By Counterforce Health Team in Oxbryta (voxelotor) —

UnitedHealthcare Coverage for Oxbryta (Voxelotor) in Washington: 2024 FDA Withdrawal and Alternative Options

Answer Box: Oxbryta Coverage Status

Oxbryta (voxelotor) is no longer available and cannot be covered by UnitedHealthcare or any insurer. Pfizer voluntarily withdrew the drug in September 2024 following FDA safety review.

Your fastest path forward: Work with your hematologist to transition to FDA-approved alternatives like hydroxyurea, L-glutamine, or crizanlizumab. If denied coverage, Washington residents can appeal through UnitedHealthcare's internal process, then request external review through an Independent Review Organization (IRO) within 60 days.

First step today: Contact your prescriber to discuss alternative sickle cell treatments and submit prior authorization requests through UnitedHealthcare's provider portal.

Table of Contents

  1. Why Oxbryta Is No Longer Available
  2. UnitedHealthcare Coverage for Sickle Cell Alternatives
  3. Prior Authorization Requirements
  4. Step Therapy and Medical Exceptions
  5. Required Documentation
  6. Appeals Process in Washington
  7. Cost Assistance Programs
  8. Frequently Asked Questions

Why Oxbryta Is No Longer Available

Pfizer voluntarily withdrew Oxbryta (voxelotor) from the U.S. market in September 2024 after the FDA requested its removal. The decision came following a confirmatory study that showed the overall benefit of the medication no longer outweighed its risks.

This withdrawal means:

  • No insurance company, including UnitedHealthcare, can cover Oxbryta
  • All existing prescriptions were discontinued
  • Claims are automatically denied due to loss of FDA approval
  • Patients need to transition to alternative treatments

If you were previously taking Oxbryta, your healthcare team should have contacted you about transitioning to other FDA-approved sickle cell disease treatments.

UnitedHealthcare Coverage for Sickle Cell Alternatives

UnitedHealthcare covers several FDA-approved treatments for sickle cell disease through its standard and specialty pharmacy benefits:

Coverage at a Glance

Treatment Prior Auth Required? Formulary Tier Step Therapy Typical Coverage
Hydroxyurea (generic) Usually No Tier 1-2 No Standard coverage
L-glutamine (Endari) Yes Tier 3-4 May require hydroxyurea trial Specialty pharmacy
Crizanlizumab (Adakveo) Yes Tier 4-5 Usually requires hydroxyurea trial Specialty pharmacy
Gene therapy (Casgevy/Lyfgenia) Yes Case-by-case Extensive criteria Medical benefit

Source: UnitedHealthcare Prior Authorization Requirements

Prior Authorization Requirements

Standard Processing Times

  • Standard review: 72 hours
  • Expedited review: 24 hours for urgent cases
  • Submission method: UnitedHealthcare Provider Portal or fax

Required Clinical Criteria

For advanced sickle cell treatments like crizanlizumab, UnitedHealthcare requires:

  1. Documented sickle cell disease diagnosis with genetic testing confirmation
  2. At least 2 vaso-occlusive crisis events requiring medical facility visits in the past year
  3. Adequate trial of conventional therapy (hydroxyurea or L-glutamine) at maximum tolerated doses
  4. Prescription by qualified specialist (hematologist/oncologist or sickle cell disease specialist)
  5. Positive clinical response to prior conventional therapy
Clinician Corner: Medical necessity letters should include specific ICD-10 codes (D57.x series), hemoglobin electrophoresis results, documentation of crisis frequency, and detailed prior treatment history with outcomes.

Step Therapy and Medical Exceptions

Standard Step Therapy Sequence

  1. First-line: Hydroxyurea (generic, usually covered without PA)
  2. Second-line: L-glutamine if hydroxyurea fails or is contraindicated
  3. Third-line: Crizanlizumab or other advanced therapies

Medical Exception Pathways

You can bypass step therapy if you have:

  • Documented contraindications to required medications
  • Previous treatment failures with adequate trials
  • Clinical urgency requiring immediate advanced therapy
  • Provider attestation of medical necessity

To request a step therapy exception, submit documentation showing why the preferred medication sequence isn't appropriate for your specific case.

Required Documentation

For Patients and Families

Gather these documents before starting your appeal:

  • Insurance card and policy information
  • Complete medical records from your hematologist
  • Lab results (hemoglobin electrophoresis, CBC)
  • Documentation of crisis episodes and hospitalizations
  • List of all medications tried and outcomes

For Healthcare Providers

Include in prior authorization requests:

  • Confirmed SCD diagnosis with genetic testing
  • ICD-10 codes (D57.00, D57.01, D57.02, etc.)
  • Hemoglobin electrophoresis results
  • Crisis frequency and severity documentation
  • Prior treatment history with specific medications, doses, and durations
  • Clinical response assessments
  • Specialist consultation notes

Appeals Process in Washington

Washington state provides strong consumer protections for insurance denials. Here's your step-by-step appeals roadmap:

Internal Appeals (First Step)

  1. Submit within 180 days of the initial denial
  2. Use UnitedHealthcare's member portal or mail/fax your appeal
  3. Include new clinical information not previously submitted
  4. Expect decision within 30 days (or 72 hours for urgent appeals)

External Independent Review (Final Step)

If your internal appeal is denied, Washington law gives you the right to external review:

  1. Timeline: Submit within 60 days of final internal denial
  2. Process: Request through UnitedHealthcare, who assigns a certified Independent Review Organization (IRO)
  3. Review period:
    • Standard cases: 20 days for fully-insured plans
    • Expedited cases: 72 hours for urgent medical situations
  4. Decision: Final and binding on UnitedHealthcare
Note: Washington's Office of the Insurance Commissioner maintains a registry of certified IROs and can assist with the appeals process. Call their consumer helpline at 1-800-562-6900.

Source: Washington State Insurance Code RCW 48.43.535

When to Escalate

Contact the Washington Office of the Insurance Commissioner if:

  • UnitedHealthcare doesn't respond within required timeframes
  • You need help understanding your appeal rights
  • You believe your case was improperly handled

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying coverage gaps, and drafting evidence-backed rebuttals that align with each payer's specific criteria. Their platform helps patients and providers navigate complex prior authorization requirements and appeal processes more effectively. Learn more about their services.

Cost Assistance Programs

Manufacturer Support Programs

  • Novartis (crizanlizumab): Patient assistance programs available
  • Emmaus Life Sciences (L-glutamine): Copay assistance and patient support

Foundation Resources

  • Patient Access Network Foundation: Provides copay assistance for sickle cell medications
  • HealthWell Foundation: Offers grants for specialty medication costs
  • National Organization for Rare Disorders (NORD): Patient assistance programs

Washington State Programs

  • Apple Health (Medicaid): Expanded coverage for low-income residents
  • Washington Prescription Drug Program: State-sponsored assistance options

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Washington? A: Standard prior authorization decisions are made within 72 hours. Expedited reviews for urgent cases are completed within 24 hours.

Q: Can I appeal if my medication is non-formulary? A: Yes. You can request a formulary exception by demonstrating medical necessity and providing clinical documentation supporting why the non-formulary medication is required.

Q: What if I was stable on Oxbryta before the withdrawal? A: Work with your hematologist to transition to an alternative treatment. Document your previous stability on Oxbryta to support medical necessity for advanced therapies if hydroxyurea alone isn't sufficient.

Q: Does UnitedHealthcare cover gene therapy for sickle cell disease? A: Yes, UnitedHealthcare covers FDA-approved gene therapies like Casgevy and Lyfgenia, but requires extensive prior authorization including genetic testing confirmation and documented inadequate response to conventional therapies.

Q: Can I request an expedited appeal in Washington? A: Yes. If your health condition could be seriously jeopardized by delays, you can request expedited internal appeals (72 hours) and expedited external review (72 hours) through the IRO process.

Q: What happens if the IRO overturns UnitedHealthcare's denial? A: The IRO decision is final and binding. UnitedHealthcare must approve coverage and cannot appeal the IRO's determination.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual policy and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized assistance with insurance appeals and prior authorization requirements, consider consulting with coverage advocacy services like Counterforce Health, which specializes in helping patients navigate complex insurance approval processes.

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