UnitedHealthcare Cabometyx Prior Auth Policy Update

Coverage Criteria and Indications

Patients less than 19 years — pediatric automatic processing / special handling

Pediatric members:

Pediatric automatic approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

RCC indications — Initial authorization criteria for renal cell carcinoma and related diagnoses

Initial authorization — renal cell carcinoma and related diagnoses:

Eligible RCC diagnoses: Diagnosis is one of: Advanced renal cell carcinoma (RCC); Relapsed renal cell carcinoma (RCC); Hereditary leiomyomatosis and RCC (HLRCC)

Authorization per policy

General reauthorization — Reauthorization general rule across indications

Reauthorization general rule:

Reauthorization requirement: Patient does not show evidence of progressive disease while on Cabometyx therapy

Authorization will be issued for 12 months

NSCLC (RET+) — Initial authorization criteria for NSCLC with RET rearrangement

Initial authorization — NSCLC with RET rearrangement:

NSCLC with RET: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) Positive for RET gene rearrangements AND (3) Disease is recurrent, advanced, or metastatic AND (4) Used as subsequent therapy following progression on one of: Gavreto (pralsetinib) or Retevmo (selpercatinib)

HCC — Initial authorization criteria for hepatocellular carcinoma

Initial authorization — Hepatocellular carcinoma (HCC):

HCC subsequent-line: (1) Diagnosis of hepatocellular carcinoma AND (2) Used as subsequent-line systemic therapy

Bone tumors / sarcomas — Initial authorization criteria for selected bone sarcomas and related tumors

Initial authorization — Selected bone sarcomas and related tumors:

Bone tumor group: (1) Diagnosis is one of: Dedifferentiated chondrosarcoma; Ewing Sarcoma; High-grade undifferentiated pleomorphic sarcoma (UPS); Mesenchymal chondrosarcoma; Osteosarcoma; Primary round cell tumor of the bone (e.g., CIC::DUX4, BCOR::CCNB3) AND (2) Disease is relapsed/refractory or metastatic AND (3) Used as second-line therapy

Authorization will be issued for 12 months

GIST — Initial authorization criteria for gastrointestinal stromal tumor

Initial authorization — Gastrointestinal stromal tumor (GIST):

GIST progression: (1) Diagnosis of GIST AND (2) Patient has one of: gross residual disease (R2 resection); unresectable primary disease; tumor rupture; recurrent/metastatic disease AND (3) Disease has progressed on all of: imatinib (Gleevec), sunitinib (Sutent), standard dose ripretinib (Qinlock), and regorafenib (Stivarga)

Authorization will be issued for 12 months

Endometrial carcinoma — Initial authorization criteria

Initial authorization — Endometrial carcinoma:

Endometrial carcinoma: (1) Diagnosis of endometrial carcinoma AND (2) Used as second-line or subsequent treatment

Reauthorization requires no evidence of progression; authorization will be issued for 12 months

Initial Authorization — Differentiated Thyroid Cancer (DTC)

Covered when ALL of the following are met

DTC initial authorization: (1) Diagnosis of differentiated thyroid cancer (DTC) AND (2) Disease is locally advanced or metastatic AND (3) Disease has progressed following prior VEGFR-targeted therapy AND (4) Disease is radioactive iodine-refractory or ineligible

Authorization will be issued for 12 months

Reauthorization — Reauthorization criteria (general and indication-specific)

Reauthorization covered when the following is met

Reauthorization: Patient does not show evidence of progressive disease while on Cabometyx therapy

Authorization will be issued for 12 months when met

Initial Authorization — Soft Tissue Sarcoma — indication-specific sets

Covered when one of the following indication-specific sets is met

Soft tissue sarcoma - subsequent line: All of the following: (a) Diagnosis of one of these soft tissue sarcoma subtypes: extremity/body wall; head/neck; pleomorphic rhabdomyosarcoma (RMS); retroperitoneal/intraabdominal AND (b) Disease is advanced/metastatic AND (c) Used as subsequent line of therapy

Authorization will be issued for 12 months

Soft tissue sarcoma - specific subtypes: Diagnosis of one of: alveolar soft part sarcoma (ASPS); epithelioid hemangioendothelioma; extraskeletal myxoid chondrosarcoma

Authorization will be issued for 12 months

Initial Authorization — Neuroendocrine Tumors — new section added per annual review

Covered when ALL of the following are met

Neuroendocrine and adrenal tumors initial authorization: (1) Diagnosis of one of: well-differentiated pancreatic neuroendocrine tumor (pNET) or well-differentiated extra-pancreatic neuroendocrine tumor (epNET) AND (2) Disease is locally advanced, metastatic, or unresectable

Authorization will be issued for 12 months

NCCN Recommended Regimens — acceptance of NCCN categories and regimens

NCCN recognized regimens: Drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Used to support coverage per policy

Some state laws may require coverage for off-label uses of medications or mandate the use of specific compendia that take precedence over this policy. Where such state mandates or compendium requirements apply, they supersede the criteria and coverage language in this document.

Coverage determinations under this policy may be affected by member-specific benefit plan exclusions, federal requirements, or other utilization management programs. UnitedHealthcare may rely on prior claim or medication history, diagnosis codes, and automated claim logic to approve or deny requests, and supply limits or other administrative constraints may apply.

For members under 19 years of age, prescriptions will automatically process without a coverage review; for all other members, applicable benefit plan terms and regulatory mandates continue to apply and may alter coverage outcomes.

Initial Therapy Criteria by Indication

Initial authorization — Initial authorization per diagnosis (grouping of indication-specific initial criteria)

Initial authorization per diagnosis

Initial therapy nodes: See coverage criteria entries for per-diagnosis initial authorization logic (e.g., RCC, NSCLC RET+, HCC, GIST, bone tumors, endometrial carcinoma)

Authorizations are generally issued per criteria; many are for 12 months

Initial Therapy Criteria — Initial authorization criteria by indication (top-level group)

Initial authorization criteria by indication

DTC initial: Diagnosis of differentiated thyroid cancer (DTC); disease locally advanced or metastatic; progressed after prior VEGFR-targeted therapy; radioactive iodine-refractory or ineligible

Authorize for 12 months

Reauthorization and Continuation Criteria

Reauthorization/continuation — Reauthorization rules across indications

Reauthorization rules across indications

Continuation requirement: Patient does not show evidence of progressive disease while on Cabometyx therapy

When met, authorization is renewed (typically 12 months)

Continuation Therapy — Reauthorization requirement (evidence of no progression, typical duration)

Reauthorization requirement

Continuation (re-authorization): Patient must not show evidence of progressive disease while on Cabometyx therapy

Authorize for 12 months if met

Reauthorization definition — Approval renewal (typical duration)

Provider Actions and Authorization Procedures

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cabometyx. Authorizations are generally issued for 12 months unless otherwise specified. Some states mandate coverage or alternative compendia that supersede these criteria. Federal requirements, member-specific benefit plan coverage, other utilization controls, or program rules may affect coverage and can lead to denial if they conflict with these criteria.

Authorizations generally valid for 12 months
State mandates and federal requirements may supersede or modify criteria
Automated approvals may be used based on prior claims/medication history and diagnosis codes

Note

Provider Actions — Member Eligibility and Pediatric Processing

Members must meet the listed coverage criteria for the requested indication. For members under 19 years of age, the prescription will automatically process without a coverage review; if processed, an authorization will be issued for 12 months. Providers should confirm member-specific benefits and any applicable state mandates before submission.

Step Therapy and Prior-Line Requirements

Indication	Required prior therapies before Cabometyx
Non-small cell lung cancer (NSCLC) with RET gene rearrangement
Progression on one of: Gavreto (pralsetinib) or Retevmo (selpercatinib)

Indication	Line-of-therapy requirement
Gastrointestinal stromal tumor (GIST)
Used as second-line or subsequent treatment after progression on prior therapies (policy requires disease progressed on listed agents before Cabometyx)

Definitions and Key Terms

Subsequent-line systemic therapy — definition

DefinitionUse of systemic anticancer therapy after prior systemic therapy has been administered for the same disease (referenced for HCC in policy).

Context in policyReferenced as the requirement for HCC initial authorization: Cabometyx is approved when used as subsequent-line systemic therapy for hepatocellular carcinoma.

Clinical implicationIndicates Cabometyx is intended as therapy given after progression on prior systemic therapy for the same disease, not as first-line systemic treatment in that indication.

Reauthorization — definition and duration

DefinitionApproval renewal when the patient does not show evidence of progressive disease while on Cabometyx therapy.

Typical duration

Background and Drug Information

Cabometyx (cabozantinib) is a multikinase inhibitor indicated across multiple oncologic settings. This policy provides prior authorization criteria for FDA‑labeled and guideline‑supported uses including advanced or relapsed renal cell carcinoma, hepatocellular carcinoma in patients who have received prior systemic therapy, differentiated thyroid cancer after prior VEGFR‑targeted therapy, and well‑differentiated pancreatic and extra‑pancreatic neuroendocrine tumors. Coverage is also specified for select soft tissue sarcomas, gastrointestinal stromal tumor after progression on listed agents, RET‑rearranged non‑small cell lung cancer as subsequent therapy, and other NCCN‑recognized regimens; authorization periods are generally for 12 months when criteria are met.

Policy Updates and Revision History

2025-09annual_reviewLatest

Added new section for neuroendocrine and adrenal tumors based on updated FDA label and NCCN guidelines (material change).

2024-11annual_review

Consolidated sections and updated coverage criteria for kidney cancer, bone cancer, HCC, and endometrial carcinoma; added criteria for soft tissue sarcoma per NCCN guidelines (material change).

2021-11update

Added Endometrial carcinoma and new indication for thyroid cancer; updated references.

OpenPayer

Cabometyx (cabozantinib) prior authorization and coverage criteria

Coverage Criteria and Indications

Initial Therapy Criteria by Indication

Reauthorization and Continuation Criteria

Provider Actions and Authorization Procedures

Step Therapy and Prior-Line Requirements

Definitions and Key Terms

Background and Drug Information

Policy Updates and Revision History