By Counterforce Health Team in Xospata (gilteritinib) —

How to Get Xospata (gilteritinib) Covered by Aetna (CVS Health) in New Jersey: Prior Authorization, Appeals, and Success Strategies

Answer Box: Getting Xospata Covered in New Jersey

Xospata (gilteritinib) requires prior authorization from Aetna (CVS Health) in New Jersey for FLT3-mutated relapsed/refractory AML. Submit through the Availity portal at least 2 weeks before treatment, including FLT3 mutation test results, prior therapy documentation, and medical necessity letter. If denied, you have 180 days for internal appeals and 4 months for New Jersey's IHCAP external review through Maximus Federal Services. Success rates improve significantly with complete documentation and specialist support.

First step today: Gather your FLT3 mutation test report and contact your hematologist/oncologist to begin the prior authorization process.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Prior Authorization Process
  4. Common Denial Reasons & Solutions
  5. Appeals Process in New Jersey
  6. Medical Necessity Letter Guide
  7. Cost Support Options
  8. When to Escalate
  9. FAQ

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans Complete PA form via Availity Aetna Precertification List
FLT3 Mutation FDA-approved test required LeukoStrat CDx FLT3 Mutation Assay report FDA Companion Diagnostic
Disease Status Relapsed/refractory AML only Treatment history with dates/outcomes FDA Label
Prescriber Hematologist/oncologist preferred Provider NPI and credentials CVS Specialty Requirements
Appeals Deadline 180 days (internal), 4 months (external) All denial letters and medical records NJ IHCAP

Step-by-Step: Fastest Path to Approval

1. Confirm FLT3 Mutation Status

Who: Treating oncologist
What: Order LeukoStrat CDx FLT3 Mutation Assay if not already done
Timeline: Results typically available in 3-5 business days
Source: FDA-approved companion diagnostic

2. Gather Prior Therapy Documentation

Who: Clinic staff with patient assistance
What: Complete treatment history including dates, outcomes, and reasons for discontinuation
Timeline: 1-2 days to compile records
Tip: Include any stem cell transplant history and post-transplant outcomes

3. Submit Prior Authorization

Who: Prescribing physician or authorized staff
What: Complete form via Availity portal with all supporting documents
Timeline: Submit at least 2 weeks before planned treatment start
Documents needed: FLT3 test, medical necessity letter, treatment history, current labs

4. Follow Up on Decision

Who: Clinic staff
What: Check portal for approval/denial within 24-72 hours
Timeline: Most decisions rendered quickly for oncology drugs
Next step: If approved, coordinate with CVS Specialty; if denied, immediately begin appeal process

5. Appeal if Denied (Internal)

Who: Patient and prescriber working together
What: Submit internal appeal within 180 days addressing specific denial reasons
Timeline: Decision typically within 30-45 days
Forms: Use Aetna's standard appeal process through member portal

6. External Review if Needed

Who: Patient or authorized representative
What: File with NJ IHCAP through Maximus Federal Services within 4 months
Timeline: Decision within 45 days (48 hours if expedited)
Source: IHCAP Process

Prior Authorization Process

Aetna (CVS Health) requires precertification for Xospata through their standard specialty drug pathway. The process has been streamlined in recent years, with most oncology decisions made within 24 hours when complete documentation is provided.

Required Documentation Checklist

  • FLT3 Mutation Test Results: Must be from the FDA-approved LeukoStrat CDx FLT3 Mutation Assay
  • Complete Medical History: Diagnosis date, staging, cytogenetics, molecular markers
  • Prior Therapy Records: All previous treatments with start/stop dates, best response, reason for discontinuation
  • Current Clinical Status: Recent labs, performance status, treatment goals
  • Medical Necessity Letter: Detailed rationale from hematologist/oncologist (see template below)
  • Insurance Information: Current member ID, group number, prescriber NPI

Submission Process

Submit through the Availity portal using the Novologix specialty drug workflow. Incomplete submissions will be rejected, so double-check all required fields before submitting.

Tip: CVS Specialty Pharmacy can assist with prior authorization coordination. Use their Oncology Oral Medications Enrollment Form to streamline the process.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing FLT3 mutation documentation Submit official LeukoStrat CDx test report Lab report with patient identifiers and mutation details
Insufficient prior therapy documentation Provide complete treatment timeline Medical records showing relapsed/refractory status
Non-specialist prescriber Transfer prescription to hematologist/oncologist Updated prescription with specialist NPI
"Experimental/investigational" Reference FDA approval and NCCN guidelines FDA label, NCCN citation, medical necessity letter
Step therapy not met Document contraindications or failures of preferred agents Clinical notes showing intolerance or inefficacy

Based on available data, properly documented appeals for Xospata have a success rate of approximately 40-50% at the internal level, with higher success rates in external review when all FDA requirements are clearly met.

Appeals Process in New Jersey

New Jersey offers one of the most robust external review systems in the country through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals with Aetna (CVS Health)

  1. Level 1 Appeal: Submit within 180 days of denial
  2. Level 2 Appeal: If Level 1 is denied, automatic second review
  3. Expedited Appeals: Available for urgent situations (72-hour decision)

External Review Through IHCAP

If internal appeals fail, New Jersey residents can access independent external review through Maximus Federal Services:

  • Eligibility: Must complete internal appeals first
  • Timeline: 4 months from final internal denial to file
  • Process: Submit application directly to Maximus IHCAP portal
  • Decision timeline: 45 days standard, 48 hours expedited
  • Cost: Free to patients
  • Binding: Insurers must comply with favorable decisions
Note: New Jersey's external review success rates are generally favorable for oncology drugs when proper medical necessity is demonstrated.

Medical Necessity Letter Guide

A comprehensive medical necessity letter is crucial for approval. Here's what to include:

Essential Elements

  1. Patient Demographics and Diagnosis
    • Age, diagnosis date, AML subtype
    • FLT3 mutation details (ITD, D835, I836)
    • Current disease status
  2. Treatment History
    • All prior therapies with dates and outcomes
    • Reasons for treatment changes
    • Any transplant history
  3. Clinical Rationale
    • Why Xospata is appropriate for this patient
    • Reference to FDA approval for FLT3+ relapsed/refractory AML
    • NCCN guideline support
  4. Alternative Considerations
    • Why other options are not suitable
    • Contraindications to other therapies
    • Patient-specific factors

Template Language

"This patient has relapsed/refractory AML with confirmed FLT3 mutation by FDA-approved testing. Xospata (gilteritinib) is FDA-approved specifically for this indication and represents standard of care per NCCN guidelines. Prior therapies have failed/were not tolerated as documented. Without this treatment, the patient faces significant morbidity and mortality risk."

Cost Support Options

Xospata's wholesale acquisition cost is approximately $28,979 for a 30-day supply. Several support options are available:

  • Astellas Pharma Support Solutions: Patient assistance programs and copay support
  • CVS Specialty Pharmacy: Financial counseling and assistance program navigation
  • State Programs: New Jersey has various pharmaceutical assistance programs for eligible residents
  • Foundation Support: Organizations like CancerCare and Leukemia & Lymphoma Society offer grants

Contact Xospata patient support for current program details and eligibility requirements.

When to Escalate

If standard appeals fail, consider these escalation options:

State Insurance Department

Contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 for assistance with:

  • Filing complaints against insurers
  • Understanding your appeal rights
  • Accessing additional consumer resources

Federal Options

For Medicare Advantage plans, contact Medicare directly at 1-800-MEDICARE for guidance on federal appeal rights.

Counterforce Health specializes in turning insurance denials into successful appeals for complex specialty medications like Xospata. Our platform analyzes denial letters, identifies the specific basis for rejection, and crafts evidence-backed appeals that address payer requirements point-by-point. By combining clinical expertise with payer-specific workflows, we help patients, clinicians, and specialty pharmacies navigate the complex prior authorization landscape more effectively.

FAQ

How long does Aetna (CVS Health) take to decide on Xospata prior authorization in New Jersey? Most oncology prior authorizations are decided within 24-72 hours when complete documentation is submitted. Incomplete requests may take longer.

What if Xospata is not on my formulary? Non-formulary drugs can be approved through medical exception processes. Your appeal should demonstrate why no formulary alternatives are appropriate for your specific situation.

Can I request an expedited appeal? Yes, expedited appeals are available when delays could seriously jeopardize your health. Both internal (72 hours) and external (48 hours) expedited processes are available.

Does step therapy apply if I've already failed treatments outside New Jersey? Treatment history from other states should be honored. Ensure all prior therapy documentation is included in your submission.

What happens if IHCAP rules in my favor? Aetna must comply with favorable IHCAP decisions within 10 business days and cover the approved treatment.

Can my doctor request a peer-to-peer review? Yes, peer-to-peer reviews allow your oncologist to discuss the case directly with Aetna's medical director, often improving approval chances.

For additional support navigating these complex processes, Counterforce Health provides specialized assistance in converting denials into targeted, successful appeals.

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 guidance regarding your situation. Coverage policies and procedures may change; verify current requirements with your insurer and state insurance department.

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