By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Denied by Aetna (CVS Health) in Georgia: Understanding the 2024 FDA Withdrawal and Your Appeal Options

Answer Box: Oxbryta (Voxelotor) Coverage Status

Oxbryta (voxelotor) is no longer FDA-approved as of September 2024 due to safety concerns showing increased vaso-occlusive crises and deaths. Aetna (CVS Health) now denies all Oxbryta claims based on loss of FDA approval. Your next steps in Georgia: 1) Consult your hematologist immediately about FDA-approved alternatives like hydroxyurea, crizanlizumab, or L-glutamine, 2) Request prior authorization for the recommended alternative therapy, and 3) If denied coverage for alternatives, you have 60 days to file an external review with the Georgia Department of Insurance.

Table of Contents

Why Oxbryta Claims Are Being Denied

Pfizer voluntarily withdrew Oxbryta (voxelotor) from the U.S. market in September 2024 after confirmatory studies showed increased rates of vaso-occlusive crises and deaths compared to placebo. The FDA supported this withdrawal after reviewing safety data that showed the drug's risks outweighed benefits in the approved patient population.

Key facts about the withdrawal:

  • All new and existing prescriptions have been terminated
  • Clinical trials were halted immediately
  • Insurance companies, including Aetna (CVS Health), are denying all claims based on loss of FDA approval
  • Appeals for Oxbryta itself will not succeed due to the regulatory withdrawal
Note: If you were taking Oxbryta, do not stop abruptly. Contact your hematologist immediately to transition to an approved alternative under medical supervision.

FDA-Approved Alternatives for Sickle Cell Disease

Several FDA-approved treatments remain available for sickle cell disease management:

Medication Type How It Works Coverage Considerations
Hydroxyurea Oral medication Increases fetal hemoglobin, reduces pain crises Generally well-covered; first-line therapy
L-glutamine (Endari) Oral supplement Reduces frequency of sickle cell crises May require prior authorization
Crizanlizumab (Adakveo) IV infusion Monoclonal antibody reduces vaso-occlusive crises Specialty tier; requires PA

Advanced therapies like hematopoietic stem cell transplantation and gene therapy are also options for select patients, though these require specialized centers and extensive coverage review.

Getting Alternative Treatments Covered by Aetna

Step-by-Step: Fastest Path to Approval

  1. Consult Your Hematologist (Patient + Provider)
    • Discuss FDA-approved alternatives based on your medical history
    • Document why the recommended therapy is medically necessary
    • Timeline: Same day or within 48 hours
  2. Submit Prior Authorization Request (Provider)
  3. Gather Supporting Documentation (Patient + Provider)
    • Recent lab results showing sickle cell disease markers
    • Documentation of previous treatments and outcomes
    • Letter of medical necessity from your hematologist
    • Timeline: Prepare within 1-2 weeks

Clinician Corner: Medical Necessity Letter Checklist

When requesting coverage for SCD alternatives, include:

  • Diagnosis confirmation: Hemoglobin electrophoresis results, genetic testing
  • Prior treatment history: Previous medications tried, including Oxbryta if applicable
  • Current clinical status: Recent hemoglobin levels, crisis frequency, hospitalizations
  • Treatment rationale: Why the specific alternative is appropriate
  • Guideline support: Reference NHLBI sickle cell disease guidelines where applicable

Georgia Appeals Process for Denied Claims

If Aetna denies coverage for alternative SCD treatments, Georgia provides robust appeal rights:

Internal Appeal (First Step)

  • Deadline: 180 days from denial date
  • Timeline: Aetna has 30-45 days to respond (72 hours for expedited)
  • How to file: Call 1-800-872-3862 or submit via member portal

External Review (Final Step)

Important: The external review decision is binding on Aetna. If approved, they must cover the treatment.

For urgent medical situations, you can request expedited external review concurrently with internal appeals if delays pose serious health risks.

Bridge Therapy and Emergency Supply Options

While transitioning from Oxbryta to approved alternatives, several options may help prevent treatment gaps:

Emergency Pharmacy Supplies

  • Most Georgia pharmacies can provide 3-7 day emergency supplies of critical medications
  • Contact your pharmacy directly to request emergency fill pending insurance approval
  • May be subject to state controlled substance regulations for pain medications

Pain Crisis Management

Research shows that timely pain medication administration (first dose within 60 minutes) significantly reduces hospitalizations for SCD patients. If you experience a crisis:

  • Seek emergency care immediately
  • Bring documentation of your SCD diagnosis and usual medications
  • Emergency departments should follow rapid pain relief protocols per national guidelines

Manufacturer Support Programs

  • Check if alternative medications offer patient assistance programs
  • Many SCD treatments have copay cards or foundation grants available
  • Contact the manufacturer directly or ask your specialty pharmacy

When to Contact Georgia Insurance Regulators

Contact the Georgia Department of Insurance Consumer Services (1-800-656-2298) if:

  • Aetna fails to respond to appeals within required timeframes
  • You need help understanding your external review rights
  • You believe Aetna is improperly denying coverage for FDA-approved alternatives
  • You need assistance with the external review application process

The department can provide guidance and may informally contact Aetna to ensure proper procedures are followed.

Counterforce Health helps patients navigate complex insurance appeals by turning denials into targeted, evidence-backed responses. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and meeting procedural deadlines. For patients facing coverage challenges with specialty medications like SCD treatments, having the right documentation and appeal strategy can make the difference between approval and denial.

FAQ: Common Questions About Oxbryta Withdrawal

Why did the FDA allow Oxbryta to be withdrawn? The FDA supported Pfizer's voluntary withdrawal after confirmatory studies showed increased vaso-occlusive crises and deaths in patients taking voxelotor compared to placebo, indicating the risks outweighed benefits.

Can I still get Oxbryta through appeals or exceptions? No. Since Oxbryta is no longer FDA-approved in the U.S., all insurance companies must deny claims. Appeals for Oxbryta itself will not succeed.

What if I was doing well on Oxbryta? Consult your hematologist immediately about transitioning to FDA-approved alternatives. Your doctor can help select the most appropriate therapy based on your response to Oxbryta and overall health status.

How long does Aetna prior authorization take for SCD alternatives? Standard prior authorization typically takes 30-45 days. For urgent situations, expedited review is available within 72 hours with provider certification of medical urgency.

Are there clinical trials available for new SCD treatments? Yes, but all Oxbryta-specific trials were halted. Consult ClinicalTrials.gov or ask your hematologist about ongoing studies for other investigational SCD therapies.

What if I can't afford the alternative treatments? Many SCD medications offer manufacturer patient assistance programs, copay cards, or foundation grants. Additionally, most SCD patients qualify for Medicaid coverage, which generally covers FDA-approved treatments.

This information is for educational purposes only and does not constitute medical or legal advice. Always consult your healthcare provider before making treatment decisions and verify current insurance policies directly with Aetna. For official Georgia insurance regulations and appeal procedures, visit the Georgia Department of Insurance website.

Sources & Further Reading

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