By Counterforce Health Team in Blenrep (belantamab mafodotin) —

How to Get Blenrep (Belantamab Mafodotin) Covered by Blue Cross Blue Shield in Virginia: Current Access Options and Appeals Guide

Answer Box: Blenrep Coverage in Virginia

Blenrep (belantamab mafodotin) is not commercially available in the U.S. as of 2025 due to GSK's voluntary withdrawal in 2022 pending FDA resubmission (PDUFA target October 2025). Current access is limited to clinical trials or expanded access programs only. For Blue Cross Blue Shield Virginia plans, submit prior authorization requests via the Availity portal with comprehensive clinical documentation. If denied, Virginia's State Corporation Commission provides external review within 120 days using Form 216-A. First step today: Contact your oncologist about trial enrollment and monitor FDA approval status at FDA.gov.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Current Blenrep Status
  3. Blue Cross Blue Shield Virginia Coverage Requirements
  4. Step-by-Step: Fastest Path to Approval
  5. Common Denial Reasons & Solutions
  6. Virginia Appeals Process
  7. Current Access Options
  8. FAQ
  9. Sources & Further Reading

What This Guide Covers

This comprehensive guide helps patients with relapsed/refractory multiple myeloma and their healthcare teams navigate Blue Cross Blue Shield coverage for Blenrep (belantamab mafodotin) in Virginia. While the drug is currently unavailable commercially, understanding the coverage framework prepares you for when it returns to market and helps with current trial/expanded access situations.

Who this helps:

  • Patients with multiple myeloma seeking Blenrep coverage
  • Oncology teams preparing prior authorization requests
  • Caregivers navigating insurance appeals in Virginia

Before You Start: Current Blenrep Status

Critical Update: Blenrep was voluntarily withdrawn from the U.S. market in November 2022 after failing to meet overall survival endpoints in the confirmatory DREAMM-3 trial. GSK has resubmitted the drug to FDA with additional data, targeting approval by October 23, 2025.

Current Access Limitations

  • No commercial sales in the U.S.
  • Clinical trials only for new patients
  • Expanded access programs may be available for eligible patients
  • International availability continues in some regions
Note: Even when commercially unavailable, understanding the prior authorization process helps prepare for future approval and may apply to expanded access situations.

Blue Cross Blue Shield Virginia Coverage Requirements

Blue Cross Blue Shield Virginia (primarily Anthem) follows standard specialty drug protocols for oncology medications like Blenrep.

Coverage at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all BCBS Virginia plans Availity Essentials portal Anthem Provider Portal
Decision Timeline 14 days standard / 72 hours expedited Policy documents Virginia Insurance Code
Formulary Status Specialty tier (when available) Member services or provider portal Plan formulary
Clinical Criteria ≥4 prior therapies including specific agents Medical policy BCBS Medical Policies
Appeal Deadline 180 days from denial notice Member handbook Virginia SCC

Medical vs. Pharmacy Benefit

Blenrep administration typically falls under medical benefit due to IV infusion requirements:

  • Medical Benefit: 15-35% coinsurance after deductible
  • Administration Site: Oncology clinic or hospital outpatient
  • REMS Requirements: Mandatory eye exams due to corneal toxicity risk
  • Coding: HCPCS J9037 for billing

Step-by-Step: Fastest Path to Approval

1. Verify Eligibility (Patient/Caregiver)

  • Confirm Blue Cross Blue Shield Virginia coverage
  • Check if plan requires referrals or specific oncology networks
  • Verify current premium and deductible status

2. Clinical Documentation (Oncologist)

Required elements for PA submission:

  • Diagnosis: ICD-10 C90.02 (multiple myeloma in relapse) or C90.00 (not in remission)
  • Prior therapies: Document ≥4 prior lines including:
    • Proteasome inhibitor (bortezomib, carfilzomib, ixazomib)
    • Immunomodulatory agent (lenalidomide, pomalidomide, thalidomide)
    • Anti-CD38 antibody (daratumumab, isatuximab)
  • Performance status: ECOG 0-2 preferred
  • Organ function: Adequate hepatic, renal, and hematologic function
  • Treatment rationale: Why Blenrep vs. alternatives

3. Submit Prior Authorization (Clinic Staff)

  • Portal: Availity Essentials (verify current link)
  • Required forms: Complete PA request with all clinical documentation
  • Timeline: Submit 2-4 weeks before planned treatment start
  • Confirmation: Save reference number and track status

4. Follow-Up Cadence

  • Week 1: Confirm receipt via portal
  • Week 2: Check decision status if no response
  • If approved: Coordinate with specialty pharmacy and REMS program
  • If denied: Review denial letter and prepare appeal

Clinician Corner: Medical Necessity Letter

Essential components for Blenrep PA requests:

✓ Patient history: Age, diagnosis date, staging, cytogenetics
✓ Prior treatments: Specific regimens, dates, best response, reason for discontinuation
✓ Current status: Disease progression evidence (imaging, labs, symptoms)
✓ Treatment plan: Dosing schedule, monitoring plan, duration
✓ Guideline support: NCCN Multiple Myeloma Guidelines reference
✓ Alternative consideration: Why other options are unsuitable
✓ REMS compliance: Plan for mandatory eye exams

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Drug not commercially available Provide trial/expanded access documentation Protocol enrollment letter, FDA correspondence
Insufficient prior therapies Document all prior treatments with dates/outcomes Treatment history summary, progress notes
Missing REMS requirements Submit ophthalmology clearance plan Eye exam schedule, specialist coordination
Non-formulary status Request formulary exception Medical necessity letter, alternative contraindications
Experimental/investigational Appeal based on FDA guidance Clinical evidence, peer-reviewed literature

Virginia Appeals Process

Virginia provides robust appeal rights through the State Corporation Commission (SCC) Bureau of Insurance.

Internal Appeals (Blue Cross Blue Shield)

  • Deadline: 180 days from denial notice
  • Timeline: 30-60 days for decision
  • Required: Written appeal with denial letter and supporting documentation
  • Expedited: Available if delay jeopardizes health (72 hours)

External Review (Virginia SCC)

  • Deadline: 120 days after final internal denial
  • Form: Form 216-A External Review Request (verify current link)
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Contact: Virginia Managed Care Ombudsman at 1-877-310-6560
  • Cost: Free to consumers
From our advocates: We've seen cases where initial denials for specialty oncology drugs were overturned at external review when patients provided comprehensive treatment histories and clear documentation of why alternatives weren't suitable. The key is thorough preparation and understanding that Virginia's external reviewers are independent specialists who take fresh looks at the medical evidence.

Appeals Documentation Checklist

  • Original denial letter with specific reason codes
  • Complete medical records from oncologist
  • Treatment history with dates and outcomes
  • Current imaging or lab results showing progression
  • Medical necessity letter addressing denial reasons
  • Any relevant clinical trial data or FDA communications

Current Access Options

While awaiting commercial availability, several options may provide access to Blenrep:

Clinical Trials

  • ClinicalTrials.gov: Search "belantamab mafodotin" for active studies
  • Eligibility: Varies by trial protocol
  • Coverage: Trial sponsors typically cover drug costs
  • Travel: Some trials provide travel assistance

Expanded Access Programs

  • GSK Compassionate Use: Contact GSK medical affairs
  • Eligibility: Patients without trial options who meet clinical criteria
  • Process: Physician-initiated request through FDA
  • Timeline: Several weeks to months for approval

International Options

  • Medical tourism: Countries where Blenrep remains available
  • Cost considerations: No insurance coverage for international treatment
  • Coordination: Requires extensive planning with international providers

FAQ

How long does Blue Cross Blue Shield PA take in Virginia?
Standard prior authorization decisions are made within 14 days. Expedited reviews for urgent cases are completed within 72 hours. Track your request through the Availity portal.

What if Blenrep is non-formulary on my plan?
Request a formulary exception by demonstrating medical necessity and why formulary alternatives are inappropriate. Include contraindications or prior failures with covered options.

Can I request an expedited appeal in Virginia?
Yes, if your physician certifies that waiting could jeopardize your life, health, or ability to regain function. Virginia processes expedited external reviews within 72 hours.

Does step therapy apply to Blenrep?
Most Blue Cross Blue Shield plans require documentation of prior therapies rather than formal step therapy. You'll need to show failure or intolerance to standard multiple myeloma treatments.

What happens when Blenrep returns to market?
Monitor FDA approval status and work with your oncologist to prepare PA documentation in advance. Counterforce Health can help streamline the approval process with evidence-backed appeals.

Are there financial assistance programs?
GSK historically offered copay assistance and patient support programs. Check GSK's website closer to re-launch for updated assistance options.

How do I contact Virginia's insurance ombudsman?
Call the Virginia Managed Care Ombudsman at 1-877-310-6560 for assistance with Blue Cross Blue Shield appeals and coverage disputes.

What's the success rate for appeals in Virginia?
Virginia's external review process provides independent medical review. Success rates vary by case specifics, but thorough documentation and clear medical necessity improve outcomes significantly.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create compelling appeals that align with payers' own rules and criteria.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your oncologist about treatment decisions and work directly with your insurance plan for specific coverage determinations. Coverage policies and requirements may vary by individual plan and change over time.

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