mhn pazopanib (Votrient) Prior Auth Coverage | OpenPayer

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mhn pazopanib (Votrient) Prior Auth Coverage | OpenPayer

Initial Therapy - Renal Cell Carcinoma (RCC)

Covered when ALL of the following are met

RCC initial therapy criteria: 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. For Votrient requests, member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Request meets one of the following: a) Dose does not exceed 800 mg (4 tablets) per day; OR b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Soft Tissue Sarcoma (STS)

Covered when ALL of the following are met

STS initial therapy criteria: 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) Member is ineligible for IV chemotherapy or is not a candidate for anthracycline‑based regimens; c) For GIST subtype, failure of one or more of the following agents unless clinically significant adverse effects are experienced, all are contraindicated, or tumor is succinate dehydrogenase (SDH)-deficient with gross residual disease: imatinib, Qinlock, Sutent, Ayvakit, Sprycel, Stivarga; d) For all other STS subtypes, failure of prior chemotherapy unless contraindicated or clinically significant adverse effects are experienced. 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. For Votrient requests, member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Request meets one of the following: a) Dose does not exceed 800 mg (4 tablets) per day; OR b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Uterine Sarcoma (off-label)

Covered when ALL of the following are met

Uterine sarcoma initial criteria: 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. For Votrient requests, member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 7. Dose is within 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).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Thyroid Carcinoma (off-label)

Covered when ALL of the following are met

Thyroid carcinoma initial criteria: 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. If papillary, follicular, or oncocytic (formerly Hurthle cell) carcinoma, disease is progressive and/or symptomatic iodine‑refractory. 6. Histology‑specific prior therapy requirements: a) For papillary/follicular/oncocytic: failure of Lenvima or Nexavar unless clinically significant adverse effects are experienced or both are contraindicated; b) For medullary: failure of Caprelsa or Cabometyx unless clinically significant adverse effects are experienced or both are contraindicated. 7. For Votrient requests, member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 8. Dose is within 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).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy - Chondrosarcoma (off-label)

Covered when ALL of the following are met

Chondrosarcoma initial criteria: 1. Diagnosis of metastatic or widespread chondrosarcoma. 2. Prescribed by or in consultation with an oncologist. 3. Age ≥ 18 years. 4. Used as single‑agent therapy. 5. For Votrient requests, member must use pazopanib if available unless contraindicated or clinically significant adverse effects are experienced. 6. Dose is within 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).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Continuation Therapy

Covered when ALL of the following are met

Continuation criteria: 1. Member is currently receiving pazopanib via the health plan benefit OR documentation supports the member has received pazopanib for a covered indication for at least 30 days. 2. Member is responding positively to therapy. 3. For Votrient requests, 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 must either: a) not exceed 800 mg (4 tablets) per day; OR b) be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).≤ 800 mg/day

Prescribed regimen must be FDA‑approved or recommended by NCCN

Covered when consistent with FDA approval or NCCN-recommended uses

Policy references NCCN-based criteria and includes FDA-approved and NCCN-recommended off-label uses with specific disease state qualifiers and bypass/prior therapy options.

General: Coverage follows FDA‑approved indications and select NCCN‑recommended off‑label uses when documentation meets this policy and compendia guidance. Policy includes NCCN‑based bypass or prior therapy exceptions for specified STS and GIST subtypes per guideline updates. Providers must submit supporting evidence when dose or off‑label use relies on practice guidelines or peer‑reviewed literature.

See policy references and history for specific NCCN‑based bypass and prior therapy details

Requests for use of pazopanib for non‑FDA approved indications not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the plan’s off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or the member’s evidence of coverage permits the indication.

Coverage for non‑FDA approved indications not addressed in this policy is excluded unless the request is supported by the payer’s off‑label use criteria (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or the member’s evidence of coverage authorizes the use.

Uses of pazopanib that lack sufficient documentation of efficacy and safety per the referenced off‑label use policies or are not supported by the member’s evidence of coverage will be considered not authorized.

Dosing and Covered Regimens

Regimen	Indication	Coverage
Pazopanib (Votrient) up to 800 mg/day or dose supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence for off‑label dosing)
FDA‑approved: advanced renal cell carcinoma (RCC); FDA‑approved: advanced soft tissue sarcoma (STS). Selected off‑label uses (e.g., uterine sarcoma, thyroid carcinoma, chondrosarcoma) when policy criteria met and guideline/peer‑reviewed support provided
Covered with criteria (prior authorization required); dose must be ≤ 800 mg/day unless higher dose is supported by practice guidelines or peer‑reviewed literature with submitted evidence

Dose	Indication	Coverage
800 mg PO QD (maximum 800 mg/day)
Renal cell carcinoma (RCC); Soft tissue sarcoma (STS)
Covered when all policy criteria are met; prior authorization required

Agent (example)	Typical Dosing (example)	Maximum Daily Dose
Imatinib (Gleevec)
400 mg PO QD
Up to 800 mg/day

Agent (example)	Typical Dosing (example)	Maximum Daily Dose
Sunitinib (Sutent)
50 mg PO QD, 4 weeks on/2 weeks off
87.5 mg/day
Regorafenib (Stivarga)
160 mg PO QD, 21 days on/7 days off
160 mg/day
Avapritinib (Ayvakit)
300 mg PO QD, until disease progression
300 mg/day
Dasatinib (Sprycel)
70 mg PO BID
140 mg/day
Ripretinib (Qinlock)
150 mg PO QD
150 mg/day

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Pazopanib (Votrient) and generic pazopanib are subject to medical necessity review and prescribers must document the diagnosis and relevant clinical information to support the request.

Prior authorization required for listed comparator agents where noted (see criteria and appendices).
Prescriber must document consultation with or prescribing by an oncologist where required.

Prior Authorization

Prior Authorization for Pazopanib and Alternatives

Therapeutic alternatives and dosing guidance (including dose limits and example chemotherapy regimens) are provided in the policy appendices. Prior authorization may be required for some listed agents (e.g., imatinib, Sutent, Ayvakit, Stivarga, Lenvima, Nexavar, Caprelsa, Cabometyx).

See Appendices/General Information for dosing regimens and maximum doses.
Prior authorization noted in criteria where applicable.

Prior Authorization

Required Prior Therapies

For certain soft tissue sarcoma subtypes and other indications, prior failure of specified agents (or ineligibility/contraindication to those agents) is required before coverage will be approved. Examples include prior failure of imatinib, Qinlock, Sutent, Ayvakit, Sprycel, or Stivarga for GIST when indicated.

Failure of specified prior therapies required unless clinically significant adverse effects are experienced, agents are contraindicated, or NCCN bypass/ineligibility criteria apply.

Step Therapy

Step Therapy and NCCN Bypass Options

Step therapy and NCCN-aligned bypass options are incorporated into the criteria. Per NCCN and policy updates, bypass of prior therapy is allowed for certain STS subtypes (e.g., angiosarcoma, desmoid tumor, extraskeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma) or when members are ineligible for IV chemotherapy or anthracycline-based regimens. Prescribers should document the reason for bypass (e.g., ineligibility, SDH‑deficient GIST with gross residual disease).

Step-through agents and bypass justifications must be documented in the request.
NCCN-recommended step or bypass options updated through 3Q 2024.

Documentation Required

Required Documentation

Provider must submit supporting documentation to demonstrate medical necessity. Acceptable documentation includes office chart notes, pathology or radiology reports, laboratory results, prior treatment history, and peer-reviewed literature when requesting off-label dosing or indications.

For off-label requests, prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature.
Documentation should demonstrate diagnosis, disease stage/status, prior therapies and responses, and rationale for the requested dose/regimen.

Note

Coverage Contingent on Member Documentation and Plan Terms

Coverage is contingent on the member's benefit documents and applicable state/federal requirements. This policy is a guide to medical necessity and does not guarantee payment; the health plan may change or withdraw the policy and coverage decisions remain subject to evidence of coverage, contract terms, and administrative policies.

Decisions subject to member's evidence of coverage, state/federal law, and Health Plan administrative policies.
Policy effective dates and regulatory requirements govern when discrepancies arise.

Denial Risk

Non‑Approved / Off‑Label Indications

Non‑FDA approved (off‑label) indications not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid). Requests for off‑label use without adequate supporting evidence may be denied.

Off‑label requests require documentation per the referenced off‑label policies.
If the requested non‑FDA indication is not included in this policy and no adequate evidence is provided, request will be denied.