ModifiedCignaPolicy N/A

PREFFERED SPECIALTY MANAGEMENT POLICY

Defines preferred vs non-preferred product placement and exception criteria for Zeposia (ozanimod) within Cigna Preferred Specialty Management Program for Multiple Sclerosis and Ulcerative Colitis, including required trials of preferred products, continuation requirements, verification via claims or prescriber, and approval durations.

Policy Summary

PayerCigna

PolicyPREFFERED SPECIALTY MANAGEMENT POLICY

Policy CodePolicy N/A

Change TypeMultiple product list updates and preferred/non-preferred status revisions

Effective DateJan 1, 2025

Next Review Date

Key ActionProvider must document that patient meets the standard 'Multiple Sclerosis and Ulcerative Colitis (Oral - Sphingosine 1-Phosphate Receptor Modulator) - Zeposia Prior Authorization Policy' criteria to support approval.

SourceLink

POLICY UPDATE CHANGES

Policy name changes and multiple product list updates effective 01/01/2026, including removal of Cyltezo as Preferred adalimumab and specifying adalimumab-ryvk NDCs starting with 82009 as Preferred; Stelara removed as Preferred ustekinumab.

Imuldosa SC was added as a Preferred ustekinumab product effective 10/01/2025.

Selarsdi, ustekinumab-ttwe, and Yesintek SC were added as Preferred ustekinumab SC products; annotated that trial of more than one ustekinumab SC product counts as one preferred product.

Ulcerative Colitis: Humira (NDCs starting with 00074) and Hyrimoz (NDCs starting with 61314) were removed from Preferred Products; Tremfya SC and Omvoh SC added as Preferred Products.

Velsipity was added as a Preferred Product for Ulcerative Colitis.

A descriptor of Choice/Alternate was added to the policy name.

2Indications addressed (MS, UC)

1 year

Typical continuation approval duration

6 monthsInitial approval duration for UC (Zeposia)

130 daysClaims look-back period for verification

Coverage Summary

This policy places Zeposia (ozanimod) as a Preferred product for Multiple Sclerosis and as Non-Preferred for Ulcerative Colitis (directed to trials of preferred products). It is part of the Cigna Preferred Specialty Management Program and defines required prior authorization rules, trial requirements of Step 1 preferred therapies for UC, continuation/verification requirements via prescription claims or prescriber verification, and standard approval durations.

Document-level stats and thresholds

Indications addressed2 (Multiple Sclerosis, Ulcerative Colitis)

Typical continuation approval duration1 year

Initial approval duration for UC (Zeposia)6 months

Claims look-back period for verification130 days

Established on Zeposia duration (continuation verification)>= 90 days with at least a 90-day supply dispensed within past 130 days

Claims history look-back (threshold entry)130 days

Non-Preferred Product Exception & Continuation Criteria

Non-Preferred Product Exception Criteria - Zeposia

Zeposia non-preferred product(s) is(are) covered as medically necessary when the following non-preferred product exception criteria is(are) met.

ANY of the following

Multiple Sclerosis
- Patient meets the standard Multiple Sclerosis and Ulcerative Colitis (Oral - Sphingosine 1-Phosphate Receptor Modulator) - Zeposia Prior Authorization Policy criteria.
Ulcerative Colitis - Initial Therapy
- Patient meets the standard Multiple Sclerosis and Ulcerative Colitis (Oral - Sphingosine 1-Phosphate Receptor Modulator) - Zeposia Prior Authorization Policy criteria.
- Patient has tried TWO of the following preferred products: an adalimumab product, Omvoh subcutaneous, Skyrizi subcutaneous (on-body injector), ustekinumab subcutaneous product, Tremfya subcutaneous, Velsipity, or Zymfentra.

Product Groups & Examples

Preferred Products - Multiple Sclerosis (Step 1)mixedCovered

Zeposia

ozanimod capsules (Preferred for Multiple Sclerosis)

Preferred Products - Ulcerative Colitis (Step 1)mixedCovered

adalimumab-adbm	adalimumab product (Preferred for UC)
adalimumab-adaz	adalimumab product (Preferred for UC)
adalmimumab-ryvk (NDCs starting with 82009)	adalimumab-ryvk NDCs starting with 82009 (Preferred for UC)
Simlandi	adalimumab product (Preferred for UC)
Omvoh SC	Preferred for UC
Skyrizi SC (on-body injector)	Preferred for UC
Imuldosa SC	ustekinumab SC product (Preferred for UC)
Selarsdi SC	ustekinumab SC product (Preferred for UC)
ustekinumab-ttwe SC	ustekinumab SC product (Preferred for UC)
Yesintek SC	ustekinumab SC product (Preferred for UC)

1–10 of 13

1/2

Non-Preferred Products - Step 2 (Ulcerative Colitis)mixedNot Covered

Zeposia

ozanimod capsules (Non-Preferred for Ulcerative Colitis; requires exception criteria)

Examples of adalimumab products (Note / examples)mixed

Humira	adalimumab example
Abrilada	adalimumab example
adalimumab-aacf	adalimumab example
adalimumab-fkjp	adalimumab example
adalimumab-aaty	adalimumab example
adalimumab-ryvk	adalimumab example (preferred when NDCs start with 82009)
Amjevita	adalimumab example
Cyltezo	adalimumab example (removed later per history)
Hadlima	adalimumab example
Hulio	adalimumab example

1–10 of 14

1/2

Examples of ustekinumab products (Note / examples)mixed

Stelara/ustekinumab	ustekinumab example (varied preferred status by plan; removed as Preferred in later history)
Wezlana	ustekinumab example
Otufli	ustekinumab example
Pyzchiva	ustekinumab example
ustekinumab-aekn	ustekinumab example
Starjemza	ustekinumab example
Steqeyma	ustekinumab example

Other IV/SC products counted as trials (examples)mixed

Remicade	infliximab IV example (including biosimilars)
Simponi SC	counts as trial
Entyvio IV/SC	vedolizumab IV or SC counts as trial
Omvoh IV	Omvoh IV counts as trial
Skyrizi IV	counts as trial
Tremfya IV	counts as trial

Provider Requirements & Authorization Actions

Prior Authorization

Meet standard Zeposia PA criteria

Provider must document that the patient meets the standard Multiple Sclerosis and Ulcerative Colitis (Oral - Sphingosine 1-Phosphate Receptor Modulator) - Zeposia Prior Authorization Policy criteria to support approval of Zeposia.

Codes: Zeposia

Step Therapy

Required trials of preferred products for UC initial therapy

For ulcerative colitis initial therapy, prior authorization for Zeposia requires that the patient has tried TWO preferred products (or qualifying alternative trials listed in the policy) before approval as a non-preferred product.

adalimumab product (examples listed in policy)
Omvoh SC

Background & Evidence

Zeposia (ozanimod), a sphingosine 1‑phosphate receptor modulator, is indicated for relapsing forms of multiple sclerosis and for moderately to severely active ulcerative colitis in adults. Within this formulary program Zeposia is listed as Preferred for Multiple Sclerosis (Step 1) and as Non-Preferred for Ulcerative Colitis (Step 2), where approval for UC is directed to trials of TWO Step 1 preferred products.

Definitions

Preferred Product (definition)Medications designated by the formulary as first-line choices; patients generally required to try preferred products prior to non-preferred unless exception criteria are met.

Verification in prescription claims history required (definition)Confirmation via paid pharmacy claims that medication was dispensed for specified duration within a 130-day look-back period.

Prescribing information reference: Zeposia capsules [prescribing information], Celgene/Bristol Myers Squibb; August 2023.

Policy Revision History

01/01/2025added

A descriptor of Choice/Alternate was added to the policy name.

01/01/2025revised

Ulcerative Colitis: Humira (NDCs starting with 00074) and Hyrimoz (NDCs starting with 61314) were removed from Preferred Products; Tremfya SC and Omvoh SC added as Preferred Products.

01/01/2025added

Velsipity was added as a Preferred Product for Ulcerative Colitis.

Policy Summary

PayerCigna

PolicyPREFFERED SPECIALTY MANAGEMENT POLICY

Policy CodePolicy N/A

Change TypeMultiple product list updates and preferred/non-preferred status revisions

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

A trial of certain IV products or other listed alternatives also counts (see Note)

Ulcerative Colitis - Patient Currently Receiving Zeposia

Patient meets the standard Multiple Sclerosis and Ulcerative Colitis (Oral - Sphingosine 1-Phosphate Receptor Modulator) - Zeposia Prior Authorization Policy criteria.
ONE of
- Patient has tried TWO of an adalimumab product, Omvoh subcutaneous, Skyrizi subcutaneous, ustekinumab subcutaneous product, Tremfya subcutaneous, Velsipity, or Zymfentra.
  A trial of infliximab IV products (e.g., Remicade, biosimilars), Simponi SC, Entyvio IV or SC, Omvoh IV, Skyrizi IV, ustekinumab IV product, or Tremfya IV also counts.
- Patient has been established on Zeposia for at least 90 days and prescription claims history indicates at least a 90-day supply of Zeposia was dispensed within the past 130 days.>= 90 days dispensed within past 130 days
  [verification in prescription claims history required]; if claims history not available, prescriber verification allowed provided patient received Zeposia via paid claims (no samples/coupons).

Program-wide continuation and verification rules

Requirements that apply to continuation of therapy for Preferred and Non-Preferred products

ALL of the following

Continuation verification: Continuation approvals must be supported with verification either via prescription claims history or prescriber verification as noted in criteria.
Claims history requirement: If patient has at least 130 days of prescription claims history, claims must show the patient received the Non-Preferred product for the specified period (90 or 120 days) within a 130-day look-back period.130 days look-back
Prescriber verification alternative: If 130 days of claims history unavailable, prescriber must verify the patient received the Non-Preferred product for the specified period and that the patient received it via paid claims (not samples/coupons).
Approval duration note: Approval duration: All approvals for continuation of therapy for Preferred and Non-Preferred Products are provided for 1 year unless noted otherwise. When initial approval is in months, 1 month = 30 days.

Requirement when criterion for trials not met

If candidate meets Zeposia PA criteria but fails required trials of preferred products

Offer to review for a Preferred Product using the respective standard Inflammatory Conditions Prior Authorization Policy criteria when trial requirements (e.g., 2 preferred products) are not met.

Lists of preferred product examples provided in policy.

Skyrizi SC (on-body injector)

ustekinumab SC product (preferred examples include Imuldosa SC, Selarsdi SC, ustekinumab-ttwe SC, Yesintek SC)

Documentation Required

Verification of prescription claims history

For continuation or established-use approvals, providers must supply verification either via prescription claims history or prescriber verification. If claims history is available (≥130 days), it must show the specified days of therapy within a 130-day look-back. If claims history is unavailable, prescriber verification must confirm the therapy was received via paid claims (no samples/coupons).

Claims look-back period: 130 days
Verification must document paid claims only (no samples or coupons)

Billing Rule

Approval duration reporting

Approvals are generally issued for 1 year unless otherwise noted. When initial approval is authorized in months, 1 month = 30 days.

Step Therapy

Offer Preferred Product review when trial criteria not met

If the patient meets the Zeposia PA criteria but has not met the required trials of preferred products, offer to review the patient for a Preferred Product using the respective standard Inflammatory Conditions Prior Authorization Policy criteria.

03/21/2025added

Selarsdi, ustekinumab-ttwe, and Yesintek SC were added as Preferred ustekinumab SC products; annotated that trial of more than one ustekinumab SC product counts as one preferred product.

03/12/2025clarified

Stelara intravenous is referred to as ustekinumab intravenous throughout the policy.

06/04/2025added

Footnote added that Stelara is non-preferred for some plans; cross-reference to alternate policy.

10/01/2025added

Imuldosa SC was added as a Preferred ustekinumab product effective 10/01/2025.

01/01/2026revisedLatest