By Counterforce Health Team in Blenrep (belantamab mafodotin) —

Getting Blenrep (Belantamab Mafodotin) Covered by Blue Cross Blue Shield in Ohio: Current Access Options and Appeals Process

Answer Box: Your Fastest Path to Blenrep Access in Ohio

Current Status: Blenrep is not commercially available but accessible through GSK's compassionate use program. Blue Cross Blue Shield in Ohio requires prior authorization for specialty drugs, with standard review taking 5-15 business days. Since Blenrep remains under FDA review (decision pending following October 2025 PDUFA date), your best option is compassionate use through your oncologist. Start by having your doctor contact GSK's Compassionate Use Portal within 2-4 weeks for approval. If commercial coverage becomes available, prepare for step therapy requirements showing failure of at least one prior multiple myeloma therapy.

First Step Today: Contact your oncologist to discuss compassionate use eligibility and initiate the GSK request process.

Table of Contents

  1. Understanding Blenrep's Current Status
  2. Blue Cross Blue Shield Coverage Requirements
  3. Compassionate Use: Your Current Best Option
  4. Step-by-Step: Preparing for Future Coverage
  5. Appeals Process for Ohio Residents
  6. Common Denial Reasons & Solutions
  7. Cost and Financial Assistance
  8. When to Escalate to State Regulators
  9. FAQ

Understanding Blenrep's Current Status

Blenrep (belantamab mafodotin) was voluntarily withdrawn from the U.S. market in 2022, but GSK resubmitted it to the FDA based on positive DREAMM-7 trial results showing a 59% reduction in disease progression risk. The FDA's target decision date was October 23, 2025, though approval status remains under review as of December 2025.

What This Means for You:

  • No commercial insurance coverage is currently available
  • Access is limited to compassionate use and clinical trials
  • REMS program enrollment remains mandatory for all access routes
  • Future coverage will require prior authorization once approved
Note: Even when Blenrep returns to market, expect significant coverage restrictions due to its high cost and specialized monitoring requirements.

Blue Cross Blue Shield Coverage Requirements

Blue Cross Blue Shield plans in Ohio (primarily Anthem) maintain strict prior authorization requirements for specialty multiple myeloma treatments. Based on current policies for similar drugs, expect these requirements once Blenrep is commercially available:

Coverage Criteria Table

Requirement What It Means Documentation Needed
Prior Authorization Required before coverage Complete PA form via provider portal
Step Therapy Must fail ≥1 prior therapy Treatment history with specific agents/timeframes
REMS Enrollment Mandatory safety program Prescriber and patient certification
Specialty Pharmacy Limited distribution network Designated pharmacy for dispensing
Diagnosis Codes Specific ICD-10 required C90.00, C90.01, or C90.02 for multiple myeloma

Timeline Expectations:

  • Standard review: 5-15 business days
  • Expedited review: 48-72 hours (urgent cases only)
  • Appeals: 180-day window for internal appeals

Compassionate Use: Your Current Best Option

GSK maintains a compassionate use program for Blenrep while commercial access remains unavailable. This expanded access program serves as your primary pathway to treatment.

Eligibility Requirements

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 in REMS program

Application Process

Step 1: Oncologist Initiation Your doctor must submit the request through GSK's Compassionate Use Portal. This cannot be initiated by patients directly.

Step 2: REMS Program Enrollment Both you and your healthcare team must complete REMS training due to significant ocular toxicity risks. Contact: 1-855-209-9188 or visit www.BLENREPREMS.com.

Step 3: Documentation Gathering Required materials include:

  • Complete treatment history
  • Recent lab values (CBC, comprehensive metabolic panel)
  • Bone marrow biopsy confirming relapsed disease
  • Ophthalmologic baseline examination

Timeline: Approval typically takes 2-4 weeks once complete documentation is submitted.

REMS Program Requirements

Because 83% of patients in clinical studies required dose modifications due to eye problems, strict monitoring is mandatory:

  • Regular eye exams before each dose
  • Use preservative-free artificial tears at least 4 times daily
  • Avoid contact lenses during treatment
  • Immediate reporting of vision changes

Step-by-Step: Preparing for Future Coverage

When Blenrep receives FDA approval, having your documentation ready will expedite the prior authorization process.

Pre-Authorization Preparation Checklist

Clinical Documentation:

  1. ✓ Complete multiple myeloma treatment history
  2. ✓ Specific prior therapy failures with dates and reasons
  3. ✓ Recent laboratory values and imaging
  4. ✓ Bone marrow biopsy results
  5. ✓ ECOG performance status assessment
  6. ✓ Baseline ophthalmologic examination

Administrative Requirements:

  1. ✓ Blue Cross Blue Shield member ID and policy details
  2. ✓ Prescriber NPI and DEA numbers
  3. ✓ ICD-10 diagnosis codes documented
  4. ✓ REMS program completion certificates
  5. ✓ Preferred specialty pharmacy identification
From our advocates: We've seen multiple myeloma approvals move significantly faster when oncology teams submit comprehensive treatment timelines showing specific drug names, doses, duration of response, and documented progression. Rather than simply stating "failed multiple prior therapies," detailed month-by-month treatment chronicles with clear progression markers help reviewers quickly understand medical necessity.

Appeals Process for Ohio Residents

Ohio provides robust consumer protections for insurance denials, including external review through independent medical experts.

Internal Appeals (Blue Cross Blue Shield)

Level 1 Appeal:

  • Timeline: Must file within 180 days of denial
  • Review period: 15 business days for standard, 72 hours for expedited
  • Submission: Through provider portal or member services

Peer-to-Peer Review:

  • Request within 5 business days of denial
  • Direct discussion between your oncologist and medical director
  • Often resolves complex cases without formal appeal

External Review (Ohio Department of Insurance)

If internal appeals fail, Ohio law provides independent review:

Eligibility: Available after exhausting internal appeals Timeline:

  • Request deadline: 180 days from final internal denial
  • Decision timeframe: 30 days standard, 72 hours expedited Cost: Free to patients Contact: Ohio Department of Insurance at 800-686-1526

Submission Process:

  1. Request external review through your health plan
  2. Plan notifies Ohio Department of Insurance
  3. Independent Review Organization (IRO) assigned
  4. You can submit additional information within 10 business days
  5. IRO decision is binding on insurer

Common Denial Reasons & Solutions

Denial Reasons Table

Denial Reason Solution Strategy Required Documentation
"Experimental/Investigational" Cite FDA approval and NCCN guidelines FDA approval letter, NCCN category evidence
"Step therapy not met" Document prior failures with specific details Treatment timeline with progression dates
"Not medically necessary" Provide clinical evidence of disease progression Recent imaging, lab values, performance status
"REMS not completed" Complete all training requirements REMS certificates for patient and provider
"Specialty pharmacy required" Use designated network pharmacy Confirm pharmacy participation with plan

Medical Necessity Letter Components

Your oncologist's letter should address:

  • Specific multiple myeloma subtype and staging
  • Complete chronological treatment history
  • Evidence of current disease progression
  • Contraindications to alternative therapies
  • Clinical guideline support (NCCN, ASH, IMWG)
  • REMS program compliance plan

Cost and Financial Assistance

While commercial pricing isn't available during the compassionate use period, prepare for significant costs once Blenrep returns to market.

Financial Assistance Options

Manufacturer Support:

  • GSK patient assistance programs (check GSK.com for updates)
  • Copay assistance cards (typically available for commercially insured patients)

Foundation Grants:

  • The Leukemia & Lymphoma Society
  • Multiple Myeloma Research Foundation
  • Patient Advocate Foundation

State Resources:

  • Ohio Patient Assistance Program (verify current availability)
  • Medicaid coverage for eligible patients

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed rebuttals aligned to each plan's specific criteria. Their platform ingests denial letters and clinical notes to identify the exact basis for denial and drafts targeted appeals using the right citations and clinical facts that payers require.

When to Escalate to State Regulators

Contact Ohio Department of Insurance if:

  • Blue Cross Blue Shield improperly denies external review eligibility
  • Appeal deadlines aren't honored
  • Required forms or processes aren't provided
  • You suspect bad faith denial practices

Contact Information:

  • Phone: 800-686-1526
  • Website: insurance.ohio.gov
  • Complaint filing available online through their consumer portal

FAQ

Q: How long does Blue Cross Blue Shield prior authorization take in Ohio? A: Standard review takes 5-15 business days, while expedited reviews are completed within 48-72 hours for urgent cases.

Q: What if Blenrep is non-formulary on my plan? A: You can request a formulary exception by demonstrating medical necessity and providing evidence that formulary alternatives are inappropriate.

Q: Can I request an expedited appeal? A: Yes, if waiting for standard review would seriously endanger your health. Your oncologist must provide clinical justification for urgency.

Q: Does step therapy apply if I received prior treatments outside Ohio? A: Treatment history from any location counts toward step therapy requirements. Ensure your oncologist documents all prior therapies regardless of where they were received.

Q: What happens if the external review upholds the denial? A: The external review decision is binding, but you retain the right to seek legal remedies or file regulatory complaints if you believe the process was flawed.

Q: How do I find a REMS-certified provider in Ohio? A: Contact the BLENREP REMS program at 1-855-209-9188 or visit www.BLENREPREMS.com for a provider directory.

Q: Will my appeal affect my relationship with Blue Cross Blue Shield? A: No. Appeals are a standard part of the healthcare coverage process and cannot result in plan termination or premium increases.

Q: Can I continue compassionate use while appealing for coverage? A: Yes, compassionate use access is independent of insurance coverage decisions and can continue during appeals processes.

For complex cases requiring detailed appeal strategies, Counterforce Health helps patients and clinicians navigate the prior authorization process by analyzing denial letters and creating targeted rebuttals that address each plan's specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and insurance plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with insurance appeals and coverage issues in Ohio, contact the Ohio Department of Insurance at 800-686-1526.

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