Neighborhood Health Plan Rhode Island Regorafenib Coverage | OpenPayer

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Neighborhood Health Plan Rhode Island Regorafenib Coverage | OpenPayer

Colorectal cancer (CRC) initial therapy: Member has metastatic colorectal cancer (including appendiceal or anal adenocarcinoma) and has progressed on fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (with or without bevacizumab); if RAS mutation status is negative (wild-type) and tumor is rectal, appendiceal, anal, or left-sided colon cancer, prior anti‑EGFR therapy is required; regorafenib to be used as a single agent.

Authorization of 12 months may be granted

GIST initial therapy: Member has locally advanced, unresectable, tumor rupture, recurrent or metastatic GIST and has progressed on imatinib and either sunitinib or ripretinib; regorafenib will be used as a single agent. Alternatively, regorafenib in combination with everolimus is permitted for disease progression after failure of at least four FDA‑approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib). SDH‑deficient GIST may be treated with regorafenib as a single agent.

Authorization of 12 months may be granted

Hepatocellular carcinoma (HCC) initial therapy: Member has unresectable or extrahepatic/metastatic hepatocellular carcinoma and has been previously treated with sorafenib; regorafenib to be used as a single agent.

Authorization of 12 months may be granted

Soft tissue sarcomas: Member has angiosarcoma, rhabdomyosarcoma, or nonadipocytic sarcoma (as specified) and regorafenib will be used as a single agent for treatment.

Authorization of 12 months may be granted

Osteosarcoma: Member has relapsed/refractory or metastatic osteosarcoma and regorafenib will be used as a single agent for subsequent treatment.

Authorization of 12 months may be granted

CNS cancers: Member has recurrent or progressive glioblastoma or high‑grade glioma and regorafenib will be used as a single agent.

Authorization of 12 months may be granted

Ewing sarcoma: Member has relapsed, progressive, or metastatic Ewing sarcoma (with or without radiation) and regorafenib will be used as a single agent.

Authorization of 12 months may be granted

Uterine sarcoma: Member has advanced, recurrent/metastatic, or inoperable uterine sarcoma and regorafenib will be used as a single agent.

Authorization of 12 months may be granted

Continuation/reauthorization: For GIST and other listed indications, reauthorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Regimen	Indication / Required prior therapies	Coverage status
Regorafenib (single agent)
GIST: locally advanced, residual, unresectable, tumor rupture, or recurrent/metastatic GIST after disease progression on imatinib and either sunitinib or ripretinib; includes SDH-deficient GIST as single agent

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior authorization required (12-month authorization possible)

Prior authorization is required for regorafenib; authorization of 12 months may be granted when the specified prior therapy and progression/intolerance criteria for the requested indication are met.

Step Therapy

Step therapy requirements by indication

The member must meet indication-specific step therapy requirements before regorafenib is authorized.

CRC: Progression on fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (with or without bevacizumab); if RAS wild-type and tumor in rectum, appendix, anus, or left-sided colon, prior anti-EGFR therapy (cetuximab or panitumumab) is required.
GIST: Progression on imatinib and either sunitinib or ripretinib; alternatively, combination with everolimus is allowed after failure of at least four FDA‑approved therapies.
HCC: Prior treatment with sorafenib is required for subsequent treatment.

Documentation Required

Required clinical documentation to support approval

Clinical documentation must demonstrate the FDA or compendial indication and prior therapies with evidence of disease progression or intolerance to required prior lines of therapy.

For CRC: documentation of metastatic disease and prior regimens including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (and anti‑EGFR therapy if RAS wild-type when applicable).
For GIST: documentation of progression on imatinib and either sunitinib or ripretinib, or failure of ≥4 FDA‑approved therapies if requesting regorafenib + everolimus; note SDH‑deficient GIST criteria where applicable.
For HCC: documentation of prior sorafenib treatment for unresectable or metastatic disease.

Denial Risk

Non‑compendial indications are not covered

Requests for indications not listed in the FDA indications or compendial uses are considered experimental/investigational and not medically necessary and may be denied.

Covered Regimens and Combinations

Regimen	Indication / Required prior therapies	Coverage status
Regorafenib + everolimus
GIST: residual, unresectable, tumor rupture, or recurrent/metastatic GIST for disease progression after the member has failed at least four FDA‑approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib)