By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Coverage by UnitedHealthcare in North Carolina: Understanding the 2024 FDA Withdrawal and Your Options

Answer Box

Oxbryta (voxelotor) is no longer covered by UnitedHealthcare or any insurer because Pfizer voluntarily withdrew it from all markets in September 2024 following FDA safety concerns. All claims for Oxbryta are now universally denied due to loss of FDA approval. If you're currently taking Oxbryta, contact your hematologist immediately to discuss transition to FDA-approved alternatives like hydroxyurea, crizanlizumab, or L-glutamine. For coverage of these alternatives in North Carolina, work with your provider to submit prior authorization through UnitedHealthcare's portal, and if denied, you can appeal through North Carolina's Smart NC external review program within 120 days.

Table of Contents

  1. Coverage Basics: Is Oxbryta Covered?
  2. Why Claims Are Being Denied
  3. FDA-Approved Alternatives for Sickle Cell Disease
  4. Getting Alternative Treatments Covered
  5. UnitedHealthcare Prior Authorization Process
  6. Appeals Process in North Carolina
  7. Patient Safety and Transition Guidelines
  8. Costs and Financial Assistance
  9. When to Contact Smart NC
  10. FAQ

Coverage Basics: Is Oxbryta Covered?

No, Oxbryta (voxelotor) is not covered by UnitedHealthcare or any other insurance plan as of September 2024. Pfizer voluntarily withdrew all lots of Oxbryta globally after new clinical data showed increased rates of vaso-occlusive crises and deaths compared to placebo.

This withdrawal affects all UnitedHealthcare plan types in North Carolina:

  • Medicare Advantage plans
  • Commercial employer plans
  • Individual marketplace plans
  • Medicaid managed care plans
Important: If you're currently taking Oxbryta, do not stop suddenly. Contact your sickle cell specialist immediately to discuss safe transition options.

Why Claims Are Being Denied

Insurance companies, including UnitedHealthcare, now deny all Oxbryta claims for the following reasons:

Denial Reason Explanation What This Means
Loss of FDA approval Drug withdrawn from market No appeals will succeed
Safety concerns Increased mortality risk identified Prescriptions cannot be filled
No longer manufactured Pfizer ceased all production No emergency supply available

Humana's official communication confirms this industry-wide approach to Oxbryta denials.

FDA-Approved Alternatives for Sickle Cell Disease

Several treatments remain FDA-approved and covered by UnitedHealthcare for sickle cell disease:

First-Line Treatments

  • Hydroxyurea - Oral medication that reduces pain crises
  • L-glutamine (Endari) - Amino acid supplement to reduce complications

Specialty Treatments

  • Crizanlizumab (Adakveo) - Injectable medication for preventing pain crises
  • Gene therapies - Casgevy and Lyfgenia for eligible patients

Supportive Care

  • Pain management protocols
  • Blood transfusions when indicated
  • Hydroxyurea optimization

Work with your hematologist to determine the most appropriate alternative based on your medical history and current condition.

Getting Alternative Treatments Covered

UnitedHealthcare requires prior authorization for many sickle cell medications, especially newer specialty drugs like crizanlizumab.

Coverage Requirements Table

Treatment Prior Auth Required? Step Therapy? Typical Coverage Tier
Hydroxyurea Usually no No Tier 1-2 (generic)
L-glutamine Yes May require hydroxyurea trial Tier 3-4
Crizanlizumab Yes Usually requires hydroxyurea trial Tier 4-5 (specialty)
Gene therapy Yes Extensive criteria Case-by-case

UnitedHealthcare Prior Authorization Process

For alternative sickle cell treatments requiring prior authorization:

Step-by-Step Process

  1. Provider Submits PA Request
  2. Required Documentation
    • Confirmed sickle cell disease diagnosis with ICD-10 codes
    • Hemoglobin electrophoresis results
    • Prior treatment history (especially hydroxyurea trials)
    • Current symptoms and complications
  3. Medical Necessity Criteria
    • Documentation of inadequate response to standard therapy
    • Evidence of contraindications to first-line treatments
    • Specialist consultation notes
Clinician Corner: Include specific details about prior hydroxyurea dosing, duration of trial, and reasons for discontinuation or inadequacy. Reference NHLBI sickle cell guidelines in your medical necessity letter.

Appeals Process in North Carolina

If UnitedHealthcare denies coverage for an alternative sickle cell treatment, North Carolina residents have strong appeal rights.

Internal Appeals with UnitedHealthcare

First-Level Appeal:

Second-Level Appeal:

  • Available if first appeal is denied
  • Same timelines and submission methods

Peer-to-Peer Review

  • Request within 5 business days of denial
  • Allows direct physician-to-physician discussion
  • Can be combined with formal appeals

When to Contact Smart NC

If UnitedHealthcare upholds their denial after internal appeals, North Carolina residents can request an external review through Smart NC.

Smart NC External Review Process

Eligibility:

  • Must exhaust UnitedHealthcare's internal appeals first
  • Denial must be based on medical necessity or experimental treatment determination
  • Must have a state-regulated plan (most commercial plans qualify)

Timeline:

  • Request deadline: 120 days after final internal denial
  • Review timeline: 45 days for standard, 72 hours for expedited
  • Success rate: Approximately 61% of external appeals are successful

How to Apply:

  • Call Smart NC at 1-855-408-1212 for free assistance
  • Submit external review request form online
  • Include all denial letters and supporting medical records
From our advocates: We've seen numerous sickle cell medication denials overturned through Smart NC's external review process. The key is comprehensive documentation showing medical necessity and failed alternatives. While outcomes aren't guaranteed, North Carolina's external review provides an important safety net for patients facing coverage barriers.

Patient Safety and Transition Guidelines

If You're Currently Taking Oxbryta

Immediate Steps:

  1. Contact your hematologist within 48 hours
  2. Do not stop Oxbryta abruptly without medical supervision
  3. Schedule transition planning appointment
  4. Discuss monitoring for withdrawal effects

Transition Monitoring:

  • Increased frequency of lab monitoring
  • Pain crisis prevention planning
  • Emergency care protocols
  • Alternative therapy initiation timing

The American Society of Hematology provides guidance for clinicians managing Oxbryta transitions.

Costs and Financial Assistance

UnitedHealthcare Coverage

  • Hydroxyurea: Typically low copay (generic tier)
  • L-glutamine: Higher copay, may require prior auth
  • Crizanlizumab: Specialty tier, often 20-40% coinsurance

Financial Assistance Programs

  • Manufacturer copay cards for brand medications
  • Patient assistance programs for uninsured/underinsured
  • State pharmaceutical assistance through North Carolina programs
  • Foundation grants for rare disease treatments

Counterforce Health specializes in helping patients navigate insurance denials and appeals for specialty medications. Their platform can help identify the specific denial reasons and draft targeted appeals that align with UnitedHealthcare's coverage policies, potentially saving weeks in the appeals process.

FAQ

Q: Can I still get Oxbryta through an appeal or special exception?
A: No. The FDA withdrawal means no insurance company can cover Oxbryta, and pharmacies cannot dispense it regardless of appeal outcomes.

Q: How long does UnitedHealthcare prior authorization take for alternative treatments?
A: Standard requests: 72 hours. Expedited requests (for urgent medical needs): 24 hours. Complex cases may take longer.

Q: What if I was stable on Oxbryta and alternatives don't work as well?
A: Work closely with your hematologist to optimize alternative treatments. Document any inadequate responses for potential access to newer therapies or clinical trials.

Q: Does UnitedHealthcare's step therapy apply if I tried alternatives before Oxbryta?
A: Generally yes, but prior treatment history should be documented in your medical records. Your doctor can request exceptions based on previous failures or contraindications.

Q: Can I request an expedited appeal in North Carolina?
A: Yes, both UnitedHealthcare and Smart NC offer expedited reviews for urgent medical situations. The standard is 72 hours for UnitedHealthcare, 72 hours for Smart NC.

Q: What documents do I need for a Smart NC external review?
A: All denial letters from UnitedHealthcare, complete medical records, prescriber letters supporting medical necessity, and the external review request form.

Q: Are there clinical trials available for new sickle cell treatments?
A: Yes, contact major sickle cell centers in North Carolina or search ClinicalTrials.gov for current studies.

Q: How can I find a sickle cell specialist in North Carolina if I need a second opinion?
A: Contact the Sickle Cell Disease Association of America for provider directories and local resources.

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 company or Counterforce Health for specific coverage questions. Insurance policies and coverage criteria can change; verify current requirements with your plan.

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