CurrentCentenePolicy CP PHAR.81

Pazopanib (Votrient)

Defines medical necessity, prior authorization, and coverage criteria for pazopanib (Votrient) for adults across approved and selected off-label oncology indications for Centene lines of business.

Policy Summary

PayerCentene

PolicyPazopanib (Votrient)

Policy CodePolicy CP PHAR.81

Change TypeNo material change

Effective DateOct 1, 2011

Next Review Date

Key ActionPrior authorization is required and the provider must submit documentation demonstrating diagnosis, oncology involvement, adult age, and indication‑specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

RCC, STS, off-labelIndications

>=18Age requirement

800 mg/dayMax daily dose

HepatotoxicitySafety alert

200 mg tabProduct

Coverage Criteria for Pazopanib (Votrient)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy — RCC

Initial Approval — Renal Cell Carcinoma (must meet ALL):

RCC initial: 1. Diagnosis of renal cell carcinoma (RCC). 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Disease is advanced, relapsed, stage IV, or von Hippel‑Lindau (VHL)‑associated. 5. Member must use pazopanib (Votrient) if available unless contraindicated or clinically significant adverse effects are experienced. 6. Dose does not exceed 800 mg per day. 7. Prescribed regimen must be FDA‑approved or recommended by NCCN; if off‑label dosing is requested, dose must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).dose <= 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy — STS

Initial Approval — Soft Tissue Sarcoma (must meet ALL):

STS initial: 1. Diagnosis of soft tissue sarcoma (STS) and meets one of the following: (a) STS subtype is angiosarcoma, desmoid tumor (aggressive fibromatosis), solitary fibrous tumor, alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, or epithelioid hemangioendothelioma; (b) For GIST subtype, failure of one or more indicated agents (unless contraindicated or not tolerated) or tumor is SDH‑deficient with gross residual disease; (c) Member is ineligible for IV chemotherapy or not a candidate for anthracycline‑based regimens; (d) For all other STS subtypes, failure of chemotherapy unless contraindicated or not tolerated. 2. Prescribed by or in consultation with an oncologist. 3. Disease is stage IV, unresectable, advanced, or recurrent with metastases. 4. Age >= 18 years. 5. Member must use pazopanib (Votrient) if available unless contraindicated or clinically significant adverse effects are experienced. 6. Dose does not exceed 800 mg per day. 7. Prescribed regimen must be FDA‑approved or recommended by NCCN; if off‑label dosing is requested, dose must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).dose <= 800 mg/day

Prior authorization is required for specified comparator agents; prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy — Uterine Sarcoma (off-label)

Initial Approval — Uterine Sarcoma (off-label, must meet ALL):

Uterine sarcoma initial: 1. Diagnosis of uterine sarcoma. 2. Prescribed by or in consultation with an oncologist. 3. Age > 18 years. 4. Disease is advanced, recurrent, metastatic, or inoperable. 5. Failure of prior cytotoxic chemotherapy (hormonal therapies such as aromatase inhibitors are not considered cytotoxic). 6. Member must use pazopanib (Votrient) if available unless contraindicated or clinically significant adverse effects are experienced. 7. Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).dose <= 800 mg/day likely applied

Off‑label — prescriber must submit supporting evidence

Initial Therapy — Thyroid Carcinoma (off-label)

Initial Approval — Thyroid Carcinoma (off-label, must meet ALL):

Thyroid carcinoma initial: 1. Diagnosis of thyroid carcinoma. 2. Prescribed by or in consultation with an oncologist. 3. Age >= 18 years. 4. Disease is unresectable, advanced, or metastatic. 5. For papillary, follicular, or oncocytic (Hurthle) carcinoma, disease is progressive and/or symptomatic iodine‑refractory. 6. Failure of specified prior agents depending on histology (e.g., failure of Lenvima or Nexavar for papillary/follicular/oncocytic; failure of Caprelsa or Cabometyx for medullary) unless contraindicated or not tolerated. 7. Member must use pazopanib (Votrient) if available unless contraindicated or clinically significant adverse effects are experienced. 8. Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prior authorization required for comparator drugs; off‑label — supporting evidence required

Initial Therapy — Chondrosarcoma (off-label)

Initial Approval — Chondrosarcoma (off-label, must meet ALL):

Chondrosarcoma initial: 1. Diagnosis of metastatic or widespread chondrosarcoma. 2. Prescribed by or in consultation with an oncologist. 3. Use as single‑agent therapy. 4. Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). 5. Member must use pazopanib (Votrient) if available unless contraindicated or clinically significant adverse effects are experienced.

Off‑label — supporting evidence required

Continuation Therapy

Continued Therapy (must meet ALL):

Continuation: 1. Member is currently receiving medication via Centene benefit or documentation supports that the member has received Votrient for at least 30 days for a covered indication. 2. Member is responding positively to therapy. 3. Member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for a dose increase, the new dose does not exceed 800 mg (4 tablets) per day or the new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).dose <= 800 mg/day for increases

Approval durations vary by line of business (Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less)

Covered Indications (FDA and NCCN-based)

Policy includes FDA‑approved indications and NCCN‑recommended off‑label uses with criteria updates over time

Indications: Coverage addresses FDA‑approved adult indications (advanced RCC; advanced STS in patients who have received chemotherapy) and selected NCCN‑recommended off‑label uses (examples include certain metastatic or unresectable STS subtypes, GIST step‑throughs per NCCN, uterine sarcoma, thyroid carcinoma, metastatic chondrosarcoma and VHL‑associated RCC).

Specific per‑indication qualifiers (stage IV, unresectable, advanced, recurrent/metastatic, iodine‑refractory for certain thyroid cancers) are cited in the per‑indication criteria and annual review notes.

Pazopanib (Votrient) has not demonstrated efficacy for certain sarcoma and GIST histologies. Specifically, the FDA label states that the efficacy of Votrient for treatment of patients with adipocytic soft tissue sarcoma (STS) or gastrointestinal stromal tumors (GIST) has not been demonstrated. As a result, requests for these diagnoses are not supported by the product’s demonstrated efficacy and are excluded from coverage under this policy unless the request otherwise meets off‑label documentation requirements referenced in the policy.

In addition, the policy excludes coverage for indications that are not FDA‑approved and are not specifically addressed in this policy unless sufficient documentation of efficacy and safety is provided per the Plan’s off‑label use policies (see below for documentation requirements).

Non‑FDA approved indications that are not addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Plan’s off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage. Providers should include literature or guideline support when requesting coverage for off‑label uses.

Requests for pazopanib for non‑FDA approved indications that lack adequate supporting documentation will not be authorized. Authorization requires submission of clinical evidence demonstrating efficacy and safety consistent with the Plan’s off‑label use criteria; absent that evidence, the request is subject to denial.

Examples of Covered Regimens and Dose Forms

Indication / Example Regimen	Strength / Notes
Renal cell carcinoma (RCC): pazopanib 800 mg PO once daily (example regimen)	Tablet available as 200 mg; maximum daily dose not to exceed 800 mg/day
Soft tissue sarcoma (STS): pazopanib 800 mg PO once daily (example regimen for eligible STS subtypes)	Tablet available as 200 mg; dose limits and regimens vary by tumor type
Other oncology indications (selected off‑label uses per policy/NCCN): regimens and dosing vary by tumor type and guideline support	Tablet: 200 mg; dose must be within FDA maximum (800 mg/day) or supported by practice guidelines/peer‑reviewed literature

Dosing Limits and Code-relevant Limits

Maximum daily dose — 800 mg per day

Maximum daily dose800 mg per day (maximum: 4 tablets/day)

Dose increase limitDose increases must not exceed 800 mg/day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

Dose requirement for continuationFor continuation requests, new dose must not exceed 800 mg/day (or be supported by guidelines/literature)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must demonstrate diagnosis, oncology involvement, adult age (≥18 years) when specified in criteria, and indication‑specific requirements are met. Requests for Votrient (pazopanib) will be reviewed against the policy criteria and dosing guidance. Prior authorization may also be required for alternative therapies referenced in the criteria (e.g., imatinib, sunitinib, avapritinib, regorafenib, lenvatinib, sorafenib, vandetanib, cabozantinib).

Prior authorization required for Votrient (pazopanib) per policy CP PHAR.81
Prior authorization may also be required for comparator agents listed in criteria

Documentation Required

Required Clinical Documentation

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, pathology or histology reports, imaging reports, prior therapy records (including dates and reasons for discontinuation), and consultation notes from the prescribing oncologist. For off‑label use, the prescriber must submit supporting peer‑reviewed literature or guideline references if the requested dose or indication is not FDA‑approved.

Office chart notes documenting diagnosis, stage, and disease status
Lab results and imaging reports supporting disease progression or refractory status
Documentation of prior therapies tried, doses, duration, and reason for failure or intolerance
Oncology consultation or attestation when required by indication
For off‑label indications or dosing, submit guideline or peer‑reviewed literature supporting use

Denial Risk

Off‑Label Indication Documentation Required / General Documentation and Precedence

Non‑FDA approved (off‑label) indications that are not specifically addressed in this policy will be denied unless the provider supplies sufficient documentation of efficacy and safety consistent with the Health Plan's off‑label use policies (CP CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or evidence of coverage documents. For Medicaid members, state Medicaid coverage provisions supersede this clinical policy where conflicts exist.

Off‑label requests must reference supporting evidence and the applicable off‑label use policy
Medicaid: state Medicaid provisions take precedence over this policy when conflicts exist

Step Therapy

Therapeutic Alternatives and Step Options

Therapeutic alternatives and step‑therapy considerations: providers should document prior use and failure, intolerance, or contraindication to listed alternative agents when required by the indication (for example: imatinib, sunitinib, avapritinib, regorafenib, dasatinib, ripretinib for GIST; doxorubicin‑based or other cytotoxic regimens for soft tissue sarcoma subtypes; lenvatinib, sorafenib, vandetanib, cabozantinib for thyroid carcinoma). If the policy requires use of pazopanib first for a specific request (e.g., Votrient requests indicating pazopanib availability), that requirement must be met unless contraindicated or not tolerated.

Document prior therapy trials, dates, and reason for discontinuation when alternatives are required
If an alternative is contraindicated or not tolerated, provide clinical rationale and documentation
Prescribed regimen must be FDA‑approved or supported by NCCN/practice guidelines or peer‑reviewed literature for off‑label uses (provide citations)

Line of Therapy Specifications

second-line

Second‑line / Line of Therapy notes:

approved and post‑chemotherapy STS: Pazopanib is indicated for adults with advanced RCC and for advanced STS in patients who have received chemotherapy; many off‑label sarcoma subtypes require prior chemotherapy failure or ineligibility for chemotherapy as specified in the per‑subtype criteria (see STS criteria).

Line of therapy specifics depend on tumor type and NCCN recommendations.

mixed

Mixed line‑of‑therapy considerations:

Line of therapy notes: Policy incorporates NCCN‑based options including bypass of prior therapy for certain STS subtypes or when the member is ineligible for IV chemotherapy or anthracycline‑based regimens; includes VHL‑associated RCC options and NCCN‑recommended off‑label single‑agent uses (e.g., metastatic chondrosarcoma).

Line of therapy specifics depend on tumor type and NCCN recommendations.

Background

Pazopanib (Votrient) is an oral multi‑targeted tyrosine kinase inhibitor indicated for adults with advanced renal cell carcinoma (RCC) and for advanced soft tissue sarcoma (STS) in patients who have previously received chemotherapy. The FDA label includes a specific limitation noting that efficacy has not been demonstrated for adipocytic STS or gastrointestinal stromal tumors (GIST).

Definitions and Abbreviations

Abbreviations

RCCrenal cell carcinoma

STSsoft tissue sarcoma

GISTgastrointestinal stromal tumor

FDAFood and Drug Administration

STS — soft tissue sarcoma

STS (abbreviation)Soft tissue sarcoma

Common eligible subtypesExamples include angiosarcoma, desmoid tumor, solitary fibrous tumor, alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma

Coverage notePazopanib indicated for advanced STS after prior chemotherapy; some subtypes require prior therapy failure or ineligibility for IV chemotherapy

GIST — gastrointestinal stromal tumor

GIST (abbreviation)Gastrointestinal stromal tumor

Prior therapy noteFor GIST subtype, policy requires failure of one or more specified agents (e.g., imatinib, sunitinib, regorafenib, others) unless contraindicated

Coverage limitationEfficacy not demonstrated for some GIST presentations; prior authorization and prior therapy documentation required

RCC — renal cell carcinoma

RCC (abbreviation)Renal cell carcinoma

Coverage contextPazopanib is indicated for advanced RCC; policy includes VHL-associated disease as an eligible condition

Age requirementAdults age >= 18 years