By Counterforce Health Team in Pemazyre (pemigatinib) —

Get Pemazyre (Pemigatinib) Covered by UnitedHealthcare in California: Prior Authorization Guide and Appeal Scripts

Answer Box: Fastest Path to Pemazyre Coverage

To get Pemazyre (pemigatinib) covered by UnitedHealthcare in California: You need prior authorization with documented FGFR2 fusion/rearrangement via FDA-approved testing, previous treatment history, and unresectable/metastatic cholangiocarcinoma diagnosis. Submit through UnitedHealthcare provider portal with complete molecular testing results. If denied, file internal appeal within 180 days, then request California Independent Medical Review (IMR) through DMHC within 30 days—IMRs overturn 55% of medical necessity denials. Start today: Confirm your FGFR2 testing meets FDA standards and gather prior treatment records.

Table of Contents

  1. UnitedHealthcare's Coverage Policy for Pemazyre
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity Limits and Renewal Rules
  5. Required Molecular Testing
  6. Specialty Pharmacy Requirements
  7. Evidence for Medical Necessity
  8. Sample Medical Necessity Letter
  9. Common Denial Reasons and Solutions
  10. California Appeals Process
  11. Cost Savings and Support Programs
  12. FAQ

UnitedHealthcare's Coverage Policy for Pemazyre

UnitedHealthcare requires prior authorization for all Pemazyre prescriptions across HMO, PPO, and Medicare Advantage plans in California. The drug is managed through OptumRx's specialty pharmacy network with specific coverage criteria that must be met before approval.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all prescriptions PA form via provider portal UHC PA Requirements
FGFR2 Testing FDA-approved molecular test showing fusion/rearrangement Lab report with specific mutation details PA Notification
Previous Treatment Must have received prior therapy Treatment records and response documentation PA Notification
Diagnosis Unresectable/metastatic cholangiocarcinoma Pathology report and imaging PA Notification
Age Exception Under 19 years auto-approved Birth date verification PA Notification
Authorization Duration 12 months initial, 12 months renewal Progress notes showing no disease progression PA Notification

FDA Indication Requirements

Pemazyre is FDA-approved for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement. UnitedHealthcare follows this indication strictly, though California state mandates may require coverage for certain off-label uses when supported by recognized compendia.

Key Coverage Points:

  • On-label use: Automatic consideration if criteria met
  • Off-label use: May be covered if listed in NCCN Compendium or other recognized sources
  • Clinical trial enrollment: Can support coverage for investigational protocols

Step Therapy and Medical Exceptions

While specific step therapy requirements aren't detailed in UnitedHealthcare's current Pemazyre policy, the "previously treated" requirement effectively creates a step therapy approach. For cholangiocarcinoma, this typically means:

Standard Treatment Sequence:

  1. First-line: Gemcitabine plus cisplatin combination
  2. Second-line: Pemazyre (if FGFR2 fusion positive)

Medical Exception Pathways:

  • Contraindication to standard therapy: Document specific medical reasons
  • Treatment failure: Include progression dates and imaging
  • Intolerance: Detail adverse events and management attempts
Tip: The FIGHT-302 clinical trial is studying Pemazyre as first-line therapy, which may influence future coverage policies.

Quantity Limits and Renewal Rules

UnitedHealthcare typically imposes quantity limits on specialty medications, though specific limits for Pemazyre aren't published. Standard practice includes:

  • Initial approval: 12 months
  • Renewal requirements: No evidence of disease progression
  • Dose modifications: May require new authorization for significant changes
  • Supply limits: Usually 30-day supplies through specialty pharmacy

Required Molecular Testing

Critical requirement: FGFR2 fusion or rearrangement must be detected by an FDA-approved test. Acceptable testing methods include:

FDA-Approved Tests:

  • FoundationOne CDx: Comprehensive genomic profiling
  • MSK-IMPACT: Memorial Sloan Kettering assay
  • Guardant360 CDx: Liquid biopsy option

Documentation Requirements:

  • Lab report showing specific FGFR2 alteration
  • Testing methodology clearly stated
  • Date of testing (recent preferred)
  • Laboratory accreditation information
Note: Generic "FGFR positive" results without specific fusion details may be insufficient for approval.

Specialty Pharmacy Requirements

Pemazyre must be dispensed through UnitedHealthcare's designated specialty pharmacy network, typically OptumRx specialty services.

Routing Requirements:

  • Specialty pharmacy only: Cannot fill at retail
  • Prior authorization completion: Must be approved before dispensing
  • Patient enrollment: Required in specialty pharmacy program
  • Coordination of benefits: Insurance and copay assistance processing

Evidence for Medical Necessity

Strong medical necessity documentation should include:

Clinical Guidelines:

  • NCCN Guidelines: Hepatobiliary Cancers recommendations
  • FDA Label: Official prescribing information
  • Peer-reviewed literature: Supporting efficacy data

Required Clinical Information:

  • Complete diagnosis with ICD-10 codes
  • Prior treatment history and outcomes
  • Current disease status and imaging
  • Contraindications to alternatives
  • Treatment goals and monitoring plan

Sample Medical Necessity Letter

Template structure for your oncologist:

"[Patient] has unresectable, metastatic cholangiocarcinoma with documented FGFR2 fusion detected by [FDA-approved test name] on [date]. Previous treatment with gemcitabine/cisplatin from [dates] resulted in disease progression documented by imaging on [date]. Per NCCN Guidelines and FDA approval, Pemazyre (pemigatinib) 13.5mg daily is the appropriate targeted therapy. Alternative treatments are limited for FGFR2-positive disease. Ophthalmologic monitoring will be performed per prescribing information. Authorization is requested for 12 months with standard quantity limits."

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No FGFR2 alteration documented Submit FDA-approved test results Lab report showing specific fusion/rearrangement
Insufficient prior treatment Provide complete treatment history Medical records, progression imaging
Off-label use Cite NCCN or compendia support Guideline excerpts, literature
Missing ophthalmology plan Submit monitoring protocol Eye exam schedule, baseline results
Drug interactions Address contraindicated medications Medication reconciliation, alternatives

California Appeals Process

If your Pemazyre prior authorization is denied, California offers strong patient protections through a two-tier system.

Step-by-Step Appeals Process:

  1. Internal Appeal with UnitedHealthcare
    • Timeline: File within 180 days of denial
    • Method: UnitedHealthcare provider portal or written request
    • Documentation: Medical necessity letter, test results, treatment records
    • Decision time: 30 days standard, 72 hours for urgent cases
  2. Independent Medical Review (IMR)

Expedited Review Options:

  • Urgent cases: 72-hour internal appeal
  • IMR expedited: 7 days or less for urgent conditions
  • Criteria: Immediate health risk or significant pain
California Advantage: The state's IMR process is binding on insurers and has one of the highest patient success rates nationally.

Cost Savings and Support Programs

Manufacturer Support:

  • Incyte Patient Assistance: Income-based free drug program
  • Commercial copay assistance: Up to $25,000 annually for eligible patients
  • Information: Contact Incyte at 1-855-463-3463

Additional Resources:

  • CancerCare: Financial assistance and copay help
  • Patient Access Network Foundation: Disease-specific grants
  • Leukemia & Lymphoma Society: Co-payment assistance program

When to Escalate

Contact California regulators if UnitedHealthcare delays or inappropriately denies coverage:

  • DMHC Help Center: 1-888-466-2219
  • Online complaints: healthhelp.ca.gov
  • Consumer advocacy: Health Consumer Alliance for complex cases

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Pemazyre. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address each payer's specific requirements. By combining clinical expertise with payer intelligence, we help patients and providers navigate complex prior authorization processes more effectively. Visit counterforcehealth.org to learn how our tools can streamline your appeals process.

FAQ

How long does UnitedHealthcare prior authorization take for Pemazyre in California? Standard PA decisions take up to 15 business days. Urgent cases can be expedited to 72 hours if immediate treatment is medically necessary.

What if Pemazyre isn't on UnitedHealthcare's formulary? Non-formulary medications can still be covered through medical exception processes. Strong clinical documentation and guideline support are essential.

Can I request a peer-to-peer review? Yes, your oncologist can request to speak directly with UnitedHealthcare's medical director to discuss the case and provide additional clinical context.

Does step therapy apply if I failed treatments outside California? Treatment history from any location counts toward step therapy requirements. Ensure all prior therapies are documented with dates and outcomes.

What happens if my IMR is denied? IMR decisions are final and binding. However, you may have options through federal appeals processes or legal consultation for potential bad faith claims.

How do I get help with the appeals process? The DMHC Help Center provides free assistance. Counterforce Health also offers specialized support for complex medication appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always consult with your healthcare provider and insurance plan for current requirements. For assistance with insurance appeals and prior authorization, contact the California DMHC Help Center at 1-888-466-2219.

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