Get Pemazyre (Pemigatinib) Covered by Humana in Pennsylvania: Complete Prior Authorization & Appeals Guide
Answer Box: Getting Pemazyre (Pemigatinib) Covered by Humana in Pennsylvania
Pemazyre (pemigatinib) requires prior authorization from Humana Medicare Advantage and Part D plans in Pennsylvania, typically covered on the specialty tier with quantity limits of 28 tablets per 28 days. The fastest path to approval: (1) Submit complete PA with FGFR2 fusion testing report, baseline eye exam, and prior therapy documentation via Humana's provider portal, (2) Request expedited review if urgent (72-hour decision), (3) If denied, appeal within 65 days and use Pennsylvania's external review program within 4 months of final denial. First step today: Call Humana Member Services at 1-800-457-4708 to verify your plan's formulary tier and obtain PA forms.
Table of Contents
- Understanding Pemazyre Coverage Basics
- Prior Authorization Requirements
- Step-by-Step: Fastest Path to Approval
- Cost Management and Assistance Options
- Appeals Process in Pennsylvania
- Common Denial Reasons & Solutions
- Frequently Asked Questions
Understanding Pemazyre Coverage Basics
Pemazyre (pemigatinib) is an oral FGFR inhibitor approved for treating previously treated, unresectable or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement, and relapsed/refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. With monthly costs often reaching five figures, understanding Humana's coverage structure is crucial for Pennsylvania patients.
Coverage at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required regardless of formulary tier | Humana Provider Portal | Humana PA policies |
| Formulary Tier | Specialty tier (typically Tier 5) | MyHumana Drug List | 2025-2026 formularies |
| Quantity Limits | 28 tablets per 28 days | Plan-specific formulary | Humana PDG documents |
| FGFR2 Testing | Molecular diagnostic proof required | Pathology report | FDA label requirements |
| Ophthalmology Exam | Baseline required before treatment | Medical records | FDA safety monitoring |
Note: Humana Medicare Advantage plans have among the lowest PA denial rates at approximately 3.5%, but denials that occur often stem from incomplete documentation or missing molecular diagnostics.
Prior Authorization Requirements
Humana requires comprehensive documentation to establish medical necessity for Pemazyre. The most common reason for denial is lack of documented FGFR alteration testing.
Essential Documentation Checklist
Medical Necessity Requirements:
- FGFR2 fusion/rearrangement testing report with pathology confirmation
- Baseline ophthalmology examination (retinal pigment epithelial detachment monitoring)
- Treatment history documenting prior therapies tried, failed, or contraindicated
- Clinical notes with cholangiocarcinoma diagnosis and appropriate ICD-10 codes
- Prescriber letter detailing diagnosis rationale, weight/BSA-based dosing, and monitoring plan
Submission Process:
- Use Humana's plan-specific PA form via the provider portal
- Include prescriber attestation and complete patient identification
- Request expedited review (72-hour turnaround) if treatment delay risks patient health
- Standard review timeline is 7 days from complete submission
Clinician Corner: Medical Necessity Letter
Your medical necessity letter should address these key elements:
- Problem statement: Confirmed cholangiocarcinoma with FGFR2 fusion via RNA-based NGS or FISH testing
- Prior treatments: Document gemcitabine/cisplatin failure or contraindications
- Clinical rationale: Reference FDA approval and FIGHT-202 trial data supporting efficacy
- Monitoring plan: Ophthalmologic assessments per FDA label requirements
- Dosing justification: 13.5mg daily based on patient weight/BSA calculations
Step-by-Step: Fastest Path to Approval
1. Verify Coverage Details
Who: Patient or clinic staff
Action: Call Humana Member Services at 1-800-457-4708
Timeline: Same day
What to ask: Formulary tier, PA form requirements, specialty pharmacy network
2. Gather Required Documentation
Who: Healthcare team
Action: Collect FGFR2 testing, eye exam, treatment history
Timeline: 1-3 business days
Key documents: Pathology report, prior therapy records, baseline ophthalmology exam
3. Submit Complete PA Request
Who: Prescriber or authorized staff
Action: Submit via Humana provider portal
Timeline: Same day submission
Include: All documentation, expedited request if urgent
4. Follow Up on Decision
Who: Clinic staff
Action: Track PA status, prepare appeal if needed
Timeline: 7 days standard, 72 hours expedited
Next steps: If approved, coordinate specialty pharmacy; if denied, begin appeal process
Cost Management and Assistance Options
Even with Humana coverage, out-of-pocket costs for specialty tier medications can be substantial. Multiple assistance programs can help reduce financial burden.
Manufacturer Support Programs
IncyteCARES Patient Assistance Program:
- Eligibility: Uninsured or underinsured patients (including some Medicare Part D) with household income <600% federal poverty level
- Benefit: Free medication for qualified patients
- Application: Call 1-855-452-5234 or visit IncyteCARES
- Timeline: Conditional approval in 2 business days
Important: Medicare patients are generally ineligible for copay cards but may qualify for the Patient Assistance Program based on income criteria.
2025 Medicare Part D Changes
The new $2,000 annual out-of-pocket cap for Medicare Part D significantly reduces financial exposure for Pemazyre patients. Once you reach this threshold, Medicare covers 100% of remaining costs for the year.
Counterforce Health helps patients navigate complex prior authorization requirements by analyzing denial letters and crafting targeted appeals with the right evidence and clinical documentation. Their platform identifies specific denial reasons and provides point-by-point rebuttals aligned with each payer's policies, potentially saving weeks in the approval process.
Appeals Process in Pennsylvania
Pennsylvania offers robust appeal options, including a state-supervised external review program that has overturned approximately 50% of appealed denials in its first year.
Internal Appeals (First Level)
- Timeline: File within 65 days of denial notice
- Process: Submit via Humana member portal or written request
- Decision timeframe: 30 days standard, 72 hours expedited for urgent cases
- Required documents: Denial letter, additional medical evidence, prescriber support letter
Pennsylvania External Review Program
Pennsylvania's Independent External Review Program, launched in January 2024, provides an independent path after exhausting internal appeals.
Key Features:
- Eligibility: Must have Final Adverse Benefit Determination from internal appeal
- Timeline: 4 months to file after final internal denial
- Process: Submit online via PA Insurance Department portal
- Decision: 45 days for standard review, 72 hours for expedited
- Success rate: Approximately 50% of appeals overturned in favor of patients
Tip: Continue treatment during appeals if already prescribed. Pennsylvania law protects patients from treatment interruption during the review process.
When to Escalate
Contact the Pennsylvania Insurance Department's Office of Consumer Services if you encounter delays or procedural issues. They provide free guidance and can intervene in complex cases.
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| No FGFR2 alteration documented | Submit molecular diagnostic report | RNA-based NGS or FISH results showing fusion/rearrangement |
| Insufficient prior therapy | Document treatment history | Records of gemcitabine/cisplatin failure or contraindications |
| Missing ophthalmologic monitoring | Provide baseline eye exam | Ophthalmology consultation addressing RPED risk |
| Off-label use | Cite FDA-approved indications | Prescription for approved cholangiocarcinoma or MLN indications |
| Quantity limit exceeded | Request exception with clinical justification | Prescriber letter explaining medical necessity for higher quantity |
Frequently Asked Questions
How long does Humana PA take in Pennsylvania? Standard prior authorization decisions are made within 7 days of complete submission. Expedited requests for urgent cases receive decisions within 72 hours.
What if Pemazyre is non-formulary on my plan? Request a formulary exception through Humana's appeals process. Provide evidence that formulary alternatives are ineffective or contraindicated for your specific condition.
Can I use a copay card with Medicare? No, federal law prohibits copay assistance for Medicare beneficiaries. However, you may qualify for IncyteCARES Patient Assistance Program based on income criteria.
Does step therapy apply if I've failed treatments outside Pennsylvania? Treatment history from any location counts toward step therapy requirements. Provide complete documentation of prior therapies and outcomes regardless of where treatment occurred.
What happens if I move between Humana plans? Prior authorization approvals don't automatically transfer between plans. You'll need to resubmit PA requests when changing plans, but existing treatment history supports faster approval.
How much will I pay out-of-pocket? Specialty tier copays typically range from $47-150 monthly, but the 2025 Medicare Part D $2,000 annual cap limits total exposure significantly.
For complex cases requiring targeted appeal strategies, Counterforce Health specializes in turning insurance denials into successful approvals by crafting evidence-backed appeals that address specific payer requirements and clinical documentation gaps.
Sources & Further Reading
- Humana Provider Portal - Prior Authorization
- Pennsylvania Insurance Department External Review
- IncyteCARES Patient Assistance Program
- Humana Medicare Drug Lists
- Pemazyre FDA Prescribing Information
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may vary by plan and change over time. Always verify current requirements with your specific Humana plan and consult your healthcare provider for medical decisions. For additional assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department's Office of Consumer Services.
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