By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Coverage with UnitedHealthcare in Virginia: FDA Withdrawal Impact and Alternative Options

Answer Box: Oxbryta Coverage Status with UnitedHealthcare in Virginia

Important: Oxbryta (voxelotor) was voluntarily withdrawn from the U.S. market by Pfizer in September 2024 following FDA review. UnitedHealthcare now typically denies claims due to loss of FDA approval. If you're currently taking Oxbryta, work with your hematologist immediately to transition to alternative sickle cell treatments like hydroxyurea, L-glutamine, or crizanlizumab. For coverage of alternatives, follow UnitedHealthcare's standard prior authorization process through OptumRx, and utilize Virginia's external review process if denied.

Table of Contents

  1. Current Status: FDA Withdrawal Impact
  2. Alternative Sickle Cell Treatments
  3. UnitedHealthcare Prior Authorization Process
  4. Virginia External Review Rights
  5. Cost and Financial Assistance
  6. Appeals Playbook
  7. Scripts and Templates
  8. FAQ

Current Status: FDA Withdrawal Impact

Oxbryta (voxelotor) was voluntarily withdrawn from the U.S. market by Pfizer in September 2024 following an FDA review of confirmatory evidence. This withdrawal means:

  • No new prescriptions can be filled in the United States
  • Existing claims are typically denied due to loss of FDA approval
  • Insurance coverage is no longer available for U.S. patients
  • Alternative treatments must be considered for ongoing sickle cell disease management
Note: The withdrawal was based on confirmatory study results that did not demonstrate clinical benefit. Patients should work closely with their hematology team to transition to appropriate alternatives.

What This Means for Current Patients

If you were taking Oxbryta, your healthcare team should have contacted you about transitioning to alternative therapies. Do not stop treatment abruptly—work with your hematologist to develop a transition plan that maintains your sickle cell disease management.

Alternative Sickle Cell Treatments

With Oxbryta no longer available, several FDA-approved alternatives exist for sickle cell disease management:

Standard Treatment Options

Treatment Mechanism Typical Coverage
Hydroxyurea Increases fetal hemoglobin production Usually first-line; minimal PA requirements
L-glutamine (Endari) Reduces oxidative stress May require PA; often covered after hydroxyurea trial
Crizanlizumab (Adakveo) P-selectin inhibitor Specialty tier; requires PA and step therapy

Advanced Therapies

For eligible patients, newer options include:

  • Gene therapy (Casgevy, Lyfgenia) - highly specialized, limited centers
  • Bone marrow transplant - for select candidates with matched donors
Clinician Corner: When requesting coverage for sickle cell alternatives, document prior therapy trials, current crisis frequency, and specific treatment goals. Include recent hemoglobin levels, crisis frequency over the past 12 months, and any contraindications to first-line therapies.

UnitedHealthcare Prior Authorization Process

UnitedHealthcare requires prior authorization for most specialty sickle cell treatments through OptumRx. Here's the fastest path to approval:

Step-by-Step Process

  1. Verify Coverage Requirements
    • Check your plan's formulary at OptumRx.com
    • Confirm specialty pharmacy requirements
    • Note any step therapy protocols
  2. Gather Required Documentation
    • Current sickle cell disease diagnosis (ICD-10: D57.xx)
    • Recent lab results (hemoglobin, reticulocyte count)
    • Documentation of prior treatments and outcomes
    • Crisis frequency and severity records
  3. Submit Prior Authorization
  4. Follow Up Timeline
    • Standard review: 15 business days
    • Expedited review: 72 hours
    • Appeals: 30 calendar days for reconsideration

Common Requirements for Specialty SCD Treatments

  • Confirmed sickle cell disease diagnosis
  • Trial and failure of hydroxyurea (unless contraindicated)
  • Documentation of ongoing vaso-occlusive crises
  • Prescriber specialization in hematology/oncology
  • Use of preferred specialty pharmacy

Virginia External Review Rights

Virginia provides robust external review rights through the State Corporation Commission's Bureau of Insurance. After completing UnitedHealthcare's internal appeals, you have additional options:

External Review Process

Timeline: 120 days from final internal denial to request external review

Eligibility: Virginia-issued plans or opted-in self-funded plans; denials based on medical necessity, experimental treatment, or clinical judgment

Process:

  1. Complete internal appeals with UnitedHealthcare first
  2. Contact Virginia Bureau of Insurance Consumer Services at 1-877-310-6560
  3. Submit Form 216-A External Review Request
  4. Independent Review Organization (IRO) reviews case within 45 days
  5. Expedited reviews available for urgent cases (72 hours)
Virginia Advantage: The state allows expedited external review for certain cancer and life-threatening conditions without exhausting internal appeals—a unique protection that may apply to severe sickle cell complications.

Required Documentation for External Review

  • Final internal appeal denial letter
  • All medical records supporting the request
  • Physician statement of medical necessity
  • Form 216-A completed and signed
  • Any additional evidence not previously submitted

Cost and Financial Assistance

Specialty sickle cell treatments can be expensive. Multiple assistance programs are available to Virginia residents:

Manufacturer Support Programs

  • Crizanlizumab (Adakveo): Novartis patient assistance programs
  • L-glutamine (Endari): Emmaus Life Sciences support programs
  • Commercial insurance copay cards (not available for Medicare/Medicaid)

National Copay Foundations

Virginia patients can access several national programs:

  • Patient Advocate Foundation Co-Pay Relief: Income up to 400% Federal Poverty Level
  • Good Days: Disease-specific funds for blood disorders
  • The Assistance Fund: Rare disease coverage including sickle cell
  • Accessia Health: Specialty drug copay assistance
Application Tip: Apply to multiple foundations simultaneously, as funding availability varies. Most require active insurance coverage and U.S. residency.

Virginia-Specific Resources

  • Virginia Poverty Law Center: Legal assistance for coverage denials
  • Medicaid expansion: Available since 2019 for income-eligible adults
  • State Corporation Commission Ombudsman: Free help with insurance disputes

Appeals Playbook

If your alternative sickle cell treatment is denied by UnitedHealthcare, follow this structured approach:

Internal Appeals Process

Level Timeline How to Submit Required Documents
First Level 30 calendar days UnitedHealthcare Provider Portal Denial letter, clinical records, medical necessity letter
Expedited 72 hours Same portal, mark urgent Medical urgency certification, all standard documents
Second Level 30 calendar days Automatic if first denied Additional clinical evidence, specialist consultation

Medical Necessity Documentation

Your appeal should include:

  • Diagnosis confirmation with ICD-10 codes
  • Prior treatment history including hydroxyurea trial/failure
  • Current clinical status with recent labs and crisis frequency
  • Treatment goals and expected outcomes
  • Guideline citations from ASH, NHLBI, or FDA labeling

When to Request Peer-to-Peer Review

Before filing an appeal, consider requesting a peer-to-peer review where your hematologist speaks directly with UnitedHealthcare's medical director. This can resolve denials faster than formal appeals.

Scripts and Templates

Patient Call Script to UnitedHealthcare

"Hello, I'm calling about a prior authorization denial for [alternative SCD treatment]. My member ID is [number]. I'd like to understand the specific denial reasons and what documentation is needed for an appeal. Can you also tell me if peer-to-peer review is available before I file an appeal?"

Key questions to ask:

  • What specific criteria weren't met?
  • Is step therapy required?
  • Can we request expedited review?
  • What's the exact appeal deadline?

Medical Necessity Letter Template

"[Patient] has confirmed sickle cell disease (ICD-10: D57.[x]) with [frequency] vaso-occlusive crises despite hydroxyurea therapy [or contraindication reason]. [Requested treatment] is medically necessary because [clinical rationale]. Expected outcomes include [specific goals]. This aligns with [guideline citation] recommendations for patients with [clinical characteristics]."

FAQ

Q: Can I still get Oxbryta coverage through UnitedHealthcare? A: No. Oxbryta was withdrawn from the U.S. market in September 2024 and is no longer available for prescription or coverage.

Q: What's the fastest alternative to get approved? A: Hydroxyurea typically has minimal prior authorization requirements. L-glutamine may be approved relatively quickly if hydroxyurea has been tried.

Q: How long does UnitedHealthcare prior authorization take in Virginia? A: Standard reviews take up to 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

Q: What if my doctor says the denial is wrong? A: Request a peer-to-peer review first, then file a formal appeal with additional clinical documentation. Virginia's external review is available after internal appeals.

Q: Does step therapy apply if I've failed treatments in another state? A: Yes, documented treatment failures from other states should count toward step therapy requirements. Include complete medical records.

Q: Can I request expedited appeal for sickle cell treatment? A: Yes, if your physician certifies that waiting could seriously jeopardize your health. Virginia also offers expedited external review.

Q: Are there financial assistance programs for specialty SCD drugs? A: Yes, manufacturer copay programs, national foundations, and Virginia-specific resources are available. Apply early as funding is limited.

Q: What happens if UnitedHealthcare and external review both deny coverage? A: You retain rights to legal action and can explore other coverage options during open enrollment. Contact Virginia Poverty Law Center for legal guidance.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance denials by creating targeted, evidence-backed appeals. Our platform transforms denial letters into comprehensive rebuttals that align with payer policies and clinical guidelines, improving approval rates for specialty medications and reducing administrative burden on healthcare teams.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. For personalized assistance with insurance appeals in Virginia, contact the State Corporation Commission's Bureau of Insurance Consumer Services at 1-877-310-6560.

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