CurrentUnitedHealthcarePolicy N/A

Zeposia (ozanimod) prior authorization

Prior authorization and reauthorization requirements for Zeposia (ozanimod) for UnitedHealthcare members; affects prescribers and pharmacies submitting PA requests.

Policy Summary

PayerUnitedHealthcare

PolicyZeposia (ozanimod) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests; initial approvals are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

MS & UCindications

Prohibitedcombination therapy

Prior Authprogram type

Coverage Criteria for Zeposia (ozanimod)

Initial Authorization - MS

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Initial Authorization - Ulcerative Colitis

Covered when ALL of the following are met

Initial Authorization - Ulcerative Colitis: Diagnosis of moderately to severely active ulcerative colitis

Initial Authorization - Ulcerative Colitis: Patient is not receiving Zeposia in combination with a systemic targeted immunomodulator for treatment of the same indication (e.g., adalimumab, vedolizumab, mirikizumab-mrkz, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab)

Authorization issued for 12 months

Reauthorization

Covered for reauthorization when ALL of the following are met

Reauthorization: Documentation of positive clinical response to Zeposia therapy

Reauthorization: Patient is not receiving Zeposia in combination with a systemic targeted immunomodulator for treatment of the same indication (e.g., adalimumab, vedolizumab, mirikizumab-mrkz, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab)

Authorization issued for 12 months

Use of Zeposia in combination with a systemic targeted immunomodulator for treatment of the same indication is not permitted. Examples of systemic targeted immunomodulators include adalimumab, vedolizumab (Entyvio), mirikizumab (Omvoh), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), and ustekinumab. Coverage may be denied or authorization withheld if Zeposia is prescribed concomitantly with any of these agents for the same condition.

Initial Therapy

Initial approval rules

Initial Therapy: MS: diagnosis of multiple sclerosis (authorization issued for 12 months)

Initial Therapy: UC: diagnosis of moderately to severely active ulcerative colitis AND patient is not receiving Zeposia in combination with a systemic targeted immunomodulator for treatment of the same indication (authorization issued for 12 months)

Continuation Therapy / Reauthorization

Reauthorization requirements

Continuation/Reauthorization: Documentation of positive clinical response to Zeposia therapy

12-month reauthorization

Continuation/Reauthorization: Patient is not receiving Zeposia in combination with a systemic targeted immunomodulator for treatment of the same indication

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continued coverage. Initial approvals for eligible indications (multiple sclerosis and moderately to severely active ulcerative colitis) will be issued for 12 months.

Initial approvals: 12 months (MS, UC)
Prior authorization required for both initial and reauthorization requests

Step Therapy

Step/Therapy and Quantity Rules

Supply limits and/or step therapy may apply; verify plan-specific step/quantity rules before prescribing. UnitedHealthcare may enforce supply limits, quantity caps, or require trial of step-therapy agents per benefit design.

Supply limits and quantity limits may be in place
Step therapy may be required per plan/program

Documentation Required

Reauthorization Documentation Required

Reauthorization requires documentation of positive clinical response to therapy. Include clinical notes, symptom assessment, objective measures when available, and treatment start date to support continued benefit.

Documentation of positive clinical response required for reauthorization
Provide objective and/or clinician-documented improvement compared to baseline

Denial Risk

Combination Therapy Prohibition

Coverage will be denied if Zeposia is used in combination with a systemic targeted immunomodulator for the same indication. Examples include adalimumab, vedolizumab (Entyvio), mirikizumab (Omvoh), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), and ustekinumab.

Combination therapy with systemic targeted immunomodulators for the same indication is not allowed
Examples: adalimumab; vedolizumab (Entyvio); mirikizumab (Omvoh); upadacitinib (Rinvoq); golimumab (Simponi); risankizumab (Skyrizi); guselkumab (Tremfya); tofacitinib (Xeljanz/Xeljanz XR); ustekinumab

Background and Definitions

Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for adults with relapsing forms of multiple sclerosis and for adults with moderately to severely active ulcerative colitis. Authorization rules differ by indication; for ulcerative colitis initial approval requires a documented diagnosis of moderately to severely active disease and other coverage criteria must be met.

Zeposia (ozanimod) mechanism class

Mechanism classSphingosine 1‑phosphate (S1P) receptor modulator

Drug nameZeposia (ozanimod)

Indications referencedRelapsing forms of multiple sclerosis; moderately to severely active ulcerative colitis

Adult useIndicated for use in adults

Therapeutic class summaryOral small‑molecule S1P receptor modulator that modulates lymphocyte trafficking

Step Therapy and Supply Limits

Program rule	Details
Step therapy / supply limits	Supply limits and/or step therapy may be in place. UnitedHealthcare may use automated approval and re‑approval processes based on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; use of these automated processes varies by program and therapeutic class.
Automated approvals	Notwithstanding coverage criteria, initial authorization and reauthorization may be approved solely on the basis of previous claims/medication history, diagnosis codes and/or claim logic when program rules permit.

Site of Care Considerations

Billing Rule

Site-of-care supply limits and step therapy may apply

Supply limits and/or site-specific step therapy may apply when Zeposia is administered in infusion center or other site-of-care settings; program rules may vary by setting.