Cigna Zeposia Prior Auth Policy Update

Coverage Criteria for Zeposia (ozanimod)

FDA-Approved Indication Criteria

Covered when ONE of the following for each indication is met (criteria are indication-specific).

MS Approve

A) Initial Therapy: Documentation the patient has a relapsing form of multiple sclerosis; AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
Approve for 1 year
B) Patient Currently Receiving Zeposia ≥1 year: Documentation the patient has a relapsing form of multiple sclerosis; AND patient meets ONE of the objective clinical response criteria; AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
Approve for 1 year; examples of objective measures provided (e.g., MRI, EDSS, NEDA, relapse reduction, functional measures)

UC Approve

A) Initial Therapy: Patient is ≥ 18 years of age; AND medication is prescribed by or in consultation with a gastroenterologist
Approve for 6 months
B) Patient Currently Receiving Zeposia: Patient has been established on therapy for at least 6 months; AND patient meets at least one of the following: (a) experienced a beneficial clinical response by at least one objective measure (e.g., fecal calprotectin, CRP, endoscopic assessment, reduced corticosteroid dose); OR (b) experienced improvement in at least one symptom compared with baseline (e.g., decreased pain, fatigue, stool frequency, or rectal bleeding)
Approve for 1 year

The policy specifies that concurrent use of Zeposia with other disease‑modifying agents used for multiple sclerosis is considered not medically necessary. The rationale notes these agents are not indicated for combination use and additional data are required to determine safety and additive efficacy; Appendix B provides examples of MS agents. The policy also states that combination therapy with biologics, targeted synthetic oral small molecule drugs, or other potent immunosuppressants is not recommended because of potentially higher adverse event rates and lack of controlled data supporting added benefit.

Appendix A is presented as a non‑inclusive list of indications and agent characteristics and explicitly directs readers to the prescribing information for each product for full FDA‑approved indications and details. The appendix uses abbreviations (e.g., SC, IV, TNF, JAK) and clarifies it does not list all possible indications or formulations.

Use of Zeposia for any indication not listed in the FDA‑approved indications is considered not medically necessary. The policy enumerates specific examples such as non‑relapsing forms of multiple sclerosis and concurrent therapy combinations to illustrate this principle.

No additional exclusions or contraindications beyond those specified in the main policy text are provided in the extracted appendix material. The appendix content focuses on listing agents and abbreviations and reiterates that the appendix is not all‑inclusive and to consult prescribing information for details.

Coding, Durations, and Related Details

Covered CPT/HCPCS/ICD-10 codesmixed

No codes listed

Drug listings (no billing codes provided)mixed

Zeposia	ozanimod tablets / capsules
Velsipity	etrasimod tablets
Otezla	apremilast tablets
Cibinqo	abrocitinib tablets
Olumiant	baricitinib tablets
Litfulo	ritlecitinib capsules
Leqselvi	deuruxolitinib tablets
Rinvoq	upadacitinib extended-release tablets / oral solution
Sotyktu	deucravacitinib tablets
Xeljanz	tofacitinib tablets / oral solution / extended-release tablets

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Approval and Therapy Durations

MS — Initial therapy durationApprove for 1 year when initial therapy criteria are met

MS — Currently receiving ≥1 yearApprove for 1 year when continuation criteria are met (patient receiving Zeposia ≥1 year)

UC — Initial therapy durationApprove for 6 months when initial therapy criteria are met (patient ≥18 years and prescribed by/with a gastroenterologist)

UC — Established on therapy ≥6 monthsApprove for 1 year when continuation criteria are met (patient established on therapy ≥6 months with documented beneficial clinical response or symptom improvement)

NoneNone

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required — Prior authorization recommended for Zeposia; approvals are for specified durations and require prescription or consultation.

Prior Authorization Required — Prior authorization is recommended for Zeposia. Approvals are provided for the durations noted in the FDA‑Approved Indications criteria below. When approvals are expressed in months, 1 month = 30 days. Zeposia must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist for MS, gastroenterologist for UC). The requested product also requires use of preferred products per the referenced Preferred Specialty Management (PSM) policies prior to approval.

Prior authorization recommended for Zeposia (IP0655).
Approval durations correspond to specific indications (see FDA‑Approved Indications: MS and UC).
Prescriber requirement: specialist or in consultation with specialist.

Prior Authorization

Approval Durations — Approval durations for MS and UC (initial and continuation) summarized for provider action.

Approval Durations — For Multiple Sclerosis: Initial therapy approvals are for 1 year; continuation (patients currently receiving Zeposia ≥1 year) approvals are for 1 year. For Ulcerative Colitis: Initial therapy approvals are for 6 months; continuation (patients established on therapy ≥6 months) approvals are for 1 year. Providers should follow the initial vs continuation criteria when requesting authorization.

Initial Therapy Approval Criteria

Initial Therapy

Initial therapy approval criteria.

MS initial: Documentation the patient has a relapsing form of multiple sclerosis; AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Approve for 1 year

UC initial: Patient is ≥ 18 years of age; AND medication is prescribed by or in consultation with a gastroenterologist

Approve for 6 months

Continuation Therapy Criteria

Continuation Therapy

Criteria for patients currently receiving Zeposia.

MS continuation: Documentation the patient has a relapsing form of multiple sclerosis; AND patient has been receiving Zeposia for ≥ 1 year; AND patient experienced a beneficial clinical response or stabilization/improvement in symptoms as assessed by at least one objective measure (examples include MRI findings, EDSS, NEDA status, relapse reduction, or functional tests); AND medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Approve for 1 year

UC continuation: Patient has been established on therapy for at least 6 months; AND patient experienced a beneficial clinical response from baseline by at least one objective measure (e.g., fecal calprotectin, CRP, endoscopic assessment, or reduced corticosteroid dose) OR experienced improvement in at least one symptom compared with baseline (e.g., decreased pain, fatigue, stool frequency, rectal bleeding); AND medication is prescribed by or in consultation with a gastroenterologist

Approve for 1 year

Step Therapy / Preferred Product Requirements

Step	Requirement
1	Use of preferred products is required before approval per the referenced Preferred Specialty Management Policies (PSM004, PSM008, PSM015).

Site of Care and Administration

Billing Rule

Ensure dosing and site of care are clinically appropriate

Dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence‑based literature and adjusted based on severity, alternatives, and prior response to therapy.

Note

Confirm administration mode per agent

Mode of administration is specified per agent in Appendix B (oral, injection self‑administered, intravenous infusion); note that some subcutaneous formulations are listed as not self‑administered.

Confirm agent-specific administration mode from Appendix B when completing PA or claims.

Biosimilars and Appendix Updates

Billing Rule

Ustekinumab (Stelara) biosimilars noted in Appendix A

Appendix A was updated to note biosimilars are available for ustekinumab (Stelara); providers should be aware of the biosimilar listing in Appendix A.

Background

Zeposia (ozanimod) is a sphingosine 1‑phosphate (S1P) receptor modulator approved for treatment of relapsing forms of multiple sclerosis in adults and for moderately to severely active ulcerative colitis in adults. The policy background and appendices note Zeposia’s drug class and reference prescribing information and guideline context for use; appendices list related agents and abbreviations but are not exhaustive.

Definitions and Abbreviations

Relapsing Forms of Multiple Sclerosis (examples)

DefinitionRelapsing forms of multiple sclerosis — examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease

Objective Measures of Response for Ulcerative Colitis (examples)

Fecal calprotectinExample of an objective fecal marker used to assess inflammatory response in UC

C-reactive protein (CRP)Example of an objective serum marker used to assess inflammatory response in UC

Endoscopic assessmentEndoscopic evaluation used as an objective measure of response in UC

Reduced corticosteroid doseReduction in corticosteroid dose used as an objective indicator of clinical response in UC

OpenPayer

Zeposia Prior Authorization Policy (Multiple Sclerosis and Ulcerative Colitis — Oral - Sphingosine 1-Phosphate Receptor Modulator)

Coverage Criteria for Zeposia (ozanimod)

Coding, Durations, and Related Details

Provider Actions, Prior Authorization, and Documentation

Initial Therapy Approval Criteria

Continuation Therapy Criteria

Step Therapy / Preferred Product Requirements

Site of Care and Administration

Biosimilars and Appendix Updates

Background

Definitions and Abbreviations