By Counterforce Health Team in Waylivra (volanesorsen) —

How to Get Waylivra (Volanesorsen) Covered by Aetna CVS Health in Michigan: Prior Authorization, Appeals, and Coding Guide

Quick Answer: Getting Waylivra Covered by Aetna CVS Health in Michigan

Waylivra (volanesorsen) is not FDA-approved in the US and requires a medical exception request through Aetna CVS Health. Your fastest path: 1) Have your specialist document confirmed FCS diagnosis with genetic testing and failed standard therapies, 2) Submit a detailed medical necessity letter citing why FDA-approved alternatives like Tryngolza aren't appropriate, and 3) If denied, file for Michigan DIFS external review within 127 days. Start by calling Aetna at 1-866-235-5660 to confirm your plan's medical exception process.

Table of Contents

Coverage Overview: Medical vs. Pharmacy Benefit

Waylivra (volanesorsen) presents unique coverage challenges because it's not FDA-approved in the United States, despite being available in Europe for familial chylomicronemia syndrome (FCS). Here's what Michigan patients need to know:

Current Coverage Status with Aetna CVS Health:

  • Not included in 2025 standard or specialty pharmacy drug lists
  • No routine prior authorization pathway available
  • Medical exception required for any coverage consideration
  • Preferred alternative: Tryngolza (olezarsen), FDA-approved in 2024 for FCS
Note: Aetna CVS Health will typically require you to try FDA-approved alternatives first, unless you can document compelling reasons why they're inappropriate for your specific case.

Medical Benefit vs. Pharmacy Benefit Considerations:

Coverage Type Likelihood Requirements Billing Codes
Medical Benefit Very Low Medical exception with extensive documentation J3490 (unclassified drugs)
Pharmacy Benefit Not Available Drug not on formulary Not applicable
Specialty Pharmacy Not Available Not stocked by CVS Specialty Not applicable

ICD-10 Coding and Documentation Requirements

Proper coding is essential for any medical exception request. The primary diagnosis code for familial chylomicronemia syndrome is E78.3 (Hyperchylomicronemia).

Required Documentation Elements:

  • Genetic confirmation of FCS with biallelic pathogenic mutations in LPL, APOC2, APOA5, LMF1, or GPIHBP1
  • Persistent fasting triglycerides >875 mg/dL documented on multiple occasions
  • History of recurrent acute pancreatitis attributable to severe hypertriglyceridemia
  • Comprehensive trial and failure of conventional therapies (fibrates, omega-3 fatty acids, niacin, statins)

Supporting ICD-10 Codes:

  • Z83.438: Family history of lipoprotein metabolism disorder
  • K85.9: Acute pancreatitis, unspecified (if applicable)
  • Z87.891: Personal history of nicotine dependence (if relevant to treatment failures)
Clinician Tip: Document specific triglyceride levels, dates of pancreatitis episodes, and detailed notes about why each previous therapy failed or caused intolerance. This documentation directly supports medical necessity.

Product Coding: HCPCS, J-Codes, and NDC

Since Waylivra lacks a specific HCPCS J-code, billing requires careful attention to unclassified drug codes:

Billing Codes for Waylivra:

  • Primary: J3490 (Unclassified drugs)
  • Hospital Outpatient: C9399 (Unclassified drugs or biologicals)
  • NDC: Verify current NDC from product packaging (varies by lot)

Dosing and Units Calculation:

  • Standard dose: 285 mg subcutaneously once weekly (initial 3 months)
  • Maintenance dose: 285 mg every two weeks
  • Dispensing unit: Pre-filled syringe containing 285 mg
  • Monthly supply: 4 syringes (weekly) or 2 syringes (biweekly maintenance)

Critical Billing Requirements:

  • Include drug name "volanesorsen" or "Waylivra" in claims description
  • Specify exact dose (285 mg) and frequency
  • Attach medical exception approval reference number
  • Provide prescriber NPI and specialty designation

Step-by-Step: Medical Exception Request

Step 1: Confirm Plan Requirements Call Aetna at 1-866-235-5660 to verify your specific plan's medical exception process and required forms.

Step 2: Gather Clinical Documentation

  • Genetic test results confirming FCS
  • Laboratory reports showing triglyceride levels >875 mg/dL
  • Medical records documenting pancreatitis episodes
  • Detailed notes on failed therapies and reasons for failure
  • Specialist consultation notes (endocrinologist, lipid specialist, or geneticist)

Step 3: Draft Medical Necessity Letter Your specialist should include:

  • Patient-specific clinical rationale for Waylivra
  • Why FDA-approved alternatives (Tryngolza) are inappropriate
  • Reference to European guidelines and clinical evidence
  • Treatment goals and monitoring plan

Step 4: Submit Request Submit via Aetna provider portal or fax to the number provided during your confirmation call. Include all supporting documentation.

Step 5: Follow Up Aetna must respond within 30-45 days for standard requests, or 72 hours for expedited requests with physician attestation of urgency.

From our advocates: We've seen medical exception requests succeed when families work closely with their lipid specialist to document not just the diagnosis, but specific reasons why the patient can't wait for or use FDA-approved alternatives. One key factor is having the specialist explain why the European approval data applies to this specific patient's case.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not FDA-approved" Emphasize medical exception criteria and lack of alternatives European approval data, clinical guidelines
"Experimental/Investigational" Cite established use in Europe and clinical evidence Published studies, European prescribing information
"Preferred alternative available" Document contraindications or failure of Tryngolza Specific medical reasons why alternatives won't work
"Insufficient documentation" Provide comprehensive genetic and clinical records Complete FCS workup, specialist consultation
"Not medically necessary" Strengthen clinical rationale with specialist support Detailed treatment history and prognosis

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Michigan Appeals Process and DIFS External Review

If Aetna denies your medical exception request, Michigan law provides robust appeal rights:

Internal Appeals Process:

  1. First-Level Appeal: File within 60 days of denial notice
    • Standard: Decision within 30 days
    • Expedited: Decision within 72 hours (requires physician urgency letter)
    • Submit via phone (1-866-235-5660), fax, or online portal
  2. Second-Level Appeal: If upheld, appeal to independent review entity within 60 days

Michigan DIFS External Review: After exhausting internal appeals, you can request external review from the Michigan Department of Insurance and Financial Services (DIFS):

  • Timeline: File within 127 days of final internal denial
  • Process: DIFS assigns case to independent medical experts
  • Decision: Binding on Aetna, typically within 60 days
  • Cost: No charge to patient
  • Contact: Call DIFS at 877-999-6442 for forms and guidance

Required Documents for DIFS Review:

  • Copy of final denial letter from Aetna
  • All medical records supporting the request
  • Completed DIFS external review form
  • Physician letter explaining medical necessity
Important: Michigan's 127-day deadline is firm. Don't wait—begin the DIFS external review process immediately after receiving your final internal denial.

Costs and Patient Assistance Programs

Estimated Costs:

  • European pricing: Varies by country, typically $100,000+ annually
  • US access: Through expanded access programs or clinical trials

Potential Assistance Options:

  • Manufacturer programs: Contact Akcea Therapeutics for compassionate use information
  • Clinical trials: Search ClinicalTrials.gov for active volanesorsen studies
  • Rare disease foundations: National Organization for Rare Disorders (NORD) may offer guidance
  • State programs: Michigan may have rare disease assistance through Medicaid waiver programs

Insurance Navigation Support: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals tailored to each payer's specific requirements.

FAQ

How long does Aetna CVS Health take to decide medical exception requests in Michigan? Standard requests receive decisions within 30-45 days. Expedited requests with physician urgency documentation are decided within 72 hours.

What if Waylivra isn't available through CVS Specialty Pharmacy? Since Waylivra isn't FDA-approved, it's not stocked by CVS Specialty. Access would require special importation arrangements through expanded access programs.

Can I appeal if I live in Michigan but have an out-of-state Aetna plan? Appeal rights depend on where your plan is regulated. Contact your plan directly and consider filing with both Michigan DIFS and your plan's home state regulator.

Does step therapy apply to medical exception requests? Yes, Aetna typically requires documentation that you've tried or can't use FDA-approved alternatives like Tryngolza before considering non-approved medications.

What counts as "urgent" for expedited appeals? Your physician must document that waiting for a standard decision would seriously jeopardize your health, such as risk of recurrent pancreatitis.

How much does the DIFS external review cost? Michigan's external review process is free to patients. DIFS covers all costs of the independent medical review.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Aetna plan and consult with your healthcare provider about treatment options. For personalized assistance with insurance appeals, consider consulting with qualified patient advocates or legal professionals specializing in healthcare coverage.

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