How to Get Cabometyx (Cabozantinib) Covered by Humana in Georgia: Complete Prior Authorization and Appeals Guide
Answer Box: Fastest Path to Cabometyx Coverage
Cabometyx (cabozantinib) requires prior authorization under Humana Medicare Advantage plans as a Tier 5 specialty drug. Submit complete documentation including ICD-10 diagnosis, prior therapy failures, recent imaging showing progression, and oncologist letter citing NCCN guidelines via Humana provider portal or fax to 1-877-486-2621. If denied, Georgia residents have 65 days to file internal appeals and 60 days for external review through the Georgia Department of Insurance. Start by verifying formulary status and gathering clinical documentation today.
Table of Contents
- Policy Overview: Humana's Coverage Framework
- FDA Indication Requirements
- Step Therapy & Medical Exceptions
- Quantity Limits and Renewal Rules
- Required Diagnostics and Documentation
- Specialty Pharmacy Network Requirements
- Evidence for Medical Necessity
- Sample Medical Necessity Letter
- Appeals Process in Georgia
- Common Denial Reasons & Solutions
- Costs and Patient Assistance
- FAQ
Policy Overview: Humana's Coverage Framework
Humana covers Cabometyx (cabozantinib) primarily through Medicare Advantage and Part D plans, with prior authorization (PA) required for all members. The drug is typically classified as Tier 5 specialty medication, requiring dispensing through Humana's specialty pharmacy network.
Plan Types and Coverage
- Medicare Advantage: Standard PA process with 72-hour standard review, 24-hour expedited
- Medicare Part D: Similar requirements with potential formulary exceptions
- Commercial plans (limited Humana presence): Follow similar specialty drug protocols
Note: Humana's PA denial rate for Medicare Advantage is approximately 3.5% (2023), among the lowest of major insurers, but denials often stem from incomplete documentation.
FDA Indication Requirements
Cabometyx tablets (not interchangeable with Cometriq capsules) are FDA-approved for specific cancer indications. Never substitute formulations due to non-bioequivalent pharmacokinetics—tablets have 19% higher Cmax versus capsules.
Approved Indications
| Indication | Dosing | Key Requirements |
|---|---|---|
| Advanced RCC (post-prior therapy) | 60 mg daily monotherapy | Prior VEGFR-targeted therapy documented |
| Advanced RCC (first-line) | 40 mg + nivolumab | Intermediate/poor risk patients |
| HCC (post-sorafenib) | 60 mg daily | Sorafenib failure/intolerance documented |
| RAI-refractory DTC (≥12 years) | Weight-based dosing | Post-VEGFR therapy; progressive disease |
Source: FDA Access Data
Off-Label Considerations
While Humana may cover NCCN-listed off-label uses, documentation requirements increase significantly. Include peer-reviewed evidence and clear rationale for why FDA-approved alternatives are inappropriate.
Step Therapy & Medical Exceptions
Humana may require step therapy depending on the specific plan and indication. Common requirements include:
Typical Step Therapy Protocols
- RCC: Prior VEGFR inhibitor (sunitinib, pazopanib) or checkpoint inhibitor
- HCC: Sorafenib trial required (unless contraindicated)
- DTC: Prior VEGFR-targeted therapy documented
Medical Exception Pathways
Submit exception requests with documentation of:
- Contraindications to required step therapy drugs
- Previous failures with specific dates and reasons for discontinuation
- Drug interactions that make alternatives inappropriate
- Clinical urgency requiring immediate Cabometyx initiation
Quantity Limits and Renewal Rules
Standard Quantity Limits
- 30-day supply maximum per fill
- Monthly refill restrictions apply
- 90-day supply may be available for established patients
Renewal Requirements
Authorization typically lasts 12 months with renewal requiring:
- Recent imaging showing stable disease or response
- Tolerability assessment from oncologist
- Updated lab values (liver/kidney function)
- Continued medical necessity justification
Tip: Submit renewal requests 30-60 days before expiration to avoid treatment gaps.
Required Diagnostics and Documentation
Essential Clinical Documentation
- Pathology report confirming diagnosis and staging
- ICD-10 diagnosis codes (e.g., C64.x for RCC, C22.0 for HCC)
- Recent imaging (within 6 months) showing disease progression per RECIST 1.1 criteria
- Prior therapy records with dates, outcomes, and reasons for discontinuation
- Laboratory values: liver function, kidney function, blood pressure
- Performance status assessment
RECIST Criteria Documentation
Include specific measurements showing:
- Target lesion growth ≥20% from baseline
- New lesions appearance
- Unequivocal progression of non-target lesions
This imaging evidence is crucial for both initial approval and renewals.
Specialty Pharmacy Network Requirements
Cabometyx must be dispensed through Humana's specialty pharmacy network, typically including CVS Specialty and other approved partners.
Site of Care Requirements
- Home administration preferred under pharmacy benefit
- Oral tablets taken on empty stomach (≥1 hour before or ≥2 hours after food)
- Medical benefit rarely applies for oral Cabometyx
Network Verification
Before prescribing, verify:
- Patient's specific Humana plan covers specialty pharmacy benefit
- Preferred specialty pharmacy in network
- PA requirements for chosen pharmacy partner
Evidence for Medical Necessity
Required Supporting Evidence
- FDA labeling for approved indications
- NCCN Guidelines recommendations (cite specific version and page)
- Peer-reviewed studies for off-label uses
- Drug compendia listings (Micromedex, Lexicomp)
Guideline Citations
Reference specific sections such as:
- NCCN Kidney Cancer Guidelines (current version)
- NCCN Hepatocellular Carcinoma Guidelines
- FDA prescribing information sections 1.1-1.3
Sample Medical Necessity Letter
Essential Components
Patient: [Name], DOB: [Date], Member ID: [Number]
Diagnosis: Advanced renal cell carcinoma (ICD-10: C64.1)
Requested Medication: Cabometyx (cabozantinib) 60 mg daily
CLINICAL RATIONALE:
Mr./Ms. [Patient] has advanced clear cell renal carcinoma with documented
progression following prior sunitinib therapy (dates: [X] to [Y]). Recent
CT imaging on [date] demonstrates 25% increase in target lesions per
RECIST 1.1 criteria.
MEDICAL NECESSITY:
Cabometyx is FDA-approved for advanced RCC following prior therapy and
is recommended by NCCN Guidelines (Version X.2024, page Y) as preferred
second-line therapy. Alternative agents are contraindicated due to
[specific reason].
SUPPORTING DOCUMENTATION:
- Pathology report confirming clear cell histology
- Imaging demonstrating progression
- Prior therapy records showing sunitinib failure
- Current labs within normal limits for safe initiation
Respectfully requesting approval for Cabometyx 60 mg daily.
[Oncologist signature and credentials]
Appeals Process in Georgia
Georgia residents have robust appeal rights under state insurance law, particularly valuable given Humana's coverage decisions.
Internal Appeals Timeline
| Appeal Type | Deadline to File | Decision Timeline |
|---|---|---|
| Standard | 65 days from denial | 7-30 days |
| Expedited | 65 days from denial | 7 days |
| Medicare Part D | 65 days from denial | 7 days standard, 72 hours expedited |
Georgia External Review Process
If internal appeals fail, Georgia law provides external review through the Georgia Department of Insurance:
- Deadline: 60 days from internal appeal denial
- Cost: Free to consumers
- Timeline: 45 days standard, 72 hours expedited
- Process: Independent medical reviewers assess case
- Outcome: Binding on insurer if approved
Important: Georgia's 60-day external review deadline is shorter than some states. Act promptly after internal appeal denial.
How to File External Review
- Submit written request to Georgia DOI Consumer Services
- Include denial notices, medical records, and supporting documentation
- Contact consumer hotline: 1-800-656-2298
Counterforce Health helps patients navigate complex prior authorization requirements and appeals processes, turning insurance denials into targeted, evidence-backed appeals that align with payer policies and state regulations.
Common Denial Reasons & Solutions
| Denial Reason | Solution Strategy |
|---|---|
| Wrong formulation | Clarify Cabometyx tablets vs. Cometriq capsules; include FDA labeling excerpt |
| Insufficient prior therapy | Document specific dates, doses, and reasons for discontinuation |
| Missing imaging | Submit recent scans with RECIST progression measurements |
| Off-label use | Provide NCCN Guidelines citation and peer-reviewed evidence |
| Drug interactions | Include interaction screening and management plan |
| Incomplete diagnosis | Add pathology report and accurate ICD-10 codes |
Peer-to-Peer Review
If initial PA is denied, request peer-to-peer review where your oncologist discusses the case directly with Humana's medical director. This often resolves documentation gaps quickly.
Costs and Patient Assistance
Expected Costs
- Humana Medicare Advantage: Typically 25-40% coinsurance after deductible
- Specialty tier: Higher cost-sharing than standard medications
Patient Assistance Options
- Exelixis Patient Assistance Program: Income-based support for eligible patients
- Manufacturer copay cards: May reduce out-of-pocket costs
- State pharmaceutical assistance: Limited programs in Georgia
- Foundation grants: CancerCare, Patient Access Network Foundation
Counterforce Health can help identify appropriate assistance programs and ensure applications include required documentation.
FAQ
How long does Humana PA take in Georgia? Standard PA decisions: 72 hours. Expedited: 24 hours. Medicare Part D: 7 days standard, 72 hours expedited.
What if Cabometyx is non-formulary on my plan? Request formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate.
Can I request expedited appeal in Georgia? Yes, if treatment delay poses serious health risk. Both Humana and Georgia external review offer expedited timelines.
Does step therapy apply if I failed treatments outside Georgia? Yes, prior therapy documentation from any location counts toward step therapy requirements.
What happens if I miss the 60-day external review deadline? Georgia's deadline is strict. Contact Georgia DOI immediately to discuss options, though extensions are rare.
How do I track my PA status? Use Humana member portal online or call member services. Keep reference numbers from all submissions.
Sources & Further Reading
- Humana Provider Portal - Prior Authorizations
- Georgia Department of Insurance - External Review
- FDA Cabometyx Prescribing Information
- Georgia Consumer Insurance Appeals Guide
- Humana Medicare Drug Coverage Determination Forms
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Consult your healthcare provider and insurance plan documents for specific guidance. For assistance with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.
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