Colorado Rocky Mountain Health Plans Votrient Prior Auth

Coverage Criteria for Votrient (pazopanib)

inv-01: Patients <19 years — Covered when ALL of the following are met

Covered when ALL of the following are met

Pediatric authorization: Patient is less than 19 years of age

Authorization will be issued for 12 months

inv-02: Renal cell carcinoma (RCC) / VHL-associated RCC — Initial Authorization: Votrient will be approved based on one of the following:

Initial Authorization: Votrient will be approved based on one of the following:

RCC criteria: (1) Both of the following: (a) Diagnosis of renal cell carcinoma (RCC) AND (b) One of: disease has relapsed, stage IV disease, or disease is advanced

VHL-associated RCC: (2) Diagnosis of von Hippel-Lindau (VHL)-associated renal cell carcinoma

inv-03: Soft tissue sarcomas and related histologies — Initial Authorization: Diagnosis of one of the listed sarcoma types

Initial Authorization: Diagnosis of one of the listed sarcoma types

Soft tissue sarcoma types: Diagnosis of one of: alveolar soft part sarcoma; angiosarcoma; dedifferentiated chordoma; dedifferentiated liposarcoma (with or without concurrent well-differentiated liposarcoma); Dermatofibrosarcoma Protuberans (DFSP) with fibrosarcomatous transformation; desmoid tumors (aggressive fibromatosis); epithelioid hemangioendothelioma; extraskeletal myxoid chondrosarcoma; soft tissue sarcoma of the extremity/superficial trunk or head/neck with disease that is stage IV or recurrent with disseminated metastases; retroperitoneal/intra-abdominal disease that is unresectable, stage IV, or postoperative treatment for residual disease; pleomorphic rhabdomyosarcoma; solitary fibrous tumor/hemangiopericytoma

Authorization will be issued for 12 months; reauthorization requires patient does not show evidence of progressive disease while on Votrient therapy

inv-04: Thyroid carcinoma (papillary, follicular, oncocytic, medullary) — Initial Authorization: Votrient will be approved based on one of the following criteria sets by thyroid histology

Initial Authorization: Votrient will be approved based on one of the following criteria sets by thyroid histology

Thyroid carcinoma - papillary/follicular: All of the following: (a) Diagnosis of follicular carcinoma OR papillary carcinoma; AND (b) One of: unresectable locoregional recurrent disease, persistent disease, or metastatic disease; AND (c) One of: symptomatic disease or progressive disease; AND (d) One of: disease refractory to radioactive iodine treatment or distant metastatic disease not amenable to radioactive iodine treatment

Authorization will be issued for 12 months

Thyroid carcinoma - oncocytic: All of the following: (a) Diagnosis of oncocytic carcinoma; AND (b) One of: unresectable locoregional recurrent disease, persistent disease, or metastatic disease; AND (c) One of: symptomatic disease or progressive disease

Thyroid carcinoma - medullary: All of the following: (a) Diagnosis of medullary carcinoma; AND (b) One of: disease is progressive or disease is symptomatic with distant metastases; AND (c) History of failure, contraindication, or intolerance to vandetanib OR cabozantinib (Cometriq)

inv-05: Uterine sarcoma — Initial Authorization: Votrient will be approved when ALL of the following are met

Initial Authorization: Votrient will be approved when ALL of the following are met

Uterine sarcoma: (1) Diagnosis of uterine sarcoma AND (2) One of: disease is advanced, disease is recurrent/metastatic, or disease is inoperable

Reauthorization requires patient does not show evidence of progressive disease while on Votrient therapy

inv-06: Epithelial ovarian / fallopian tube / primary peritoneal cancer — Initial Authorization

Initial Authorization

Epithelial ovarian/fallopian tube/primary peritoneal cancer: (1) Diagnosis of epithelial ovarian cancer OR fallopian tube cancer OR primary peritoneal cancer; AND (2) One of: disease is persistent OR disease is recurrent

Authorization will be issued for 12 months

inv-07: Reauthorization — Reauthorization criteria summary

Reauthorization

Reauthorization requirement: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization typically issued for 12 months when met

inv-08: Initial Therapy — Ovarian / Fallopian Tube / Primary Peritoneal Cancer — Initial authorization for ovarian/fallopian tube/primary peritoneal cancer

Initial authorization for ovarian/fallopian tube/primary peritoneal cancer

Ovarian series initial auth: Patient has diagnosis of epithelial ovarian cancer OR fallopian tube cancer OR primary peritoneal cancer AND disease is persistent OR recurrent

Authorization will be issued for 12 months

inv-09: Reauthorization — general — Reauthorization general rule

Reauthorization general rule

Reauthorization: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization will be issued for 12 months

inv-10: Initial Therapy — Chondrosarcoma — Initial authorization for chondrosarcoma

Initial authorization for chondrosarcoma

Chondrosarcoma initial auth: Diagnosis of chondrosarcoma AND disease is metastatic and widespread

Authorization will be issued for 12 months

inv-11: Initial Therapy — GIST — Initial authorization for GIST

Initial authorization for GIST

GIST initial auth: Diagnosis of GIST AND disease is residual, unresectable, progressive, or metastatic AND (used as first-line therapy in SDH-deficient GIST OR used after progression on imatinib AND sunitinib AND regorafenib (Stivarga) AND standard dose ripretinib (Qinlock))

Authorization will be issued for 12 months

inv-12: Initial Therapy — Merkel Cell Carcinoma — Initial authorization for Merkel cell carcinoma

Initial authorization for Merkel cell carcinoma

Merkel cell initial auth: Diagnosis of Merkel Cell Carcinoma AND (anti-PD-L1 or anti-PD-1 therapy is contraindicated OR disease has progressed on anti-PD-L1 or anti-PD-1 therapy)

Authorization will be issued for 12 months when reauthorization criteria met

Some states have enacted statutes or regulations that require coverage for certain off-label uses of medications or mandate reliance on specific compendium references. Where such state mandates apply, they supersede and override the criteria in this policy.

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for Votrient (pazopanib) for members 19 years and older. Prescriptions for members under 19 years will automatically process without coverage review and, when approved, authorization will be issued for 12 months. Failure to meet the clinical criteria below for the specific indication may result in denial.

Prior authorization required for members ≥19 years
Automatic processing for members <19 years; approval period = 12 months

Prior Authorization

Ovarian / Fallopian tube / Primary peritoneal cancer

Initial authorization for Votrient for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer requires a documented diagnosis of one of these cancers and evidence that disease is persistent or recurrent. When criteria are met, authorization will be issued for 12 months.

Diagnosis: epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Disease status: persistent or recurrent

Initial Therapy Criteria

inv-28: Initial therapy — Initial authorization requires documented diagnosis and indication-specific criteria as listed.

Initial authorization requires documented diagnosis and indication-specific criteria as listed.

Initial therapy: Meets the specific initial authorization criteria for the indicated tumor type (see criteria sets for details)

Authorization typically for 12 months

inv-29: Initial — Ovarian-related cancers — 1 top-level node

Initial — Ovarian-related cancers

Ovarian group initial: Diagnosis of epithelial ovarian OR fallopian tube OR primary peritoneal cancer AND disease persistent OR recurrent

Authorization for 12 months

inv-30: Initial — Chondrosarcoma — 1 top-level node

Reauthorization and Continuation Criteria

inv-33: Continuation therapy / Reauthorization — Reauthorization conditions

Reauthorization conditions

Continuation therapy: Patient does not show evidence of progressive disease while on Votrient therapy

Authorization will be issued for 12 months when criterion met

inv-34: Reauthorization — Reauthorization requirements for continued Votrient therapy

Reauthorization requirements for continued Votrient therapy

Continuation: Patient must not show evidence of progressive disease while on Votrient therapy

Authorization will be issued for 12 months on reapproval

Step Therapy and Prior Trial Requirements

Requirement	Details
Prior trial or intolerance required
History of failure, contraindication, or intolerance to vandetanib or cabozantinib (Cometriq) is required prior to approval for medullary thyroid carcinoma; authorization will be issued for 12 months.

Requirement	Details
Prior progression required (unless first-line SDH-deficient)
For GIST: trial and progression on imatinib, sunitinib, regorafenib (Stivarga), and standard-dose ripretinib (Qinlock) are required prior to Votrient unless used as first-line therapy in SDH-deficient GIST; authorization will be issued for 12 months.

Background

Votrient (pazopanib) is recognized in clinical compendia for multiple oncologic indications. For Colorado Rocky Mountain Health Plans members, prescriptions for patients under 19 years of age will automatically process without coverage review. All other requests must meet the coverage criteria in this document and any applicable prior authorization requirements.

Definitions and References

Votrient (pazopanib) — definition and key facts

Generic namepazopanib

Brand nameVotrient

Drug classKinase inhibitor (multikinase/tyrosine kinase inhibitor)

FDA-indicated uses (per document)Treatment of adults with advanced renal cell carcinoma and advanced soft tissue sarcoma in patients who have received prior chemotherapy

Additional NCCN-recommended tumor typesMedullary, follicular, oncocytic, and papillary thyroid carcinomas; ovarian cancer; additional soft tissue sarcomas; chondrosarcoma; uterine sarcoma; Merkel cell carcinoma; gastrointestinal stromal tumors (GIST)

Typical authorization duration (policy)12 months when criteria are met

OpenPayer

Votrient (pazopanib) prior authorization and coverage criteria

Coverage Criteria for Votrient (pazopanib)

Provider Requirements and Authorization Workflow

Initial Therapy Criteria

Reauthorization and Continuation Criteria

Step Therapy and Prior Trial Requirements

Background

Definitions and References