Amisulpride (Barhemsys) Form

Amisulpride (Barhemsys®) is a dopamine-2 (D2) antagonist. FDA Approved Indication(s) Barhemsys is indicated in adults for: • Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class • Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Barhemsys is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Postoperative Nausea and Vomiting (must meet all):

1. Prescribed for the prevention or treatment of PONV;
2. Member is scheduled to undergo surgery;

3. Member meets one of the following (a or b): a. For prevention: failure of one multimodal regimen consisting of two or more formulary agents for PONV, each from different therapeutic classes (e.g. 5HT3 receptor antagonist + oral corticosteroid, neurokinin 1 receptor antagonist + 5HT3 receptor antagonist, neurokinin 1 receptor antagonist + oral corticosteroid), at up to maximally indicated does, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B); b. For treatment: Member did not receive a preoperative D2 antagonist (e.g., metoclopramide);

   4. Request meets one of the following (a or b): a. For prevention: Dose does not exceed 5 mg once; b. For treatment: Dose does not exceed 10 mg once. Approval duration: 1 month (one time approval) Page 1 of 6

   CLINICAL POLICY Amisulpride B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Postoperative Nausea and Vomiting
   3. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
   4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
      Page 2 of 6

   CLINICAL POLICY Amisulpride IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration PONV: postoperative nausea and vomiting Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Pharmacologic Class Combination
   PONV
   5-HT3 receptor antagonist + oral corticosteroid Examples of pharmacologic combination therapy Ondansetron (preferred) + dexamethasone, palonosetron + dexamethasone, granisetron + dexamethasone Ondansetron + aprepitant, palonosetron + aprepitant
   5-HT3 receptor antagonist + neurokinin 1 receptor antagonist Neurokinin 1 receptor antagonist

   • oral corticosteroid 5-HT3 receptor antagonist + droperidol
     Other 5-HT3 receptor antagonists Ondansetron + haloperidol, dexamethasone + Ondansetron + droperidol, granisetron + droperidol, palonosetron + droperidol Aprepitant + dexamethasone
     Other antidopaminergic combinations Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *Off-label haloperidol + ondansetron Dexamethasone + haloperidol, metoclopramide + dimenhydrinate, haloperidol + midazolam
     Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to amisulpride • Boxed warning(s): none reported V. Dosage and Administration
     Indication Prevention of PONV Treatment of PONV Dosing Regimen 5 mg as a single IV dose infused over 1 to 2 minutes at the time of induction of anesthesia 10 mg as a single IV dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure Maximum Dose 5 mg/dose 10 mg/dose VI. Product Availability
     Single-dose vial for injection: 5 mg/2 mL, 10 mg/4 mL Page 3 of 6

   CLINICAL POLICY Amisulpride VII.