By Counterforce Health Team in Darzalex / Darzalex Faspro (daratumumab) —

How to Get Darzalex/Darzalex Faspro (Daratumumab) Approved by Aetna in Georgia: Prior Authorization Guide and Appeals Process

Quick Answer: Getting Darzalex/Darzalex Faspro Covered by Aetna in Georgia

Aetna requires prior authorization for Darzalex (daratumumab) in Georgia. Your fastest path to approval: Have your oncologist complete Aetna's 2024 Darzalex precertification form with complete multiple myeloma documentation, including prior therapies tried and failed. Submit via fax (1-888-267-3277) or Aetna's provider portal. If denied, you have 180 days to appeal internally, then 60 days for external review through Georgia's Department of Insurance. Start by verifying your plan's formulary status and gathering your complete treatment history today.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Understanding Timelines
  7. Handling Requests for Additional Information
  8. If Your Request is Denied
  9. Appeals Process in Georgia
  10. Renewal and Reauthorization
  11. Quick Reference Checklist
  12. FAQ

What This Guide Covers

This guide helps patients with multiple myeloma and their healthcare teams navigate Aetna's prior authorization process for Darzalex (daratumumab-IV) and Darzalex Faspro (daratumumab-subcutaneous) in Georgia. Whether you're newly diagnosed or facing relapsed disease, we'll walk you through the exact forms, documentation, and timelines needed for approval.

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed rebuttals tailored to each payer's specific requirements. Our platform analyzes denial letters, identifies the exact criteria your case needs to meet, and drafts compelling appeals using the right medical literature and clinical documentation.

Before You Start: Verify Your Coverage

Check Your Plan Type

First, determine if you have:

  • Commercial Aetna plan (employer-sponsored or individual)
  • Aetna Medicare Advantage
  • Aetna Medicaid plan

Each has different forms and processes. Call the member services number on your insurance card to confirm.

Verify Formulary Status

Darzalex typically requires prior authorization on most Aetna plans. Check your plan's formulary to see:

  • Tier placement (usually specialty tier 4-5)
  • Step therapy requirements (may need to try alternatives first)
  • Quantity limits per cycle

Medical vs. Pharmacy Benefit

Darzalex can be covered under either:

  • Medical benefit: When administered in clinic/hospital
  • Pharmacy benefit: When dispensed through specialty pharmacy

CVS Specialty Pharmacy handles most Aetna specialty medications and can help coordinate prior authorization.

Gather Required Documentation

Clinical Information Needed

Document Type Specific Requirements Where to Get It
Diagnosis Multiple myeloma with ICD-10 code (C90.00, C90.01, or C90.02) Oncologist's records
Prior Therapies Complete list of previous treatments, dates, responses, reasons for discontinuation Treatment summary from clinic
Lab Results Recent M-protein levels, CBC, comprehensive metabolic panel Lab reports from past 30 days
Imaging Bone survey, PET/CT, or MRI showing disease status Radiology reports
Treatment Plan Proposed regimen, dosing, duration, combination drugs Oncologist's treatment note

Required Forms

Download the appropriate Aetna form:

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Complete the form entirely: Missing fields cause automatic delays
  2. Include all supporting documents: Attach clinical notes, lab results, and prior therapy documentation
  3. Submit via preferred method:
    • Fax: 1-888-267-3277
    • Online: Aetna provider portal or Availity
    • Phone: 1-888-267-3277 (for urgent cases)

Clean Request Packet Checklist

✅ Completed prior authorization form with all fields filled
✅ Current diagnosis with ICD-10 code
✅ Documentation of prior therapies and outcomes
✅ Recent lab results and imaging
✅ Treatment plan with dosing and duration
✅ Prescriber's contact information and NPI
✅ Patient's complete insurance information

Follow-Up and Tracking

When to Call

  • Day 3-5: Confirm receipt of your submission
  • Day 10-14: Check status if no response
  • Day 25: Follow up before the 30-day deadline

Sample Call Script

"Hi, I'm calling to check the status of a prior authorization for [patient name], DOB [date], member ID [number]. The request was submitted on [date] for Darzalex. Can you provide the reference number and current status?"

Document everything: Reference numbers, representative names, and dates of all communications.

Understanding Timelines

Aetna Response Times

Request Type Standard Timeline Expedited Timeline
Standard PA 15 business days 72 hours
Urgent/Expedited 72 hours 24 hours
Appeals 30 calendar days 72 hours

Georgia-Specific Deadlines

  • Internal appeal deadline: 180 days from denial date
  • External review deadline: 60 days from final internal denial
  • External review decision: Typically 60 days from complete submission

Handling Requests for Additional Information

Common Information Requests

"Not Medically Necessary": Provide NCCN guidelines showing Darzalex as preferred therapy for your specific myeloma type and treatment line.

"Step Therapy Required": Document previous treatments tried, including:

  • Specific drug names and dates
  • Reasons for discontinuation (progression, intolerance, contraindications)
  • Clinical evidence of failure

"Dosing Questions": Reference FDA labeling and provide patient-specific factors (weight, BSA, renal function).

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason How to Address Documentation Needed
Step therapy not completed Request exception with contraindication/intolerance evidence Prior therapy records, adverse event documentation
Not medically necessary Provide clinical guidelines and disease progression evidence NCCN guidelines, imaging showing progression
Non-formulary Request formulary exception Medical necessity letter, alternative failure documentation
Dosing/quantity limits Justify patient-specific factors Weight, BSA, renal function, FDA labeling

First-Level Appeal Essentials

  1. Submit within 180 days of denial date
  2. Address every denial reason point by point
  3. Include new supporting evidence if available
  4. Request peer-to-peer review with oncologist

Appeals Process in Georgia

Internal Appeals with Aetna

Timeline: Must file within 180 days of denial
Response time: 30 days for standard, 72 hours for expedited
How to file: Online portal, fax, or mail

External Review Through Georgia Department of Insurance

If your internal appeal is denied, you can request an independent external review:

Deadline: 60 days from Aetna's final denial letter
Cost: Free to consumers
Process: Submit application to Georgia Office of Insurance and Safety Fire Commissioner
Contact: 1-800-656-2298
Timeline: Typically 60 days for decision

The external review decision is binding on Aetna and must be honored if approved.

From Our Advocates: We've seen many Darzalex denials overturned at the external review level in Georgia when patients provide comprehensive documentation of disease progression and prior therapy failures. The key is organizing your clinical timeline clearly and linking each treatment decision to established guidelines. While outcomes vary by case, thorough preparation significantly improves your chances.

Renewal and Reauthorization

When to Reapply

Most Darzalex authorizations are approved for:

  • 6 months for ongoing therapy
  • Specific number of cycles (often 16 doses maximum)

Renewal Documentation

✅ Current disease status and response to therapy
✅ Recent labs showing stable or improved parameters
✅ Absence of unacceptable toxicity
✅ Continued medical necessity
✅ Updated treatment plan

Set calendar reminders 30 days before your authorization expires to avoid treatment interruptions.

Quick Reference Checklist

Before Starting

  • Verify plan type and formulary status
  • Identify medical vs. pharmacy benefit
  • Download correct Aetna form

Documentation Gathering

  • Complete diagnosis with ICD-10 code
  • Prior therapy history with outcomes
  • Recent labs and imaging
  • Treatment plan with dosing

Submission

  • Complete form entirely
  • Attach all supporting documents
  • Submit via fax (1-888-267-3277) or portal
  • Document reference number

Follow-Up

  • Confirm receipt within 3-5 days
  • Check status at 10-14 days
  • Prepare appeal if denied
  • Set renewal reminders

FAQ

How long does Aetna prior authorization take in Georgia?
Standard requests: 15 business days. Expedited requests: 72 hours. You can request expedited review if treatment delay poses health risks.

What if Darzalex is non-formulary on my plan?
You can request a formulary exception by demonstrating medical necessity and documenting failure or contraindications to preferred alternatives.

Can I get help with appeals in Georgia?
Yes. Contact Georgia's Department of Insurance Consumer Services (1-800-656-2298) or Counterforce Health for specialized appeal assistance.

Does step therapy apply if I've already tried other treatments?
Previous treatments count toward step therapy requirements. Ensure your oncologist documents all prior therapies, including dates and outcomes.

What's the difference between Darzalex and Darzalex Faspro coverage?
Both require prior authorization, but Darzalex Faspro (subcutaneous) has a separate form and may have different administration site requirements.

How much does Darzalex cost without insurance?
Cash prices typically run several thousand dollars per dose. Patient assistance programs through Janssen may help reduce costs.

Can I request a peer-to-peer review?
Yes. If denied, request that your oncologist speak directly with Aetna's medical director to discuss your case.

What happens if I miss the appeal deadline?
Georgia law requires internal appeals within 180 days and external reviews within 60 days. Missing these deadlines may eliminate your appeal rights for that denial.

Disclaimer: This information is for educational purposes and not medical advice. Insurance policies and state regulations change frequently. Always verify current requirements with your insurer and consult your healthcare team for treatment decisions.

Sources & Further Reading

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