CurrentUnitedHealthcarePolicy N/A

Step therapy and coverage criteria for Velsipity (etrasimod) — ulcerative colitis

Defines UnitedHealthcare's step therapy requirements and coverage criteria that must be met for coverage of Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis; affects providers submitting prior authorization for this medication under UnitedHealthcare pharmacy benefits.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy and coverage criteria for Velsipity (etrasimod) — ulcerative colitis

Policy CodePolicy N/A

Change TypeMaterial updates to step therapy agents and clarifications

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document two self‑administered injectable trials plus failures/intolerance to three preferred agents and Zeposia.

SourceLink

POLICY UPDATE CHANGES

Tremfya (guselkumab) was added as a step therapy agent.

Removed examples for adalimumab in step therapy and revised ustekinumab language to 'One of the preferred ustekinumab products'.

Added Entyvio, Omvoh and Skyrizi as therapy agents in the step sequence.

Program explicitly requires trying two self-administered injectable products before coverage of Velsipity, and infused medications are excluded from the criteria.

2required self-administered injectable trials before Velsipity

12 moauthorization duration if approved

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Coverage Criteria for Velsipity (etrasimod)

Initial coverage criteria

Covered when ALL of the following are met:

Overall requirement: Member is an adult with moderately to severely active ulcerative colitis.

Step therapy injectable requirement: Member has trialed two self-administered injectable products (document date and duration).

Infused medications do not count toward this requirement.

Preferred agent trials: Member has history of failure, contraindication, or intolerance to three of the following preferred products (document date and duration for each): one of the preferred adalimumab products; Omvoh (mirikizumab-mrkz); Entyvio (vedolizumab); Skyrizi (risankizumab); Rinvoq (upadacitinib); Simponi (golimumab); one of the preferred ustekinumab products; Xeljanz/Xeljanz XR (tofacitinib).

S1P modulator trial: History of failure, contraindication, or intolerance to Zeposia (ozanimod) (document date and duration).

Velsipity (etrasimod) is excluded from coverage for the majority of UnitedHealthcare benefits. This exclusion is stated in the program summary and the Additional Clinical Rules and applies across most UnitedHealthcare benefit designs unless a specific exception or alternate authorization pathway is documented.

Use of Velsipity without first meeting the program's step therapy requirements is not supported by this policy and may be considered not medically necessary. The step therapy rules require documented trials of required agents — including two self‑administered injectable products (with dates and duration) and documented failure, contraindication, or intolerance to specified preferred therapies and to Zeposia (ozanimod). Failure to provide the required trial documentation and meet the step therapy sequence can result in denial of coverage.

Coding and Authorization Duration

Affected codes (document reference)mixed

affected codes

placeholder from document referencing affected codes

Authorization duration

Authorization durationAuthorization will be issued for 12 months (state mandates, federal requirements, and member benefit plans may affect coverage)

Reauthorization ruleIf previously approved, authorization will be issued for 12 months

Operational noteOther policies and utilization management programs may apply and could affect authorization

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Velsipity (etrasimod). If approved, authorization will be issued for 12 months. State mandates, federal regulatory requirements, and the member's specific benefit plan may affect coverage. Other policies and utilization management programs may also apply.

Authorization duration: 12 months
State and federal mandates and member benefit plan may impact coverage
Other utilization management programs may apply

Step Therapy

Step Therapy Requirement

Step therapy is required. Member must have tried two self-administered injectable products (document date and duration of each trial) and meet the broader step/failure requirements below before Velsipity will be approved.

Member must trial two self-administered injectable products (document dates and duration)
Infused medications are not part of the step therapy requirement

Background

Velsipity (etrasimod) is a sphingosine 1‑phosphate (S1P) receptor modulator indicated in adults with moderately to severely active ulcerative colitis. Within UnitedHealthcare's step therapy program for Velsipity, coverage is allowed only when the member meets the defined step sequence: documentation of trials and reasons for failure, contraindication, or intolerance to required prior agents, including a trial of Zeposia (ozanimod) and trials of preferred biologic or small‑molecule therapies, plus trialing two self‑administered injectable products. Infused medications are explicitly excluded from counting toward the required self‑administered injectable trials. Prior authorization is required for Velsipity and, when approved, is issued for 12 months.

Definitions

S1P modulator definition

TermS1P modulator

DefinitionSphingosine 1-phosphate receptor modulator

Examples in policyVelsipity (etrasimod) and Zeposia (ozanimod) are S1P receptor modulators indicated for moderately to severely active ulcerative colitis in adults

Failure/contraindication/intolerance — definition

DefinitionHistory of failure, contraindication, or intolerance refers to documented lack of efficacy, adverse reaction, or clinical reason preventing use

Documentation requiredMedical records must document dates and duration of the trial and the reason for failure, contraindication, or intolerance for each required prior agent

Initial Therapy Criteria for Velsipity

Initial therapy requirements

Initial authorization conditions for Velsipity:

Initial therapy nodes: Member must meet step therapy requirements: trial of two self-administered injectable products (document date and duration) and documented failure, contraindication, or intolerance to three preferred products and to Zeposia (ozanimod).

Infused medications are not part of the criteria and should not be counted toward the required self-administered injectable trials.

Continuation and Reauthorization Criteria

Continuation therapy / reauthorization

Reauthorization

Reauthorization duration: If previously approved, authorization will be issued for 12 months.

Step Therapy Details

Requirement	Details
Two self‑administered injectable trials	Member must have trialed two self‑administered injectable products (document dates and duration). Infused medications are not counted toward this requirement.
Preferred agent failures (three)	History of failure, contraindication, or intolerance to three of the listed preferred products (document date and duration for each). Preferred products include preferred adalimumab products, Omvoh (mirikizumab‑mr kz), Entyvio (vedolizumab), Skyrizi (risankizumab), Rinvoq (upadacitinib), Simponi (golimumab), one of the preferred ustekinumab products, and Xeljanz/Xeljanz XR (tofacitinib). Tremfya (guselkumab) was later added to the step sequence per change control.
S1P modulator trial (Zeposia)	History of failure, contraindication, or intolerance to Zeposia (ozanimod) (document date and duration).
Overall condition for approval	Member has moderately to severely active ulcerative colitis and is an adult; all above trials and documentation must be met for Velsipity to be approved under this step therapy program.

Site of Care and Infusion Guidance

Note

Do not count infused medications toward injectable trials

Infused medications must not be counted toward the requirement to trial two self‑administered injectable products.