By Counterforce Health Team in Rezlidhia (olutasidenib) —

How to Get Rezlidhia (olutasidenib) Covered by Aetna (CVS Health) in Pennsylvania: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Rezlidhia (olutasidenib) Covered by Aetna (CVS Health) in Pennsylvania

Fastest path to approval: Submit prior authorization through CVS Caremark or Aetna provider portal with IDH1 mutation test results, AML diagnosis confirmation, and documented failure of preferred alternatives. If denied, request peer-to-peer review within 180 days, then file Pennsylvania external review within 4 months of final denial. Start today: Call CVS Caremark at 1-855-344-0930 to verify PA requirements for your specific plan.

Table of Contents

  1. Read the Denial Letter
  2. Common Fixable Causes
  3. Prior Authorization Requirements
  4. First-Level Appeal Strategy
  5. Peer-to-Peer Review Process
  6. Pennsylvania External Review
  7. Appeal Templates and Scripts
  8. Cost Savings and Support Options
  9. When to Escalate Further

Read the Denial Letter

When Aetna (CVS Health) denies Rezlidhia (olutasidenib), the denial letter contains crucial information for your appeal strategy. Look for these key elements:

Denial reason codes typically include:

  • Medical necessity not established - Missing clinical documentation
  • Non-formulary drug - Requires formulary exception
  • Step therapy not met - Must try preferred alternatives first
  • Quantity limits exceeded - Requesting more than plan allows
  • Experimental/investigational - Plan doesn't consider treatment proven

Critical deadlines:

  • 180 days to file internal appeal (commercial plans)
  • 30-45 days for Aetna's decision on standard appeals
  • 72 hours for expedited appeals when delay risks serious harm
Note: Aetna processes over 95% of eligible prior authorizations within 24 hours when complete documentation is submitted electronically through their provider portal.

Common Fixable Causes

Many Rezlidhia denials can be overturned by addressing documentation gaps:

Denial Reason How to Fix Required Documentation
IDH1 mutation not documented Submit FDA-approved test results Abbott RealTime IDH1 Assay report
Medical necessity unclear Provide detailed treatment history Prior therapy failures, contraindications
Off-label use Cite NCCN guidelines Peer-reviewed studies, clinical rationale
Non-oncology prescriber Add specialist consultation Hematologist/oncologist co-signature
Missing monitoring plan Include safety protocols Differentiation syndrome management plan

Prior Authorization Requirements

Aetna (CVS Health) requires prior authorization for Rezlidhia through their 2025 precertification list. The typical criteria include:

Medical Necessity Criteria

Diagnosis Requirements:

  • Confirmed acute myeloid leukemia (AML) in adults ≥18 years
  • Relapsed or refractory disease after prior therapy
  • IDH1 mutation confirmed by FDA-approved test

Clinical Documentation:

  • Complete treatment history with responses and toxicities
  • ECOG performance status
  • Current disease status (morphologic relapse, measurable residual disease)
  • Baseline liver function tests and CBC

Prescriber Qualifications:

  • Hematologist/oncologist or under their supervision
  • Include NPI and specialty certification

Submission Process

For pharmacy benefit (most oral medications):

For medical benefit:

First-Level Appeal Strategy

When your initial PA request is denied, a well-structured appeal can achieve 67-75% overturn rates with Aetna, according to recent data.

Medical Necessity Letter Components

Opening paragraph: State the specific request and FDA indication

  • "I am requesting approval of Rezlidhia (olutasidenib) 150 mg twice daily for [patient name] with relapsed/refractory AML harboring a susceptible IDH1 mutation, consistent with FDA-approved indication."

Clinical rationale section:

  • Confirmed AML diagnosis with staging and molecular profile
  • IDH1 mutation test results (include assay name and date)
  • Complete prior treatment history with specific agents, dates, responses, and reasons for discontinuation
  • Current disease status and urgency of treatment

Guideline support:

  • FDA labeling for relapsed/refractory IDH1-mutated AML
  • NCCN guidelines category and recommendation level
  • Published efficacy data (35% CR/CRh rate, 25.3-month median duration)

Safety and monitoring plan:

  • Differentiation syndrome monitoring protocol
  • Hepatotoxicity surveillance schedule
  • Drug interaction assessment
From our advocates: We've seen the strongest appeals combine specific Aetna Clinical Policy Bulletin language with front-loaded clinical evidence in the first paragraph. This approach, paired with peer-to-peer discussion, has helped many patients access targeted AML therapies that were initially denied.

Peer-to-Peer Review Process

Requesting a peer-to-peer (P2P) call with an Aetna medical director increases overturn rates to approximately 78%, compared to 67% for written-only appeals.

Scheduling Your P2P Call

Contact information:

  • Call the provider services number on the denial letter
  • Request "peer-to-peer review with a medical director"
  • Have your authorization reference number ready

Preparation checklist:

  • Patient's complete medical history in chronological order
  • IDH1 mutation test report with specific mutation identified
  • Prior AML treatments with dates, responses, and toxicity profiles
  • Current performance status and disease burden
  • Specific Aetna Clinical Policy Bulletin criteria that are met

P2P Call Script

Opening statement: "I'm requesting approval of Rezlidhia for [patient] who meets Aetna's medical necessity criteria for relapsed/refractory IDH1-mutated AML per your Clinical Policy Bulletin."

Key points to emphasize:

  • FDA-approved indication with confirmed biomarker
  • Prior therapy failures or contraindications to alternatives
  • Risk of disease progression without targeted therapy
  • Monitoring plan for known adverse events

Questions to ask:

  • "What specific criteria does the reviewer believe are not met?"
  • "Can you provide the exact policy language being applied?"
  • "Is an oncology specialist available for this review?"

Pennsylvania External Review

Pennsylvania's Independent External Review process offers a powerful second chance, with approximately 50% of appealed denials overturned in 2024, according to the Pennsylvania Insurance Department.

Eligibility and Timeline

Prerequisites:

  • Complete Aetna's internal appeal process
  • Receive Final Adverse Benefit Determination (FABD) letter
  • Commercial (non-self-funded) Aetna plan

Filing deadline: 4 months from FABD letter date

Submission Methods

Fastest options:

  • Online form (recommended)
  • Email or fax to Pennsylvania Insurance Department

Required documents:

  • Copy of Aetna's FABD letter
  • Front and back of insurance card
  • Medical records supporting medical necessity
  • Physician letter explaining why Rezlidhia is essential

Review Timeline

Standard review:

  • 5 business days: Aetna confirms eligibility
  • 1 business day: Independent Review Organization (IRO) assigned
  • 15 business days: Submit additional evidence to IRO
  • 45 days: Final IRO decision

Expedited review (life-threatening situations):

  • 24 hours: Eligibility confirmation
  • 72 hours: Final IRO decision
  • 24 hours: Aetna must implement favorable decision
Tip: Pennsylvania's external review is free to patients, and IRO decisions are binding on Aetna. The state reports most requests receive final decisions within 60 days.

Appeal Templates and Scripts

Patient Phone Script for Aetna

"Hello, I'm calling about a prior authorization denial for Rezlidhia. My member ID is [number]. I'd like to request a peer-to-peer review with a medical director and understand my appeal rights. Can you also confirm the exact deadline for filing an internal appeal?"

Medical Necessity Letter Template

Subject: Appeal for Prior Authorization Denial - Rezlidhia (olutasidenib) for IDH1-Mutated AML

Dear Aetna Medical Director,

I am formally appealing the denial of Rezlidhia (olutasidenib) for [patient name], DOB [date], Member ID [number]. This patient has relapsed/refractory acute myeloid leukemia with a susceptible IDH1 mutation and meets all criteria for coverage under Aetna's medical policy.

Clinical Summary: [Include diagnosis, staging, IDH1 mutation details, prior treatments, current status]

Medical Necessity Rationale: [Reference FDA labeling, NCCN guidelines, contraindications to alternatives]

Request: Immediate approval of Rezlidhia 150 mg twice daily for treatment of relapsed/refractory IDH1-mutated AML.

Sincerely, [Physician name and credentials]

Cost Savings and Support Options

While pursuing coverage appeals, explore these financial assistance programs:

Manufacturer Support:

  • Rigel Pharmaceuticals patient assistance programs
  • Copay assistance for eligible commercially insured patients
  • Contact manufacturer directly for current offerings

Foundation Grants:

  • Leukemia & Lymphoma Society financial assistance
  • CancerCare Emergency Financial Assistance
  • Patient Access Network Foundation

CVS Health Programs:

  • CVS Specialty Pharmacy support services
  • Patient financial counseling through CVS Caremark

When to Escalate Further

If appeals are unsuccessful, consider these additional options:

State Regulator Complaint

Contact the Pennsylvania Insurance Department if:

  • Aetna misses appeal deadlines
  • Improper denial reasons are cited
  • Process violations occur

Pennsylvania Health Law Project: Provides free assistance with insurance appeals Cancer Legal Resource Center: Offers guidance on insurance issues

Alternative Coverage Strategies

Formulary exception requests: For non-formulary status Medical benefit coverage: If pharmacy benefit is denied Clinical trial participation: May provide access while appealing

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through targeted, evidence-backed strategies. Their platform analyzes denial letters and creates point-by-point rebuttals aligned with each insurer's specific policies and requirements. Learn more at www.counterforcehealth.org.

Frequently Asked Questions

How long does Aetna prior authorization take in Pennsylvania? Standard PAs are typically decided within 24 hours when complete documentation is submitted electronically. Complex oncology cases may take up to 45 days.

What if Rezlidhia is non-formulary on my plan? Request a formulary exception through CVS Caremark with documentation of medical necessity and failure of formulary alternatives.

Can I request expedited review for AML treatment? Yes, if delay would seriously jeopardize your health. Include physician certification of urgency with your request.

Does step therapy apply if I failed treatments outside Pennsylvania? Treatment history from any state counts toward step therapy requirements. Provide complete documentation of prior failures.

What happens if Aetna misses appeal deadlines? For ERISA plans, missed deadlines may result in automatic approval. Contact Pennsylvania Insurance Department for guidance.

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. Coverage policies and appeal processes may vary by plan type and can change without notice.

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