ModifiedCentenePolicy CP.PMN.284

Dextromethorphan/Bupropion (Auvelity) coverage

Defines medical necessity criteria, prior authorization, dosing limits, and continuity rules for Auvelity for treatment of major depressive disorder in adults for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyDextromethorphan/Bupropion (Auvelity) coverage

Policy CodePolicy CP.PMN.284

Change TypeStep therapy clarifications and state-specific bypass additions

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, age ≥18, required prior trials or applicable state bypass, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

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

Clarified that the two required prior antidepressant trials must be preferred formulary antidepressants.

Added redirection bypass for members in states with limitations on step therapy in certain mental health settings (Appendix D).

Updated Appendix B dosing regimen for therapeutic alternatives per Clinical Pharmacology.

≥18minimum age for coverage

2required failed preferred antidepressant trials

90/210 mgmaximum dose (dextromethorphan/bupropion)

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12 monthsapproval duration

TX, ILstate bypass referenced

Coverage Criteria

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued MDD criteria: 1) Member meets ONE of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed BOTH: (a) dextromethorphan 90 mg and bupropion 210 mg per day; and (b) 2 tablets per day.

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless coverage is established in the member’s evidence of coverage.

Where state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence and will govern coverage determinations for Medicaid members. Providers must follow Health Plan coverage decisions, administrative policies, and any applicable state or federal requirements when submitting documentation or requesting coverage.

Auvelity is not approved for use in pediatric patients. The product carries a boxed warning that antidepressants, including Auvelity, are associated with an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients; all antidepressant‑treated patients should be closely monitored for clinical worsening and emergence of suicidal thoughts and behaviors.

Coding & Dose Limits

Product codesNDC

NDC	Not specified in this portion of document

inv-07: Maximum daily dose — Dextromethorphan 90 mg / Bupropion 210 mg

Maximum daily dextromethorphan / bupropion90 mg dextromethorphan / 210 mg bupropion per day

Dose limit referenceInitial and continued therapy criteria state dose must not exceed 90 mg dextromethorphan and 210 mg bupropion per day

Approval duration related to dosingApproval duration (initial and continued): 12 months — dosing limits apply throughout approval period

inv-08: Maximum tablets per day — 2 tablets/day

Maximum tablets per day2 tablets per day

Dosing schedule contextRecommended regimen: 1 tablet PO QD for first 3 days, then 1 tablet PO BID at least 8 hours apart

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Auvelity (dextromethorphan/bupropion). Initial approvals will be granted only when the Initial Approval Criteria for Major Depressive Disorder are met (diagnosis of MDD, age ≥ 18 years, required step therapy or applicable state-specific redirection bypass, and dosing limits). Failure to follow step-therapy or applicable state-specific redirection/bypass provisions may result in denial of coverage.

Prior authorization required for initial and continuation requests
Approval duration for initial therapy: 12 months
Dose limits: ≤ 90 mg dextromethorphan and ≤ 210 mg bupropion per day; ≤ 2 tablets per day

Documentation Required

Clinical Documentation Required

Requests must include supporting clinical documentation. Provider must submit office chart notes, lab results, progress notes, or other relevant clinical information that demonstrates the member meets all approval criteria (including diagnosis, prior medication trials, dates and doses tried, adverse effects or contraindications when applicable, and rationale for any bypass). Requests lacking adequate documentation may be denied.

Pharmacotherapy

inv-20: Pharmacotherapy (Auvelity)

Dosing regimen: Start: 1 tablet PO once daily for the first 3 days, then 1 tablet PO twice daily given at least 8 hours apart; maximum 2 tablets/day (dextromethorphan 90 mg / bupropion 210 mg).

Definitions

inv-18: Auvelity — fixed-dose combination of dextromethorphan hydrobromide and bupropion hydrochloride indicated for MDD in adults

Product compositionFixed‑dose combination of dextromethorphan hydrobromide and bupropion hydrochloride

Mechanism notesDextromethorphan: uncompetitive NMDA receptor antagonist and sigma‑1 receptor agonist; Bupropion: aminoketone and CYP2D6 inhibitor

FDA indicationIndicated for the treatment of major depressive disorder (MDD) in adults

inv-19: Health Plan definition — Health Plan means a health plan that has adopted this clinical policy and that is operated or administered by Centene affiliates

Definition of Health PlanHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Scope of definition

Background

Auvelity is an extended‑release fixed‑dose combination of dextromethorphan hydrobromide and bupropion hydrochloride. Dextromethorphan acts as an uncompetitive NMDA receptor antagonist and a sigma‑1 receptor agonist, while bupropion is an aminoketone that functions as a CYP2D6 inhibitor; together these pharmacologic actions underlie the product’s antidepressant effect in adults with major depressive disorder. Prescribing should follow the FDA‑approved dosing schedule and account for known contraindications and safety warnings, including seizure risk and the boxed warning regarding increased suicidal thoughts and behaviors in younger patients.

Revision History

2025-07-25material_updateLatest

4Q 2025 annual review added step therapy bypass for Illinois HIM per IL HB 5395 and updated references.

2024-07-30review_update

4Q 2024 annual review made no significant clinical changes but updated Appendix B dosing regimen for therapeutic alternatives per Clinical Pharmacology.

2023-09-06clarification

Policy Summary

PayerCentene

PolicyDextromethorphan/Bupropion (Auvelity) coverage

Policy CodePolicy CP.PMN.284

Change TypeStep therapy clarifications and state-specific bypass additions

Effective DateDec 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, age ≥18, required prior trials or applicable state bypass, and dosing within limits.

SourceLink

On This Page

Dose checks for continuationContinued therapy: any dose increase requested must not exceed 2 tablets per day

Submit office notes, lab results, or other clinical information with the prior authorization request
Documentation must show trials of prior antidepressants (agents, start/stop dates, doses, and reason for discontinuation if applicable) or documentation supporting a state-specific bypass

Step Therapy

Step Therapy and State-Specific Bypass Requirements

Step therapy requirements must be met for most members unless a state-specific redirection/bypass applies. For initial approval of Auvelity, the member must have failed two preferred formulary antidepressants, each used for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated. Preferred agents include SSRI, SNRI, bupropion, or mirtazapine. State-specific exceptions (redirection/bypass) are documented in Appendix D and in plan updates (e.g., Texas and Illinois provisions).

Step therapy: failure of TWO preferred formulary antidepressants (each ≥ 4 weeks at up to maximally indicated doses) — agents: SSRI, SNRI, bupropion, mirtazapine
Appendix D lists states with limitations on redirections in certain mental health settings and the applicable bypass rules
Texas: for HIM requests, single-drug redirection/less stringent step may apply per Appendix D
Illinois: as of 1/1/2026 IL HB 5395 removes step therapy requirements for HIM requests; 4Q 2025 update added IL HIM bypass per IL HB 5395

Denial Risk

Denial Risk if Requirements Not Met

Failure to meet the step therapy requirements or to provide documentation of an applicable state-specific bypass (where permitted) may result in denial of the request. Providers should follow Health Plan coverage decisions and administrative policies and submit documentation consistent with plan requirements and any state law exceptions.

Noncompliance with step therapy or missing bypass documentation may trigger denial (example: IL HB 5395 bypass provisions affect HIM requests)
Providers must follow Health Plan administrative policies and state/federal requirements when submitting prior authorization requests

Applies to entities using this clinical policy for coverage decisions and administration of benefits

Policy contextDefinition appears within the policy Important Reminder and guides applicability across Centene-affiliated plans

4Q 2023 annual review clarified that the two required antidepressant trials must be preferred formulary antidepressants and removed redirection to individual Auvelity components.

2023-07-11material_update

Added redirection bypass for members in states with limitations on step therapy in certain mental health settings and added Appendix D (includes Texas requirements for single drug redirection for HIM requests).

2022-11-22creation_and_pt_approval

Policy created and received P&T approval.

2022-09-27creation

Policy created (initial document date).