CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pazopanib (Votrient) — Coverage Criteria for Oncology Indications

Policy governing coverage and authorization criteria for pazopanib (Votrient) for FDA-approved and compendial oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPazopanib (Votrient) — Coverage Criteria for Oncology Indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are generally granted for up to 12 months when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period for approvals

2FDA-approved indications listed (RCC, STS)

6compendial tumor types enumerated

4+example prior GIST therapies referenced before pazopanib

Coverage and Medical Necessity Criteria

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Renal Cell Carcinoma

Covered when ALL of the following are met for Renal Cell Carcinoma (authorization of 12 months may be granted):

RCC single-agent criteria: 1. The requested medication will be used as a single agent for treatment of advanced, relapsed, or stage IV renal cell carcinoma. 2. The requested medication will be used as a single agent for treatment of von Hippel-Lindau (VHL)-associated renal cell carcinoma.

Supports 12-month authorization

Gastrointestinal Stromal Tumors

Covered when ANY of the following are met for Gastrointestinal Stromal Tumors (authorization of 12 months may be granted):

GIST criteria: 1. The requested medication will be used as a single agent for treatment of residual, unresectable, recurrent, or metastatic/tumor rupture GIST after the member has failed at least four FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib). 2. The requested medication will be used as a single agent for treatment of residual, unresectable, tumor rupture or recurrent/metastatic succinate dehydrogenase (SDH)-deficient GIST.failed >=4 FDA-approved therapies

Authorization of 12 months may be granted

Soft Tissue Sarcoma

Covered when ANY of the following are met for Soft Tissue Sarcoma (authorization of 12 months may be granted):

Soft tissue sarcoma criteria: 1. The requested medication will be used as a single agent for treatment of soft tissue sarcoma excluding adipocytic sarcoma and GIST. 2. The requested medication will be used for angiosarcoma or dedifferentiated chordoma in combination with gemcitabine.

Adipocytic sarcoma excluded; supports 12-month authorization

Differentiated Thyroid Carcinomas (non-medullary)

Covered when ALL of the following are met for Papillary, Oncocytic/Hürthle Cell, or Follicular Thyroid Carcinoma:

Thyroid carcinoma: Authorization of 12 months may be granted for treatment of progressive and/or symptomatic papillary, oncocytic/Hürthle cell, or follicular thyroid carcinoma not amenable to radioactive iodine (RAI) therapy.

Medullary Thyroid Carcinoma

Covered when ANY of the following are met for Medullary Thyroid Carcinoma:

Medullary thyroid carcinoma: 1. Member has an intolerance or contraindication to FDA-approved systemic therapy options (e.g., cabozantinib, vandetanib). 2. Member has disease progression while on FDA-approved systemic therapy options (e.g., cabozantinib, vandetanib).

Authorization of 12 months may be granted

Continuation of Therapy

Continuation of therapy — Covered when the following are met:

Continuation criteria for GIST: Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for treatment of GIST when there is no evidence of unacceptable toxicity while on the current regimen.

Continuation criteria for other indications: Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for all other indications listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Per the FDA product labeling and the policy’s compendial references, pazopanib (Votrient) has not demonstrated efficacy for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors (GIST). The FDA-approved indications include treatment of adults with advanced renal cell carcinoma and adults with advanced soft tissue sarcoma who have received prior chemotherapy, but explicitly note this limitation of use. Compendial sources cited in the policy list multiple tumor types for which pazopanib may be considered; however, the FDA limitation for adipocytic STS and GIST should guide clinical expectations and authorization decisions.

Requests for pazopanib for indications beyond the FDA-approved uses and the compendial tumor types enumerated in this policy are considered experimental/investigational and not medically necessary. Providers must rely on the listed FDA and compendial indications in the policy when seeking authorization; all other indications are subject to denial.

Regimen	Indication	Coverage
Pazopanib + gemcitabine
Angiosarcoma or dedifferentiated chordoma (soft tissue sarcoma)
Covered when used in combination for the listed soft tissue sarcoma subtypes

Regimen	Indication	Coverage
Pazopanib (single-agent)
Multiple soft tissue sarcoma subtypes (excluding adipocytic sarcoma and GIST)
Covered when used as a single agent for the listed soft tissue sarcoma subtypes

Prior Authorization, Documentation, and Prescribing Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are generally granted for up to 12 months when indication‑based criteria are met.

Prior authorization required for all indications listed in the policy.
Typical approval duration: up to 12 months when criteria are met.

Step Therapy

GIST Prior Therapy Requirement

For gastrointestinal stromal tumors (GIST), authorization will be considered only after the member has failed at least four FDA‑approved therapies (for example: imatinib, sunitinib, regorafenib, ripretinib).

GIST prior therapy requirement: failure of ≥ 4 FDA‑approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib).

Documentation Required

Reauthorization Documentation

Requests for continuation/reauthorization must include documentation demonstrating the member is deriving continued clinical benefit and is not experiencing unacceptable toxicity on the current regimen. Approvals for continuation are generally granted for up to 12 months when this documentation is provided.

Reauthorization documentation must show no evidence of unacceptable toxicity while on therapy.
Reauthorization documentation must show continued benefit (no disease progression) for indications other than GIST as specified in the policy.

Permitted Drug Regimens and Combinations

Regimen	Indication	Coverage
Pazopanib (single-agent)
Soft tissue sarcoma subtypes excluding adipocytic sarcoma and GIST; renal cell carcinoma (advanced, relapsed, or stage IV; includes VHL-associated RCC)
Covered when used as a single agent for the listed indications; authorization of up to 12 months may be granted

Regimen	Indication	Coverage
Pazopanib + gemcitabine
Angiosarcoma or dedifferentiated chordoma (examples of soft tissue sarcoma)
Covered when used in combination for these soft tissue sarcoma examples; authorization of up to 12 months may be granted

Line of Therapy Positioning

salvage

Salvage use — Covered when the following are met:

Salvage/GIST prior lines: Failure of at least four FDA‑approved therapies is required for authorization in residual, unresectable, recurrent, metastatic, or tumor-rupture GIST (examples: imatinib, sunitinib, regorafenib, ripretinib).failed >=4 FDA-approved therapies

Line of therapy: salvage

second-line

Second-line / subsequent therapy — Covered when the following are met:

Second-line/subsequent indications: Pazopanib may be used as single-agent subsequent therapy for listed tumor types (e.g., renal cell carcinoma, uterine sarcoma, differentiated thyroid carcinomas not amenable to RAI, select bone cancers, and multiple soft tissue sarcoma subtypes) consistent with labeling and compendial recommendations.

Line of therapy: second-line

Limitations of Use and Definitions

Limitations of use

FDA limitationEfficacy of pazopanib (Votrient) has not been demonstrated for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors (GIST)

Compendial exception — GISTGIST (including SDH‑deficient GIST) is listed as a compendial use and is addressed under compendial criteria despite the FDA limitation

Compendial exception — other tumor typesMultiple non‑adipocytic soft tissue sarcomas, uterine sarcoma, thyroid carcinomas, and select bone cancers are supported by compendia

Drug Background and Context

Pazopanib (Votrient) is an oral multikinase angiogenesis inhibitor with FDA approval for treatment of adults with advanced renal cell carcinoma and for adults with advanced soft tissue sarcoma who have received prior chemotherapy. The product labeling also includes a limitation of use stating that efficacy has not been demonstrated for adipocytic soft tissue sarcoma or GIST. Compendial references cited in the policy expand on potential uses in relapsed or stage IV RCC, uterine sarcoma, select GIST subtypes, non-adipocytic soft tissue sarcomas, several thyroid carcinoma types, and selected bone cancer subtypes.