By Counterforce Health Team in Blenrep (belantamab mafodotin) —

How to Get Blenrep (Belantamab Mafodotin) Approved by UnitedHealthcare in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Blenrep Covered by UnitedHealthcare in Georgia

Important: Blenrep (belantamab mafodotin) was withdrawn from the US market in November 2022 and remains unavailable for commercial coverage. Access is limited to clinical trials or GSK's expanded access program. UnitedHealthcare will deny coverage requests outside these pathways. If denied, you have 60 days to file an external review with the Georgia Department of Insurance. First step: Contact your oncologist to explore clinical trial enrollment or GSK's compassionate use program.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Understanding Blenrep's Current Status
  3. Gather What You Need
  4. Submit the Request
  5. Appeals Playbook for Georgia
  6. Clinical Trial and Expanded Access Options
  7. Common Denial Reasons & Next Steps
  8. When to Escalate in Georgia
  9. Quick Reference Checklist
  10. Frequently Asked Questions

What This Guide Covers

This guide helps patients with relapsed/refractory multiple myeloma and their healthcare teams navigate Blenrep (belantamab mafodotin) coverage with UnitedHealthcare in Georgia. While Blenrep is currently off-market, understanding the process prepares you for potential reapproval (FDA target date: October 23, 2025) and helps access alternative pathways.

Who this helps:

  • Patients with multiple myeloma after ≥4 prior therapies
  • Oncologists preparing prior authorization requests
  • Families navigating insurance denials and appeals

Expected outcome: Most commercial coverage requests will be denied due to market withdrawal, but this guide ensures you follow proper channels and preserve appeal rights while exploring clinical trials and expanded access programs.

Before You Start: Understanding Blenrep's Current Status

Current Market Status

Blenrep was voluntarily withdrawn from the US market by GSK on November 22, 2022, following FDA concerns about efficacy data. The drug is under FDA review with a target action date of October 23, 2025.

UnitedHealthcare Coverage Position

UnitedHealthcare follows FDA guidance and does not cover withdrawn medications outside of approved clinical trials. According to UnitedHealthcare's oncology medication policy, investigational drugs require specific documentation of trial enrollment or expanded access approval.

Verify Your Plan Type

Before proceeding, confirm your UnitedHealthcare plan type:

  • Commercial/Exchange plans: PA through UnitedHealthcare medical management
  • Medicare Advantage: PA through OptumRx for pharmacy benefit drugs
  • Community Plan (Medicaid): State-specific PA requirements may apply

Use the UnitedHealthcare Provider Portal to verify your specific plan's requirements.

Gather What You Need

Essential Documentation

Document Type Specific Requirements Where to Obtain
Diagnosis Confirmation Multiple myeloma (ICD-10 C90.0), bone marrow biopsy, cytogenetics Hematology/oncology records
Prior Treatment History ≥4 prior lines including PI, IMiD, anti-CD38 mAb Treatment summary from oncologist
Current Disease Status Recent labs (SPEP, UPEP, free light chains), imaging Most recent oncology visit
Clinical Trial Documentation Trial enrollment letter or expanded access approval GSK or trial coordinator
Insurance Information Member ID, group number, plan type Insurance card

Medical Necessity Requirements

For any future coverage consideration, UnitedHealthcare requires documentation of:

  • Relapsed/refractory multiple myeloma after standard therapies
  • ECOG performance status ≤2
  • Adequate baseline blood counts and organ function
  • Ophthalmologic evaluation (due to corneal toxicity risks)
  • Prescribing by board-certified hematologist/oncologist

Submit the Request

Step 1: Access the Prior Authorization System

For Georgia UnitedHealthcare members:

  1. Log into the UnitedHealthcare Provider Portal
  2. Navigate to "Prior Authorization and Notification"
  3. Search for the member and verify plan type
  4. Check if Blenrep requires PA (it will, but may be listed as "not covered")

Step 2: Complete the PA Request

Required information:

  • Patient demographics and insurance details
  • Diagnosis: Relapsed/refractory multiple myeloma (C90.0)
  • Requested drug: Belantamab mafodotin (NDC varies by vial size)
  • Clinical justification: Trial enrollment or expanded access documentation
  • Prescriber information: Board-certified oncologist

Step 3: Submit Supporting Documentation

Attach all gathered documents through the portal or fax to the number provided in your PA determination letter.

Tip: Even though denial is expected, submitting a complete PA creates a paper trail for appeals and demonstrates you've followed proper channels.

Appeals Playbook for Georgia

Internal Appeal Process

Timeline: File within 180 days of initial denial Process: Submit through UnitedHealthcare Provider Portal or member services Expected outcome: Likely upheld due to market withdrawal status

External Review Through Georgia DOI

Georgia residents have strong appeal rights through the Georgia Department of Insurance.

Review Type Deadline Decision Timeline How to Request
Standard External Review 60 days from final internal denial 30 days Georgia DOI external review form
Expedited External Review Same 60-day window 72 hours Same form, check "urgent" box

Contact Information:

Required Documents for External Review

  • Original denial letter from UnitedHealthcare
  • All internal appeal correspondence
  • Complete medical records supporting medical necessity
  • Clinical trial documentation (if applicable)
  • Physician letter explaining urgency (for expedited review)

Clinical Trial and Expanded Access Options

GSK Expanded Access Program

GSK maintains a compassionate use program for eligible patients.

Eligibility criteria:

  • Relapsed/refractory multiple myeloma
  • ≥4 prior therapies including PI, IMiD, and anti-CD38 antibody
  • ECOG performance status 0-2
  • No prior progression on Blenrep
  • Adequate organ function

How to apply:

  1. Contact your oncologist to initiate the request
  2. Complete GSK expanded access application
  3. Provide comprehensive medical history
  4. Obtain institutional review board approval (if required)

Clinical Trials

Search ClinicalTrials.gov for "belantamab mafodotin" to find active DREAMM program studies. Many trials are testing combination regimens for earlier lines of therapy.

Common Denial Reasons & Next Steps

Denial Reason UnitedHealthcare's Position Your Next Step
"Drug not FDA approved" Accurate - withdrawn from market Pursue clinical trial or expanded access
"Investigational/experimental" Accurate for commercial use Document trial enrollment for coverage
"Not medically necessary" Standard for off-market drugs Appeal with clinical trial documentation
"No prior authorization on file" Administrative denial Resubmit with complete documentation

Sample Appeal Language

"This patient has relapsed/refractory multiple myeloma after four prior lines of therapy and has exhausted standard treatment options. Belantamab mafodotin is being accessed through [GSK expanded access program/clinical trial] under FDA oversight. Coverage is requested for compassionate use under the patient's medical benefit."

When to Escalate in Georgia

Contact Georgia Department of Insurance

If UnitedHealthcare fails to follow proper appeal procedures or timeline requirements:

Georgia Office of Commissioner of Insurance
Consumer Services Division
Phone: 1-800-656-2298
Online: oci.georgia.gov

Additional Georgia Resources

  • Georgians for a Healthy Future: Consumer assistance with insurance appeals
  • Georgia Legal Services Program: Legal aid for complex coverage disputes
  • CancerCare: Financial assistance and case management

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify denial patterns and draft point-by-point rebuttals aligned to UnitedHealthcare's policies, even for complex cases involving withdrawn medications and expanded access programs.

Quick Reference Checklist

Before you start:

  • Confirm Blenrep's current FDA status
  • Verify UnitedHealthcare plan type
  • Gather complete medical records

For PA submission:

  • Submit through UnitedHealthcare Provider Portal
  • Include trial enrollment documentation
  • Attach comprehensive clinical history
  • Document all prior therapies and failures

If denied:

  • File internal appeal within 180 days
  • Request external review within 60 days of final denial
  • Contact Georgia DOI if needed
  • Explore clinical trial options

Alternative access:

  • Contact GSK expanded access program
  • Search ClinicalTrials.gov for DREAMM studies
  • Consider other BCMA-targeted therapies

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Georgia?
A: Standard PA decisions are made within 15 days for pre-service requests. However, expect denial for Blenrep due to market withdrawal status.

Q: What if Blenrep becomes available again?
A: Monitor FDA announcements for reapproval. UnitedHealthcare typically updates formularies quarterly and will establish new PA criteria upon relaunch.

Q: Can I request an expedited appeal?
A: Yes, if delay poses serious risk to health. Georgia allows expedited external review with 72-hour decision timelines.

Q: Does step therapy apply to withdrawn drugs?
A: No, but when Blenrep returns to market, expect requirements for prior failure of proteasome inhibitors, IMiDs, and anti-CD38 antibodies.

Q: What are my alternatives while waiting?
A: Discuss BCMA-targeted CAR-T therapy (ide-cel, cilta-cel), bispecific antibodies (teclistamab, elranatamab), or other clinical trials with your oncologist.

Q: Will insurance cover clinical trial costs?
A: Many costs are covered by trial sponsors. Verify with your plan about routine care coverage during trial participation.

Q: How do I find financial assistance?
A: Contact CancerCare Co-Payment Assistance, Patient Access Network Foundation, or GSK patient assistance programs for expanded access.

Q: What if I'm on Medicare Advantage?
A: Same appeal rights apply. Medicare Advantage plans must follow CMS guidelines for coverage determinations and appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult your healthcare provider and insurance plan for personalized guidance. For additional support with complex appeals, consider consulting with Counterforce Health, which helps patients and clinicians navigate insurance denials with evidence-backed appeal strategies.

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