CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sunitinib (Sutent) — Coverage Criteria

Defines prior authorization, indications, authorization durations, 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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation, including FLT3 testing when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization length

up to 54 wksadjuvant RCC limit

FLT3biomarker

multiplecovered tumor types

Coverage Criteria for Sunitinib (Sutent)

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General coverage precondition

Indication-specific paths: One of the specific indication criteria below must be met.
Each indication has its own subcriteria

Indication-specific subcriteria

GIST (after imatinib): Treatment of residual, unresectable, tumor rupture, recurrent, or metastatic GIST after failure of imatinib due to disease progression or intolerable side effects as a single agent; OR neoadjuvant single-agent therapy to decrease surgical morbidity for SDH-deficient GIST; OR combination with everolimus for disease progression after the member has failed at least four FDA-approved therapies.
See chunk 7
Renal cell carcinoma (RCC): Relapsed, advanced, or stage IV RCC: authorization of 12 months may be granted as single-agent therapy; Adjuvant high-risk RCC following nephrectomy: authorization up to 54 weeks total may be granted.
See chunk 5
Pancreatic neuroendocrine tumor (pNET): Progressive, well-differentiated pancreatic neuroendocrine tumors: authorization of 12 months may be granted.
See chunk 8
Soft tissue sarcoma subtypes: Alveolar soft-part sarcoma, angiosarcoma, solitary fibrous tumor, or extraskeletal myxoid chondrosarcoma: authorization of 12 months may be granted as single-agent therapy.
See chunk 6
Thymic carcinoma with failure or intolerance of one previous chemotherapy regimen: authorization of 12 months may be granted as single-agent therapy.
See chunk 10
Differentiated thyroid carcinoma (papillary/oncocytic/Hurthle/follicular): Progressive and/or symptomatic disease not amenable to radioactive iodine (RAI) therapy: authorization of 12 months may be granted.
See chunk 11
Medullary thyroid carcinoma: Recurrent or metastatic medullary thyroid carcinoma when either the member has a contraindication or intolerance to FDA‑approved systemic therapy options (e.g., vandetanib, cabozantinib) OR the member has disease progression while on FDA‑approved systemic therapy options: authorization of 12 months may be granted.
See chunk 12
Meningioma: Surgically inaccessible recurrent or progressive meningioma for which radiation is not possible: authorization of 12 months may be granted.
See chunk 13
Chordoma: Recurrent chordoma as single-agent therapy: authorization of 12 months may be granted.
See chunk 14
Myeloid/lymphoid neoplasms with eosinophilia: Myeloid and/or lymphoid neoplasms with eosinophilia and FLT3 rearrangement in the chronic phase or blast phase: authorization of 12 months may be granted; submit testing confirming FLT3 rearrangement if applicable.
See chunks 15 and 4
Pheochromocytoma/Paraganglioma: Locally unresectable or metastatic pheochromocytoma or paraganglioma as single-agent therapy: authorization of 12 months may be granted.
See chunk 9

inv-02: Continuation of Therapy

Covered continuation when ALL of the following are met:

Continuation general: No evidence of unacceptable toxicity or disease progression while on the current regimen for the specified indications; authorization of 12 months may be granted for continued treatment when this condition is met.

See chunk 16 for list of indications eligible for reauthorization

Adjuvant RCC continuation: For adjuvant treatment of renal cell carcinoma, authorization of up to 54 weeks total may be granted for continued therapy when ALL of the following are met: Disease is not recurrent; AND Member has not exceeded a maximum of nine 6‑week cycles.

See chunk 16 and chunk 5

Regimens and Dosing Contexts Covered

Indication	Regimen / Pathway	Authorization duration
Gastrointestinal stromal tumor (GIST) — after imatinib failure
Sunitinib as single‑agent for residual, unresectable, tumor rupture, recurrent or metastatic GIST; OR sunitinib in combination with everolimus for disease progression after failure of at least four FDA‑approved therapies
Authorization of 12 months may be granted

Indication	Regimen / Notes	Authorization duration / Limits
Renal cell carcinoma (RCC) — relapsed, advanced, or stage IV
Sunitinib single‑agent
Authorization of 12 months may be granted
Renal cell carcinoma (RCC) — adjuvant high‑risk following nephrectomy
Sunitinib single‑agent (adjuvant use) — duration limited by cycle count
Authorization of up to 54 weeks total may be granted

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for therapies described in this section. Typical authorization duration is 12 months for most indications listed below; adjuvant RCC may be authorized up to 54 weeks. Exceptions to the 12-month duration are noted in the criteria for specific diagnoses (for example, adjuvant renal cell carcinoma).

Authorization duration: typically 12 months for single‑agent treatment
Adjuvant renal cell carcinoma: up to 54 weeks total

Documentation Required

Required Diagnostic Testing

Molecular or diagnostic testing must be submitted when clinically relevant to the requested indication. For example, testing or documentation confirming FLT3 rearrangement is required for myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement; documentation of SDH‑deficient status is required when requesting neoadjuvant therapy for SDH‑deficient GIST. Provide test reports or clinical documentation to support indication.

Required testing when applicable: FLT3 rearrangement testing or equivalent documentation
Documentation of SDH‑deficient status for SDH‑deficient GIST requests
General: include relevant molecular/pathology reports with the PA submission

Step Therapy

Step Therapy / Prior Lines Required

Step therapy / prior‑line requirements apply for certain indications. For gastrointestinal stromal tumor (GIST), the requested medication is for residual, unresectable, ruptured, recurrent or metastatic GIST only after failure of imatinib due to disease progression or intolerance. For advanced thymic carcinoma the member must have failure or intolerance of one prior chemotherapy regimen. For medullary thyroid carcinoma the member must have contraindication/intolerance to or disease progression on FDA‑approved systemic therapies (e.g., vandetanib, cabozantinib).

GIST: failure of imatinib (progression or intolerance) is required prior to approval
Thymic carcinoma: prior failure or intolerance of one chemotherapy regimen required
Medullary thyroid carcinoma: contraindication/intolerance to or progression on FDA‑approved options (vandetanib, cabozantinib)

Line-of-Therapy Specifications

inv-12: second-line

GIST second-line: Used after failure of imatinib due to disease progression or intolerable side effects; authorization of 12 months may be granted for treatment of residual, unresectable, tumor rupture, recurrent, or metastatic GIST as single-agent therapy.

See chunk 7

inv-13: second-line

Medullary thyroid carcinoma second-line: Member has a contraindication or intolerance to FDA‑approved systemic therapy options (e.g., vandetanib, cabozantinib) OR member has disease progression while on FDA‑approved systemic therapy options; authorization of 12 months may be granted.

See chunk 12

Biomarker and Genetic Testing Requirements

inv-14: FLT3 rearrangement — biomarker requirement referenced for myeloid/lymphoid neoplasms with eosinophilia

BiomarkerFLT3 rearrangement

Required for indicationMyeloid/lymphoid neoplasms with eosinophilia (chronic or blast phase)

Documentation to submitTesting or analysis confirming FLT3 rearrangement must be submitted if applicable

Authorization durationAuthorization of 12 months may be granted for this indication

inv-11: FLT3 rearrangement — testing/analysis requirement and operational detail

Required testTesting or analysis confirming FLT3 rearrangement

When to submitSubmit test results with prior authorization request when treating myeloid/lymphoid neoplasms with eosinophilia and suspected FLT3 rearrangement

Source instruction"Submission of the following information is necessary to initiate the prior authorization review: Testing or analysis confirming FLT3 rearrangement (if applicable)"

Associated coverage noteAuthorization of 12 months may be granted for neoplasms with eosinophilia and FLT3 rearrangement (chronic or blast phase)

OpenPayer