By Counterforce Health Team in Oxbryta (voxelotor) —

If Oxbryta (Voxelotor) Isn't Approved by Blue Cross Blue Shield in Michigan: Formulary Alternatives & Exception Paths

Answer Box: Oxbryta (Voxelotor) Status Update

Oxbryta (voxelotor) was withdrawn from the U.S. market in September 2024 by Pfizer following FDA's request based on post-marketing studies showing potential harm despite hemoglobin improvements. Blue Cross Blue Shield of Michigan now denies Oxbryta claims due to loss of FDA approval. Alternative sickle cell treatments are available: hydroxyurea and L-glutamine are covered on Michigan formularies with prior authorization. If your doctor prescribed Oxbryta, contact them immediately to discuss switching to an approved alternative. Start with your BCBS Michigan member portal to review current formulary options.

Table of Contents

When Alternatives Make Sense

The withdrawal of Oxbryta creates an immediate need for patients to transition to alternative sickle cell disease treatments. This transition is medically necessary, not optional, since Oxbryta is no longer available in the United States.

Current approved alternatives work through different mechanisms than Oxbryta's HbS polymerization inhibition:

  • Hydroxyurea increases fetal hemoglobin production
  • L-glutamine addresses amino acid deficiency and oxidative stress
  • Crizanlizumab blocks P-selectin to reduce vaso-occlusive crises

Your healthcare provider will determine the most appropriate alternative based on your medical history, current symptoms, and previous treatment responses.

Current Sickle Cell Treatment Options

First-Line Therapies

Hydroxyurea (Droxia, Hydrea)

  • Mechanism: Increases fetal hemoglobin levels to prevent sickling
  • Benefits: Reduces pain crises, may reduce transfusion needs and hospital stays
  • Contraindications: Pregnancy; can increase infection risk
  • Monitoring: Regular blood counts required

L-glutamine (Endari)

  • Mechanism: Oral powder that reduces oxidative stress
  • Benefits: Decreases frequency of pain crises
  • Advantages: Oral administration improves accessibility vs. injectable options
  • Side effects: Generally well-tolerated

Newer Targeted Therapies

Crizanlizumab (Adakveo)

  • Mechanism: P-selectin inhibitor administered by injection
  • Indication: Adults and children 16+ years
  • Side effects: Nausea, joint pain, back pain, fever
  • Status note: Lost European approval in May 2023, but remains FDA-approved in U.S.
Note: Gene therapies (exagamglogene autotemcel and lovotibeglogene autotemcel) are now FDA-approved for ages 12+ and offer potential curative options, though they require specialized centers.

Coverage Overview: BCBS Michigan Formulary

Medication Formulary Status Prior Authorization Quantity Limits Age Restrictions
Hydroxyurea (Droxia) Covered Required Yes Yes (AL)
L-glutamine (Endari) Covered Required Yes Yes (AL)
Crizanlizumab Specialty tier Required 30-day supply 16+ years

Source: Michigan Medicaid Health Plan Common Formulary

Getting Current Coverage Information

Contact Blue Cross Blue Shield Michigan Pharmacy Services:

  • Phone: 1-866-601-4425
  • Address: Pharmacy Services — Mail Code 512C, Detroit, MI 48226-2998
  • Online: Review your plan's Drug List (Formulary) at bcbsm.com

Formularies update monthly, so verify current status before starting any new medication.

Switching from Oxbryta: What to Expect

Immediate Steps

  1. Contact your hematologist immediately if you were taking Oxbryta
  2. Don't stop treatment abruptly without medical supervision
  3. Schedule transition appointment within 1-2 weeks
  4. Gather medical records documenting your response to Oxbryta

Clinical Considerations

Your healthcare provider will evaluate:

  • Previous treatment responses and failures
  • Current disease severity and complications
  • Contraindications to alternative medications
  • Your preference for oral vs. injectable therapy

From our advocates: Patients transitioning from withdrawn medications often worry about losing progress. Document your current symptoms, pain frequency, and quality of life measures before switching. This baseline helps your doctor adjust the new treatment and provides valuable information if you need to appeal for additional options later.

Coordination with Pharmacy

  • Specialty pharmacies may handle distribution for newer agents like crizanlizumab
  • Prior authorization will be required for all alternatives
  • Insurance verification should occur before first fill
  • Patient assistance programs may be available to reduce costs

Exception Strategy for Non-Formulary Options

When to Request Exceptions

Consider formulary exceptions when:

  • Standard alternatives are contraindicated
  • You've experienced significant side effects with covered options
  • Previous treatments failed to control symptoms
  • Medical literature supports off-label use

Building Your Exception Request

Required documentation includes:

  • Detailed medical necessity letter from prescriber
  • Documentation of prior therapy failures or contraindications
  • Clinical notes supporting diagnosis and severity
  • Relevant laboratory results or imaging
  • Published medical literature supporting the request
Clinician Corner: Medical necessity letters should include: (1) specific diagnosis with ICD-10 codes, (2) prior treatments tried with dates and outcomes, (3) contraindications to formulary alternatives, (4) clinical rationale with guideline citations, and (5) monitoring plan. Reference FDA labeling and specialty society guidelines when available.

Appeals Process in Michigan

Internal Appeals with BCBS Michigan

Standard Timeline: 60 calendar days for decision Expedited Review: 72 hours (requires physician attestation of urgency)

Required documents:

  • Copy of denial letter
  • Medical records supporting necessity
  • Prescriber's clinical justification
  • Any relevant lab results or imaging

Michigan External Review Process

If internal appeals fail, Michigan's Department of Insurance and Financial Services (DIFS) offers external review under the Patient's Right to Independent Review Act.

Key deadlines:

  • Filing window: 127 days after final internal denial
  • Standard decision: 28-56 days (up to 84 days if additional information needed)
  • Expedited decision: 72 hours with physician certification

Contact DIFS:

  • Phone: 877-999-6442 (Monday-Friday, 8 a.m. to 5 p.m.)
  • Online portal: michigan.gov/difs
  • Forms: FIS 0018 (Health Care Request for External Review)

Success Strategy

Michigan's external review is binding on insurers. Success rates improve with:

  • Thorough clinical documentation
  • Clear evidence of medical necessity
  • Compliance with all procedural requirements
  • Physician support for urgency (if applicable)

Patient Assistance Programs

Copay Assistance

HealthWell Foundation provides prescription copay assistance for sickle cell disease medications including Endari and other covered alternatives. Patients with insurance and household incomes up to 300-500% of Federal Poverty Level may qualify for average grants of $3,520 annually.

Endari Copay Program reduces patient responsibility to $10 monthly copayment for eligible patients with commercial insurance.

Comprehensive Support

Siklos Patient Assistance Program offers medication at no charge for uninsured patients or those whose insurance doesn't provide coverage.

NMDP Financial Assistance provides up to $10,000 in fertility preservation grants for patients considering cell therapy or transplant options.

Contact information and applications available through Counterforce Health's resource directory and individual manufacturer websites.

FAQ

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

Q: Will BCBS Michigan cover the transition to alternative medications?
A: Yes, medically necessary transitions from withdrawn medications are typically covered, though prior authorization is required for alternatives.

Q: How long does prior authorization take for sickle cell medications? A: Standard reviews take 1-5 days initially, with final decisions within 15 calendar days. Urgent requests can be expedited to 72 hours with physician support.

Q: What if I can't tolerate hydroxyurea or L-glutamine? A: Document side effects and treatment failures carefully. This information supports formulary exception requests for non-preferred alternatives like crizanlizumab.

Q: Can I appeal to get coverage for treatments not on the formulary? A: Yes. Michigan law provides appeal rights through BCBS internal process, then external review through DIFS if needed.

Q: Are gene therapies covered by BCBS Michigan? A: Coverage varies by plan. These high-cost treatments typically require extensive prior authorization and may need medical director review.

When Treatment Alternatives Aren't Sufficient

If formulary alternatives prove inadequate, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform helps patients and clinicians identify denial reasons and draft point-by-point rebuttals using FDA labeling, peer-reviewed studies, and specialty guidelines aligned to each plan's specific requirements.

For complex cases involving specialty medications, having professional support can significantly improve approval odds and reduce the time between denial and access to needed treatments.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions and medication changes. For official appeals guidance and forms, contact Michigan DIFS at 877-999-6442 or visit michigan.gov/difs.

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