FOTIVDA (tivozanib)

FOTIVDA (tivozanib)

Self Administration - Oral

Indications for Prior Authorization:

• Indicated for the treatment of adult patients with metastatic, relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Coverage Criteria:

For diagnosis of renal cell carcinoma (RCC):

• Dose does not exceed 1.34 mg once daily, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist or urologist, AND
• Disease is either relapsed or refractory, AND
• Patient has received two or more prior systemic therapies supported by the National Comprehensive Cancer Network (NCCN) for the treatment of clear cell renal carcinoma

Reauthorization Criteria:

For diagnosis of renal cell carcinoma (RCC):

• Dose does not exceed 1.34 mg once daily, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 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:

• Warnings and precautions
  • Hypertension and hypertensive crisis
  • Cardiac failure
  • Cardiac ischemia and arterial thromboembolic events
  • Venous thromboembolic events
  • Hemorrhagic events
  • Proteinuria
  • Thyroid dysfunction
  • Risk of impaired wound healing
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
  • Embryo-fetal toxicity
  • Allergic reactions to tartrazine
• Drug interactions
  • Avoid concomitant use of strong CYP3A inducers
• Use in specific populations
  • Lactation: advise not to breastfeed
  • Females and males of reproductive potential: can impair fertility
  • Hepatic impairment: adjust dosage in patients with moderate hepatic impairment
    • Avoid use in patients with severe hepatic impairment

Policy Updates:

• 8/17/2021 – New policy approved by P&T

References:

• American Society of Clinical Oncology (ASCO). Tivozanib approved in the European Union for the treatment of advanced renal cell carcinoma. 2017. ASCO Post Web site. https://ascopost.com/News/57980. Accessed May 4, 2021.
• Atkins MB. Overview of the treatment of renal cell carcinoma. UpToDate Web site. Updated February 25, 2021. http://www.uptodate.com. Accessed April 14, 2021.
• ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/home. Identifiers: NCT02627963, NCT04645160, NCT03970616, NCT03136627. Accessed April 27, 2021.
• European Medicines Agency. Fotivda. Web site. Updated 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda#assessment-history-section. Accessed May 4, 2021.
• Food and Drug Administration. Multi-discipline review: Fotivda. 2018. FDA Web site. Review (fda.gov). Accessed April 7, 2021.
• Food and Drug Administration. Press Release: FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma. March 10, 2021. FDA Web site. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma. Accessed April 26, 2021.
• Fotivda [package insert], Boston, MA: AVEO Pharmaceuticals, Inc.; March 2021.
• Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase 3 trial. J Clin Oncol. 2013;31:3791-3799.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Kidney cancer, version 4.2021 – April 19, 2021. NCCN Web site. kidney.pdf (nccn.org). Accessed April 20, 2021.
• Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
• Pal SK, Escudier BJ, Atkins MB, et al. Final overall survival results from a phase 3 study to compare tivozanib to sorafenib as third-or fourth-line therapy in subjects with metastatic renal cell carcinoma. European Urology. 2020;78:783-785.
• Rini BI, Pal SK, Escudier BJ, et al. TIVO-3: tivozanib in patients with advanced renal cell carcinoma (aRCC) who have progressed after treatment with axitinib [abstract]. J Clin Oncol. 2021;39:6S. Abstract 278. Available at https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.6_suppl.278. Accessed May 3, 2021.
• Rini BI, Pal SK, Escudier BJ, et al. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicenter, randomized, controlled, open-label study. Lancet Oncol. 2020;21:95-104.
• Surveillance, Epidemiology, and End Results program (SEER) Cancer Stat Facts: Kidney and Renal Pelvis Cancer. SEER Web site. Kidney and Renal Pelvis Cancer — Cancer Stat Facts. Accessed April 14, 2021.