Subject: pazopanib-Votrient 2009-A SGM P2024

Drug

VOTRIENT  (pazopanib)

pazopanib

Policy:

      I.  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.

          A.  FDA-Approved Indications
               1.  Treatment of adults with advanced renal cell carcinoma (RCC)
               2.  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.

          B.  Compendial Uses
               1.  Relapsed or stage IV renal cell carcinoma
               2.  Uterine sarcoma
               3.  Gastrointestinal stromal tumors (GIST)
               4.  Soft tissue sarcoma that is not an adipocytic sarcoma
               5.  Medullary, papillary, oncocytic/Hürthle cell, or follicular thyroid carcinoma
               6.  Bone cancer of one of the following subtypes:
                    a.  Chordoma
                    b.  Chondrosarcoma
                    c.  Osteosarcoma

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Renal Cell Carcinoma
               Authorization of 12 months may be granted when either the following criteria are met:
               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.

          B.  Gastrointestinal Stromal Tumors
               Authorization of 12 months may be granted for treatment of GIST when any of the following
               criteria are met:
               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 and ripretinib).
               2.  The requested medication will be used for treatment of residual, unresectable, tumor
                    rupture or recurrent/metastatic succinate dehydrogenase (SDH)-deficient GIST as a
                    single agent.

          C.  Soft Tissue Sarcoma
               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 are met:
               1.  The requested medication will be used as a single agent
               2.  The requested medication will be used for treatment of angiosarcoma or dedifferentiated
                    chordoma and the requested medication will be used in combination with gemcitabine

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

          E.  Papillary, Oncocytic/Hürthle Cell, or Follicular 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.

          F.  Medullary Thyroid Carcinoma
               Authorization of 12 months may be granted for treatment of recurrent or metastatic
               medullary thyroid carcinoma when either of the following criteria are met:
               1.  Member has an intolerance or contraindication to FDA approved systemic therapy
                    options (e.g., cabozantinib [Cometriq], vandetanib [Caprelsa]); OR
               2.  Member has disease progression while on FDA approved systemic therapy options (e.g.,
                    cabozantinib [Cometriq], vandetanib [Caprelsa]).

          G.  Bone cancer
               Authorization of 12 months may be granted for treatment of one of the following subtypes of
               bone cancer:
               1.  Chordoma
               2.  Chondrosarcoma
               3.  Osteosarcoma


   III.  CONTINUATION OF THERAPY

          A.  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.

          B.  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.

 

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; April 2023.
3. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 3, 2024.
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 2.2024. Accessed May 2, 2024.

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 03, 2024