By Counterforce Health Team in Oxbryta (voxelotor) —

How to Get Oxbryta (Voxelotor) Covered by Cigna in Georgia: Appeals Guide After FDA Withdrawal

Important Update: Oxbryta (voxelotor) was withdrawn from the U.S. market in 2024 following FDA's request after confirmatory evidence review. Current claims are typically denied due to loss of FDA approval. However, if you're dealing with a prior denial or need alternative SCD treatments, Georgia's external review process through the Department of Insurance remains available within 60 days of Cigna's final denial. Contact your prescriber immediately to discuss approved alternatives like hydroxyurea, L-glutamine, or crizanlizumab.

Table of Contents

Understanding Cigna's Current Position

Oxbryta (voxelotor) is no longer FDA-approved in the United States. In 2024, Pfizer voluntarily withdrew the drug following FDA's request after a confirmatory evidence review. This means:

  • New prescriptions cannot be filled
  • Existing prior authorizations have been terminated
  • Claims are automatically denied due to loss of regulatory approval
  • The drug remains unavailable through Cigna's specialty pharmacy partners
Note: Status may differ outside the U.S., but this guide focuses on Georgia coverage under U.S. regulations.

What This Means for Current Patients

If you were previously taking Oxbryta, your prescriber should have contacted you about transitioning to alternative treatments. Cigna's specialty pharmacy network will not process new claims for this medication.

Plan Types and Coverage Implications

Understanding your specific Cigna plan type affects how alternative SCD treatments are covered:

Plan Type Network Requirements Referrals Needed Specialty Drug Coverage
HMO In-network only Yes, from PCP Covered with PA; requires referral to hematologist
PPO In/out-of-network No Broader access; higher out-of-network costs
EPO In-network only No Direct specialist access; no out-of-network coverage
Georgia-Specific: Cigna markets these as "Cigna EPO," "Cigna PPO," and "Cigna OAP" in Georgia. Verify your plan type on your member ID card.

Specialty Pharmacy Requirements

Cigna routes most SCD medications through Express Scripts/Accredo specialty pharmacy. This includes:

  • Prior authorization processing
  • Step therapy enforcement
  • Quantity limit monitoring
  • Patient education and support

Alternative SCD Treatment Options

With Oxbryta no longer available, focus shifts to FDA-approved alternatives:

Currently Approved Options

Hydroxyurea (generic/Droxia/Hydrea)

  • Formulary status: Typically Tier 1-2 (generic preferred)
  • PA requirements: Usually minimal for documented SCD
  • Coverage: Widely covered across all Cigna plan types

L-glutamine (Endari)

  • Formulary status: Tier 4 specialty
  • PA requirements: Required; must demonstrate SCD diagnosis
  • Specialty pharmacy: Dispensed through Accredo

Crizanlizumab (Adakveo)

  • Formulary status: Tier 4 specialty
  • PA requirements: Extensive; requires failure of hydroxyurea
  • Administration: Infusion therapy (buy-and-bill)

Step Therapy Patterns

Most Cigna policies require trial of hydroxyurea before approving newer agents. Formulary exception processes are available if:

  • Contraindications exist to first-line therapy
  • Previous treatment failure documented
  • Adverse reactions prevent use

Appeals Process for Prior Denials

If you received a denial for Oxbryta before the withdrawal, you still have appeal rights:

Internal Appeals Timeline

  1. Standard Appeal: Must file within 180 days of denial date
  2. Review Period: Cigna responds within 30 days for pre-service, 60 days for post-service
  3. Expedited Option: 72-hour response for urgent situations

Required Documentation

Even for withdrawn drugs, appeals require:

  • Original denial letter
  • Prescriber's medical necessity statement
  • Documentation of diagnosis (ICD-10: D57.x series for SCD)
  • Prior treatment history and outcomes
  • Current clinical status and treatment goals
Tip: While Oxbryta appeals are unlikely to succeed due to FDA withdrawal, the process helps establish medical necessity for alternative treatments.

Georgia External Review Rights

Georgia provides robust external review protections for fully insured plans:

Key Deadlines and Process

  • Filing deadline: 60 days from Cigna's final internal denial
  • Review timeline: 30 business days (72 hours for urgent cases)
  • Cost: Free to consumers
  • Decision: Binding on Cigna

How to Request External Review

  1. Contact Georgia DOI: Call 1-800-656-2298 or use the online complaint form
  2. Submit required documents:
    • Cigna's final denial letter
    • All medical records supporting the request
    • Completed external review application
  3. Independent review: Georgia DOI assigns an independent review organization
Important: External review applies to medical necessity disputes, not regulatory compliance issues like FDA withdrawal.

Success Rates and Outcomes

While Georgia doesn't publish drug-specific overturn rates, national Medicare Advantage data shows that when patients appeal denials, approximately two-thirds achieve at least partial success. Cigna members appeal denials at higher rates (18%) compared to other major insurers.

When to Contact State Regulators

Contact the Georgia Department of Insurance if:

  • Cigna misses appeal deadlines
  • Claims processing errors occur
  • You need help with the external review process
  • Transition to alternative therapies is delayed

Georgia DOI Consumer Services: 1-800-656-2298

Patient Support Resources

Financial Assistance

  • Manufacturer programs: Check current offerings for approved alternatives
  • Foundation support: Organizations like Good Days, PAN Foundation may help with copays
  • State programs: Georgia's limited Medicaid expansion may provide options for eligible individuals

Clinical Support

Counterforce Health specializes in helping patients navigate insurance denials for specialty medications. Their platform can help identify the strongest clinical arguments for alternative SCD treatments and draft targeted appeals that align with Cigna's specific policies.

From our advocates: "When Oxbryta was withdrawn, we helped several Georgia patients transition their appeals to focus on expedited access to crizanlizumab. The key was demonstrating continuous medical need and documenting why standard step therapy timelines posed clinical risks during the transition period."

Support Organizations

  • Sickle Cell Disease Association of America: Local Georgia chapters provide advocacy support
  • Georgians for a Healthy Future: Consumer assistance with insurance appeals
  • Georgia Legal Services Program: Free legal help for Medicaid/PeachCare appeals

FAQ

Q: Can I still get Oxbryta if I was already taking it? A: No. The FDA withdrawal means no U.S. pharmacy can legally dispense voxelotor. Your prescriber should help transition you to an approved alternative.

Q: Will Cigna cover my transition to a new SCD medication? A: Yes, but prior authorization may be required. The withdrawal of your previous medication may help justify expedited review of alternatives.

Q: How long does Cigna prior authorization take for SCD drugs in Georgia? A: Standard reviews take up to 72 hours for specialty drugs. Expedited reviews (for urgent situations) are completed within 24 hours.

Q: What if my new SCD medication requires step therapy? A: Document that you were successfully treated with Oxbryta and that standard step therapy would create a treatment gap. This may qualify for a step therapy override.

Q: Can I request an external review for a withdrawn drug? A: Georgia's external review applies to medical necessity disputes, not regulatory compliance. However, you can appeal delays in accessing alternative treatments.

Q: Does Cigna cover gene therapy for SCD? A: Coverage varies by plan and clinical criteria. These treatments typically require extensive prior authorization and may be subject to site-of-care restrictions.

Q: How do I find a sickle cell specialist in Cigna's Georgia network? A: Use Cigna's online provider directory or call member services. Major centers include Children's Healthcare of Atlanta and Emory University Hospital.

Q: What should I do if Cigna denies my alternative SCD medication? A: File an internal appeal within 180 days, then pursue external review through Georgia DOI if needed. Counterforce Health can help develop targeted appeal strategies.

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 Cigna member services or the Georgia Department of Insurance for plan-specific guidance. Coverage policies and procedures may change; verify current requirements with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.