How to Get Blenrep (belantamab mafodotin) Covered by Aetna in New York: Complete Guide to Appeals and Access

Quick Answer: Getting Blenrep Covered by Aetna in New York

Important Update: Blenrep (belantamab mafodotin) was voluntarily withdrawn from the U.S. market in 2022 and is currently under FDA review with a decision expected October 23, 2025. Standard commercial coverage through Aetna is not available at this time.

Current access options in New York:

  1. Clinical trials through FDA-approved studies
  2. Expanded access programs via GSK for qualifying patients
  3. External appeal if denied as "experimental/investigational" using New York's robust appeal system

First step today: Contact your oncologist to discuss clinical trial enrollment or expanded access eligibility while monitoring FDA approval status.


Table of Contents

Current Status and Access Pathways

Blenrep (belantamab mafodotin-blmf) is not currently available through standard commercial insurance coverage, including Aetna plans. The drug was withdrawn from the U.S. market in November 2022 after failing to meet efficacy endpoints in confirmatory trials. GSK has since resubmitted for FDA approval with additional data, and a decision is expected by October 23, 2025.

What This Means for New York Patients

  • No active HCPCS J-code for billing (previously J9037)
  • No standard prior authorization process until FDA re-approval
  • Limited access through clinical trials or expanded access programs only
Note: Even if you receive a denial letter from Aetna citing "experimental/investigational" status, this reflects the current regulatory situation rather than a coverage decision you can immediately appeal for standard access.

Understanding Aetna's Coverage Criteria

When Blenrep was commercially available, Aetna's clinical policy considered it medically necessary only for adults with relapsed or refractory multiple myeloma who had received at least four prior therapies, including:

  • An anti-CD38 monoclonal antibody (daratumumab)
  • A proteasome inhibitor (bortezomib, ixazomib, carfilzomib)
  • An immunomodulatory agent (lenalidomide, pomalidomide)

Coverage Requirements That May Apply Upon Re-approval

Requirement Details Documentation Needed
Prior therapies ≥4 lines including the three drug classes above Treatment history, dates, outcomes
Disease status Relapsed or refractory multiple myeloma ICD-10 code C90.02, clinical notes
REMS compliance Risk evaluation and mitigation strategy enrollment REMS documentation, eye exams
Dosing 2.5 mg/kg IV every 3 weeks Prescriber attestation

New York External Appeal Process

New York offers one of the most consumer-friendly external appeal processes in the country. If you receive a denial for Blenrep as "experimental/investigational," you can request an independent medical review.

Step-by-Step External Appeal Process

  1. File internal appeal first with Aetna (required before external review)
  2. Request external appeal within 4 months of final denial
  3. Submit documentation including medical records and supporting literature
  4. Independent review by medical experts
  5. Binding decision that Aetna must follow

Key Advantages in New York

  • Expedited appeals: 72-hour decisions for urgent cases
  • Low cost: Maximum $25 fee (waived for Medicaid or financial hardship)
  • Searchable database: Review past decisions at the DFS External Appeals Database
  • Expert review: Independent medical professionals evaluate cases
Tip: Search the DFS database for previous "belantamab mafodotin" or "experimental drug" decisions to understand how similar cases have been decided.

Clinical Trial and Expanded Access Options

Since standard coverage isn't available, focus on these pathways for potential access:

Clinical Trials

  • Search ClinicalTrials.gov for active Blenrep studies
  • Contact major cancer centers in New York (Memorial Sloan Kettering, NYU Langone, Mount Sinai)
  • Trial sponsors typically cover drug costs

Expanded Access Programs

  • Contact GSK directly for compassionate use eligibility
  • Requires physician request and documentation of medical need
  • Limited to patients who don't qualify for clinical trials

Alternative BCMA-Targeted Therapies

Consider discussing these FDA-approved options with your oncologist:

  • CAR-T therapies: Ide-cel (Abecma), Cilta-cel (Carvykti)
  • Bispecific antibodies: Teclistamab (Tecvayli), Elranatamab (Elrexfio)

Preparing for Future Coverage

If Blenrep receives FDA approval in October 2025, be prepared with comprehensive documentation:

Essential Documentation Checklist

  • Complete treatment history with dates and outcomes
  • ICD-10 diagnosis code C90.02 (multiple myeloma in relapse)
  • Evidence of prior therapy failures or intolerance
  • Current disease status and progression documentation
  • REMS enrollment and eye exam results
  • Prescriber medical necessity letter

Medical Necessity Letter Components

Your oncologist should include:

  1. Diagnosis: Relapsed/refractory multiple myeloma with ICD-10 code
  2. Prior treatments: Detailed list of all previous therapies and outcomes
  3. Clinical rationale: Why Blenrep is appropriate for your case
  4. Monitoring plan: REMS compliance and safety monitoring
  5. Treatment goals: Expected outcomes and duration

Appeals Playbook for New York Residents

Internal Appeal with Aetna

  • Timeline: 60 days to file after denial
  • Decision time: 30 days (expedited: 72 hours for urgent cases)
  • Submit to: Aetna member portal or appeals address on denial letter

External Appeal with New York DFS

  • Timeline: 4 months after final internal denial
  • Decision time: 30 days (expedited: 72 hours)
  • Cost: Up to $25 (refunded if you win)
  • Submit to: NY DFS External Appeal Application

Getting Help

  • Community Health Advocates: 888-614-5400 (free assistance)
  • New York State Department of Financial Services: Consumer hotline and online resources

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Experimental/investigational External appeal with medical literature Peer-reviewed studies, FDA guidance
Not medically necessary Medical necessity letter Treatment history, clinical rationale
Non-formulary Formulary exception request Prior auth with clinical justification
Step therapy required Step therapy exception Evidence of contraindications or failures

FAQ

Q: Can I appeal a Blenrep denial while it's off the market? A: You can appeal denials citing "experimental/investigational" status through New York's external appeal process, though standard commercial access remains unavailable until FDA re-approval.

Q: How long does Aetna prior authorization take in New York? A: Standard requests: up to 30 days. Expedited requests: 72 hours. These timelines will apply if/when Blenrep returns to market.

Q: What if I can't afford the external appeal fee? A: New York waives the $25 fee for Medicaid enrollees and those with financial hardship. The fee is also refunded if your appeal is successful.

Q: Are there financial assistance programs for clinical trials? A: Yes, clinical trials typically cover drug costs. Additional support may be available through organizations like the Multiple Myeloma Research Foundation.

Q: What should I do if Aetna approves coverage after FDA re-approval? A: Ensure REMS enrollment, coordinate with CVS Specialty Pharmacy for drug delivery, and maintain regular ophthalmologic monitoring as required.

Q: Can I use New York's external appeal for other denied cancer drugs? A: Yes, New York's external appeal process applies to all coverage denials for medically necessary treatments, not just Blenrep.


From Our Advocates

We've seen many New York patients successfully navigate complex appeals for experimental cancer treatments. The key is thorough documentation and persistence—external appeals in New York have a strong track record when supported by solid medical evidence. Don't let initial denials discourage you from pursuing all available options.


Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by analyzing denial letters, plan policies, and clinical notes to create compelling appeals that align with each payer's specific requirements.

When Blenrep returns to market, Counterforce Health can help streamline the prior authorization process by identifying denial patterns, pulling the right medical evidence, and crafting appeals that meet Aetna's specific criteria—saving time for clinicians and improving approval rates for patients.


Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific guidance. Insurance coverage and appeal processes may vary by plan type and individual circumstances. Verify all forms, deadlines, and contact information with official sources before submitting requests.

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