By Counterforce Health Team in Pemazyre (pemigatinib) —

How to Get Pemazyre (pemigatinib) Covered by Humana in North Carolina: Complete Guide to Prior Authorization, Appeals, and Approval

Answer Box: Fastest Path to Pemazyre Coverage

Pemazyre (pemigatinib) requires prior authorization from Humana in North Carolina. You'll need documented FGFR2 fusion/rearrangement testing, baseline ophthalmologic monitoring plan, and proof of prior systemic therapy failure. Submit complete documentation through Humana's provider portal for 72-hour standard review. If denied, you have 65 days for internal appeal, then external review through North Carolina's Smart NC program.

First step today: Contact your oncologist to ensure FGFR2 testing results and eye exam documentation are ready for submission.

Table of Contents

Plan Types & Coverage Implications

Humana offers several plan types in North Carolina, each with different coverage rules for Pemazyre:

Medicare Advantage Plans: Most common Humana coverage in North Carolina. Pemazyre requires prior authorization across all Medicare Advantage plans, with strict documentation requirements for FGFR2 testing and ophthalmologic monitoring.

Medicare Part D: Standalone prescription drug plans that follow federal Medicare guidelines. Appeals process includes 65-day filing deadlines and Independent Review Entity (IRE) external review.

Commercial Plans: Employer-sponsored and individual marketplace plans may have different formulary tiers and prior authorization criteria. Always verify your specific plan's requirements through the Humana provider portal.

Formulary Status & Tier Placement

Pemazyre is included on most Humana formularies for 2024-2025 but requires prior authorization regardless of tier placement. The medication typically appears as:

  • Specialty Tier: High-cost medication requiring specialty pharmacy dispensing
  • Non-Formulary with Medical Exception: Some plans require formulary exception requests
  • Quantity Limits: Standard restriction of 28 tablets per 28 days
Note: Formulary status can change annually. Always verify current placement through your plan's formulary lookup tool.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
FGFR2 Testing Confirmed fusion/rearrangement from tumor tissue Pathology lab report Before PA submission
Ophthalmologic Plan Baseline eye exam + monitoring schedule Ophthalmologist documentation Before PA submission
Prior Therapy History Documentation of systemic treatment failure Medical records, clinic notes Before PA submission
Medical Necessity Letter Prescriber justification Oncologist's office With PA submission

Required Documentation

1. FGFR2 Fusion/Rearrangement Testing

  • Full laboratory pathology report from tumor tissue (blood-only tests insufficient)
  • Specific alteration must be documented, not just "FGFR2 positive"
  • Test must be from validated assay

2. Clinical Diagnosis

  • Pathologically confirmed unresectable, locally advanced, or metastatic cholangiocarcinoma
  • Appropriate ICD-10 diagnosis codes

3. Treatment History

  • Records of prior systemic therapies tried, failed, or contraindicated
  • Pemazyre is indicated for previously treated patients

4. Ophthalmologic Monitoring Plan

  • Baseline comprehensive eye exam with optical coherence tomography (OCT)
  • Scheduled follow-up exams every 2 months for first 6 months, then every 3 months
  • Plan for managing ocular toxicity including dose modifications

Step-by-Step: Fastest Path to Approval

  1. Verify Plan Coverage (Patient/Clinic)
    • Check formulary status through Humana member portal
    • Confirm prior authorization requirements
    • Timeline: Same day
  2. Gather Required Documentation (Clinic)
    • Obtain complete FGFR2 testing report
    • Schedule and complete baseline eye exam
    • Compile treatment history records
    • Timeline: 1-2 weeks
  3. Submit Prior Authorization (Prescriber)
    • Use Humana's current PA forms via provider portal
    • Include all required documentation in initial submission
    • Fax option: 877-486-2621
    • Timeline: Same day submission
  4. Track Decision (Patient/Clinic)
    • Standard review: Up to 72 hours
    • Expedited review: Within 24 hours if urgent
    • Timeline: 1-3 business days
  5. Coordinate Specialty Pharmacy (Patient)
    • CenterWell Specialty Pharmacy will contact you upon approval
    • Provide insurance and shipping information
    • Timeline: 2-3 business days
  6. Appeal if Denied (Patient/Prescriber)
    • File internal appeal within 65 days
    • Include additional supporting documentation
    • Timeline: 7 days for decision
  7. External Review if Needed (Patient)
    • Contact Smart NC for external review
    • File within 120 days of final internal denial
    • Timeline: 45 days standard, 72 hours expedited

Specialty Pharmacy Requirements

Pemazyre must be dispensed through Humana's specialty pharmacy network, primarily CenterWell Specialty Pharmacy. Using out-of-network pharmacies may result in coverage denial or significantly higher costs.

Setup Process:

  1. Upon prior authorization approval, CenterWell will contact you directly
  2. Provide insurance information and preferred delivery address
  3. Schedule delivery timing around treatment schedule
  4. Coordinate with your oncology team for administration guidance

Counterforce Health helps patients navigate specialty pharmacy requirements and ensures proper coordination between your clinical team and pharmacy benefits.

Cost-Share Dynamics

Medicare Advantage/Part D Plans:

  • 2025 out-of-pocket maximum: $2,000 for prescription drugs
  • Specialty tier medications typically have higher coinsurance
  • Coverage gap (donut hole) protections apply

Commercial Plans:

  • Cost-sharing varies by specific plan design
  • Deductible may apply before copay/coinsurance kicks in
  • Annual out-of-pocket maximums provide protection
Important: These are educational examples only. Consult your specific plan documents or contact Humana Member Services for exact cost-sharing details.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing FGFR2 Testing Submit complete lab report Full pathology report from tumor tissue
Incomplete Eye Monitoring Provide detailed monitoring plan Baseline exam results + scheduled follow-ups
Insufficient Prior Therapy Document treatment history Medical records showing systemic therapy failure
Medical Necessity Strengthen clinical justification Enhanced prescriber letter with guidelines

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

  • Problem Statement: Specific diagnosis with ICD-10 codes
  • Prior Treatments: Detailed history of systemic therapies tried and outcomes
  • Clinical Rationale: Why Pemazyre is appropriate based on FGFR2 testing
  • Guideline Support: Reference to FDA labeling and NCCN guidelines
  • Monitoring Plan: Specific ophthalmologic monitoring schedule
  • Urgency: If applicable, clinical need for expedited review

Appeals Process in North Carolina

Internal Appeals (Humana)

  • Filing Deadline: 65 days from denial notice
  • Decision Timeline: 7 days standard, 72 hours expedited
  • Submission: Online portal, mail, or fax
  • Required: Additional supporting documentation

External Review (Smart NC)

North Carolina offers robust external review through the Smart NC program:

  • Eligibility: After exhausting internal appeals or qualifying for expedited review
  • Filing Deadline: 120 days from final internal denial
  • Decision Timeline: 45 days standard, 72 hours expedited
  • Contact: 1-855-408-1212 for free advocacy support
  • Outcome: Binding decision on insurance company

Smart NC provides free assistance with:

  • Completing external review request forms
  • Gathering medical records
  • Communicating with insurers
  • Finding clinical guidelines to support your case

For urgent situations, Smart NC can waive the requirement to complete internal appeals first, ensuring faster access to needed medications.

Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed responses that align with each payer's specific requirements.

Patient Support & Financial Assistance

IncyteCARES Program:

  • Patient assistance for eligible individuals
  • Contact: 1-855-452-5234
  • Program website

Medicare Coverage:

  • Copay cards not available for Medicare beneficiaries
  • 2025 Part D out-of-pocket cap provides protection
  • Low Income Subsidy (LIS) may reduce costs further

Foundation Grants:

  • Various cancer foundations offer medication assistance
  • Eligibility typically based on income and insurance status
  • Your oncology social worker can help identify options

FAQ

How long does Humana prior authorization take in North Carolina? Standard prior authorization decisions are made within 72 hours. Expedited reviews for urgent cases can be completed within 24 hours with proper clinical justification.

What if Pemazyre is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and providing documentation that preferred alternatives are inappropriate or have failed.

Can I request an expedited appeal if denied? Yes, if delaying treatment could seriously jeopardize your health. Your oncologist must certify the urgent medical need for expedited processing.

Does step therapy apply to Pemazyre? Most Humana plans require documentation of prior systemic therapy failure rather than formal step therapy. However, specific requirements vary by plan.

What happens during a peer-to-peer review? Your prescribing oncologist speaks directly with Humana's medical director to discuss the clinical rationale for Pemazyre coverage. This often resolves denials when clinical documentation alone is insufficient.

How do I track my prior authorization status? Log into your Humana member portal or contact Member Services. Your prescriber can also check status through the provider portal.

What if I move from North Carolina during treatment? Your Humana coverage typically continues, but you should verify network providers and pharmacy access in your new state. External review rights may differ by state.

Can I get a 90-day supply of Pemazyre? Most plans limit initial fills to 30 days, with potential for 90-day supplies after demonstrating tolerance. Quantity limits are common and may require justification for exceptions.

From Our Advocates

"We've seen the strongest Pemazyre approvals when patients coordinate early between their oncologist, ophthalmologist, and pathology lab. Having all three pieces—FGFR2 results, eye monitoring plan, and treatment history—ready before submitting the prior authorization prevents the back-and-forth that delays coverage. The key is treating it as a package deal rather than submitting pieces separately."

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult your healthcare provider and insurance plan documents for specific guidance. For assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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