By Counterforce Health Team in Blenrep (belantamab mafodotin) —

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

Answer Box: Quick Path to Blenrep Access in Virginia

Blenrep (belantamab mafodotin) is currently unavailable for commercial coverage in the U.S. as GSK resubmits for FDA approval (decision expected October 23, 2025). Virginia patients with Humana can access Blenrep only through:

  1. Clinical trials - Contact your oncologist about ongoing DREAMM studies
  2. Compassionate use programs - GSK is developing structured access for REMS-enrolled prescribers
  3. If denied for trial access - Use Virginia's external review process through the State Corporation Commission Bureau of Insurance

First step today: Ask your multiple myeloma specialist about clinical trial eligibility and REMS program enrollment at www.counterforcehealth.org for appeals support.

Table of Contents

Current Blenrep Status & Access Options

Blenrep (belantamab mafodotin) was voluntarily withdrawn from the U.S. market in 2022, but GSK has resubmitted for FDA approval with a PDUFA action date of October 23, 2025. This means no commercial insurance, including Humana, can provide standard coverage until FDA re-approval.

Available Access Routes

Clinical Trials

  • Ongoing DREAMM studies evaluating efficacy in relapsed/refractory multiple myeloma
  • REMS (Risk Evaluation and Mitigation Strategy) enrollment required due to ocular toxicity risks
  • Contact major myeloma centers for trial availability

Compassionate Use Programs

  • GSK is developing structured expanded access programs
  • Available to REMS-enrolled prescribers for eligible patients
  • Requires documentation of refractory disease and failed standard therapies
Note: Even when Blenrep returns to market, Humana will likely require prior authorization due to its specialty drug classification and significant ocular safety concerns requiring regular monitoring.

Clinical Trial Access Through Humana

Humana Medicare Advantage plans generally cover routine patient care costs associated with approved clinical trials, including:

  • Standard medical visits and monitoring
  • Laboratory tests and imaging required for safety
  • Management of side effects and complications
  • Hospitalization for trial-related adverse events

What Humana Won't Cover:

  • The investigational drug itself (provided by the study sponsor)
  • Research-specific procedures not part of standard care
  • Travel or lodging expenses

Finding Eligible Trials

Step 1: Contact your oncologist to discuss trial options Step 2: Search ClinicalTrials.gov for "belantamab mafodotin" studies Step 3: Verify the trial site accepts Humana coverage for routine care costs

Tip: Major academic medical centers in Virginia like VCU Massey Cancer Center often participate in myeloma trials and have established relationships with Humana for coverage coordination.

Compassionate Use Programs

GSK's Expanded Access Program

GSK is developing compassionate use access for Blenrep through REMS-participating facilities. Eligibility typically requires:

  • Relapsed/refractory multiple myeloma diagnosis
  • Exhausted standard treatment options
  • No suitable clinical trial available
  • REMS program enrollment for ocular monitoring
  • Prescriber at REMS-certified facility

Documentation Requirements

Your oncologist will need to provide:

  • Medical necessity letter detailing prior therapies and failures
  • Treatment history with specific drug names, dates, and reasons for discontinuation
  • Current disease status with recent imaging and lab results
  • REMS certification and monitoring plan for ocular toxicity

Humana's Role: While Humana cannot cover the drug itself until FDA approval, they may cover associated medical care, monitoring visits, and management of side effects under your existing plan benefits.

When Coverage Becomes Available: Renewal Preparation

Anticipating FDA Re-Approval

If the FDA approves Blenrep on or before October 23, 2025, prepare for Humana coverage by understanding likely requirements:

Expected Prior Authorization Criteria:

  • Multiple myeloma diagnosis with specific ICD-10 codes
  • Documentation of relapsed/refractory disease
  • Trial and failure of standard therapies (lenalidomide, bortezomib, anti-CD38 antibodies)
  • REMS program enrollment and ongoing ocular monitoring

Formulary Placement Expectations

Based on Humana's specialty drug policies, Blenrep will likely be:

  • Tier 5 specialty drug with high cost-sharing
  • Prior authorization required for all requests
  • Specialty pharmacy dispensing through CenterWell required
  • Quantity limits based on FDA-approved dosing

Evidence Documentation for Future Approval

Building Your Medical Necessity Case

Treatment History Documentation:

  • Complete list of prior multiple myeloma therapies with dates
  • Specific reasons for discontinuation (progression, toxicity, intolerance)
  • Response duration for each prior therapy
  • Current performance status and disease burden

Clinical Monitoring Records:

  • Recent bone marrow biopsy results
  • Imaging studies showing disease progression
  • Laboratory values (M-protein, free light chains, LDH)
  • Baseline ophthalmologic examination results

Medical Necessity Letter Framework

Your oncologist's letter should address:

  1. Diagnosis confirmation with staging and risk stratification
  2. Prior therapy failures with specific drug names and outcomes
  3. Clinical rationale for Blenrep based on BCMA expression or prior response
  4. Safety monitoring plan including REMS compliance
  5. Treatment goals and expected duration of therapy
From our advocates: We've seen successful appeals when oncologists include specific details about why standard therapies failed—not just "disease progression" but measurable increases in M-protein levels or new bone lesions with dates and imaging reports.

Virginia Appeals Process for Denials

Humana Internal Appeals

First Level: Standard Appeal

  • Timeline: 65 days from denial notice for Medicare members
  • How to file: Online through Humana member portal or by phone
  • Required documents: Denial letter, additional clinical documentation, prescriber letter
  • Decision timeframe: 30 days for pre-service decisions

Expedited Appeals for Urgent Situations

  • When to use: If waiting could seriously jeopardize health
  • Timeline: 72 hours for expedited decisions
  • Documentation: Physician certification of urgent medical need

Virginia External Review Process

If Humana's internal appeals are unsuccessful, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance.

External Review Requirements:

  • Must complete Humana's internal appeal process first
  • Request within 4 months of final internal denial
  • Applies to medical necessity denials (common for specialty drugs)
  • No cost to the patient for external review

Expedited External Review:

  • Available when delay would seriously jeopardize health
  • Decision within 72 hours for urgent medical situations
  • Special provision allows expedited review for cancer treatments without exhausting internal appeals

How to File:

  1. Contact SCC Bureau of Insurance Consumer Services at 1-877-310-6560
  2. Complete Form 216-A (External Review Request)
  3. Submit supporting medical documentation
  4. Independent Review Organization makes binding determination

Timeline Management & Deadlines

Critical Deadlines for Virginia Patients

Action Deadline Notes
Internal Appeal 65 days from denial Medicare timeline
External Review Request 4 months from final denial Virginia specific
Expedited Appeal As soon as possible For urgent situations
Clinical Trial Enrollment Varies by study Check eligibility early

2025-2026 Planning Timeline

Now through October 2025:

  • Monitor FDA approval status
  • Maintain clinical trial or compassionate use access
  • Document all treatment responses and side effects

Post-FDA Approval:

  • Expect 30-90 days for Humana formulary updates
  • Submit prior authorization immediately upon availability
  • Have comprehensive medical necessity documentation ready

Cost Considerations & Patient Assistance

Medicare Part D Changes for 2025

Starting January 1, 2025, Medicare Part D eliminates the coverage gap and caps annual out-of-pocket costs at $2,000 for covered prescription drugs.

Key Points for Blenrep:

  • Once approved, specialty drug costs count toward the $2,000 cap
  • After reaching the cap, patients pay $0 for covered drugs
  • GSK manufacturer discounts will apply (10% initial coverage, 20% catastrophic)

Patient Assistance Options

GSK Support Programs:

  • Patient Assistance Program for income-eligible patients
  • REMS program support and education
  • Clinical trial cost coverage for investigational use

Third-Party Assistance:

  • PAN Foundation grants for multiple myeloma patients
  • Leukemia & Lymphoma Society financial assistance
  • Virginia-specific charitable care programs
Note: Medicare patients are generally not eligible for manufacturer copay cards, but may qualify for need-based patient assistance programs.

FAQ: Common Questions

Q: Can I get Blenrep covered by Humana right now in Virginia? A: No. Blenrep is not commercially available in the U.S. until FDA re-approval (expected by October 23, 2025). Access is only through clinical trials or compassionate use programs.

Q: What happens if my clinical trial ends before FDA approval? A: Your oncologist can apply for compassionate use access through GSK's expanded access program if you meet eligibility criteria and are enrolled in REMS.

Q: How long does Humana's prior authorization process take? A: Humana commits to one business day decisions for 95% of electronically submitted requests by 2026, but specialty drugs may take longer due to clinical review requirements.

Q: What if Humana denies coverage when Blenrep becomes available? A: You can appeal through Humana's internal process, then request external review through Virginia's State Corporation Commission if the internal appeal is unsuccessful.

Q: Does Virginia have special protections for cancer drug appeals? A: Yes. Virginia allows expedited external review for cancer treatments without exhausting internal appeals, and urgent cases are decided within 72 hours.

Q: Can I switch to a different Humana plan that covers Blenrep better? A: During open enrollment, you can compare Humana plans' formularies. However, most Humana plans will likely have similar prior authorization requirements for specialty oncology drugs.

Getting Expert Help

Navigating insurance coverage for specialty cancer drugs like Blenrep can be complex, especially when dealing with clinical trial access and compassionate use programs. Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals. Their platform can help identify denial reasons and draft targeted rebuttals aligned with Humana's specific policies, increasing your chances of approval when Blenrep becomes commercially available.

Whether you're preparing for future coverage or appealing a current denial for related treatments, having expert support can make the difference between paying out-of-pocket and getting the coverage you deserve.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Always consult with your healthcare provider about treatment options and your insurance company about coverage details. Insurance policies and drug availability can change. Verify current information with official sources before making healthcare decisions.

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