By Counterforce Health Team in Oxbryta (voxelotor) —

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

Answer Box: Oxbryta Coverage Status

Oxbryta (voxelotor) was voluntarily withdrawn from all U.S. markets in September 2024 due to increased risk of vaso-occlusive crises and deaths. UnitedHealthcare and all insurers have delisted the medication—no new claims or renewals are being approved. If you're currently taking Oxbryta, contact your hematologist immediately to discuss stopping the medication and transitioning to FDA-approved sickle cell disease treatments like hydroxyurea, L-glutamine, or crizanlizumab.

Table of Contents

Understanding the Oxbryta Withdrawal

In September 2024, Pfizer voluntarily withdrew Oxbryta (voxelotor) from all global markets following new clinical data from the HOPE-KIDS 2 study. The FDA found that patients taking Oxbryta experienced:

  • Increased frequency of vaso-occlusive crises
  • Higher risk of death compared to placebo
  • Safety risks that outweighed any potential benefits

The FDA recommends all patients stop taking Oxbryta immediately and work with their healthcare provider to find alternative treatments. There are no bridge programs or transition supplies available due to the urgent safety concerns.

Important: Do not attempt to continue taking Oxbryta or seek it from international sources. The withdrawal was based on serious safety findings that affect all patients with sickle cell disease.

Current Coverage Status with UnitedHealthcare

Following the FDA withdrawal, UnitedHealthcare has removed Oxbryta from all formularies effective immediately. This includes:

  • Individual & Family Plans (ACA Marketplace)
  • Medicare Advantage plans
  • Medicaid managed care plans
  • Employer-sponsored plans

What This Means for Members

Coverage Status Details
New prescriptions Denied - drug no longer FDA-approved
Existing refills Denied - no supply available
Prior authorizations Automatically cancelled
Appeals for coverage Will not be approved due to withdrawal

UnitedHealthcare's 2025 formulary updates reflect the removal of Oxbryta across all plan types in Florida.

Alternative Treatments and Prior Authorization

If you were taking Oxbryta or had it prescribed, your healthcare team should help transition you to FDA-approved sickle cell disease treatments. UnitedHealthcare typically covers these alternatives with prior authorization:

FDA-Approved SCD Medications

Hydroxyurea (Droxia, Siklos, generic)

  • Most commonly prescribed first-line therapy
  • Usually requires step therapy completion before other agents
  • Generic versions typically preferred on formulary

L-glutamine (Endari)

  • Oral powder for patients ≥5 years old
  • Requires documentation of inadequate response to hydroxyurea
  • Prior authorization criteria typically require specialist management

Crizanlizumab (Adakveo)

  • IV infusion for patients ≥16 years old
  • Requires evidence of recurrent vaso-occlusive crises
  • Must be administered at approved infusion centers

Prior Authorization Process

UnitedHealthcare's OptumRx system has streamlined PA processing for many specialty medications:

  1. Electronic submission via provider portal
  2. Automated approvals for qualifying cases (median 29 seconds)
  3. Standard review completed within 24 hours
  4. Renewal requirements eliminated for over 140 chronic condition drugs

If You Were Previously Denied Oxbryta

If you had an Oxbryta denial before the September 2024 withdrawal, those appeals are now moot since the drug is no longer available. However, you can use that denial as supporting evidence for alternative treatments:

Converting Your Oxbryta Denial to Alternative Coverage

  1. Gather your original denial letter and clinical documentation
  2. Document why Oxbryta was prescribed (frequency of crises, failed prior therapies)
  3. Work with your hematologist to identify the most appropriate alternative
  4. Submit new PA request for the alternative medication, referencing your previous clinical need
From our advocates: We've seen patients successfully transition from denied Oxbryta requests to approved alternative therapies by emphasizing the same clinical rationale—frequent vaso-occlusive crises despite standard care. The key is maintaining continuity in your medical narrative while pivoting to available treatments.

Appeals Process for Alternative Medications

If UnitedHealthcare denies coverage for an alternative sickle cell medication in Florida, you have specific appeal rights:

Internal Appeals (First Level)

Timeline: 180 days from denial notice Process: Submit via UnitedHealthcare member portal or mail Required documents:

  • Original denial letter
  • Prescriber's medical necessity letter
  • Clinical notes showing disease severity
  • Lab results and hospitalizations
  • Documentation of failed prior therapies

External Review (Florida)

If your internal appeal is denied, Florida's external review process provides independent medical review:

Timeline: 4 months after final internal denial Cost: Free to consumers Process: Submit request to Florida Department of Financial Services Contact: Florida Insurance Consumer Helpline at 1-877-693-5236

Expedited Reviews

For urgent cases where delay could seriously jeopardize your health:

  • Internal expedited: 72 hours
  • External expedited: Available simultaneously with internal review
  • Criteria: Life-threatening condition or severe symptom exacerbation

Florida-Specific Resources

State Insurance Assistance

Florida Department of Financial Services

  • Consumer helpline: 1-877-693-5236
  • Online complaint portal for coverage disputes
  • Free assistance with insurance appeals and external review

Florida Medicaid (if applicable)

Patient Support Organizations

For assistance navigating coverage issues and finding alternative treatments, consider contacting:

  • Sickle Cell Disease Association of America
  • National Sickle Cell Disease Program
  • Local Florida sickle cell organizations

FAQ

Can I still get Oxbryta through my insurance if I pay out-of-pocket? No. Oxbryta has been completely withdrawn from the U.S. market by the manufacturer. No supply is available regardless of payment method.

How long does UnitedHealthcare prior authorization take for sickle cell medications? OptumRx's automated system approves qualifying requests in a median of 29 seconds. Manual reviews typically complete within 24 hours.

What if my doctor says I need Oxbryta specifically? Your doctor should be aware of the FDA withdrawal. If they haven't been informed, share the FDA safety communication and ask about appropriate alternatives.

Do I need to see a specialist for sickle cell medication coverage? Most UnitedHealthcare policies require that specialty SCD medications be prescribed by or in consultation with a hematologist or sickle cell specialist.

Can I appeal to get brand-name versions of generic sickle cell medications? Yes, but you'll need to provide medical necessity documentation showing why the generic version is inappropriate for your specific case.

What happens if I can't afford my alternative medication? Contact the manufacturer's patient assistance program, look into foundation grants, or speak with a social worker at your treatment center about financial assistance options.

How do I track my prior authorization status with OptumRx? Log into the UnitedHealthcare member portal or call OptumRx customer service at 1-800-356-3477 for 24/7 assistance.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed rebuttals that align with each insurer's specific requirements. We specialize in complex specialty medication cases and understand the unique challenges patients face when navigating coverage for rare disease treatments.

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 before making medication changes and verify current coverage policies with your insurance plan. Insurance policies and formularies change regularly—confirm current requirements before submitting requests.

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