By Counterforce Health Team in Blenrep (belantamab mafodotin) —

Work With Your Doctor to Get Blenrep (belantamab mafodotin) Covered by Blue Cross Blue Shield in Pennsylvania: Provider Collaboration Guide

Answer Box: Getting Blenrep Covered in Pennsylvania

Current Status: Blenrep is withdrawn from the US market until FDA review concludes (October 2025 PDUFA date). Access is limited to GSK's compassionate use program or clinical trials.

Fastest Path: Work with your oncologist to apply for GSK's expanded access program while preparing for future commercial coverage. For current denials, use Pennsylvania's external review program (50% success rate).

First Step Today: Schedule an appointment with your myeloma specialist to discuss expanded access eligibility and document your treatment history for future appeals.

Table of Contents

  1. Set Your Goal: Understanding Current Access Options
  2. Visit Preparation: Building Your Case
  3. Evidence Kit: What Your Doctor Needs
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After-Visit Documentation
  7. Respectful Persistence and Follow-Up
  8. Pennsylvania Appeals Process
  9. FAQ

Set Your Goal: Understanding Current Access Options

Since Blenrep's voluntary withdrawal in 2022, getting coverage requires understanding what's actually available. Your partnership with your oncologist focuses on two pathways:

Current Access Through GSK's Compassionate Use Program

Eligibility Requirements:

  • Confirmed relapsed/refractory multiple myeloma
  • Failure of ≥4 prior lines of therapy
  • ECOG performance status 0-2
  • Adequate organ function
  • Treating oncologist willing to participate in REMS monitoring

Your Role: Provide complete treatment history and undergo baseline eye examination. Insurance typically covers standard medical care (infusions, labs, visits) but not the drug cost itself.

Doctor's Role: Initiates application through GSK's portal, completes REMS enrollment, and manages ongoing monitoring requirements.

Preparing for Future Commercial Coverage

When Blenrep returns to market (pending October 2025 FDA decision), Blue Cross Blue Shield plans will likely require prior authorization with documentation of multiple therapy failures and step therapy completion.

Note: Counterforce Health helps patients and providers navigate complex specialty drug appeals by analyzing denial letters and crafting evidence-backed responses aligned to payer policies.

Visit Preparation: Building Your Case

Come to your appointment with organized documentation that tells your complete myeloma story.

Symptom and Treatment Timeline

Create a chronological list including:

For Each Prior Treatment:

  • Medication names and doses
  • Start and stop dates
  • Best response achieved
  • Reason for discontinuation (progression, toxicity, intolerance)
  • Specific side effects experienced

Current Disease Status:

  • Recent symptoms and functional impact
  • Latest lab values and imaging results
  • Performance status changes
  • Quality of life concerns

Insurance Information to Bring

  • Current insurance card (front and back)
  • Policy number and group number
  • Previous denial letters or EOBs
  • Formulary information if available
Tip: If you've already received a denial for Blenrep, bring the complete letter. Even though the drug isn't commercially available, this documentation will be valuable for future appeals.

Evidence Kit: What Your Doctor Needs

Your oncologist needs specific clinical evidence to support either compassionate use applications or future commercial appeals.

Clinical Documentation Checklist

Diagnosis Confirmation:

  • Original pathology report
  • Bone marrow biopsy results
  • Cytogenetics and molecular studies
  • Disease staging information

Treatment History:

  • Complete list of prior regimens
  • Response assessments for each line
  • Toxicity documentation
  • Reasons for treatment changes

Current Status:

  • Recent imaging (CT, PET, MRI)
  • Laboratory values (CBC, chemistry, LDH, beta-2 microglobulin)
  • Performance status assessment
  • Symptom burden documentation

Guideline Evidence Your Doctor Should Reference

NCCN Guidelines: Multiple myeloma guidelines support BCMA-targeted therapies for triple-class refractory disease.

EHA-EMN 2025 Recommendations: Include earlier use of immunotherapies (CAR-T, bispecifics, ADCs) in relapsed/refractory multiple myeloma.

Clinical Trial Data: DREAMM-2 showed approximately 30% overall response rate in heavily pretreated patients with triple-class refractory disease.

Medical Necessity Letter Structure

When your doctor writes a medical necessity letter (for compassionate use or future appeals), it should follow this proven structure:

Essential Components

1. Patient Demographics and Diagnosis

  • Age, diagnosis date, ICD-10 codes
  • High-risk features (del(17p), t(4;14), extramedullary disease)
  • Current disease stage and status

2. Treatment History and Refractoriness

  • Document exposure to immunomodulatory drugs (IMiDs)
  • Proteasome inhibitor history
  • Anti-CD38 antibody therapy outcomes
  • CAR-T or bispecific therapy eligibility/outcomes

3. Guideline Alignment

  • Reference NCCN, EHA-EMN guidelines supporting BCMA-targeted therapy
  • Cite belantamab mafodotin as recognized option for triple-class exposed disease
  • Note lack of superior alternatives in this setting

4. Medical Necessity Rationale

  • Expected survival without treatment (<1 year based on historical data)
  • Reasonable probability of response (30% ORR from DREAMM-2)
  • Acceptable safety profile with proper monitoring

5. Safety and Monitoring Plan

  • Ophthalmologic monitoring protocol
  • Hematologic assessment schedule
  • Dose modification guidelines

Peer-to-Peer Review Support

If your doctor requests a peer-to-peer review with Blue Cross Blue Shield medical directors, you can help prepare them for success.

Information to Provide Your Doctor

Before the Call:

  • Your availability for urgent treatment if approved
  • Transportation arrangements for frequent monitoring
  • Understanding of eye care requirements
  • Commitment to REMS participation

Key Points for Your Doctor to Emphasize:

  • Triple-class refractory status with documented progression
  • Lack of suitable alternatives (CAR-T unavailable/failed)
  • NCCN guideline support for BCMA-targeted therapy
  • Acceptable risk-benefit ratio with proper monitoring

Supporting Your Doctor's Preparation

Offer to help gather:

  • Complete treatment records from all providers
  • Pathology reports and imaging studies
  • Documentation of prior therapy failures
  • Current performance status assessment

After-Visit Documentation

Maintain organized records of all interactions and decisions.

What to Save

From Each Visit:

  • Clinical notes and assessments
  • Treatment recommendations
  • Lab and imaging orders
  • Referral documentation

Communication Records:

  • Portal messages about treatment decisions
  • Phone call summaries
  • Insurance pre-authorization submissions
  • Denial letters and appeals

How to Use Patient Portals Effectively

For Treatment Updates:

  • Message your care team about new symptoms
  • Request clarification on treatment plans
  • Ask for copies of test results
  • Confirm appointment scheduling

For Insurance Issues:

  • Request letters of medical necessity
  • Ask for peer-to-peer review scheduling
  • Get copies of prior authorization submissions
  • Confirm appeals filing

Respectful Persistence and Follow-Up

Effective advocacy requires consistent, professional communication with your healthcare team.

Appropriate Follow-Up Cadence

Weekly Check-ins: For active applications or appeals in process

Bi-weekly Updates: For routine monitoring of application status

Monthly Reviews: For long-term planning and preparation

How to Escalate Politely

Step 1: Direct communication with your oncologist's office Step 2: Request care coordinator or nurse navigator assistance
Step 3: Ask to speak with practice manager about urgent needs Step 4: Consider second opinion consultation if needed

From our advocates: A composite of successful cases shows that patients who maintain organized documentation and regular communication with their care teams while remaining respectful of clinical workflows achieve better outcomes in complex specialty drug access situations.

Pennsylvania Appeals Process

Pennsylvania offers robust appeal rights through its Independent External Review program.

Coverage at a Glance

Requirement What It Means Timeline Source
Internal Appeal First Must complete insurer's appeal process 180 days to file PA Insurance Dept
External Review State-supervised independent review 4 months after final denial PA Insurance Dept
Success Rate IRO overturns approximately 50% of denials 45 days standard, 72 hours expedited WHYY Report

Step-by-Step Appeals Process

1. File Internal Appeal (You + Doctor)

  • Submit within 180 days of denial
  • Include medical necessity letter and supporting documentation
  • Request expedited review for urgent cases

2. Receive Final Adverse Benefit Determination

  • Wait for insurer's final decision letter
  • Note the date - starts your 4-month external review clock
  • Gather additional supporting evidence

3. File External Review with Pennsylvania

  • Submit online through PA Insurance Department portal
  • Include FABD letter and insurance card
  • Add any new clinical evidence within 15 days

4. Independent Review Organization Decision

  • IRO assigned within 1 business day
  • Decision within 45 days (standard) or 72 hours (expedited)
  • Binding on insurer if overturned

FAQ

Q: Can I get Blenrep covered by Blue Cross Blue Shield in Pennsylvania right now? A: Blenrep is not commercially available until FDA review concludes (October 2025). Access is through GSK's compassionate use program, where insurance covers medical care but not drug costs.

Q: How long does the compassionate use application take? A: Typical review time is 2-4 weeks once your oncologist submits a complete application through GSK's portal with required REMS enrollment.

Q: What if my doctor isn't familiar with the compassionate use process? A: Ask them to contact GSK medical information directly. Counterforce Health also provides guidance on specialty drug access programs.

Q: Will I need eye exams for Blenrep treatment? A: Yes, belantamab mafodotin requires baseline and pre-dose ophthalmologic evaluations due to potential keratopathy. This is part of the REMS program.

Q: Can I appeal a denial for experimental treatment? A: Yes, Pennsylvania's external review covers experimental/investigational determinations. The IRO will review medical necessity based on available evidence.

Q: What happens if Blenrep gets FDA approval in October 2025? A: It will become commercially available with likely prior authorization requirements. Your documented treatment history will support future coverage requests.

Q: How much does the Pennsylvania external review process cost? A: External review is free to patients. The insurance company pays for completed reviews regardless of outcome.

Q: Can I get help with the appeals process? A: Yes, contact the Pennsylvania Insurance Department Consumer Services Bureau or organizations like the Pennsylvania Health Law Project for free assistance.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance coverage varies by plan and individual circumstances. Contact your insurance company and the Pennsylvania Insurance Department for specific coverage questions and appeal rights.

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