By Counterforce Health Team in Vyndaqel / Vyndamax (tafamidis) —

Do You Qualify for Vyndaqel / Vyndamax (Tafamidis) Coverage by Aetna (CVS Health) in Michigan? Decision Tree & Next Steps

Answer Box: Quick Eligibility Check
You likely qualify for Vyndaqel/Vyndamax coverage if you have: (1) confirmed ATTR-CM by PYP scan grade 2-3 or biopsy, (2) excluded AL amyloidosis with negative monoclonal studies, and (3) NYHA Class I-III symptoms. First step today: Have your cardiologist submit prior authorization through Aetna's provider portal with complete diagnostic proof. If denied, Michigan gives you 127 days to file external review with DIFS. Standard PA decisions take 30-45 days; expedited reviews ≤72 hours for urgent cases.

Table of Contents

How to Use This Guide

This decision tree helps you determine whether you qualify for Vyndaqel or Vyndamax (tafamidis) coverage through Aetna (CVS Health) in Michigan, and what steps to take based on your situation.

Start here: Answer the questions in the eligibility triage section below. Based on your answers, you'll be directed to one of four paths: "Likely Eligible," "Possibly Eligible," "Not Yet," or appeals guidance if you've already been denied.

For patients navigating complex insurance approvals, Counterforce Health helps turn denials into targeted, evidence-backed appeals by analyzing your specific denial letter, plan policy, and clinical notes to draft point-by-point rebuttals aligned to your plan's own rules.

Eligibility Triage: Do You Qualify?

Core Requirements Checklist

Diagnosis Confirmation (Answer Yes/No):

  • ✓ Do you have confirmed ATTR-CM (transthyretin amyloid cardiomyopathy)?
  • ✓ Was this confirmed by PYP/DPD/HMDP scan showing grade 2-3 uptake OR cardiac/extracardiac biopsy?
  • ✓ Have you excluded AL amyloidosis with negative serum/urine immunofixation and free light chains?

Clinical Status:

  • ✓ Are you NYHA Class I, II, or III (not Class IV)?
  • ✓ Do you have heart failure symptoms due to ATTR-CM?
  • ✓ Is your prescriber a cardiologist or heart failure specialist?

Plan Status:

  • ✓ Do you have active Aetna (CVS Health) coverage?
  • ✓ Are you 18 years or older?

Your Path Forward

If you answered "Yes" to ALL questions: → Go to "Likely Eligible"

If you answered "No" to 1-2 diagnostic questions but "Yes" to clinical/plan questions: → Go to "Possibly Eligible"

If you answered "No" to 3+ questions: → Go to "Not Yet"

If you've already been denied: → Go to "If Denied: Michigan Appeal Process"

If "Likely Eligible": Document Checklist

You meet Aetna's core criteria. Here's what your cardiologist needs to submit for prior authorization:

Required Documentation

Diagnostic Proof:

  • Complete PYP/DPD/HMDP scan report showing grade 2-3 myocardial uptake
  • OR cardiac biopsy report with Congo red staining and TTR typing
  • Serum and urine immunofixation electrophoresis (negative)
  • Serum free light chain assay (normal ratio)

Clinical Evidence:

  • Current NYHA functional class (I-III)
  • Echocardiogram showing wall thickness and diastolic dysfunction
  • NT-proBNP or BNP levels (if elevated)
  • Documentation of heart failure symptoms
  • 6-minute walk test results (if available)

Prescriber Information:

  • Letter from cardiologist or heart failure specialist
  • Medical necessity statement citing ATTR-ACT trial data
  • Proposed dosing: Vyndamax 61 mg daily OR Vyndaqel 80 mg daily

Submission Process

  1. Submit via Aetna Provider Portal or fax to 1-866-249-6155
  2. Expected Timeline: 30-45 days for standard review
  3. Expedited Option: Available if delay would seriously jeopardize health (72-hour decision)
  4. Follow Up: Track status through provider portal
Tip: Include a cover letter explicitly stating: "Patient meets all criteria per Aetna's Vyndaqel-Vyndamax SGM Policy 3076-A for confirmed ATTR-CM with AL exclusion and NYHA Class [I/II/III] symptoms."

If "Possibly Eligible": Tests to Request

You may qualify but need additional testing. Work with your cardiologist to obtain:

Missing Diagnostic Tests

If PYP scan not done or grade 0-1:

  • Request technetium-99m PYP scintigraphy with SPECT
  • Ensure report includes visual grading (Perugini scale)
  • If grade 1 with high suspicion, consider cardiac biopsy

If AL amyloidosis not excluded:

  • Serum immunofixation electrophoresis
  • Urine immunofixation electrophoresis
  • Serum free light chain assay with kappa/lambda ratio
  • If any abnormal, urgent hematology referral needed

If cardiac involvement unclear:

  • Echocardiogram with strain imaging
  • Cardiac MRI with late gadolinium enhancement
  • Consider cardiac biomarkers (NT-proBNP, troponin)

Timeline to Re-apply

  • Complete testing: 2-4 weeks
  • Results review: 1 week
  • PA submission: Submit immediately once all criteria met
  • Total timeline: 4-6 weeks from initial request

If "Not Yet": Alternative Options

If you don't currently meet criteria, discuss these options with your cardiologist:

Diagnostic Workup

  • Complete ATTR-CM evaluation if suspected but not confirmed
  • Rule out other causes of heart failure with preserved ejection fraction
  • Consider genetic counseling if family history suggests hereditary ATTR

Treatment Alternatives

  • Optimize standard heart failure therapy (ACE inhibitors, diuretics, beta-blockers)
  • Manage symptoms while pursuing definitive diagnosis
  • Monitor disease progression with serial imaging and functional assessments

Preparing for Future Application

  • Document treatment failures or intolerance to standard therapies
  • Track functional decline or hospitalization patterns
  • Maintain relationship with specialized cardiology team

If Denied: Michigan Appeal Process

Michigan provides strong appeal rights under the Patient's Right to Independent Review Act. Here's your roadmap:

Level 1: Internal Appeal with Aetna

Timeline: File within 60 days of denial Decision: 7 days standard, 72 hours expedited How to File:

  • Online through Aetna member portal
  • Mail: Customer Service, Aetna Inc., P.O. Box 14079, Lexington, KY 40512
  • Phone: Member services number on your ID card

What to Include:

  • Original denial letter
  • Point-by-point rebuttal addressing each denial reason
  • Additional clinical documentation
  • Medical necessity letter from cardiologist

Level 2: Michigan DIFS External Review

If internal appeal fails, Michigan's Department of Insurance and Financial Services (DIFS) offers independent review:

Timeline: File within 127 days of final internal denial Decision: Up to 60 days (often faster) Cost: Free to you How to File:

Expedited External Review: Available if delay would seriously jeopardize health (72-hour decision with physician letter)

Michigan Advantage: DIFS external reviews are binding on insurers. If the Independent Review Organization overturns the denial, Aetna must cover the treatment.

Peer-to-Peer Review Strategy

Before or during appeals, request a peer-to-peer review with Aetna's medical director:

Key Points to Emphasize:

  • ATTR-ACT trial showed 30% mortality reduction vs placebo
  • 5-year data: 53% vs 32% survival with continuous tafamidis
  • Patient meets all stated policy criteria
  • No effective alternatives for disease modification

Aetna CVS Health Coverage Requirements

Based on Aetna's 2024 Vyndaqel-Vyndamax SGM Policy:

Requirement Details Documentation Needed
Diagnosis ATTR-CM (wild-type or hereditary) PYP scan grade 2-3 OR biopsy with TTR typing
AL Exclusion No light-chain amyloidosis Negative SIFE, UIFE, SFLC
Symptoms NYHA Class I-III heart failure Clinical assessment, functional testing
Prescriber Cardiologist or specialist Provider credentials verification
Dosing FDA-approved doses only Vyndamax 61mg daily OR Vyndaqel 80mg daily
Monitoring Beneficial response for renewal Functional assessments, hospitalization data

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"Diagnosis not confirmed" Submit complete PYP scan or biopsy report Full radiology/pathology report with interpretation
"AL not excluded" Provide negative monoclonal studies SIFE, UIFE, SFLC lab reports
"Not medically necessary" Cite ATTR-ACT data and guidelines Medical necessity letter with trial citations
"Step therapy required" Document HF therapy failures/intolerance Chart notes showing prior treatment attempts
"Non-formulary" Request formulary exception Clinical justification for tafamidis over alternatives

Frequently Asked Questions

How long does Aetna PA take in Michigan? Standard prior authorization decisions take 30-45 days. Expedited reviews are completed within 72 hours if delay would seriously jeopardize health.

What if Vyndaqel/Vyndamax is non-formulary on my plan? You can request a formulary exception through Aetna's Medical Exception Unit (fax 1-866-249-6155) with clinical justification from your cardiologist.

Can I request an expedited appeal in Michigan? Yes, both Aetna and DIFS offer expedited reviews (72 hours) when delay would seriously jeopardize your health, supported by physician documentation.

Does step therapy apply if I've tried treatments outside Michigan? Yes, document all prior heart failure treatments and their outcomes, regardless of where they were tried. This supports step therapy override requests.

What's the cost if I pay out-of-pocket? Vyndamax cash price is approximately $21,800 per 30 capsules (about $260,000 annually). Medicare Part D has out-of-pocket caps that may apply.

How does Michigan's 127-day appeal deadline work? You have exactly 127 days from receiving Aetna's final internal denial to file for DIFS external review. This deadline is strict and cannot be extended.

When navigating these complex requirements and potential denials, Counterforce Health specializes in turning insurance denials into successful appeals by analyzing your specific situation and crafting evidence-based responses that align with payer policies.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for coverage details specific to your policy. For assistance with Michigan insurance appeals, contact DIFS at 877-999-6442.

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