ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1101-15

Sutent® (sunitinib malate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization and notification criteria for coverage of Sutent (sunitinib malate) across multiple oncologic indications for UnitedHealthcare Commercial Plans, including pediatric automatic approval under age 19 and NCCN-recognized off-label uses per state mandates.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySutent® (sunitinib malate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1101-15

Change TypeAnnual review (updated soft tissue sarcoma coverage)

Effective DateJun 1, 2025

Next Review Date

Key ActionCoverage for Sutent requires prior authorization/notification per the listed indication-specific criteria; approvals typically issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

3/2025 annual review updated soft tissue sarcoma to include coverage for extraskeletal myxoid chondrosarcoma per NCCN guidelines and updated references.

3/2024 annual review updated GIST, neuroendocrine/adrenal tumors, and thyroid carcinoma per NCCN recommendations.

3/2023 annual review updated Myeloid/Lymphoid and Thymic cancer criteria and added state mandate footnote.

3/2022 annual review updated renal cell and neuroendocrine carcinoma criteria per NCCN guidelines.

3/2021 annual review added NCCN recommendation for Myeloid/Lymphoid Neoplasms to background and updated treatment criteria.

12Authorization duration (months)

MultipleIndications covered (labeled + NCCN off-label)

Pediatric auto-approve

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Members <19 years processing

Coverage Summary

UnitedHealthcare policy 2025 P 1101-15 covers Sutent (sunitinib malate) with specific authorization criteria across multiple oncologic indications (coverage stance: covered with criteria). Scope includes labeled and NCCN-recognized off-label uses for Commercial Plans; members under 19 years automatically process without coverage review. Authorizations are typically issued for 12 months. Prior authorization/notification is required and state mandates or member-specific benefits may supersede the criteria.

Scope & stats

Authorization duration12 months

Indications coveredLabeled oncologic indications plus NCCN-recognized off-label uses (multiple tumor types)

Pediatric processingMembers <19 years: prescription automatically processes without coverage review (automatic approval)

Effective date2025-06-01

Last review date2025-03

Initial Therapy Criteria

Gastrointestinal Stromal Tumor (GIST) - Initial Authorization

Authorization will be issued for 12 months.

ALL of the following

Diagnosis of gastrointestinal stromal tumor (GIST)
ONE of
- History of disease progression on, contraindication, or intolerance to Gleevec (imatinib), Stivarga (regorafenib), or standard dose Qinlock (ripretinib)
- SDH-deficient GIST

Renal Cell Carcinoma (RCC) - Initial Authorization

Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

GIST - Reauthorization

Authorization will be issued for 12 months.

Patient does not show evidence of progressive disease while on Sutent therapy

RCC - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

pNET - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

Soft Tissue Sarcomas - Reauthorization

Unproven / Exclusions

Coverage is limited to the listed labeled indications and NCCN-recognized uses; the policy ties approval to the specified diagnosis-based criteria and NCCN Drugs and Biologics Compendium recognition (Category 1, 2A, or 2B). The brief does not provide a separate set of 'not medically necessary' criteria — instead coverage is restricted to the indications, criteria, and any applicable state mandates noted in the policy.

Applicable Codes & References

Drugs referenced for prior therapy or comparatorsNDC|drug_name

imatinib	Gleevec (imatinib) - referenced as prior therapy for GIST
regorafenib	Stivarga (regorafenib) - referenced as prior therapy for GIST
ripretinib	Qinlock (ripretinib) - referenced as prior therapy for GIST
vandetanib	Caprelsa (vandetanib) - preferred systemic therapy example for medullary thyroid carcinoma
cabozantinib	Cometriq (cabozantinib) - preferred systemic therapy example for medullary thyroid carcinoma

Diagnosis references mentionedICD-10

No codes listed

Prior-therapy and comparator references used in the criteria include imatinib (Gleevec), regorafenib (Stivarga), ripretinib (Qinlock) for GIST prior therapy requirements, and vandetanib (Caprelsa) and cabozantinib (Cometriq) cited as preferred systemic therapy examples for medullary thyroid carcinoma.

Provider Actions

Prior Authorization

Prior authorization required

Coverage for Sutent requires prior authorization/notification per the listed indication-specific criteria; approvals typically issued for 12 months.

Documentation Required

Clinical documentation of non-progression for reauthorization

For reauthorization, provider must document that the patient does not show evidence of progressive disease while on Sutent therapy.

Documentation Required

Documentation of prior therapy or resistance

For certain indications (e.g., GIST, medullary thyroid carcinoma), provider must document history of progression on, contraindication to, or intolerance to specified prior therapies or that preferred therapies or clinical trials are not available or appropriate.

Clinical Evidence & Background

Background: Sutent (sunitinib malate) is a tyrosine kinase inhibitor with labeled indications for GIST after progression or intolerance to imatinib, advanced renal cell carcinoma (RCC), adjuvant treatment of high-risk RCC post-nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET). The NCCN also recommends Sutent for several additional tumor types, including thyroid cancers (medullary, follicular, oncocytic, papillary), chordoma, meningiomas, thymic carcinoma, myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement, and soft tissue sarcomas such as alveolar soft part sarcoma, angiosarcoma, solitary fibrous tumor/hemangiopericytoma, and extraskeletal myxoid chondrosarcoma.

Evidence

P&T approval historyP&T approvals: 8/2008 through 3/2025 (annual reviews)

NCCN recognitionRecognized by NCCN Drugs & Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B for some uses

Definitions: SDH-deficient GIST — gastrointestinal stromal tumor characterized by deficiency in the succinate dehydrogenase complex; documented SDH-deficient GIST qualifies under the GIST initial authorization criteria.

Revision History

3/2025revisedLatest

3/2025 annual review updated soft tissue sarcoma to include coverage for extraskeletal myxoid chondrosarcoma per NCCN guidelines and updated references.

3/2024revised

3/2024 annual review updated GIST, neuroendocrine/adrenal tumors, and thyroid carcinoma per NCCN recommendations.

3/2023revised

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySutent® (sunitinib malate) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1101-15

Change TypeAnnual review (updated soft tissue sarcoma coverage)

Effective DateJun 1, 2025

Next Review Date

Key ActionCoverage for Sutent requires prior authorization/notification per the listed indication-specific criteria; approvals typically issued for 12 months.

SourceLink

On This Page

ALL of the following

Diagnosis of renal cell carcinoma (RCC)
ONE of
- Disease has relapsed
- Disease is advanced
- ALL of the following
  - Patient has a high risk of recurrence following nephrectomy

Pancreatic Neuroendocrine Tumors (pNET) - Initial Authorization

Diagnosis of progressive pancreatic neuroendocrine tumors (pNET)

Soft Tissue Sarcomas (ASPS, Angiosarcoma, Solitary fibrous tumor/hemangiopericytoma, Extraskeletal myxoid chondrosarcoma) - Initial Authorization

ALL of the following

ONE of
- Alveolar soft part sarcoma (ASPS)
- Angiosarcoma
- Solitary fibrous tumor / hemangiopericytoma
- Extraskeletal myxoid chondrosarcoma

Thyroid Carcinoma - Initial Authorization

ANY of the following

ALL of the following
- Unresectable locoregional recurrent disease; Persistent disease; Metastatic disease
- Patient has symptomatic disease; Patient has progressive disease
- Disease is refractory to radioactive iodine treatment
ALL of the following
- Patient has progressive disease; Patient has symptomatic metastatic disease
- Clinical trials or preferred systemic therapy options are not available or appropriate; There is progression on preferred systemic therapy options (e.g., Caprelsa (vandetanib), Cometriq (cabozantinib))

Recurrent Chordoma - Initial Authorization

Authorization will be issued for 12 months.

Diagnosis of recurrent chordoma

Meningiomas - Initial Therapy

ALL of the following

Disease is recurrent; Disease is progressive
Further radiation is not possible

Thymic Carcinoma - Initial Therapy

Diagnosis of thymic carcinoma

NCCN Recommended Regimens

Authorization will be issued for 12 months.

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Patient does not show evidence of progressive disease while on Sutent therapy

Thyroid Carcinoma - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

Recurrent Chordoma - Reauthorization

Authorization will be issued for 12 months.

Patient does not show evidence of progressive disease while on Sutent therapy

Meningiomas - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

Thymic Carcinoma - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

Myeloid/Lymphoid Neoplasms - Reauthorization

Patient does not show evidence of progressive disease while on Sutent therapy

Billing Rule

Pediatric automatic processing

For members under the age of 19 years, the prescription will automatically process without a coverage review; authorization will be issued for 12 months.

Denial Risk

State mandates may supersede

Some states mandate benefit coverage for off-label use or other compendium references; where such mandates apply they supersede the policy language, and claims may be denied if criteria or applicable state mandates are not met.

3/2023 annual review updated Myeloid/Lymphoid and Thymic cancer criteria and added state mandate footnote.

3/2022revised

3/2022 annual review updated renal cell and neuroendocrine carcinoma criteria per NCCN guidelines.

3/2021revised

3/2021 annual review added NCCN recommendation for Myeloid/Lymphoid Neoplasms to background and updated treatment criteria.