Subject: sorafenib-Nexavar SGM 2027-A P2025

Drug

NEXAVAR  (sorafenib)

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

Hepatocellular Carcinoma

Nexavar is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Renal Cell Carcinoma

Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

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.

Compendial Uses^3-5

• Hepatocellular carcinoma
• Acute myeloid leukemia with FLT3-ITD mutation
• Soft tissue sarcoma subtypes
  • Angiosarcoma
  • Desmoid tumors (aggressive fibromatosis)
  • Solitary fibrous tumor
  • Leiomyosarcoma
• Gastrointestinal stromal tumors (GIST)
• Thyroid carcinoma (medullary carcinoma, papillary carcinoma, oncocytic/Hürthle cell carcinoma, or follicular carcinoma)
• Osteosarcoma
• Chordoma
• Epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
• 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.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: FLT3-ITD mutation or FLT3 rearrangement testing results (where applicable).

Coverage Criteria

Hepatocellular Carcinoma^1-3

Authorization of 12 months may be granted for treatment of hepatocellular carcinoma as a single agent.

Acute Myeloid Leukemia (AML)^3,5

Authorization of 12 months may be granted for treatment of acute myeloid leukemia with FLT3-ITD mutation when either of the following criteria are met:

• For use in relapsed/refractory disease in combination with azacitidine or decitabine
• For use in maintenance therapy after HSCT as a single agent

Soft Tissue Sarcoma^3-5

Authorization of 12 months may be granted for treatment for the following types of soft tissue sarcoma:

• Leiomyosarcoma
• Angiosarcoma, solitary fibrous tumor, or desmoid tumor/aggressive fibromatosis, as single agent therapy.

Gastrointestinal Stromal Tumor (GIST)³

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

Renal Cell Carcinoma^1,2

Authorization of 12 months may be granted for treatment of advanced renal cell carcinoma.

Papillary or Follicular Thyroid Carcinoma^1-3

Authorization of 12 months may be granted for treatment of progressive and/or symptomatic papillary or follicular thyroid carcinoma not amenable to radioactive iodine (RAI) therapy.

Oncocytic Thyroid Carcinoma^1-3

Authorization of 12 months may be granted for treatment of progressive and/or symptomatic oncocytic/Hürthle cell thyroid carcinoma.

Medullary Thyroid Carcinoma³

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

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

Bone Cancer³

Authorization of 12 months may be granted for treatment of bone cancer as a single agent for the following subtypes:

• Relapsed/refractory or metastatic osteosarcoma, as second line therapy
• Recurrent chordoma

Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer³

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.

Myeloid/Lymphoid Neoplasms with Eosinophilia³

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.

Continuation of Therapy

GIST

Authorization of 12 months may be granted for continued 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 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. Nexavar [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; August 2023.
2. Sorafenib [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; July 2024.
3. The NCCN Drugs & Biologic Compendium 2025 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 7, 2025.
4. 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.
5. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com [available with subscription]. Accessed May 7, 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