BARHEMSYS (amisulpride)

Office Administration – IV

Indications for Prior Authorization:
  • Indicated in adults for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • Indicated in adults for treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis
Coverage Criteria:

For diagnosis of PONV:

  • Dose does not exceed 5 mg (single intravenous dose) for prevention of PONV and 10 mg (single intravenous dose) for treatment of PONV, AND
  • Patient is 18 years of age and older, AND
  • One of the following:
    • Prevention of PONV and will be used alone or in combination with an antiemetic of a different class, OR
    • Treatment of PONV in patient’s who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis, AND
  • Prescriber agrees to monitor electrocardiogram (ECG) for QTc prolongation, as clinically indicated
    • QT Prolongation: Occurs in a dose- and concentration-dependent manner. Avoid use in patients with congenital long QT syndrome and in patients taking droperidol. ECG monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders; electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia); congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval
Coverage Duration:
  • 1 tretment
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:
  • QT prolongation
    • ECG monitoring is recommended
  • Barhemsys should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
  • Use of Barhemsys is not recommended in patients with moderate or severe renal impairment (eGFR < 30 mL/min).
Policy Updates:
  • 06/15/2021 – New policy approved by P&T.
References:
  • Acacia Pharma. Press release. https://acaciapharma.com/news/2019/05/complete-response-letter-from-fda-for-barhemsys. May 3, 2019. Accessed November 11, 2020.
  • Apfel CC, Laara E, Koivuranta M, et al. A simplified risk score for predicting postoperative nausea and vomiting. Anesthesiology. 1999;91;693-700.
  • Barhemsys [package insert], Indianapolis, IN: Acacia Pharma; February 2020.
  • Candiotti KA, Kranke P, Bergese SD, et al. Randomized, double-blind, placebo-controlled study of intravenous amisulpride as treatment of established postoperative nausea and vomiting in patients who have had no prior prophylaxis. Anesth Analg. 2019;128:1098-1105.
  • Feinleib J, Kwan LH, Yamani A. Postoperative nausea and vomiting. UpToDate Web site. Updated March 3, 2020. http://www.uptodate.com. Accessed November 6, 2020.
  • Food and Drug Administration. FDA multi-discipline review of Barhemsys. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209510Orig1s000MultidisciplineR.pdf. August 26, 2019. Accessed November 4, 2020.
  • Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131:411-448.
  • Gan TJ, Kranke P, Minkowitz HS, et al. Intravenous amisulpride for the prevention of nausea and vomiting. Anesthesiology. 2017;126:268-275.
  • Habib AS, Kranke P, Bergese SD, et al. Amisulpride for the rescue treatment of postoperative nausea or vomiting in patients failing prophylaxis. Anesthesiology. 2019;130:203-212.
  • Kranke P, Bergese SD, Minkowitz HS, et al. Amisulpride prevents postoperative nausea and vomiting in patients at high risk: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2018;128(6):1099-1106.

 

 

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