By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Coverage with Humana in North Carolina: What You Need to Know After FDA Withdrawal

Answer Box: Oxbryta (Voxelotor) Coverage Status

Oxbryta (voxelotor) is no longer available in the United States. Pfizer voluntarily withdrew the medication from all global markets on September 25-26, 2024, following FDA safety alerts. Humana and other insurers now deny all claims due to loss of FDA approval. If you're currently taking Oxbryta, contact your hematologist immediately to transition to alternative sickle cell disease treatments like hydroxyurea, L-glutamine (Endari), or crizanlizumab (Adakveo). Do not stop treatment without medical guidance.

Next steps: Schedule urgent appointment with your sickle cell specialist, review alternative treatments, and discuss insurance coverage for new medications with Humana.

Table of Contents

  1. Why Oxbryta Was Withdrawn
  2. Current Insurance Coverage Status
  3. Alternative Sickle Cell Disease Treatments
  4. Transitioning Your Care
  5. Humana Coverage for Alternative Treatments
  6. Appeals Process (If Applicable)
  7. North Carolina Resources
  8. FAQ

Why Oxbryta Was Withdrawn

The FDA alerted healthcare professionals on September 26, 2024, that Pfizer voluntarily withdrew Oxbryta (voxelotor) from all markets due to safety concerns. Post-marketing studies showed higher rates of vaso-occlusive crises (severe pain episodes) and deaths in patients taking Oxbryta compared to placebo.

Important: The FDA determined that the benefits of Oxbryta no longer outweigh the risks for sickle cell disease treatment.

Key timeline:

  • September 25-26, 2024: Pfizer announces global withdrawal
  • September 26, 2024: FDA issues safety alert
  • Immediately: All prescribing, distribution, and clinical trials halted

Current Insurance Coverage Status

All U.S. insurers, including Humana, now deny Oxbryta claims due to the loss of FDA approval. This applies to:

  • New prescriptions
  • Refills of existing prescriptions
  • Specialty pharmacy transfers
  • Compassionate use programs (currently uncertain)

Humana has notified providers to warn patients and transition care immediately. No coverage exceptions are available for a withdrawn medication.

Alternative Sickle Cell Disease Treatments

Your healthcare team can help you transition to FDA-approved alternatives:

Treatment Type How It Works Coverage Status
Hydroxyurea Oral medication Increases fetal hemoglobin, reduces crises First-line; widely covered
L-glutamine (Endari) Oral powder Reduces vaso-occlusive crises FDA-approved; prior auth may apply
Crizanlizumab (Adakveo) IV infusion Targets P-selectin to prevent crises Specialty drug; requires prior auth
Luspatercept (Reblozyl) Injection Treats anemia in beta-thalassemia Limited SCD use; case-by-case
Note: Curative options like stem cell transplant or gene therapies (Casgevy, Lyfgenia) may be appropriate for select patients.

Transitioning Your Care

Immediate Steps (Next 1-2 Weeks)

  1. Contact your hematologist urgently - Do not stop Oxbryta abruptly without medical supervision
  2. Schedule transition appointment - Discuss alternative treatments and timing
  3. Gather medical records - Recent labs, crisis history, prior treatment responses
  4. Review insurance benefits - Check Humana formulary for alternative medications

What Your Doctor Will Consider

Your healthcare provider will evaluate:

  • Current disease severity and crisis frequency
  • Previous treatments tried and their effectiveness
  • Lab values (hemoglobin, reticulocyte count, bilirubin)
  • Contraindications to alternative therapies
  • Your treatment goals and preferences

Humana Coverage for Alternative Treatments

Prior Authorization Requirements

Most alternative sickle cell treatments require Humana prior authorization. Common requirements include:

For Crizanlizumab (Adakveo):

  • Confirmed sickle cell disease diagnosis (ICD-10 codes)
  • Documentation of vaso-occlusive crises
  • Trial and failure of hydroxyurea (unless contraindicated)
  • Prescriber specialization in hematology

For L-glutamine (Endari):

  • SCD diagnosis with crisis history
  • Age and weight requirements
  • Baseline lab values

Expedited Processing

If you need urgent treatment transition, request expedited prior authorization by having your doctor certify that delays could jeopardize your health. Humana processes expedited requests within 72 hours for Medicare Advantage plans.

Appeals Process (If Applicable)

While Oxbryta itself cannot be appealed due to FDA withdrawal, you may need to appeal denials for alternative treatments:

Humana Medicare Advantage Appeals

Timeline: 65 days from denial notice Methods:

  • Online: Humana member portal
  • Phone: Number on your ID card
  • Mail: Address on denial letter

Required Documentation:

  • Copy of denial letter
  • Medical necessity letter from hematologist
  • Lab results and crisis history
  • Prior treatment records

North Carolina External Review

Important: Medicare Advantage plans do not use North Carolina's Smart NC external review system. Instead, denied internal appeals go to the federal Independent Review Entity (IRE) process.

For commercial Humana plans, North Carolina residents can use Smart NC external review within 120 days of denial.

North Carolina Resources

State Support Services

  • Smart NC Helpline: 1-855-408-1212 (commercial insurance appeals assistance)
  • NC Department of Insurance: Consumer protection and guidance
  • Medicaid Ombudsman: For Medicaid-related issues (separate from private insurance)

Patient Advocacy

Organizations like Counterforce Health help patients navigate insurance denials and appeals, turning complex medical necessity requirements into targeted, evidence-backed submissions that align with payer policies.

From our advocates: "When transitioning from a withdrawn medication like Oxbryta, we've seen success by immediately documenting the medical necessity for alternative treatments before gaps in therapy occur. Having your hematologist submit prior authorization requests proactively, rather than reactively after a crisis, often leads to faster approvals."

FAQ

Q: Can I still get Oxbryta through a patient assistance program? A: No. Pfizer has withdrawn Oxbryta globally, and all patient assistance programs have been discontinued.

Q: Will Humana cover the cost of transitioning to a new medication? A: Yes, if the alternative medication is on Humana's formulary or approved through prior authorization. Transition supplies may be available during the approval process.

Q: How long do I have to transition off Oxbryta? A: This is a medical decision that should be made with your hematologist. The FDA recommends contacting your healthcare provider immediately to discuss discontinuation and alternative treatments.

Q: What if I can't afford my new medication? A: Check for manufacturer patient assistance programs, copay cards, and foundation grants for your specific alternative treatment. Your specialty pharmacy can also help identify financial assistance options.

Q: Can I appeal to get Oxbryta back? A: No. Insurance appeals cannot override FDA safety decisions. The medication is no longer available in the United States.

Q: Will my medical records from Oxbryta help with prior authorization for alternatives? A: Yes. Your treatment history, including response to Oxbryta and any side effects, will help your doctor justify medical necessity for alternative treatments.

Getting Additional Help

If you need assistance navigating insurance coverage for alternative sickle cell treatments, Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed submissions that align with payer policies and clinical guidelines.

For immediate questions about your Humana coverage, contact member services at the number on your insurance card or log into your online member portal.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider before making treatment decisions. Insurance coverage varies by plan and individual circumstances. Verify current policies and procedures with your insurer and healthcare team.

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