WHA

 

 

 

NEXAVAR (sorafenib)

Self-Administration (oral tablet)

 

Diagnosis considered for coverage:
  • Renal cell carcinoma (RCC) - treatment of patients with advanced RCC.
  • Hepatocellular carcinoma (HCC) - treatment of patients with unresectable HCC.
  • Differentiated thyroid carcinoma (DTC) - treatment of locally recurrent or metastatic, progressive, DTC refractory to radioactive iodine treatment.
  • Acute lymphoid leukemia (AML) – off-label support listed in NCCN (category 2A)
  • Advanced medullary thyroid carcinoma – off-label support listed in NCCN (category 2A)
  • Angiosarcoma – off-label support listed in NCCN (category 2A)
  • Desmoid tumor (aggressive fibromatosis) – off-label support listed in NCCN (category 1)
  • Gastrointestinal Stromal Tumor (GIST) – off-label support listed in NCCN (category 2A)
  • Solitary Fibrosis Tumor – off-label support listed in NCCN (category 2A)
Coverage Criteria:

For diagnosis of advanced Renal Cell Carcinoma (RCC):

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Documentation supports a diagnosis of metastatic RCC (kidney cancer); AND
  • Prescribed by or in consultation with an oncologist or nephrologist; AND
  • If used as first-line treatment of metastatic RCC: medical rationale is provided why alternative treatment options are not appropriate.

For diagnosis of Hepatocellular Carcinoma (HCC)

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Documentation supports a diagnosis of HCC; AND
  • Prescribed by or in consultation with an oncologist, hepatologist, or gastroenterologist; AND
  • Documentation supports ONE of the following:
    • Patient has metastatic HCC disease
    • Patient has extensive liver tumor burden
    • Patient is inoperable by performance status, comorbidity, or with minimal or unknown extrahepatic disease
    • Disease is unresectable

For diagnosis of Differentiated Thyroid Carcinoma (DTC) (i.e., papillary, follicular [including Hürthle cell], and poorly differentiated):

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Prescribed by or in consultation with an oncologist; AND
  • Documentation supports a diagnosis of locally recurrent, advanced, metastatic, or unresectable DTC; AND
  • Disease is refractory to radioactive iodine (RAI) treatment; AND
  • Documentation supports symptomatic or progressive disease.

For diagnosis of Medullary Thyroid Carcinoma [Off-Label]:

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Prescribed by or in consultation with an oncologist; AND
  • Documentation supports a diagnosis of locally recurrent, advanced, metastatic, or unresectable medullary thyroid carcinoma; AND
  • Trial and failure, contraindication, or intolerance to Caprelsa tablets (vandetanib) or Cometriq capsules (cabozantinib); AND
  • Documentation supports symptomatic or progressive disease.

For diagnosis of Acute Myeloid Leukemia (AML) [Off-Label]:

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with an oncologist or hematologist; AND
  • Documentation supports a diagnosis of AML disease with FLT3-ITD mutation; AND
  • Will be used in combination with azacitidine or decitabine.

For diagnosis of Gastrointestinal Stromal Tumor (GIST) [Off-Label]:

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with an oncologist; AND
  • Documentation supports a diagnosis of unresectable GIST; AND
  • Trial and failure, contraindication, or intolerance to Gleevec (imatinib), Sutent (sunitinib), Stivarga (regorafenib), and Qinlock (ripretinib).

For diagnosis of Desmoid Tumor (aggressive fibromatosis) or Solitary Fibrosis Tumor [Off-Label]:

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Patient is 18 years of age or older; AND
  • Documentation supports a diagnosis of desmoid tumor or solitary fibrosis tumor (soft tissue carcinoma subtypes); AND
  • Prescribed by or in consultation with an oncologist.

For diagnosis of Angiosarcoma [Off-Label]:

  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Patient is 18 years of age or older; AND
  • Documentation supports a diagnosis of angiosarcoma (a soft tissue carcinoma subtype); AND
  • Trial and failure, contraindication, or intolerance to a preferred regimen (e.g. paclitaxel, anthracycline- or gemcitabine- based regimen); AND
  • Prescribed by or in consultation with an oncologist.
Reauthorization Criteria:
  • Dose does not exceed 400 mg orally twice daily (i.e., 800 mg per day); AND
  • Patient does not show evidence of progressive disease while on therapy.
Coverage Duration:
  • 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • The NCCN Kidney Cancer Panel does not recommend sorafenib (Nexavar) use for patients with stage IV non-clear cell (nonconventional) RCC (NCCN Version 2.2022). Some examples of non-clear cell RCCs include papillary RCC (type 1 and type 2), chromophobe RCC, collecting (Bellini) duct carcinoma, and medullary RCC.
  • Based on multiple alternative options and lack of current clinical use as first-line therapy among NCCN Panel Members, the NCCN Kidney Cancer Panel no longer recommends sorafenib as first line treatment for patients with relapsed of medically unresectable stage IV clear cell (conventional) RCC.
  • Anthracycline drugs used for soft tissue sarcoma subtypes with non-specific histologies or angiosarcomas include doxorubicin (Adriamycin), liposomal doxorubicin (Doxil), and epirubicin (Ellence).
  • Unresectable refers to the inability to remove the tumor completely with surgery.
  • Differentiated thyroid carcinoma includes papillary carcinoma, follicular carcinoma, Hurthle cell carcinoma, and poorly differentiated carcinoma.
Policy Updates:

02/15/2022 – New policy approved by P&T.

References:
  1. Brose MS, Nutting CM, Sherman SI, et al. Rationale and design of DECISION: a double blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011;349.
  2. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F. Sorafenib in advanced clear-cell renal-cell carcinoma. New England Journal of Medicine. 2007 Jan 11;356(2):125-34.
  3. Kim JK, Kim TK, Ahn HJ, Kim CS, Kim KR, Cho KS. Differentiation of subtypes of renal cell carcinoma on helical CT scans. American Journal of Roentgenology. 2002 Jun;178(6):1499-506.
  4. Linehan WM, Srinivasan R, Garcia JA. Non-clear cell renal cancer: disease-based management and opportunities for targeted therapeutic approaches. In Seminars in oncology 2013 Aug 1 (Vol. 40, No. 4, pp. 511-520). WB Saunders.
  5. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Kidney Cancer. V.2.2022. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed November 11, 2021.
  6. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. V.5.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed November 11, 2021.
  7. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. V.3.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed November 11, 2021.
  8. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. V.3.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed November 11, 2021.
  9. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Gastrointestinal Stromal Tumors (GIST). V.1.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/gist.pdf. Accessed November 11, 2021.
  10. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Soft Tissue Sarcoma. V.2.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed November 11, 2021.
  11. Nexavar Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. July 2020.

 

Last review date: February 15, 2022