By Counterforce Health Team in Kymriah (tisagenlecleucel) —

How to Get Kymriah (tisagenlecleucel) Covered by UnitedHealthcare in New Jersey: Appeals Guide with Templates

Answer Box: Getting Kymriah Covered by UnitedHealthcare in New Jersey

Kymriah requires prior authorization from UnitedHealthcare/OptumRx. If denied, you have strong appeal options in New Jersey through internal reviews and the state's Independent Health Care Appeals Program (IHCAP). First step today: Contact your oncologist to request prior authorization with complete clinical documentation showing CD19-positive disease, prior treatment failures, and REMS-certified facility availability. If denied, file an internal appeal within 180 days, then escalate to New Jersey's external review through Maximus within 4 months.

Table of Contents

  1. Understanding Kymriah Coverage Requirements
  2. Prior Authorization: Your First Step
  3. Common Denial Reasons and How to Fix Them
  4. Internal Appeals Process
  5. Peer-to-Peer Review Strategy
  6. New Jersey External Review Process
  7. Medical Necessity Letter Template
  8. Cost Assistance and Patient Support
  9. When to Escalate to Regulators
  10. Frequently Asked Questions

Understanding Kymriah Coverage Requirements

Kymriah (tisagenlecleucel) is a CD19-directed CAR-T cell therapy with a list price around $373,000-$475,000, making prior authorization mandatory across all UnitedHealthcare plans. The therapy treats specific blood cancers in patients who meet strict clinical criteria.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans OptumRx formulary UnitedHealthcare CAR-T Policy
Age Limits ≤25 years (ALL), ≥18 years (DLBCL) FDA labeling FDA Kymriah Label
REMS Certification Treatment center must be certified Provider must verify Kymriah REMS Program
CD19 Positivity Must be documented Lab reports required Clinical documentation
Prior Therapies ≥2 lines for DLBCL, refractory/relapsed ALL Medical records Treatment history

Prior Authorization: Your First Step

UnitedHealthcare requires comprehensive documentation before approving Kymriah. Here's exactly what your oncologist needs to submit:

Step-by-Step: Fastest Path to Approval

  1. Confirm Eligibility (Patient/Clinic)
    • Verify CD19-positive B-cell malignancy
    • Document age and diagnosis criteria
    • Timeline: Same day as consultation
  2. Gather Clinical Documentation (Clinic)
    • Prior treatment records with dates and responses
    • Pathology reports confirming CD19 expression
    • Performance status assessment
    • Timeline: 2-3 business days
  3. Identify REMS-Certified Center (Clinic)
    • Major New Jersey centers include Rutgers Cancer Institute, Hackensack Meridian Health, and Morristown Medical Center
    • Verify current certification status
    • Timeline: 1 business day
  4. Submit Prior Authorization (Clinic)
    • Use UnitedHealthcare provider portal or OptumRx forms
    • Include complete clinical package
    • Timeline: Submit within 5 business days
  5. Track Decision (Patient/Clinic)
    • Standard review: 15 business days
    • Expedited review: 72 hours if urgent
    • Follow up if no response by deadline
Clinician Corner: Medical Necessity Checklist

Your medical necessity letter should address:Problem: Specific diagnosis with ICD-10 codePrior treatments: List all regimens, dates, and outcomesClinical rationale: Why Kymriah is appropriate nowGuidelines: Reference NCCN guidelines and FDA labelingMonitoring plan: Detail post-infusion care and follow-up

Common Denial Reasons and How to Fix Them

Understanding why UnitedHealthcare denies Kymriah requests helps you build a stronger appeal:

Denial Reason How to Overturn Required Documents
Missing CD19 positivity Submit flow cytometry or immunohistochemistry results Lab reports with CD19 expression data
Not at certified center Transfer care or get center certified REMS certification documentation
Insufficient prior therapy Document all previous treatments and failures Complete treatment timeline with outcomes
"Experimental" designation Cite FDA approval and NCCN guidelines FDA labeling, clinical guidelines
Missing conditioning plan Provide lymphodepleting chemotherapy protocol Treatment protocol from certified center

Internal Appeals Process

If your prior authorization is denied, UnitedHealthcare offers two levels of internal appeals before you can access New Jersey's external review.

Timeline and Requirements

  • First-level appeal: Submit within 180 days of denial
  • Second-level appeal: Available if first level is denied
  • Expedited appeals: Available for urgent cases (72-hour decision)
  • Required documents: Original denial letter, medical records, physician statement

What to Include in Your Appeal

  1. Complete medical records showing diagnosis and treatment history
  2. Detailed physician letter explaining medical necessity
  3. Clinical guidelines supporting Kymriah use
  4. Treatment center verification of REMS certification
  5. Patient impact statement describing disease progression
Tip: Request a peer-to-peer review within 3-5 business days of denial. This gives your oncologist direct access to UnitedHealthcare's medical director to discuss your case.

Peer-to-Peer Review Strategy

The peer-to-peer call is often your best chance to reverse a denial quickly. UnitedHealthcare schedules these calls with oncology specialists familiar with CAR-T therapy.

Preparation Checklist

  • Clinical summary: One-page overview of patient history
  • Treatment timeline: Chronological list of all prior therapies
  • Rationale statement: Why Kymriah is medically necessary now
  • Guideline references: NCCN, FDA labeling, peer-reviewed studies
  • Center documentation: Proof of REMS certification

Key Talking Points

  1. Patient meets FDA-approved criteria for Kymriah
  2. Prior therapies failed or patient was intolerant
  3. No contraindications to CAR-T therapy
  4. Certified treatment center available in New Jersey
  5. Time-sensitive nature of patient's condition

New Jersey External Review Process

New Jersey's Independent Health Care Appeals Program (IHCAP) provides an independent review of UnitedHealthcare denials after you complete internal appeals.

How IHCAP Works

New Jersey contracts with Maximus Federal Services to manage external reviews. The process is free to patients and binding on insurers.

Eligibility Requirements:

  • Completed UnitedHealthcare's internal appeal process
  • Denial based on medical necessity or experimental status
  • Fully-insured commercial plan or NJ FamilyCare/Medicaid

Timeline:

  • Filing deadline: 4 months from final internal denial
  • Review process: 45 days for standard cases, 48 hours for urgent
  • Decision: Binding on UnitedHealthcare

How to File External Review

  1. Submit online: Visit njihcap.maximus.com
  2. Required documents:
    • Completed external review request form
    • Final denial letter from UnitedHealthcare
    • All medical records and physician statements
    • Any additional supporting documentation
  3. Track your case: Maximus provides updates throughout the review process
From Our Advocates: In complex CAR-T cases, we've seen external reviews succeed when the appeal clearly demonstrates that standard treatments have failed and the patient meets all FDA criteria. The key is comprehensive documentation showing both medical necessity and compliance with safety requirements.

Medical Necessity Letter Template

Here's a framework your oncologist can use to structure a compelling medical necessity letter:

Essential Components

Header Information:

  • Patient demographics and policy information
  • Treating physician credentials and contact information
  • Date and reference to denial letter

Clinical Summary:

[Patient Name] is a [age]-year-old [gender] with [diagnosis] 
who meets FDA criteria for Kymriah therapy. The patient has 
CD19-positive disease confirmed by [test type] on [date] and 
has failed [number] prior lines of therapy including [list treatments].

Prior Treatment History:

  • Chronological list of all therapies
  • Dates of treatment and duration
  • Response to each treatment (complete response, partial response, progression)
  • Reasons for discontinuation (progression, toxicity, intolerance)

Medical Necessity Statement:

Kymriah is medically necessary for this patient because:
1. FDA-approved indication is met
2. Standard therapies have failed
3. No contraindications exist
4. Treatment will be administered at REMS-certified facility
5. Patient has adequate performance status for CAR-T therapy

Supporting Evidence:

  • Reference to FDA labeling and approval
  • NCCN guideline recommendations
  • Peer-reviewed literature on CAR-T efficacy
  • Treatment center certification documentation

Cost Assistance and Patient Support

Even with insurance coverage, Kymriah can involve significant out-of-pocket costs. Several programs can help:

Manufacturer Support Programs

Novartis Oncology Patient Assistance:

  • Copay assistance for eligible patients
  • Free drug program for uninsured/underinsured
  • Case management support
  • Contact: Novartis Patient Assistance

Foundation Grants

  • Leukemia & Lymphoma Society: Financial assistance for treatment costs
  • CancerCare: Emergency financial assistance
  • Patient Advocate Foundation: Copay relief program

State Resources

New Jersey offers additional support through various programs. Contact the New Jersey Department of Banking and Insurance consumer hotline at 1-800-446-7467 for guidance on available assistance programs.

When to Escalate to Regulators

If you've exhausted appeals and external review without success, you can file complaints with regulatory agencies:

New Jersey Department of Banking and Insurance

Contact Information:

When to Contact:

  • Insurance company not following appeal timelines
  • Denial appears to violate state or federal law
  • External review decision not being honored

Federal Agencies

For Medicare Advantage or self-funded employer plans, contact:

  • Centers for Medicare & Medicaid Services: 1-800-MEDICARE
  • Department of Labor: For ERISA plan issues

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in New Jersey? Standard prior authorization decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Kymriah is not on my formulary? Even non-formulary drugs can be covered through medical exceptions. Your oncologist should request a formulary exception along with the prior authorization.

Can I request an expedited appeal if my condition is worsening? Yes, UnitedHealthcare must provide expedited appeals for urgent cases where delay could jeopardize life or health. The decision timeline is reduced to 72 hours.

Does step therapy apply to CAR-T therapies like Kymriah? Step therapy typically doesn't apply to CAR-T since these are reserved for patients who have already failed multiple prior therapies. However, documentation of prior treatment failures is required.

What happens if my external review is denied? External review decisions are binding, but you may have legal remedies available. Consider consulting with a healthcare attorney specializing in insurance coverage disputes.

Can I appeal if I received Kymriah but UnitedHealthcare won't pay? Yes, you can appeal payment denials for services already received. The same appeal process applies, and New Jersey's external review covers reimbursement disputes.

How do I find REMS-certified treatment centers in New Jersey? Contact Novartis directly or check with major cancer centers. Rutgers Cancer Institute, Hackensack Meridian Health, and Morristown Medical Center are among certified facilities.

What if I'm on a Medicare Advantage plan through UnitedHealthcare? Medicare Advantage appeals follow federal timelines and may have different external review processes. Contact Medicare at 1-800-MEDICARE for specific guidance.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-backed strategies. Our platform analyzes denial letters, identifies specific denial reasons, and creates targeted rebuttals aligned with each payer's policies and clinical guidelines.

When navigating complex prior authorization requirements for treatments like Kymriah, having the right documentation and appeal strategy can make the difference between coverage and denial. Counterforce Health streamlines this process by providing the clinical evidence and procedural knowledge needed to build compelling cases for coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official appeals processes and current forms, refer to your UnitedHealthcare member materials and New Jersey Department of Banking and Insurance resources.

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