Subject: pazopanib-Votrient SGM 2009-A P2025

Drug

VOTRIENT  (pazopanib)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1,2

• Treatment of adults with advanced renal cell carcinoma (RCC)
• Treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy

Limitations of Use: The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Compendial Uses^3-10

• Relapsed or stage IV renal cell carcinoma
• Uterine sarcoma
• Gastrointestinal stromal tumors (GIST)
• Soft tissue sarcoma that is not an adipocytic sarcoma
• Medullary, papillary, oncocytic/Hürthle cell, or follicular thyroid carcinoma
• Merkel cell carcinoma
• Bone cancer of one of the following subtypes:
  • Chordoma
  • Chondrosarcoma
  • Osteosarcoma

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Renal Cell Carcinoma^1-3

Authorization of 12 months may be granted when either the following criteria is met:

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

Gastrointestinal Stromal Tumors^3,4

Authorization of 12 months may be granted for treatment of GIST when any of the following criteria is met:

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

Soft Tissue Sarcoma^1-5

Authorization of 12 months may be granted for treatment of soft tissue sarcoma, excluding adipocytic sarcoma and GIST (see specific criteria for GIST) when either of the following criteria is met:

• The requested medication will be used as a single agent
• The requested medication will be used for treatment of angiosarcoma, dedifferentiated chordoma, or epithelioid hemangioendothelioma and the requested medication will be used in combination with gemcitabine

Uterine Sarcoma³

Authorization of 12 months may be granted as a single agent for subsequent treatment of advanced, recurrent/metastatic or inoperable uterine sarcoma.

Papillary, Oncocytic/Hürthle Cell, or Follicular Thyroid Carcinoma³

Authorization of 12 months may be granted for treatment of progressive and/or symptomatic disease for either of the following:

• Papillary or follicular thyroid carcinoma that is unresectable or metastatic and not amenable to radioactive iodine (RAI) therapy
• Oncocytic/Hürthle cell thyroid carcinoma that is unresectable or metastatic

Medullary Thyroid Carcinoma^3,10

Authorization of 12 months may be granted for treatment of recurrent or metastatic medullary thyroid carcinoma when either of the following criteria is met:

• Member has an intolerance or contraindication to FDA approved systemic therapy options (e.g., cabozantinib [Cometriq], vandetanib [Caprelsa]); OR
• Member has disease progression while on FDA approved systemic therapy options (e.g., cabozantinib [Cometriq], vandetanib [Caprelsa]).

Merkel Cell Carcinoma³

Authorization of 12 months may be granted for the treatment of regional disease, when used as a single agent, if anti-PD-L1 or anti-PD-1 therapy is contraindicated and curative surgery and curative radiation are not feasible.

Bone Cancer^3,7-9

Authorization of 12 months may be granted for treatment of one of the following subtypes of bone cancer:

• Chordoma
• Chondrosarcoma as a single agent
• Osteosarcoma

Continuation of Therapy

Gastrointestinal Stromal Tumors

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.

All Other Indications

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Votrient [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; January 2024.
2. Pazopanib [package insert]. Parsippany, NJ: Teva Pharmaceuticals; May 2024.
3. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 14, 2025.
4. Ganjoo KN, Villalobos VM, Kamaya A, et al. A multicenter phase II study of pazopanib in patients with advanced gastrointestinal stromal tumors (GIST) following failure of at least imatinib and sunitinib. Ann Oncol 2014;25(1):236-40.
5. van der Graaf WT, Blay JY, Chawla SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879-1886.
6. Nakano K, Motoi N, Inagaki L, et al. Differences in the responses to pazopanib and the prognoses of soft tissue sarcomas by their histological eligibility for the PALETTE study. Jpn J Clin Oncol. 2015;45(5):449-455.
7. Lipplaa A, Dijkstra S, Gelderblom H. Efficacy of pazopanib and sunitinib in advanced axial chordoma: a single reference centre case series. Clin Sarcoma Res. 2016;6:19.
8. Jones RL, Katz D, Loggers ET, et al. Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma. Med Oncol. 2017;34:167.
9. Safwat A, Boysen A, Lücke A, et al. Pazopanib in metastatic osteosarcoma: Significant clinical response in three consecutive patients. Acta Oncol. 2014;53(10):1451-1454.
10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Thyroid Carcinoma. Version 1.2025. Accessed May 21, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

November 11, 2025