By Counterforce Health Team in Oxbryta (voxelotor) —

How to Get Oxbryta (Voxelotor) Covered by Cigna in New York: 2024 Withdrawal Update and Alternative Paths

Answer Box: Critical Update on Oxbryta (Voxelotor) Coverage

Important: Oxbryta (voxelotor) was voluntarily withdrawn from the U.S. market by Pfizer in September 2024 due to safety concerns and insufficient clinical benefit. The drug is no longer FDA-approved and cannot be prescribed or covered by any U.S. insurer, including Cigna. If you're currently taking Oxbryta, contact your hematologist immediately to transition to FDA-approved alternatives like hydroxyurea, L-glutamine, or crizanlizumab. New York residents have strong appeal rights through the Department of Financial Services if coverage for alternative treatments is denied.

Table of Contents

Critical FDA Withdrawal Information

Oxbryta (voxelotor) was withdrawn from the U.S. market on September 26, 2024, after postmarketing studies showed higher rates of vaso-occlusive crises and deaths compared to placebo. The FDA requested this withdrawal, and Pfizer complied by discontinuing all clinical trials and expanded access programs.

What This Means for Patients

  • No new prescriptions can be written for Oxbryta in the U.S.
  • All insurance claims will be denied due to loss of FDA approval
  • Existing prescriptions cannot be filled at any U.S. pharmacy
  • Immediate transition to alternatives is required for patient safety
Critical: If you're currently taking Oxbryta, do not stop abruptly. Contact your hematologist within 48 hours to arrange a safe transition to an approved alternative.

Understanding the Withdrawal Impact

The withdrawal affects approximately 45,000 Medicaid members who previously met FDA criteria for Oxbryta. For Cigna members in New York, this means:

Impact Area Details Action Needed
Active Prescriptions Cannot be filled after withdrawal date Schedule urgent hematology visit
Insurance Coverage All claims automatically denied Request PA for alternatives
Medical Records Document transition rationale Update treatment plans
Billing Codes NDC/HCPCS codes invalid Remove from formularies

Alternative Sickle Cell Disease Treatments

With Oxbryta no longer available, several FDA-approved alternatives remain covered by Cigna:

Primary Alternatives

  1. Hydroxyurea (Droxia, Siklos)
    • First-line therapy for most SCD patients
    • Reduces crisis frequency by 50%
    • Typically covered without prior authorization
  2. L-Glutamine (Endari)
    • Reduces acute complications
    • Oral powder formulation
    • May require step therapy documentation
  3. Crizanlizumab (Adakveo)
    • Monthly IV infusion
    • Reduces vaso-occlusive crises
    • Specialty pharmacy dispensing required

Advanced Therapies

  • Gene therapy (Casgevy, Lyfgenia) for eligible patients
  • Bone marrow transplant in select cases
  • Chronic transfusion therapy with iron chelation

Cigna Coverage for SCD Alternatives in New York

Cigna manages specialty drugs through Express Scripts and Accredo Specialty Pharmacy. Coverage requirements vary by medication:

Coverage Requirements Table

Medication Formulary Status Prior Auth Required Step Therapy Quantity Limits
Hydroxyurea Tier 2 Generic Usually No No 30-day supply
L-Glutamine Tier 4 Specialty Yes May apply Weight-based
Crizanlizumab Tier 5 Specialty Yes Yes Monthly dose

ICD-10 Coding Requirements

All SCD treatments require appropriate diagnosis coding:

  • D57.1: Sickle-cell disease without crisis
  • D57.00: Sickle-cell anemia with crisis, unspecified
  • D57.01: Sickle-cell anemia with acute chest syndrome
  • D57.02: Sickle-cell anemia with splenic sequestration

New York Appeals Process

New York residents have robust appeal rights through the Department of Financial Services (DFS). The process includes:

Internal Appeals (Required First Step)

  1. File within 180 days of initial denial
  2. Submit through Cigna member portal or by phone
  3. Include supporting documentation from hematologist
  4. Receive decision within 30 days (72 hours if urgent)

External Appeals (After Internal Denial)

  1. File within 4 months of final internal denial
  2. Submit to DFS with $25 fee (waived for financial hardship)
  3. Independent medical review by specialty experts
  4. Binding decision on insurer if approved
New York Advantage: The state's external appeal program has overturned many specialty drug denials, especially when supported by peer-reviewed literature and specialty guidelines.

Step-by-Step: Getting Alternative Treatment Approved

For Hydroxyurea (Usually Straightforward)

  1. Hematologist prescribes standard dose based on weight
  2. Pharmacy submits claim - typically auto-approved
  3. Monitor response with regular lab work
  4. Document effectiveness for future treatments

For Specialty Drugs (L-Glutamine, Crizanlizumab)

  1. Gather documentation: SCD diagnosis, prior treatments, lab results
  2. Submit prior authorization via CoverMyMeds or Cigna portal
  3. Include medical necessity letter with specific criteria
  4. Await determination (72 hours standard, 24 hours urgent)
  5. Appeal if denied with additional clinical support
  6. Coordinate specialty pharmacy if approved

Medical Necessity Letter Checklist

  • ✅ Confirmed SCD diagnosis with genotype
  • ✅ Previous treatment history and outcomes
  • ✅ Current symptoms and crisis frequency
  • ✅ Clinical rationale for specific medication
  • ✅ Contraindications to alternatives
  • ✅ Expected monitoring plan

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Documentation Needed
"Not medically necessary" Submit specialty guidelines ASH/NHLBI treatment guidelines
"Step therapy required" Document prior therapy failures Treatment logs, hospital records
"Experimental/investigational" Cite FDA approval FDA label, peer-reviewed studies
"Non-formulary" Request formulary exception Comparative effectiveness data

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to identify the specific basis for denial—whether PA criteria, step therapy, or "not medically necessary" determinations—then crafting point-by-point rebuttals aligned to each plan's own rules.

When to Escalate in New York

Contact the New York Department of Financial Services if:

  • Internal appeals are repeatedly denied
  • Cigna fails to meet response deadlines
  • Coverage is terminated without proper notice
  • Specialty pharmacy access is restricted

DFS Contact Information

  • Consumer Hotline: 1-800-342-3736
  • Online Portal: DFS Consumer Portal
  • External Appeals: Submit via online portal or mail

You can also contact Community Health Advocates at 888-614-5400 for free assistance with insurance appeals in New York.

FAQ: Sickle Cell Disease Coverage

Q: Can I still get Oxbryta from Canada or overseas? A: No. U.S. insurance will not cover medications obtained from outside the country, and importing prescription drugs is generally illegal.

Q: How quickly can I transition to an alternative? A: Most alternatives can be started within 1-2 weeks with proper prior authorization. Hydroxyurea often requires no PA.

Q: What if Cigna denies coverage for all alternatives? A: This would be unusual given FDA approval status. File an immediate appeal and contact New York DFS for external review.

Q: Do I need to see a specialist for SCD medications? A: While not always required, hematologist involvement strengthens prior authorization requests and ensures optimal care.

Q: How much will alternatives cost? A: Costs vary by medication and insurance tier. Patient assistance programs are available for most specialty SCD treatments.

Q: Can I request an expedited appeal for urgent needs? A: Yes. New York allows expedited external appeals with decisions within 72 hours for urgent medical needs.

Q: What documentation do I need for appeals? A: Medical records, prior treatment history, specialist letters, and relevant clinical guidelines strengthen your case.

Q: Does step therapy apply if I was previously on Oxbryta? A: This varies by plan, but prior Oxbryta use may satisfy step therapy requirements for some alternatives.

From Our Advocates

"We've seen many New York patients successfully transition from withdrawn medications to covered alternatives by working closely with their hematologists to document medical necessity. The key is moving quickly—don't wait for your current prescription to run out. New York's external appeal process is particularly strong for rare disease cases when you have proper clinical support."

When navigating complex coverage decisions for sickle cell disease treatments, Counterforce Health helps patients and clinicians by ingesting denial letters and plan policies to identify specific denial reasons, then drafting targeted appeals with the right evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—woven together with required clinical facts like diagnosis codes, prior treatment failures, and dosing rationale.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals in New York, contact the resources listed above.

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