By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Denied by UnitedHealthcare in Michigan? FDA Withdrawal & Alternative Coverage Options

Answer Box: Oxbryta Coverage Status & Next Steps

Oxbryta (voxelotor) is no longer available in the US after Pfizer's voluntary withdrawal in September 2024 due to safety concerns. UnitedHealthcare automatically denies all Oxbryta claims since the drug lost FDA approval. If you're currently taking Oxbryta, work with your hematologist immediately to transition to FDA-approved alternatives like hydroxyurea, crizanlizumab (Adakveo), or L-glutamine (Endari). For coverage denials of alternative sickle cell medications, you can appeal through UnitedHealthcare's internal process, then file for external review with Michigan DIFS within 127 days.

First step today: Contact your sickle cell specialist to discuss transitioning to an approved alternative and request a letter of medical necessity for insurance coverage.

Table of Contents

  1. Why Oxbryta Was Withdrawn
  2. Current Coverage Status with UnitedHealthcare
  3. FDA-Approved Alternatives for Sickle Cell Disease
  4. How to Get Alternative Medications Covered
  5. UnitedHealthcare Appeal Process in Michigan
  6. Medical Necessity Letter Checklist
  7. Michigan External Review Process
  8. Cost Assistance Programs
  9. FAQ

Why Oxbryta Was Withdrawn

Pfizer voluntarily withdrew Oxbryta from all global markets on September 25-26, 2024, following FDA alerts about serious safety concerns. Post-marketing studies showed patients taking Oxbryta experienced:

  • Higher rates of vaso-occlusive crises (severe pain episodes)
  • Increased deaths compared to placebo groups
  • Benefits that no longer outweighed the risks

The FDA recommends that healthcare professionals stop prescribing Oxbryta immediately and help patients transition to alternative treatments. Patients should not stop taking Oxbryta abruptly without medical supervision to avoid triggering a sickle cell crisis.

Important: If you're currently taking Oxbryta, contact your hematologist immediately. Do not stop the medication without medical guidance, as sudden discontinuation could trigger a life-threatening crisis.

Current Coverage Status with UnitedHealthcare

All US insurers, including UnitedHealthcare, now automatically deny Oxbryta coverage because:

  • The drug lost FDA approval status
  • Manufacturing and distribution have ceased
  • No prescriptions or refills are available

UnitedHealthcare's denial notices cite the FDA withdrawal as the primary reason. These denials are not appealable since the medication is no longer legally available in the United States.

FDA-Approved Alternatives for Sickle Cell Disease

Several effective treatments remain available for sickle cell disease management:

Medication How It Works Typical Coverage
Hydroxyurea Increases fetal hemoglobin; reduces crises Usually covered as first-line therapy
L-glutamine (Endari) Reduces oxidative stress; decreases crises Requires prior authorization
Crizanlizumab (Adakveo) Blocks P-selectin; prevents blood cell adhesion Requires prior authorization and step therapy
Gene therapies Casgevy, Lovo-Cel for eligible patients Hospital-based; complex approval process

Your hematologist will determine the most appropriate alternative based on your medical history, previous treatments, and current symptoms.

How to Get Alternative Medications Covered

Step-by-Step Coverage Process

  1. Schedule urgent appointment with your sickle cell specialist
  2. Document current symptoms and treatment history
  3. Request letter of medical necessity for the recommended alternative
  4. Submit prior authorization through your provider
  5. Track submission via UnitedHealthcare provider portal
  6. Prepare for potential denial and appeal process
  7. File appeal within deadlines if coverage is denied

UnitedHealthcare requires prior authorization for most sickle cell medications except hydroxyurea. The process typically takes 1-3 business days for standard requests.

UnitedHealthcare Appeal Process in Michigan

If your alternative medication is denied, follow this two-level appeal process:

Internal Appeal (Level 1)

  • Timeline: Submit within 180 days of denial
  • Method: UnitedHealthcare provider portal or call OptumRx at 1-844-368-8740
  • Required documents: Denial letter, medical records, letter of medical necessity
  • Decision timeframe: Typically within 30 days (72 hours for urgent cases)

Peer-to-Peer Review Option

Before filing a formal appeal, request a peer-to-peer review within 24 hours of denial. This allows your physician to speak directly with a UnitedHealthcare medical director to discuss the case.

External Review (Level 2)

If the internal appeal is denied, you can file for external review with Michigan DIFS:

  • Timeline: 127 days from final internal denial
  • Method: Online at difs.state.mi.us or mail to DIFS Office of Appeals
  • Phone assistance: 877-999-6442
  • Decision timeframe: Up to 60 days (72 hours for expedited cases)

Medical Necessity Letter Checklist

Clinician Corner: Essential Documentation

Your physician's letter of medical necessity should include:

Patient Information:

  • Sickle cell disease type and severity
  • Current symptoms and crisis frequency
  • Functional limitations and quality of life impact

Treatment History:

  • Previous medications tried (including Oxbryta)
  • Reasons for discontinuation or failure
  • Adverse reactions or contraindications

Clinical Rationale:

  • Why the requested medication is appropriate
  • Expected benefits and treatment goals
  • Monitoring plan and safety considerations

Supporting Evidence:

  • Relevant lab values (hemoglobin levels, reticulocyte count)
  • Recent hospitalizations or emergency visits
  • Specialist recommendations

Counterforce Health specializes in helping patients and providers create compelling medical necessity letters that address specific payer requirements and increase approval rates for complex medications.

From our advocates: We've seen success when providers clearly document the progression from Oxbryta to the new medication, emphasizing continuity of care and the medical urgency of maintaining effective treatment to prevent life-threatening crises.

Michigan External Review Process

Michigan's Patient's Right to Independent Review Act provides strong protections for denied medications:

Filing Requirements

  1. Complete internal appeals first with UnitedHealthcare
  2. Submit within 127 days of final denial
  3. Include all documentation: denial letters, medical records, physician statements
  4. Specify expedited review if health would be jeopardized by delay

Review Process

  • DIFS accepts or rejects the request within 14 days
  • Independent Review Organization (IRO) evaluates medical necessity
  • Binding decision that UnitedHealthcare must follow
  • Judicial appeal option within 60 days if unsatisfied

Michigan DIFS maintains a consumer-friendly approach and often reverses inappropriate denials when medical necessity is clearly documented.

Cost Assistance Programs

While transitioning from Oxbryta, explore these financial support options:

Manufacturer Programs

  • Novartis (Adakveo): Patient assistance and copay programs
  • Emmaus Life Sciences (Endari): Financial assistance for eligible patients
  • Generic hydroxyurea: Often covered with minimal copay

Foundation Support

  • National Organization for Rare Disorders (NORD): Medication assistance
  • Sickle Cell Disease Association: Local chapter support programs
  • Patient Access Network Foundation: Copay assistance for qualifying patients

State Resources

  • Michigan Medicaid: May cover medications if eligible
  • Healthy Michigan Plan: Expanded coverage options
  • Michigan Department of Health: Additional support programs

The landscape for sickle cell treatment support has evolved since Oxbryta's withdrawal, with manufacturers and foundations adapting their programs to help patients access remaining therapies.

FAQ

How long does UnitedHealthcare prior authorization take in Michigan? Standard requests typically take 1-3 business days. Urgent cases requiring expedited review can be processed within 24-72 hours when medical necessity is clearly documented.

What if the alternative medication is non-formulary? Request a formulary exception through your provider. Include documentation showing why formulary alternatives are inappropriate or have failed in your specific case.

Can I request an expedited appeal? Yes, if your health would be seriously jeopardized by waiting for standard review timelines. Your physician must provide written documentation of the urgent medical need.

Does step therapy apply if I was stable on Oxbryta? UnitedHealthcare may waive step therapy requirements if you can document previous treatment failures or contraindications to preferred alternatives. Counterforce Health can help structure these arguments effectively.

What happens if both internal and external appeals fail? Consider working with your physician to try different alternatives, explore clinical trials, or investigate whether you qualify for gene therapy programs at specialized centers.

Are there any compassionate use programs for Oxbryta? Currently, no compassionate use programs are confirmed for Oxbryta in the US following the withdrawal. Focus efforts on accessing approved alternatives.

How do I report problems with the transition process? Contact Michigan DIFS at 877-999-6442 for insurance-related issues or report adverse events to FDA MedWatch at 1-800-332-1088.

Can I appeal to get Oxbryta covered for compassionate use? Since Pfizer has ceased all manufacturing and the FDA has withdrawn approval, appealing for Oxbryta coverage is not viable. Direct efforts toward securing coverage for appropriate alternatives.

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 and insurance plan for specific guidance regarding your individual situation. Coverage policies and appeal processes may vary by plan type and can change over time.

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