DraftUnitedHealthcarePolicy 2024 P 1113-13

Votrient (pazopanib) prior authorization

UnitedHealthcare pharmacy prior authorization and notification criteria for Votrient (pazopanib) covering indications, initial authorization and reauthorization rules, and duration; applies to members subject to the payer's pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyVotrient (pazopanib) prior authorization

Policy CodePolicy 2024 P 1113-13

Change TypeAdded and revised indication criteria (GIST, chondrosarcoma, Merkel cellNCCN alignment)

Effective DateFeb 15, 2025

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating diagnosis and required prior therapy or disease status for the specific indication to receive a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

Added Merkel Cell Carcinoma criteria per NCCN recommendations.

Moved and updated criteria for GIST into its own section and specified prior therapy lines for GIST.

Added chondrosarcoma criteria (metastatic and widespread).

Updated criteria to align with NCCN recommendations for ovarian and uterine cancers and added NCCN-recommended regimens criterion.

12 monthsauthorization duration when approved

auto-processmembers <19

multipledistinct tumor types included

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state mandates may apply

multipleindications with specific criteria

Coverage Criteria

inv-01: Initial — Renal Cell Carcinoma

Initial Authorization — renal cell carcinoma (RCC)

RCC initial auth: Both of the following: (1) Diagnosis of renal cell carcinoma (RCC); AND (2) One of the following: disease has relapsed OR disease is advanced

Alternatively, diagnosis of von Hippel-Lindau (VHL)-associated RCC is an alternate pathway to approval.

inv-02: Initial — VHL-associated RCC

Initial Authorization — VHL-associated RCC

VHL-associated RCC: Diagnosis of von Hippel-Lindau (VHL)-associated renal cell carcinoma

This qualifies as an alternate pathway to approval for RCC indications.

inv-04: Initial — Soft Tissue Sarcoma

Initial Authorization — Soft Tissue Sarcoma

STS indications: Diagnosis of one of the listed soft tissue sarcoma histologies (e.g., angiosarcoma; pleomorphic rhabdomyosarcoma; alveolar soft part sarcoma; unresectable retroperitoneal/intra‑abdominal stage IV or postoperative residual disease; solitary fibrous tumor/hemangiopericytoma; extremity/superficial trunk or head/neck STS with stage IV or recurrent disseminated metastases; desmoid tumors; DFSP with fibrosarcomatous transformation; dedifferentiated chordoma; extraskeletal myxoid chondrosarcoma; epithelioid hemangioendothelioma)

Specific histologies and disease extent required depending on tumor type.

inv-05: Initial — Thyroid Carcinoma

Initial Authorization — Thyroid carcinoma

Differentiated thyroid carcinoma: Diagnosis of follicular, oncocytic, or papillary carcinoma AND one of: unresectable locoregional recurrent disease OR persistent disease OR metastatic disease AND one of: symptomatic disease OR progressive disease; AND one of: disease refractory to radioactive iodine OR distant metastatic disease not amenable to radioactive iodine treatment

Complex nested criteria for differentiated thyroid carcinomas.

Medullary thyroid carcinoma: Diagnosis of medullary carcinoma AND one of: disease is progressive OR disease is symptomatic with distant metastases AND history of failure, contraindication, or intolerance to vandetanib (Caprelsa) or cabozantinib (Cometriq)

Requires prior failure/intolerance to listed agents before Votrient.

inv-06: Initial — Uterine Sarcoma

Initial Authorization — Uterine sarcoma

Uterine sarcoma: Diagnosis of uterine sarcoma AND one of: disease is advanced OR disease is recurrent/metastatic OR disease is inoperable

Authorization will be issued for 12 months when criteria are met.

inv-07: Initial — Ovarian Cancer

Initial Authorization — Ovarian cancer

Ovarian cancer: Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer AND one of: disease is persistent OR disease is recurrent

Authorization will be issued for 12 months when criteria are met.

inv-08: Ovarian / Fallopian Tube / Primary Peritoneal Cancer - Initial

Covered when ALL of the following are met

Ovarian cancer initial authorization: (1) Diagnosis of one of: epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; AND (2) One of: disease is persistent OR disease is recurrent

Authorization issued for 12 months

inv-10: Chondrosarcoma - Initial

Covered when BOTH are met

Chondrosarcoma initial authorization: (1) Diagnosis of chondrosarcoma AND (2) Disease is metastatic and widespread

Authorization will be issued for 12 months.

inv-12: Gastrointestinal Stromal Tumors (GIST) - Initial

Covered when ALL of the following are met

GIST initial authorization: (1) Diagnosis of gastrointestinal stromal tumor (GIST) AND (2) Disease is unresectable, progressive, or metastatic AND (3) One of: (a) used as first-line therapy in SDH-deficient GIST OR (b) used after progression on all of: imatinib, sunitinib, regorafenib, and standard dose ripretinib

Authorization will be issued for 12 months.

inv-14: Merkel Cell Carcinoma - Initial

Covered when ALL of the following are met

Merkel Cell Carcinoma initial authorization: (1) Diagnosis of Merkel cell carcinoma AND (2) Disease is disseminated AND (3) One of: (a) Anti-PD-L1 or anti-PD-1 therapy is contraindicated OR (b) Disease has progressed on anti-PD-L1 or anti-PD-1 therapy

inv-16: NCCN Recommended Regimens

NCCN recommended regimens recognition

NCCN recognized regimens: Drug recognized by the NCCN Drugs & Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B may be approved

Authorization will be issued for 12 months when met.

Some states have laws that require coverage for certain off‑label uses or prescribe specific compendia to determine medically necessary use. When a state mandate applies, that state law supersedes the coverage criteria in this policy. Also note that prescriptions for members <19 years of age process without a coverage review per the policy.

UnitedHealthcare may use prior claim/medication history, diagnosis codes (ICD‑10), and claim logic to make initial or reauthorization decisions; automated approval processes vary by program and therapeutic class. In addition, a supply limit may be in place, and other utilization management programs or benefit rules may apply to requests for Votrient.

Initial Therapy Criteria (by indication)

inv-31: Initial Therapy (general grouping)

Initial authorization rules per indication

General: Initial authorizations require a documented diagnosis matching one of the listed indications and meeting the listed disease‑status criteria (e.g., unresectable, metastatic, relapsed, refractory).

Authorization will be issued for 12 months when criteria are met.

inv-32: Initial therapy (detailed per indication)

Initial authorization criteria by indication

Ovarian cancers initial: Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer AND disease persistent or recurrent

Authorization issued for 12 months

Chondrosarcoma initial:

Continuation / Reauthorization Criteria

inv-03: Reauthorization — General

Reauthorization/Continuation

Continuation: Patient must not show evidence of progressive disease while on Votrient therapy for reauthorization; approval typically issued for 12 months.

inv-09: Ovarian and other indications - Reauthorization

Reauthorization for multiple indications

General reauthorization rule: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization issued for 12 months

inv-11: Chondrosarcoma - Reauthorization

Reauthorization

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Votrient (pazopanib) except for members under 19 years of age, whose prescriptions will automatically process without a coverage review. Authorization (initial and reauthorization) may be issued for up to 12 months.

Member age < 19: automatic processing (no coverage review)
Authorization duration: up to 12 months

Prior Authorization

Indication-Specific Prior Authorization

Coverage approvals must be based on indication-specific criteria. Examples include, but are not limited to: renal cell carcinoma, medullary thyroid carcinoma, ovarian cancer (epithelial ovarian, fallopian tube, primary peritoneal) when persistent or recurrent, chondrosarcoma when metastatic and widespread, GIST with unresectable/progressive/metastatic disease and prior therapy requirements or SDH-deficient first-line use, and Merkel cell carcinoma for disseminated disease when anti‑PD‑1/PD‑L1 therapy is contraindicated.

Renal cell carcinoma: diagnosis required

Step Therapy Requirements

Prior agent / criterion	Requirement
Vandetanib (Caprelsa) or cabozantinib (Cometriq)
History of failure, contraindication, or intolerance to vandetanib or cabozantinib required before Votrient for medullary thyroid carcinoma

Prior agents / clinical scenario	Requirement
SDH-deficient GIST (first-line)
Votrient may be used as first-line therapy for SDH-deficient GIST
Imatinib (Gleevec), sunitinib (Sutent), regorafenib (Stivarga), standard dose ripretinib (Qinlock)
Use of Votrient after progression on all listed agents is required when not SDH-deficient (must have progressed on imatinib, sunitinib, regorafenib, and standard dose ripretinib)

Definitions

Votrient (pazopanib) key facts

Drug class and generic namePazopanib (brand: Votrient), an oral kinase inhibitor/tyrosine kinase inhibitor (anti‑angiogenic)

FDA‑labeled indications referencedAdvanced renal cell carcinoma and advanced soft tissue sarcoma (patients who have received chemotherapy)

Additional recommended uses (NCCN)NCCN recommends Votrient for medullary, follicular, oncocytic, and papillary thyroid carcinomas; ovarian cancer; additional soft tissue sarcomas; chondrosarcoma; uterine sarcoma; Merkel cell carcinoma; and GIST

Typical authorization durationAuthorization issued for 12 months when criteria are met

Provider action notePrior authorization required per UnitedHealthcare pharmacy clinical programs

Quantity Limits

Votrient (pazopanib) quantity limit note

Quantity limit summarySupply limit may be in place for Votrient (pazopanib)

Authorization relianceUnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic

Program variabilityUse of automated approval and re‑approval processes varies by program and/or therapeutic class

Provider implicationClaims may be subject to automated limits or logic rather than manual review; check program rules for supply limits

Background

Pazopanib (Votrient) is an oral tyrosine kinase inhibitor with anti‑angiogenic activity that is indicated for adults with advanced renal cell carcinoma and for certain soft tissue sarcomas. The policy recognizes pazopanib as a treatment option across multiple tumor types and disease settings (for example, unresectable, metastatic, relapsed or refractory disease) consistent with the drug’s labeled indications and NCCN‑recommended regimens.

Revision History

2025-02-15policy_updateLatest

Policy updated to align criteria with NCCN recommendations for ovarian and uterine cancers and to add recognition of NCCN‑recommended regimens.

2025-02-15addition

Added chondrosarcoma criteria (metastatic and widespread) as a covered indication with 12‑month authorization.

2025-02-15reorganization

Moved and updated GIST criteria into its own section specifying prior therapy lines and SDH‑deficient first‑line use.

Policy Summary

PayerUnitedHealthcare

PolicyVotrient (pazopanib) prior authorization

Policy CodePolicy 2024 P 1113-13

Change TypeAdded and revised indication criteria (GIST, chondrosarcoma, Merkel cellNCCN alignment)

Effective DateFeb 15, 2025

Next Review Date

Key ActionSubmit prior authorization documentation demonstrating diagnosis and required prior therapy or disease status for the specific indication to receive a 12-month authorization.

SourceLink

On This Page

Diagnosis of chondrosarcoma AND disease metastatic and widespread

Authorization issued for 12 months

GIST initial: Diagnosis of GIST AND unresectable/progressive/metastatic disease AND either first-line in SDH-deficient GIST OR after progression on imatinib, sunitinib, regorafenib, and ripretinib

Authorization issued for 12 months

Merkel cell initial: Diagnosis of Merkel cell carcinoma AND disseminated disease AND either contraindication to anti-PD-1/PD-L1 or progression on anti-PD-1/PD-L1 therapy

Authorization will be issued for 12 months when criteria are met.

Chondrosarcoma reauthorization: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization will be issued for 12 months

inv-13: GIST - Reauthorization

Reauthorization

GIST reauthorization: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization will be issued for 12 months

inv-15: Merkel Cell Carcinoma - Reauthorization

Reauthorization

Merkel cell reauthorization: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization issued for 12 months

inv-33: Continuation Therapy (grouped)

Reauthorization/Continuation

Continuation: Patient must not show evidence of progressive disease while on Votrient therapy for reauthorization; approval typically issued for 12 months.

inv-34: Continuation/Reauthorization (grouped for multiple indications)

Reauthorization for multiple indications

General reauthorization rule: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization issued for 12 months

Medullary thyroid carcinoma: indication-specific step/criteria required

Ovarian/fallopian tube/primary peritoneal cancer: persistent or recurrent disease required

Chondrosarcoma: metastatic and widespread disease required

GIST: unresectable/progressive/metastatic AND either SDH-deficient first-line or progression after imatinib, sunitinib, regorafenib, and standard-dose ripretinib

Merkel cell carcinoma: disseminated disease AND anti‑PD‑1/PD‑L1 contraindication

Step Therapy

Step Requirement for Medullary Thyroid Carcinoma

For medullary thyroid carcinoma, approval requires documentation of the diagnosis and meeting the listed indication-specific criteria prior to authorization.

Step Therapy

GIST Step Therapy Requirements

For gastrointestinal stromal tumor (GIST), document that disease is unresectable, progressive, or metastatic and whether treatment is first-line for SDH-deficient GIST or following progression on imatinib, sunitinib, regorafenib, and standard-dose ripretinib.

GIST must be unresectable, progressive, or metastatic
If not SDH-deficient first-line, document prior use of: imatinib, sunitinib, regorafenib, ripretinib (standard dose)

Documentation Required

Required Clinical Documentation

Provide clinical documentation to support the requested indication and treatment history. Documentation may include relevant diagnosis codes (ICD‑10), prior medication history (claims or medical record), imaging/pathology reports, and provider notes demonstrating disease status (e.g., metastatic, recurrent, unresectable).

Include ICD‑10 diagnosis codes supporting the indication
Provide prior medication claim history when step therapy or prior-line failure is required
Attach imaging, pathology, or clinical notes that document disease status

Note

Required Documentation and Automated Approval

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic. Automated approval and re-approval processes vary by program and therapeutic class. A supply limit may apply.

Approvals may be granted via automated claim/medication history review
Supply limits may be enforced

Note

Coverage Review Trigger

Coverage review will be triggered for requests that do not meet automated-processing criteria (e.g., members ≥19 years, missing required documentation, or indication not evident from claims).

Members ≥19 years: requires coverage review
Requests lacking required documentation or indication will trigger manual review

Denial Risk

Denial / Triggers

Denials may occur if required documentation is not provided, if the indication or prior‑therapy requirements are not met, or if claim/medication history does not support the requested use. Providers should ensure all supporting records and prior‑line therapy information are included to avoid denial.

Missing documentation or unsupported indication may result in denial
Failure to show required prior therapies for GIST or contraindication to PD‑1/PD‑L1 for Merkel cell carcinoma may result in denial

SDH-deficient (definition)

TermSDH‑deficient

Definition (as used in policy)GIST that is succinate dehydrogenase (SDH)‑deficient; Votrient may be used as first‑line therapy in SDH‑deficient GIST

Implication for step therapyIf GIST is SDH‑deficient, Votrient may be approved as first‑line therapy rather than requiring prior progression on listed TKIs

Disseminated (definition)

TermDisseminated

Definition (as used in policy)Disease described as disseminated in the policy is used to qualify metastatic/widely spread Merkel cell carcinoma for Votrient coverage

Policy consequenceMerkel cell carcinoma must be disseminated plus either contraindication to or progression on anti‑PD‑1/PD‑L1 therapy to meet initial authorization criteria

2025-02-15addition

Added Merkel cell carcinoma initial authorization criteria, including disseminated disease and prior anti‑PD‑1/PD‑L1 therapy considerations.