By Counterforce Health Team in Kanuma (sebelipase alfa) —

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

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

Kanuma (sebelipase alfa) requires prior authorization from Aetna CVS Health for LAL-D treatment. Key requirements: confirmed LAL enzyme deficiency or LIPA gene mutation, elevated ALT ≥1.5x normal on two occasions, and specialist consultation. Submit via Aetna's Availity portal or fax 1-877-269-9916. Standard review takes 14 days; urgent requests 72 hours. If denied, you have 180 days to appeal internally, then request external review through Washington's Insurance Commissioner. Start by gathering your LAL-D diagnosis confirmation and liver function tests today.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Kanuma prescriptions Aetna formulary, precert list Aetna 2025 Precert List
Diagnosis Confirmation LAL enzyme activity deficiency OR LIPA gene mutation Lab results, genetic testing Aetna Kanuma Policy
Elevated ALT ≥1.5x upper normal limit, two separate occasions Liver function tests Aetna Kanuma Policy
Specialist Requirement Prescribed by/with metabolic or lysosomal disorder specialist Provider credentials Aetna Kanuma Policy
Appeals Deadline 180 days from denial Policy documents Washington Extenuating Circumstances

Step-by-Step: Fastest Path to Approval

1. Confirm Your LAL-D Diagnosis

Who: Your metabolic specialist or hepatologist
What: LAL enzyme activity test showing deficiency OR genetic testing confirming LIPA gene mutations
Timeline: Results typically available within 1-2 weeks
Source: FDA Kanuma Label

2. Document Elevated Liver Enzymes

Who: Your healthcare team
What: ALT levels ≥1.5x upper normal limit on two separate occasions (at least one week apart)
Timeline: May require repeat testing if not already documented
Source: Aetna Kanuma Policy

3. Complete Prior Authorization Request

Who: Your prescribing physician's office
What: Submit Aetna's Kanuma Precert Form
How: Fax to 1-877-269-9916 or via Availity portal
Timeline: Standard review 14 days, urgent 72 hours

4. Include Required Documentation

Who: Healthcare team
What:

  • Complete medical history and physical exam
  • Laboratory confirmation of LAL-D diagnosis
  • Prior treatment attempts (if any) and outcomes
  • Specialist consultation notes Source: Aetna Kanuma Policy

5. Monitor Request Status

Who: Patient or clinic staff
What: Track approval status through Aetna member portal or by calling member services
Timeline: Follow up if no response within stated timeframes

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Diagnosis not confirmed" Submit enzyme assay or genetic testing results LAL enzyme activity <10% normal OR LIPA mutation report
"ALT not sufficiently elevated" Provide repeat lab work showing ≥1.5x ULN Two separate ALT tests, minimum one week apart
"Not prescribed by specialist" Add specialist consultation or referral Metabolic specialist or hepatologist consultation notes
"Experimental/investigational" Cite FDA approval and guidelines FDA approval letter, clinical guidelines
"Step therapy required" Document no alternative ERT exists Medical literature showing Kanuma is only FDA-approved ERT for LAL-D
Note: Aetna recognizes that no alternative enzyme replacement therapies exist for LAL-D, making step therapy arguments typically unsuccessful. Focus on diagnostic confirmation and medical necessity instead.

Appeals Process for Washington Residents

Internal Appeals (Level 1)

  • Timeline: Must file within 180 days of denial
  • Process: Submit written appeal with additional clinical documentation
  • Decision: Aetna has up to 30 days for standard appeals, 72 hours for urgent
  • Contact: Use address on denial letter or submit via member portal

External Review (Washington State)

If internal appeals fail, Washington residents can request independent external review:

  • Who: Certified Independent Review Organization (IRO) assigned by Washington Insurance Commissioner
  • Timeline: 180 days from final internal denial to request external review
  • Process: Submit request to Office of Insurance Commissioner at 1-800-562-6900
  • Decision: IRO has 30 days for standard review, 72 hours for urgent
  • Outcome: IRO decision is binding on Aetna if favorable
  • Source: Washington RCW 48.43.535
Washington Advantage: The state's robust external review process has helped many residents overturn denials for rare disease medications. The Insurance Commissioner maintains a registry of qualified medical specialists who review cases independently.

Medical Necessity Documentation

Clinician Corner: Building a Strong Medical Necessity Case

Essential Elements for Your Letter:

  1. Clear LAL-D diagnosis with specific test results (enzyme activity level or genetic variants)
  2. Clinical manifestations - hepatomegaly, elevated transaminases, dyslipidemia, growth failure (if pediatric)
  3. Disease progression without treatment and expected benefits of Kanuma
  4. FDA-approved indication - cite the specific labeling for LAL-D
  5. Absence of alternatives - no other approved enzyme replacement therapies exist

Key Clinical Guidelines to Reference:

  • FDA Kanuma Prescribing Information
  • American College of Gastroenterology guidance on lysosomal storage disorders
  • Pediatric endocrinology society recommendations (for pediatric cases)

Monitoring Plan: Document your plan to track treatment response through:

  • Serial liver function tests (ALT, AST)
  • Lipid panels (LDL-C, HDL-C, triglycerides)
  • Growth parameters (pediatric patients)
  • Hepatic imaging when indicated

Costs and Patient Support Options

Manufacturer Support Programs

Alexion Access Navigator:

  • Copay assistance for eligible commercially insured patients
  • Prior authorization support and appeals assistance
  • Patient education and injection training resources
  • Contact: Visit alexionaccessnavigator.com or call patient support

Foundation Grants

  • National Organization for Rare Disorders (NORD): Medication assistance programs
  • Patient Advocate Foundation: Copay relief and insurance appeals support
  • HealthWell Foundation: May offer grants for rare disease treatments

Washington State Resources

  • Washington Apple Health (Medicaid): May cover Kanuma for eligible patients
  • Washington Prescription Drug Program: State pharmaceutical assistance for qualifying residents
Cost Reality Check: Kanuma can cost $890,000-$4.9 million annually depending on patient weight and dosing. Most patients will need manufacturer copay assistance or foundation support even with insurance coverage.

FAQ: Kanuma Coverage Questions

Q: How long does Aetna's prior authorization take in Washington? A: Standard requests take up to 14 calendar days. Urgent requests (when delay could cause serious harm) are reviewed within 72 hours. Submit urgent requests by calling 1-855-240-0535.

Q: What if Kanuma isn't on my Aetna formulary? A: You can request a formulary exception by demonstrating medical necessity. Since no alternative ERTs exist for LAL-D, exceptions are often granted when diagnostic criteria are met.

Q: Can I get an expedited appeal in Washington? A: Yes, if your health could be seriously harmed by delays. Both Aetna's internal process and Washington's external review offer expedited timelines (typically 72 hours).

Q: What if I was diagnosed with LAL-D in another state? A: Your diagnosis remains valid. Ensure all diagnostic documentation (enzyme testing or genetic results) is included in your Washington Aetna prior authorization request.

Q: Does step therapy apply to Kanuma? A: Typically no. Aetna's policy recognizes that Kanuma is the only FDA-approved enzyme replacement therapy for LAL-D, making step therapy medically inappropriate.

Q: What happens if I move from Washington while on Kanuma? A: Contact Aetna to understand how your coverage may change. Some states have different external review processes, but your established medical necessity should transfer.

When to Contact Washington Insurance Commissioner

Contact the Office of Insurance Commissioner if:

  • Aetna fails to respond within required timeframes
  • You need help understanding your appeal rights
  • You want to file a complaint about claim handling
  • You need assistance with the external review process

Contact: 1-800-562-6900 or visit insurance.wa.gov

Getting Expert Help with Your Appeal

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Kanuma. Their platform analyzes denial letters, identifies the specific reasons for rejection, and creates targeted, evidence-backed appeals that address each point in the payer's own language. For patients facing Aetna denials in Washington, this type of specialized support can significantly improve approval chances by ensuring all medical necessity criteria are properly documented and presented.

Whether you're navigating your first prior authorization request or preparing for an appeal, having the right documentation and understanding Aetna's specific requirements for LAL-D treatment can make the difference between approval and denial. Washington's strong consumer protection laws provide additional leverage through the external review process, giving you multiple opportunities to secure coverage for this life-saving treatment.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeal processes. It is not medical advice and does not guarantee coverage approval. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations. For personalized help with Washington insurance issues, contact the Office of Insurance Commissioner at 1-800-562-6900.

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