By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Coverage After FDA Withdrawal: What New York Patients Need to Know About Blue Cross Blue Shield Transitions

Answer Box: Oxbryta Coverage Status in New York

Oxbryta (voxelotor) is no longer FDA-approved as of September 2024 due to safety concerns. Blue Cross Blue Shield plans in New York now deny claims for this discontinued medication. If you were taking Oxbryta, immediately contact your healthcare provider to discuss alternative sickle cell treatments like hydroxyurea or crizanlizumab. Your doctor can request formulary exceptions for alternative therapies through Blue Cross Blue Shield's standard prior authorization process. For transition assistance, call your Blue Cross plan's member services or contact Community Health Advocates at 888-614-5400.

Table of Contents

  1. FDA Withdrawal Timeline & Safety Concerns
  2. Current Coverage Status with Blue Cross Blue Shield
  3. Alternative Treatment Options
  4. Formulary Exception Process for Alternatives
  5. Appeals Process in New York
  6. Patient Assistance & Transition Support
  7. FAQ: Common Questions

FDA Withdrawal Timeline & Safety Concerns

Pfizer voluntarily withdrew Oxbryta (voxelotor) from worldwide markets on September 25, 2024, with the FDA issuing an official alert on September 26, 2024. The withdrawal followed postmarketing clinical data showing:

  • Higher rates of vaso-occlusive crisis (severe pain episodes) in patients taking Oxbryta compared to placebo
  • Increased mortality in the treatment group
  • Real-world registry studies confirming elevated crisis rates among users

The company ceased all distribution, discontinued active clinical trials, and halted expanded access programs immediately upon withdrawal.

Important: If you were taking Oxbryta, discontinue use immediately and contact your healthcare provider about alternative treatments. Do not stop other sickle cell medications.

Current Coverage Status with Blue Cross Blue Shield

Coverage Denial for Discontinued Drugs

Blue Cross Blue Shield plans across New York now automatically deny claims for Oxbryta due to its loss of FDA approval. When the FDA deems a drug unsafe or a manufacturer removes it from the market, Blue Cross Blue Shield notifies members and removes it from all formularies.

No Compassionate Use Coverage

Unlike some drug shortages where compassionate use exceptions exist, Oxbryta's safety-based withdrawal means no formal exception programs are available through insurance plans.

Alternative Treatment Options

FDA-Approved Medications for Sickle Cell Disease

Three medications remain FDA-approved for reducing sickle cell disease severity:

Medication Brand Name Mechanism Coverage Notes
Hydroxyurea Droxia®, Siklos® Established SCD treatment Generally covered; first-line therapy
L-glutamine Endari® Amino acid supplement May require prior authorization
Crizanlizumab Adakveo® Vaso-occlusive crisis inhibitor Specialty tier; requires PA

Curative Treatment Options

Gene Therapy: Casgevy (CRISPR/Vertex) represents a potentially curative approach without requiring a donor match.

Stem Cell Transplantation: Available through HLA-identical sibling donors, haploidentical related donors, or unrelated HLA-matched donors.

Formulary Exception Process for Alternatives

When You Need a Formulary Exception

You may need to request coverage exceptions if:

  • Your alternative treatment isn't on your Blue Cross formulary
  • The medication requires step therapy (trying other drugs first)
  • You need a higher tier medication with lower copays

Required Documentation

Submit formulary exception requests with:

  • Completed formulary exception form (available through your Blue Cross member portal)
  • Prescriber's supporting medical statement explaining medical necessity
  • Documentation of Oxbryta discontinuation and transition needs
  • Previous treatment history showing what you've tried and outcomes

Submission Process

Timeline: Blue Cross Blue Shield must decide within 72 hours of receiving your prescriber's supporting statement.

Submission Methods:

  • Fax: 1-877-378-4727 (verify current number with your plan)
  • Online through your Blue Cross member portal
  • Mail to address indicated on the exception form
Tip: Request expedited review if your situation is medically urgent or if you're running low on medication supplies.

Appeals Process in New York

Internal Appeals with Blue Cross Blue Shield

If Blue Cross denies coverage for an alternative treatment:

  1. File internal appeal within 60 days of denial
  2. Include supporting documentation from your healthcare provider
  3. Blue Cross has 30 days to respond to standard appeals

External Appeals Through New York DFS

New York offers robust external appeal rights through the Department of Financial Services:

Filing Timeline: Up to 4 months from final denial (extended to 180 days as of March 2025)

Expedited Appeals: Available for urgent medical situations

  • 24 hours for non-formulary drug denials
  • 72 hours for other urgent appeals

Cost: Maximum $25 fee (waived for financial hardship or Medicaid enrollees)

Binding Decision: External reviewer's decision is binding on your health plan

How to File External Appeal

Submit to:

  • New York State Department of Financial Services
  • 99 Washington Avenue, Box 177
  • Albany, NY 12210
  • Fax: (800) 332-2729

Patient Assistance & Transition Support

Free Appeal Assistance in New York

Community Health Advocates: Call 888-614-5400 for free help with insurance denials and appeals. They can assist New Yorkers in filing appeals and understanding their rights.

Healthcare Appeals Ombudsman: Call 1-800-NYS-APPEAL for guidance through complex external appeal processes.

Manufacturer Support Programs

Check with manufacturers of alternative medications for:

  • Patient assistance programs for uninsured/underinsured patients
  • Copay assistance cards for commercially insured patients
  • Bridge programs during insurance transitions
From our advocates: We've seen patients successfully transition from discontinued medications by working closely with their care teams to document medical necessity for alternatives. The key is starting the process early and gathering comprehensive medical records showing your response to previous treatments.

Working with Specialty Pharmacies

Many sickle cell medications require specialty pharmacy dispensing. Your healthcare provider can help coordinate:

  • Prior authorization submissions
  • Insurance benefit verification
  • Patient assistance program enrollment
  • Delivery scheduling

FAQ: Common Questions

Q: Can I still get Oxbryta if I was responding well to it? A: No. Due to safety concerns, Oxbryta is no longer available in the United States through any channel, including compassionate use programs.

Q: Will Blue Cross Blue Shield cover my transition to a new medication? A: Yes, if the alternative medication is medically necessary and meets coverage criteria. Your doctor may need to submit prior authorization or formulary exception requests.

Q: How long do I have to find an alternative treatment? A: Contact your healthcare provider immediately. Don't delay transitioning to an alternative therapy, as sudden discontinuation could worsen your sickle cell disease.

Q: What if my new medication costs more than Oxbryta did? A: Explore manufacturer copay assistance programs, patient assistance programs, and discuss formulary exceptions with your Blue Cross plan to potentially lower costs.

Q: Can I appeal if Blue Cross denies coverage for my alternative medication? A: Yes. New York offers internal appeals through Blue Cross and external appeals through the Department of Financial Services with binding decisions.

Q: Do I need to see a specialist to get alternative treatments covered? A: While not always required, having a hematologist or sickle cell specialist involved can strengthen prior authorization requests and appeals.

Counterforce Health: Streamlining Your Appeals Process

Counterforce Health helps patients and healthcare providers navigate complex insurance appeals by turning denials into targeted, evidence-backed requests. Their platform can assist with formulary exceptions and appeals for alternative sickle cell treatments, ensuring your documentation meets Blue Cross Blue Shield's specific requirements and New York's procedural standards.

When facing coverage challenges for alternative therapies after Oxbryta's withdrawal, having expert support can significantly improve your chances of approval and reduce delays in accessing critical treatment.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for coverage determinations. For personalized help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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