How to Get Waylivra (Volanesorsen) Covered by Humana in New York: Complete Appeal Guide with Forms and Timelines
Quick Answer: Getting Waylivra Covered by Humana in New York
Waylivra (volanesorsen) isn't FDA-approved in the US, making Humana coverage challenging but possible through formulary exceptions and appeals. Start with a prior authorization request using genetic FCS confirmation and triglyceride levels ≥880 mg/dL. If denied, file an internal appeal within 65 days, then escalate to New York's external review system through the Department of Financial Services within 4 months. New York's binding external appeals have strong success rates for well-documented specialty drug cases.
First step today: Contact your prescribing specialist to gather genetic test results, triglyceride labs, and documentation of failed conventional therapies before submitting Humana's coverage determination form.
Table of Contents
- Understanding the Coverage Challenge
- Reading Your Denial Letter
- Gathering Required Documentation
- Step-by-Step: Fastest Path to Approval
- Medical Necessity Letter Essentials
- Humana Appeals Process in New York
- New York External Review System
- Common Denial Reasons & Solutions
- Cost Assistance Options
- When to Escalate Further
- Frequently Asked Questions
Understanding the Coverage Challenge
Waylivra (volanesorsen) faces unique coverage hurdles in the US because it's only approved in Europe for familial chylomicronemia syndrome (FCS). While the FDA hasn't approved it here, patients with genetically confirmed FCS can still pursue coverage through Humana's formulary exception process.
Key Coverage Facts:
- Not on standard Humana formularies
- Requires genetic confirmation of FCS
- Weekly subcutaneous injection targeting APOC3
- Typically costs over $200,000 annually in Europe
Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying coverage gaps, and crafting evidence-backed rebuttals that align with each plan's specific policies and requirements.
Reading Your Denial Letter
Humana denials for Waylivra typically cite one of these reasons:
| Denial Code | Meaning | Next Steps |
|---|---|---|
| "Not FDA-approved" | Drug lacks US approval | Request formulary exception with medical necessity |
| "Experimental/Investigational" | Considered unproven | Cite European approval, specialty guidelines |
| "Step therapy required" | Must try other drugs first | Document failures of fenofibrate, omega-3s, diet |
| "Not medically necessary" | Doesn't meet criteria | Provide genetic confirmation, triglyceride levels |
Tip: Look for the appeals deadline in your denial notice—you have 65 days to file with Humana, then 4 months for New York external review.
Gathering Required Documentation
Essential Documents for Your Appeal:
Medical Records:
- Genetic testing results showing FCS-causing variants (LPL, APOC2, APOA5, GPIHBP1, LMF1 genes)
- Multiple fasting triglyceride levels ≥880 mg/dL (ideally ≥1000 mg/dL)
- Documentation of acute pancreatitis episodes
- Specialist consultation notes (endocrinologist or lipidologist)
Treatment History:
- Failed trials of fenofibrate (doses, duration, outcomes)
- High-dose omega-3 fatty acid trials
- Strict dietary fat restriction records (<15g/day)
- Any hospitalizations related to pancreatitis
Supporting Evidence:
- FDA guidance on FCS (even though Waylivra isn't approved)
- European Medicines Agency approval documentation
- National Lipid Association FCS guidelines
- Peer-reviewed studies on volanesorsen efficacy
Step-by-Step: Fastest Path to Approval
1. Submit Initial Prior Authorization (1-5 days)
Who: Your prescribing physician
What: Humana PA form with complete medical necessity letter
How: Fax to 502-508-9300 or call 866-421-5663
Timeline: 7-14 days standard; 72 hours if expedited
2. Request Formulary Exception if Denied (Same day)
Who: Patient or prescriber
What: Medicare Prescription Drug Coverage Determination form
How: Fax to 877-486-2621 or submit via Humana portal
Timeline: 72 hours standard; 24 hours expedited
3. File Internal Appeal (Within 65 days of denial)
Who: Patient or authorized representative
What: Appeal form with additional evidence addressing denial reasons
How: Humana member portal or mail/fax
Timeline: 30 days for decision
4. Escalate to New York External Review (Within 4 months)
Who: Patient or provider
What: NY DFS External Appeal form
How: Online portal or fax to (800) 332-2729
Timeline: 30 days standard; 72 hours expedited
Medical Necessity Letter Essentials
Clinician Corner: Letter Components
Your prescriber's medical necessity letter should include:
Patient Demographics & Diagnosis:
- Full name, DOB, Humana member ID
- ICD-10 code E78.3 (hyperchylomicronemia)
- Genetic confirmation details with specific variants identified
Clinical Justification:
- Persistent triglycerides >1000 mg/dL despite maximal therapy
- History of acute pancreatitis episodes
- Failed conventional treatments (specific drugs, doses, durations)
- Risk of recurrent pancreatitis without targeted therapy
Sample Appeal Paragraph:
"The denial states Waylivra is 'not medically necessary,' but this contradicts established medical evidence. Patient has genetically confirmed familial chylomicronemia syndrome with persistent triglycerides >1000 mg/dL despite maximal conventional therapy including strict dietary fat restriction (<15g/day), fenofibrate 200mg daily, and high-dose omega-3 fatty acids. She has suffered three episodes of acute pancreatitis requiring hospitalization. FCS is a distinct genetic disorder that does not respond to standard hypertriglyceridemia treatments, making Waylivra the appropriate targeted therapy as supported by EMA approval and National Lipid Association FCS guidelines."
Humana Appeals Process in New York
Internal Appeal Timeline
| Appeal Level | Deadline to File | Humana Decision Time | How to Submit |
|---|---|---|---|
| First Level | 65 days from denial | 30 days standard | Member portal or fax |
| Expedited | Any time if urgent | 72 hours | Check "expedited" box with physician statement |
Required Forms & Contacts
For Medicare Advantage: Use Humana's Appeal/Grievance forms (available in English and Spanish)
Key Contact Information:
- Appeals fax: Check your denial notice for plan-specific number
- Phone: Member services number on your insurance card
- Online: MyHumana portal for status tracking
Note: You can appoint someone to file appeals on your behalf using Humana's Authorization Representative form.
New York External Review System
New York offers one of the strongest external appeal systems in the country. After exhausting Humana's internal process, you can request an independent review.
External Review Requirements
Eligibility: Must complete Humana's internal appeal first (or wait 30 days if they don't respond)
Timeline: File within 4 months of final Humana denial
Cost: $25 fee (waived for Medicaid enrollees or financial hardship)
Decision Time:
- Standard: 30 days
- Expedited: 72 hours (24 hours for urgent drug appeals)
How to File
- Download the form: NY DFS External Appeal Application
- Gather documents: Final Humana denial, medical records, physician letters
- Submit: Online at DFS portal or fax to (800) 332-2729
Free Help Available: Community Health Advocates provides free assistance at 888-614-5400 for New York residents navigating insurance appeals.
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn | Key Documents |
|---|---|---|
| "Not FDA-approved" | Request formulary exception citing medical necessity and lack of alternatives | EMA approval, genetic test, failed therapies |
| "Experimental" | Cite established use in Europe, specialty guidelines | Peer-reviewed studies, NLA guidelines |
| "Step therapy not met" | Document specific failures of conventional therapies | Pharmacy records, physician notes on adverse effects |
| "Triglycerides too low" | Provide multiple labs showing persistently high levels | Serial triglyceride measurements ≥880 mg/dL |
Cost Assistance Options
While pursuing coverage, explore these financial assistance programs:
Manufacturer Support:
- Ionis Pharmaceuticals may offer expanded access programs
- Contact medical affairs for compassionate use options
Foundation Grants:
- National Organization for Rare Disorders (NORD)
- Patient Advocate Foundation
- HealthWell Foundation
State Programs:
- New York State of Health marketplace plans
- Medicaid coverage for qualifying individuals
When to Escalate Further
If your external appeal fails, additional options include:
Federal Medicare Appeals: For Medicare Advantage plans, you can escalate to CMS after state review
State Insurance Complaints: File with NY Department of Financial Services for plan violations
Legal Consultation: Consider healthcare law attorneys for complex cases
The team at Counterforce Health can also help analyze failed appeals and identify new angles for resubmission based on updated medical evidence or policy changes.
Frequently Asked Questions
Q: How long does Humana prior authorization take for Waylivra in New York?
A: Standard PA decisions take 7-14 days. You can request expedited review (72 hours) if your health is at immediate risk.
Q: What if Waylivra is completely non-formulary on my Humana plan?
A: You can request a formulary exception using the Medicare coverage determination form. Your prescriber must provide supporting documentation.
Q: Can I get expedited appeals in New York?
A: Yes, both Humana (72 hours) and NY external review (24-72 hours) offer expedited timelines when delays could jeopardize your health.
Q: Does step therapy apply if I tried medications outside New York?
A: Yes, prior failures from any location should count. Provide pharmacy records and physician documentation of outcomes.
Q: What genetic tests confirm FCS for coverage purposes?
A: Look for pathogenic variants in LPL, APOC2, APOA5, GPIHBP1, or LMF1 genes through comprehensive lipid panel genetic testing.
Q: How much does external appeal cost in New York?
A: $25 maximum, waived for Medicaid enrollees or financial hardship. Fee is refunded if you win the appeal.
Q: Can Community Health Advocates help with Humana Medicare appeals?
A: Yes, call 888-614-5400 for free assistance with documentation, form completion, and appeal strategy for NY-regulated plans.
Q: What happens if my external appeal succeeds?
A: The decision is binding on Humana—they must cover Waylivra and may need to reimburse previous denials. The external reviewer's decision cannot be overturned.
This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for the most current coverage policies and requirements.
Need additional help? Contact Community Health Advocates at 888-614-5400 for free insurance appeal assistance, or visit the NY Department of Financial Services for external review resources.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.