Sancuso (granisetron) patch

Sancuso (granisetron) patch is a transdermal formulation of granisetron, a selective serotonin (5-HT3) receptor antagonist. It has a unique FDA indication for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving multiday, moderately and/or highly emetogenic chemotherapy. The patch is applied to the upper outer arm 24-48 hours prior to chemotherapy and is kept on until at least 24 hours after chemotherapy is completed. The patch can be worn for up to 7 days, depending on chemotherapy regimen duration.

Definitions

Moderately or Highly emetogenic chemotherapy is chemotherapy that has >30%-90% or >90% frequency of nausea and/or vomiting (i.e., cisplatin, doxorubicin, carboplatin)

Medical Necessity Criteria for Authorization

1. The Plan considers Sancuso (granisetron) patch medically necessary when ONE of the following criteria is met:
• Sancuso is being used to treat stage IV advanced, metastatic cancer [based upon applicable state regulations]; OR
• ALL the following criteria are met:
• The member is 18 years or older; and
• The member is receiving moderately or highly emetogenic chemotherapy for 3 days or more; and
• ONE of the following criteria is met:
• The member is unable to use, or has tried and failed at least one oral 5HT-3 antagonist such as granisetron tablet or ondansetron tablet; or
• The member is unable to swallow tablets or solutions.
2. If the above prior authorization criteria are met, Sancuso (granisetron) patch will be approved for the duration of the chemotherapy regimen.

Experimental or Investigational / Not Medically Necessary

Sancuso (granisetron) patch for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Boccia RV, et al. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011;19(10):1609. Epub 2010 Sep 12.
2. Flank J, Robinson PD, Holdsworth M, et al. Guideline for the Treatment of Breakthrough and the Prevention of Refractory Chemotherapy-Induced Nausea and Vomiting in Children With Cancer. Pediatr Blood Cancer. 2016;63(7):1144-1151.[PubMed 26960036]
3. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO guideline update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296
4. Hesketh PJ. Prevention and Treatment of chemotherapy-induced nausea and vomiting in adults. https://www.uptodate.com/contents/prevention-and-treatment-of-chemotherapy-induced-nausea-and-vomiting-in-adults/print. Updated March 28, 2021. Accessed May 2, 2021.
5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Antiemesis. National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Updated July 20, 2011. Accessed December 18, 2019.
6. Sancuso (granisetron transdermal) [prescribing information]. Bedminster, NJ: Kyowa Kirin; July 2022.
7. Schulmeister L. Granisetron transdermal system: a new option to help prevent chemotherapy-induced nausea and vomiting. Clin J Oncol Nurs. 2009;13(6):711-714. doi:10.1188/09.CJON.711-714.

Clinical Guideline Revision / History Information

Original Date: 08/06/2020

Reviewed/Revised: 06/24/2021, 12/01/2021, 06/23/2022, 06/29/2023