By Counterforce Health Team in Cabometyx (cabozantinib) —

UnitedHealthcare's Coverage Criteria for Cabometyx (cabozantinib) in Ohio: What Counts as "Medically Necessary"?

Answer Box: Getting Cabometyx Covered by UnitedHealthcare in Ohio

UnitedHealthcare requires prior authorization for Cabometyx (cabozantinib) with specific medical necessity criteria by cancer type. Fastest path: Have your oncologist submit PA through the UHC Provider Portal with complete diagnosis, staging, prior therapy documentation, and imaging results. For RCC: Stage IV diagnosis required. For HCC: Must be subsequent-line therapy post-sorafenib. For thyroid cancer: RAI-refractory with progression after VEGFR therapy. Start today: Contact your oncologist's office to verify they have your complete treatment history and can submit PA within 24-48 hours.

Table of Contents

  1. UnitedHealthcare Policy Overview
  2. Medical Necessity by Cancer Type
  3. Step Therapy Requirements & Exceptions
  4. Required Documentation & Diagnostics
  5. Specialty Pharmacy Requirements
  6. Appeals Process in Ohio
  7. Common Denial Reasons & Solutions
  8. Cost Assistance Options
  9. FAQ

UnitedHealthcare Policy Overview

UnitedHealthcare manages Cabometyx coverage through its Prior Authorization and Notification program, with OptumRx handling specialty pharmacy benefits. The current policy (Program Number 2024 P 1196-11, effective February 15, 2025) applies to commercial plans, while Medicare Advantage and Medicaid have similar but distinct criteria.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all indications UHC Provider Portal
Formulary Tier Specialty Tier 4-5 OptumRx formulary
Step Therapy Indication-specific Policy document
Quantity Limits 30-day supply standard Plan-specific
Age Restrictions <19 years auto-approved UHC policy
Appeals Deadline 180 days from denial Ohio law

Medical Necessity by Cancer Type

UnitedHealthcare's Cabometyx policy establishes indication-specific criteria for medical necessity:

Renal Cell Carcinoma (RCC)

Initial Approval Criteria:

  • Stage IV or relapsed RCC diagnosis (including hereditary leiomyomatosis RCC)
  • Used as first-line combination with nivolumab OR subsequent-line monotherapy
  • Pathology confirmation and staging documentation required

Reauthorization: No evidence of progressive disease on current therapy

Hepatocellular Carcinoma (HCC)

Initial Approval Criteria:

  • Confirmed HCC diagnosis (ICD-10 C22.0)
  • Used as subsequent-line systemic therapy
  • Prior systemic treatment (typically sorafenib) documented with failure or intolerance

Reauthorization: Continued clinical benefit without progression

Differentiated Thyroid Cancer (DTC)

Initial Approval Criteria:

  • Adults and pediatric patients ≥12 years
  • Locally advanced or metastatic DTC
  • RAI-refractory disease
  • Progression following prior VEGFR-targeted therapy
  • Not suitable for curative surgery or radioiodine

RET-Rearranged NSCLC

Initial Approval Criteria:

  • Recurrent, advanced, or metastatic NSCLC
  • RET gene rearrangement-positive tumor confirmed by molecular testing
  • Prior systemic therapy documented
Clinician Corner: Medical Necessity Letter Checklist

Your letter should address:Specific diagnosis with ICD-10 code and stagingPrior therapies with dates, responses, and reasons for discontinuationCurrent performance status and organ functionImaging showing disease progression (when required)NCCN guideline support for the indicationPlanned dosing and monitoring schedule

Step Therapy Requirements & Exceptions

While UnitedHealthcare frames requirements as "medical necessity criteria" rather than rigid step therapy, practical step requirements exist:

Implicit Step Therapy by Indication

  • HCC: Must try at least one prior systemic agent (usually sorafenib)
  • DTC: Requires failure of prior VEGFR-targeted therapy
  • NCCN off-label uses: Generally subsequent-line therapy after standard agents

Medical Exception Pathways

Step therapy exceptions are granted when:

  • Alternative agents are contraindicated due to drug interactions or allergies
  • Patient experienced severe toxicity requiring discontinuation
  • Tumor characteristics make alternative agents inappropriate
  • Emergency/urgent clinical situation exists

Required Documentation & Diagnostics

Essential Clinical Documentation

Pathology & Staging:

  • Tissue confirmation of cancer type
  • Molecular testing results (RET status for NSCLC)
  • Current staging with imaging dates

Treatment History:

  • Complete prior therapy timeline with dates
  • Response assessments and progression documentation
  • Toxicity profiles and discontinuation reasons

Current Status:

  • Recent imaging (within 3 months for active disease)
  • Performance status assessment
  • Baseline organ function labs

Timing Requirements

Most documentation should be within 90 days of PA submission, with imaging typically required within 3 months for progressive disease documentation.

Specialty Pharmacy Requirements

Cabometyx must be dispensed through UnitedHealthcare's specialty pharmacy network, typically managed by OptumRx. Key requirements include:

  • Network Participation: Prescription must be filled at contracted specialty pharmacy
  • NDC Accuracy: Correct tablet formulation NDCs (42388-023-26 for 20mg, -36 for 40mg, -37 for 60mg)
  • Quantity Limits: Standard 30-day supplies with refill authorization
  • Monitoring: Regular follow-up and adherence tracking
Note: Cabometyx tablets and Cometriq capsules are distinct formulations with separate PA policies. Ensure correct product is prescribed for the intended indication.

Appeals Process in Ohio

Internal Appeals with UnitedHealthcare

Peer-to-Peer Review:

  • Request within 3 business days of denial for urgent cases
  • Direct physician-to-physician discussion
  • Often resolves denials without formal appeal

Formal Internal Appeal:

  • Submit within 180 days of denial
  • Include additional clinical documentation
  • Decision typically within 30 days (72 hours for urgent)

Ohio External Review

After exhausting internal appeals, Ohio residents can request external review through the Ohio Department of Insurance:

Timeline: 180 days from final internal denial to request external review Process: Independent Review Organization (IRO) conducts medical review Decision: Binding on UnitedHealthcare if overturned Contact: 1-800-686-1526 for assistance

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Incomplete PA Resubmit with missing elements Full clinical package
Wrong formulation Clarify Cabometyx vs Cometriq Correct NDC and indication
Insufficient prior therapy Document treatment history Pharmacy records, clinic notes
Missing progression evidence Provide imaging comparison Radiology reports with dates
Off-label use Cite NCCN compendium support Guideline references

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient): Check formulary status via UHC member portal
  2. Gather Records (Clinic): Compile complete treatment history and imaging
  3. Submit PA (Oncologist): Use UHC Provider Portal with complete documentation
  4. Monitor Status (Both): Track submission through portal
  5. Peer-to-Peer (If denied): Request physician review within 24-48 hours
  6. Formal Appeal (If needed): Submit within 180 days with additional evidence
  7. External Review (Last resort): File with Ohio DOI if internal appeals fail

Cost Assistance Options

Manufacturer Support:

Foundation Grants:

  • Cancer-specific foundations may provide medication assistance
  • Applications often require financial documentation

State Programs:

  • Ohio may have additional assistance programs for cancer medications
  • Contact Ohio Department of Health for current options
From Our Advocates: We've seen cases where initial denials were overturned within 48 hours after the oncologist provided detailed progression imaging and prior therapy failure documentation. The key is comprehensive documentation upfront rather than piecemeal submissions.

FAQ

How long does UnitedHealthcare PA take in Ohio? Standard decisions within 15 days; urgent cases within 72 hours. Electronic submissions through the provider portal typically process faster.

What if Cabometyx is non-formulary on my plan? Request a formulary exception with medical necessity documentation showing why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Provide clinical documentation supporting urgency.

Does step therapy apply if I failed treatments in another state? Yes, prior therapy history from any location counts toward step therapy requirements with proper documentation.

What's the difference between Cabometyx and Cometriq? Different formulations with separate FDA approvals and PA policies. Cabometyx tablets for RCC/HCC/thyroid; Cometriq capsules primarily for medullary thyroid cancer.

Who can help if UnitedHealthcare continues to deny coverage? Contact Ohio Department of Insurance at 1-800-686-1526 for external review assistance, or consider working with a patient advocacy organization.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements, significantly improving approval rates for specialty medications like Cabometyx.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage questions. For assistance with insurance appeals in Ohio, contact the Ohio Department of Insurance at 1-800-686-1526.

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