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

Requirements Checklist: Get Vyndaqel/Vyndamax (Tafamidis) Covered by Aetna CVS Health in California

Answer Box: Getting Tafamidis Coverage in California

To get Vyndaqel/Vyndamax (tafamidis) covered by Aetna CVS Health in California: First, ensure you have confirmed ATTR-CM diagnosis with PYP scan Grade 2-3 uptake or cardiac biopsy, plus AL amyloidosis exclusion. Your cardiologist must submit prior authorization through Aetna's provider portal with complete diagnostic documentation. If denied, file internal appeal within 180 days, then request Independent Medical Review (IMR) through California's DMHC within 6 months. Start today: Contact your cardiologist to confirm diagnostic requirements are met and request PA submission.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. CVS Specialty Pharmacy Enrollment
  8. After Submission: What to Expect
  9. Appeals Process in California
  10. Common Pitfalls & How to Avoid Them
  11. Quick Reference Checklist

Who Should Use This Guide

This checklist is designed for California residents with confirmed ATTR-CM (transthyretin amyloid cardiomyopathy) who need tafamidis covered by Aetna CVS Health plans. You'll find this most helpful if:

  • Your cardiologist has recommended Vyndaqel (20mg capsules) or Vyndamax (61mg capsules)
  • You have Aetna commercial insurance, Medicare Advantage, or managed Medicaid through CVS Health
  • You're preparing for initial prior authorization or appealing a denial

Expected outcome: With complete documentation, most medically appropriate requests are approved within 30-45 days. California's strong consumer protections provide excellent appeal options if initially denied.

Member & Plan Basics

Coverage Requirements

  • Active Aetna CVS Health membership in California
  • Prior authorization mandatory for both Vyndaqel and Vyndamax
  • Specialty pharmacy distribution required (typically CVS Specialty)
  • Annual reauthorization needed with updated clinical documentation

Plan Type Considerations

Plan Type Key Points
Commercial PPO/HMO Standard 30-45 day PA review; 180-day appeal window
Medicare Advantage Expedited reviews available (≤72 hours for urgent cases)
Medicaid Managed Care May have additional state-specific requirements
Note: Verify your specific plan's formulary status at Aetna's drug lookup tool before starting the process.

Clinical Criteria Requirements

Primary Indication

  • Confirmed ATTR-CM diagnosis (wild-type or hereditary)
  • NYHA Class I-III heart failure symptoms (Class IV typically excluded)
  • Cardiology specialist oversight required

Diagnostic Documentation Required

  1. PYP scan results: Grade 2 or 3 cardiac uptake on SPECT/CT imaging
  2. AL amyloidosis exclusion: Negative serum/urine immunofixation and normal free light chain ratio
  3. Genetic testing: TTR gene sequencing to confirm wild-type vs. hereditary
  4. Cardiac imaging: Recent echocardiogram showing amyloid involvement
Alternative: If PYP scan is indeterminate (Grade 0-1) or monoclonal protein detected, cardiac biopsy with Congo red staining and TTR typing is required.

Clinical Monitoring Parameters

  • Baseline labs: NT-proBNP, troponin, renal function
  • Functional status: 6-minute walk test or similar
  • No contraindications: Liver transplant, concurrent amyloidosis therapies

Coding & Billing Information

Essential Codes

Code Type Code Description
ICD-10 E85.82 Wild-type transthyretin-related (ATTR) amyloidosis
HCPCS J8499 Prescription drug, oral, non-chemotherapeutic, NOS
NDC 0069-0334-xx Vyndaqel 20mg (verify on packaging)
NDC 0069-0346-xx Vyndamax 61mg (verify on packaging)

Dosing Specifications

  • Vyndaqel: 80mg daily (four 20mg capsules)
  • Vyndamax: 61mg daily (one 61mg capsule)
  • Administration: Oral, once daily with or without food

Documentation Packet Essentials

Medical Necessity Letter Components

Your cardiologist's letter should include:

  1. Patient demographics and insurance information
  2. Diagnosis confirmation: "Patient has confirmed ATTR-CM based on..."
  3. Diagnostic evidence: PYP scan results, genetic testing, AL exclusion
  4. Clinical rationale: Current symptoms, functional limitations, prognosis
  5. Treatment plan: Dosing, monitoring, expected outcomes
  6. Literature support: Reference to ATTR-ACT trial data

Required Attachments

  • Complete diagnostic workup (PYP scan, genetic testing, AL exclusion)
  • Recent cardiac imaging (echo, MRI if available)
  • Laboratory results (NT-proBNP, troponin, renal function)
  • Specialist consultation notes
  • Previous therapy documentation (if applicable)

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

Submission Process

Step-by-Step Submission

  1. Gather documentation (see checklist above)
  2. Complete PA request through Aetna provider portal or fax
  3. Include all attachments in single submission
  4. Submit to CVS Specialty enrollment simultaneously
  5. Track submission with confirmation numbers
  6. Follow up if no response within 5 business days

Submission Methods

  • Provider portal: Aetna's online PA system (preferred)
  • Fax: Check current fax number in provider directory
  • Phone: 1-855-240-0535 for urgent cases
Tip: Submit PA request and specialty pharmacy enrollment concurrently to avoid delays.

CVS Specialty Pharmacy Enrollment

Enrollment Requirements

  1. Download cardiology enrollment form from CVS Specialty website
  2. Complete patient demographics, prescriber information, and prescription details
  3. Submit via fax or e-prescribe using contact information on form
  4. Coordinate with insurance approval timeline

What CVS Specialty Handles

  • Insurance benefit verification
  • Prior authorization coordination
  • Financial assistance programs
  • Direct-to-patient shipping
  • Refill management and adherence support

After Submission: What to Expect

Timeline Expectations

Review Type Timeline When Available
Standard PA 30-45 days Most cases
Expedited PA ≤72 hours Urgent medical need
Internal Appeal 30 days After denial
California IMR 30-45 days After internal appeal

Status Monitoring

  • Confirmation number: Record and save
  • Check status weekly through provider portal
  • Document all communications with dates and reference numbers
  • Set calendar reminders for renewal 90 days before expiration

Appeals Process in California

Internal Appeal (First Level)

  • Deadline: 180 days from denial
  • Method: Submit through Aetna member portal or written request
  • Documentation: Include additional clinical evidence, peer-reviewed studies
  • Timeline: 30 days for standard, expedited available for urgent cases

Independent Medical Review (IMR)

California residents have strong external appeal rights through the Department of Managed Health Care (DMHC):

  • Eligibility: After internal appeal completion or 30-day plan non-response
  • Deadline: 6 months from plan's final decision
  • Process: Independent physician reviewers evaluate medical necessity
  • Timeline: 30-45 days for standard, 7 days for expedited
  • Cost: Free to patients
  • Decision: Binding on insurance plan

How to File IMR

  1. Contact DMHC Help Center: 1-888-466-2219
  2. Submit online application: healthhelp.ca.gov
  3. Include all documentation: Medical records, denial letters, clinical studies
  4. Request expedited review if urgent medical need
California Advantage: The state has one of the highest IMR success rates for specialty drugs with strong clinical evidence.

Common Pitfalls & How to Avoid Them

Top 5 Denial Prevention Tips

  1. Incomplete AL amyloidosis exclusion
    • Fix: Ensure both serum/urine immunofixation AND free light chain ratio are normal and documented
  2. Missing genetic testing results
    • Fix: Include TTR gene sequencing confirming wild-type or hereditary variant
  3. Inadequate PYP scan documentation
    • Fix: Specify Grade 2 or 3 uptake with SPECT/CT imaging interpretation
  4. Lack of cardiology specialist involvement
    • Fix: Ensure cardiologist (not PCP) is prescriber and provides ongoing care
  5. Insufficient clinical monitoring plan
    • Fix: Detail follow-up schedule, lab monitoring, and outcome measures

Quick Reference Checklist

Before You Start

  • Confirmed ATTR-CM diagnosis with appropriate testing
  • Active Aetna CVS Health insurance in California
  • Cardiology specialist as prescriber
  • All diagnostic documentation gathered

Documentation Requirements

  • PYP scan showing Grade 2-3 uptake OR cardiac biopsy with TTR typing
  • AL amyloidosis exclusion (immunofixation + free light chains)
  • TTR genetic testing results
  • Recent cardiac imaging and functional assessment
  • Medical necessity letter from cardiologist

Submission Checklist

  • Prior authorization submitted through Aetna provider portal
  • CVS Specialty enrollment form completed
  • All attachments included in single submission
  • Confirmation numbers recorded
  • Follow-up calendar reminders set

If Denied

  • Internal appeal filed within 180 days
  • Additional clinical evidence gathered
  • IMR application prepared for DMHC
  • Consider Counterforce Health assistance for targeted appeal strategy

From our advocates: "We've seen many tafamidis approvals succeed when the diagnostic workup is complete and clearly documented. The key is ensuring the PYP scan interpretation explicitly states Grade 2 or 3 uptake, and that AL amyloidosis exclusion includes both immunofixation studies and free light chain ratios. Don't rush the initial submission—complete documentation prevents delays and improves approval odds."

FAQ

How long does Aetna CVS Health prior authorization take in California? Standard reviews take 30-45 days. Expedited reviews for urgent medical need are completed within 72 hours.

What if tafamidis is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. If denied, appeal through internal process then IMR.

Can I request an expedited appeal in California? Yes, both Aetna and California's IMR process offer expedited reviews for urgent medical situations, typically completed within 72 hours to 7 days.

Does step therapy apply to tafamidis? Aetna may require documentation of heart failure management optimization, but specific step therapy requirements vary by plan. Check your formulary.

What happens if my appeal is denied? After internal appeal denial, California residents can request binding Independent Medical Review through DMHC at no cost.

How much does tafamidis cost without insurance? Vyndamax cash price is approximately $21,800 per 30 capsules (~$260,000 annually). Manufacturer assistance programs are available.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not replace professional medical advice. Coverage decisions depend on individual medical circumstances and specific plan terms. Consult your healthcare provider and insurance plan for personalized guidance. For assistance with complex appeals, consider working with coverage advocates who specialize in rare disease treatments.

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