna CVS Health in California: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Kanuma Covered by Aetna CVS Health in California

Kanuma (sebelipase alfa) requires prior authorization from Aetna CVS Health. To get approved in California: 1) Have your doctor submit a PA request with LAL-D diagnosis confirmation (enzyme testing or genetic results), clinical evidence of disease severity, and dosing rationale through the Aetna provider portal or by calling 1-800-222-5000. 2) If denied, file an internal appeal within 180 days, then request an Independent Medical Review (IMR) through California's DMHC. 3) Start today by gathering your lab results, genetic testing, and prior treatment records. California's consumer-friendly appeal system offers strong protections for rare disease treatments.

Table of Contents

Why California's Rules Matter for Kanuma Coverage

California has some of the strongest patient protections in the nation for specialty medications like Kanuma. The state's Department of Managed Health Care (DMHC) regulates most commercial health plans and provides binding Independent Medical Review (IMR) for denials—a powerful tool for rare disease treatments.

Key California advantages:

  • No-cost appeals: IMR is free to patients
  • Binding decisions: If DMHC overturns your denial, Aetna must cover the treatment
  • Expedited timelines: 72 hours for urgent cases, 45 days for standard IMR
  • High success rates: Medical necessity denials are overturned 55% of the time

For Aetna CVS Health members, these state protections work alongside your plan's internal processes to create multiple pathways to coverage.

Prior Authorization Requirements for Aetna CVS Health

Kanuma appears on Aetna's 2025 precertification list as a specialty drug requiring prior authorization for medical benefit coverage. Here's what Aetna typically requires:

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before first dose Aetna Precert List 2025
Formulary Tier Tier 5 (Specialty) - 50% coinsurance typical Member portal or formulary guide
Site of Care Outpatient infusion center or home health Aetna Site of Care Policy
Diagnosis Confirmation LAL-D via enzyme activity or genetic testing Clinical documentation required
Reauthorization Every 6-12 months with response monitoring Provider submits updated labs/imaging

Medical Necessity Criteria

Based on Aetna's specialty drug policies, expect these requirements:

  • Confirmed LAL-D diagnosis through reduced lysosomal acid lipase enzyme activity or LIPA gene mutations
  • Evidence of disease severity such as elevated liver enzymes (ALT/AST), hepatomegaly, or dyslipidemia
  • Age and weight-appropriate dosing per FDA labeling (infants: 1-3 mg/kg weekly; children/adults: 1 mg/kg every 2 weeks)
  • Failure or contraindication to supportive therapies where applicable

Step-by-Step: Fastest Path to Approval

1. Gather Documentation (Patient/Family)

Timeline: 1-2 days

  • Insurance card with member and policy ID
  • Complete medical records showing LAL-D diagnosis
  • Lab results (liver enzymes, lipid panel)
  • Genetic testing results if available
  • List of prior treatments tried

2. Provider Submits PA Request (Clinic)

Timeline: Same day

  • Submit through Aetna provider portal or call 1-800-222-5000
  • Include ICD-10 code E75.5 (lipid storage disorder)
  • Attach clinical notes, labs, and dosing rationale
  • Request expedited review if patient has severe symptoms

3. Aetna Review Process

Timeline: 30-45 days standard, 24 hours expedited

  • Medical review team evaluates against coverage criteria
  • May request additional documentation
  • Peer-to-peer review available if initially denied

4. If Approved

  • Coverage typically authorized for 6-12 months
  • Coordinate with Aetna-contracted specialty pharmacy
  • Schedule first infusion at approved facility

5. If Denied - Internal Appeal (Clinic/Patient)

Timeline: File within 180 days

  • Submit additional clinical evidence
  • Include peer-reviewed literature on Kanuma efficacy
  • Consider peer-to-peer discussion with Aetna medical director

6. External Review Through DMHC (Patient)

Timeline: File after internal denial

  • Apply for IMR at healthhelp.ca.gov
  • Include all medical records and denial letters
  • DMHC assigns independent physician reviewer

7. IMR Decision

Timeline: 45 days standard, 7 days expedited

  • Binding decision—Aetna must comply if overturned
  • 55% success rate for medical necessity denials in California

California Appeal Timelines and Deadlines

California provides strict timelines that protect patients and ensure timely decisions:

Standard Process

  • Prior authorization response: 30-45 days (verify with current Aetna policy)
  • Internal appeal filing: Within 180 days of denial
  • Internal appeal decision: 30 calendar days
  • IMR filing: After internal denial or 30-day plan non-response
  • IMR decision: 45 calendar days

Expedited/Urgent Process

  • Criteria: Serious threat to health, severe pain, risk of significant impairment
  • PA response: 24 hours for exigent circumstances, 72 hours for urgent
  • Internal appeal: 72 hours
  • Expedited IMR: 7 days or less (often within 72 hours)
Note: If Aetna fails to respond within required timeframes, the request may be deemed approved under California law.

Step Therapy and Medical Exception Protections

California's AB 347 (2021) provides strong step therapy override protections. Since there are no approved alternatives to Kanuma for LAL-D, step therapy requirements are inappropriate and should be challenged.

Exception Criteria Under California Law

Your doctor can request a step therapy exception if:

  • The required first-line drug is contraindicated
  • You've previously tried and failed the step therapy drug
  • The step therapy drug is expected to be ineffective based on clinical factors
  • You're currently stable on Kanuma (for plan changes)

Documentation That Helps

  • Medical necessity statement: "Patient has confirmed LAL-D requiring enzyme replacement therapy. No therapeutic alternatives exist for this genetic condition."
  • Clinical evidence: FDA approval specifically for LAL-D, not general lipid management
  • Failure documentation: If supportive care (lipid-lowering drugs) was inadequate

Continuity of Care During Plan Transitions

If you're switching to Aetna CVS Health from another plan while on Kanuma, California provides strong continuity protections:

Your Rights

  • 12-month continuation with previous specialty provider if you have an established relationship
  • Formulary exception coverage for medications you were previously taking
  • Expeditious review of medical necessity for non-formulary drugs

Steps to Protect Coverage

  1. Notify Aetna immediately upon enrollment about current Kanuma therapy
  2. Have your doctor submit a medical necessity request for formulary exception
  3. Document stability on current therapy to support continuation
  4. Request expedited review if there's any treatment interruption risk

Contact Aetna member services at the number on your card to initiate continuity of care protections.

External Review Through California's DMHC

California's Independent Medical Review system is one of your strongest tools for overturning Kanuma denials:

When to File IMR

  • After Aetna upholds a denial in internal appeal
  • If Aetna fails to respond to your internal appeal within 30 days
  • For denials based on "not medically necessary" or "experimental/investigational"

How to File

  1. Online: Complete IMR application at healthhelp.ca.gov
  2. Phone: Call DMHC Help Center at 888-466-2219
  3. Required documents: All medical records, denial letters, clinical notes

What Happens Next

  • DMHC assigns an independent physician expert in rare diseases
  • Reviewer evaluates medical necessity without Aetna's involvement
  • Decision is binding—Aetna must comply if overturned
  • No cost to you for the review process

Scripts and Templates for Success

Patient Phone Script for Aetna

"I'm calling about prior authorization for Kanuma, generic name sebelipase alfa, for lysosomal acid lipase deficiency. This is a rare genetic disease with FDA-approved enzyme replacement therapy. My doctor is submitting the PA request today. Given the serious nature of LAL-D, I'm requesting expedited review. Can you confirm the fastest submission method and provide a reference number?"

Clinic Staff Peer-to-Peer Request

"I'm requesting a peer-to-peer discussion regarding the Kanuma denial for [patient]. This patient has confirmed LAL-D with [specific test results]. Kanuma is the only FDA-approved treatment for this condition—there are no therapeutic alternatives. The denial appears to be based on [reason from denial letter]. I have additional clinical documentation that supports medical necessity."

Medical Necessity Letter Template

Your doctor should include:

  • Problem: "Patient has lysosomal acid lipase deficiency (ICD-10: E75.5), a rare genetic disorder requiring enzyme replacement therapy"
  • Prior treatments: Document any supportive care attempts and outcomes
  • Clinical rationale: "Kanuma is the only FDA-approved treatment for LAL-D, providing the missing enzyme"
  • Monitoring plan: "Response will be monitored via liver enzymes, lipid levels, and hepatic imaging"

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn
"Not medically necessary" Submit enzyme activity test results, genetic confirmation, and FDA labeling showing approval for LAL-D
"Experimental/investigational" Provide FDA approval date (2015) and clinical trial data from NEJM publications
"Non-formulary" Request formulary exception with medical necessity documentation
"Insufficient documentation" Include complete diagnostic workup, specialist consultation notes, and treatment history
"Dosing outside guidelines" Reference FDA labeling for age/weight-specific dosing (verify current prescribing information)

For each denial, request the specific coverage policy Aetna used to make the decision—this helps target your appeal.

Costs and Financial Assistance

Kanuma is extremely expensive, with annual costs ranging from $890,000 to $4.9 million depending on patient weight and dosing. Even with insurance, your out-of-pocket costs can be substantial.

Financial Resources

  • Alexion Access Navigator: Patient support program offering copay assistance and case management (verify current program at alexion.com)
  • California state programs: Medi-Cal may provide secondary coverage for eligible patients
  • Rare disease foundations: Organizations like NORD and EveryLife Foundation offer grants
Tip: Apply for manufacturer assistance programs before starting therapy, as some have income requirements or enrollment deadlines.

When dealing with coverage challenges, Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Kanuma. Their platform helps patients, clinicians, and specialty pharmacies navigate the prior authorization process by creating evidence-backed appeals tailored to each payer's specific requirements.

FAQ: Your Most Common Questions

How long does Aetna CVS Health prior authorization take for Kanuma in California? Standard review is 30-45 days, but you can request expedited review (24-72 hours) if your condition poses serious health risks. California law requires specific response timelines.

What if Kanuma isn't on my Aetna formulary? You can request a formulary exception. Since Kanuma is the only FDA-approved treatment for LAL-D, medical necessity should support coverage even if it's non-formulary.

Can I request an expedited appeal in California? Yes, if denial creates serious health threats. Expedited internal appeals must be decided within 72 hours, and expedited IMR within 7 days.

Does step therapy apply if I was stable on Kanuma with my previous insurer? California's continuity of care laws should protect you. Document your previous stable response and request continuation of therapy.

What's the success rate for Kanuma appeals in California? While specific data isn't available, California's IMR system overturns 55% of medical necessity denials, with higher rates for rare disease treatments with strong FDA approval.

Who can help me with the appeal process? The DMHC Help Center (888-466-2219), Health Consumer Alliance, and specialized services like Counterforce Health can assist with complex appeals.

What if my employer plan is self-funded? Self-funded ERISA plans may not be subject to all California state protections, but federal appeal rights still apply. Consult your Summary Plan Description for specific procedures.

How do I prove LAL-D for the prior authorization? Include enzyme activity test results showing reduced lysosomal acid lipase, genetic testing for LIPA mutations, and clinical evidence like elevated liver enzymes or hepatomegaly.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for coverage determinations. California insurance regulations may change—verify current requirements with the DMHC or your plan.

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