By Counterforce Health Team in Oxbryta (voxelotor) —

Oxbryta (Voxelotor) Denied by Aetna CVS Health in New Jersey: Understanding the 2024 FDA Withdrawal and Your Appeal Options

Answer Box: Oxbryta Coverage Status

Oxbryta (voxelotor) is no longer FDA-approved as of September 2024 due to increased vaso-occlusive crises and deaths in sickle cell disease patients. Aetna CVS Health now categorically denies all Oxbryta claims based on this regulatory withdrawal. Your immediate steps: 1) Contact your hematologist to plan a safe transition to FDA-approved alternatives like hydroxyurea, crizanlizumab, or L-glutamine, 2) Have your provider submit prior authorization for alternative treatments through Aetna's standard process, and 3) If alternatives are denied, use New Jersey's Independent Health Care Appeals Program (IHCAP) administered by Maximus Federal Services within 180 days.

Table of Contents

Why Oxbryta Claims Are Being Denied

In September 2024, Pfizer voluntarily withdrew Oxbryta from the U.S. market after confirmatory clinical trials showed the medication increased rates of vaso-occlusive crises and deaths in sickle cell disease patients. The FDA supported this withdrawal, making Oxbryta no longer an approved treatment option.

What this means for your coverage:

  • All new and existing Oxbryta prescriptions have been terminated
  • Prior authorization requests for Oxbryta are automatically denied
  • Appeals for Oxbryta coverage will not succeed due to loss of FDA approval
  • No U.S. insurer, including Aetna CVS Health, can legally cover withdrawn medications
Important: Do not stop Oxbryta abruptly if you're currently taking it. Contact your hematologist immediately to discuss a safe transition plan to alternative FDA-approved therapies.

Alternative Sickle Cell Disease Treatments

Several FDA-approved medications remain available for sickle cell disease management:

Medication Generic Name How It Works Typical Use
Hydroxyurea hydroxyurea Increases fetal hemoglobin production First-line therapy for most patients
Endari L-glutamine Reduces oxidative stress Add-on therapy or hydroxyurea alternative
Adakveo crizanlizumab Prevents blood cell adhesion For patients with frequent crises

Additional options may include blood transfusions, bone marrow transplant, or gene therapy in specialized centers, depending on your specific medical situation.

Getting Alternatives Covered by Aetna CVS Health

Aetna CVS Health covers FDA-approved sickle cell disease medications through their standard prior authorization process. Here's what you need to know:

Coverage Requirements:

  • Confirmed sickle cell disease diagnosis with appropriate ICD-10 codes
  • Prescription from or consultation with a hematologist
  • Documentation of medical necessity
  • Compliance with step therapy requirements (hydroxyurea typically required first)

Prior Authorization Timeline:

Submission Methods:

  • Electronic systems (CoverMyMeds®, SureScripts)
  • Fax submission with complete documentation
  • Provider portal submission
Clinician Corner: When submitting prior authorization requests, include comprehensive medical history, lab results showing hemoglobin levels and crisis frequency, documentation of previous treatment failures or contraindications, and clear treatment goals. Reference current clinical guidelines and FDA labeling to support medical necessity.

Appeals Process in New Jersey

If Aetna CVS Health denies coverage for alternative sickle cell disease treatments, New Jersey offers robust appeal options through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (Required First):

  1. File with Aetna CVS Health within 60 days of denial
  2. Submit all supporting medical documentation
  3. Request expedited review if medically urgent
  4. Allow up to 45 days for standard decision

External Appeals Through IHCAP:

  • Who can file: Any covered person or provider with consent
  • Timeline: 180 days from final internal denial (60 days for NJ FamilyCare/Medicaid)
  • Administrator: Maximus Federal Services
  • Cost: Free to patients (insurers pay all costs)
  • Decision timeline: 45 calendar days for standard appeals

IHCAP Contact Information:

Note: IHCAP decisions are binding on insurance companies. If they rule in your favor, Aetna must comply and provide coverage.

Step-by-Step: Transitioning to Covered Alternatives

Step 1: Emergency Consultation (Within 48 hours)

  • Contact your hematologist immediately
  • Discuss safe discontinuation of Oxbryta if currently prescribed
  • Review alternative treatment options based on your medical history

Step 2: Treatment Selection (Within 1 week)

  • Work with your provider to select appropriate alternative therapy
  • Consider your previous treatment history and current health status
  • Review Aetna's formulary for covered options

Step 3: Prior Authorization Submission (Within 2 weeks)

  • Your provider submits PA request with complete documentation
  • Include medical necessity letter addressing specific clinical needs
  • Attach relevant lab results and treatment history

Step 4: Monitor Authorization Status

  • Check status through Aetna member portal or by calling member services
  • Follow up if additional information is requested
  • Request expedited review if treatment delay poses health risks

Step 5: Appeal if Denied

  • File internal appeal within 60 days of denial
  • Gather additional supporting documentation if needed
  • Consider peer-to-peer review with Aetna medical director

Step 6: External Review if Necessary

  • Submit IHCAP appeal within 180 days of final internal denial
  • Use Maximus portal or contact 1-888-393-1062 for assistance
  • Await binding decision within 45 days

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific rules.

Common Questions About SCD Coverage

How long does Aetna CVS Health prior authorization take in New Jersey? Standard reviews typically take 30-45 days, but Aetna has committed to deciding over 95% of eligible authorizations within 24 hours. Expedited reviews for urgent situations are completed within 72 hours.

What if my preferred SCD medication is non-formulary? You can request a formulary exception by having your provider submit documentation showing medical necessity and why formulary alternatives are inappropriate for your specific situation.

Can I request an expedited appeal in New Jersey? Yes, both Aetna's internal appeals and IHCAP external reviews offer expedited processing when delays would seriously jeopardize your health or ability to regain maximum function.

Does step therapy apply if I've failed treatments outside New Jersey? Yes, documented treatment failures from other states are typically accepted as long as you provide complete medical records showing the trials and outcomes.

What happens if I'm currently taking Oxbryta? Contact your hematologist immediately. Do not stop abruptly, as this could trigger a sickle cell crisis. Your provider will help you transition safely to an alternative FDA-approved therapy.

Are there patient assistance programs for SCD medications? Yes, most manufacturers offer copay cards for commercially insured patients and patient assistance programs for uninsured individuals. Independent foundations like HealthWell Foundation may also provide support.

When to Escalate Your Case

Consider escalating to additional resources if standard appeals aren't successful:

New Jersey Department of Banking and Insurance:

  • Consumer Hotline: 1-800-446-7467
  • File complaints about insurer practices
  • Request assistance with complex coverage disputes

Federal Resources:

  • Medicare appeals (if applicable): 1-800-MEDICARE
  • ACA marketplace issues: HealthCare.gov
  • Department of Health and Human Services complaint portal

Patient Advocacy Organizations:

  • Sickle Cell Disease Association of America
  • National Sickle Cell Disease Program
  • Local patient advocacy groups in New Jersey

Cost Assistance Programs

Commercial Insurance Patients:

  • Manufacturer copay cards (varies by drug)
  • Independent foundation grants (HealthWell Foundation, Patient Advocate Foundation)
  • Employer-based assistance programs

Medicare/Medicaid Patients:

  • Low Income Subsidy ("Extra Help") through Social Security
  • State pharmaceutical assistance programs
  • Independent foundation support (income-restricted)

Uninsured Patients:

  • Manufacturer patient assistance programs
  • Federally Qualified Health Centers
  • Hospital charity care programs
From our advocates: We've seen cases where patients initially denied coverage for specialty SCD medications successfully obtained approval after submitting comprehensive appeals that included detailed treatment histories, peer-reviewed literature supporting the specific therapy choice, and clear documentation of why standard treatments weren't appropriate. The key is thorough documentation and persistence through the appeals process.

When navigating coverage challenges, Counterforce Health can help streamline the appeals process by analyzing your specific denial reasons and crafting targeted responses that address payer requirements while highlighting the medical necessity of your prescribed treatment.

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 before making treatment decisions and verify current coverage policies with your insurance plan. Coverage policies and appeal procedures may change; confirm current requirements with official sources before taking action.

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