By Counterforce Health Team in Waylivra (volanesorsen) —

How to Get Waylivra (Volanesorsen) Covered by Humana in Washington: Complete Guide with Forms and Appeals

Answer Box: Getting Waylivra Covered by Humana in Washington

Waylivra (volanesorsen) requires prior authorization from Humana as it's not FDA-approved in the US. Coverage depends on confirmed familial chylomicronemia syndrome (FCS) with triglycerides ≥880 mg/dL, genetic testing, and specialist prescription. First step: Have your lipidologist submit a Humana prior authorization request with genetic test results and triglyceride labs. If denied, Washington residents can appeal through Humana's internal process, then request external review through an Independent Review Organization (IRO) within 180 days under RCW 48.43.535.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for Washington Residents
  5. Medical Necessity Documentation
  6. Costs & Financial Assistance
  7. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all requests Humana provider portal Humana PA Process
Diagnosis Confirmed FCS with genetic testing Lipidologist evaluation FDA Guidance
Triglyceride Level ≥880 mg/dL on multiple fasting tests Lab results from past 6 months EMA Product Information
Specialist Prescriber Endocrinologist or lipidologist Provider credentials Humana Medical Policies
Prior Therapies Failed fibrates, omega-3s, diet Pharmacy records, clinical notes Clinical Guidelines
Appeals Deadline 65 days from denial (internal) Denial letter Humana Appeals

Step-by-Step: Fastest Path to Approval

1. Confirm FCS Diagnosis (Patient & Clinician)

Who: Your lipidologist or endocrinologist
What: Genetic testing for FCS variants (LPL, APOC2, APOA5, GPIHBP1, LMF1)
Timeline: 2-4 weeks for results
Source: FCS Diagnostic Criteria

2. Document Triglyceride Levels (Clinician)

Who: Healthcare provider
What: Multiple fasting triglyceride tests ≥880 mg/dL over 6 months
How: Lab orders through your clinic
Timeline: Ongoing monitoring required

3. Submit Prior Authorization (Clinician)

Who: Prescribing specialist
What: Complete Humana PA form with supporting documentation
How: Humana provider portal or fax to 502-508-9300
Timeline: 7-14 days standard, 72 hours expedited
Source: Humana PA Guidelines

4. Request Formulary Exception if Denied (Patient/Clinician)

Who: Patient or prescriber
What: Medicare Prescription Drug Coverage Determination form
How: Fax to 877-486-2621 or submit online
Timeline: 72 hours standard, 24 hours expedited
Source: CMS Exception Process

5. File Internal Appeal if Exception Denied (Patient)

Who: Patient or appointed representative
What: Written appeal with additional medical evidence
How: MyHumana portal or mail to address on denial letter
Timeline: Must file within 65 days of denial
Source: Humana Appeals Process

6. Request External Review in Washington (Patient)

Who: Patient
What: Independent Review Organization (IRO) review
How: Submit request to Washington Office of Insurance Commissioner
Timeline: 180 days from final internal denial to file
Source: Washington External Review Law

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Not medically necessary" Request peer-to-peer review with lipidologist Updated triglyceride trends, pancreatitis history
"Diagnosis not confirmed" Submit genetic testing results Confirmed FCS variants, specialist consultation notes
"Step therapy not completed" Document prior therapy failures Pharmacy records showing fibrate/omega-3 intolerance
"Experimental/investigational" File formulary exception with EMA approval data EMA conditional approval documentation
"Prescriber not qualified" Ensure endocrinologist/lipidologist prescription Specialist credentials, DEA number
From our advocates: We've seen several FCS patients successfully overturn "not medically necessary" denials by requesting an expedited peer-to-peer review where their lipidologist directly discussed the case with Humana's medical director. Having serial triglyceride labs showing levels consistently above 1000 mg/dL despite maximum medical therapy was often the turning point in these conversations.

Appeals Process for Washington Residents

Internal Appeals (Humana)

  • Deadline: 65 days from denial notice
  • Method: MyHumana portal, mail, or fax (number on denial letter)
  • Timeline: 7 days for Part D appeals
  • Required: Written request with additional medical evidence
  • Source: Humana Appeals Process

External Review (Washington State)

Washington offers robust external review rights under state law:

  • Deadline: 180 days from final internal denial
  • Process: Independent Review Organization (IRO) conducts impartial review
  • Timeline: 30 days standard, 72 hours expedited for urgent cases
  • Cost: Free to patient
  • Binding: IRO decision is binding on Humana if approved
  • Source: Washington Insurance Code RCW 48.43.535

To request external review:

  1. Contact Washington Office of Insurance Commissioner at 1-800-562-6900
  2. Submit written request with denial documentation
  3. IRO assigned automatically from certified registry
  4. Submit additional medical evidence within 5 business days
  5. IRO issues written decision within 30 days
Note: Washington's external review process is particularly effective for rare disease medications because the state has access to specialists at major research institutions who often serve as IRO reviewers.

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Waylivra Coverage:

  • Problem Statement: Confirmed FCS diagnosis with genetic testing results
  • Prior Treatments: Document failures/intolerance of:
    • Very low-fat diet (<10-15% calories from fat)
    • Fibrates (fenofibrate, gemfibrozil)
    • High-dose omega-3 fatty acids
    • Other lipid-lowering agents as appropriate
  • Clinical Rationale: Risk of recurrent pancreatitis, inability to achieve triglyceride control
  • Guideline Citations: Reference EMA approval criteria and FCS management guidelines
  • Monitoring Plan: Platelet count monitoring per REMS requirements
  • Treatment Goals: Reduce triglycerides and prevent pancreatitis episodes

Key Laboratory Values to Include:

  • Multiple fasting triglyceride levels ≥880 mg/dL (preferably ≥1000 mg/dL)
  • Genetic testing confirming FCS variants
  • Evidence of inadequate response to conventional therapies

At Counterforce Health, we help clinicians and patients navigate complex prior authorization requirements by analyzing denial letters and crafting evidence-backed appeals that align with payer-specific policies. Our platform specializes in turning insurance denials into targeted rebuttals using the right clinical evidence and procedural requirements.

Costs & Financial Assistance

Manufacturer Support

  • Ionis Pharmaceuticals: May offer expanded access programs (verify with prescriber)
  • Patient Assistance: Contact manufacturer directly for compassionate use options

Foundation Grants

  • National Organization for Rare Disorders (NORD): Rare disease patient assistance
  • Patient Advocate Foundation: Copay relief programs
  • HealthWell Foundation: Disease-specific grants

State Resources

  • Washington Apple Health (Medicaid): May cover for eligible patients
  • Washington Prescription Drug Program: State assistance options

FAQ

How long does Humana prior authorization take for Waylivra in Washington? Standard PA decisions take 7-14 days. Expedited requests (for urgent medical situations) are processed within 72 hours. You can check status through the MyHumana portal.

What if Waylivra is not on Humana's formulary? File a formulary exception using the Medicare Prescription Drug Coverage Determination form. This allows coverage for non-formulary drugs when medically necessary. Fax to 877-486-2621 or submit online.

Can I request an expedited appeal in Washington? Yes. Both Humana and Washington's external review process offer expedited timelines for urgent cases where standard timeframes could jeopardize your health. Expedited external reviews are decided within 72 hours.

Does step therapy apply if I failed similar drugs outside Washington? Yes. Document all prior therapy failures regardless of where they occurred. Pharmacy records and clinical notes from previous providers are acceptable evidence for Humana's review.

What happens if the external review upholds Humana's denial? If Washington's IRO upholds the denial, you can contact the Office of Insurance Commissioner for further guidance. You may also explore manufacturer patient assistance programs or clinical trials.

Who can help me with the appeals process in Washington? The Washington Office of Insurance Commissioner offers free consumer assistance at 1-800-562-6900. They can help you understand your rights and guide you through the external review process.

When to Escalate

Contact Washington Office of Insurance Commissioner if:

  • Humana fails to respond within required timeframes
  • You need help understanding your appeal rights
  • You suspect the denial was inappropriate
  • You need assistance with the external review process

Phone: 1-800-562-6900
Website: insurance.wa.gov

The OIC can provide template appeal letters and ensure Humana follows proper procedures under Washington law.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with complex appeals, Counterforce Health specializes in helping patients and clinicians navigate insurance denials with evidence-backed appeal strategies.

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