CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Votrient (pazopanib) — Coverage Criteria

Defines medical necessity criteria, covered indications (FDA and compendial) and authorization durations for Votrient (pazopanib) for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVotrient (pazopanib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization; authorizations may be 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 monthstypical authorization duration

2FDA indications

multiplecompendial uses

Coverage Criteria for Votrient (pazopanib)

FDA‑approved indications

Covered when ALL of the following are met for FDA‑approved indications:

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Compendial indications

Covered when ALL of the following compendial criteria are met:

Compendial tumor types: Uterine sarcoma; relapsed or stage IV renal cell carcinoma; gastrointestinal stromal tumors (GIST); medullary, papillary, oncocytic/Hurthle cell, or follicular thyroid carcinoma; soft tissue sarcoma that is not an adipocytic sarcoma; select bone cancers (chordoma, chondrosarcoma, osteosarcoma).

See indication‑specific criteria for GIST and medullary thyroid carcinoma.

Renal cell carcinoma

Authorization conditions for renal cell carcinoma:

RCC use: Requested medication will be used as a single agent for treatment of advanced, relapsed, or stage IV renal cell carcinoma, including von Hippel‑Lindau (VHL)‑associated RCC.

Authorization of 12 months may be granted.

GIST

Authorization conditions for gastrointestinal stromal tumor (GIST):

GIST - post‑multiple therapies: Used as a single agent for residual, unresectable, recurrent, or metastatic GIST after the member has failed at least four FDA‑approved therapies (imatinib, sunitinib, regorafenib, ripretinib).

Also covered as single agent for succinate dehydrogenase (SDH)‑deficient GIST.

Soft tissue sarcoma

Authorization conditions for soft tissue sarcoma:

STS: Used as a single agent for soft tissue sarcoma excluding adipocytic sarcoma and GIST. For angiosarcoma, use is specified in combination with gemcitabine.

Authorization of 12 months may be granted.

Thyroid carcinoma

Authorization conditions for thyroid carcinomas:

Papillary/Oncocytic/Follicular thyroid carcinoma: Progressive and/or symptomatic papillary, oncocytic/Hurthle cell, or follicular thyroid carcinoma not amenable to radioactive iodine therapy.

Authorization of 12 months may be granted.

Medullary thyroid carcinoma: Used for recurrent or metastatic medullary thyroid carcinoma when member has intolerance/contraindication to, OR disease progression while on, FDA‑approved systemic therapies (e.g., cabozantinib, vandetanib).

Authorization of 12 months may be granted.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiated therapy. Authorizations may be granted for up to 12 months when the listed indication‑specific criteria are met. For reauthorization/continuation, documentation must show no evidence of unacceptable toxicity or disease progression while on the current regimen. Use of the medication for indications not listed in the policy (including any indications outside the covered FDA‑approved or compendial uses specified in Section II) is considered experimental and investigational and therefore not medically necessary.

Authorizations may be granted up to 12 months when criteria are met.
Reauthorization requires documentation of absence of unacceptable toxicity or disease progression.
Indications not listed in the policy are considered experimental/investigational and are not covered.

Step Therapy

Step Therapy for GIST

For gastrointestinal stromal tumors (GIST), prior authorization may require documentation of prior treatment failure with at least four FDA‑approved therapies (imatinib, sunitinib, regorafenib, and ripretinib) before coverage is approved.

GIST: failure of imatinib, sunitinib, regorafenib, and ripretinib typically required prior to authorization.

Denial Risk

Non‑covered Indications

Use of the medication for any indication not explicitly listed as covered (including indications outside the FDA‑approved or compendial uses enumerated in Section II) is considered experimental/investigational and is not medically necessary. Claims for such uses are subject to denial.

Non‑covered/experimental: any indication not listed in Section II.

Regimen	Indication	Coverage status
Pazopanib + gemcitabine	Angiosarcoma	Covered

Regimen	Indication(s)	Coverage status
Pazopanib (single agent)	Soft tissue sarcoma (excluding adipocytic sarcoma and GIST); renal cell carcinoma (including VHL‑associated); other listed tumors (uterine sarcoma, thyroid carcinomas, select bone cancers)	Covered

Place in Therapy

salvage

Salvage (GIST context): For GIST, authorization may require failure of at least four FDA‑approved therapies (imatinib, sunitinib, regorafenib, ripretinib) prior to pazopanib; this represents salvage‑line use.

See GIST criteria for SDH‑deficient GIST which can also be treated as single agent.

second-line

Second‑line: Used as subsequent therapy for advanced or relapsed disease: for soft tissue sarcoma after prior chemotherapy per FDA indication, and as subsequent therapy for renal cell carcinoma.

Authorization of 12 months may be granted.

Background and Definitions

Pazopanib (Votrient) is an oral, multi‑targeted tyrosine kinase inhibitor used in oncology. It is primarily indicated for adults with advanced soft tissue sarcoma who have received prior chemotherapy and for adults with advanced renal cell carcinoma. Compendia additionally support use in several sarcomas (non‑adipocytic STS, uterine sarcoma), gastrointestinal stromal tumors (GIST), select thyroid carcinomas, and certain bone cancers. The FDA labeling notes limitations of use, specifically that efficacy has not been demonstrated for adipocytic soft tissue sarcoma or for gastrointestinal stromal tumors.

Limitations of Use — FDA labeling

Limitation — adipocytic STSEfficacy of Votrient (pazopanib) for treatment of patients with adipocytic soft tissue sarcoma has not been demonstrated per FDA labeling.

Limitation — GISTEfficacy of Votrient (pazopanib) for treatment of gastrointestinal stromal tumors (GIST) has not been demonstrated per FDA labeling.

Source — FDA labelStatement referenced in Votrient package insert (Novartis; Dec 2021) noting limitations of use regarding adipocytic STS and GIST.

Supporting evidence — compendia/trialsNCCN Drugs & Biologics Compendium 2023 and published studies (e.g., phase II GIST study) are cited in references for context but do not alter the FDA‑stated limitations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVotrient (pazopanib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization; authorizations may be granted for up to 12 months when indication-specific criteria are met.

SourceLink

On This Page

OpenPayer

Votrient (pazopanib) — Coverage Criteria

Coverage Criteria for Votrient (pazopanib)

Provider Requirements and Prior Authorization

Permitted Regimens and Combinations

Place in Therapy

Background and Definitions