By Counterforce Health Team in Symdeko / Symkevi (tezacaftor/ivacaftor) —

Do You Qualify for Symdeko/Symkevi Coverage by Aetna CVS Health in Virginia? Decision Tree & Next Steps

Quick Answer: Your Path to Symdeko/Symkevi Coverage in Virginia

Eligibility: You likely qualify if you're ≥6 years old with cystic fibrosis and documented F508del mutations (homozygous or with another responsive mutation). Fastest approval: Have your CF specialist submit prior authorization with genotype report, clinic notes, and medical necessity letter through Aetna's provider portal. First step today: Gather your CFTR genetic test results and contact your CF clinic to initiate the PA process. If denied, Virginia offers free external review through the State Corporation Commission within 120 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternative Options
  6. If Denied: Virginia Appeal Path
  7. Coverage Requirements at a Glance
  8. Patient Assistance Programs
  9. FAQ: Common Questions

How to Use This Decision Tree

This guide helps you determine if you qualify for Symdeko/Symkevi (tezacaftor/ivacaftor) coverage through Aetna CVS Health in Virginia and shows your next steps based on your situation.

Start here: Answer the questions in the eligibility triage section below. Each path leads to specific action items tailored to your circumstances.

Important: Symdeko requires prior authorization from Aetna and is typically covered as a specialty drug when criteria are met.

Eligibility Triage: Do You Qualify?

Step 1: Basic Requirements Check

Age: Are you 6 years or older?

  • ✅ Yes → Continue to Step 2
  • ❌ No → See "Not Yet" section

Diagnosis: Do you have confirmed cystic fibrosis?

  • ✅ Yes, with documentation → Continue to Step 2
  • ❌ No or uncertain → See "Not Yet" section

Step 2: Genetic Testing Requirements

CFTR Genotype: Do you have lab results showing your CFTR mutations?

  • ✅ Yes, I have results → Continue to Step 3
  • ❌ No, I need testing → See "Possibly Eligible" section

Step 3: Mutation Analysis

Check your genetic test results against FDA-approved indications:

F508del Homozygous (F508del/F508del):

  • ✅ This qualifies → "Likely Eligible"

F508del Heterozygous (one F508del + another mutation):

  • ✅ Second mutation is on FDA responsive list → "Likely Eligible"
  • ❌ Second mutation not listed → "Possibly Eligible"

No F508del mutations:

  • ✅ Both mutations on FDA responsive list → "Likely Eligible"
  • ❌ Mutations not listed → "Possibly Eligible"

Step 4: Prior Treatment History

Previous CFTR modulators:

  • Used Trikafta but had side effects/contraindications → "Likely Eligible"
  • Never tried any CFTR modulators → "Likely Eligible"
  • Currently on another modulator successfully → See "Not Yet" section

If "Likely Eligible": Document Checklist

You have strong qualification for coverage. Here's what to gather:

Required Documentation

Clinical Records:

  • CFTR genotype report from FDA-cleared test
  • CF diagnosis confirmation (sweat chloride test, clinical notes)
  • Last 12 months of CF clinic visit notes
  • Recent pulmonary function tests (FEV1)
  • Hospitalization/exacerbation history

Insurance Information:

  • Aetna member ID card and plan details
  • Current formulary status (check here)

Submission Path: Fastest Route to Approval

  1. Contact your CF specialist (not primary care) to initiate prior authorization
  2. Provider submits through:
  3. Expected timeline: Standard PA decisions within 30-45 days; expedited within 24 hours if urgent
Tip: Request expedited review if you're experiencing frequent exacerbations or declining lung function.

If "Possibly Eligible": Tests to Request

You may qualify but need additional documentation or testing.

Missing Genetic Information

If you don't have CFTR genotype results:

  • Ask your CF clinic to order comprehensive CFTR mutation testing
  • Ensure test is FDA-cleared and includes F508del detection
  • Timeline: Results typically available in 2-4 weeks

Unclear Mutation Status

If your mutations aren't clearly on the FDA list:

  • Request your provider to submit for formulary exception
  • Include literature supporting off-label use if available
  • Consider genetic counseling consultation

What to Track While Waiting

  • Document any CF symptom changes
  • Track pulmonary function trends
  • Note any hospitalizations or antibiotic courses
  • Keep records of current CF therapies and adherence

If "Not Yet": Alternative Options

Your situation may require different approaches or timing.

Age Under 6 Years

  • Monitor FDA label updates for age expansion
  • Discuss alternative CFTR modulators with appropriate age indications
  • Consider clinical trial opportunities

Alternative CFTR Modulators to Discuss

Based on your genotype, ask your CF team about:

  • Trikafta (elexacaftor/tezacaftor/ivacaftor) - broader mutation coverage
  • Kalydeco (ivacaftor) - for specific gating mutations
  • Orkambi (lumacaftor/ivacaftor) - F508del homozygous patients

Preparing for Future Exception Requests

  • Document treatment responses to current therapies
  • Track quality of life measures
  • Build relationship with CF specialist for future advocacy

If Denied: Virginia Appeal Path

Virginia provides strong patient protections for insurance appeals.

Internal Appeals (Required First Step)

Level 1 - Standard Internal Appeal:

  • Deadline: 180 days from denial notice
  • Timeline: ~30 days for decision
  • How to file: Through Aetna member portal or written request
  • Required: Point-by-point response to denial reasons

Level 2 - Expedited Appeal (if applicable):

  • Timeline: 72 hours for urgent medical situations
  • Requirement: Provider must certify delay risks serious harm

Virginia External Review (Independent Review)

If internal appeals fail, Virginia offers free external review:

Eligibility:

  • Virginia-issued plan or opted-in self-funded plan
  • Denial based on medical necessity or experimental/investigational determination

Process:

  1. File Form 216-A within 120 days of final internal denial
  2. Submit to: Virginia State Corporation Commission, Bureau of Insurance - External Review, P.O. Box 1157, Richmond, VA 23218
  3. Phone support: 1-877-310-6560
  4. Timeline: 45 days standard, 72 hours expedited

Required documents:

  • Completed Form 216-A
  • All denial letters
  • Supporting medical records
  • Provider attestation (Form 216-C for expedited)
Virginia Advantage: External review decisions are binding on insurers and have helped many patients access necessary treatments.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Age ≥6 years Date of birth FDA Label
Diagnosis Confirmed CF Sweat chloride, genetic testing Clinical records
Genotype F508del or responsive mutations CFTR genetic test report FDA Label
Prescriber CF specialist preferred Provider credentials Aetna Policy
Prior Auth Required PA form submission Aetna Specialty List
Appeals Deadline 180 days internal, 120 days external Denial notices Virginia Law

Patient Assistance Programs

Vertex GPS (Guidance & Patient Support)

The manufacturer offers comprehensive support:

  • Copay assistance for commercially insured patients
  • Free drug programs for qualifying uninsured/underinsured patients
  • Bridge programs during insurance appeals
  • Contact: Through your CF clinic or Vertex patient services

Cystic Fibrosis Foundation Resources

  • CFF Compass: 1-on-1 insurance navigation and appeal assistance
  • Financial assistance: Help finding copay foundations and charitable grants
  • Educational materials: Coverage guides and appeal templates

For patients facing coverage challenges, services like Counterforce Health specialize in turning insurance denials into evidence-backed appeals, helping patients navigate complex prior authorization requirements and build compelling cases for medical necessity.

Virginia-Specific Resources

  • Virginia Medicaid: May cover CFTR modulators for eligible patients
  • Hospital charity care: Ask your CF center about financial assistance programs
  • Virginia Bureau of Insurance Consumer Services: Free guidance on appeals and rights

FAQ: Common Questions

How long does Aetna CVS Health prior authorization take in Virginia? Standard PA decisions take 30-45 days. Expedited requests are decided within 24 hours when medical urgency is documented.

What if Symdeko is on Aetna's exclusion list? You can request a formulary exception with documentation showing preferred alternatives are inappropriate.

Can I request expedited appeal in Virginia? Yes, both internal appeals (72 hours) and external review (72 hours) can be expedited when delay would seriously jeopardize health or ability to regain function.

Does step therapy apply if I tried modulators outside Virginia? Yes, documented treatment history from any location is typically accepted. Ensure your CF specialist includes complete records in the PA submission.

What counts as medical necessity for Symdeko? FDA-approved indications, appropriate genotype, age ≥6 years, and clinical need demonstrated through CF specialist evaluation.

Who can help me understand Virginia's external review process? Contact the Virginia Managed Care Ombudsman at 1-877-310-6560 for free guidance on appeals and Form 216-A completion.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits, medical circumstances, and current policies. Always consult your healthcare provider and insurance plan directly for personalized guidance. For additional support with insurance appeals and prior authorization, consider consulting with specialized services like Counterforce Health.

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