Colorado Rocky Mountain HP Stivarga Prior Auth

Coverage Criteria for Indications

Colorectal cancer (CRC)

Covered when ALL of the following are met for metastatic colorectal cancer:

CRC Initial

Prior chemo/targeted therapy: History of failure, contraindication, or intolerance to oxaliplatin-based chemotherapy, irinotecan-based chemotherapy, and anti-VEGF-based chemotherapy
RAS/EGFR conditions: Either tumor is RAS mutant-type OR (tumor is RAS wild-type AND history of failure, contraindication, or intolerance to anti-EGFR therapy [e.g., cetuximab, panitumumab])

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

Authorization will be issued for 12 months

Soft tissue sarcoma

Covered when ALL of the following are met for soft tissue sarcoma:

STS Initial: Diagnosis of soft tissue sarcoma AND disease meets specific anatomic/histologic criteria (examples: non-adipocytic extremity/trunk/head/neck with disseminated metastases; retroperitoneal or intra-abdominal non-adipocytic unresectable or stage IV; advanced pleomorphic rhabdomyosarcoma; angiosarcoma).

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

Authorization will be issued for 12 months

Gastrointestinal stromal tumor (GIST)

Covered when ALL of the following are met for gastrointestinal stromal tumor (GIST):

GIST Initial diagnosis: Diagnosis of gastrointestinal stromal tumor (GIST) AND disease status of one of: gross residual (R2 resection), unresectable primary, tumor rupture, or recurrent/metastatic disease.

GIST molecular/prior therapy: Either SDH-deficient GIST OR history of disease progression on both imatinib (Gleevec) and one of sunitinib (Sutent) or ripretinib (Qinlock).

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

Authorization will be issued for 12 months

Biliary tract cancers and hepatocellular carcinoma (HCC)

Covered when ONE of the following indication-specific sets is met for biliary tract cancers or HCC:

Biliary tract cancers: Diagnosis of gallbladder cancer OR extrahepatic cholangiocarcinoma OR intrahepatic cholangiocarcinoma AND disease that is unresectable, gross residual (R2), or metastatic.

Hepatocellular carcinoma (HCC): Diagnosis of hepatocellular carcinoma AND used as subsequent-line therapy for disease progression.

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

Authorization will be issued for 12 months

Bone cancer

Covered when ALL of the following are met for specified primary bone tumors:

Bone cancer Initial: Diagnosis of one of the following bone cancers: dedifferentiated chondrosarcoma; Ewing sarcoma; high grade undifferentiated pleomorphic sarcoma (UPS); mesenchymal chondrosarcoma; osteosarcoma; or other primary round cell tumors of the bone (e.g., CIC::DUX4, BCOR::CCNB3).

Bone cancer Reauthorization: Patient does not show evidence of progressive disease while on Stivarga therapy

Authorization will be issued for 12 months

Bone Cancer

Covered when ALL of the following are met

Bone cancer - Initial Therapy: Diagnosis of one of the following 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). AND used as second-line therapy.

Bone cancer - Reauthorization: Patient does not show evidence of progressive disease while on Stivarga therapy.

Authorization will be issued for 12 months.

Glioblastoma

Covered when ALL of the following are met

Glioblastoma - Initial Therapy: Diagnosis of recurrent or progressive glioblastoma.

Glioblastoma - Reauthorization: Patient does not show evidence of progressive disease while on Stivarga therapy.

Authorization will be issued for 12 months.

Uterine Sarcoma

Covered when ALL of the following are met

Uterine Sarcoma - Initial Therapy: Diagnosis of uterine sarcoma AND disease that is advanced, recurrent/metastatic, or inoperable AND used as second-line or subsequent therapy.

Uterine Sarcoma - Reauthorization: Patient does not show evidence of progressive disease while on Stivarga therapy.

Authorization will be issued for 12 months.

NCCN Recommended Regimens

NCCN Recommended Regimens: Drug recognized by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B supports use.

No explicit exclusions are listed in the provided coverage excerpt. Coverage is defined by meeting the indication-specific criteria in the policy; there are no separate exclusion statements in the cited text.

Coverage may be affected by external requirements: state mandates can supersede benefit document language for off‑label uses or compendia requirements, and member-specific benefit plan coverage or federal regulatory requirements may also impact whether a request is covered. Additionally, other policies and utilization management programs may apply and influence coverage determinations.

Coverage for Stivarga (regorafenib) is contingent on meeting the indication-specific criteria set forth in this policy. The policy requires that members satisfy the detailed initial‑therapy or reauthorization criteria for the cancer indication under review; failure to meet those indication‑specific rules may result in denial.

The cited document does not include explicit "not medically necessary" statements in the provided excerpts. Programs may use automated approval or re‑approval processes in some circumstances (for example, based on prior claim/medication history or diagnosis codes), and supply limits may be in place, so authorization outcomes can vary by program and therapeutic class.

Initial Therapy Requirements

Initial therapy requirements

Indication-specific initial approval requirements including prior therapy history or disease characteristics:

Pediatrics: Patient is less than 19 years of age.

Authorization will be issued for 12 months; prescriptions for members <19 process without coverage review.

CRC Initial: Diagnosis of advanced or metastatic colorectal cancer AND history of failure, contraindication, or intolerance to oxaliplatin-based chemotherapy, irinotecan-based chemotherapy, and anti-VEGF-based chemotherapy; plus RAS/EGFR conditions as specified (RAS mutant-type OR RAS wild-type with prior failure/contraindication/intolerance to anti-EGFR therapy).

Authorization will be issued for 12 months.

GIST Initial: Diagnosis of GIST with gross residual (R2), unresectable primary, tumor rupture, or recurrent/metastatic disease AND either SDH-deficient GIST OR history of progression on both imatinib and one of sunitinib or ripretinib.

Reauthorization and Continuation Criteria

Reauthorization / Continuation

Reauthorization (continuation) is approved when the patient does not show evidence of progressive disease while on Stivarga:

Continuation criterion: No evidence of progressive disease while on Stivarga therapy.

Authorization typically for 12 months.

Reauthorization

Common reauthorization condition across indications:

Reauthorization Rule: Patient does not show evidence of progressive disease while on Stivarga therapy.

Authorization will be issued for 12 months.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Stivarga (regorafenib) for members age 19 and older; prescriptions for members under age 19 will automatically process without a coverage review. Approvals are typically issued for 12 months for initial and reauthorization determinations, though automated approval practices vary by program/therapeutic class.

Prior authorization required for members ≥ 19 years
Members < 19 years: prescription auto-processes without coverage review
Approvals generally issued for 12 months
Use of automated approval and re-approval processes varies by program/therapeutic class

Denial Risk

Denial Triggers

Coverage may be denied if the request does not meet the indication-specific criteria (including required prior therapies, line-of-therapy rules, or documented disease characteristics). Failure to provide required documentation to support diagnosis, prior therapies, or lack of response/intolerance/contraindication to prior agents may trigger denial.

Step Therapy and Prior-Line Requirements

Requirement	Details
History of failure, contraindication, or intolerance to specified prior chemotherapies or targeted agents
Oxaliplatin-based chemotherapy; Irinotecan-based chemotherapy; Anti-VEGF-based chemotherapy (for CRC). For GIST: progression on imatinib and on sunitinib or ripretinib.

Indication	Step therapy requirement
Bone cancer
Used as second-line therapy (prior therapy required).
Uterine sarcoma
Used as second-line or subsequent therapy (prior therapy required).

Site of Care and Supply Limits

Note

Supply limits and site-of-care considerations

Supply limits may be applied for Stivarga; site-of-care rules are not specified in this policy excerpt, and state mandates or the member’s benefit plan may affect coverage at infusion centers or other settings.

Background and Drug Information

Regorafenib (Stivarga) is an oral multikinase inhibitor indicated for certain patients with metastatic colorectal cancer, previously treated gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma after sorafenib, and it has additional recognized uses in oncology per NCCN. The policy references the drug by its trade name Stivarga (regorafenib) and notes that NCCN Drugs and Biologics Compendium listings support its use for multiple cancer indications with assigned categories of evidence.

Definitions and Recognitions

Stivarga (regorafenib) — definition

Drug nameStivarga (regorafenib)

Drug classMultikinase inhibitor (kinase inhibitor)

FDA-indicated uses (selected)Metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti‑VEGF (and anti‑EGFR if RAS wild-type); previously treated, locally advanced/unresectable or metastatic GIST after imatinib and sunitinib; hepatocellular carcinoma after sorafenib.

Route of administrationOral

Typical authorization duration12 months (per policy authorization statements)

NCCN recognition

OpenPayer

Stivarga (regorafenib) — Prior Authorization and Coverage Criteria

Coverage Criteria for Indications

Initial Therapy Requirements

Reauthorization and Continuation Criteria

Provider Actions, Prior Authorization & Documentation

Step Therapy and Prior-Line Requirements

Site of Care and Supply Limits

Background and Drug Information

Definitions and Recognitions