By Counterforce Health Team in Waylivra (volanesorsen) —

How to Get Waylivra (Volanesorsen) Covered by Humana in Georgia: Forms, Appeals, and Success Strategies

Quick Answer: Getting Waylivra Covered by Humana in Georgia

Waylivra (volanesorsen) requires prior authorization from Humana for familial chylomicronemia syndrome (FCS). The fastest path: 1) Confirm your FCS diagnosis meets criteria (persistent triglycerides ≥880 mg/dL, genetic testing), 2) Submit Humana's PA form via fax (502-508-9300) or phone (866-421-5663) with complete medical documentation, 3) If denied, file internal appeal within 65 days, then external review through Georgia DOI within 60 days. Start today by gathering your genetic test results and triglyceride labs spanning at least three separate blood draws.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all Waylivra prescriptions Humana PA Requirements
Diagnosis Genetically confirmed FCS with TG ≥880 mg/dL FDA Risk Management Plan
Age Requirement ≥18 years old Humana Coverage Policy
Prescriber Specialist in lipid/metabolic disorders Humana PA Lists
Appeals Deadline 65 days for internal, 60 days for GA external review Georgia DOI External Review

Step-by-Step: Fastest Path to Approval

1. Verify Your Diagnosis (Patient + Physician)

Timeline: Before submission

  • Confirm fasting triglycerides ≥880 mg/dL across three separate blood draws
  • Obtain genetic testing results showing biallelic pathogenic variants in FCS-related genes (LPL, APOC2, APOA5, GPIHBP1, LMF1)
  • Document failed response to standard therapies (fibrates, omega-3s, dietary changes)

2. Gather Required Documentation (Physician)

Timeline: 1-2 weeks

  • Complete medical history including recurrent pancreatitis episodes
  • Laboratory results excluding secondary causes (diabetes, hypothyroidism)
  • Prior treatment records showing inadequate response or intolerance
  • Specialist consultation notes from endocrinologist or lipidologist

3. Submit Prior Authorization Request

Timeline: Same day

  • Fax: 502-508-9300
  • Phone: 866-421-5663 (Monday-Friday, 6 AM - 6 PM ET)
  • Include completed Humana PA form and all supporting documentation

4. Track Your Request

Timeline: 7-14 days for standard review

  • Standard decisions typically within 14 days
  • Expedited reviews (urgent medical situations) within 72 hours
  • Check status through Humana member portal or call customer service

5. If Denied: File Internal Appeal

Timeline: Within 65 days of denial

  • Submit appeal through Humana exceptions and appeals portal
  • Include additional medical documentation addressing specific denial reasons
  • Request peer-to-peer review if clinical expertise needed

6. If Still Denied: External Review in Georgia

Timeline: Within 60 days of final internal denial

Forms and Submission Portals

Primary Submission Methods

Online Portal (Providers)

Fax Submission

  • Primary: 502-508-9300
  • Include cover sheet with patient ID, prescriber NPI, and "Waylivra Prior Authorization"
  • Confirm receipt within 24-48 hours

Phone Submission

  • Number: 866-421-5663 (Monday-Friday, 6 AM - 6 PM ET)
  • Have all documentation ready for verbal review
  • Request confirmation number for tracking

Required Forms

  • Humana Prior Authorization Request Form (verify current version)
  • Medical necessity letter from prescribing specialist
  • Genetic testing report and interpretation
  • Laboratory results (triglyceride levels, exclusion of secondary causes)

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Your letter should address:Problem: Confirmed FCS diagnosis with genetic testing resultsPrior treatments: Document failed response to fibrates, omega-3 fatty acids, dietary interventionsClinical rationale: Risk of recurrent pancreatitis, impact on quality of lifeGuideline citations: Reference FDA labeling and National Lipid Association FCS guidelinesDosing: Weekly subcutaneous injection protocolMonitoring: Platelet count, liver function, injection site reactions

Core Documentation Requirements

Genetic Testing Evidence

  • Biallelic pathogenic variants in FCS-related genes
  • Laboratory report with interpretation from certified genetic counselor
  • If genetic testing inconclusive, detailed clinical justification required

Laboratory Results

  • Minimum three fasting triglyceride measurements ≥880 mg/dL
  • Results should be at least one month apart
  • Exclusion of secondary causes (TSH, HbA1c, comprehensive metabolic panel)

Treatment History

  • Detailed records of prior therapies and outcomes
  • Documentation of intolerance or inadequate response
  • Dietary consultation records if available

Specialist Evaluation

  • Consultation notes from endocrinologist, lipidologist, or metabolic specialist
  • Assessment of pancreatitis risk
  • Treatment plan and monitoring strategy

Appeals Process for Georgia Residents

Internal Appeals (First Level)

Timeline: 65 days from denial notice Process:

  1. Submit through Humana member portal
  2. Include additional medical evidence addressing denial reasons
  3. Request expedited review if urgent (72-hour decision)
  4. Standard internal appeals decided within 30 days

External Review (Georgia DOI)

Timeline: 60 days from final internal denial Process:

  1. Obtain external review application from Georgia DOI
  2. Submit completed form with supporting documentation
  3. Independent Review Organization (IRO) assigned
  4. Decision within 30 business days (72 hours if expedited)
  5. Binding decision - Humana must cover if approved

Contact Information:

  • Phone: 1-800-656-2298
  • Online: Georgia DOI complaint portal
  • Process is free for Georgia consumers
From Our Advocates: "We've seen several FCS patients in Georgia successfully overturn initial denials by providing comprehensive genetic testing documentation and detailed treatment failure records. The key is demonstrating that standard triglyceride-lowering therapies were genuinely inadequate, not just partially effective."

Specialty Pharmacy Network

Humana-Preferred Specialty Pharmacies

Accredo Health Group

  • Patient line: 800-596-7701
  • Provider fax: 888-302-1028
  • Onboarding timeline: 5-7 days
  • Free home delivery with cold-chain handling

CVS Specialty

  • Website: cvsspecialty.com
  • Patient care coordinator assigned
  • Financial assistance programs available
  • Specialty injection training provided

Transfer Process

  1. Initiate transfer through new specialty pharmacy
  2. Prior authorizations transfer automatically (if active)
  3. Controlled substances require new prescription
  4. Processing time: 5-7 days typical
  5. Patient action: Confirm insurance, address, and delivery preferences
Tip: Contact your specialty pharmacy 1-2 weeks before your next refill to ensure seamless transfer and avoid treatment gaps.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Insufficient genetic evidence Obtain comprehensive FCS gene panel Genetic testing report with pathogenic variants
Triglycerides below threshold Provide multiple fasting measurements Lab results ≥880 mg/dL across 3+ draws
Inadequate prior therapy trial Document treatment failures Pharmacy records, provider notes, intolerance documentation
Non-specialist prescriber Transfer to appropriate specialist Consultation with endocrinologist/lipidologist
Missing clinical justification Strengthen medical necessity letter Detailed letter addressing FDA criteria

Financial Assistance Options

Manufacturer Support

  • Ionis Patient Assistance: Contact manufacturer for eligibility (verify with current prescribing information)
  • Copay assistance: May be available for commercially insured patients
  • Free drug programs: For uninsured patients meeting income criteria

Foundation Grants

  • National Organization for Rare Disorders (NORD): Rare disease medication assistance
  • Patient Access Network Foundation: Specialty medication grants
  • HealthWell Foundation: Chronic disease copay assistance

State Resources

  • Georgia Department of Community Health: Medicaid coverage information
  • Georgians for a Healthy Future: Consumer assistance and advocacy

Frequently Asked Questions

How long does Humana prior authorization take for Waylivra in Georgia? Standard PA requests are typically decided within 14 days. Expedited reviews for urgent situations are completed within 72 hours.

What if Waylivra is not on Humana's formulary? You can request a formulary exception through the same PA process. Include medical necessity documentation explaining why covered alternatives are inappropriate.

Can I request an expedited appeal if my triglycerides are dangerously high? Yes, if delay in treatment could seriously jeopardize your health, you can request expedited internal appeals (72 hours) and external review in Georgia.

Does step therapy apply to FCS treatments? Humana may require documentation that you've tried and failed standard triglyceride-lowering therapies before approving Waylivra.

What if I move from another state to Georgia - do my approvals transfer? Prior authorizations typically remain valid if you maintain the same Humana plan. Contact member services to confirm your specific situation.

How often do I need to renew prior authorization for Waylivra? Most specialty drug PAs require annual renewal. Your specialty pharmacy will typically coordinate this process 30-60 days before expiration.

When to Escalate and Get Help

If you've exhausted Humana's appeals process and Georgia's external review, additional resources include:

Legal Assistance

  • Georgia Legal Services Program: Free legal aid for low-income residents
  • Health law attorneys: Specializing in insurance coverage disputes

Regulatory Complaints

  • Georgia Department of Insurance: File complaints about insurer practices
  • Centers for Medicare & Medicaid Services: For Medicare Advantage issues

Advocacy Organizations

  • Counterforce Health helps patients navigate complex prior authorization and appeals processes by analyzing denial letters, plan policies, and clinical documentation to create targeted, evidence-backed appeals. Their platform specializes in turning insurance denials into successful approvals for specialty medications like Waylivra. Learn more about their services.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult your healthcare provider for medical decisions and verify current insurance policies and procedures with your plan. Coverage policies and forms may change; confirm current requirements with Humana and Georgia regulatory authorities.

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