By Counterforce Health Team in Oxbryta (voxelotor) —

Getting Oxbryta (Voxelotor) Covered by Cigna in New Jersey After FDA Withdrawal: Appeals Guide and Alternatives

Answer Box: Key Facts for New Jersey Patients

Oxbryta (voxelotor) was withdrawn from the U.S. market in September 2024 due to safety concerns. Cigna now denies all new prior authorization requests. For New Jersey residents, your fastest path forward is: (1) Work with your hematologist to transition to FDA-approved alternatives like hydroxyurea, L-glutamine, or crizanlizumab, (2) If denied coverage for alternatives, file a Cigna internal appeal within 180 days, then (3) Request external review through New Jersey's IHCAP program via Maximus Federal Services within 4 months of final denial.

Table of Contents

Understanding Oxbryta's Current Status

Pfizer voluntarily withdrew Oxbryta (voxelotor) from all markets in September 2024 after postmarketing data showed the benefits no longer outweighed the risks for sickle cell disease patients. The withdrawal followed reports of increased vaso-occlusive crises and fatalities in some patients.

What this means for patients:

  • No new prescriptions can be filled
  • Insurance companies, including Cigna, automatically deny coverage requests
  • Patients currently taking Oxbryta should work immediately with their hematologist to transition to alternative therapies
  • Appeals for new Oxbryta prescriptions will not succeed due to loss of FDA approval
Important: Do not abruptly stop Oxbryta without medical supervision. Contact your sickle cell specialist immediately to plan a safe transition.

Cigna's Coverage Policy After Withdrawal

As of October 2024, Cigna's national coverage policies explicitly state that Oxbryta coverage "will not be approved." This policy applies to all Cigna plans, including those managed through Express Scripts specialty pharmacy.

Coverage at a Glance

Requirement Current Status What It Means Source
FDA Approval Withdrawn Sept 2024 No new coverage possible Cigna Policy Updates
Prior Authorization Automatically denied All PA requests rejected Cigna Coverage Bulletins
Appeal Rights Limited to pre-withdrawal claims Only historical denials eligible Standard Appeal Process
Formulary Status Excluded Removed from all formularies Express Scripts Exclusion List

Alternative Sickle Cell Disease Treatments

With Oxbryta no longer available, several FDA-approved alternatives remain covered by Cigna, though they may require prior authorization and step therapy compliance.

First-Line Therapy

Hydroxyurea remains the gold standard first-line treatment. Cigna typically covers this with minimal restrictions due to its established efficacy and cost-effectiveness.

Advanced Therapies (Require Prior Authorization)

  • L-glutamine (Endari): Reduces pain crises and hospitalizations
  • Crizanlizumab (Adakveo): P-selectin inhibitor for vaso-occlusive crisis prevention
  • Gene therapies: Exagamglogene autotemcel and lovotibeglogene autotemcel offer potential cures but require extensive documentation

Step Therapy Requirements

Cigna typically requires documentation of:

  • Trial and failure of hydroxyurea (unless contraindicated)
  • Adequate trial duration (usually 3-6 months at maximum tolerated dose)
  • Documented intolerance or medical contraindications
  • Frequency of pain crises or hospitalizations
Clinician Corner: When documenting step therapy failure, include specific dates, doses tried, duration of therapy, reasons for discontinuation, and measurable outcomes like crisis frequency or hemoglobin levels.

Step-by-Step Appeals Process in New Jersey

Internal Appeals with Cigna

Step 1: File Internal Appeal (Within 180 days)

  • Submit through Cigna member portal or mail written request
  • Include denial letter, medical records, and physician letter of medical necessity
  • Expected timeline: 30 days for standard review, 72 hours for expedited

Step 2: Second-Level Internal Review

  • If first appeal denied, request second-level review
  • Same documentation requirements
  • Timeline: Additional 30 days

Step 3: Peer-to-Peer Review (Optional)

  • Your physician can request direct discussion with Cigna medical director
  • Most effective for complex cases requiring clinical nuance
  • Request through provider services line

Required Documentation for Appeals

  • Complete medical records from sickle cell specialist
  • Laboratory results (hemoglobin electrophoresis, CBC, reticulocyte count)
  • Documentation of previous treatments and outcomes
  • Frequency of pain crises, hospitalizations, and emergency visits
  • Letter of medical necessity from treating physician

New Jersey External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review for coverage denials after internal appeals are exhausted.

IHCAP Process Overview

  • Administrator: Maximus Federal Services
  • Filing deadline: 4 months (120 days) after final internal denial
  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases
  • Cost: Free to patients
  • Binding: Decision is binding on both patient and insurer

How to File External Appeal

  1. Complete internal appeals first (both levels with Cigna)
  2. Gather documentation: All medical records, denial letters, physician statements
  3. Submit online at njihcap.maximus.com or mail to Maximus
  4. Include physician letter explaining medical necessity and addressing denial reasons
From Our Advocates: We've seen cases where patients initially denied coverage for alternative sickle cell therapies successfully obtained approval through New Jersey's external review process. The key was comprehensive documentation showing hydroxyurea failure and detailed clinical rationale from the treating hematologist. While outcomes vary, having an independent medical review often provides a fair evaluation when initial denials seem inappropriate.

Contact Information for IHCAP

Medical Necessity Documentation

Effective appeals require comprehensive medical documentation that clearly establishes the necessity for alternative sickle cell therapies.

Physician Letter Template Elements

Your physician's letter should include:

  1. Patient identification and diagnosis (include ICD-10 codes)
  2. Clinical history including onset, severity, and progression
  3. Previous treatments with specific dates, doses, and outcomes
  4. Current clinical status with recent laboratory values
  5. Treatment rationale with references to clinical guidelines
  6. Contraindications to standard therapies if applicable
  7. Expected outcomes and monitoring plan

Supporting Evidence to Include

  • Recent hemoglobin electrophoresis results
  • Complete blood counts showing anemia severity
  • Documentation of pain crises (emergency visits, hospitalizations)
  • Specialist consultation notes
  • References to published clinical guidelines (ASH, NHLBI)

Patient Assistance and Financial Support

While Oxbryta is no longer available, financial assistance may be available for alternative therapies.

Manufacturer Programs

  • Novartis Adakveo Connect: Patient assistance for crizanlizumab
  • Emmaus Life Sciences: Support program for L-glutamine (Endari)
  • Bluebird Bio: Financial assistance for gene therapies

Foundation Support

  • Patient Access Network (PAN) Foundation: Provides copay assistance for sickle cell medications
  • HealthWell Foundation: Financial assistance for eligible patients
  • National Organization for Rare Disorders (NORD): Patient assistance programs

New Jersey State Resources

  • NJ FamilyCare: Medicaid program with comprehensive prescription coverage
  • Pharmaceutical Assistance to the Aged and Disabled (PAAD): Prescription assistance for eligible seniors and disabled residents

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex coverage requirements and identify the specific documentation needed for approval. Visit www.counterforcehealth.org to learn how we can help streamline your appeals process and improve approval rates for specialty medications.

FAQ: Common Questions

Q: Can I still appeal an Oxbryta denial from before the withdrawal? A: Yes, if you received a denial before September 2024 and are within the 180-day appeal window, you may still file an appeal. However, focus on transitioning to available alternatives.

Q: How long does Cigna's prior authorization process take for alternative therapies? A: Standard reviews take up to 15 days, while urgent requests must be processed within 24-72 hours. Incomplete submissions may extend timelines.

Q: What if I live near the Pennsylvania border but have New Jersey coverage? A: Your appeal rights are determined by where your insurance policy is regulated, not where you receive care. New Jersey residents with NJ-regulated plans can use IHCAP regardless of treatment location.

Q: Does step therapy apply if I failed hydroxyurea in another state? A: Yes, documented treatment failures from any location are typically accepted, provided you have adequate medical records showing the trial and outcome.

Q: Can my doctor request expedited review for alternative therapies? A: Yes, if delay in treatment could cause serious harm to your health, both Cigna and IHCAP offer expedited review processes with shortened timelines.

Q: What happens if IHCAP overturns Cigna's denial? A: The decision is binding, and Cigna must provide coverage as directed by the independent reviewers. This is mandated by New Jersey law.

When to Escalate Beyond Standard Appeals

If standard appeals are unsuccessful, consider these additional options:

State Insurance Department

Contact the New Jersey Department of Banking and Insurance if you believe Cigna is not following proper procedures:

  • Consumer Hotline: 1-800-446-7467
  • Website: nj.gov/dobi
  • File complaints for procedural violations or unfair claim practices

For complex cases involving potential bad faith denial or ERISA violations, consult with an attorney specializing in insurance law.

Patient Advocacy Organizations

  • Sickle Cell Disease Association of America: National advocacy and support
  • National Organization for Rare Disorders (NORD): Rare disease patient advocacy

The transition away from Oxbryta presents challenges, but multiple effective alternatives remain available. Success in obtaining coverage often depends on thorough documentation, persistence through the appeals process, and leveraging New Jersey's strong external review protections. Counterforce Health can help navigate these complex requirements and improve your chances of approval for alternative sickle cell therapies.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan documents for the most current coverage information. Insurance policies and appeal procedures may vary by plan type and employer group.

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