By Counterforce Health Team in Waylivra (volanesorsen) —

How to Get Waylivra (Volanesorsen) Covered by Humana in Michigan: Complete Appeal Guide with Forms and Timelines

Answer Box: Getting Waylivra (Volanesorsen) Covered by Humana in Michigan

Waylivra requires prior authorization from Humana and isn't FDA-approved in the U.S., making coverage challenging but possible through formulary exceptions. First step: Have your prescriber submit a formulary exception request with medical necessity documentation to Humana at 800-555-2546 or fax 877-486-2621. If denied, you have 65 days to appeal internally, then 127 days to file for external review with Michigan DIFS. Success depends on documenting confirmed FCS diagnosis with triglycerides >880 mg/dL and failure of standard therapies.

Table of Contents

Understanding Waylivra Coverage Challenges

Waylivra (volanesorsen) presents unique coverage challenges because it's not FDA-approved in the United States. The drug has conditional approval in Europe for familial chylomicronemia syndrome (FCS) but was rejected by the FDA in 2018 despite strong advisory committee support.

However, some U.S. patients have successfully obtained coverage through formulary exceptions when they meet strict criteria for confirmed FCS and have documented failure of all available alternatives. The key is building an airtight case for medical necessity.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned to each payer's specific requirements. Their platform helps clinicians navigate complex prior authorization requirements for specialty medications like Waylivra.

Coverage at a Glance: Humana Requirements

Requirement What It Means Where to Find It Source
Prior Authorization Required for all non-formulary drugs Check Humana formulary lookup Humana PA Lists
Formulary Exception Needed since Waylivra isn't on formulary Submit via Clinical Pharmacy Review Exception Process
FCS Diagnosis Triglycerides >880 mg/dL, genetic testing NAFCS or Moulin scoring preferred FCS Criteria
Prior Therapy Failure Standard treatments ineffective Document fibrates, statins, diet trials Clinical documentation
Appeal Deadline 65 days from denial notice Medicare Advantage standard Humana Appeals
External Review 127 days after final internal denial Michigan DIFS process Michigan Appeals

Step-by-Step: Fastest Path to Approval

1. Confirm FCS Diagnosis (Prescriber)

  • Document minimum 2 fasting triglyceride levels >880 mg/dL
  • Complete NAFCS or Moulin scoring system
  • Order genetic testing if not already done
  • Timeline: 2-4 weeks for complete workup

2. Document Treatment Failures (Prescriber)

  • Record trials and failures of fibrates, statins, ezetimibe
  • Note any adverse reactions or contraindications
  • Include dietary modification attempts
  • Timeline: Review 6-12 months of treatment history

3. Submit Formulary Exception (Prescriber)

  • Call Humana Clinical Pharmacy Review: 800-555-2546
  • Fax completed request to 877-486-2621
  • Include comprehensive medical necessity letter
  • Timeline: Decision within 72 hours (standard) or 24 hours (expedited)

4. Follow Up on Decision (Patient/Prescriber)

  • Check Humana member portal for status updates
  • If approved, coordinate with specialty pharmacy
  • If denied, immediately begin appeal process
  • Timeline: Monitor within 3-5 business days

5. File Internal Appeal if Denied (Patient)

  • Submit within 65 days of denial notice
  • Include additional supporting documentation
  • Request expedited review if clinically urgent
  • Timeline: 30 days for decision

6. Request External Review if Needed (Patient)

  • File with Michigan DIFS within 127 days of final denial
  • Use online form or call 877-999-6442
  • Include all prior documentation and physician support
  • Timeline: 60 days for standard review, 72 hours for expedited

7. Coordinate Specialty Pharmacy (Patient/Prescriber)

  • Work with Humana-contracted specialty pharmacy
  • Ensure proper NDC codes and administration plan
  • Set up monitoring for platelet counts and liver function
  • Timeline: 1-2 weeks for first shipment

Medical Necessity Letter Checklist

Your prescriber's medical necessity letter should include these essential elements:

Patient Information

  • Confirmed FCS diagnosis with ICD-10 code E78.3
  • Age at symptom onset (typically childhood/adolescence)
  • History of acute pancreatitis or severe abdominal pain
  • Current triglyceride levels with dates

Clinical Rationale

  • NAFCS score ≥60 (definite FCS) or 45-60 (likely FCS)
  • Genetic testing results showing pathogenic variants in LPL, GPIHBP1, APOA5, APOC2, or LMF1
  • Documented resistance to standard therapies
  • Risk of recurrent pancreatitis without treatment

Treatment History

  • Specific fibrates tried (fenofibrate, gemfibrozil) with doses and duration
  • Statin trials and outcomes
  • Dietary modifications attempted
  • Any adverse reactions or contraindications to alternatives

Supporting Evidence

  • Reference to NEJM study showing 77% triglyceride reduction
  • European approval for FCS indication
  • Safety monitoring plan for thrombocytopenia
From Our Advocates

We've seen success when prescribers emphasize the patient's young age at diagnosis and documented pancreatitis episodes. One case involved a 28-year-old with childhood-onset FCS who had three hospitalizations for pancreatitis despite maximum medical therapy. The appeal succeeded when the physician clearly linked the patient's specific genetic mutation to treatment failure and included photos of lipemic plasma samples.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Experimental/Investigational" Cite EMA approval and published efficacy data EMA approval document
"Not medically necessary" Strengthen FCS diagnosis documentation NAFCS score ≥45, genetic testing results
"Alternatives available" Document specific failures of each alternative Detailed treatment log with doses, duration, outcomes
"Insufficient documentation" Submit comprehensive clinical records Lab results, hospitalization records, genetic reports
"Off-label use" Emphasize lack of FDA-approved FCS treatments Literature review of treatment gaps

Appeals Playbook for Humana in Michigan

Internal Appeals (First Level)

Standard Appeal

  • Deadline: 65 days from denial notice
  • How to Submit: Availity provider portal or written request
  • Timeline: 30 days for Part C decisions, 7 days for Part D
  • Required: Original denial letter, additional medical records, updated physician letter

Expedited Appeal

  • When to Use: Delay would jeopardize health
  • Timeline: 72 hours for decision
  • Requirements: Physician attestation of urgency

External Review (Second Level)

If Humana's internal appeal fails, Michigan residents can request an independent external review through the Department of Insurance and Financial Services (DIFS).

Standard External Review

  • Deadline: 127 days from final internal denial
  • How to Submit: Online form or call 877-999-6442
  • Timeline: 60 days maximum for decision
  • Cost: Free to patients

Expedited External Review

  • Timeline: 72 hours for decision
  • Requirements: Physician letter verifying necessity of expedited review
  • Eligibility: Pre-service denials only (not post-service)
Note: External review decisions are binding on Humana and must be implemented within 30 days if favorable.

When to Request Peer-to-Peer Review

A peer-to-peer review allows your prescriber to speak directly with Humana's medical director about your case. Request this when:

  • Initial PA was denied for "not medically necessary"
  • Complex clinical circumstances need explanation
  • Genetic testing results are indeterminate but clinical picture strongly suggests FCS

How to Schedule:

  1. Call Humana provider services at 866-488-5995
  2. Request peer-to-peer review for formulary exception
  3. Provide case summary and preferred call times
  4. Follow up within 24-48 hours if no response

Talking Points for Prescribers:

  • Emphasize confirmed FCS diagnosis with supporting scores
  • Detail specific failures of each alternative therapy
  • Reference published efficacy data from NEJM study
  • Discuss patient's quality of life impact and pancreatitis risk

Michigan External Review Process

Michigan's external review system provides an independent assessment when Humana denies coverage. The process involves:

Independent Review Organization (IRO)

  • DIFS assigns a qualified IRO with relevant medical expertise
  • IRO reviews all submitted documentation
  • Independent medical experts make binding determination
  • No cost to patients

Required Documentation

  • Complete Humana denial letters and internal appeal decisions
  • All medical records supporting FCS diagnosis
  • Physician statement of medical necessity
  • Treatment history and failure documentation

Timeline and Outcomes

  • Standard review: 60 days maximum
  • Expedited review: 72 hours for urgent cases
  • Decisions are binding on Humana
  • Insurer must implement favorable decisions within 30 days

Contact Michigan DIFS at 877-999-6442 for assistance with the external review process.

Cost Assistance and Alternative Options

Manufacturer Support Programs

Since Waylivra isn't commercially available in the U.S., traditional copay assistance programs don't apply. However, patients may explore:

Compassionate Use Programs

  • Contact Ionis Pharmaceuticals directly
  • Requires physician application
  • Limited to patients with severe, life-threatening FCS

Clinical Trials

  • Monitor ClinicalTrials.gov for olezarsen studies
  • May provide access to similar therapy
  • Requires meeting specific eligibility criteria

Alternative Treatments

If Waylivra coverage isn't achievable:

Olezarsen (Tryngolza)

  • FDA-approved December 2024 for severe hypertriglyceridemia
  • Same mechanism as Waylivra with improved safety profile
  • May be easier to obtain coverage

Lomitapide (Juxtapid)

  • FDA-approved for homozygous familial hypercholesterolemia
  • Sometimes used off-label for severe hypertriglyceridemia
  • Requires REMS program participation

FAQ: Waylivra Coverage Questions

Q: How long does Humana prior authorization take in Michigan? A: Humana must respond within 72 hours for standard requests and 24 hours for expedited requests when medical urgency is documented.

Q: What if Waylivra isn't on Humana's formulary? A: You'll need to request a formulary exception through Humana's Clinical Pharmacy Review team at 800-555-2546, providing medical necessity documentation.

Q: Can I request an expedited appeal if my triglycerides are dangerously high? A: Yes, if your physician documents that delay would jeopardize your health or ability to regain maximum function, you can request expedited review at both internal and external levels.

Q: Does step therapy apply to Waylivra in Michigan? A: Since Waylivra isn't formulary, step therapy requirements depend on your specific plan. Your prescriber must document failures of covered alternatives like fibrates and statins.

Q: What happens if both internal and external appeals fail? A: You may file a complaint with Michigan DIFS about the external review process, explore compassionate use programs, or consider alternative treatments like olezarsen.

Q: How much does Waylivra cost without insurance? A: Waylivra isn't commercially available in the U.S., so pricing information isn't applicable. European pricing varies by country but is typically in the high-cost orphan drug range.

Q: Can Counterforce Health help with my Waylivra appeal? A: Yes, Counterforce Health specializes in complex specialty drug appeals and can help craft targeted, evidence-backed appeals specifically aligned to Humana's requirements and Michigan's regulatory framework.

Q: What genetic tests confirm FCS diagnosis? A: Testing should identify pathogenic variants in LPL, GPIHBP1, APOA5, APOC2, or LMF1 genes. Even with indeterminate genetic results, strong clinical criteria may support FCS diagnosis.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider. Coverage decisions depend on individual circumstances, specific plan benefits, and clinical documentation. Always verify current forms, deadlines, and contact information with your insurer and state regulatory agencies, as these may change. For personalized assistance with complex appeals, consider consulting with healthcare coverage specialists like Counterforce Health.

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