CurrentCentenePolicy CP PMN.236

Amisulpride (Barhemsys)

Defines medical necessity criteria, dosing limits, approval duration, coding, and exclusions for Barhemsys (amisulpride) when used for prevention or treatment of postoperative nausea and vomiting (PONV) for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyAmisulpride (Barhemsys)

Policy CodePolicy CP PMN.236

Change TypeAnnual reviews, coding additions, criteria revisions, legislative bypass

Effective Date09.01.20

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

3Q 2024 annual review added age requirement per prescribing information and revised approval duration wording from one time "approval" to "dose".

Added HCPCS code J01841 to coding implications.

3Q 2022 revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy.

1Covered Indication (PONV)

2Dose Limits (prevention/treatment)

2HCPCS codes listed

1Age restriction (>=18)

Scope: This policy defines medical necessity criteria, dosing limits, approval duration, coding, and exclusions for Barhemsys (amisulpride) when used for the prevention or treatment of postoperative nausea and vomiting (PONV) for Centene lines of business (Commercial, HIM, Medicaid).

Coverage stance: covered_with_criteria — Barhemsys is medically necessary when all initial criteria are met for prevention or treatment of PONV.

Subject and approved indications: Amisulpride (Barhemsys) for prevention and treatment of PONV in adults; FDA‑approved for prevention of PONV (alone or in combination with an antiemetic of a different class) and treatment of PONV (in patients who have received prophylaxis with an agent of a different class or have not received prophylaxis).

Age requirement: ≥ 18 years (per prescribing information and policy criteria).

Approval duration / re-authorization: Approval is for a single dose (policy notes approval duration phrased as one month (one time dose) and re-authorization is not permitted).

Dosing limits: For prevention the dose limit is ≤ 5 mg once; for treatment the dose limit is ≤ 10 mg once (see dosing limits and product dosing).

Key thresholds

Age requirement≥ 18 years

Prevention dose limit≤ 5 mg once (single IV dose at induction)

Treatment dose limit≤ 10 mg once (single IV dose if nausea/vomiting occurs)

Approval duration / Re-authorizationApproval duration: one month (single dose). Re-authorization is not permitted; requests require initial criteria each time.

Initial Therapy Criteria

Covered when ALL of the following are met:

ALL of the following

Prescribed for the prevention or treatment of postoperative nausea and vomiting (PONV).
Postoperative Nausea and Vomiting (must meet all):
- Member is scheduled to undergo surgery.
- Age ≥ 18 years.
Indication-specific requirements (ONE of):
- a
  - For prevention: Failure of one multimodal regimen consisting of two or more formulary agents for PONV, each from different therapeutic classes (e.g., 5-HT3 receptor antagonist + oral corticosteroid; neurokinin‑1 receptor antagonist + 5-HT3 receptor antagonist; neurokinin‑1 receptor antagonist + oral corticosteroid), administered at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B).
  - For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.
- b
  - For treatment: Member did not receive a preoperative D2 antagonist (e.g., metoclopramide).
Dose limits (ONE of):
- a: For prevention: Dose does not exceed 5 mg once.<= 5 mg once
- b: For treatment: Dose does not exceed 10 mg once.<= 10 mg once

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required. Submit a prior authorization request with supporting documentation; approval is granted only when all initial criteria are met. Relevant HCPCS codes: J0184 and J01841. Approval duration: one month (single dose) as specified.

HCPCS: J0184
HCPCS: J01841
Approval duration: 1 month (one time dose / single dose)

Documentation Required

Support clinical necessity

Providers must submit documentation (office chart notes, lab results, or other clinical information) that demonstrates the member meets all initial approval criteria for Barhemsys.

Step Therapy

Step therapy requirement for prevention

For prevention of PONV, the policy requires failure of one multimodal regimen consisting of two or more formulary agents from different classes at up to maximally indicated doses, unless clinically significant adverse effects occur or all are contraindicated. For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 effective 01/01/2026.

Failure of one multimodal regimen (two or more agents from different classes) required unless contraindicated or adverse effects.
IL HIM bypass per IL HB 5395 effective 01/01/2026.

Denial Risk

Re-authorization denied

Requests for re-authorization or continuation will be denied; re-authorization is not permitted.

Clinical Evidence & Guidelines

Key evidence sources cited: Barhemsys Prescribing Information, Acacia Pharma Inc., September 2022 (accessed April 21, 2025).

Guideline support: Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting, Anesthesia & Analgesia, 2020.

Note: The policy states that dosing and age requirements (prevention: 5 mg single IV dose; treatment: 10 mg single IV dose; adults ≥18 years) align with the prescribing information.

Background

Amisulpride (Barhemsys) is described as a dopamine‑2 (D2) antagonist.

FDA approval: Barhemsys is FDA‑approved in adults for the prevention and treatment of postoperative nausea and vomiting (PONV) (prevention alone or with an antiemetic of a different class; treatment for patients who have received prophylaxis with an agent of a different class or who have not received prophylaxis).

Available single‑dose vial strengths: 5 mg/2 mL and 10 mg/4 mL.

Dosing per prescribing information: Prevention — 5 mg as a single IV dose infused over 1–2 minutes at induction of anesthesia; Treatment — 10 mg as a single IV dose infused over 1–2 minutes for nausea/vomiting after surgery.

Revision History

06.26.25addedLatest

Added step therapy bypass for IL HIM per IL HB 5395 (material).

05.06.24revised

Revised age requirement per prescribing information and updated approval duration wording from one time "approval" to "dose" (non-material).

10.27.23added

Added HCPCS code J01841 to coding implications (non-material).

04.07.22clarified

Updated Appendix B with guideline examples and revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy (material).