By Counterforce Health Team in Waylivra (volanesorsen) —

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

Answer Box: Quick Path to Coverage

Important note: Waylivra (volanesorsen) is not FDA-approved in the United States for familial chylomicronemia syndrome (FCS), despite European approval. This means standard insurance coverage through Humana is not available. However, if you're seeking coverage for off-label use or through expanded access programs, here's your fastest path:

  1. Contact your lipid specialist to explore expanded access programs or clinical trials
  2. Submit a medical necessity request to Humana with comprehensive FCS documentation
  3. Prepare for appeals using Virginia's external review process through the State Corporation Commission

First step today: Call your prescribing specialist to discuss alternative pathways and documentation needs.

Table of Contents

Understanding Waylivra Coverage Challenges

Waylivra (volanesorsen) faces unique coverage challenges in the United States. The FDA declined to approve this antisense oligonucleotide for familial chylomicronemia syndrome in 2019, despite a 12-8 advisory committee vote in favor. This means no standard insurance pathway exists through Humana or other U.S. insurers for FCS treatment.

However, patients and clinicians may still pursue coverage for:

  • Off-label use (though this faces significant barriers)
  • Expanded access programs
  • Clinical trial participation
  • Compassionate use protocols
Note: The European Medicines Agency approved Waylivra in 2019, and it's available in several European countries with specialist prescription requirements.

Pre-Submission Preparation (0-2 Days)

Before attempting any coverage request with Humana, gather comprehensive documentation:

Essential Documentation Checklist

  • Insurance verification: Current Humana member ID, plan type (Medicare Advantage, commercial), and formulary status
  • Genetic confirmation: Laboratory report showing biallelic pathogenic variants in FCS-related genes (LPL, APOC2, APOA5, GPIHBP1, LMF1)
  • Laboratory evidence: Minimum three fasting triglyceride measurements ≥880 mg/dL, taken at least one month apart
  • Treatment history: Documented failure or intolerance of fibrates, omega-3 fatty acids, and dietary interventions
  • Specialist consultation: Notes from endocrinologist, lipidologist, or metabolic specialist
  • Secondary cause exclusion: TSH, HbA1c, comprehensive metabolic panel results

Coding Requirements

For any submission, ensure proper diagnostic coding:

  • ICD-10: E78.3 (Hyperchylomicronemia) or E78.9 (Disorder of lipoprotein metabolism, unspecified)
  • CPT codes: For monitoring and administration (if applicable)

Submission to Initial Review (1-5 Days)

Humana Submission Process

Contact Information:

  • Prior Authorization Fax: 502-508-9300
  • Phone: 866-421-5663 (Monday-Friday, 6 AM - 6 PM ET)
  • Provider Portal: Available through Humana's online system

What Reviewers Check First

Humana's utilization management team will immediately assess:

  1. FDA approval status (major barrier for Waylivra)
  2. Medical necessity criteria
  3. Formulary placement (typically non-formulary)
  4. Prior authorization requirements
  5. Step therapy compliance
Reality Check: Given the lack of FDA approval, initial denials are expected. The goal is creating a strong foundation for appeals.

Additional Information Requests (1-7 Days)

If Humana requests additional information, respond within 5 business days to avoid automatic denial. Common requests include:

  • Peer-to-peer review with medical director
  • Additional clinical documentation
  • Alternative therapy trial records
  • Specialist consultation reports

How to Respond Quickly

  • Use Humana's provider portal for fastest submission
  • Include a cover letter summarizing the clinical urgency
  • Reference specific policy sections when possible
  • Provide direct contact information for follow-up questions

Decision Timeline and Outcomes

Standard Review Process

  • Initial determination: 72 hours for standard reviews after complete documentation
  • Complex cases: May extend beyond standard timeframe
  • Notification: Provider and member receive written determination

Expected Outcomes

Given Waylivra's FDA status, expect:

  1. Initial denial based on non-FDA approval
  2. Medical necessity denial
  3. Non-formulary status denial
  4. Experimental/investigational classification

Appeals Process in Virginia

Virginia provides robust external review protections through the State Corporation Commission Bureau of Insurance.

Internal Appeals Timeline

  • Deadline: 65 days from denial notification
  • Process: Submit through Humana's member portal or by mail
  • Documentation: Include all original submission materials plus additional evidence

External Review Process

Eligibility: After exhausting Humana's internal appeals

Timeline:

  • Request deadline: 120 days from final internal denial
  • Submission: Use Form 216-A to Virginia Bureau of Insurance
  • Standard review: 45 days maximum
  • Expedited review: 72 hours (with Form 216-C certification)

Contact Information:

Required Forms:

Virginia Advantage: The state's external review process is binding on insurers and provides independent medical expertise review.

Clinician Corner: Medical Necessity Letter Essentials

When drafting appeals, include these critical elements:

  • Problem statement: Severe FCS with recurrent pancreatitis risk
  • Prior treatments: Documented failure of fibrates, omega-3s, dietary management
  • Clinical rationale: Waylivra's mechanism of action and European approval data
  • Guideline citations: European Society of Cardiology guidelines, FDA advisory committee materials
  • Monitoring plan: Platelet count monitoring, triglyceride tracking
  • Treatment goals: Pancreatitis prevention, quality of life improvement

Alternative Access Pathways

Since standard insurance coverage is unavailable, consider these options:

Expanded Access Programs

Contact the manufacturer (Ionis Pharmaceuticals) directly to inquire about:

  • Compassionate use protocols
  • Expanded access programs
  • Clinical trial opportunities

Patient Assistance Programs

  • Manufacturer support: Contact Ionis for potential assistance programs
  • Foundation grants: Organizations like the National Organization for Rare Disorders (NORD) may provide support
  • State programs: Virginia may have rare disease assistance programs

Clinical Trials

Search ClinicalTrials.gov for:

  • Active Waylivra studies
  • Alternative FCS treatments
  • Registry studies for long-term data collection

Timeline Overview

Phase Timeline Key Actions Expected Outcome
Preparation 0-2 days Gather documentation, verify insurance Ready to submit
Initial submission 1-5 days Submit PA request to Humana Likely denial
Internal appeal 65 days max File comprehensive appeal Likely denial
External review 120 days to file, 45 days decision Submit to Virginia SCC Independent review
Alternative pathways Ongoing Explore expanded access Potential access

When to Escalate

Contact Virginia regulators if you experience:

  • Procedural violations in the appeals process
  • Unreasonable delays beyond stated timelines
  • Lack of response to properly submitted requests

Virginia State Corporation Commission Bureau of Insurance Consumer Services Phone: 1-877-310-6560

Frequently Asked Questions

Q: Can I get Waylivra covered by Humana in Virginia? A: Standard coverage is not available due to lack of FDA approval. However, you can pursue appeals and alternative access pathways.

Q: How long does the appeals process take? A: Internal appeals must be decided within 65 days. External reviews take up to 45 days (72 hours if expedited).

Q: What if I'm already receiving Waylivra from Europe? A: Continuing coverage for established therapy may have different considerations. Consult your specialist about importation regulations and insurance implications.

Q: Are there alternatives to Waylivra for FCS? A: Yes, including Tryngolza (olezarsen), which received FDA approval in 2024, and traditional therapies like plasmapheresis for severe cases.

Q: Can I request expedited review? A: Yes, if your physician certifies medical urgency using Form 216-C for the Virginia external review process.

From our advocates: We've seen patients successfully navigate complex coverage situations by building strong relationships with their specialists and maintaining detailed documentation throughout the process. While Waylivra presents unique challenges, persistence and thorough preparation often lead to alternative solutions.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based strategies. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and develop targeted appeal strategies that align with payer-specific policies and procedures.

For complex cases like Waylivra, where standard pathways don't exist, having expert guidance can make the difference between abandoning treatment and finding alternative access routes. Counterforce Health's approach combines deep knowledge of payer policies with understanding of regulatory pathways to help patients access needed therapies.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with qualified healthcare professionals regarding treatment decisions and insurance coverage options. Coverage policies vary by plan and individual circumstances.

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