By Counterforce Health Team in Blenrep (belantamab mafodotin) —

Getting Blenrep (Belantamab Mafodotin) Covered by Humana in Illinois: Complete Guide to Access, Appeals, and Clinical Trial Options

Answer Box: Getting Blenrep (Belantamab Mafodotin) Covered in Illinois

Blenrep is currently unavailable commercially in the U.S. pending FDA re-approval (expected October 2025). Your fastest path to access is through GSK's clinical trials or expanded access program. For Humana coverage once re-approved: submit a coverage determination with medical necessity documentation, use Illinois' 65-day appeal window if denied, and leverage the state's external review process with 30-day filing deadline. Start today: Ask your oncologist about ongoing DREAMM trials or compassionate use eligibility.

Table of Contents

  1. Current Blenrep Availability Status
  2. Humana Coverage Requirements (Post-Approval)
  3. Step-by-Step: Fastest Path to Access
  4. Appeals Playbook for Humana in Illinois
  5. Medical Necessity Documentation
  6. Clinical Trial and Expanded Access Options
  7. Illinois External Review Process
  8. Common Scenarios and Solutions
  9. FAQ

Current Blenrep Availability Status

Blenrep (belantamab mafodotin) was withdrawn from the U.S. market in November 2022 after the DREAMM-3 trial failed to confirm benefit. GSK has resubmitted to the FDA with an expected PDUFA decision date of October 23, 2025.

Until re-approval, access is limited to:

  • Clinical trials (DREAMM program and combination studies)
  • GSK's expanded access/compassionate use program for eligible patients
  • No commercial insurance coverage is available currently
Note: Health plans, including Humana, classify belantamab mafodotin as "investigational" or "non-covered" until FDA re-approval.

Humana Coverage Requirements (Post-Approval)

Once Blenrep receives FDA re-approval, Humana Medicare Advantage and Part D plans will need 30-90 days to update formularies. Expected requirements based on similar specialty oncology drugs:

Requirement Details Source
Prior Authorization Required for all specialty oncology biologics Humana PA Lists
Medical Necessity Triple-class exposed/refractory multiple myeloma Clinical guidelines
Prescriber Requirements Oncology/hematology specialist Standard for MM therapies
Site of Care Infusion center or hospital outpatient REMS requirements
Monitoring Plan Ophthalmologic exams per REMS protocol FDA safety requirements

Step-by-Step: Fastest Path to Access

Current Access (Pre-Approval)

  1. Contact Your Oncologist
    • Ask about eligibility for ongoing DREAMM trials
    • Discuss GSK's expanded access program if no suitable trials available
    • Gather documentation of triple-class exposure/refractoriness
  2. Clinical Trial Screening
    • Your oncologist searches active DREAMM studies
    • Confirm trial coverage includes study drug and monitoring
    • Complete enrollment if eligible
  3. Expanded Access Request (if no trials available)
    • Oncologist contacts GSK medical affairs
    • Submit single-patient expanded access request
    • Provide documentation of exhausted standard options

Future Coverage (Post-FDA Approval)

  1. Submit Coverage Determination
    • Use Humana's provider portal or call 866-488-5995
    • Mark as expedited if delay could jeopardize health
    • Timeline: 72 hours for standard, 24 hours for expedited
  2. Prepare Appeal if Denied

Appeals Playbook for Humana in Illinois

Level 1: Humana Redetermination (Part D)

  • Timeline: 65 days from denial notice
  • Submit via: Online portal, fax, or mail
  • Form: Request for Redetermination of Medicare Prescription Drug Denial
  • Decision time: 7 days standard, 72 hours expedited

Level 2: Independent Review Entity (IRE)

Illinois External Review (State Plans)

For non-Medicare plans, Illinois provides additional protection:

  • Timeline: 30 days from final denial (shorter than most states)
  • Process: Illinois Department of Insurance assigns Independent Review Organization
  • Decision time: 5 business days after IRO receives all materials
  • Cost: Free to consumers; insurers pay IRO fees
Important: Illinois' 30-day external review deadline is stricter than the 4-month window in many states. Act promptly after appeal denial.

Medical Necessity Documentation

When Blenrep becomes available, your oncologist should include:

Required Clinical Elements

  • Diagnosis: Confirmed multiple myeloma with staging
  • Prior therapies: Document triple-class exposure:
    • Proteasome inhibitor (bortezomib, carfilzomib)
    • IMiD (lenalidomide, pomalidomide)
    • Anti-CD38 antibody (daratumumab, isatuximab)
  • Current status: Relapsed/refractory with progression documentation
  • Rationale: Why CAR-T or bispecifics aren't appropriate

Supporting Evidence

  • Guidelines: Reference NCCN, EHA-EMN recommendations
  • Clinical data: DREAMM-2 ORR 32%, median DoR 12.5 months
  • Safety plan: Ophthalmologic monitoring per REMS requirements

Clinical Trial and Expanded Access Options

Current DREAMM Trials

GSK's ongoing studies include:

  • DREAMM-7: Combination studies in earlier lines
  • DREAMM-8: Later-line and combination approaches
  • Other combinations: With immunomodulatory agents

Eligibility typically requires:

  • Relapsed/refractory multiple myeloma
  • Adequate performance status
  • Ability to comply with REMS monitoring

Expanded Access Program

For patients ineligible for trials:

  • Contact: GSK medical affairs through your oncologist
  • Requirements: Exhausted standard options, no suitable trials
  • Process: Single-patient IND application
  • Timeline: Variable based on urgency and documentation
From our advocates: We've seen patients successfully access expanded use programs when their oncologist clearly documents why standard BCMA-targeted therapies (CAR-T, bispecifics) aren't feasible due to age, comorbidities, or logistical barriers. The key is comprehensive documentation of medical necessity.

Illinois External Review Process

Illinois strengthened its external review protections in 2025:

Key Features

  • Binding decisions: IRO determinations are enforceable
  • Penalties: Up to $50,000 for insurer non-compliance
  • No fees: Free external review for consumers
  • Fast turnaround: 5 business days for IRO decision

When to Use External Review

  • Final denial from health plan after internal appeal
  • Plan missed internal appeal deadlines
  • "Experimental/investigational" denials (common for oncology drugs)

Filing Process

  1. Request form from Illinois Department of Insurance
  2. Submit within 30 days of final adverse determination
  3. Include supporting documentation: denial letters, clinical notes, guidelines
  4. Expedited review available if delay could jeopardize health

For assistance: Illinois Department of Insurance Consumer Helpline at 877-527-9431.

Common Scenarios and Solutions

Scenario 1: "Experimental/Investigational" Denial

Solution: Challenge with published evidence

  • Cite DREAMM-2 phase 2 data showing efficacy
  • Reference EHA-EMN guideline inclusion
  • Document triple-class refractory status

Scenario 2: "Not Medically Necessary"

Solution: Comprehensive clinical rationale

  • Detail prior therapy failures with dates and responses
  • Explain ineligibility for CAR-T/bispecifics
  • Include oncologist letter with guideline citations

Scenario 3: Step Therapy Requirements

Solution: Document prior exposures

  • Create detailed therapy timeline
  • Show progression or intolerance to required agents
  • Request step therapy exception based on clinical history

FAQ

How long does Humana prior authorization take in Illinois? Standard coverage determinations: 72 hours. Expedited: 24 hours. Appeals (redeterminations): 7 days standard, 72 hours expedited.

What if Blenrep is non-formulary when approved? Request a formulary exception with medical necessity documentation. Humana must respond within standard timeframes and provide appeal rights if denied.

Can I request expedited review? Yes, if delay could seriously jeopardize life, health, or ability to regain maximum function. Your oncologist must certify the urgency.

Does Illinois external review apply to Medicare plans? No, Medicare plans follow federal appeal processes. Illinois external review applies to state-regulated individual and fully-insured group plans.

What happens if I miss the 65-day appeal deadline? You lose appeal rights for that denial. However, you may be able to request a new coverage determination if circumstances change.

Who pays for external review in Illinois? External review is free to consumers. Insurance companies pay the Independent Review Organization fees.

Can my doctor appeal on my behalf? Yes, prescribers can file appeals for Medicare Part D denials and participate in peer-to-peer reviews.

What if GSK withdraws Blenrep again after approval? GSK has committed to maintaining expanded access for existing patients if regulatory status changes again.

Counterforce Health helps patients and clinicians navigate complex insurance appeals for specialty medications like Blenrep. Our platform analyzes denial letters, identifies the specific denial basis, and drafts evidence-backed appeals aligned to each plan's requirements. By pulling the right clinical citations and weaving them into targeted rebuttals, we help turn denials into approvals. Visit Counterforce Health to learn how we can support your appeal process.

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 coverage decisions. Coverage policies and appeal processes may change. For assistance with insurance appeals in Illinois, contact the Illinois Department of Insurance at 877-527-9431 or visit idoi.illinois.gov.

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