ModifiedCignaPolicy N/A

Ustekinumab subcutaneous drug quantity management (per days)

Defines quantity limits, overrides, and medical-necessity exceptions for subcutaneous ustekinumab products across Cigna-administered health plans. Applies to retail and home delivery dispensing and affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerCigna

PolicyUstekinumab subcutaneous drug quantity management (per days)

Policy CodePolicy N/A

Change TypeMaterial operational updates to quantity limits, mg unit conversion, and new overrides

Effective Date

Next Review DateJan 4, 2024

Key ActionFor initiation overrides, prescribers must document absence of ustekinumab claims in the past 130 days to qualify for additional dosing.

SourceLink

POLICY UPDATE CHANGES

A note was added that all ustekinumab SC products of the same strength accumulate toward the total quantity limit.

Throughout policy changed the quantity approved to be in 'mg' units; previously approval quantities were provided in '# of syringes or vials'.

New override for Stelara 90 mg prefilled syringes for Crohn's disease or ulcerative colitis with prior 90 mg SC Q8W for 64 weeks to allow up to 90 mg per 28 days (retail) or 270 mg per 84 days (home).

New override was added to approve the requested quantity, not to exceed 1 syringe per 28 days at retail or 3 syringes per 84 days at home delivery for Stelara 90 mg prefilled syringes when used to treat Crohn's disease or ulcerative colitis and the patient has received Stelara 90 mg SC once every 8 weeks for 24 weeks or longer.

New quantity limits and the same overrides previously applied to Stelara were added for multiple additional ustekinumab products and brands (Wezlana, Yesintek, ustekinumab-ttwe, Selarsdi, Imuldosa, Otulfi, Pyzchiva, Ustekinumab-aekn, Ustekinumab-aauz, CDV Pyzchiva, Starjemza, and others).

Override criteria were updated to approve an additional 90 mg at retail or home delivery for initiation or additional induction dosing for plaque psoriasis or psoriatic arthritis.

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Coverage Criteria and Quantity Limits

Quantity limits and medically necessary exceptions

Standard quantity limits apply unless an exception meeting the listed criteria is documented.

Standard quantity limits for 45 mg products: Retail and Home Delivery Maximum Quantity Limit = 45 mg (1 syringe, vial, or autoinjector) per 84 days for 45 mg strength products.45 mg per 84 days

Applies to listed 45 mg strengths and forms; all same-strength products accumulate toward limit.

Standard quantity limits for 90 mg products: Retail and Home Delivery Maximum Quantity Limit = 90 mg (1 syringe or autoinjector) per 56 days for 90 mg strength products.90 mg per 56 days

Applies to listed 90 mg strengths and forms; all same-strength products accumulate toward limit.

Initiation or additional induction dosing override for 45 mg: If initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing, as verified by absence of ustekinumab claims in the past 130 days, approve an override for an additional 90 mg at retail or home delivery.absence of claims in past 130 days

Approval quantity = mg received in past 84 days plus 90 mg.

Initiation or additional induction dosing override for 90 mg: If initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing, as verified by absence of ustekinumab claims in the past 130 days, approve an override for an additional 180 mg at retail or home delivery.absence of claims in past 130 days

Approval quantity = mg received in past 56 days plus 180 mg.

IBD escalation — qualifying intensified maintenance dosing: Approve 90 mg per 28 days (retail) or 270 mg per 84 days (home delivery) when ALL of the following are met: A) ustekinumab is being used to treat Crohn's disease or ulcerative colitis; AND B) patient has received ustekinumab 90 mg SC once every 8 weeks for 24 weeks or longer; AND C) prescriber documents continued evidence of inflammation (e.g., elevated CRP, ESR, fecal calprotectin, or endoscopic signs).90 mg Q8W for ≥24 weeks and objective inflammation

Enables intensified maintenance dosing for active IBD patients.

IBD escalation — continuation of prior intensified dosing: Approve 90 mg per 28 days (retail) or 270 mg per 84 days (home delivery) when BOTH of the following are met: A) ustekinumab is being used to treat Crohn's disease or ulcerative colitis; AND B) patient has been receiving ustekinumab 90 mg SC once every 4 weeks or once every 6 weeks.prior Q4W or Q6W dosing

Permits continuation of previously intensified regimens.

Standard quantity limits for subcutaneous ustekinumab products apply as stated in the policy. Any exception not meeting the specified criteria is considered not medically necessary. This means requests seeking quantities beyond the listed limits must meet one of the policy’s explicit exception criteria to be approved; otherwise the request will be denied as not medically necessary.

Requests that exceed the stated quantity limits must meet one of the policy’s defined exception pathways to be covered. Requests exceeding the quantity limits without meeting the listed exception criteria are considered not medically necessary. Providers should ensure documentation supports an exception before submitting requests that exceed the published limits.

Coding and Claim Lookback

Covered CPT Codesmixed

No codes listed

inv-05: Claim lookback — 130 days

Lookback periodAbsence of claims for ustekinumab in the past 130 days is required to qualify for initiation/additional induction overrides.

PurposeUsed to verify treatment initiation or eligibility for induction dosing overrides for plaque psoriasis or psoriatic arthritis.

Operational noteApproval quantity when override granted equals mg received in the applicable prior window plus the additional induction mg (see product-specific notes).

inv-06: IBD maintenance duration — Q8W for ≥24 weeks

Required prior maintenancePatient must have received 90 mg SC once every 8 weeks (Q8W) for 24 weeks or longer to qualify for IBD intensified maintenance override.

Indications applicable

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Authorization duration and general prior authorization rule

This Drug Quantity Management program requires prior authorization for ustekinumab subcutaneous products when the Drug Quantity Management rule is not met at point of sale. If the rule is not met, coverage will be determined by the clinical criteria in the policy. All approvals are provided for 1 year in duration unless otherwise noted. All ustekinumab SC products of the same strength (vials, prefilled syringes, autoinjectors) accumulate toward the total quantity limit.

Billing Rule

Quantity limit prior authorization

Prior authorization requests must conform to the policy's quantity limits expressed in milligrams (mg). Examples of operational quantity rules: retail supply limits (expressed as mg per 28 days) and home delivery limits (expressed as mg per 84 days). Requests that exceed the stated quantity limits or the policy-specific overrides are subject to denial unless a documented exception applies.

Background and Key Definitions

Ustekinumab subcutaneous products are interleukin‑12/23 inhibitors used for indications including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, with dosing and permitted exceptions varying by product strength and dispensing setting. Quantity limits in this policy (for example, 90 mg per 56 days for many 90 mg products) govern routine coverage; the policy provides narrow, documented exceptions for initiation, induction, or disease‑specific escalation that must be met to exceed those limits.

inv-16: Dose escalation — definition & operational note

DefinitionDose escalation refers to increasing ustekinumab dosing frequency (e.g., from Q8W to Q6W or Q4W) for patients with IBD who do not achieve remission on standard maintenance dosing.

Clinical supportEvidence from trials and cohort studies supports escalation from Q8W to Q4W or Q6W in some patients with Crohn's disease or ulcerative colitis who do not achieve remission.

Operational noteContinuation of previously intensified regimens (Q4W or Q6W) may be approved as continuation therapy when documented; new escalations require meeting policy criteria (objective inflammation or prior Q8W for ≥24 weeks).

Initial Therapy Exceptions and Induction Overrides

Initial therapy exceptions

Initial treatment induction overrides.

45 mg initiation override: If initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing and there are no ustekinumab claims in the past 130 days, approve an additional 90 mg at retail or home delivery.

90 mg initiation override: If initiating treatment for plaque psoriasis or psoriatic arthritis or requires additional induction dosing and there are no ustekinumab claims in the past 130 days, approve an additional 180 mg at retail or home delivery.

Continuation and Intensified IBD Dosing

Continuation therapy for intensified IBD dosing

Continuation of intensified dosing in IBD.

Continuation after prior intensified dosing: Approve intensified dispensing (90 mg per 28 days at retail or 270 mg per 84 days at home delivery) if the patient has been receiving ustekinumab 90 mg SC once every 4 weeks or once every 6 weeks.

Step Therapy and Dose Escalation

Step	Description	Supporting evidence / notes
1	Dose escalation from Q8W to Q4W or Q6W may be supported for patients with Crohn's disease or ulcerative colitis who do not achieve clinical, biochemical, or endoscopic remission on Q8W dosing; dose intensification decisions should be based on clinical data documenting lack of remission.	Randomized phase 3b STARDUST trial and additional systematic reviews and cohort studies report benefit of escalation from Q8W to more frequent dosing for some IBD patients who fail to achieve remission on Q8W dosing.

Quantity Limits by Product and Strength

inv-21: Ustekinumab SC products (brands & generics)

Products listedStelara (ustekinumab) and multiple branded/biosimilar ustekinumab SC products including Imuldosa, Otulfi, Pyzchiva, CDV Pyzchiva, Selarsdi, Starjemza, Steqeyma, Wezlana, Yesintek, and unbranded ustekinumab SC injections.

Available strengths45 mg and 90 mg strengths available depending on product and formulation (prefilled syringes, autoinjectors, vials).

FormsPrefilled syringes, autoinjectors, and vials are included across the listed products.

inv-22: Ustekinumab 90 mg products — IBD escalation allowances

Retail allowance (90 mg)90 mg per 28 days at retail when approved for IBD escalation or continuation of intensified dosing.

Home delivery allowance (90 mg)

Dispensing Site Specifics

Note

Retail vs home delivery quantity limits and overrides

Quantity limits and overrides are defined separately for retail dispensing and home delivery; prior authorization and overrides reference the retail per‑28‑day and home delivery per‑84‑day limits as specified in this policy.

Retail and Home Delivery Maximum Quantity Limits are specified separately (examples: 45 mg per 84 days for 45 mg products; 90 mg per 56 days for 90 mg products).
IBD escalation and Stelara 90 mg overrides specify retail (per 28 days) and home delivery (per 84 days) limits.

Policy Summary

PayerCigna

PolicyUstekinumab subcutaneous drug quantity management (per days)

Policy CodePolicy N/A

Change TypeMaterial operational updates to quantity limits, mg unit conversion, and new overrides

Effective Date

Next Review DateJan 4, 2024

Key ActionFor initiation overrides, prescribers must document absence of ustekinumab claims in the past 130 days to qualify for additional dosing.

SourceLink

On This Page

Documentation Required

Override qualification documentation

When requesting an override to exceed standard quantity limits, documentation must clearly support the qualifying condition for the override. For initiation or additional induction dosing overrides, prescribers must document the absence of ustekinumab claims in the prior 130 days to verify treatment initiation. For Crohn's disease or ulcerative colitis dose-escalation overrides, provide prescriber-attested evidence of the diagnosis, prior dosing history, and objective evidence of continued inflammation as required by the policy.

Initiation/additional induction override: prescriber documents no ustekinumab claims in the past 130 days.
IBD override (example): document diagnosis (Crohn's disease or ulcerative colitis), prior ustekinumab dosing history per policy (e.g., 90 mg SC once every 8 weeks for ≥24 weeks or alternative qualifying regimens), and objective markers of inflammation (elevated CRP, elevated ESR, elevated fecal calprotectin, or endoscopic evidence).
Approval quantity for induction overrides should equal the mg received in the lookback period plus the policy-specified additional mg (e.g., +90 mg for 45 mg products; +180 mg for 90 mg products).