Step therapy for select antidepressants (Auvelity, Trintellix, Fetzima)
Defines step therapy requirements for coverage of Auvelity (dextromethorphan/bupropion), Trintellix (vortioxetine), and Fetzima (levomilnacipran) for members covered under UnitedHealthcare Pharmacy Clinical Pharmacy Programs; affects new therapy starts and members changing plans.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Covered when ANY of the following criteria are met:
Trials should be documented; automated approval available if claims show three step-one meds in prior 180 days.
inv-02: Continuation / Reauthorization
Authorization and continuation rules
State mandates, federal requirements, and the member-specific benefit plan may impact coverage.
Supply limits may apply; automated processes vary by program.
None explicitly stated in this document.
Use of Auvelity (dextromethorphan/bupropion), Trintellix (vortioxetine), or Fetzima (levomilnacipran) without documentation that the member has experienced failure, contraindication, or intolerance to at least three specified first-line agents may be considered not meeting step therapy requirements. The policy requires documentation of the drug and date for each trial and specifies a minimum trial duration of 4 weeks for establishing failure/intolerance; automated approval is possible if claims show three step-one medications within the prior 180 days.
Initial Therapy
inv-12: Initial Therapy
Initial therapy coverage conditions
Document drug name and date of trials; claims history may be used for automated approval if three step-one medications appear within the prior 180 days.
Continuation Therapy
inv-13: Continuation Therapy
Continuation allowed when member is already stabilized or has prior claim history
UnitedHealthcare may approve based on prior claim/medication history, diagnosis codes, and/or claim logic; supply limits may apply.
Step Therapy Requirements
| Medication name | Date of trial | Duration of trial |
|---|---|---|
| 1. bupropion | ||
| [enter date of trial] | ||
| [enter duration in weeks; minimum 4 weeks required] | ||
| 2. citalopram | ||
| [enter date of trial] | ||
| [enter duration in weeks; minimum 4 weeks required] | ||
| 3. duloxetine | ||
| [enter date of trial] | ||
| [enter duration in weeks; minimum 4 weeks required] |
Claims Look-back and Continuity Thresholds
Provider Actions and Documentation
Prior Authorization Required
Prior authorization is required for Auvelity, Trintellix, and Fetzima unless the member has three step‑one medications in claims history within the previous 180 days. Members with documented prior use of Auvelity, Trintellix, or Fetzima in claims history will be allowed continued coverage of their current therapy. Members new to therapy must meet the step therapy criteria below.
- Applies to: Auvelity, Trintellix, Fetzima
- Auto‑adjudication: If claims history shows ≥3 step‑one medications within prior 180 days, prior authorization is not required
Step Therapy Requirement
Member must have trialed at least three step‑one antidepressant medications (any formulation) with documentation of drug name and date of trial. Each trial must be a minimum of 4 weeks unless there is documented intolerance or contraindication. If the member has documented failure, contraindication, or intolerance to at least three of the listed agents, coverage for Auvelity, Trintellix, or Fetzima will be approved.
- Required agents (examples include, but are not limited to): bupropion; citalopram; duloxetine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine IR/ER (capsules)
- Minimum trial duration: 4 weeks per agent (unless stopped for intolerance/contraindication)
Required Trial Documentation
Document the drug name, date of each trial, and duration for at least three step‑one medications. Claims history may be used as acceptable evidence of prior trials. If the requested medication was initiated during a recent inpatient mental health hospitalization and the member is stabilized, or the member is new to the plan and currently stabilized on the requested medication with coverage effective ≤120 days, provide evidence to support these conditions.
- Documentation must include: drug name, start/end dates (or medication duration), and reason for discontinuation if <4 weeks (e.g., intolerance)
- Acceptable evidence: pharmacy/medical claims history, hospitalization records, plan effective date ≤120 days for new‑to‑plan continuation
Insufficient Prior Trials — Denial Risk
If documentation does not show trials of at least three listed step‑one antidepressants (including drug name, date, and duration of at least 4 weeks each) and there is no documented intolerance or contraindication, the request may be denied for insufficient prior trials.
- Insufficient documentation may result in non‑coverage/denial
- Ensure all three prior trials are clearly documented with dates and durations
Definitions
Background
Step therapy programs are designed to encourage use of lower-cost, established alternatives before covering newer or higher-cost agents. This policy applies that sequencing logic to these three antidepressants by requiring a trial of at least three step-one medications (from the listed first-line agents) prior to approval, with an automated processing pathway when claims history documents those three agents within the prior 180 days and allowance for continued coverage when the member is already stabilized on the requested medication.
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