By Counterforce Health Team in Blenrep (belantamab mafodotin) —

How to Get Blenrep (belantamab mafodotin) Covered by Aetna in California: Decision Tree, Appeals, and Access Options

Answer Box: Your Path to Blenrep Coverage in California

Blenrep (belantamab mafodotin) is currently unavailable for commercial coverage through Aetna CVS Health because GSK withdrew it from the U.S. market in November 2022. The FDA is reviewing resubmission with a PDUFA date of October 23, 2025. Your fastest path to access: Contact your oncologist about clinical trial enrollment or GSK's compassionate use program. If denied coverage for any reason, California's Independent Medical Review (IMR) process has a 55-72% success rate for specialty oncology drugs. Start with your treating physician today.

Table of Contents

  1. Current Status: Why Blenrep Coverage is Denied
  2. Eligibility Triage: Do You Qualify for Access?
  3. If You're Likely Eligible: Clinical Trial and Compassionate Use Paths
  4. If You're Possibly Eligible: Building Your Case
  5. If Not Yet Eligible: Alternative Treatments
  6. If Denied: California Appeals Process
  7. Decision Tree Flowchart
  8. Resources and Next Steps

Current Status: Why Blenrep Coverage is Denied

Blenrep (belantamab mafodotin) was voluntarily withdrawn from the U.S. market by GSK in November 2022 after the DREAMM-3 confirmatory trial didn't meet its primary endpoint. This means Aetna CVS Health cannot provide standard commercial coverage because the drug lacks FDA marketing approval.

However, there's hope on the horizon. GSK has resubmitted Blenrep to the FDA based on positive results from the DREAMM-7 trial, which showed the combination of Blenrep plus bortezomib and dexamethasone reduced the risk of disease progression or death by 59% compared to a Darzalex-based combination. The FDA's target decision date is October 23, 2025.

Coverage at a Glance

Requirement Status What This Means Source
FDA Approval Withdrawn (resubmission pending) No commercial coverage available FDA/GSK
Aetna Prior Authorization Required when available Listed on 2024 and 2025 precertification lists Aetna 2025 Precert List
Clinical Trial Access Available Through DREAMM studies and others GSK Clinical Trials
Compassionate Use Available For patients with no alternatives GSK Compassionate Use Portal

Eligibility Triage: Do You Qualify for Access?

Since standard coverage isn't available, let's determine your best path to access:

Likely Eligible for Clinical Trial or Compassionate Use

✅ You likely qualify if you have:

  • Confirmed relapsed/refractory multiple myeloma
  • Failed 4 or more prior therapies
  • No suitable treatment alternatives available
  • ECOG performance status 0-2
  • Adequate organ function
  • Oncologist willing to enroll you in REMS program

Possibly Eligible

⚠️ You might qualify if you have:

  • Relapsed/refractory multiple myeloma with 2-3 prior therapies
  • Contraindications to other available treatments
  • Rapidly progressive disease
  • Previous response to anti-BCMA therapy

Not Yet Eligible

❌ Consider alternatives first if you have:

  • Newly diagnosed multiple myeloma
  • Haven't tried standard therapies (lenalidomide, bortezomib, dexamethasone combinations)
  • Suitable clinical trial options for other investigational agents
  • Good response to current therapy

If You're Likely Eligible: Clinical Trial and Compassionate Use Paths

Document Checklist

Before contacting GSK or clinical trial sites, gather:

  • Medical records showing multiple myeloma diagnosis with ICD-10 codes
  • Prior therapy documentation including dates, doses, and reason for discontinuation
  • Recent lab results (CBC, comprehensive metabolic panel, LDH, beta-2 microglobulin)
  • Imaging studies showing current disease status
  • Ophthalmologic evaluation (required due to Blenrep's ocular toxicity)

Submission Path: Compassionate Use

Step 1: Your oncologist must initiate the request

Step 2: Complete regulatory requirements

  • IRB approval (if required by institution)
  • Informed consent process
  • REMS training completion
From Our Advocates: We've seen patients successfully access Blenrep through compassionate use when their oncologist documented exhaustion of all other BCMA-targeted options and provided clear evidence of progressive disease. The key is having a specialist familiar with the REMS requirements who can articulate why this specific therapy is medically necessary.

If You're Possibly Eligible: Building Your Case

Tests to Request

Ask your oncologist about:

  • Flow cytometry to confirm BCMA expression on plasma cells
  • Cytogenetics/FISH to identify high-risk features
  • PET/CT scan to document extent of disease
  • Comprehensive ophthalmologic exam with optical coherence tomography

What to Track

Document everything that could strengthen your case:

  • Response duration to prior therapies
  • Adverse events that limited other treatments
  • Quality of life impacts from current disease burden
  • Rate of progression between treatments

Timeline to Re-apply

  • Clinical trials: New studies open regularly; check monthly
  • Compassionate use: Can reapply if disease progresses or other options fail
  • Commercial coverage: Monitor FDA decision expected October 23, 2025

If Not Yet Eligible: Alternative Treatments

BCMA-Targeted Options to Discuss

CAR-T Cell Therapy:

  • Ide-cel (Abecma) - FDA approved for 4+ prior therapies
  • Cilta-cel (Carvykti) - FDA approved for 1-3 prior therapies

Bispecific Antibodies:

  • Teclistamab (Tecvayli) - FDA approved for 4+ prior therapies
  • Elranatamab (Elrexfio) - FDA approved for 4+ prior therapies

Standard Combinations:

  • Daratumumab-based triplets
  • Carfilzomib combinations
  • Pomalidomide regimens

Prepare for Exception Requests

When Blenrep returns to market, you'll need:

  • Documentation of failed alternatives
  • Clinical rationale for Blenrep specifically
  • Formulary exception request through Aetna

If Denied: California Appeals Process

California offers one of the strongest consumer protection systems in the nation for health insurance appeals.

Appeals Playbook for Aetna in California

Level 1: Internal Appeal

  • Timeline: File within 180 days of denial
  • Decision time: 30 days (72 hours for urgent)
  • How to file: Call 1-888-632-3862 or use member portal
  • Required: Written denial letter, supporting clinical documentation

Level 2: Independent Medical Review (IMR)

California's external review process has a 55-72% success rate for specialty oncology drugs.

Eligibility:

  • Denial based on medical necessity
  • Experimental/investigational determination
  • Emergency or out-of-network disputes

Process:

  1. File grievance with Aetna first
  2. If denied, request IMR through DMHC
  3. Independent physicians review your case
  4. Decision within 45 days (7 days for urgent)
  5. Binding decision - Aetna must comply if overturned

Contact Information:

Note: There's no fee to request an IMR in California, and the success rate for complex oncology cases is significantly higher than the national average.

Common Denial Reasons & Fixes

Denial Reason How to Overturn Documents Needed
"Experimental/Investigational" Cite FDA approval status, clinical guidelines FDA label, NCCN guidelines, peer-reviewed studies
"Not medically necessary" Document failed alternatives, disease progression Prior therapy records, imaging, lab results
"Non-formulary" Request formulary exception Clinical rationale letter, prior authorization form

Decision Tree Flowchart

Do you have relapsed/refractory multiple myeloma?
├── No → Discuss with oncologist about appropriate first-line therapy
└── Yes → Have you failed 4+ prior therapies?
    ├── No → Consider standard options (CAR-T, bispecifics, triplets)
    └── Yes → Are other BCMA-targeted therapies unsuitable?
        ├── No → Try ide-cel, cilta-cel, teclistamab, or elranatamab first
        └── Yes → Contact oncologist about:
            ├── Clinical trial enrollment
            ├── GSK compassionate use program
            └── Prepare for commercial availability (Oct 2025)

Resources and Next Steps

Immediate Actions

  1. Contact your oncologist to discuss clinical trial options
  2. Review GSK's compassionate use criteria with your care team
  3. Register for clinical trial alerts through ClinicalTrials.gov

Key Contacts

  • GSK Compassionate Use: GSK Portal
  • Aetna Prior Authorization: 1-888-632-3862
  • California DMHC Help Center: 888-466-2219
  • Clinical Trial Information: ClinicalTrials.gov

Financial Assistance

While commercial coverage isn't available, these resources may help with clinical trial costs:

  • Patient Access Network (PAN) Foundation
  • Leukemia & Lymphoma Society
  • International Myeloma Foundation

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. When Blenrep returns to market, our platform can help you navigate Aetna's prior authorization requirements and draft evidence-backed appeals if needed.

Frequently Asked Questions

Q: When will Blenrep be available for commercial coverage again? A: The FDA's target decision date is October 23, 2025. If approved, Aetna will likely require prior authorization based on their 2025 precertification list.

Q: Can I get Blenrep through my Aetna plan right now? A: No, because GSK withdrew it from the U.S. market. Access is only through clinical trials or compassionate use programs.

Q: What's the success rate for appeals in California? A: California's Independent Medical Review has a 55-72% success rate for specialty oncology drugs, significantly higher than the national average.

Q: Do I need to try CAR-T therapy before Blenrep? A: When Blenrep returns, step therapy requirements will depend on Aetna's updated policy. Currently, ide-cel and cilta-cel are FDA-approved alternatives.

Q: How long does compassionate use approval take? A: Typically 2-4 weeks once your oncologist submits a complete request through GSK's portal.

Q: What if my oncologist isn't familiar with the REMS program? A: GSK provides training materials and support. The REMS program is mandatory due to Blenrep's potential for serious eye problems.

Q: Can I appeal to California regulators if denied compassionate use? A: Compassionate use decisions are made by GSK, not insurance companies. However, you can file complaints with the FDA if you believe you're inappropriately denied access.

Q: Will I need eye exams if I get Blenrep? A: Yes, the REMS program requires regular ophthalmologic monitoring due to the risk of serious eye problems, including vision loss.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage policies change frequently - verify current requirements with your plan. For personalized help with insurance appeals and coverage decisions, consider working with experienced advocates like those at Counterforce Health.

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