By Counterforce Health Team in Oxbryta (voxelotor) —

Getting Oxbryta (Voxelotor) Coverage from Blue Cross Blue Shield in Ohio: Post-FDA Withdrawal Guide to Alternative Therapies

Answer Box: Oxbryta Coverage in Ohio (2024-2025)

Oxbryta (voxelotor) was voluntarily withdrawn from the U.S. market in September 2024 due to safety concerns, and Blue Cross Blue Shield plans in Ohio now automatically deny coverage. Your fastest path forward: 1) Schedule an urgent appointment with your hematologist to discuss alternative sickle cell disease therapies, 2) Request prior authorization for covered alternatives like hydroxyurea, crizanlizumab, or L-glutamine, and 3) If currently on Oxbryta, work with your doctor on a safe transition plan while exploring manufacturer patient assistance programs for your new therapy.

Table of Contents

  1. Why Blue Cross Blue Shield Denies Oxbryta in 2024
  2. Alternative SCD Therapies and Coverage
  3. Prior Authorization Process for Alternatives
  4. Appeals Strategy (If You Were Stable on Oxbryta)
  5. Timeline and Milestones
  6. Patient Assistance Programs
  7. Ohio External Review Process
  8. Common Questions

Why Blue Cross Blue Shield Denies Oxbryta in 2024

Blue Cross Blue Shield plans across Ohio—including Anthem Blue Cross Blue Shield—are denying all Oxbryta prior authorization requests because the FDA announced the drug's voluntary withdrawal on September 26, 2024. Pfizer stopped all distribution and clinical trials after postmarketing data showed higher rates of vaso-occlusive crises and deaths compared to placebo.

Current Coverage Status

  • New prescriptions: Automatically denied due to market withdrawal
  • Existing prescriptions: Coverage ending as pharmacy stock depletes
  • Appeals: Unlikely to succeed given FDA safety alert and cessation of distribution
  • Prior authorizations: Being removed from formularies or converted to exclusions
Important: The FDA advises patients to contact their healthcare provider about stopping Oxbryta and starting alternative treatment—not to stop abruptly on their own.

Alternative SCD Therapies and Coverage

With Oxbryta no longer available, Ohio patients should work with their hematology team to transition to covered alternatives. Here's what Blue Cross Blue Shield typically covers:

Coverage at a Glance

Medication Formulary Status Prior Auth Required Step Therapy Typical Coverage
Hydroxyurea Tier 1-2 (generic) Usually no No ✓ Widely covered
Crizanlizumab (Adakveo) Specialty tier Yes Often required ✓ With documentation
L-glutamine (Endari) Specialty tier Yes May be required ✓ With SCD diagnosis
Chronic transfusion Medical benefit Case-by-case No ✓ For severe cases

Source: Anthem Ohio Provider Manual

Medical Necessity Requirements

For specialty SCD therapies, Blue Cross Blue Shield typically requires:

  • Confirmed SCD diagnosis with hemoglobin electrophoresis or genetic testing
  • Documentation of vaso-occlusive crises (frequency, hospitalizations, ER visits)
  • Prior treatment history including hydroxyurea trial/failure when applicable
  • Baseline labs (CBC, reticulocyte count, LDH, bilirubin)
  • Specialist consultation from hematology or sickle cell center

Prior Authorization Process for Alternatives

Step-by-Step: Fastest Path to Alternative Coverage

1. Pre-Authorization Preparation (Day 0-1)

  • Gather complete medical records from the past 6 months
  • Document all prior SCD treatments, including Oxbryta response and duration
  • Obtain current labs and imaging if relevant
  • Verify Blue Cross Blue Shield formulary status via Availity portal or member services

2. Clinical Documentation (Day 1-2) Your hematologist should prepare:

  • Letter of medical necessity detailing SCD severity and treatment history
  • Prior authorization form with complete clinical justification
  • Supporting records: recent office notes, hospital discharge summaries, lab results

3. Submission (Day 2-3)

  • Submit via Anthem's provider portal or designated utilization management vendor
  • Mark as expedited if delay would seriously jeopardize health
  • Include all required attachments to avoid delays

4. Review Timeline

  • Standard review: Up to 15 calendar days for commercial plans
  • Expedited review: 72 hours when urgency criteria are met
  • Medicare Advantage: 7 days standard, 72 hours expedited (effective 2026)

Appeals Strategy (If You Were Stable on Oxbryta)

While new Oxbryta approvals are unlikely, patients who were clinically stable on the medication may have limited appeal options for continuity of care.

Internal Appeal Process

Level 1: Formulary Exception Appeal

  • Timeline: Must file within 60-180 days of denial (check your denial letter)
  • Documentation needed:
    • Clinical response to Oxbryta (hemoglobin levels, VOC frequency)
    • Evidence of stability and risks of abrupt discontinuation
    • Letter from hematologist supporting continued therapy
  • Decision timeframe: 30 days standard, 72 hours expedited

Level 2: Peer-to-Peer Review

  • Request direct physician-to-physician discussion
  • Have your hematologist prepare clinical summary and rationale
  • Focus on individual patient factors and withdrawal risks
From our advocates: In rare cases where patients had exceptional clinical responses to Oxbryta, some plans have approved short-term continuations (30-90 days) to allow for safe transitions to alternatives. Success requires comprehensive documentation of clinical stability and detailed transition plans.

Timeline and Milestones

Typical Coverage Timeline for SCD Alternatives

Milestone Standard Timeline Expedited Timeline Action Required
PA submission Day 0 Day 0 Complete documentation
Initial review Days 1-5 Days 1-2 None (plan reviews)
Additional info request Days 3-10 Day 2 Respond within 48 hours
Final decision Days 7-15 Day 3 Review approval letter
Appeal (if denied) Within 60-180 days Within 72 hours File formal appeal

Source: Ohio Department of Insurance Appeals Process

Time-Saving Tips

  • Use electronic portals for faster processing
  • Bundle all evidence in initial submission to avoid information requests
  • Request expedited review when clinically appropriate
  • Maintain regular follow-up with your hematology team during transitions

Patient Assistance Programs

Since Oxbryta manufacturer programs have ended, focus on assistance for alternative therapies:

Manufacturer Support Programs

Crizanlizumab (Adakveo)

  • Novartis patient assistance program
  • Commercial copay assistance (may reduce costs to $5-25/month)
  • Uninsured patient program for qualifying individuals

L-glutamine (Endari)

  • Emmaus Medical patient support program
  • Financial assistance based on income eligibility
  • Bridge therapy during insurance approval process

General SCD Resources

Note: Counterforce Health helps patients navigate insurance denials by creating targeted, evidence-backed appeals that align with payer policies. Our platform can assist in transitioning from Oxbryta denials to successful alternative therapy approvals.

Ohio External Review Process

If Blue Cross Blue Shield denies coverage for alternative SCD therapies after internal appeals, Ohio residents can request an independent external review.

External Review Eligibility

  • Must complete all internal appeals first
  • File within 180 days of final denial
  • Denial must involve medical necessity determination
  • No cost to patient

Process and Timeline

  1. Request external review through your health plan (not directly with Ohio DOI)
  2. Submit additional evidence within 10 business days of assignment
  3. Independent review organization (IRO) conducts medical review
  4. Decision issued within 30 days (72 hours for expedited cases)
  5. Binding decision on the health plan

For assistance with external review, contact the Ohio Department of Insurance consumer hotline at 800-686-1526.

Common Questions

Q: Can I still get Oxbryta if I pay cash? A: No. Pfizer has stopped all distribution worldwide, so the medication is not available through any channel.

Q: How long does prior authorization take for alternative SCD therapies? A: Standard reviews take up to 15 days, but expedited reviews for urgent medical needs are completed within 72 hours.

Q: What if Blue Cross Blue Shield requires step therapy for alternatives? A: You can request a step therapy exception if you've previously failed required medications or have contraindications. Document all prior treatments thoroughly.

Q: Are there clinical trials available for new SCD treatments? A: Yes. Contact comprehensive sickle cell centers in Ohio or search ClinicalTrials.gov for current studies.

Q: Can I appeal to keep using remaining Oxbryta supplies? A: While technically possible, appeals are unlikely to succeed given the FDA safety alert and manufacturer withdrawal.

Q: What documentation do I need for alternative therapy approval? A: SCD diagnosis confirmation, treatment history, current clinical status, specialist recommendation, and evidence of medical necessity for the specific alternative requested.

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 and insurance plan for specific coverage decisions. Coverage policies and appeal rights may vary by specific Blue Cross Blue Shield plan and product type.

For personalized assistance with insurance appeals and prior authorization strategies, Counterforce Health provides specialized support for complex coverage decisions, helping patients and providers navigate payer requirements effectively.

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