Subject: sorafenib-Nexavar 2027-A SGM P2023
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NEXAVAR
(sorafenib)
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sorafenib
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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. Hepatocellular carcinoma
Nexavar is indicated for the treatment of patients with
unresectable hepatocellular carcinoma (HCC).
2. Renal cell carcinoma
Nexavar is indicated for the treatment of patients with
advanced renal cell carcinoma (RCC).
3. Differentiated thyroid carcinoma
Nexavar is indicated for the treatment of patients with
locally recurrent or metastatic, progressive, differentiated
thyroid carcinoma (DTC) that is refractory to radioactive
iodine treatment.
B. Compendial Uses
1. Hepatocellular carcinoma (Child-Pugh Class A or B7),
inoperable or metastatic disease
2. Acute myeloid leukemia with FLT3-ITD mutation
3. Soft tissue sarcoma subtypes
a. Angiosarcoma
b. Desmoid tumors (aggressive fibromatosis)
c. Solitary fibrous tumor
d. Leiomyosarcoma
4. Gastrointestinal stromal tumors (GIST)
5. Thyroid carcinoma (medullary carcinoma, papillary
carcinoma, oncocytic/Hürthle cell carcinoma, or follicular
carcinoma)
6. Osteosarcoma
7. Chordoma
8. Epithelial ovarian cancer, fallopian tube cancer, and
primary peritoneal cancer
9. Lymphoid, myeloid or mixed lineage neoplasms with
eosinophilia and FLT3 rearrangement in chronic phase or
blast phase
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review: FLT3-ITD mutation or FLT3
rearrangement testing results (where applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Hepatocellular Carcinoma
Authorization of 12 months may be granted for treatment of
hepatocellular carcinoma as a single agent.
B. Acute Myeloid Leukemia (AML)
Authorization of 12 months may be granted for treatment of
acute myeloid leukemia with FLT3-ITD mutation when any of
the following criteria are met:
1. For use in low-intensity treatment induction, post-
induction therapy, or consolidation therapy as a single
agent or in combination with azacitidine or decitabine
2. For use in relapsed/refractory disease in combination with
azacitidine or decitabine
3. For use in maintenance therapy after HSCT as a single
agent
C. Soft Tissue Sarcoma
Authorization of 12 months may be granted for treatment for
the following types of soft tissue sarcoma:
1. Leiomyosarcoma
2. Angiosarcoma, solitary fibrous tumor, or desmoid
tumor/aggressive fibromatosis, as single agent therapy.
D. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of
GIST as a single agent for residual, unresectable, recurrent,
or metastatic/tumor rupture disease and the member has
failed at least four FDA-approved therapies (e.g., imatinib,
sunitinib, regorafenib, ripretinib)
E. Renal Cell Carcinoma
Authorization of 12 months may be granted for treatment of
advanced renal cell carcinoma.
F. Papillary, Oncocytic, 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.
G. 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., vandetanib
[Caprelsa], cabozantinib [Cometriq]); OR
2. Member has disease progression while on FDA approved
systemic therapy options (e.g., vandetanib [Caprelsa],
cabozantinib [Cometriq]).
H. Bone Cancer
Authorization of 12 months may be granted for
treatment of bone cancer as a single agent for the following
subtypes:
1. Relapsed/refractory or metastatic osteosarcoma, as
second line therapy
2. Recurrent chordoma
I. Epithelial Ovarian Cancer/Fallopian Tube
Cancer/Primary Peritoneal Cancer
Authorization of 12 months may be granted for treatment of
epithelial ovarian, fallopian tube, or primary peritoneal
cancer if the disease is platinum-resistant and the requested
drug is given in combination with topotecan for persistent
disease or recurrence.
J. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of
myeloid and/or lymphoid neoplasms with eosinophilia and
FLT3 rearrangement in the chronic phase or blast phase.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication in Section III 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:
- Nexavar [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2020.
- Sorafenib [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; November 2021.
- The NCCN Drugs & Biologic Compendium 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 4, 2023.
- Santoro A, Comandone A, et al. Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy. Ann Oncol. 2013. 24 (4): 1093-8.
- IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com [available with subscription]. Accessed May 4, 2023.
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
