By Counterforce Health Team in Rezlidhia (olutasidenib) —

How to Get Rezlidhia (Olutasidenib) Covered by UnitedHealthcare in New York: Prior Authorization Guide

Answer Box: Getting Rezlidhia Covered by UnitedHealthcare in New York

Rezlidhia (olutasidenib) requires prior authorization from UnitedHealthcare OptumRx in New York. You'll need documented IDH1 mutation results, confirmed relapsed/refractory AML diagnosis, and evidence of prior therapy failures. Submit through the UnitedHealthcare Provider Portal with complete documentation for fastest approval (15 business days standard, 72 hours expedited). If denied, New York's external appeal process through the Department of Financial Services provides binding review within 4 months of final internal denial.

Start today: Verify your plan's formulary tier and gather your IDH1 mutation test results and AML treatment history.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Understanding Timelines
  7. Handling Requests for Additional Information
  8. If You're Denied: Appeals Process
  9. Renewal and Reauthorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This guide helps patients with relapsed/refractory AML and their healthcare teams navigate UnitedHealthcare's prior authorization process for Rezlidhia (olutasidenib) in New York. Rezlidhia is an oral IDH1 inhibitor approved for adults with relapsed/refractory AML who have a susceptible IDH1 mutation, priced at approximately $32,000 per month.

Who this helps:

  • Patients with confirmed IDH1-mutated AML seeking Rezlidhia coverage
  • Oncologists submitting prior authorization requests
  • Caregivers navigating insurance appeals in New York

Before You Start: Verify Your Coverage

Check Your Plan Type

UnitedHealthcare operates several plan types in New York:

  • Commercial/Employer plans: Standard PA through OptumRx
  • Medicare Advantage: Enhanced appeal rights under federal law
  • Medicaid Managed Care: Additional New York state protections
  • Essential Plan: State-specific formulary requirements
Tip: Log into your UnitedHealthcare member portal or call the number on your insurance card to confirm your specific plan type.

Formulary Status

Rezlidhia is not listed on UnitedHealthcare's New York Preferred Drug Lists for Medicaid or Essential Plan, indicating it's likely non-formulary and requires prior authorization. Most commercial plans classify it as Tier 4-5 (specialty tier).

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plan types UHC PA Requirements
IDH1 Mutation FDA-approved test confirming susceptible mutation Lab report from CLIA-certified facility
Specialist Prescriber Board-certified hematology/oncology Provider certification documentation
Prior Therapies Documented failures/intolerance Treatment records with dates and outcomes
Monitoring Plan Differentiation syndrome and liver function Oncologist's safety protocol

Gather Required Documentation

Essential Documents Checklist

1. IDH1 Mutation Testing

  • Lab report from FDA-approved assay specifying mutation subtype
  • Variant allele frequency (VAF) if available
  • CLIA-certified laboratory certification

2. AML Diagnosis Confirmation

  • Pathology report with WHO/ICC criteria
  • Bone marrow biopsy showing ≥20% blasts
  • Current staging and molecular markers
  • ICD-10 code: C92.00 (AML, not having achieved remission)

3. Prior Therapy Documentation

  • Complete treatment timeline with dates
  • Response outcomes and reasons for discontinuation
  • Side effects or contraindications experienced
  • Performance status (ECOG ≤2 preferred)

4. Current Clinical Status

  • Recent labs (CBC, comprehensive metabolic panel, liver function)
  • Imaging studies if applicable
  • Current medications and contraindications
  • Treatment goals and prognosis

Medical Necessity Letter Requirements

Your oncologist should include:

  • Patient demographics and insurance information
  • Detailed AML history and molecular profile
  • Rationale for Rezlidhia citing FDA labeling
  • References to NCCN or ASH guidelines
  • Monitoring plan for differentiation syndrome and hepatotoxicity
  • Expected treatment duration and response monitoring

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Access the UnitedHealthcare Provider Portal

  • Visit uhcprovider.com
  • Log in with provider credentials
  • Navigate to Prior Authorization section

2. Complete the PA Form

  • Patient demographics and insurance ID
  • Provider NPI and specialty certification
  • Drug information: Rezlidhia (olutasidenib), NDC, dosing
  • Clinical justification with ICD-10 codes

3. Upload Supporting Documents

  • IDH1 mutation test results
  • Medical necessity letter
  • Prior therapy records
  • Current labs and imaging
  • Any previous denial letters

4. Submit and Document

  • Note confirmation number
  • Save submission receipt
  • Set calendar reminders for follow-up
Note: Urgent cases may qualify for expedited 72-hour review. Check the "urgent" box if treatment delays could jeopardize the patient's health.

Follow-Up and Tracking

Monitoring Your Request

Check Status Regularly

  • Provider portal updates daily
  • Call UnitedHealthcare Provider Services: 1-866-842-3278
  • Reference your PA confirmation number

Sample Phone Script: "I'm calling to check the status of prior authorization request #[number] for patient [name] requesting Rezlidhia for IDH1-mutated AML. Can you provide an update on the review timeline and any additional documentation needed?"

What to Track

  • Submission date and confirmation number
  • Assigned case reviewer (if provided)
  • Any requests for additional information
  • Decision date and outcome
  • Appeal deadlines if denied

Understanding Timelines

Standard Review Process

Review Type Timeline When to Use
Standard PA 15 business days Most cases
Expedited PA 72 hours Urgent medical need
Additional Information 14 days to respond When UHC requests more docs

New York-Specific Timelines

Internal Appeals:

  • File within 180 days of denial
  • Decision within 21 days (outpatient) or 3 days (inpatient)
  • Expedited appeals: 72 hours

External Appeals:

  • File within 4 months of final internal denial
  • Standard decision: 30 days
  • Expedited decision: 72 hours (24 hours for urgent drug denials)

Handling Requests for Additional Information

Common Information Requests

Clinical Clarifications:

  • Specific IDH1 mutation subtype
  • Detailed prior therapy outcomes
  • Current performance status
  • Contraindications to alternative treatments

Documentation Updates:

  • Recent lab values
  • Updated provider letters
  • Additional guideline citations
  • Peer-reviewed literature supporting off-label use

Response Strategy

  • Respond within the specified timeframe (usually 14 days)
  • Address each question specifically
  • Provide additional supporting literature
  • Request peer-to-peer review if appropriate

If You're Denied: Appeals Process

Understanding Common Denial Reasons

Denial Reason How to Address Required Documentation
No IDH1 mutation documented Submit complete test results FDA-approved lab report with mutation subtype
Insufficient prior therapy Detail treatment failures Timeline with dates, doses, outcomes, side effects
Non-specialist prescriber Transfer to oncologist Board certification and patient evaluation
No monitoring plan Add safety protocol Differentiation syndrome and liver function monitoring plan
Not medically necessary Strengthen clinical rationale Updated letter with guidelines and literature

Internal Appeal Process

1. Request Peer-to-Peer Review (within 24 hours of denial)

  • Call UnitedHealthcare Provider Services
  • Request clinical discussion with medical director
  • Prepare clinical summary and key talking points

2. File Formal Internal Appeal

  • Submit within 180 days of denial
  • Use UHC Appeals Portal
  • Include all original documentation plus new evidence
  • Address specific denial reasons point-by-point

External Appeal Through New York DFS

If your internal appeal is denied, you can file an external appeal with the New York Department of Financial Services:

Filing Requirements:

  • Must file within 4 months of final internal denial
  • Complete DFS External Appeal Form
  • Include all medical records and denial letters
  • Pay $25 fee (waived for Medicaid or financial hardship)

Contact Information:

  • Mail: NY DFS, 99 Washington Ave, Box 177, Albany, NY 12210
  • Phone: 1-800-400-8882
  • Online: DFS Portal

External Review Benefits:

  • Independent medical expert review
  • Decision is binding on UnitedHealthcare
  • Fee refunded if appeal is successful
  • Expedited review available for urgent cases

Renewal and Reauthorization

Planning for Renewal

Timeline:

  • Start renewal process 30-45 days before expiration
  • UnitedHealthcare may eliminate reauthorization requirements for some chronic medications post-July 2025

Required Documentation for Renewal:

  • Updated clinical response assessment
  • Current labs and imaging
  • Continued medical necessity
  • Any new safety concerns or side effects
  • Treatment modifications or dose adjustments

Evidence of Response

Include documentation of:

  • IDH1 mutation burden reduction
  • Blast count improvements
  • Transfusion independence
  • Quality of life measures
  • Absence of disease progression

Quick Reference Checklist

Before Submitting:

  • IDH1 mutation test results (FDA-approved assay)
  • AML diagnosis confirmation with pathology report
  • Prior therapy documentation with outcomes
  • Board-certified oncologist prescription
  • Medical necessity letter with monitoring plan
  • Current labs and imaging
  • Insurance verification and plan type confirmation

After Submission:

  • Save confirmation number and receipt
  • Set calendar reminders for follow-up
  • Monitor provider portal for updates
  • Prepare for potential peer-to-peer review
  • Know your appeal deadlines and options

FAQ

How long does UnitedHealthcare prior authorization take in New York? Standard PA reviews take 15 business days, while expedited reviews for urgent medical needs are completed within 72 hours.

What if Rezlidhia is non-formulary on my plan? Non-formulary medications can still be covered through medical exception processes. Your oncologist will need to demonstrate medical necessity and why formulary alternatives aren't appropriate.

Can I request an expedited appeal in New York? Yes, both UnitedHealthcare internal appeals and New York external appeals offer expedited options when standard timelines could jeopardize your health.

Does step therapy apply if I've failed treatments outside New York? Treatment failures from other states should be documented and accepted, but ensure your medical records clearly show the treatments tried, doses, duration, and reasons for discontinuation.

What happens if I need Rezlidhia while my appeal is pending? You may be able to access medication through manufacturer patient assistance programs or request emergency/bridge coverage from UnitedHealthcare while appeals are processed.

How much does external appeal cost in New York? The filing fee is $25 per appeal for patients (waived for Medicaid enrollees or financial hardship cases) and is refunded if your appeal is successful.

Patient Support and Cost Assistance

For patients facing coverage challenges, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer-specific requirements, potentially saving weeks in the appeals process.

Additionally, Rigel Pharmaceuticals may offer patient assistance programs for eligible individuals. Contact their patient support team to explore copay assistance or free drug programs based on income and insurance status.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Insurance requirements may vary by specific plan and can change over time. Always verify current requirements with your insurance provider and consult with your healthcare team for medical decisions. For personalized assistance with insurance appeals and prior authorization, consider consulting with healthcare advocates like Counterforce Health who specialize in navigating complex payer requirements.

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