By Counterforce Health Team in Rezlidhia (olutasidenib) —

The Complete Guide to Getting Rezlidhia (Olutasidenib) Covered by UnitedHealthcare in New Jersey: Requirements, Appeals, and Step Therapy

Answer Box: Getting Rezlidhia Covered in New Jersey

UnitedHealthcare requires prior authorization for Rezlidhia (olutasidenib) in New Jersey, with specific requirements for documented IDH1 mutation and AML diagnosis. The fastest path: (1) Submit PA through the UnitedHealthcare Provider Portal with IDH1 mutation test results, (2) Include medical necessity letter addressing any step therapy requirements, (3) If denied, file internal appeal within 180 days. New Jersey's IHCAP external review through Maximus Federal Services provides binding decisions within 45 days if internal appeals fail.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: Tracking Your Request
  9. Appeals Process in New Jersey
  10. Common Denial Reasons & Solutions
  11. Cost Assistance Programs
  12. Frequently Asked Questions

Who Should Use This Guide

This comprehensive guide is designed for patients with relapsed or refractory acute myeloid leukemia (AML) and their healthcare teams seeking UnitedHealthcare coverage for Rezlidhia (olutasidenib) in New Jersey. You'll benefit from this resource if you're facing:

  • Initial prior authorization requirements
  • Step therapy denials requiring alternative treatments first
  • Coverage denials based on medical necessity
  • Appeals processes after initial rejections

Expected Outcome: Following this guide increases your likelihood of approval by ensuring all required documentation is complete and properly submitted. Counterforce Health specializes in turning insurance denials into successful appeals by identifying specific denial reasons and crafting targeted, evidence-backed responses that align with each plan's own coverage policies.

Member & Plan Basics

Coverage Requirements

Active Coverage Verification: Before starting the prior authorization process, confirm your UnitedHealthcare plan is active and includes prescription drug coverage. Check your member ID card for OptumRx pharmacy benefits.

Plan Types: Requirements apply to all UnitedHealthcare plan types in New Jersey:

  • Commercial employer plans
  • Individual marketplace plans
  • Medicare Advantage plans (with additional Medicare Part B requirements)

Deductible Considerations: Rezlidhia's approximate cost of $32,000 per month means most patients will meet their annual deductible quickly. High-deductible health plans may require significant out-of-pocket costs before coverage begins.

Clinical Criteria Requirements

FDA-Approved Indication

Rezlidhia is approved specifically for adults with relapsed or refractory AML harboring a susceptible IDH1 mutation. UnitedHealthcare requires documentation of:

  1. Confirmed AML diagnosis with appropriate staging
  2. IDH1 mutation testing using FDA-approved diagnostic tests
  3. Relapsed or refractory status after prior therapy

Step Therapy Requirements

UnitedHealthcare may require patients to try preferred IDH1 inhibitors or alternative AML treatments first. Documentation requirements include:

  • Prior therapy failures: Clinical notes showing inadequate response to preferred agents
  • Intolerance documentation: Adverse events or contraindications to first-line treatments
  • Continuation therapy: If previously on Rezlidhia within 12 months, continuation may be approved

Dosing and Monitoring

Standard Dosing: 150 mg orally twice daily until disease progression or unacceptable toxicity

Required Monitoring Plan: Your oncologist must document:

  • Differentiation syndrome monitoring protocol
  • Hepatic function assessment schedule
  • Regular disease response evaluations

Coding and Billing Information

NDC and Billing Codes

Code Type Number Description Units
NDC 71332-005-01 150 mg capsules, 30-count bottle Per capsule
HCPCS J3490 or J9999* Miscellaneous drug codes Per 150 mg

*Permanent HCPCS J-code not yet assigned; verify current requirements with UnitedHealthcare.

ICD-10 Diagnosis Codes

Primary diagnosis codes for AML:

  • C92.00: Acute myeloblastic leukemia, not having achieved remission
  • C92.02: Acute myeloblastic leukemia, in relapse

Documentation Packet Essentials

Medical Necessity Letter Components

Your oncologist's letter should include:

  1. Patient Information: Demographics, diagnosis, staging
  2. Clinical History: Previous treatments, responses, failures
  3. IDH1 Mutation Status: Test results and methodology
  4. Treatment Rationale: Why Rezlidhia is medically necessary
  5. Monitoring Plan: Safety oversight and response assessment
  6. Literature Support: Relevant clinical studies or guidelines

Required Attachments

  • Complete medical records from AML diagnosis
  • IDH1 mutation test results
  • Prior treatment summaries with outcomes
  • Current laboratory values
  • Imaging studies showing disease status
Clinician Corner: Medical Necessity Letter Checklist

✓ Document specific IDH1 mutation subtype and testing method ✓ Detail prior therapies with dates, doses, and response/toxicity ✓ Reference FDA labeling for approved indication ✓ Include differentiation syndrome monitoring protocol ✓ Cite relevant NCCN or ASH guidelines supporting treatment choice

Submission Process

Prior Authorization Submission

  1. Access Portal: Log into the UnitedHealthcare Provider Portal using One Healthcare ID
  2. Navigate to Specialty Pharmacy: Select "Specialty Pharmacy Transactions" tile
  3. Complete PA Form: Fill all required fields completely
  4. Upload Documents: Attach medical necessity letter and supporting documentation
  5. Submit Request: Note confirmation number and submission date

Contact Information

  • OptumRx Prior Authorization: 888-397-8129
  • Provider Portal Support: Available through portal messaging system

Processing Timeline

  • Standard Review: 72 hours from complete submission
  • Expedited Review: 24 hours for urgent medical needs

Specialty Pharmacy Requirements

Authorized Distributors

Rezlidhia is only available through limited distribution specialty pharmacies. Authorized vendors include:

  • Optime Care: 1-888-287-2017
  • Biologics by McKesson: Contact through prescriber

Prescription Transfer Process

  1. Verify Authorization: Confirm PA approval before transfer
  2. Contact Specialty Pharmacy: Call authorized distributor directly
  3. Provide Information: Insurance details, prescriber information, patient demographics
  4. Schedule Delivery: Coordinate shipment timing with patient

After Submission: Tracking Your Request

Status Monitoring

  • Confirmation Number: Record from initial submission
  • Portal Tracking: Check status through provider portal
  • Timeline Tracking: Standard 72-hour processing period

Documentation to Maintain

  • Submission confirmation
  • All correspondence with UnitedHealthcare
  • Status updates and decision notifications

Appeals Process in New Jersey

Internal Appeals

Timeline: 180 days from denial notification to file internal appeal

Submission Options:

  • Online through member/provider portal
  • Mail to address on denial letter
  • Fax (number provided in denial notification)

External Review Through IHCAP

If internal appeals are unsuccessful, New Jersey offers binding external review through the Independent Health Care Appeals Program (IHCAP).

Process Overview:

  1. Complete Internal Appeals: Must exhaust UnitedHealthcare's internal process first
  2. File with Maximus: Submit to njihcap.maximus.com within 4 months
  3. Review Timeline: 45 days for standard review, 48 hours for expedited cases
  4. Binding Decision: Maximus decision is final and must be implemented by UnitedHealthcare

Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Services: 1-800-446-7467

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
IDH1 mutation not documented Submit complete genetic testing report FDA-approved test results with mutation subtype
Step therapy not completed Request exception or document failures Prior treatment records with outcomes/toxicity
Non-oncology prescriber Transfer to hematology/oncology Specialist consultation and prescription
Insufficient monitoring plan Provide detailed safety protocol Differentiation syndrome management plan

Cost Assistance Programs

Manufacturer Support

Contact Rigel Pharmaceuticals patient assistance programs (verify current offerings through prescriber or specialty pharmacy).

Foundation Resources

  • Leukemia & Lymphoma Society: Financial assistance for blood cancer patients
  • CancerCare: Copayment assistance and financial counseling

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in New Jersey? A: Standard processing is 72 hours; expedited reviews for urgent cases are completed within 24 hours.

Q: What if Rezlidhia is non-formulary on my plan? A: Non-formulary drugs can still be covered through medical exception processes with strong clinical justification.

Q: Can I request an expedited appeal? A: Yes, if delayed treatment would jeopardize your health or ability to function. Document urgency clearly in your request.

Q: Does step therapy apply if I failed treatments outside New Jersey? A: Treatment history from any location counts toward step therapy requirements with proper documentation.

Q: What happens if my external appeal is denied? A: IHCAP decisions are final and binding. Consider discussing alternative treatment options with your oncologist.

From our advocates: We've seen patients successfully overturn initial denials by ensuring their IDH1 mutation testing documentation includes the specific mutation subtype and FDA-approved testing methodology. This level of detail often makes the difference between approval and denial in complex oncology cases.

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan for specific coverage determinations.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed responses that address specific denial reasons and align with each plan's coverage policies.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.