By Counterforce Health Team in Blenrep (belantamab mafodotin) —

How to Get Blenrep (Belantamab Mafodotin) Covered by Cigna in Pennsylvania: Complete Appeals Guide

Answer Box: Getting Blenrep Covered by Cigna in Pennsylvania

Blenrep (belantamab mafodotin) is currently withdrawn from the U.S. market as of 2022, with FDA resubmission under review (PDUFA date October 2025). Access is limited to clinical trials or expanded access programs. If you're seeking coverage, you'll need to demonstrate enrollment in an approved study or expanded access protocol. Start by contacting Cigna's specialty pharmacy at 1-800-351-3606 to verify current coverage policies, then work with your oncologist to document clinical trial participation or expanded access eligibility.

Table of Contents

  1. Understanding Blenrep's Current Status
  2. Verify Your Cigna Plan Coverage
  3. Required Forms and Documentation
  4. Submission Portals and Contact Information
  5. The Appeals Process in Pennsylvania
  6. Specialty Pharmacy Coordination
  7. Pennsylvania External Review Process
  8. Support Resources and Assistance
  9. FAQ
  10. Sources and Further Reading

Understanding Blenrep's Current Status

Blenrep (belantamab mafodotin) was voluntarily withdrawn from the U.S. market by GSK in November 2022 due to concerns about benefit-risk balance in accelerated approval studies. The drug is currently under FDA review with a PDUFA (Prescription Drug User Fee Act) goal date of October 23, 2025.

Current Access Options:

  • Clinical trials investigating Blenrep combinations
  • Expanded access programs (compassionate use)
  • International procurement (rarely covered by U.S. insurance)
Note: Since Blenrep is not commercially available, traditional prior authorization processes don't apply. Instead, coverage requests typically involve demonstrating participation in approved research protocols.

Verify Your Cigna Plan Coverage

Before pursuing any coverage request, confirm your specific Cigna plan details:

Step 1: Check Your Plan Type

  • Commercial plans (employer-sponsored or individual)
  • Medicare Advantage plans
  • Medicaid managed care plans

Step 2: Understand Specialty Drug Coverage Most Cigna plans manage specialty drugs through Express Scripts/Accredo specialty pharmacy. Call the number on your insurance card to verify:

  • Whether experimental/investigational drugs are covered
  • Requirements for clinical trial participation
  • Prior authorization processes for expanded access

Required Forms and Documentation

For Clinical Trial Coverage

Cigna Prior Authorization Form for Blenrep

Required Documentation:

  • IRB-approved clinical trial protocol
  • Informed consent documentation
  • Principal investigator letter confirming enrollment
  • Clinical notes supporting medical necessity
  • ICD-10 diagnosis codes for multiple myeloma

For Expanded Access Requests

FDA Expanded Access Documentation:

  • FDA Form 3926 (if applicable)
  • Treating physician's medical rationale
  • Documentation of standard treatment failures
  • Risk-benefit assessment

Submission Portals and Contact Information

Cigna Submission Methods

Online Portals:

Phone Numbers:

Fax Numbers:

The Appeals Process in Pennsylvania

Internal Appeals with Cigna

Timeline: 180 days from denial date

Step 1: Gather Documentation

  • Original denial letter
  • Complete medical records
  • Clinical trial documentation
  • Physician statement of medical necessity

Step 2: Submit Appeal

  • Use Cigna appeals portal or mail written appeal
  • Include all supporting documentation
  • Request expedited review if medically urgent

Review Timeline:

Common Denial Reasons and Solutions

Denial Reason How to Address Documentation Needed
Experimental/investigational Demonstrate FDA oversight of trial IRB approval, FDA IND number
Not medically necessary Show standard treatment failures Prior therapy records, progression notes
Not FDA approved Reference expanded access provisions FDA guidance on compassionate use

Specialty Pharmacy Coordination

Since Blenrep requires REMS (Risk Evaluation and Mitigation Strategy) monitoring for ocular toxicity, specialty pharmacy coordination is essential:

Accredo Specialty Pharmacy Setup:

  1. Call 866-759-1557 for enrollment
  2. Provide clinical trial or expanded access documentation
  3. Coordinate REMS training and monitoring
  4. Arrange for drug shipment and administration

Required REMS Elements:

  • Ophthalmologic examinations
  • Provider certification
  • Patient monitoring program enrollment

Pennsylvania External Review Process

If Cigna denies your internal appeal, Pennsylvania offers a robust external review process with high success rates.

Pennsylvania's Independent External Review

Eligibility: Available after completing Cigna's internal appeals process Timeline: 4 months from final denial to file Success Rate: Over 50% of appeals overturned in 2024

How to File:

Review Timeline:

From our advocates: We've seen success when families include detailed clinical trial protocols and FDA correspondence in their external review submissions. The independent reviewers often have more specialized knowledge of experimental therapies than initial insurance reviewers.

Support Resources and Assistance

Pennsylvania Health Law Project

The Pennsylvania Health Law Project (PHLP) provides free legal assistance for insurance appeals:

Counterforce Health

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to identify the specific reasons for denial and drafts point-by-point rebuttals aligned with the insurer's own rules. For complex cases involving withdrawn drugs like Blenrep, they help identify the right clinical evidence and regulatory pathways to support coverage requests.

Additional Resources

  • GSK Patient Assistance: Contact GSK directly for expanded access program information
  • Clinical Trial Matching Services: ClinicalTrials.gov for ongoing Blenrep studies
  • Multiple Myeloma Organizations: Patient advocacy groups with insurance navigation support

FAQ

Q: Can I get Blenrep covered if it's withdrawn from the market? A: Coverage is limited to clinical trial participation or expanded access programs. You'll need documentation of enrollment in an FDA-supervised study.

Q: How long does Cigna's prior authorization process take? A: Standard requests: 72 hours; expedited requests: 24 hours once all documentation is received.

Q: What if my doctor isn't familiar with expanded access programs? A: Direct them to FDA guidance on expanded access at FDA.gov, or contact GSK's medical affairs team for protocol information.

Q: Does Pennsylvania's external review apply to experimental drugs? A: Yes, the Pennsylvania external review process covers denials for experimental treatments when medically necessary.

Q: Can I appeal if I'm in a Medicare Advantage plan? A: Yes, Medicare Advantage appeals follow similar timelines but may have additional federal oversight requirements.

Q: What happens if the external review is denied? A: External review decisions are final and binding, but you may have options through federal appeals processes or legal action in certain circumstances.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific guidance. For legal assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Health Law Project at 1-800-274-3258.

When facing complex insurance denials, specialized services like Counterforce Health can help navigate the appeals process by analyzing your specific denial and crafting targeted responses based on your insurer's policies and clinical evidence requirements.

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