CurrentUnitedHealthcarePolicy 2025 P 1021-13

Cometriq (cabozantinib) prior authorization criteria

UnitedHealthcare prior authorization/notification policy for Cometriq (cabozantinib) detailing initial and reauthorization clinical criteria for coverage for pediatric and adult oncology indications (medullary thyroid cancer, other thyroid carcinomas per NCCN, and NSCLC with RET rearrangement), authorization durations, and program notes including state mandate overrides and automated approval rules.

Policy Summary

PayerUnitedHealthcare

PolicyCometriq (cabozantinib) prior authorization criteria

Policy CodePolicy 2025 P 1021-13

Change TypeAnnual review — references updated

Effective DateSep 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization meeting the specified clinical criteria for adult members; initial and reauthorization approvals are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review June 2025: Updated references (no change to clinical criteria).

Effective date set to 9/1/2025 for the prior authorization program.

3Adult covered indications (thyroid variants + NSCLC)

12Authorization duration (months)

AutoMembers <19 years

Coverage Summary

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Coverage stance: UnitedHealthcare covers Cometriq (cabozantinib) with clinical criteria for adults when used for the specified oncology indications: progressive, metastatic medullary thyroid cancer and other thyroid carcinomas per NCCN (follicular, oncocytic, papillary) as well as non-small cell lung cancer (NSCLC) with a documented RET gene rearrangement.

Pediatric rule: prescriptions for members 19 years of age automatically process without a coverage review.

Off-label / compendia note: Some state mandates or compendium requirements may supersede the policy and affect coverage for off-label uses; providers should document compendium-recommended uses where applicable.

Key policy facts

Effective date2025-09-01

Last review2025-06-01

Authorization duration12 months from approval (initial and reauthorization)

Policy number2025 P 1021-13

Quick highlightsMembers <19 years: Pediatric auto-approval; Adult approvals require prior authorization meeting clinical criteria

Initial Authorization Criteria

Initial Authorization - Thyroid cancers (including medullary and others per NCCN)

Cometriq will be approved when ALL of the following are met:

ALL of the following

Diagnosis (one of)
- Diagnosis of medullary carcinoma
- Diagnosis of follicular carcinoma
- Diagnosis of oncocytic cell carcinoma
- Diagnosis of papillary carcinoma
Prior treatment (disease is progressive after treatment with one of)
- Progressive disease after treatment with Lenvima (lenvatinib)
- Progressive disease after treatment with Nexavar (sorafenib)
Disease extent (one of)
- Unresectable locoregional recurrent or persistent disease
- Symptomatic iodine-refractory disease
- Distant metastatic disease

Initial Authorization - NSCLC with RET rearrangement

Cometriq will be approved when ALL of the following are met:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Positive for RET gene rearrangements

General pediatric rule

Members under age 19 automatically process without coverage review.

Patient is less than 19 years of age

Prescription will automatically process without a coverage review

Reauthorization Criteria

Reauthorization - Thyroid cancers

Cometriq will be reauthorized when the following is met:

Patient does not show evidence of progressive disease while on Cometriq therapy

Refer to policy definition of 'Progressive disease'

Reauthorization - NSCLC

Cometriq will be reauthorized when the following is met:

Patient does not show evidence of progressive disease while on Cometriq therapy

Refer to policy definition of 'Progressive disease'

Authorization duration

When approved:

Authorization will be issued for 12 months

Applies to initial and reauthorization approvals as specified

Unproven Uses and Exclusions

Policy limits coverage to the specified indications and criteria: thyroid carcinomas (medullary and the NCCN-recognized follicular, oncocytic and papillary subtypes) and NSCLC with documented RET gene rearrangement. Adults must meet the listed clinical criteria to qualify for approval.

Off-label uses: although the policy restricts routine coverage to the listed indications, the NCCN recognizes other regimens and some off-label uses may be considered when supported by compendia or when state mandates require coverage; state mandates, federal requirements, and member-specific benefit plans may impact coverage for off-label uses.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for Cometriq in adults

Prior authorization is required for Cometriq (cabozantinib) in adults. Providers must obtain authorization prior to dispensing for adult members unless automated approval criteria (see below) apply.

Billing Rule

Pediatric auto-approval

Prescriptions for members under the age of 19 will automatically process without a coverage review or prior authorization.

Applies to members < 19 years of age

Documentation Required

Documentation of diagnosis and molecular testing

Document the clinical diagnosis and relevant molecular testing in the medical record to support coverage. For NSCLC approvals, the record must include a histologic diagnosis of non-small cell lung cancer and documentation of a positive RET gene rearrangement test. For thyroid cancers, document the histologic diagnosis (medullary, follicular, oncocytic/ Hurthle cell, or papillary) and prior treatments (for example, lenvatinib or sorafenib) when required by the criteria.

NSCLC: histologic diagnosis of non-small cell lung cancer + positive RET gene rearrangement documented
Thyroid cancers: document histologic subtype and prior therapies (e.g., lenvatinib, sorafenib) or reason therapy is indicated (unresectable, iodine-refractory, metastatic)

Documentation Required

State mandate and benefit plan considerations

State mandate and member benefit plan language may supersede or expand coverage for off-label uses. Verify applicable state mandates and the member's benefit plan for mandated coverage of off-label indications or required compendia; if a state or plan mandate applies, that requirement takes precedence over the criteria in this policy.

Some states mandate benefit coverage for off-label uses or require other compendia — those mandates supersede policy language where applicable
Check the member-specific benefit plan for any additional coverage requirements or limitations

Denial Risk

Reauthorization denial risk if progression

Reauthorization may be denied if there is evidence of progressive disease while on therapy. Providers should document disease status and response to therapy when requesting reauthorization.

Reauthorization requires documentation that the patient does not show evidence of progressive disease on Cometriq

Prior Authorization

Automated approval possibility

UnitedHealthcare may use automated approval processes for initial or reauthorization decisions based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic without a manual review.

Approvals may be issued solely on prior claims, medication history, and diagnosis (ICD-10) data
Automated approval/re-approval processes vary by program and therapeutic class

Clinical Evidence & Guidance

Evidence references cited in the policy include recognition in the NCCN Drugs and Biologics Compendium (NCCN categories I, 2A, or 2B are referenced) and the Exelixis Cometriq prescribing information (August 2023).

The policy explicitly references NCCN category levels (I, 2A, 2B) in its supporting evidence; no individual trial metrics are provided in the policy.

Definitions

Progressive diseaseDisease progression while on therapy as assessed by the treating clinician; absence of progression is required for reauthorization

RET gene rearrangementA documented positive molecular alteration (RET gene rearrangement) in NSCLC is required for approval

Background

Cometriq (cabozantinib) is a kinase inhibitor indicated for treatment of patients with progressive, metastatic medullary thyroid cancer.

NCCN guidance: the NCCN recommends Cometriq for medullary thyroid carcinoma and also for follicular, oncocytic (Hurthle cell / oncocytic) and papillary thyroid carcinomas; NCCN also recommends Cometriq for NSCLC when a RET gene rearrangement is present.

Compendia/state mandate implications: the policy notes that state mandates or compendium requirements may supersede standard coverage criteria and affect off-label coverage; providers should document compendium-recommended uses where mandates apply.

C73	Thyroid carcinoma (example: medullary thyroid cancer) - document references diagnosis codes (ICD-10) may be used for automated approval
C34	Malignant neoplasm of bronchus and lung (NSCLC) - policy requires RET gene rearrangement

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