CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy requirements for Zeposia (ozanimod)

Defines step therapy and coverage criteria requiring trial of preferred self‑administered injectable alternatives before coverage of Zeposia for ulcerative colitis; applies to members governed by UnitedHealthcare Pharmacy Clinical Pharmacy Programs administered for Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy requirements for Zeposia (ozanimod)

Policy CodePolicy N/A

Change TypeMaterial — step therapy agent list updated

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain documentation of two failed (or contraindicated/intolerant) preferred self‑administered injectable products or evidence of documented current Zeposia use for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added Tremfya as a step therapy agent.

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

2preferred self‑administered injectable products required before Zeposia

12 moauthorization length

Moderately to severely active UCindication required for approval

Program 1program type

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage / Eligibility Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Ulcerative Colitis approval: Patient has a diagnosis of moderately to severely active ulcerative colitis

Step therapy or current use: One of the following must be met: (1) History of failure, contraindication, or intolerance to two preferred products from the specified list OR (2) patient is currently on Zeposia therapy and was not established via manufacturer sample or assistance program2 preferred product trials OR current documented use

Preferred products include preferred adalimumab products; Entyvio (vedolizumab); Omvoh (mirikizumab-mrkz); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab); one of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib)

Infused medications are excluded from the program requirements. The step therapy rule specifically requires members to trial two self‑administered injectable preferred products prior to coverage of Zeposia (ozanimod); intravenous or other infused therapies do not satisfy this requirement.

Members who are documented as currently receiving Zeposia may qualify under the continuation pathway only if their use was not established solely by receipt of manufacturer‑supplied samples or by assistance from the Bristol Myers Squibb Zeposia 360 Support Program. Patients established only via samples or program assistance must meet initial authorization criteria as if new to therapy.

Prior Authorization, Documentation, and Step Therapy Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. Zeposia (ozanimod) for ulcerative colitis will be approved only when the criteria below are met; authorization is for up to 12 months. State mandates, federal requirements, member benefit plan coverage, and other utilization management programs may affect coverage.

Authorization duration: 12 months
See drug coverage tools for list of preferred products

Step Therapy

Step Therapy Requirement

Step therapy: trial requirement and exclusions. For members not already established on Zeposia, documentation must show failure, contraindication, or intolerance to two preferred self‑administered injectable or oral products from the list below prior to approval. Infused medications are excluded from this step therapy requirement.

Required trials: two preferred products (self‑administered injectables or oral agents) from list in criteria

Key Definitions

Current user via sample/assistance

DefinitionA patient established on Zeposia therapy documented in claims history; patients established solely via manufacturer samples or Bristol Myers Squibb Zeposia 360 Support Program assistance are NOT considered current users for exemption and must meet initial authorization criteria.

Documentation needed to prove current userClaims history showing prior paid fills for Zeposia (ozanimod) — mere receipt of manufacturer samples or program assistance is insufficient.

Effect on authorizationMembers documented as current users (per claims) may qualify for continuation criteria; those only established via samples/assistance must meet initial authorization requirements including step therapy rules.

Initial Authorization Criteria

Initial Therapy — Zeposia (ozanimod) initial authorization criteria

Initial authorization for Zeposia:

Initial authorization: Diagnosis of moderately to severely active ulcerative colitis

Step therapy alternatives: History of failure, contraindication, or intolerance to two preferred products from the list OR documented current Zeposia user meeting program rules2 preferred agents or documented current use

Preferred products enumerated in policy include preferred adalimumab products; Entyvio (vedolizumab); Omvoh (mirikizumab-mrkz); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab); preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib). Infused medications are excluded from the step therapy requirement.

Continuation of Therapy

Continuation Therapy — criteria for ongoing authorization/renewal

Continuation of therapy

Continuation: Members currently on Zeposia therapy as documented in claims history will be allowed to continue on their current therapy

Authorization will be issued for 12 months

Step Therapy Requirements and Preferred Agents

Step	Requirement	Preferred agents
1	Member must trial two preferred self-administered injectable products for ulcerative colitis prior to coverage of Zeposia (ozanimod). Infused medications are excluded from the step therapy requirement.	One of the preferred adalimumab products; Entyvio (vedolizumab); Omvoh (mirikizumab-mrkz); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab); one of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib).

Quantity Limits

Zeposia (ozanimod) — Quantity limits summary

Per-fill supply limitsSupply limits and/or notification may be in place for Zeposia; specific limits applied per program rules.

Unit of measurePer-fill limits are applied as supply limits (days' supply or quantity) per the program's dispensing rules.

Additional rulesSupply limits and notifications are considered additional clinical rules and may restrict quantity dispensed at pharmacy.

Site of Care / Infusion Exclusion

Note

Infused medications excluded from step therapy

Step therapy exclusions: infused medications are not considered in the two‑product trial requirement — the step therapy applies only to self‑administered injectable products.

Applies only to self‑administered injectables; infused medications are excluded from the step therapy requirement

Background

Zeposia (ozanimod) is a sphingosine 1‑phosphate receptor modulator approved for relapsing forms of multiple sclerosis and for moderately to severely active ulcerative colitis in adults. Within this program, coverage for Zeposia for UC is managed through step therapy that encourages trial of lower‑cost, self‑administered injectable alternatives prior to approval.