By Counterforce Health Team in Kymriah (tisagenlecleucel) —

How to Get Kymriah (tisagenlecleucel) Covered by UnitedHealthcare in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Kymriah Covered by UnitedHealthcare in Virginia

UnitedHealthcare covers Kymriah (tisagenlecleucel) under medical benefits as autologous stem cell therapy, requiring prior authorization through OptumHealth Transplant Solutions. For B-cell ALL (≤25 years) or relapsed/refractory DLBCL after ≥2 therapy lines, submit via the UHC Provider Portal with CD19+ confirmation, treatment history, and certified center documentation. Standard review takes 5-15 business days; expedited review available within 72 hours for urgent cases. If denied, Virginia's external review through the State Corporation Commission Bureau of Insurance provides independent oversight within 45 days using Form 216-A.

First step today: Verify your plan type and gather diagnosis confirmation, prior therapy records, and CD19+ pathology results before submitting your prior authorization request.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. Common Denial Reasons and Solutions
  7. Appeals Process in Virginia
  8. Clinician Corner: Medical Necessity Letters
  9. Costs and Financial Assistance
  10. FAQ: Common Questions

What This Guide Covers

This comprehensive guide helps patients and clinicians navigate UnitedHealthcare's prior authorization process for Kymriah (tisagenlecleucel) in Virginia. Kymriah is a CD19-directed CAR-T cell therapy manufactured by Novartis, with list prices around $475,000 for ALL and $373,000 for DLBCL (excluding facility costs).

Who this helps:

  • Patients with B-cell precursor ALL (≤25 years) or relapsed/refractory DLBCL
  • Oncologists submitting prior authorization requests
  • Care coordinators managing CAR-T approvals
  • Families navigating insurance appeals

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to identify denial reasons and draft point-by-point rebuttals aligned with each plan's specific requirements, helping patients access life-saving treatments like Kymriah.

Before You Start: Plan Verification

Coverage at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all CAR-T therapies UHC Provider Portal UHC CAR-T Guidelines
Benefit Type Medical benefit (transplant), not pharmacy Member benefits summary UHC Oncology Policy
Age Limits ≤25 years for ALL indication FDA labeling UHC CAR-T Guidelines
Treatment Center FACT-certified or seeking certification Facility verification UHC CAR-T Guidelines

Step 1: Confirm Your Plan Type

Call the member services number on your insurance card to verify:

  • Plan type (commercial, Medicare Advantage, or Medicaid managed care)
  • Whether OptumHealth Transplant Solutions manages your transplant benefits
  • In-network status of your treatment facility
Note: Virginia residents with UnitedHealthcare Cardinal Care (Medicaid managed care) follow the same prior authorization process but may have different appeal timelines.

Gather Required Documentation

Essential Clinical Documentation

For B-cell Precursor ALL (≤25 years):

  • Pathology report confirming CD19+ B-cell precursor ALL
  • Documentation of Philadelphia chromosome status
  • Prior therapy records showing:
    • Primary refractory disease, OR
    • First relapse ≤12 months from remission, OR
    • Refractory/relapsed after ≥2 systemic therapy lines
  • Bone marrow biopsy showing ≥5% lymphoblasts
  • Performance status assessment (ECOG ≤1 preferred)

For DLBCL/Large B-cell Lymphoma:

  • Pathology confirming CD19+ DLBCL or transformed lymphoma
  • Documentation of ≥2 prior systemic therapy lines
  • Imaging showing relapsed or refractory disease
  • Adequate organ function assessments

Administrative Requirements

  1. Insurance verification with current member ID
  2. Treatment center certification (FACT immune effector cell standards)
  3. Physician orders specifying Kymriah by name
  4. ICD-10 codes: C91.00 (ALL) or C83.30 (DLBCL)
  5. Prior authorization form from UHC Provider Portal

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Access the UHC Provider Portal

  • Log in at UHCprovider.com
  • Navigate to Prior Authorization tools
  • Select "Medical Services" (not pharmacy)

2. Complete the Request

  • Reference UnitedHealthcare's CAR-T Clinical Guideline
  • Include all clinical documentation listed above
  • Specify manufacturing and administration timeline

3. Alternative Submission Methods

  • Phone: 866-889-8054 for provider services
  • OptumRx specialty coordination: 888-397-8129

Clean Request Packet Checklist

✅ Complete prior authorization form
✅ Pathology report with CD19+ confirmation
✅ Treatment history with dates and outcomes
✅ Current imaging and laboratory results
✅ Physician letter of medical necessity
✅ Treatment center FACT certification
✅ Insurance verification and member ID

Follow-Up and Timeline Expectations

Standard Timelines

Review Type Timeline Trigger
Standard Review 5-15 business days Routine requests
Expedited Review 72 hours Life/health jeopardy certification
Peer-to-Peer 24-48 hours to schedule Upon request or denial

Follow-Up Best Practices

Week 1: Call to confirm receipt and completeness

  • Reference number documentation
  • Missing information requests
  • Expected decision timeline

Week 2: Status check if no decision received

  • Request peer-to-peer review if concerns arise
  • Escalate to medical director if appropriate
Tip: Document all phone calls with date, time, representative name, and reference numbers for appeal purposes.

Common Denial Reasons and Solutions

Denial Reason Required Fix Documentation Needed
Missing CD19 positivity Submit flow cytometry Pathology report with CD19+ confirmation
Insufficient prior therapy Document treatment failures Pharmacy records, physician notes, imaging
Non-certified center Verify FACT status Center certification letter
Not medically necessary Strengthen clinical rationale Guidelines citations, medical necessity letter
Missing performance status Complete functional assessment ECOG or Karnofsky score documentation

Sample Appeal Points

For "not medically necessary" denials:

  • Reference FDA approval for your specific indication
  • Cite NCCN Guidelines supporting CAR-T therapy
  • Include treatment center's expertise documentation
  • Emphasize time-sensitive nature of disease progression

Appeals Process in Virginia

Internal Appeals with UnitedHealthcare

Timeline: 60 days from denial to file internal appeal Method: UHC Provider Portal or written submission Decision: 30 days for standard, 72 hours for expedited

Virginia External Review Process

If internal appeals are unsuccessful, Virginia's State Corporation Commission Bureau of Insurance provides independent review.

Key Deadlines:

  • 120 days from final internal denial to request external review
  • 45 days for standard external review decision
  • 72 hours for expedited external review

Required Forms:

  • Form 216-A for standard external review
  • Form 216-C for expedited review with physician urgency certification

Submission Methods:

  • Fax: 804-371-9915
  • Email: [email protected]
  • Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
Virginia Advantage: The state allows expedited external review for cancer treatment denials without exhausting all internal appeals, recognizing the time-sensitive nature of oncology care.

For guidance on the external review process, contact Virginia's Office of the Managed Care Ombudsman at 1-877-310-6560.

Clinician Corner: Medical Necessity Letters

Essential Elements for CAR-T Medical Necessity

Clinical Rationale Section:

  1. Diagnosis confirmation with staging and molecular markers
  2. Prior therapy documentation with specific agents, dates, and response
  3. Disease progression evidence with recent imaging
  4. Treatment urgency due to rapidly progressive disease
  5. Center expertise and patient selection criteria met

Supporting Literature:

  • FDA prescribing information for tisagenlecleucel
  • NCCN Guidelines for your patient's specific diagnosis
  • ASTCT consensus recommendations for CAR-T therapy
  • Peer-reviewed efficacy data from pivotal trials

Template Language

"This patient meets FDA-approved criteria for tisagenlecleucel based on [specific indication]. Prior therapies including [list agents] resulted in [outcomes]. Current disease status shows [progression evidence]. Treatment at our FACT-certified center is medically necessary and time-sensitive given [clinical urgency factors]."

Costs and Financial Assistance

Manufacturer Support Programs

Novartis Patient Assistance:

  • Income-based copay assistance
  • Free drug programs for eligible uninsured patients
  • Coverage gap support during appeals
  • Contact: 1-844-4KYMRIAH

Additional Resources

Virginia-Specific Programs:

  • Virginia Medicaid expansion (for eligible patients)
  • Hospital charity care programs
  • Cancer foundation grants through Virginia Cancer Institute

National Programs:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • Leukemia & Lymphoma Society copay assistance

FAQ: Common Questions

How long does UnitedHealthcare prior authorization take in Virginia? Standard review takes 5-15 business days. Expedited review is available within 72 hours if your physician certifies that delays would jeopardize your health.

What if Kymriah is denied for step therapy requirements? Document all prior therapies with specific agents, dates, and reasons for discontinuation. Step therapy exceptions are available when alternatives failed, caused intolerable side effects, or are contraindicated.

Can I request a peer-to-peer review? Yes. Your oncologist can request to speak directly with a UnitedHealthcare medical director to discuss your case. This often helps clarify clinical rationale and resolve denials.

Does UnitedHealthcare require treatment at specific centers? Yes. Treatment must occur at FACT-certified centers or those actively seeking certification. Verify your center's status before submitting your request.

What happens if my external review is denied in Virginia? The external review decision is final and binding on the insurance company. However, you retain rights to pursue legal action separately, and you may explore other coverage options or assistance programs.

How often does Kymriah need reauthorization? CAR-T therapy is typically a one-time treatment. However, if complications require additional interventions or if treatment is delayed, additional authorizations may be needed for supportive care.

When navigating complex prior authorization requirements, Counterforce Health's platform can help by analyzing your specific denial reasons and generating targeted appeals with the right clinical evidence and policy citations. Our system understands payer-specific workflows and can significantly improve your chances of approval.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice or a guarantee of coverage. Always consult with your healthcare team and insurance company for decisions specific to your situation. For additional help with Virginia insurance issues, contact the Virginia State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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