Subject: Votrient 2009-A SGM P2023
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 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
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:
- Votrient [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2021.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 3, 2023.
- 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.
- 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.
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 20, 2023
