UnitedHealthcare Stivarga Prior Auth Update

Coverage Criteria — Indication-specific Authorization Rules

inv-01: Patients less than 19 years of age

Covered when ALL of the following are met

Pediatric auto-approval: Patient is less than 19 years of ageage < 19

Authorization issued for 12 months

inv-02: Initial therapy — Metastatic colorectal cancer

Covered when ALL of the following are met

CRC baseline criteria: (1) Diagnosis of advanced or metastatic colorectal cancer; (2) History of failure, contraindication, or intolerance to oxaliplatin-based chemotherapy, irinotecan-based chemotherapy, and anti-VEGF-based chemotherapy; (3) One of the following: (a) Tumor is RAS mutant-type; OR (b) Tumor is RAS wild-type AND history of failure, contraindication, or intolerance to anti-EGFR therapy (e.g., cetuximab, panitumumab)prior therapy per list; RAS status

Authorization issued for 12 months

inv-04: Initial therapy — Soft tissue sarcoma

Covered when ALL of the following are met

Soft tissue sarcoma criteria: (1) Diagnosis of soft tissue sarcoma; (2) Disease is one of the following: extremity/superficial trunk or head/neck that is non-adipocytic with advanced/metastatic disease with disseminated metastases; retroperitoneal/intra-abdominal that is non-adipocytic with recurrent unresectable or stage IV disease; advanced/metastatic pleomorphic rhabdomyosarcoma; angiosarcoma.specified histologies/locations

inv-05: Initial therapy — Gastrointestinal stromal tumor (GIST)

Covered when ALL of the following are met

GIST baseline criteria: (1) Diagnosis of gastrointestinal stromal tumor (GIST); (2) Disease is one of: gross residual (R2 resection), unresectable primary, tumor rupture, or recurrent/metastatic disease; (3) One of the following: SDH-deficient GIST OR history of disease progression on both imatinib and one of sunitinib or ripretinib.prior progression on specified TKIs or SDH-deficient status

Authorization issued for 12 months

inv-06: Initial therapy — Biliary tract cancers and hepatocellular carcinoma

Covered when ONE of the following sets is met

Biliary tract cancers: Both: (a) Diagnosis of gallbladder cancer, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma; (b) Disease is unresectable, gross residual (R2), or metastatic.disease extent

Authorization issued for 12 months

Hepatocellular carcinoma subsequent-line: Both: (a) Diagnosis of hepatocellular carcinoma; (b) Used as subsequent-line therapy for disease progression.subsequent-line after prior therapy

Authorization issued for 12 months

inv-07: Initial therapy — Bone cancer

Covered when ALL of the following are met

Bone cancer criteria: (1) Diagnosis of one of the following primary bone cancers: dedifferentiated chondrosarcoma; Ewing sarcoma; high-grade undifferentiated pleomorphic sarcoma (UPS); mesenchymal chondrosarcoma; osteosarcoma; other primary round cell tumors of the bone (e.g., CIC::DUX4, BCOR::CCNB3); (2) Clinical context consistent with advanced, unresectable, or metastatic disease per standard oncologic practice.specified histologies

inv-08: Bone Cancer - Initial Therapy

Covered when ALL of the following are met

Bone cancer initial therapy: (1) Diagnosis of a listed primary bone cancer (dedifferentiated chondrosarcoma; Ewing sarcoma; high-grade undifferentiated pleomorphic sarcoma (UPS); mesenchymal chondrosarcoma; osteosarcoma; other primary round cell tumors of the bone, e.g., CIC::DUX4, BCOR::CCNB3) AND (2) Used as second-line therapy.

inv-10: Glioblastoma - Initial Therapy

Covered when the following criterion is met

Glioblastoma initial therapy: Diagnosis of recurrent or progressive glioblastoma.

inv-12: Uterine Sarcoma - Initial Therapy

Covered when ALL of the following are met

Uterine sarcoma initial therapy: (1) Diagnosis of uterine sarcoma; (2) Disease is advanced, recurrent/metastatic, or inoperable; (3) Used as second-line or subsequent therapy.

Added as new indication in 6/2025.

inv-14: NCCN Recommended Regimens — Covered when regimen is recognized by NCCN

Covered when regimen is recognized by NCCN

NCCN regimen recognition: Drug has NCCN Drugs and Biologics Compendium recognition with Category of Evidence and Consensus of 1, 2A, or 2B.

Used to support coverage decisions per policy.

State and federal mandates may affect coverage determinations for off‑label uses or when compendia requirements apply. Where a state law or other mandate requires coverage for an off‑label indication or requires use of a particular compendium, that mandate supersedes the language in this policy.

This policy has been revised periodically to align with NCCN guidance and to reflect clinical updates. Prior updates removed the solitary fibrous tumor indication to conform with NCCN (6/2022) and added SDH‑deficient GIST language and other STS and hepatobiliary criteria (6/2023). Subsequent annual reviews updated glioblastoma and other references and modified reauthorization wording (6/2024). The most recent annual review (6/2025) added a new indication for uterine sarcoma and revised coverage criteria for colorectal cancer, GIST, and bone cancer to reflect NCCN recommendations.

Automated approval and reapproval processes may be used where prior claim/medication history, diagnosis codes (ICD‑10), or claim logic satisfy the clinical rules. Requests that lack the requisite prior treatment documentation or that do not meet automated criteria (for example, missing diagnosis code linkage or medication history) may be denied. Supply limits and member‑specific plan terms may also affect approval.

Initial Authorization Rules by Indication

inv-29: Initial therapy overview

Initial authorization rules by indication

Follow indication-specific initial criteria: Initial approval requires meeting the detailed, indication-specific prior therapy and disease-state criteria as listed in the policy (see respective indication sections).

inv-30: Bone Cancer - Initial Therapy

Covered when ALL of the following are met

Bone cancer initial therapy: Diagnosis of specified primary bone cancer AND used as second-line therapy.

inv-31: Glioblastoma - Initial Therapy

Covered when the following criterion is met

Reauthorization / Continuation Criteria

inv-03: Reauthorization — All indications with reauthorization language

Covered when the following is met

No progression on therapy: Patient does not show evidence of progressive disease while on Stivarga therapy.no PD

Authorization issued for 12 months

inv-33: Reauthorization — No progression

Reauthorization criteria across indications

Continuation requirement: Patient must not show evidence of progressive disease while on Stivarga therapy to be eligible for reauthorization.

inv-34: Reauthorization - General

Prior-line and Step Therapy Requirements

Prior agent / therapy	Required prior result
Oxaliplatin-based chemotherapy
History of failure, contraindication, or intolerance
Irinotecan-based chemotherapy
History of failure, contraindication, or intolerance
Anti-VEGF–based chemotherapy
History of failure, contraindication, or intolerance
Imatinib (for GIST)
History of disease progression on imatinib (when GIST indication) or prior failure/intolerance to specified TKIs
Sunitinib or ripretinib (for GIST)
History of disease progression on both imatinib and one of sunitinib or ripretinib
Anti‑EGFR therapy (e.g., cetuximab, panitumumab) — when RAS wild-type CRC
History of failure, contraindication, or intolerance (required if tumor is RAS wild‑type)

Indication	Requirement before coverage
Bone cancer (listed primary bone cancers)
Must be used as second-line therapy
Uterine sarcoma (advanced, recurrent/metastatic, or inoperable)
Must be used as second-line or subsequent therapy

Provider Actions, Documentation, and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved only when indication-specific criteria and prior-therapy requirements are met. Authorizations are typically issued for 12 months for approved indications. Note: state mandates and member-specific benefit plans may supersede or modify these requirements.

Authorizations issued for 12 months for approved indications

Documentation Required

Required Clinical History and Reauthorization Notes

Documentation should clearly support the diagnosis, staging (e.g., advanced, metastatic, unresectable), and prior therapy history specific to the requested indication. For reauthorization, document lack of disease progression while on Stivarga.

Include diagnosis and disease status (advanced/metastatic/unresectable/recurrent).
For reauthorization: clinical evidence showing no progressive disease while on therapy.

Definitions and Reference Terms

RAS status — Tumor RAS mutation status

DefinitionTumor RAS mutation status (wild-type versus mutant) used to determine the prior anti‑EGFR therapy requirement for metastatic colorectal cancer.

Practical ruleIf tumor is RAS mutant-type, anti‑EGFR therapy is not required; if tumor is RAS wild-type, there must be history of failure, contraindication, or intolerance to anti‑EGFR therapy for coverage consideration.

Examples of anti‑EGFR agents referencedErbitux (cetuximab), Vectibix (panitumumab)

NCCN recognized regimen — Category of Evidence and Consensus

DefinitionNCCN recognized regimen: listed in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Use in policy

Background — Drug and Indication Context

Stivarga (regorafenib) is an oral multikinase inhibitor indicated for several oncology settings. The drug is approved for metastatic colorectal cancer after prior standard chemotherapies and targeted agents, for advanced gastrointestinal stromal tumor after specified tyrosine kinase inhibitors (or for SDH‑deficient GIST), and for hepatocellular carcinoma as a subsequent‑line therapy after sorafenib; NCCN additionally recognizes regorafenib for other tumor types. The policy references periodic updates to the drug background and literature (see references and annual reviews).

OpenPayer

Stivarga (regorafenib) prior authorization

Coverage Criteria — Indication-specific Authorization Rules

Initial Authorization Rules by Indication

Reauthorization / Continuation Criteria

Prior-line and Step Therapy Requirements

Provider Actions, Documentation, and Authorization Process

Definitions and Reference Terms

Background — Drug and Indication Context