By Counterforce Health Team in Alecensa (alectinib) —

The Requirements Checklist to Get Alecensa (alectinib) Covered by Aetna (CVS Health) in Virginia

Answer Box: Getting Alecensa (alectinib) Covered by Aetna (CVS Health) in Virginia

Fastest path to approval: Ensure ALK-positive test results are documented, complete Aetna's prior authorization form with clinical notes showing step therapy compliance (typically crizotinib failure/intolerance), and submit via CVS Caremark portal. Most approvals take 30-45 days. First step today: Confirm your ALK mutation status is documented by FDA-approved testing and gather records of prior ALK inhibitor treatments. If denied, Virginia offers expedited external review within 72 hours for cancer drugs through the State Corporation Commission Bureau of Insurance.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Required Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Setup
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Virginia
  11. Printable Requirements Checklist

Who Should Use This Checklist

This guide helps Virginia patients with ALK-positive non-small cell lung cancer (NSCLC) navigate Aetna (CVS Health) coverage for Alecensa (alectinib). You'll need this if:

  • Your oncologist prescribed Alecensa for ALK-positive NSCLC
  • You have Aetna insurance through CVS Health
  • You received a prior authorization request or denial
  • You're switching from another ALK inhibitor like crizotinib

Expected outcome: With complete documentation, most Alecensa prior authorizations are approved within 30-45 days. Virginia's external review process has overturned many cancer drug denials when proper evidence is submitted.

Member & Plan Basics

Coverage Requirements

  • Active Aetna coverage through CVS Health required
  • Most plans require prior authorization for Alecensa
  • Specialty pharmacy enrollment typically mandatory
  • Annual deductible may apply before coverage begins

Plan Type Considerations

  • Commercial plans: Standard PA process applies
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Different forms may be required
Note: Verify your specific plan's formulary status at Aetna's member portal or call the number on your insurance card.

Clinical Criteria Requirements

Primary Indication

Alecensa must be prescribed for FDA-approved indications:

  • ALK-positive metastatic NSCLC
  • ALK-positive adjuvant NSCLC (post-surgical resection, tumors ≥4cm or node-positive)

Step Therapy Requirements

Aetna typically requires prior trial of crizotinib (Xalkori) unless:

  • Patient has CNS metastases (where Alecensa shows superior efficacy)
  • Documented intolerance to crizotinib
  • Clinical contraindication to first-line agents

Required Testing

  • ALK rearrangement confirmed by FDA-approved test
  • Pathology report with specific mutation details
  • Staging information (TNM classification)

Dosing Parameters

  • Standard dose: 600 mg twice daily with food
  • Duration: Up to 12 months initially, renewable up to 2 years for adjuvant treatment
  • Single-agent therapy (not combination)

Coding and Documentation

ICD-10 Codes for NSCLC

Use the most specific diagnosis code:

Location ICD-10 Code Description
Upper lobe C34.10-C34.12 Right/left/unspecified upper lobe
Lower lobe C34.30-C34.32 Right/left/unspecified lower lobe
Main bronchus C34.00-C34.02 Right/left/unspecified main bronchus
Overlapping sites C34.80-C34.82 Multiple lung involvement

Billing Codes

  • HCPCS: J8999 (oral chemotherapy, not otherwise specified)
  • NDC: 50242-130-01 (Alecensa 150mg, 240 capsules)
  • Units: Document total daily dose and duration

Required Documentation Packet

Provider Letter of Medical Necessity Must Include:

  1. Patient demographics and insurance information
  2. Diagnosis: ALK-positive NSCLC with staging
  3. ALK testing results with lab report
  4. Prior treatments and outcomes (especially crizotinib)
  5. Clinical rationale for Alecensa specifically
  6. Dosing plan and monitoring schedule
  7. Treatment goals and expected duration

Essential Attachments:

  • Copy of insurance card (front and back)
  • Pathology report confirming ALK-positive status
  • Imaging studies showing disease extent
  • Previous treatment records and response/toxicity data
  • Current lab values (liver function, CPK)
Clinician Corner: Include specific quotes from NCCN Guidelines or FDA labeling to support medical necessity. Reference ALK inhibitor sequencing recommendations and cite Alecensa's superior CNS penetration when applicable.

Submission Process

Aetna (CVS Health) Prior Authorization

  1. Complete the specialty medication PA form (available at Aetna provider portal)
  2. Submit via preferred method:
    • Online: Availity.com portal
    • Fax: 1-866-249-6155 (specialty medications)
    • Phone: 1-866-814-5506 (specialty drugs)

Required Form Fields

  • Patient name, DOB, member ID
  • Prescriber NPI and DEA numbers
  • Diagnosis with ICD-10 code
  • Drug name, strength, quantity, directions
  • Clinical justification narrative

Common Rejection Causes

  • Missing ALK test results
  • Incomplete prior therapy documentation
  • Wrong ICD-10 code or missing staging
  • Unsigned forms or missing provider credentials

Specialty Pharmacy Setup

CVS Specialty Enrollment

Your oncologist must complete the Oncology Oral Medications Solid Tumors Enrollment Form and submit directly to CVS Specialty. Patients cannot self-enroll.

The process includes:

  1. Provider submits enrollment form electronically
  2. CVS Specialty verifies insurance and processes PA
  3. Patient receives welcome call for onboarding
  4. Delivery arrangements made (home, office, or CVS location)
  5. Ongoing clinical support and refill coordination

Enrollment Timeline

  • Average processing: 7-10 business days
  • PA delays: Additional 1-2 weeks if authorization needed
  • Expedited options: Available for urgent cases

After Submission: What to Expect

Standard Timeline

  • Initial review: 5-7 business days
  • PA determination: 30-45 days for standard review
  • Expedited review: 72 hours if urgent criteria met

Status Tracking

  • Confirmation number: Record from submission
  • Online portal: Check status via Aetna member site
  • Phone follow-up: Call specialty pharmacy team weekly

What to Document

  • Submission date and confirmation number
  • All communication with Aetna representatives
  • Any additional information requests
  • Appeal deadlines if denied

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid:

  1. Missing ALK Testing: Always include the actual pathology/molecular testing report, not just a mention in clinical notes.
  2. Inadequate Step Therapy Documentation: If bypassing crizotinib, provide detailed clinical rationale (CNS mets, contraindications, prior intolerance).
  3. Wrong Diagnosis Codes: Use specific NSCLC location codes rather than unspecified lung cancer codes.
  4. Incomplete Prior Authorization Forms: Double-check all required fields are completed and signed.
  5. Missing Clinical Context: Include staging, performance status, treatment goals, and monitoring plan.

Success Strategies

  • Submit complete packages the first time
  • Use specific medical terminology from FDA labeling
  • Include relevant guideline citations
  • Provide clear treatment timeline and goals

Appeals Process in Virginia

Internal Appeals (First Step)

  • Timeline: 180 days from denial to file
  • Standard review: 30 days for determination
  • Expedited review: 72 hours if urgent

Virginia External Review

If internal appeals fail, Virginia offers independent external review through the State Corporation Commission Bureau of Insurance.

Process:

  1. Complete Form 216-A (External Review Request)
  2. For cancer drugs: Expedited review available (72-hour decision)
  3. Submit within 120 days of final internal denial
  4. Include Form 216-C if requesting expedited review

Contact Information:

External Review Benefits

  • Independent physician review by cancer specialists
  • Binding decision on the insurance company
  • No cost to Virginia residents
  • High success rate for well-documented cases
From our advocates: We've seen many Alecensa denials overturned at external review when patients included comprehensive ALK testing documentation and clear evidence of crizotinib failure or contraindication. The key is providing the independent reviewer with the same clinical picture that convinced your oncologist to prescribe Alecensa.

Printable Requirements Checklist

Before You Start

  • Insurance card (front and back copies)
  • ALK-positive pathology report
  • Staging/imaging studies
  • Prior treatment records
  • Current lab values

Clinical Documentation

  • FDA-approved ALK test results
  • Specific NSCLC diagnosis with staging
  • Prior crizotinib trial or contraindication rationale
  • Performance status and treatment goals
  • Planned monitoring schedule

Submission Requirements

  • Complete PA form with all fields
  • Provider signature and credentials
  • Correct ICD-10 and HCPCS codes
  • Clinical letter of medical necessity
  • All required attachments

After Submission

  • Record confirmation number
  • Set calendar reminders for follow-up
  • Prepare appeal documents if needed
  • Coordinate with specialty pharmacy

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and regulatory citations to support coverage decisions. Visit www.counterforcehealth.org to learn how we can help streamline your prior authorization and appeals process.

Frequently Asked Questions

How long does Aetna (CVS Health) prior authorization take for Alecensa in Virginia? Standard PA decisions take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Alecensa is not on my Aetna formulary? You can request a formulary exception with clinical documentation showing medical necessity and lack of suitable alternatives.

Can I appeal if I haven't tried crizotinib first? Yes, with proper clinical justification such as CNS metastases, contraindications, or prior intolerance to crizotinib.

Does Virginia offer expedited external review for cancer drugs? Yes, Virginia provides expedited external review for cancer treatment denials with decisions within 72 hours.

What happens if my external review is approved? Aetna must provide coverage within 24 hours for expedited approvals, or 1-3 days for standard approvals.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. For personalized guidance, consult your healthcare provider and insurance plan directly. Virginia residents can contact the State Corporation Commission Bureau of Insurance Consumer Services at 1-877-310-6560 for assistance with insurance appeals.

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