By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Denied by Humana in Illinois? Understanding the 2024 Withdrawal and Your Appeal Options

Answer Box: Quick Facts About Oxbryta Coverage in 2024

Oxbryta (voxelotor) was voluntarily withdrawn from the U.S. market by Pfizer in September 2024 due to safety concerns, including increased vaso-occlusive crises and fatalities. If you received a Humana denial for Oxbryta, it's likely because the drug is no longer FDA-approved. However, you still have appeal rights for alternative sickle cell disease treatments. In Illinois, you have 65 days to appeal Humana denials, with automatic external review available for medical necessity denials. Start by requesting coverage for approved alternatives like hydroxyurea, crizanlizumab, or L-glutamine through your hematologist.

Table of Contents

Understanding the Oxbryta Withdrawal

In September 2024, Pfizer voluntarily withdrew Oxbryta (voxelotor) from all markets due to new safety data showing increased rates of vaso-occlusive crises and deaths compared to placebo. The FDA supported this decision after reviewing post-marketing clinical trial data.

What this means for coverage:

  • Humana and other insurers now deny Oxbryta claims because it lacks FDA approval
  • Appeals for Oxbryta specifically will not succeed
  • Coverage efforts should focus on approved alternative treatments
Important: If you were taking Oxbryta, work immediately with your hematologist to transition to an approved alternative. Do not stop treatment abruptly without medical supervision.

Current Sickle Cell Disease Treatment Options

With Oxbryta no longer available, several FDA-approved treatments remain for sickle cell disease:

First-Line Treatments

  • Hydroxyurea: Disease-modifying therapy that increases fetal hemoglobin
  • L-glutamine (Endari): Reduces acute complications and pain crises
  • Crizanlizumab (Adakveo): Monthly infusion that reduces vaso-occlusive crises

Advanced Therapies

Treatments in Development

Several new medications are in clinical trials, including osivelotor (a next-generation polymerization inhibitor designed to replace Oxbryta) and etavopivat (a pyruvate kinase activator).

Humana Appeals Process in Illinois

Even though Oxbryta appeals won't succeed, understanding Humana's process helps when seeking coverage for alternative treatments.

Timeline and Requirements

Appeal Type Deadline Decision Timeline Required Forms
Part D (Prescription) 65 days from denial 7 calendar days Request for Redetermination form
Part C (Medical) 65 days from denial 30 days (pre-service) Standard appeal form
Expedited Immediate (if urgent) 24-72 hours Same forms + urgency documentation

Key contacts for Humana appeals:

  • Member services number on your ID card
  • Humana appeals portal (verify current link)
  • Written appeals can be mailed or faxed using addresses on denial letters

Step-by-Step: Getting Alternative Treatments Covered

1. Review Your Denial Letter

  • Identify the specific denial reason (non-formulary, step therapy, etc.)
  • Note the appeal deadline (65 days from denial date)
  • Gather your member ID, policy details, and prescriber information

2. Consult Your Hematologist

  • Discuss approved alternatives to Oxbryta
  • Request a detailed letter of medical necessity for the recommended treatment
  • Document why alternatives to standard treatments (like hydroxyurea) aren't suitable

3. Check Humana's Formulary

  • Visit Humana's drug lookup tool to verify coverage tier
  • Identify any prior authorization or step therapy requirements
  • Note quantity limits or site-of-care restrictions

4. Gather Supporting Documentation

  • Complete medical records showing sickle cell disease diagnosis
  • Laboratory results (hemoglobin levels, crisis frequency)
  • Documentation of previous treatments and their outcomes
  • Current symptoms and functional limitations

5. Submit Your Appeal

  • Use Humana's official appeal forms
  • Include all supporting documentation
  • Request expedited review if treatment delay poses health risks
  • Keep copies of all submissions

Medical Necessity Documentation

When appealing for sickle cell disease treatments, your physician's letter should include:

Required Clinical Elements

  • Diagnosis: Confirmed sickle cell disease with ICD-10 codes
  • Disease severity: Frequency of pain crises, hospitalizations, complications
  • Prior treatments: Detailed history of previous medications and outcomes
  • Medical rationale: Why the requested treatment is necessary
  • Contraindications: Why standard alternatives aren't appropriate

Supporting Evidence

  • Recent hemoglobin electrophoresis results
  • Emergency department visits or hospitalizations
  • Functional status assessments
  • Relevant clinical guidelines from organizations like the American Society of Hematology
Clinician Tip: Reference specific sections of FDA labeling and professional guidelines. For crizanlizumab appeals, cite the clinical trial data showing 45% reduction in vaso-occlusive crises compared to placebo.

Illinois External Review Rights

Illinois provides strong consumer protections through the Health Carrier External Review Act. As of 2025, medical necessity denials are automatically referred for external review unless you opt out.

Key Features

  • Automatic referral: No need to request external review for medical necessity denials
  • Independent reviewers: Board-certified physicians in the relevant specialty
  • Binding decisions: Insurers must comply with favorable external review decisions
  • No cost: Illinois prohibits charging fees for external reviews

Timeline

  • Standard review: Maximum 45 days from request to final decision
  • Expedited review: 24-72 hours for urgent cases
  • Filing deadline: 4 months from final internal denial

Getting help: Contact the Illinois Department of Insurance at 877-527-9431 or the Illinois Attorney General's Health Care Helpline at 877-305-5145.

Cost Assistance Programs

While navigating coverage appeals, several programs can help with medication costs:

Manufacturer Programs

  • Novartis Adakveo: Patient assistance program for crizanlizumab
  • Emmaus Life Sciences: Support program for L-glutamine (Endari)
  • Bristol Myers Squibb: Assistance for hydroxyurea formulations

Foundation Support

  • Patient Advocate Foundation: Copay assistance and case management
  • HealthWell Foundation: Financial assistance for eligible patients
  • Good Days: Chronic disease financial assistance programs

State Resources

Illinois residents may qualify for additional support through Medicaid expansion or state pharmaceutical assistance programs.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to create targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and develop compelling medical necessity arguments that align with payer-specific criteria. Visit www.counterforcehealth.org to learn more about their appeal assistance services.

Frequently Asked Questions

Q: Can I still get Oxbryta through an appeal? A: No. Oxbryta was withdrawn from the market due to safety concerns and is no longer available in the United States.

Q: What's the fastest way to get an alternative treatment approved? A: Start with hydroxyurea if you haven't tried it, as it's typically first-line and widely covered. For newer treatments, work with your hematologist to submit comprehensive medical necessity documentation.

Q: How long do Humana Part D appeals take in Illinois? A: Standard Part D appeals are decided within 7 calendar days. Expedited appeals for urgent situations are processed within 24-72 hours.

Q: What if my doctor recommends gene therapy? A: Gene therapies like Casgevy and Lyfgenia are FDA-approved but require specialized centers and extensive prior authorization. Expect lengthy review processes and potential need for external review.

Q: Can I get help with the appeal process? A: Yes. Illinois offers free assistance through the Department of Insurance consumer helpline, and organizations like Counterforce Health specialize in appeal assistance.

Q: What happens if Humana denies my appeal? A: In Illinois, medical necessity denials are automatically sent for external review by an independent physician. This decision is binding on Humana.

Q: Are there clinical trials available for new sickle cell treatments? A: Yes. Ask your hematologist about trials for osivelotor (Oxbryta replacement), etavopivat, and other investigational treatments at major medical centers.

Q: Does step therapy apply to sickle cell disease treatments? A: Often yes. Most plans require trying hydroxyurea before approving newer treatments like crizanlizumab, unless contraindicated.

From our advocates: We've seen success when families work closely with their hematology team to document not just clinical markers, but real-world impact—missed school days, emergency visits, and functional limitations. This comprehensive picture often strengthens appeals for newer therapies when standard treatments aren't sufficient.

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 with qualified professionals about insurance matters. Coverage policies and procedures may change; verify current requirements with your insurer and state regulators.

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