Neighborhood Health Plan RI regorafenib Coverage | OpenPayer

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Neighborhood Health Plan RI regorafenib Coverage | OpenPayer

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months for covered indications. Requests must include documentation of prior therapies and evidence of disease progression or intolerance when applicable.

Authorization duration: up to 12 months
Submit documentation of prior therapies and progression/intolerance

Step Therapy

Prior Therapy Requirements

Step therapy / prior therapy requirements vary by indication. For colorectal cancer, GIST, hepatocellular carcinoma, soft tissue sarcoma, osteosarcoma, and glioblastoma, the provider must document prior systemic therapies and progression or intolerance as specified below.

Colorectal cancer: progression on fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF therapy; and if RAS wild type, an anti-EGFR therapy (e.g., cetuximab or panitumumab), unless contraindicated or intolerant
GIST: progression after single-agent imatinib and sunitinib OR used in combination with everolimus for members who have failed at least four FDA‑approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib)
Hepatocellular carcinoma: use as subsequent treatment (document prior therapy and progression/intolerance)
Soft tissue sarcomas (angiosarcoma, solitary fibrous tumor, retroperitoneal/intra-abdominal, rhabdomyosarcoma, non-adipocytic sarcoma): document prior therapies and progression/intolerance as applicable
Osteosarcoma: second‑line treatment for relapsed/refractory or metastatic disease — document prior systemic therapy and progression/intolerance
Glioblastoma: recurrent disease — document prior therapies and progression/intolerance

Documentation Required

Required Clinical Documentation

Providers must supply clinical documentation with the prior authorization request demonstrating prior therapies tried, reasons for discontinuation (progression or intolerance), tumor type, line of therapy, and any relevant biomarker status (e.g., RAS mutation status for colorectal cancer). Reauthorization requests must show no unacceptable toxicity and no disease progression on the current regimen.

Document prior systemic regimens and dates administered
Document clinical evidence of disease progression or intolerance to prior therapies
Include biomarker status when relevant (e.g., RAS wild type for anti‑EGFR requirement)
For continuation/reauthorization: document absence of unacceptable toxicity and lack of disease progression while on therapy

Denial Risk

Non‑covered Indications

Use of the drug for indications not listed in the covered indications (e.g., indications outside section II/B Compendial Uses) is considered experimental and investigational and is not medically necessary.

All indications not explicitly listed as covered (section II) are non‑covered

Regimens and Formulations Covered

Regimen	Indication / clinical context	Prior therapy requirement	Coverage status
Regorafenib + everolimus	Progressive gastrointestinal stromal tumor (GIST)	Member has failed at least four FDA‑approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib)	Covered

Regimen	Indication / clinical context	Prior therapy requirement	Coverage status
Regorafenib (single-agent)	Advanced or metastatic colorectal cancer	Progressed on fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF therapy; and if RAS wild type, an anti-EGFR therapy	Covered
Regorafenib (single-agent)	Hepatocellular carcinoma	Used as subsequent single-agent treatment after sorafenib	Covered
Regorafenib (single-agent)	Soft tissue sarcomas (angiosarcoma; solitary fibrous tumor; retroperitoneal/intra-abdominal soft tissue sarcoma; rhabdomyosarcoma; non-adipocytic sarcoma)	No specific systemic prior therapy required beyond diagnosis-specific treatment failures as clinically appropriate	Covered
Regorafenib (single-agent)	Osteosarcoma (relapsed/refractory or metastatic)	Second-line single-agent therapy for relapsed/refractory or metastatic disease	Covered
Regorafenib (single-agent)	Recurrent glioblastoma	Used as single-agent therapy for recurrent disease	Covered