CurrentCignaPolicy N/A

Inflammatory Conditions - Ustekinumab Subcutaneous Drug Quantity Management Policy - Per Days

Defines Cigna's drug quantity limits, overrides, and medical necessity exceptions for all listed ustekinumab subcutaneous products (multiple brands/biosimilars) for retail and home delivery; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ustekinumab Subcutaneous Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeQuantity limits / overrides updated

Effective DateN/A

Next Review DateN/A

Key ActionProviders must request an override and supply documentation (e.g., absence of claims in past 130 days for initiation/induction overrides; documentation of continued inflammation or dosing history for Crohn's/UC escalations) to support approval.

SourceLink

POLICY UPDATE CHANGES

A specific override was added allowing requested quantity up to 1 syringe per 28 days retail (or 3 syringes per 84 days home delivery) for Stelara 90 mg when used for Crohn's disease or ulcerative colitis and meeting criteria.

New quantity limits and overrides were added for multiple new ustekinumab products/brands (Wezlana, Yesintek, ustekinumab-ttwe, Selarsdi, Imuldosa, Otulfi, Pyzchiva, Steqeyma).

Throughout policy changed the quantity approved to be in 'mg' units rather than '# of syringes or vials'.

45 mg/84dStandard maximum for 45 mg strength (retail/home accumulation period)

90 mg/56dStandard maximum for 90 mg strength (retail accumulation period)

1 yr

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Ustekinumab Quantity Limits and Overrides

Drug quantity limit baseline

Standard quantity limits apply per product/strength; exceptions are allowed only when criteria below are met.

ALL of the following

45 mg strength: approve up to 45 mg (1 syringe or vial) per 84 days
90 mg strength: approve up to 90 mg (1 syringe) per 56 days

Exceptions — 45 mg prefilled syringes or vials (override rules)

Overrides for 45 mg products when initiation or additional induction dosing is verified:

ALL of the following

If patient is initiating treatment for plaque psoriasis or psoriatic arthritis OR requires additional induction dosing for plaque psoriasis or psoriatic arthritis, 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
Approval quantity = number of mg patient has received in past 84 days plus 90 mg

Exceptions — 90 mg prefilled syringes (override rules)

Overrides and escalation rules for 90 mg products:

ANY of the following

If patient is initiating treatment for plaque psoriasis or psoriatic arthritis OR requires additional induction dosing for plaque psoriasis or psoriatic arthritis, 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
Approval quantity = number of mg patient has received in past 56 days plus 180 mg
Crohn's disease/Ulcerative colitis escalation — pathway A
- Ustekinumab is being used to treat Crohn's disease or ulcerative colitis
- Patient has received ustekinumab 90 mg SC once every 8 weeks for 24 weeks or longer
- Prescriber documents continued evidence of inflammation based on one or more: elevated CRP, elevated ESR, elevated fecal calprotectin, or signs of inflammation on endoscopic evaluation

Thresholds

Claim absence window for initiationno ustekinumab claims in the past 130 days

Lookback for mg-based approval (45 mg products)number of mg received in past 84 days + override mg

Lookback for mg-based approval (90 mg products)number of mg received in past 56 days + override mg

IBD sustained Q8W treatment durationreceived 90 mg SC once every 8 weeks for 24 weeks or longer

Products and Strengths Targeted

Product list (brand/biologic names targeted by this policy)mixed

Stelara	ustekinumab subcutaneous injection (Janssen)
ustekinumab (Janssen)	unbranded
Imuldosa	ustekinumab-srlf (Accord)
Otulfi	ustekinumab-aauz (Fresenius)
Pyzchiva	ustekinumab-ttwe (Sandoz/Samsung)
ustekinumab-ttwe	Quallent
Selarsdi	ustekinumab-aekn (Teva)
ustekinumab-aekn	Teva unbranded
Steqeyma	ustekinumab-stba (Celltrion)
Wezlana	ustekinumab-auub (Amgen)

1–10 of 11

1/2

Strength / dosage form groupsmixed

45 mg/0.5 mL PFS	Prefilled syringe, 45 mg strength
90 mg/mL PFS	Prefilled syringe, 90 mg strength
45 mg vial	45 mg/0.5 mL vial (limited products)

What Providers Must Do

Prior Authorization

Quantity limit overrides require documentation

Providers must submit a quantity‑limit override request and supply supporting documentation (for example, evidence of no ustekinumab claims in the past 130 days for initiation/induction overrides, or documentation of continued inflammation or dosing history for Crohn's/UC escalation requests). All approvals are provided for 1 year in duration unless otherwise noted.

Examples of acceptable documentation: absence of claims in past 130 days to verify initiation/induction; prescriber documentation of inflammation or dosing history for IBD escalations.

Documentation Required

Inflammation evidence for IBD dose escalation

For Crohn's disease or ulcerative colitis patients who have been treated with 90 mg SC every 8 weeks for 24 weeks or longer, the prescriber must document continued evidence of inflammation — elevated C‑reactive protein (CRP), elevated erythrocyte sedimentation rate (ESR), elevated fecal calprotectin, or signs of inflammation on endoscopic evaluation — to support approval of increased frequency to 90 mg per 28 days (retail) or 270 mg per 84 days (home delivery).

Clinical and Administrative Context

Ustekinumab is an interleukin-12/23 blocker with FDA‑approved indications for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The policy targets subcutaneous (SC) formulations including the marketed branded and biosimilar prefilled syringes and selected vials; all same‑strength SC products accumulate toward the total quantity limit. (See FDA indications and product list.)

Standard drug quantity limits are strength‑specific and expressed in milligrams: the baseline maxima are 45 mg per 84 days for 45 mg prefilled syringes or vials and 90 mg per 56 days for 90 mg prefilled syringes. These limits apply across the listed Stelara and ustekinumab products and newly added brands/biosimilars with the same strengths.

The policy includes defined override pathways to manage initiation, induction, and clinically supported dose intensification. For initiation or additional induction for plaque psoriasis or psoriatic arthritis (verified by no ustekinumab claims in the past 130 days), an override may be approved: for 45 mg products the approval quantity = mg received in the past 84 days plus an additional 90 mg; for 90 mg products the approval quantity = mg received in the past 56 days plus an additional 180 mg.

Because inflammatory bowel disease (Crohn's disease and ulcerative colitis) may require intensification of maintenance dosing, the policy provides specific escalation pathways to avoid inappropriate premature increases while permitting clinically supported dosing changes. Evidence supports escalation from Q8W to Q4W or Q6W in some IBD patients who do not achieve remission. For patients on 90 mg SC Q8W for ≥ 24 weeks with continued objective evidence of inflammation (e.g., elevated CRP, ESR, fecal calprotectin, or endoscopic signs) a higher frequency may be approved to 90 mg per 28 days (retail) or 270 mg per 84 days (home delivery). An alternate pathway allows the same approved quantity when the patient is already receiving 90 mg SC every 4 or every 6 weeks.

Providers seeking overrides must request authorization and supply documentation (dosing history, absence of prior claims for initiation/induction, and for IBD dose escalation, prescriber documentation of continued inflammation). Approvals under these exception pathways are granted for 1 year unless otherwise noted.

Defined Terms

Definitions

SCSubcutaneous

PFSPrefilled syringe

Policy Changes

2025-05-07added (operational/coverage)Latest

A selected/early annual revision added new quantity limits for multiple unbranded ustekinumab products and noted that the same quantity limits and overrides apply to all listed ustekinumab products; the policy text was updated to express approval quantities in mg units.

2024-05-17clarified (operational)

Throughout the policy the quantity approved was changed to be expressed in mg units rather than number of syringes or vials.

2024-02-14added (exception pathway)