CurrentCignaPolicy N/A

Oncology (Oral) - Cabometyx Prior Authorization Policy

Defines prior authorization requirements and coverage criteria for oral cabozantinib (Cabometyx) across FDA-approved indications and select other uses with supportive evidence for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral) - Cabometyx Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 25, 2026

Key ActionObtain prior authorization for Cabometyx; approvals are generally provided for 1 year when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approved + supportiveindications addressed

1 yearapproval duration

≥12minimum age (some)

NCCNguideline support

Coverage Criteria for Cabometyx (cabozantinib)

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Hepatocellular Carcinoma (HCC): Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has been previously treated with at least one systemic regimen.

Examples of a systemic regimen include atezolizumab, bevacizumab, tremelimumab, durvalumab, sorafenib, lenvatinib, or nivolumab.

Neuroendocrine Tumors (NET): Approve for 1 year if ALL: A) patient is ≥ 12 years of age; AND B) patient has locally advanced, unresectable, or metastatic disease; AND C) patient has well-differentiated neuroendocrine tumors; AND D) patient has ONE of the following tumor types: a) pancreatic neuroendocrine tumors; OR b) extra‑pancreatic neuroendocrine tumors (examples: small bowel, lung, thymus, rectum, cecum, non‑cecum colon, stomach, appendix); AND E) the medication will be used as subsequent therapy.

Policy specifies use as subsequent therapy and examples of extra‑pancreatic sites.

Renal Cell Carcinoma (RCC): Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has relapsed or Stage IV disease.

May be used as monotherapy or combined with nivolumab per overview, but criteria require relapsed or Stage IV disease.

Differentiated Thyroid Carcinoma: Approve for 1 year if ALL: A) patient is ≥ 12 years of age; AND B) patient has differentiated thyroid carcinoma (examples include papillary, follicular, and oncocytic [formerly Hürthle cell] carcinoma); AND C) disease is radioactive iodine‑refractory or patient is radioactive iodine‑ineligible; AND D) disease has progressed following prior VEGFR‑targeted therapy (examples: lenvatinib or sorafenib).

Age and prior VEGFR‑targeted therapy requirements specified in overview.

Other Uses with Supportive Evidence

Covered when the following indication-specific criteria are met (each approval for 1 year).

Adrenal Gland Tumor (Adrenocortical Carcinoma): Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has locoregional unresectable or metastatic adrenocortical carcinoma.

Listed under supportive evidence.

Bone Cancer (Ewing sarcoma or Osteosarcoma): Approve for 1 year if BOTH: A) patient has Ewing sarcoma OR osteosarcoma; AND B) patient has tried at least one previous systemic regimen.

Examples of systemic regimens include vincristine, doxorubicin, cyclophosphamide, topotecan, irinotecan, cisplatin, ifosfamide, regorafenib, or sorafenib.

Endometrial Carcinoma: Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has tried at least one systemic regimen.

Examples of systemic regimens include carboplatin, paclitaxel, trastuzumab, docetaxel, doxorubicin, cisplatin, and topotecan.

Gastrointestinal Stromal Tumors (GIST): Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has tried ALL of the following prior therapies: i) imatinib or avapritinib; AND ii) sunitinib or dasatinib; AND iii) regorafenib; AND iv) ripretinib.

Exhaustive prior‑TKI requirement specified.

Non‑Small Cell Lung Cancer (RET rearrangement positive): Approve for 1 year if ALL: A) patient is ≥ 18 years of age; AND B) tumor is RET rearrangement positive; AND C) patient has progressed on one of the first‑line therapies pralsetinib (Gavreto) or selpercatinib (Retevmo).

Specifically requires progression on Gavreto or Retevmo.

Pheochromocytoma/Paraganglioma: Approve for 1 year if BOTH: A) patient is ≥ 18 years of age; AND B) patient has locally unresectable disease or distant metastases.

Supportive evidence indication expanded to include distant metastases.

Soft Tissue Sarcoma: Approve for 1 year if ALL: A) patient is ≥ 18 years of age; AND B) patient has advanced, metastatic, or unresectable disease; AND C) patient has been previously treated with at least one systemic therapy; AND D) patient has ONE of the following subtypes: i) extremity/body wall, head/neck soft tissue sarcoma; OR ii) retroperitoneal/intra‑abdominal soft tissue sarcoma; OR iii) rhabdomyosarcoma; OR iv) borderline/malignant phyllodes tumor of the breast; OR v) alveolar soft part sarcoma; OR vi) extraskeletal myxoid chondrosarcoma; OR vii) epithelioid hemangioendothelioma.

Examples of systemic regimens include pazopanib, eribulin, trabectedin, temozolomide, and regorafenib.

Example prior systemic regimens (by indication)
Hepatocellular carcinoma: examples include Tecentriq (atezolizumab) + bevacizumab, Imjudo (tremelimumab), Imfinzi (durvalumab), sorafenib, Lenvima (lenvatinib), or Opdivo (nivolumab).
Neuroendocrine tumors (pNET/epNET): prior systemic regimens may include agents such as somatostatin analogs and therapies listed for other indications; examples of systemic agents elsewhere in the policy include sorafenib and regorafenib (see policy for specifics).
Differentiated thyroid carcinoma: prior VEGFR‑targeted therapy examples include lenvatinib or sorafenib (required prior therapy for this indication).
Gastrointestinal stromal tumors (GIST): prior-TKI sequence examples required by policy include imatinib (or avapritinib), sunitinib (or dasatinib), regorafenib (Stivarga), and ripretinib (Qinlock).
Non–small cell lung cancer (RET+): progression on first‑line RET inhibitors pralsetinib (Gavreto) or selpercatinib (Retevmo) is required prior to approval per the policy.
Other sarcomas, bone cancers, endometrial, adrenal, pheochromocytoma/paraganglioma, and soft tissue sarcoma indications: examples of prior systemic regimens listed in the policy include cytotoxics and targeted agents such as vincristine, doxorubicin, cyclophosphamide, topotecan, irinotecan, cisplatin, ifosfamide, carboplatin, paclitaxel, docetaxel, and regorafenib depending on indication.
General note: the policy lists examples of systemic regimens across indications and specifies that approval for many indications requires prior systemic therapy (examples include atezolizumab + bevacizumab, sorafenib, lenvatinib, pralsetinib, selpercatinib, imatinib, sunitinib, regorafenib, ripretinib).

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Cabometyx. Approvals are provided for the durations noted in the policy (typically 1 year).

Step Therapy

Prior/systemic therapy requirements

Many indications require prior systemic therapy or documented progression on specified agents; required prior regimens vary by indication (examples provided in the policy).

HCC: previously treated with at least one systemic regimen (examples: atezolizumab, bevacizumab, tremelimumab, durvalumab, sorafenib, lenvatinib, nivolumab).
Differentiated thyroid carcinoma: refractory to radioactive iodine and patient has tried lenvatinib or sorafenib.
GIST: patient must have tried imatinib (or avapritinib), sunitinib (or dasatinib), regorafenib, and ripretinib.
NSCLC (RET+): progression on first-line pralsetinib (Gavreto) or selpercatinib (Retevmo).
Bone cancers and soft tissue sarcoma: prior treatment with at least one systemic regimen (examples listed).

Documentation Required

Documentation and coding expectations

Coverage determinations must consider the terms of the applicable benefit plan, any applicable laws/regulations, relevant collateral source materials including coverage policies, and the specific facts of the request; providers must use the most appropriate codes as of the submission date.

Review the applicable benefit plan document and any controlling mandates before submitting requests.
Use the most appropriate diagnosis and procedure codes in effect on the submission date.

Denial Risk

Coding/claims denial risk

Claims submitted for services that are not accompanied by covered diagnosis and/or procedure codes under the applicable coverage policy will be denied as not covered.

Line of Therapy Requirements

Second-line or Subsequent Therapy Requirement

Line of therapy notes: Policy commonly requires prior systemic therapy or that Cabometyx be used as subsequent (second‑line or later) therapy for many listed indications; specific prior therapy requirements vary by indication and are detailed in the indication criteria.

Examples include prior sorafenib for hepatocellular carcinoma; prior lenvatinib or sorafenib for differentiated thyroid carcinoma; prior targeted agents for GIST, RET‑positive NSCLC, and others.

OpenPayer

Oncology (Oral) - Cabometyx Prior Authorization Policy

Coverage Criteria for Cabometyx (cabozantinib)

Coding Guidance

Provider Actions and Authorization Requirements

Background

Definitions

Line of Therapy Requirements

Biomarker Requirements