By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Coverage Denial by Humana in Virginia: Understanding FDA Withdrawal and Alternative Treatment Appeals

Answer Box: Oxbryta Coverage Status in Virginia

Oxbryta (voxelotor) is no longer available in the United States as of September 2024 due to FDA withdrawal following safety concerns. Humana and all insurers now automatically deny coverage because the drug lost FDA approval. If you're currently on Oxbryta or seeking sickle cell treatment, immediately contact your hematologist to transition to FDA-approved alternatives like hydroxyurea, L-glutamine (Endari), or crizanlizumab (Adakveo). Appeals for Oxbryta itself will not succeed, but you can appeal denials for alternative treatments using Virginia's external review process within 120 days of denial.

Next step today: Call your prescribing physician to discuss transitioning to an approved sickle cell therapy and request a prior authorization for the new medication through Humana's member portal.

Table of Contents

  1. Why Oxbryta Coverage Was Withdrawn
  2. Virginia's Prior Authorization Laws for Alternative Treatments
  3. Humana's Appeal Process for Sickle Cell Therapies
  4. Step Therapy Protections in Virginia
  5. External Review Process
  6. Alternative Sickle Cell Treatment Options
  7. Appeals Playbook for Denied Alternatives
  8. When to Contact Virginia Regulators
  9. FAQ: Common Questions About Sickle Cell Coverage

Why Oxbryta Coverage Was Withdrawn

On September 25-26, 2024, Pfizer voluntarily withdrew Oxbryta (voxelotor) from all global markets after post-marketing data revealed higher rates of vaso-occlusive crises and deaths compared to placebo. The FDA confirmed that the drug's benefits no longer outweighed its risks.

What this means for coverage:

  • All insurance companies, including Humana, automatically deny claims for withdrawn drugs
  • Prior authorizations are immediately terminated
  • No appeals for Oxbryta itself will succeed due to loss of FDA approval
  • Patients must transition to FDA-approved alternatives
Important: Do not stop sickle cell treatment abruptly. Contact your hematologist immediately to discuss transitioning to an approved therapy.

Virginia's Prior Authorization Laws for Alternative Treatments

Virginia Code § 38.2-3407.9:05 provides strong protections for patients seeking alternative sickle cell treatments when step therapy requirements create barriers. Under Virginia law, insurers must grant immediate coverage of your provider's selected drug if specific criteria are met.

Coverage Requirements Table

Requirement What It Means Timeline Source
Prior authorization response Standard decisions ≤72 hours Virginia Code § 38.2-3407.9:05
Urgent/exigent requests Life-threatening situations ≤24 hours Virginia Code § 38.2-3407.9:05
Step therapy override Medical necessity exceptions Same as above Virginia Code § 38.2-3407.9:05

Humana's Appeal Process for Sickle Cell Therapies

For Humana Medicare Advantage plans in Virginia, you have multiple ways to appeal prior authorization denials for alternative sickle cell treatments.

Filing Methods and Timelines

Standard Appeal (60 calendar days from denial):

  • Phone: 1-844-881-4482 (TTY: 711)
  • Online: Humana member portal > Documents/Forms > Appeal > Medication
  • Mail: Humana Healthy Horizons in Virginia, Grievance and Appeals Dept., P.O. Box 14163, Lexington, KY 40512-4163
  • Fax: 800-949-2961

Expedited Appeal (for urgent situations):

  • Phone: 804-371-8488 (TTY: 711), Monday–Friday 8 a.m.–8 p.m. ET
  • Decision timeline: Within 72 hours
  • Criteria: Waiting could seriously jeopardize your ability to maintain health or maximum function
Tip: For sickle cell crises or urgent medication needs, always request expedited review and have your physician document the urgency.

Step Therapy Protections in Virginia

Virginia law requires insurers to grant step therapy exceptions when specific criteria are met. This is particularly relevant for sickle cell patients who may have tried and failed multiple therapies.

Override Criteria (Any ONE qualifies)

  1. Contraindication: Required drug is contraindicated for the patient
  2. Ineffectiveness: Required drug would be ineffective based on patient's clinical characteristics
  3. Prior failure: Patient tried the required drug and discontinued due to lack of efficacy or adverse events
  4. Current positive outcome: Patient is receiving positive therapeutic outcome on the requested drug

Documentation Requirements

Your hematologist should include:

  • Specific clinical rationale citing Virginia override criteria
  • Patient history with dates, prior trials, and outcomes
  • Why the override is medically necessary
  • For sickle cell: genotype, crisis frequency, organ damage details

External Review Process

If Humana denies your appeal for an alternative sickle cell treatment, Virginia provides a free external review process through the State Corporation Commission Bureau of Insurance.

Step-by-Step External Review Process

  1. Complete Humana's internal appeal first (or wait for deadline to pass)
  2. Download Form 216-A from Virginia Administrative Code
  3. Gather required documents:
    • Final denial letter from Humana
    • Medical records proving necessity
    • Signed medical release
    • Clinical evidence from your hematologist
  4. Submit within 120 days of final denial to:
    • Email: [email protected]
    • Mail: P.O. Box 1157, Richmond, VA 23218
    • Phone for assistance: 1-877-310-6560

Timeline for External Review

Review Type Timeline When to Use
Standard 45 days Most denials
Expedited 72 hours Life-threatening situations requiring Form 216-C

Alternative Sickle Cell Treatment Options

With Oxbryta no longer available, several FDA-approved treatments remain available for sickle cell disease:

Current FDA-Approved Options

First-line therapies:

  • Hydroxyurea - Reduces crisis frequency and severity
  • L-glutamine (Endari) - Amino acid supplement to reduce crises

Advanced therapies:

  • Crizanlizumab (Adakveo) - P-selectin inhibitor for crisis prevention
  • Voxelotor alternatives - Discuss with your hematologist

Emerging options:

  • Gene therapy (in select centers)
  • Bone marrow transplant (for eligible patients)
From our advocates: We've seen patients successfully transition from Oxbryta to alternative therapies by working closely with their hematology team to document the medical rationale for each new treatment. The key is maintaining detailed records of your sickle cell history and treatment responses to support prior authorization requests.

Appeals Playbook for Denied Alternatives

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Not medically necessary Hematologist letter citing guidelines NHLBI sickle cell guidelines, crisis history
Step therapy required Virginia override criteria Prior therapy failures, contraindications
Non-formulary status Formulary exception request Medical necessity, formulary alternatives tried
Quantity limits Dosing justification Weight-based calculations, physician rationale

Medical Necessity Letter Checklist

Your hematologist's appeal letter should include:

  • Patient's sickle cell genotype (HbSS, HbSC, etc.)
  • Crisis frequency and severity before and during treatment
  • Prior therapies tried with specific dates and outcomes
  • Contraindications to formulary alternatives
  • Clinical rationale citing current guidelines
  • Treatment goals and monitoring plan

When to Contact Virginia Regulators

If Humana's appeals process doesn't resolve your coverage issue, Virginia's State Corporation Commission Bureau of Insurance can help.

SCC Bureau of Insurance Contact Information

When to contact:

  • Humana doesn't respond within required timelines
  • You need help understanding your appeal rights
  • The external review decision seems incorrect
  • You suspect violations of Virginia insurance law

FAQ: Common Questions About Sickle Cell Coverage

Q: How long does Humana prior authorization take in Virginia? A: Standard requests: 30 days for pre-service, 60 days for post-service. Urgent requests: 72 hours or less.

Q: What if my alternative sickle cell treatment is non-formulary? A: Request a formulary exception through Humana's process, emphasizing medical necessity and lack of formulary alternatives.

Q: Can I request an expedited appeal for sickle cell medications? A: Yes, if your physician certifies that waiting could jeopardize your health or ability to function.

Q: Does step therapy apply if I failed treatments in another state? A: Yes, Virginia law recognizes prior failures under current or previous plans. Document all prior therapies with dates and outcomes.

Q: What happens to my Oxbryta prescription now? A: All Oxbryta prescriptions are invalid. Contact your hematologist immediately to transition to an approved alternative.

Q: Are there patient assistance programs for sickle cell treatments? A: Yes, manufacturers offer copay assistance and foundations provide grants. Ask your clinic's financial counselor for current programs.

Q: How do I prove medical necessity for expensive sickle cell treatments? A: Your hematologist should document crisis frequency, prior treatment failures, and how the requested therapy fits evidence-based guidelines.

Q: What if I'm in the middle of a sickle cell crisis and need immediate coverage? A: Call Humana's expedited appeal line at 804-371-8488 and have your physician document the emergency nature of your situation.

About Coverage Appeals Support

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance denials by creating targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify the specific basis for denial—whether PA criteria, step therapy, non-formulary status, or medical necessity—and drafts point-by-point rebuttals aligned to the plan's own rules. For sickle cell patients facing coverage challenges, having expert support in crafting appeals can make the difference between approval and ongoing denials.

When dealing with specialty drug denials like those for sickle cell treatments, Counterforce Health pulls the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with the required clinical facts including diagnosis codes, prior trials and failures, contraindications, and treatment goals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and state regulations may change. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with your plan. For personalized assistance with appeals, contact Virginia's State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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