By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (pemigatinib) Covered by UnitedHealthcare in Texas: Appeals Guide & Templates

Answer Box: Getting Pemazyre Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Pemazyre (pemigatinib) with step therapy requirements. First step: Submit PA through the UnitedHealthcare Provider Portal with FGFR2/FGFR1 testing results, prior therapy documentation, and ophthalmologic monitoring plan. If denied, you have 180 days to file an internal appeal, followed by Texas Independent Review Organization (IRO) external review within 4 months. Most denials stem from missing molecular testing or inadequate step therapy documentation.

Table of Contents

  1. Understanding UnitedHealthcare's Pemazyre Coverage
  2. Reading Your Denial Letter
  3. Common Fixable Issues
  4. First-Level Appeal Strategy
  5. Peer-to-Peer Review Process
  6. Texas External Review (IRO)
  7. Appeal Templates & Scripts
  8. Tracking Your Case
  9. When Appeals Fail: Alternatives
  10. FAQ

Understanding UnitedHealthcare's Pemazyre Coverage

UnitedHealthcare covers Pemazyre (pemigatinib) through OptumRx for FDA-approved indications: cholangiocarcinoma with FGFR2 fusion/rearrangement and myeloid/lymphoid neoplasms with FGFR1 rearrangement. However, prior authorization is required with step therapy criteria typically mandating failure of preferred alternatives first.

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Prior Authorization Required via Provider Portal Complete PA form with clinical notes
FGFR Testing FDA-approved assay results Pathology report showing FGFR2/FGFR1 alteration
Step Therapy Prior therapy failure/intolerance Treatment history with dates and outcomes
Ophthalmologic Monitoring Baseline eye exam required Ophthalmology consultation report
Age Restriction Adults ≥18 years Patient demographics
ICD-10 Codes C22.1 (cholangiocarcinoma), C94.80-C96.9 (MLNs) Diagnosis documentation

Source: UnitedHealthcare Prior Authorization Requirements

Reading Your Denial Letter

UnitedHealthcare denial letters include specific reason codes that reveal exactly what's missing. Here's how to decode them:

Common Denial Reasons:

  • PA001: No prior authorization submitted
  • ST002: Step therapy requirements not met
  • DX003: Diagnosis not supported by submitted documentation
  • LAB004: Required laboratory/pathology results missing
  • MON005: Monitoring plan incomplete
Tip: The denial letter includes your appeal deadline (typically 180 days) and specific documentation needed. Don't ignore these details—they're your roadmap to approval.

Common Fixable Issues

Many Pemazyre denials can be overturned by addressing these common problems:

Missing FGFR Testing Documentation

Problem: No molecular testing report or non-FDA-approved assay used. Fix: Submit FoundationOne CDx, MSK-IMPACT, or equivalent FDA-approved test showing FGFR2 fusion (cholangiocarcinoma) or FGFR1 rearrangement (MLNs).

Inadequate Step Therapy Documentation

Problem: No evidence of prior therapy failure. Fix: Provide detailed treatment history showing progression on or intolerance to gemcitabine/cisplatin (cholangiocarcinoma) or standard treatments (MLNs).

Missing Ophthalmologic Clearance

Problem: No baseline eye exam documented. Fix: Schedule ophthalmology consultation and submit report confirming suitability for FGFR inhibitor therapy.

First-Level Appeal Strategy

What to Include in Your Appeal

Your medical necessity letter should address these key points:

Clinical Documentation Checklist:

  • Confirmed diagnosis with appropriate ICD-10 code
  • FDA-approved FGFR testing results
  • Complete prior treatment history with dates and outcomes
  • Baseline ophthalmologic examination
  • Current imaging showing disease status
  • NCCN guideline citations supporting Pemazyre use

Medical Necessity Letter Template

[Date]
UnitedHealthcare Medical Director
[Address from denial letter]

RE: Appeal for Pemazyre (pemigatinib) Coverage
Member: [Patient Name], Policy #: [Number]
Diagnosis: [Specific diagnosis], ICD-10: [Code]

Dear Medical Director,

I am appealing the denial of Pemazyre for my patient with [diagnosis] confirmed by FDA-approved molecular testing showing [FGFR alteration]. This targeted therapy is medically necessary and appropriate per FDA labeling and NCCN guidelines.

Clinical Justification:
1. Confirmed FGFR2 fusion/FGFR1 rearrangement via [test name and date]
2. Disease progression following [prior therapies with dates]
3. Patient meets FDA-approved indication criteria
4. Baseline ophthalmologic clearance obtained [date]
5. NCCN Category 2A recommendation for this clinical scenario

Attached documentation includes molecular testing report, treatment history, imaging, and ophthalmology consultation. Pemazyre represents the most appropriate targeted therapy for this patient's specific molecular alteration.

Requesting immediate approval for this medically necessary treatment.

Sincerely,
[Physician Name and Credentials]
[Contact Information]

Peer-to-Peer Review Process

If your initial appeal is denied, request a peer-to-peer review to discuss the case directly with a UnitedHealthcare medical director.

Scheduling Your Review

Contact: UnitedHealthcare Provider Services at 1-877-842-3210 Process: Request peer-to-peer review through the Provider Portal or by calling after receiving adverse determination Timeline: Reviews typically scheduled within 5-7 business days

Peer-to-Peer Preparation Checklist

  • Patient's complete medical history readily available
  • FGFR testing results and interpretation
  • Prior therapy timeline with specific dates and outcomes
  • NCCN guideline excerpts supporting Pemazyre use
  • Published clinical trial data (FIGHT-202 study)
  • Clear explanation of why alternatives are inappropriate

Key Talking Points:

  • FDA approval for specific FGFR alteration
  • NCCN Category 2A recommendation
  • 36% objective response rate in FIGHT-202 trial
  • Lack of effective alternatives for FGFR-driven disease

Texas External Review (IRO)

If internal appeals fail, Texas residents can request an Independent Review Organization (IRO) external review through the Texas Department of Insurance.

IRO Process Timeline

Step Deadline Action Required
Complete internal appeals Before IRO request Exhaust UnitedHealthcare's internal process
Submit IRO request Within 4 months of final denial Complete LHL009 form
UnitedHealthcare forwards to TDI Within 1 working day Automatic
IRO decision 20 calendar days (8 for urgent) Binding determination

How to Request IRO Review

  1. Get the form: Request LHL009 from UnitedHealthcare or download from Texas Department of Insurance
  2. Complete and sign: Include medical record release authorization
  3. Submit to UnitedHealthcare: They forward to TDI (don't send directly to TDI)
  4. Follow up: Track progress through TDI at 1-866-554-4926
Note: IRO review is free to patients and the decision is binding on UnitedHealthcare.

Appeal Templates & Scripts

Patient Phone Script for UnitedHealthcare

"Hello, I'm calling about a prior authorization denial for Pemazyre. My policy number is [number] and the denial reference is [reference]. I'd like to understand the specific requirements for approval and start the appeal process. Can you transfer me to someone who can help with specialty drug appeals?"

Clinic Staff Script for Peer-to-Peer Request

"I'm calling to schedule a peer-to-peer review for a Pemazyre denial. The patient has [diagnosis] with confirmed [FGFR alteration] and has failed [prior therapies]. The attending physician would like to discuss this case with your oncology medical director."

Tracking Your Case

Appeal Timeline Tracker

Date Action Deadline Status Notes
[Date] Denial received 180 days for appeal ☐ Reference #:
[Date] Appeal submitted 30 days for decision ☐ Confirmation #:
[Date] Peer-to-peer scheduled N/A ☐ Medical director:
[Date] IRO requested 4 months from final denial ☐ TDI case #:

When to Escalate

Contact the Texas Department of Insurance at 1-800-252-3439 if:

  • UnitedHealthcare misses appeal deadlines
  • You're not receiving required notifications
  • The IRO process isn't proceeding properly

When Appeals Fail: Alternatives

Manufacturer Support Programs

Incyte Cares: Patient assistance program offering copay support and free drug programs for eligible patients. Visit hcp.incytecares.com or call 1-855-463-3463.

Foundation Grants

  • Patient Access Network (PAN) Foundation: Copay assistance for cancer patients
  • CancerCare: Financial assistance and case management
  • Leukemia & Lymphoma Society: Patient aid program

Alternative Therapies

For FGFR2-positive cholangiocarcinoma:

  • Futibatinib (Lytgobi): Alternative FGFR inhibitor
  • Clinical trials: Search ClinicalTrials.gov for FGFR-targeted studies

FAQ

How long does UnitedHealthcare prior authorization take in Texas? Standard PA decisions are made within 15 days. Urgent requests (when delay could jeopardize health) are decided within 72 hours.

What if Pemazyre isn't on my formulary? Request a formulary exception with your appeal. Provide clinical justification for why formulary alternatives are inappropriate for your specific FGFR alteration.

Can I get an expedited appeal? Yes, if delaying treatment could seriously jeopardize your health. Request expedited review when submitting your appeal and provide clinical documentation supporting urgency.

Does step therapy apply if I failed treatments in another state? Yes, treatment history from any location counts toward step therapy requirements. Provide complete documentation from all previous providers.

What's the success rate for Pemazyre appeals in Texas? While specific statistics aren't published, appeals with complete FGFR testing documentation and clear step therapy failure evidence have higher success rates. Texas IRO reviews provide an additional layer of independent medical review.

How much does Pemazyre cost without insurance? Monthly costs typically range in the high four to five figures. Contact Incyte Cares immediately for patient assistance if paying out-of-pocket.

Counterforce Health helps patients and clinicians navigate insurance denials by turning rejection letters into targeted, evidence-backed appeals. Our platform analyzes denial reasons and drafts point-by-point rebuttals aligned to each plan's specific requirements, significantly improving approval rates for specialty medications like Pemazyre. Learn more at CounterforceHealth.org.

When facing a UnitedHealthcare denial for Pemazyre, remember that appeals are often successful when properly documented. The key is providing complete FGFR testing results, demonstrating step therapy compliance, and clearly articulating medical necessity. Counterforce Health's automated appeal platform can help streamline this process, ensuring your documentation meets UnitedHealthcare's specific requirements while saving valuable time for both patients and clinicians.

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 procedures may vary by plan type and can change without notice.

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