CurrentCentenePolicy CP.PMN.236

Amisulpride (Barhemsys) (PDF)

Defines medical necessity criteria, dosing limits, prior authorization expectations, exclusions, and coding implications for amisulpride (Barhemsys) for postoperative nausea and vomiting (PONV) across Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyAmisulpride (Barhemsys) (PDF)

Policy CodePolicy CP.PMN.236

Change TypePeriodic revisions & coding updates

Effective Date09.01.20

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J0184 to coding implications.

Revised initial approval duration language from one time 'approval' to 'dose' and added age requirement per prescribing information.

Revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy.

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

Revised initial approval duration from 3 days to 1 month (historical change).

2FDA-approved indications (PONV prevention and treatment)

1Adult age requirement (≥18 yrs)

Re-authorization allowed

1HCPCS code listed (J0184)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: This policy defines medical necessity criteria, dosing limits, prior authorization expectations, exclusions, and coding implications for amisulpride (Barhemsys) for postoperative nausea and vomiting (PONV) across Centene lines of business (Commercial, HIM, Medicaid). The policy requires prior authorization and documents that approval is granted as a single dose (one dose) with dosing limits of ≤ 5 mg once for prevention and ≤ 10 mg once for treatment. HCPCS coding implications list J0184 (Injection, amisulpride, 1 mg).

Thresholds

Age requirement≥ 18 years

Prevention single dose≤ 5 mg once

Treatment single dose≤ 10 mg once

Recent label change windowwithin the last 6 months

Initial Therapy Criteria — Postoperative Nausea and Vomiting

Initial Approval Criteria - Postoperative Nausea and Vomiting

Barhemsys is medically necessary when ALL of the following are met:

ALL of the following

Prescribed for the prevention or treatment of postoperative nausea and vomiting (PONV)
Age ≥ 18 years≥ 18 years
Age requirement per prescribing information
Member is scheduled to undergo surgery
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, at up to maximally indicated dose, unless clinically significant adverse effects are experienced or all are contraindicated

Initial Therapy Criteria — Other Diagnoses / Indications

Initial Approval Criteria - Other diagnoses/indications

For requested uses not PONV or label changes within last 6 months:

ANY of the following

If drug underwent a label change within last 6 months that is not yet reflected in this policy, refer to the applicable no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use (diagnosis, age, dosing) is NOT listed under section III and criterion above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Re-authorization / Continuation Therapy

Re-authorization Criteria

Re-authorization rules for PONV:

Re-authorization is not permitted; members must meet the initial approval criteria

Approval duration is one dose; re-authorization not permitted

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for the following:

Non–FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies is provided

Refer to off-label policies CP.CPA.09, HIM.PA.154, CP.PMN.53 for requirements

Applicable Codes

HCPCS codes (informational)HCPCS

J0184

Injection, amisulpride, 1 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with criteria

Prior authorization approval is required and will only be granted when all initial criteria are met for prevention or treatment of postoperative nausea and vomiting (PONV). Criteria include: indication for prevention or treatment of PONV, age ≥ 18 years, member scheduled to undergo surgery, and for prevention failure of one multimodal regimen of two or more formulary agents from different therapeutic classes at up to maximally indicated doses (unless contraindicated or adverse effects). For treatment, member must not have received a preoperative D2 antagonist. Dosing limits apply (prevention ≤ 5 mg single dose; treatment ≤ 10 mg single dose).

Affected code: J0184
Required criteria summary: Indication is PONV prevention or treatment; age ≥ 18; surgery scheduled; prevention requires prior failure of one multimodal regimen of ≥2 formulary agents from different classes at maximally indicated doses (unless contraindicated); for treatment, no preoperative D2 antagonist; dosing limits (prevention ≤5 mg once; treatment ≤10 mg once).

Clinical Evidence & References

Evidence sources referenced in the policy: Label reference — Barhemsys Prescribing Information, September 2022; Guideline — Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting, Anesthesia & Analgesia 2020. No additional trial metrics or study-specific efficacy numbers are provided in the brief or policy.

Background

Background: Amisulpride (Barhemsys) is a D2 antagonist indicated in adults for prevention and treatment of postoperative nausea and vomiting (PONV). Single-dose vials are available in 5 mg/2 mL and 10 mg/4 mL strengths. The policy aligns coverage to FDA-approved indications and, for prevention of PONV, requires prior failure of one multimodal regimen consisting of two or more formulary agents from different therapeutic classes at up to maximally indicated doses unless contraindicated or significant adverse effects occur.

Definitions and Policy Dates

Definition - PONVPostoperative nausea and vomiting

Policy numberCP.PMN.236

Effective date09.01.20

Last review date08.25

Scope summaryDefines medical necessity criteria, dosing limits, prior authorization expectations, exclusions, and coding implications for amisulpride (Barhemsys) for postoperative nausea and vomiting (PONV) across Centene lines of business (Commercial, HIM, Medicaid).

Revision History

03.19.21revised

Revised initial approval duration from 3 days to 1 month to allow time to obtain medication; references and HIM off-label use updated (P&T Approval Date 08.21).

04.07.22revised

Revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy and updated Appendix B with examples (P&T Approval Date 08.22).

10.27.23added

Added HCPCS code J0184 to coding implications.

Policy Summary

PayerCentene

PolicyAmisulpride (Barhemsys) (PDF)

Policy CodePolicy CP.PMN.236

Change TypePeriodic revisions & coding updates

Effective Date09.01.20

Next Review Date

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

SourceLink

On This Page

Examples of combination therapy classes: 5-HT3 receptor antagonist + oral corticosteroid; neurokinin 1 receptor antagonist + 5-HT3 receptor antagonist; neurokinin 1 receptor antagonist + oral corticosteroid (see Appendix B). Illinois HIM bypass per IL HB 5395 effective 01/01/2026.

b. For treatment: Member did not receive a preoperative D2 antagonist (e.g., metoclopramide)

Request meets one of the following (a or b)

a. For prevention: Dose does not exceed 5 mg once≤ 5 mg single dose
Prevention dosing per prescribing information (5 mg single IV dose)
b. For treatment: Dose does not exceed 10 mg once≤ 10 mg single dose
Treatment dosing per prescribing information (10 mg single IV dose)

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, lab results, or other clinical information demonstrating the member meets all approval criteria. Documentation must show evidence that the applicable criteria (e.g., indication, age, scheduled surgery, prior multimodal regimen failure for prevention or no preoperative D2 antagonist for treatment, and dosing limits) are met.

Office chart notes
Laboratory results
Other clinical information showing criteria met

Billing Rule

Single-dose approval/duration

Approval is for a single dose (one dose) only and re-authorization is not permitted for PONV. The policy specifies dosing limits by indication: prevention requests must not exceed 5 mg as a single dose; treatment requests must not exceed 10 mg as a single dose.

Approval duration: one dose (one-time dose)
Re-authorization: not permitted for PONV
Dosing limits: prevention ≤ 5 mg single dose; treatment ≤ 10 mg single dose

Step Therapy

Step therapy requirement for prevention

For PONV prevention, step therapy requires documented failure of one multimodal regimen consisting of two or more formulary agents from different therapeutic classes at up to maximally indicated doses unless clinically significant adverse effects occur or all are contraindicated. Note: Illinois HIM requests are exempt from the step therapy requirement per Illinois HB 5395 effective 01/01/2026.

Failure of one multimodal regimen of ≥2 formulary agents from different classes at maximally indicated doses required
Exceptions: significant adverse effects or contraindications to agents
IL HIM bypass: IL HB 5395 effective 01/01/2026

05.06.24revised

Added age requirement per prescribing information and revised approval duration language from one time 'approval' to 'dose' (P&T Approval Date 08.24).

06.26.25clarifiedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (P&T Approval Date 08.25).