CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sunitinib (Sutent) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage indications, and continuation criteria for sunitinib (Sutent) for Neighborhood Health Plan of Rhode Island members, including FDA-approved and compendial uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySunitinib (Sutent) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (including FLT3 testing when applicable) — authorization durations commonly 12 months, up to 54 weeks for adjuvant RCC.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for most indications

up to 54 weeksauthorization duration for adjuvant RCC

Ref 2022-Adocument reference number

NCCN 2024compendia reference cited

Coverage Criteria for Sunitinib (Sutent)

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inv-01: Covered Indications and Criteria

Covered when ALL of the following are met for the specified indication groups

General coverage: Medication is prescribed for an FDA‑approved or compendial indication listed in the policy and the member has no exclusions to the prescribed therapy.

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Authorization duration: Authorization may be granted for 12 months for most indications; up to 54 weeks total for adjuvant renal cell carcinoma.

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GIST-specific: For GIST: used for residual, unresectable, ruptured, recurrent or metastatic GIST after failure of imatinib due to progression or intolerance; alternative sequences allow single-agent neoadjuvant use for SDH‑deficient GIST or combination with everolimus for progression after failure of at least four FDA‑approved therapies.

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Adjuvant RCC: Adjuvant treatment of high‑risk RCC following nephrectomy may be authorized; authorization for adjuvant RCC may be granted for up to 54 weeks total.

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Soft tissue sarcoma subtypes: Authorization of 12 months may be granted for single‑agent treatment of specified soft tissue sarcoma subtypes (alveolar soft‑part sarcoma, angiosarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma).

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Pancreatic neuroendocrine tumor (pNET): Authorization of 12 months may be granted for treatment of progressive, well‑differentiated pancreatic neuroendocrine tumors.

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Pheochromocytoma/Paraganglioma: Authorization of 12 months may be granted for treatment of locally unresectable or metastatic pheochromocytoma or paraganglioma as a single agent.

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Thymic carcinoma: Authorization of 12 months may be granted for treatment of thymic carcinoma with failure or intolerance of one previous chemotherapy regimen as a single agent.

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Differentiated thyroid carcinoma: Authorization of 12 months may be granted for progressive and/or symptomatic papillary, oncocytic/Hurthle cell, or follicular thyroid carcinoma not amenable to radioactive iodine therapy.

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Medullary thyroid carcinoma: Authorization of 12 months may be granted for recurrent or metastatic medullary thyroid carcinoma when the member has intolerance to FDA‑approved systemic therapy options or disease progression on those options (e.g., vandetanib, cabozantinib).

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Meningioma: Authorization of 12 months may be granted for surgically inaccessible recurrent or progressive meningioma when radiation is not possible.

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Chordoma: Authorization of 12 months may be granted for treatment of recurrent chordoma as single‑agent therapy.

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Myeloid/Lymphoid neoplasms with eosinophilia: Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid neoplasms with eosinophilia and FLT3 rearrangement in chronic or blast phase; documented testing confirming FLT3 rearrangement is required.

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inv-02: Not Medically Necessary / Experimental

Not covered indications: All other indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and not medically necessary.

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inv-03: Continuation of Therapy

Continuation criteria: For reauthorization, there must be no evidence of unacceptable toxicity or disease progression while on the current regimen for the specified indications. For adjuvant RCC reauthorization, member must not have exceeded a maximum of nine 6‑week cycles and disease must not be recurrent; authorization for adjuvant RCC continuation may be granted up to 54 weeks total.

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All other indications not specifically listed as FDA‑approved or compendial uses in this policy are considered experimental/investigational and not medically necessary.

Uses that are not described as FDA‑approved indications or as compendial uses in this document are considered not medically necessary.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for sunitinib. Authorization durations vary by indication (commonly 12 months; up to 54 weeks for adjuvant renal cell carcinoma).

Typical authorizations: 12 months for most indications; up to 54 weeks total for adjuvant RCC following nephrectomy.

Step Therapy

Step Therapy / Prior Failure Requirements

For gastrointestinal stromal tumor (GIST), sunitinib is authorized only after failure of imatinib due to disease progression or intolerable side effects. For thymic carcinoma, authorization requires failure or intolerance of one prior chemotherapy regimen. For medullary thyroid carcinoma, authorization requires either contraindication/intolerance to FDA‑approved systemic therapies (e.g., vandetanib, cabozantinib) or disease progression while on FDA‑approved systemic therapy.

GIST: prior failure of imatinib (progression or intolerance) is required.
Thymic carcinoma: failure or intolerance of one prior chemotherapy regimen required.
Medullary thyroid carcinoma: contraindication/intolerance to or progression on FDA‑approved systemic therapy required.

Documentation Required

Required Testing Documentation

Submission of testing or analysis confirming an FLT3 rearrangement (when applicable) is necessary to initiate the prior authorization review.

Required documentation: FLT3 rearrangement testing/analysis for myeloid/lymphoid neoplasms with eosinophilia where FLT3 rearrangement is claimed.

Line of Therapy Specifications

inv-13: second-line

Second‑line (GIST): Sunitinib used after failure of imatinib due to disease progression or intolerable side effects; authorization of 12 months may be granted. Alternative sequences described include single‑agent neoadjuvant use for SDH‑deficient GIST and combination with everolimus for progression after failure of at least four FDA‑approved therapies.

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inv-14: adjuvant

Adjuvant use (RCC): Adjuvant treatment of high‑risk renal cell carcinoma following nephrectomy may be authorized; authorization of up to 54 weeks total may be granted for adjuvant treatment and continuation is limited by a maximum of nine 6‑week cycles and absence of recurrent disease.

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Covered Regimens and Dosing Context

Indication	Regimen	Coverage
Gastrointestinal stromal tumor (GIST) - residual, unresectable, ruptured, recurrent, or metastatic
Single‑agent sunitinib after failure of imatinib due to disease progression or intolerable side effects
Authorization of 12 months may be granted when criteria are met; combination with everolimus allowed for disease progression after failure of at least four FDA‑approved therapies

Indication	Regimen	Coverage
Soft tissue sarcoma — alveolar soft‑part sarcoma (ASPS)
Single‑agent sunitinib
Authorization of 12 months may be granted
Soft tissue sarcoma — angiosarcoma
Single‑agent sunitinib
Authorization of 12 months may be granted
Soft tissue sarcoma — solitary fibrous tumor
Single‑agent sunitinib
Authorization of 12 months may be granted
Soft tissue sarcoma — extraskeletal myxoid chondrosarcoma
Single‑agent sunitinib
Authorization of 12 months may be granted

Biomarker and Testing Requirements

FLT3 rearrangement — testing requirement

Required biomarkerTesting or analysis confirming FLT3 rearrangement is required for myeloid/lymphoid neoplasms with eosinophilia (chronic or blast phase)

When requiredSubmission of FLT3 testing/analysis is necessary to initiate prior authorization review

Indication linkageFLT3 rearrangement requirement applies specifically to myeloid and/or lymphoid neoplasms with eosinophilia

Definitions and Compendial Uses

Compendial uses (selected)

Compendial tumor types (selected)Soft tissue sarcoma subtypes: angiosarcoma, alveolar soft-part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma

Thyroid cancersDifferentiated thyroid carcinoma (papillary, oncocytic/Hurthle cell, follicular) and medullary thyroid carcinoma (recurrent/metastatic) as compendial uses

Other compendial usesMeningioma, recurrent chordoma, pheochromocytoma/paraganglioma, and lymphoid/myeloid or mixed lineage neoplasms with eosinophilia (with FLT3 rearrangement)

GIST after imatinib — coverage notes

IndicationTreatment of residual, unresectable, ruptured, recurrent, or metastatic GIST after failure of imatinib due to disease progression or intolerable side effects

Authorized regimenSingle-agent sunitinib as the treatment option after imatinib failure

Alternative sequencesSunitinib may be used in combination with everolimus for progression after failure of at least four FDA‑approved therapies; neoadjuvant use permitted for SDH‑deficient GIST to decrease surgical morbidity

Background

Sunitinib (Sutent) is indicated for multiple adult solid tumor types, including listed compendial uses such as specified soft tissue sarcoma subtypes, gastrointestinal stromal tumors, thymic carcinomas, medullary and differentiated thyroid carcinomas, meningioma, chordoma, pheochromocytoma/paraganglioma, and lymphoid or myeloid neoplasms with eosinophilia and FLT3 rearrangement. All other indications are considered experimental/investigational and not medically necessary.