Subject: Votrient_2009-A_SGM_P2021

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.  Advanced renal cell carcinoma (RCC)  
     2.  Advanced soft tissue sarcoma (STS) in patients 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, 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 as a single agent for treatment of advanced,
           relapsed, or stage IV renal cell carcinoma.

      B.  Gastrointestinal Stromal Tumors
           Authorization of 12 months may be granted for treatment of unresectable, recurrent, or metastatic GIST as a single agent after the member has failed at least four FDA-approved therapies (e.g., imatinib, sunitinib,
           regorafenib and ripretinib).

      C.  Soft Tissue Sarcoma
           Authorization of 12 months may be granted as a single agent for treatment of soft tissue
           sarcoma, excluding adipocytic sarcoma and GIST (see specific criteria for GIST).

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

      E.  Papillary, Hürthle Cell, or Follicular Thyroid Carcinoma
           Authorization of 12 months may be granted for treatment of progressive and/or
           symptomatic papillary, Hürthle cell, or follicular thyroid carcinomanot amenable to radioactive iodine (RAI) therapy .

      F.  Medullary Thyroid Carcinoma
           Authorization of 12 months may be granted for the treatment of 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  

       Authorization of 12 months may be granted for continued treatment in members requesting
       reauthorization for an indication 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; August 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 6, 2021.  
3. 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.
4. 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.
5. 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.
6. 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.
7. Jones RL, Katz D, Loggers ET, et al. Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma. Med Oncol. 2017;34:167.
8. Safwat A, Boysen A, Lücke A, et al. Pazopanib in metastatic osteosarcoma: Significant clinical response in three consecutive patients. Acta Oncol.;53(10):1451-1454.

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.

September 21, 2021