CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Votrient (pazopanib) drug coverage

Defines clinical indications, inclusion and exclusion criteria, coding, and authorization/management rules for coverage of Votrient (pazopanib) for members managed by the payer's utilization management program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVotrient (pazopanib) drug coverage

Policy CodePolicy N/A

Change TypeMinor / administrative (no material clinical changes)

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization and ensure continuation requests meet continuity criteria (no progression, used within last year without >30-day lapse, and no added medications).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

800 mgsingle dose maximum

120 tablets/momonthly limit

J8999billing code

FDA 2024reference

Coverage criteria for Votrient (pazopanib)

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Continuation request continuity: For continuation requests: member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND additional medication(s) are not being added to the continuation request.

Indications - Renal Cell Carcinoma: Votrient (pazopanib) may be used in members with recurrent/metastatic renal cell carcinoma as a single agent for first‑line therapy in IMDC favorable risk disease OR as a single agent for subsequent‑line therapy regardless of IMDC risk category.

Indications - Soft Tissue Sarcoma: Palliative therapy for recurrent or metastatic soft tissue sarcoma as a single agent, as subsequent‑line therapy.

Coverage for Votrient (pazopanib) is provided when all required criteria are met. For continuation requests, the member must have no disease progression on the requested medication, the medication must have been used within the last year without a lapse of more than 30 days in active authorization, and no additional medications may be added to the continuation request. For renal cell carcinoma (RCC), Votrient may be used as a single agent either as first-line therapy for IMDC favorable-risk recurrent/metastatic RCC or as subsequent-line single-agent therapy regardless of IMDC risk category. For soft tissue sarcoma, coverage is limited to palliative single-agent use for recurrent or metastatic disease as subsequent-line therapy.

The following are excluded from coverage: members with stage I–III RCC, soft tissue sarcoma, or gastrointestinal stromal tumors; use of Votrient concurrently with other anticancer therapy; members who have disease progression while taking Votrient; dosing that exceeds the single-dose maximum of 800 mg; or a monthly supply that exceeds 120 (200 mg) tablets. In addition, investigational or off‑label indications that lack sufficient evidence or are not generally accepted by the medical community (i.e., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are considered not medically necessary and will be denied. The policy defines adequacy of evidence by criteria such as representativeness of the patient population and regimen, clinically meaningful outcomes (for example ASCO‑recommended thresholds), appropriate study design, and the limitations of case reports or meeting abstracts as sole evidence sources.

Coding and billing

HCPCS billing codeHCPCS

J8999

pazopanib

Monthly tablet limit

Monthly tablet limitDo not exceed 120 (200 mg) tablets per month

Unit strength referenced200 mg tablets

Reporting consequenceRequests exceeding this monthly limit will be excluded/denied

Single dose limit

Single dose maximum800 mg

Denial thresholdRequests with dosing that exceeds 800 mg will be excluded/denied

Related quantity ruleApplies in conjunction with the monthly tablet limit (120 x 200 mg tablets/month)

Provider requirements and authorization rules

Prior Authorization

Prior Authorization Required

Prior authorization required for initial and continuation requests unless continuation exemption criteria are met (see items). Continuation requests for medications that would otherwise be not approvable are exempt when ALL of the following are true: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for initial therapy and most continuation requests.
Continuation exemption applies when ALL three continuation rules are met (no progression; used within last year with ≤30-day lapse; no additional agents added).

Denial Risk

Concurrent Therapy or Early‑Stage Disease Exclusions

Votrient (pazopanib) is NOT covered when used concurrently with other anticancer therapy or when used for early-stage disease. Specifically, requests will be denied when the member has Stage I–III renal cell carcinoma, soft tissue sarcoma, or gastrointestinal stromal tumor, or when pazopanib is prescribed to be given concurrently with other anticancer agents.

Exclusion: Stage I–III RCC, soft tissue sarcoma, or GIST — not covered.
Exclusion: Concurrent use with other anticancer therapy — not covered.

Documentation Required

Required Clinical Support Documentation

Supporting clinical documentation must be provided with all requests. Acceptable evidence includes FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets criteria described in the policy (e.g., clinically meaningful outcomes, appropriate study design, adequate representation of patient/cancer characteristics). Off‑label uses lacking these references will be considered insufficient and may be denied.

Provide relevant FDA label or FDA‑approved indication.
Cite CMS‑recognized compendia or NCCN/ASCO guidelines when applicable.
If relying on peer‑reviewed literature, include full articles (not abstracts) demonstrating clinically meaningful benefit per ASCO metrics (e.g., HR < 0.80 or ≥3 months OS/PFS benefit) and adequate study design/population representation.
Case reports and meeting abstracts without full peer‑reviewed publication are insufficient.

Step Therapy

No step therapy sequencing requirements are specified in this policy.

Initial therapy coverage conditions

Initial therapy

Initial therapy coverage when criteria are met

RCC initial or subsequent: Single‑agent first‑line for IMDC favorable risk renal cell carcinoma OR single‑agent subsequent‑line therapy for recurrent/metastatic renal cell carcinoma.

STS subsequent‑line: Palliative single‑agent use for recurrent or metastatic soft tissue sarcoma as subsequent‑line therapy.

Continuation therapy requirements

Continuation therapy

Continuation requests are allowed if all continuity conditions are met.

Continuation criteria: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; no additional medication(s) are being added to the continuation request.

Step	Requirement
1	No formal step therapy sequencing requirements are specified for pazopanib (Votrient); policy allows single‑agent first‑line use for IMDC favorable‑risk recurrent/metastatic renal cell carcinoma or single‑agent subsequent‑line use regardless of IMDC risk.

Dose and quantity limits

pazopanib (Votrient) — Monthly tablet limit

Drug-specific monthly limitDo not exceed 120 (200 mg) tablets per month

Drug namepazopanib (Votrient)

EnforcementRequests exceeding this quantity will be excluded/denied

pazopanib (Votrient) — Single dose limit

Drug-specific single dose limit800 mg

Drug namepazopanib (Votrient)

EnforcementRequests with dosing >800 mg will be excluded/denied

Background and drug information

Votrient (pazopanib) is a tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGF) receptors and is used in oncology primarily for advanced disease. The agent is indicated in this policy for treatment of recurrent/metastatic renal cell carcinoma (with specific IMDC risk–based recommendations) and for palliative, single‑agent therapy in metastatic soft tissue sarcoma. Providers should follow the FDA label, relevant guideline recommendations, and accepted compendia when selecting and monitoring therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVotrient (pazopanib) drug coverage

Policy CodePolicy N/A

Change TypeMinor / administrative (no material clinical changes)

Effective DateJan 31, 2025

Next Review DateJan 8, 2025

Key ActionObtain prior authorization and ensure continuation requests meet continuity criteria (no progression, used within last year without >30-day lapse, and no added medications).

SourceLink

On This Page

OpenPayer

Votrient (pazopanib) drug coverage

Coverage criteria for Votrient (pazopanib)

Coding and billing

Provider requirements and authorization rules

Initial therapy coverage conditions

Continuation therapy requirements

Step therapy and sequencing

Dose and quantity limits

Background and drug information

Definitions and clinical terms

Administration and monitoring