By Counterforce Health Team in Kanuma (sebelipase alfa) —

How to Get Kanuma (sebelipase alfa) Covered by Aetna (CVS Health) in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Kanuma Covered by Aetna (CVS Health) in Virginia

Kanuma (sebelipase alfa) requires prior authorization from Aetna (CVS Health) in Virginia. Your fastest path to approval: 1) Gather LAL enzyme activity results (<10% normal) and LIPA gene testing confirming pathogenic variants, 2) Submit Aetna's Kanuma-specific PA form with liver function tests and lipid panels, and 3) Include a medical necessity letter from your specialist. If denied, you have 60 days for internal appeals and can request Virginia's external review through Form 216-A within 120 days.

Table of Contents

  1. Read Your Denial: Understanding Aetna's Requirements
  2. Fixable Causes: Common Issues and Solutions
  3. First-Level Appeal: Building Your Case
  4. Peer-to-Peer Review: Direct Doctor Discussion
  5. Virginia External Review: Independent Decision
  6. Appeal Templates and Scripts
  7. Tracking Your Case
  8. Win-Rate Boosters: Strengthening Your Appeal
  9. If Appeals Fail: Alternative Options
  10. FAQ: Common Questions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Aetna Precertification List Aetna 2025
Formulary Tier Specialty tier (high cost-share) CVS Specialty Pharmacy Plan documents
Step Therapy Not typically required Individual plan benefits Member portal
Diagnosis Documentation LAL enzyme + LIPA genetics FDA prescribing information FDA Label
Infusion Site In-network facility required Provider network Plan directory
Appeals Deadline 60 days (internal), 120 days (external) Virginia Insurance Code SCC Bureau of Insurance

Read Your Denial: Understanding Aetna's Requirements

When Aetna (CVS Health) denies Kanuma coverage, the denial letter will include specific reason codes. Here's how to decode the most common ones:

"Prior Authorization Required" - You haven't submitted the required Kanuma PA form with supporting documentation.

"Not Medically Necessary" - Aetna questions whether Kanuma meets their clinical criteria, typically due to insufficient diagnostic evidence or missing prior therapy documentation.

"Non-Formulary Drug" - Kanuma isn't on your plan's preferred drug list, requiring a formulary exception with clinical justification.

Note: Aetna processes most specialty drug requests through CVS Specialty Pharmacy. Check if your denial came from the medical benefit (Aetna) or pharmacy benefit (CVS Caremark), as appeal processes may differ.

The denial letter must include your appeal rights and deadlines. In Virginia, you typically have 60 days to file an internal appeal from the date of the denial notice.

Fixable Causes: Common Issues and Solutions

Denial Reason Quick Fix Required Documentation
Missing LAL enzyme results Submit lab report showing <10% normal activity LAL enzyme testing from certified lab
No genetic confirmation Provide LIPA gene sequencing results Pathogenic/likely pathogenic variants per ACMG guidelines
Insufficient liver abnormalities Include recent ALT/AST (≥1.5x ULN) Two separate occasions documented
Wrong prescriber type Specialist consultation required Endocrinologist, hepatologist, or gastroenterologist
Coding mismatch Verify ICD-10 codes E75.5 (LAL deficiency) or related codes
Missing infusion site Designate approved facility In-network outpatient infusion center

First-Level Appeal: Building Your Case

Submit within 60 days of your denial notice. Use Aetna's standard appeal form or write a formal letter including:

Medical Necessity Letter Checklist

Your prescribing physician should address these points:

  • Confirmed LAL-D diagnosis with specific enzyme activity levels and genetic testing results
  • Clinical presentation including hepatomegaly, elevated transaminases, and dyslipidemia
  • Disease progression without treatment and risk of liver failure
  • FDA approval for LAL deficiency in all ages (FDA prescribing information)
  • No alternative treatments - Kanuma is the only FDA-approved enzyme replacement therapy for LAL-D
  • Weight-based dosing justification per FDA label (1 mg/kg every 2 weeks for most patients)

Required Supporting Documents

  • Complete medical records documenting LAL-D diagnosis
  • Laboratory results (LAL enzyme activity, LIPA genetics, liver function tests, lipid panels)
  • Imaging studies showing hepatomegaly (if available)
  • Previous treatment attempts and outcomes
  • Specialist consultation notes

Submit via fax to the number on your denial letter or through the Aetna provider portal (verify current submission method).

Peer-to-Peer Review: Direct Doctor Discussion

If your initial appeal is denied, request a peer-to-peer review where your doctor speaks directly with Aetna's medical director.

Preparation Checklist for Your Doctor

  • Review FDA prescribing information for Kanuma
  • Prepare patient's diagnostic timeline and clinical progression
  • Have lab results and imaging readily available
  • Emphasize lack of alternative treatments for LAL-D
  • Discuss potential complications without enzyme replacement therapy

To request: Call Aetna's provider services line and ask for a "peer-to-peer review for prior authorization denial."

Virginia External Review: Independent Decision

If Aetna upholds their denial after internal appeals, Virginia law provides an independent external review process through the State Corporation Commission (SCC) Bureau of Insurance.

Timeline and Process

  • When to file: Within 120 days of final internal denial
  • Review timeline: 30 working days for standard review, 5 working days for expedited
  • Cost: Free to patients
  • Decision: Binding on Aetna

How to Submit

  1. Complete Form 216-A (External Review Request)
  2. Attach all denial letters and supporting medical documentation
  3. Mail or fax to the SCC Bureau of Insurance
  4. Contact the Bureau at 1-877-310-6560 for guidance
Virginia Advantage: The state's Managed Care Ombudsman can help navigate the external review process and sometimes resolve issues informally before formal review.

Appeal Templates and Scripts

Patient Phone Script for Aetna

"I'm calling to appeal the denial for Kanuma (sebelipase alfa) for my lysosomal acid lipase deficiency. My member ID is [number]. I have confirmed LAL-D with enzyme testing showing less than [X]% normal activity and genetic testing confirming pathogenic LIPA variants. Can you please tell me the specific clinical criteria I need to meet and help me start the appeal process?"

Medical Necessity Letter Template

"[Patient name] has confirmed lysosomal acid lipase deficiency based on:

  • LAL enzyme activity of [X]% of normal (reference lab report attached)
  • LIPA gene analysis showing [specific variants] (genetics report attached)
  • Clinical presentation including hepatomegaly and elevated ALT/AST
  • Progressive lipid abnormalities despite supportive care

Kanuma (sebelipase alfa) is the only FDA-approved enzyme replacement therapy for LAL-D. Without treatment, patients progress to liver failure. The requested dosing of 1 mg/kg every 2 weeks follows FDA prescribing guidelines."

Tracking Your Case

Create a simple log to track your appeal:

Date Action Contact Person Outcome Next Step
[Date] Initial PA submitted [Name] Denied - insufficient documentation Gather missing labs
[Date] First appeal filed [Name] Under review Wait 30 days
[Date] Peer-to-peer completed Dr. [Name] Still denied File external review

Keep copies of all correspondence and note confirmation numbers for phone calls.

Win-Rate Boosters: Strengthening Your Appeal

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons and draft point-by-point rebuttals using the right clinical evidence and procedural requirements.

Key Strategies

  • Cite specific FDA language about Kanuma's indication and dosing
  • Document disease progression with serial lab values showing worsening liver function
  • Emphasize orphan disease status - LAL-D affects fewer than 200,000 Americans
  • Reference published studies showing hepatic and lipid improvements with Kanuma therapy
  • Address safety requirements - note need for medically supervised infusion due to hypersensitivity risk

From Our Advocates

A composite example: One Virginia patient initially received a "not medically necessary" denial because their genetic testing wasn't included in the original submission. After gathering the LIPA gene analysis showing compound heterozygous pathogenic variants and resubmitting with a detailed timeline of progressive liver dysfunction, Aetna approved the prior authorization within two weeks. The key was demonstrating both biochemical and molecular confirmation of LAL-D.

If Appeals Fail: Alternative Options

Manufacturer Support Programs

  • Alexion Access Navigator provides financial assistance and appeals support
  • Patient assistance programs may offer free drug for qualifying patients
  • Contact: alexionaccessnavigator.com/kanuma

Formulary Exception Process

If Kanuma remains non-formulary, work with Counterforce Health to submit a comprehensive formulary exception request demonstrating medical necessity and lack of therapeutic alternatives.

State Resources

  • Virginia Poverty Law Center may provide legal assistance for insurance appeals
  • SCC Consumer Services can help with insurance complaints: 1-877-310-6560

FAQ: Common Questions

How long does Aetna prior authorization take in Virginia? Standard reviews take 14-30 business days. Expedited reviews for urgent medical need are completed within 72 hours.

What if Kanuma is non-formulary on my plan? Request a formulary exception with clinical documentation showing medical necessity and lack of covered alternatives.

Can I get expedited review for LAL-D? Yes, if your doctor certifies that delays could seriously jeopardize your health. Use expedited PA and appeal processes.

Does step therapy apply to Kanuma? Generally no, since Kanuma is the only FDA-approved treatment for LAL-D. However, some plans may require documentation of supportive care attempts.

What counts as sufficient diagnostic evidence? LAL enzyme activity <10% of normal plus LIPA genetic testing confirming pathogenic variants, following current clinical guidelines.

How much does Kanuma cost without insurance? Approximately $0.89M-$4.9M annually depending on patient weight and dosing, making insurance coverage critical.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For personalized assistance with insurance appeals, consider working with Counterforce Health, which specializes in turning denials into successful appeals through targeted, evidence-backed strategies.

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