How to Get Bavencio (Avelumab) Covered by Humana in Pennsylvania: Complete Prior Authorization Guide
Answer Box: Getting Bavencio Covered by Humana in Pennsylvania
Bavencio (avelumab) requires prior authorization from Humana for both Medicare Advantage and commercial plans in Pennsylvania. For fastest approval: (1) Confirm your diagnosis meets FDA indications (metastatic Merkel cell carcinoma or maintenance urothelial carcinoma), (2) Have your oncologist submit PA through Humana's provider portal with complete clinical documentation, and (3) If denied, file appeals within 60-65 days using Pennsylvania's new external review system for commercial plans or Medicare's federal process. Most approvals take 7-30 days with proper documentation.
First step today: Call Humana member services to verify your plan's formulary status and obtain the current PA form.
Table of Contents
- Policy Overview: How Humana Covers Bavencio
- FDA Indication Requirements
- Step Therapy & Medical Exceptions
- Quantity and Frequency Limits
- Required Diagnostics & Documentation
- Site of Care & Specialty Pharmacy Rules
- Evidence to Support Medical Necessity
- Sample Medical Necessity Letter
- Common Denial Reasons & Solutions
- Pennsylvania Appeals Process
- Cost-Saving Resources
- FAQ
Policy Overview: How Humana Covers Bavencio
Humana covers Bavencio (avelumab) across their Pennsylvania plans—including Medicare Advantage, Medicare Part D, and commercial insurance—but prior authorization is required for all plan types. The drug typically sits on specialty tiers requiring higher copays or coinsurance.
Plan Types in Pennsylvania:
- Medicare Advantage: Most common Humana coverage in PA; follows CMS guidelines with Humana-specific PA requirements
- Commercial Plans: Employer-sponsored and individual marketplace plans with varying formulary placement
- Medicare Part D: Standalone prescription coverage with federal appeals rights
Note: Self-funded employer plans may have different criteria. Always verify your specific plan's coverage by calling the member services number on your insurance card.
Where to Find Official Policies:
- Humana Provider Portal for current PA forms
- Humana Drug Lists for formulary placement
- Plan-specific Evidence of Coverage documents (mailed annually)
FDA Indication Requirements
Bavencio has FDA approval for two oncology indications that Humana recognizes as medically necessary:
Approved Indications
1. Metastatic Merkel Cell Carcinoma
- FDA-approved March 2017 for adults and patients ≥12 years
- No prior therapy required
- NCCN Guidelines list as Category 1 (preferred) first-line treatment
2. Urothelial Carcinoma Maintenance
- Locally advanced or metastatic disease
- Must have stable disease or response to first-line platinum-based chemotherapy
- No disease progression documented before starting Bavencio
- Treatment should begin within 4-10 weeks of last platinum dose
Off-Label Considerations
Humana may cover off-label uses if supported by:
- Peer-reviewed medical literature
- Recognized drug compendia (DRUGDEX, Clinical Pharmacology)
- Professional society guidelines
Documentation must include: rationale for off-label use, failed standard therapies, and literature citations.
Step Therapy & Medical Exceptions
Humana generally does NOT require step therapy for Bavencio when used for FDA-approved indications, recognizing it as a specialized immunotherapy. However, medical exceptions may be needed if:
- Your plan requires trying other checkpoint inhibitors first
- Bavencio is non-formulary on your specific plan
- You're requesting off-label use
Medical Exception Pathways
Contraindication to Preferred Agents:
- Document allergies or adverse reactions
- Include specific medications tried and reactions experienced
- Provide dates and clinical notes
Clinical Superiority:
- Cite medical literature showing Bavencio's advantages
- Include tumor characteristics (PD-L1 expression, if relevant)
- Reference guideline recommendations
Quantity and Frequency Limits
Standard Dosing Limits
Indication | Standard Dose | Frequency | Maximum per Authorization |
---|---|---|---|
Merkel Cell Carcinoma | 800 mg IV | Every 2 weeks | 6 months initial approval |
Urothelial Carcinoma | 800 mg IV | Every 2 weeks | 6 months initial approval |
Renewal Requirements:
- Clinical response documentation
- Imaging showing stable disease or improvement
- Tolerability assessment
- Ongoing medical necessity justification
Tip: Request renewals 30-45 days before current authorization expires to avoid treatment delays.
Required Diagnostics & Documentation
Essential Clinical Documentation
For All Indications:
- Pathology report confirming diagnosis
- Current staging information (imaging reports)
- ECOG performance status (typically 0-2)
- Complete blood count and comprehensive metabolic panel
- Liver function tests
For Merkel Cell Carcinoma:
- Histologic confirmation of MCC
- Evidence of metastatic disease
- Prior treatment history (if any)
For Urothelial Carcinoma:
- Pathology confirming urothelial origin
- Documentation of platinum-based chemotherapy
- Critical: Imaging showing no progression after chemotherapy
- Dates of last chemotherapy cycle
Documentation Timing
Lab Values: Within 30 days of PA submission Imaging: Within 60 days for initial requests Clinical Notes: Current visit documenting treatment plan
Site of Care & Specialty Pharmacy Rules
Humana requires Bavencio administration at approved facilities:
Approved Administration Sites
- Hospital outpatient infusion centers
- Oncology clinics with infusion capabilities
- Ambulatory surgery centers (ASCs)
- Home infusion: Available with additional PA for qualified patients
Network Requirements
- Both the prescriber AND infusion site must be in-network
- Out-of-network administration requires separate authorization
- Find providers using Humana's directory
Specialty Pharmacy Routing: Some Humana plans require specialty drugs be dispensed through CenterWell Specialty Pharmacy. Verify if your plan has this requirement.
Evidence to Support Medical Necessity
Key Clinical Evidence to Include
Guideline Support:
- NCCN Guidelines for Merkel Cell Carcinoma (Category 1 recommendation)
- NCCN Guidelines for Bladder Cancer (maintenance setting)
- ASCO Clinical Practice Guidelines
Peer-Reviewed Literature:
- JAVELIN Merkel 200 trial data (for MCC)
- JAVELIN Bladder 100 trial data (for UC maintenance)
- Real-world evidence studies
FDA Resources:
- FDA approval letter and prescribing information
- FDA Breakthrough Therapy designation (MCC)
From our advocates: "We've seen the strongest approvals when oncologists include both the NCCN guideline reference and specific trial data showing survival benefits. Payers respond well to evidence-based medicine that aligns with standard of care."
Sample Medical Necessity Letter
Template Structure for Oncologists:
Patient: [Name], DOB: [Date], Member ID: [Number]
Diagnosis: [Specific diagnosis with ICD-10 code]
Requested Medication: Bavencio (avelumab) 800 mg IV every 2 weeks
CLINICAL RATIONALE:
This [age]-year-old patient with [specific diagnosis] meets FDA-approved indications for Bavencio therapy. [Brief clinical history and current status].
PRIOR TREATMENTS: [List previous therapies, dates, and outcomes]
SUPPORTING EVIDENCE:
- FDA-approved indication: [Cite specific approval]
- NCCN Guidelines: Category 1 recommendation for [indication]
- Clinical trials: [Reference key studies]
MEDICAL NECESSITY:
Bavencio is medically necessary because [specific clinical rationale]. Patient has [contraindications to alternatives/clinical factors supporting choice].
Expected duration: 6 months with clinical monitoring and imaging every 8-12 weeks.
[Physician signature and credentials]
Common Denial Reasons & Solutions
Denial Reason | Documentation to Include | Success Strategy |
---|---|---|
"Not FDA-approved indication" | FDA label, prescribing information | Highlight specific approved indication |
"Insufficient documentation" | Complete clinical notes, imaging, labs | Resubmit with comprehensive packet |
"Step therapy required" | Medical exception request | Document contraindications to preferred agents |
"Experimental/investigational" | NCCN guidelines, peer-reviewed studies | Emphasize standard-of-care status |
"Quantity exceeds limits" | Clinical rationale for dosing | Reference FDA-approved dosing schedule |
Most Effective Appeal Strategy: Include both clinical documentation AND reference to Humana's own medical policy, which you can request through their provider services.
Pennsylvania Appeals Process
For Humana Medicare Plans
Federal Medicare Appeals Process:
- Redetermination (Level 1): File within 60 days of denial
- Timeline: 7 days for Part D drugs
- Submit via Humana member portal or mail
- Reconsideration (Level 2): Independent review within 60 days
- Timeline: 7 days standard, 72 hours expedited
- Administrative Law Judge: If amount in controversy ≥$180 (2024)
Expedited Appeals: Available when delay could seriously jeopardize health
For Commercial Humana Plans
Pennsylvania External Review Process (New in 2024): After exhausting Humana's internal appeals, you can request external review through the Pennsylvania Insurance Department.
Key Benefits:
- 53% success rate in first half of 2024
- 45-day timeline for standard reviews
- Binding decision on Humana
- No cost to patients
How to File:
- Complete internal appeals with Humana first
- Submit external review request within 4 months
- Use PA.gov review portal or call 1-877-881-6388
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals aligned with payers' own rules.
Cost-Saving Resources
Manufacturer Support
- Bavencio Co-pay Program: May reduce out-of-pocket costs for eligible patients
- Patient Assistance Program: Income-based free drug program
- Contact: Bavencio.com patient support
Foundation Grants
- Patient Advocate Foundation
- CancerCare Co-Payment Assistance
- Leukemia & Lymphoma Society (for blood cancers)
State Resources
- Pennsylvania PACE/PACENET programs for seniors
- Medicaid coverage for eligible low-income patients
FAQ
How long does Humana prior authorization take in Pennsylvania? Standard PA decisions: 15 business days. Expedited requests (urgent medical need): 72 hours. Submit complete documentation to avoid delays.
What if Bavencio is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Include clinical rationale and evidence that formulary alternatives are inappropriate.
Can I get expedited review for cancer treatment? Yes. Both Humana and Pennsylvania's external review offer expedited processes when delays could jeopardize health. Document urgency in your request.
Does step therapy apply if I've tried other immunotherapies outside Pennsylvania? Medical records from any state count toward step therapy requirements. Provide documentation of previous treatments and outcomes.
What happens if my appeal is denied? For Medicare: Continue to higher appeal levels (ALJ, Appeals Council). For commercial plans: Pennsylvania external review is your final option, with a 53% overturn rate.
How much does Bavencio cost without insurance? Wholesale acquisition cost varies; contact manufacturer for current pricing. Patient assistance programs may provide free drug for eligible patients.
Sources & Further Reading
- Humana Prior Authorization Forms
- Pennsylvania Insurance Department External Review
- FDA Bavencio Prescribing Information
- NCCN Guidelines for Merkel Cell Carcinoma
- Medicare Appeals Process
Disclaimer: This information is for educational purposes and should not replace professional medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. For personalized guidance on your specific situation, consult your healthcare provider and insurance plan directly.
Getting the right cancer treatment shouldn't depend on navigating complex insurance rules alone. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing targeted, evidence-backed support that speaks directly to payers' own coverage criteria.
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