CurrentUnitedHealthcarePolicy 2025 P 2264-8

Zeposia (ozanimod) prior authorization / medical necessity

UnitedHealthcare prior authorization and medical necessity policy for Zeposia (ozanimod) covering indications for relapsing forms of MS and moderately to severely active ulcerative colitis in adults, with detailed initial and reauthorization clinical criteria, combination therapy exclusions, prescriber requirements, authorization duration, and change history. Effective 2025-06-01.

Policy Summary

PayerUnitedHealthcare

PolicyZeposia (ozanimod) prior authorization / medical necessity

Policy CodePolicy 2025 P 2264-8

Change TypeAdministrative/step therapy updates

Effective DateJun 1, 2025

Next Review Date

Key ActionZeposia requires prior authorization; approval duration is 12 months for both initial authorization (MS or UC) and reauthorization.

POLICY UPDATE CHANGES

Policy maintained through multiple P&T reviews with step therapy/ preferred product list updates; latest annual/administrative updates through 4/2025 noting adjustments to preferred adalimumab and ustekinumab language.

2Indications listed

12Authorization duration (months)

multipleP&T review dates

Coverage Summary

Initial Therapy Criteria

Authorization - Multiple Sclerosis

Zeposia will be approved based on the following criterion:

ALL of the following

Diagnosis of multiple sclerosis (MS)

Authorization will be issued for 12 months.

Initial Authorization - Ulcerative Colitis (UC)

Zeposia will be approved based on all of the following criteria:

Diagnosis of moderately to severely active UC

ONE of the following

ANY of the following
- Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)
- Patient has been previously treated with a biologic or targeted synthetic DMARD documented by claims history or submission of medical records (Document drug, date, and duration of therapy). Examples include: adalimumab, Simponi (golimumab), ustekinumab, Xeljanz (tofacitinib), Rinvoq (upadacitinib)
  Examples of biologic/targeted agents are provided as operational guidance and mirror code group listings.

ONE of the following

History of failure to two preferred products: History of failure, contraindication, or intolerance to two 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); Simponi (golimumab); Skyrizi (risankizumab); One of the preferred ustekinumab products; Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib)
See drug coverage tools for list of preferred adalimumab/ustekinumab products.
OR alternative for current users: Both of the following: Patient is currently on Zeposia therapy as documented by claims history or submission of medical records (Document drug, date, and duration of therapy); and patient has not received a manufacturer supplied sample at no cost in the prescriber's office, or any form of assistance from the Bristol Myers Squibb sponsored Zeposia 360 Support Program as a means to establish as a current user of Zeposia
Patients established on therapy via manufacturer samples/assistance must meet initial criteria as if new to therapy.

Patient is not receiving Zeposia in combination with a targeted immunomodulator (examples: adalimumab, Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), ustekinumab, Skyrizi (risankizumab), Omvoh (mirikizumab-mrkz), Entyvio (vedolizumab))

Examples reflect targeted immunomodulators listed in policy.

Prescribed by or in consultation with a gastroenterologist

Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Reauthorization

Zeposia will be approved for reauthorization based on both of the following criteria:

Documentation of positive clinical response to Zeposia therapy

Patient is not receiving Zeposia in combination with another targeted immunomodulator (examples: adalimumab, Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), ustekinumab, Skyrizi (risankizumab), Omvoh (mirikizumab-mrkz), Entyvio (vedolizumab))

Examples reflect targeted immunomodulators listed in policy.

Authorization will be issued for 12 months.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Zeposia requires prior authorization. Approval will be issued for 12 months for both initial authorization and reauthorization.

Documentation Required

Document prior therapies and responses

For UC initial criteria, document prior biologic or targeted synthetic DMARD therapy or trials of corticosteroids/immunosuppressants by recording the drug name, date, and duration of therapy. For current users, document claims history or submit medical records showing drug, date, and duration.

Document drug name, date, and duration for prior biologic/targeted synthetic DMARDs
Document drug name, date, and duration for corticosteroid or immunosuppressant trials (e.g., azathioprine, 6-mercaptopurine)
Claims history or submission of medical records is acceptable for documentation

Documentation Required

Combination therapy exclusion

Do not approve if the patient is receiving Zeposia in combination with another targeted immunomodulator. Verify concomitant medications and ensure the patient is not on any listed targeted immunomodulators.

Examples of targeted immunomodulators to exclude: adalimumab, Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), ustekinumab, Skyrizi (risankizumab), Omvoh (mirikizumab-mrkz), Entyvio (vedolizumab)

Documentation Required

Prescriber specialty requirement

For ulcerative colitis, Zeposia must be prescribed by or in consultation with a gastroenterologist.

Billing Rule

Automated approvals may apply

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claims/medication history, diagnosis codes (ICD-10), and/or claim logic. Automated approval and re-approval processes may be used and supply limits may apply.

Approvals may be based on claims history, medication history, and ICD-10 diagnosis codes
Supply limits may be in place

Background

Zeposia is an S1P (sphingosine 1-phosphate) receptor modulator indicated for relapsing forms of multiple sclerosis and moderately to severely active ulcerative colitis in adults. The policy requires prior authorization and sets step-therapy-like requirements for UC (documenting prior corticosteroid/immunosuppressant or biologic/targeted synthetic DMARD therapy) and includes explicit combination therapy exclusions.

Targeted immunomodulator: Includes biologic and targeted synthetic disease-modifying therapies listed in the policy (e.g., adalimumab, etanercept, golimumab, ustekinumab, tofacitinib, upadacitinib, etc.).

Revision History

12/2021P&T update

New prior authorization program created for Zeposia (new program).

5/2022P&T update

P&T update (5/2022) with program maintenance; added Xeljanz and Rinvoq as preferred products for UC step therapy and added Rinvoq as an example of a JAK inhibitor.

1/2023P&T update

P&T update (1/2023) updated step therapy examples to reference Humira or Amjevita and updated listed examples from Humira to adalimumab.

4/2023P&T update

P&T update (4/2023) changed step therapy requirement from Humira or Amjevita to 'one of the preferred adalimumab products' and added a footnote directing to drug coverage tools for preferred adalimumab product list.

4/2024P&T update

Annual review (4/2024) retained preferred adalimumab product footnote directing to drug coverage tools; no change to clinical intent for combination therapy examples.

10/2024P&T update

P&T update (10/2024) updated step therapy examples to note Adalimumab-adaz (Hyrimoz unbranded), Amjevita, and Humira as preferred adalimumab products; removed preferred adalimumab footnote and added Entyvio, Omvoh and Skyrizi as step therapy agents.

11/2024P&T update

P&T update (11/2024) added Tremfya as a step therapy agent.

4/2025P&T updateLatest

P&T update (4/2025) removed adalimumab examples from step therapy language, changed Stelara wording to 'one of the preferred ustekinumab products', and added the footnote: 'For a list of preferred products please reference drug coverage tools.'

OpenPayer

Zeposia (ozanimod) prior authorization / medical necessity

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Combination Therapy Exclusions

Referenced Agents / Code Groups

Provider Actions & Authorization Requirements

Clinical Evidence & References

Background

Revision History

	adalimumab (examples include Humira, Amjevita, adalimumab-adaz/Hyrimoz/unbranded)
	Simponi (golimumab)
	ustekinumab (Stelara / preferred ustekinumab products)
	Xeljanz (tofacitinib)
	Rinvoq (upadacitinib)
	Entyvio (vedolizumab)
	Omvoh (mirikizumab-mrkz)
	Skyrizi (risankizumab)
	Tremfya (guselkumab)
	Enbrel (etanercept)