By Counterforce Health Team in Rezlidhia (olutasidenib) —

Blue Cross Blue Shield New York Coverage Criteria for Rezlidhia (Olutasidenib): Complete Prior Authorization and Appeals Guide

Answer Box: Getting Rezlidhia Covered by Blue Cross Blue Shield in New York

Blue Cross Blue Shield of New York requires prior authorization for Rezlidhia (olutasidenib) in adults with relapsed/refractory AML and susceptible IDH1 mutation. Your fastest path to approval: 1) Confirm IDH1 mutation via FDA-approved test, 2) Submit PA with oncologist letter documenting failed prior therapies and monitoring plan, 3) If denied, file internal appeal within 180 days, then external review through New York Department of Financial Services within 4 months. Start by gathering your IDH1 test results and treatment history today.

Table of Contents

Policy Overview

Blue Cross Blue Shield of New York (BCBSNY) follows Blue Cross Blue Shield Association (BCBSA) guidelines for Rezlidhia coverage, requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug typically appears on Tier 4-5 specialty formularies with quantity limits and step therapy requirements.

Plan Types Covered:

  • Commercial employer-sponsored plans
  • Individual/family marketplace plans
  • Medicare Advantage (with additional CMS requirements)
  • Some Medicaid managed care plans (verify specific coverage)

Find your specific formulary and PA requirements by logging into your BCBSNY member portal or calling member services. Each plan year may have updated criteria, so verify current requirements even if previously approved.

Note: Policies vary slightly between Blue Cross Blue Shield affiliates. This guide focuses on BCBSNY but references BCBSA standards that apply across most Blue plans.

Indication Requirements

FDA-Approved Use

Rezlidhia is approved specifically for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation. BCBSNY covers on-label use when documentation confirms:

  • Diagnosis: Pathology-confirmed AML (≥20% blasts in bone marrow)
  • Disease status: Relapsed after initial treatment or refractory to standard therapy
  • Age: 18 years or older
  • IDH1 mutation: Susceptible variant detected by FDA-approved test

Off-Label Considerations

BCBSNY may cover off-label use with exceptional medical necessity documentation, but approval rates are significantly lower. Required evidence includes:

  • Peer-reviewed literature supporting use
  • NCCN Compendium listing (if available)
  • Detailed rationale for why FDA-approved alternatives are inappropriate

Step Therapy & Exceptions

Required Prior Therapies

Most BCBS plans require documented trial and failure of:

  1. Standard AML induction therapy (e.g., cytarabine + anthracycline)
  2. Ivosidenib (Tibsovo) for IDH1-mutated AML (primary step therapy requirement)
  3. Hypomethylating agents with or without venetoclax (age-appropriate)

Medical Exceptions

You can bypass step therapy with documentation of:

  • Contraindications: Allergies, organ dysfunction, drug interactions
  • Prior intolerance: Documented adverse events requiring discontinuation
  • Clinical urgency: Rapid disease progression requiring immediate targeted therapy

Exception Documentation

Submit a detailed letter including:

  • Specific therapies tried (drug names, doses, dates, duration)
  • Reasons for failure (progression, toxicity, intolerance)
  • Clinical rationale for Rezlidhia as next appropriate option
  • Supporting lab values and imaging if relevant
Tip: Include exact dates and doses of failed therapies. Vague statements like "patient failed chemotherapy" often result in denials.

Quantity and Frequency Limits

Standard Limits

  • Quantity: 180 capsules per 90 days (150 mg capsules)
  • Dosing: 150 mg twice daily (300 mg total daily dose)
  • Initial approval: 12 months maximum
  • Renewal: Requires documentation of continued benefit and acceptable toxicity

Dose Modifications

BCBSNY covers dose reductions for toxicity management:

  • First reduction: 100 mg twice daily
  • Second reduction: 50 mg twice daily
  • Temporary holds for differentiation syndrome or hepatotoxicity

Document dose changes with clinical rationale and monitoring plans to maintain coverage during modifications.

Required Diagnostics

IDH1 Mutation Testing

Essential requirement: FDA-approved IDH1 mutation test showing susceptible variant (typically R132H or R132C). Acceptable tests include:

  • Abbott RealTime IDH1 Assay
  • CLIA-certified laboratory sequencing panels
  • Next-generation sequencing (NGS) with IDH1 coverage

Documentation must include:

  • Test methodology and laboratory certification
  • Specific mutation identified (not just "IDH1 positive")
  • Variant allele frequency if available
  • Date of testing (preferably within 6 months)

Additional Required Labs

  • Complete blood count with differential
  • Comprehensive metabolic panel including liver function tests
  • Bone marrow biopsy confirming AML diagnosis and blast percentage
  • Cytogenetics and molecular profiling (comprehensive AML panel preferred)
Important: Retest IDH1 status at relapse, as mutation patterns can change between diagnosis and recurrence.

Site of Care Requirements

Rezlidhia is an oral medication that doesn't require infusion center administration, but BCBSNY may have specialty pharmacy network requirements:

Specialty Pharmacy Network

  • Must use BCBSNY-contracted specialty pharmacy
  • Prior authorization required before specialty pharmacy dispensing
  • 30-day supply limits common for initial fills
  • Coordination between oncology practice and specialty pharmacy required

Prescriber Requirements

  • Hematology/oncology specialist must prescribe and monitor
  • Prescriber must be in-network or obtain prior authorization for out-of-network services
  • Regular monitoring visits required (typically every 2-4 weeks initially)

Contact BCBSNY member services to identify in-network specialty pharmacies and confirm your oncologist's network status.

Evidence for Medical Necessity

Clinical Guidelines Support

Reference these authoritative sources in your medical necessity letter:

  • FDA prescribing information for Rezlidhia
  • NCCN Guidelines for Acute Myeloid Leukemia (Category 1 recommendation for IDH1-mutated relapsed/refractory AML)
  • ELN (European LeukemiaNet) recommendations for IDH inhibitors
  • ASH (American Society of Hematology) guidelines on targeted AML therapy

Key Clinical Evidence

  • Phase 1/2 clinical trial data showing overall response rates
  • Real-world evidence of efficacy in relapsed/refractory setting
  • Safety profile and differentiation syndrome management protocols
  • Pharmacokinetic data supporting twice-daily dosing

Patient-Specific Factors

Document individual medical necessity:

  • Previous treatment failures with specific outcomes
  • Comorbidities affecting other treatment options
  • Performance status and treatment goals
  • Molecular profile supporting targeted therapy approach

Sample Medical Necessity Letter

Template paragraph for oncologist letters:

"[Patient name] is a [age]-year-old with relapsed acute myeloid leukemia harboring an IDH1 R132H mutation confirmed by [test name] on [date]. Following initial diagnosis in [month/year], the patient received standard induction therapy with cytarabine and daunorubicin, achieving initial remission. Disease relapsed in [month/year], and subsequent treatment with ivosidenib was discontinued after [duration] due to [specific reason - progression/toxicity]. Given the patient's IDH1-mutated disease and failure of standard therapies including the preferred IDH1 inhibitor ivosidenib, olutasidenib (Rezlidhia) represents the most appropriate targeted therapy option per NCCN guidelines. The patient will be monitored weekly for differentiation syndrome and hepatotoxicity per FDA prescribing information protocols."

Include with letter:

  • IDH1 mutation test report
  • Pathology report confirming AML diagnosis
  • Treatment history with dates and outcomes
  • Current performance status and lab values

Common Denial Reasons & Solutions

Denial Reason Solution
IDH1 mutation not documented Submit FDA-approved test report with specific mutation identified
Step therapy not completed Provide detailed documentation of ivosidenib trial/failure or contraindication
Not medically necessary Include NCCN guidelines citation and oncologist letter with clinical rationale
Prescriber not qualified Ensure hematology/oncology specialist is prescribing
Quantity exceeds limits Justify dosing with FDA label and monitoring plan
Missing monitoring plan Include specific protocols for differentiation syndrome and hepatotoxicity surveillance
From our advocates: We've seen denials overturned when families included a detailed timeline of all prior treatments with specific dates, doses, and reasons for discontinuation. Insurance reviewers need to see the complete treatment journey to understand why Rezlidhia is the logical next step.

New York Appeals Process

Internal Appeal (First Level)

  • Timeline: File within 180 days of denial
  • Decision deadline: 30 days (15 days for expedited)
  • Submission: BCBSNY member portal, phone, or written request
  • Required documents: Denial letter, medical records, physician letter

External Review (Final Level)

If internal appeal fails, New York offers binding external review through the Department of Financial Services:

  • Timeline: File within 4 months of final internal denial
  • Decision deadline: 30 days standard, 72 hours expedited
  • Cost: $25 maximum (waived for financial hardship)
  • Submission: DFS online portal

Required for external review:

  • Completed DFS external appeal form
  • Copy of final adverse determination
  • Medical records supporting medical necessity
  • Any additional evidence not previously submitted

Expedited Appeals

Available when delay could seriously jeopardize health:

  • Internal expedited: 72 hours
  • External expedited: 24 hours for drug denials
  • Must include physician attestation of urgency

Contact Community Health Advocates at 888-614-5400 for free assistance with appeals in New York.

Cost Assistance Programs

Counterforce Health helps patients navigate the complex prior authorization process by analyzing denial letters and crafting evidence-based appeals that address specific payer requirements. Their platform identifies the exact denial reasons and generates targeted rebuttals using FDA labeling, clinical guidelines, and peer-reviewed evidence tailored to Blue Cross Blue Shield's criteria.

Manufacturer Support

  • Rigel Pharmaceuticals patient assistance: Income-based copay support and free drug programs
  • Eligibility: Varies by insurance type and household income
  • Application: Through prescribing oncologist's office or directly with manufacturer

Additional Resources

  • Leukemia & Lymphoma Society: Financial assistance for treatment costs
  • CancerCare: Copayment assistance and emergency financial aid
  • New York State pharmaceutical assistance programs: For eligible residents

FAQ

How long does BCBSNY prior authorization take? Standard PA decisions are issued within 15 business days. Expedited requests (when clinical urgency is documented) receive decisions within 72 hours.

What if Rezlidhia isn't on my formulary? Request a formulary exception with medical necessity documentation. BCBSNY must cover medically necessary treatments even if non-formulary, though higher copays may apply.

Can I appeal if I live in New York but have out-of-state Blue Cross coverage? Appeal rights depend on your plan's home state, but you may also have New York consumer protection rights. Contact the New York Department of Financial Services for guidance.

Does step therapy apply if I failed treatments in another state? Yes, documented treatment failures from other states count toward step therapy requirements. Ensure complete medical records are transferred.

How often do external appeals succeed for cancer drugs? New York external appeals have higher overturn rates for oncology medications when supported by clinical guidelines and documented medical necessity.

What happens if my doctor isn't in-network? You may need prior authorization for out-of-network services, or consider transferring care to an in-network hematology/oncology specialist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For personalized assistance with prior authorizations and appeals, Counterforce Health provides specialized support for patients navigating complex insurance requirements for specialty medications like Rezlidhia.

Last updated: January 2025. Insurance policies and state regulations may change. Verify current requirements with your specific plan and state insurance department.

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