ModifiedUnitedHealthcarePolicy 2025 P 3182-4

Velsipity™ (etrasimod) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare's step therapy program requiring trials of specified self-administered injectable and oral therapies before coverage of Velsipity (etrasimod) for moderately to severely active ulcerative colitis in adults; notes Velsipity is excluded for the majority of benefits and authorization is for 12 months when approved.

Policy Summary

PayerUnitedHealthcare

PolicyVelsipity™ (etrasimod) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3182-4

Change TypeStep therapy additions and clarifications

Effective DateJun 1, 2025

Next Review Date

Key ActionProvider must document trials (drug, date, and duration) showing failure, contraindication, or intolerance to three preferred products listed and to Zeposia (ozanimod) prior to approval for Velsipity; authorization when approved will be issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Step therapy program requires member to try two self-administered injectable products before coverage for Velsipity; infused medications are not part of the criteria.

Updated step requirement to specify preferred adalimumab products (Humira, Amjevita, Hyrimoz) previously, and later removed examples; added Entyvio, Omvoh, Skyrizi, and Tremfya as step therapy agents.

Changed Stelara reference to 'One of the preferred ustekinumab products' (i.e., ustekinumab).

P&T approval dates updated (4/2024,10/2024,11/2024,4/2025) and Effective Date set to 6/1/2025.

9Step agents listed (must fail 3)

1Required trial of Zeposia

12 mo

Summary of changes and impact

Material change: The step therapy program now requires trial of two self‑administered injectable products before coverage of Velsipity (etrasimod) for moderately to severely active ulcerative colitis in adults; overall step criteria require documented failure, contraindication, or intolerance to three preferred products (from the listed agents) plus a documented trial of Zeposia (ozanimod). Infused medications are excluded from the step criteria. (See provider documentation requirements for trial details.)

Effective Date: 2025-06-01. P&T / review dates: P&T Approval Date entries include 4/2024, 10/2024, 11/2024, and 4/2025 as noted in the policy history.

Key policy details

Effective date2025-06-01

P&T / last review dates4/2024, 10/2024, 11/2024, 4/2025

Authorization duration12 months

Policy statusMODIFIED

Initial approval criteria for Velsipity (etrasimod)

Ulcerative Colitis (UC) - Initial Approval Criteria for Velsipity (etrasimod)

Velsipity will be approved based on both of the following criteria:

ALL of the following

History of failure, contraindication, or intolerance to three of the following preferred products (document drug, date, and duration of trial):
- One of the preferred adalimumab products
- Entyvio (vedolizumab)
- Omvoh (mirikizumab-mrkz)
- Rinvoq (upadacitinib)

Step therapy agent list and updates

Agent	Role in step	Notes
One of the preferred adalimumab products	Required step agent (part of the list from which three must be failed)	Examples of adalimumab products were previously listed and later removed; see drug coverage tools for preferred product lists
Entyvio (vedolizumab)	Required step agent (part of the list from which three must be failed)	Infused medications are excluded from the step criteria; Entyvio is listed as a preferred product
Omvoh (mirikizumab-mrkz)	Required step agent (part of the list from which three must be failed)	Listed as a preferred product for step therapy
Rinvoq (upadacitinib)	Required step agent (part of the list from which three must be failed)	Oral agent included in the step list
Simponi (golimumab)	Required step agent (part of the list from which three must be failed)	Listed as a preferred product for step therapy
Skyrizi (risankizumab)	Required step agent (part of the list from which three must be failed)	Added to the step therapy agents per updates
One of the preferred ustekinumab products	Required step agent (part of the list from which three must be failed)	Stelara reference changed to 'One of the preferred ustekinumab products'; see drug coverage tools for preferred product lists
Tremfya (guselkumab)	Required step agent (part of the list from which three must be failed)	Added to the step therapy agents per updates
Xeljanz/Xeljanz XR (tofacitinib)	Required step agent (part of the list from which three must be failed)	Oral JAK inhibitor included in the step list
Zeposia (ozanimod)	Separate required trial	History of failure, contraindication, or intolerance to Zeposia must be documented (date and duration of trial)

Step Therapy

Step therapy requirement before Velsipity coverage

Provider must document trials (drug, date, and duration) showing failure, contraindication, or intolerance to three preferred products listed and to Zeposia (ozanimod) prior to approval for Velsipity. Document the specific drug name, start/stop dates, and duration of each trial. Infused medications are excluded from the step criteria; only self‑administered injectable and oral agents are required. Authorization when approved will be issued for 12 months. Verify member‑specific benefit coverage and any state or federal mandates.

Authorization: 12 months
Verify member-specific benefit coverage / exclusions

What providers must do

Prior Authorization

Step therapy requirement before Velsipity coverage

Prior authorization/step therapy: Member must have history of failure, contraindication, or intolerance to three of the listed preferred products (document drug, date, and duration of trial) and to Zeposia (ozanimod) (document date and duration). Authorization will be issued for 12 months.

Document trials: drug name
Document trials: date(s) of trial
Document trials: duration of trial

Documentation Required

Document prior medication history

Document drug name, dates, and duration of prior trials for the required step agents. UnitedHealthcare may also approve initial and reauthorization requests based solely on previous claim/medication history and diagnosis codes (ICD‑10) as substantiation.

Policy definitions

Preferred products: Refer to drug coverage tools for the list of preferred products (adalimumab and ustekinumab products).

Definition — History of failure, contraindication, or intolerance: Member must have documented trials (drug name, date, and duration) showing failure, contraindication, or intolerance to three of the preferred products listed in the criteria and to Zeposia (ozanimod) prior to approval for Velsipity. Authorization when approved will be issued for 12 months.

Note: UnitedHealthcare may also approve based on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; state mandates and member‑specific benefit plan coverage may further impact criteria.

Policy revision timeline

2024-04P&T Approval

New step therapy program established requiring members to try two self-administered injectable products before coverage of Velsipity; infused medications excluded from criteria.

2024-10P&T Approval / Revision

Updated step requirement to note preferred adalimumab products (Humira, Amjevita, Hyrimoz) with no change to clinical intent; removed preferred adalimumab footnote and added Entyvio, Omvoh, and Skyrizi as step therapy agents.

2024-11P&T Approval / Revision

Added Tremfya as a step therapy agent and updated background and references.

Coding references

ICD-10ICD-10

No codes listed