CurrentCignaPolicy PSM015

Multiple Sclerosis and Ulcerative Colitis - Zeposia Preferred Specialty Management

Defines Cigna's preferred specialty management and non-preferred product exception criteria for ozanimod (Zeposia) for members with relapsing forms of multiple sclerosis and moderately to severely active ulcerative colitis across specified drug list plans.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis and Ulcerative Colitis - Zeposia Preferred Specialty Management

Policy CodePolicy PSM015

Change TypePreferred product list updates

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization and document either two trials of preferred products for UC initial approval or claims-based verification (90-day supply within a 130-day look-back) for continuation.

SourceLink

POLICY UPDATE CHANGES

Velsipity was added as a Preferred Product for ulcerative colitis.

Omvoh subcutaneous was added as a Preferred Product for ulcerative colitis.

Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous were added as Preferred ustekinumab SC products.

Stelara was removed as a Preferred ustekinumab product.

Specified that adalimumab-ryvk NDCs starting with 82009 are identified as a preferred adalimumab product.

130Look-back period (days)

90 daysContinuation supply threshold

6 months

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Coverage Criteria for Zeposia (ozanimod)

Non-Preferred Product Exception Criteria

Zeposia is considered medically necessary when the following non-preferred product exception criteria are met. Any other exception is considered not medically necessary.

Main indication branches

1. Multiple Sclerosis: Approve for 1 year if the patient meets the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy criteria.
MS approvals follow standard PA criteria
2. Ulcerative Colitis - Initial Therapy: Approve for 6 months if BOTH criteria i and ii are met: i) patient meets the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy criteria; AND ii) patient has tried TWO of the specified preferred products (adalimumab products, Omvoh subcutaneous, Skyrizi subcutaneous, preferred ustekinumab subcutaneous products, Tremfya subcutaneous, Velsipity, Zymfentra) or an acceptable alternative IV/subcutaneous biologic trial as specified in policy.
Two preferred-product trials required; alternatives (certain IV/subcutaneous biologics) may count per policy
3. Ulcerative Colitis - Patient is Currently Receiving Zeposia: Approve for 1 year if BOTH criteria i and ii are met: i) patient meets the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy criteria; AND ii) patient meets ONE of the following: (a) patient has tried TWO of the listed preferred products or acceptable alternative biologic trials; OR (b) patient has been established on Zeposia for at least 90 days and prescription claims history shows at least a 90-day supply dispensed within the past 130 days (verification in prescription claims history required); if 130 days of claims history is unavailable, prescriber verification that the patient has received Zeposia for at least 90 days via paid claims is acceptable per policy.
Continuation criteria include claims-based verification or prescriber attestation

Operational note: All approvals must also meet the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy criteria. If criteria for preferred-product trials are not met, requests for Preferred Products may be reviewed under their respective prior authorization criteria as described in policy.

See policy for examples of preferred products and acceptable alternative biologic trials

Any request for Zeposia that does not meet the policy's specified non-preferred product exception criteria is not medically necessary. The policy defines Zeposia as a Step 2 non-preferred product for ulcerative colitis and permits approval only when one of the documented exception pathways in the Non-Preferred Product Exception Criteria is satisfied.

Requests for Zeposia that fail to meet the designated exception criteria will be denied as not medically necessary. Providers should refer to the Non-Preferred Product Exception Criteria for the specific approval pathways (Multiple Sclerosis, Ulcerative Colitis initial therapy, and continuation scenarios) that must be met for coverage.

Initial Therapy Criteria — Ulcerative Colitis

Ulcerative Colitis - Initial Therapy

Initial therapy exceptions for Zeposia (non-preferred for ulcerative colitis).

UC initial therapy exception

i: Patient meets the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy criteria.
Standard PA criteria required
ii: Patient has tried TWO of the following preferred products: adalimumab products; Omvoh subcutaneous; Skyrizi subcutaneous; preferred ustekinumab subcutaneous products (examples listed in policy); Tremfya subcutaneous; Velsipity; or Zymfentra. A trial of certain IV/subcutaneous biologics (e.g., infliximab intravenous products, Simponi subcutaneous, Entyvio IV/SC, Omvoh IV, Skyrizi IV, ustekinumab IV, or Tremfya IV) also counts as an acceptable trial per policy.
If criterion ii is not met, a Preferred Product request may be reviewed under the respective prior authorization criteria

Continuation of Therapy Criteria

Continuation of Therapy

Continuation of therapy rules for patients already on Zeposia or other non-preferred products.

Continuation requirements

Verification options
- a: Prescription claims history on file for at least 130 days that documents the patient has received the Non-Preferred Product for the specified period (e.g., at least a 90-day supply within the past 130 days).130 days look-back; >= 90 days supply
  Claims history must show at least a 90-day supply within the 130-day look-back when required
- b: When 130 days of the patient's prescription claim history file is unavailable, the prescriber must verify that the patient has been receiving the Non-Preferred Product for the specified period (e.g., at least 90 days) and that therapy was obtained via paid claims (no samples/coupons/waivers).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Zeposia requires prior authorization and must meet the referenced Prior Authorization Policy criteria (Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy). Requests for Zeposia will be reviewed under that prior authorization program.

Refer to the standard Multiple Sclerosis and Ulcerative Colitis - Zeposia Prior Authorization Policy for condition-specific criteria and documentation requirements.

Step Therapy

Preferred Product Trial Requirement

The Inflammatory Conditions program requires trials of Preferred Products when clinically appropriate before approving Non‑Preferred products. Requests for Zeposia as a Non‑Preferred product must demonstrate that the patient has tried the required Preferred Product(s) per the program criteria (exceptions are specified in the Non‑Preferred Product Exception Criteria).

Preferred product trials: see Step 1 Preferred products list for Multiple Sclerosis and Ulcerative Colitis (e.g., adalimumab products, Omvoh SC, Skyrizi SC, ustekinumab SC, Tremfya SC, Velsipity).

Coding and Prescription History

inv-05: Prescription claims look-back period

Look-back period130 days (prescription claims history look-back for verification)

PurposeUsed to verify continuity of therapy and required prior supply when evaluating continuation requests

When unavailableIf 130 days of claims history is unavailable, prescriber verification may be accepted per policy revision

inv-06: Required prior supply for continuation — 90 days within last 130 days

Required prior supply90 days (must show at least a 90-day supply dispensed within the 130-day look-back)

Verification methodClaims history must indicate the 90-day supply; if claims history unavailable, prescriber must verify duration and that product was obtained via paid claims (no samples/coupons)

Step Therapy Requirements

Step	Requirement
Step 1 (Preferred)	Preferred products must be tried when clinically appropriate prior to approval of non-preferred Zeposia for ulcerative colitis. Step 1 preferred products for UC include adalimumab products, Omvoh SC, Skyrizi SC (on-body injector), preferred ustekinumab SC products (Selarsdi SC, ustekinumab-ttwe SC, Yesintek SC), Tremfya SC, and Velsipity.
Step 2 (Non-Preferred) — Zeposia	Non-preferred Zeposia (Step 2) requires prior trials of TWO Step 1 preferred products for initial ulcerative colitis therapy; approval is granted only if exception criteria are met (see Non-Preferred Product Exception Criteria).

Definitions

inv-12: Definition — ozanimod; sphingosine 1-phosphate receptor modulator indicated for relapsing MS and moderate-to-severe UC

Generic name and classOzanimod — sphingosine 1-phosphate (S1P) receptor modulator

Indication 1Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing remitting, and active secondary progressive disease) in adults

Indication 2Moderately to severely active ulcerative colitis in adults

Background

Zeposia (ozanimod) is a sphingosine 1‑phosphate receptor modulator indicated for relapsing forms of multiple sclerosis and for moderately to severely active ulcerative colitis in adults. Within this policy, Zeposia is treated as a non‑preferred product for ulcerative colitis (Step 2) and as a preferred option for multiple sclerosis (Step 1); approval for non‑preferred use in ulcerative colitis requires meeting the documented exception criteria, including trials of preferred products or continuation verification.

Revision History

2026-01-01annual_revisionLatest

Annual revision: policy reviewed (Coverage Policy Number PSM015); specified that adalimumab-ryvk NDCs starting with 82009 are identified as a preferred adalimumab product.

2025-09-01annual_revision

Annual revision: Ulcerative Colitis preferred product list clarified to specify adalimumab-ryvk NDCs starting with 82009 as preferred.

2025-04-15removal

Ulcerative Colitis: adalimumab-adaz was removed from the Preferred Product list; note updated with examples of ustekinumab products.