CurrentCignaPolicy N/A

Ustekinumab (Selarsdi, Ustekinumab-ttwe, Yesintek) patient information and prior authorization form

This document is a Cigna patient information and prior-authorization intake form for subcutaneous ustekinumab products (Selarsdi, Ustekinumab-ttwe, Yesintek 45mg) and governs information collection and prerequisites for coverage decisions; it is intended for prescribing providers and dispensing sites.

Policy Summary

PayerCigna

PolicyUstekinumab patient information and prior authorization form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization patient information form with indication, specialty consult, prior therapy history, and induction dosing (for IBD).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

45mgvial strength

Accredopreferred specialty pharmacy

Urgent vs Standardurgency option

Coverage and Authorization Criteria

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Indication-specific prior-authorization criteria

Coverage assessment follows indication-specific criteria and documentation of prior therapy, specialty involvement, induction dosing (for IBD), and objective or symptomatic improvement when on therapy.

Crohn's disease criteria: If Crohn's disease: determine if patient is currently receiving an ustekinumab product; if yes, confirm the patient has received at least 6 months of therapy with the requested medication (answer No if <6 months or restarting) and, when assessed by at least one objective measure (fecal markers, serum CRP, MRE/CTE, endoscopy, or reduced corticosteroid dose), has experienced a beneficial clinical response from baseline; if no objective measures, document symptomatic improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or blood in stool). If not currently receiving or on <6 months, require that the medication is prescribed by or in consultation with a gastroenterologist and that the patient will receive or has received a single IV induction dose with ustekinumab within 2 months of initiating SC therapy.6 months for response assessment

Examples of objective measures include fecal markers (eg, fecal lactoferrin, fecal calprotectin), serum CRP, imaging (MRE/CTE), endoscopy, or reduced corticosteroid dose.

Ulcerative colitis criteria: If ulcerative colitis: determine if patient is currently receiving an ustekinumab product; if yes, confirm at least 6 months of therapy with the requested medication (answer No if <6 months or restarting) and, when assessed by at least one objective measure (fecal calprotectin, serum CRP, endoscopy, and/or reduced corticosteroid dose), has experienced a beneficial clinical response from baseline; if no objective measures, document symptomatic improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding). If not currently receiving or on <6 months, require that the medication is prescribed by or in consultation with a gastroenterologist and that the patient will receive or has received a single IV induction dose with ustekinumab within 2 months of initiating SC therapy.6 months for response assessment

Examples of assessment include fecal calprotectin, CRP, endoscopy, or steroid reduction.

Plaque psoriasis criteria: If plaque psoriasis: determine if patient is currently receiving an ustekinumab product; if yes, confirm the patient has received at least 3 months of therapy with the requested medication (answer No if <3 months or restarting) and has experienced a beneficial clinical response from baseline, defined as improvement in at least one of estimated body surface area, erythema, induration/thickness, and/or scale, and/or symptomatic improvement (decreased pain, itching, or burning). If not currently receiving or on <3 months, require that the medication is prescribed by or in consultation with a dermatologist and that the patient has tried at least one traditional systemic agent for psoriasis for ≥3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin, or 3-month PUVA); alternatively a prior trial or intolerance to at least one biologic (other than the requested drug), Otezla, or Sotyktu satisfies prior therapy requirements.3 months

A biosimilar of the requested biologic does not count toward the biologic alternative; a patient who already tried a biologic, Otezla, or Sotyktu is not required to step back to traditional systemic therapy.

Psoriatic arthritis (PsA) criteria: If PsA: determine if patient is currently receiving an ustekinumab product; if yes, confirm the patient has received at least 6 months of therapy with the requested medication (answer No if <6 months or restarting) and, when assessed by at least one standardized measure of disease activity (eg, DAPSA, CPDAI, PsA DAS, MDA, PsAID-12) or serum markers (CRP, ESR), has experienced a beneficial clinical response from baseline; if no objective measures, document symptomatic improvement (less joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling). If not currently receiving or on <6 months, require that the medication is prescribed by or in consultation with a rheumatologist or dermatologist.6 months

Examples of standardized measures provided on the form include DAPSA, CPDAI, PsA DAS, MDA, etc.

Concomitant therapy disclosure: Form requires disclosure if the requested medication will be given in combination with another biologic, a targeted synthetic oral small molecule drug, or a conventional synthetic DMARD; if combination biologic or targeted therapy is planned, this must be indicated on the form.

The form provides examples of agents and requests documentation of combination therapy.

The prior authorization form requires providers to disclose if the requested ustekinumab will be given in combination with another biologic, a targeted synthetic oral small‑molecule drug, or a conventional synthetic DMARD. The form lists specific examples of combination biologic agents (e.g., adalimumab products, Bimzelx, Cimzia, Cosentyx, etanercept products, Entyvio, Ilumya, infliximab IV products, Kevzara, Kineret, Omvoh, Orencia, rituximab IV products, Skyrizi, Siliq, Simponi, Taltz, tocilizumab products, Tremfya, ustekinumab IV [Stelara IV], Zymfentra) and examples of targeted synthetic oral agents (e.g., Cibinqo, Leqselvi, Litfulo, Sotyktu, Olumiant, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Xeljanz/Xeljanz XR, Velsipity, Zeposia) to guide accurate reporting.

Billing and Coding

Billing code fieldmixed

J-code

Field for entering billing J-code for medication

inv-04: Minimum duration of therapy for IBD to assess response

Minimum duration>= 6 months

Applies toCrohn's disease and Ulcerative colitis

Response assessmentBeneficial response must be documented by an objective measure (e.g., fecal markers, CRP, imaging, endoscopy) or symptom improvement

If <6 months or not receivingPrescriber must be or consult a gastroenterologist and plan/confirm a single IV induction dose within 2 months of initiating SC therapy

inv-05: Minimum duration of therapy for plaque psoriasis to assess response

Minimum duration>= 3 months

Applies toPlaque psoriasis

Prior therapy requirementIf not currently on ustekinumab or <3 months, trial of >=1 traditional systemic agent for >=3 months is requested unless intolerant (alternatively prior biologic/Otezla/Sotyktu may satisfy)

Response assessmentBeneficial clinical response defined by improvement in BSA, erythema, induration/thickness, and/or scale or symptom improvement (pain, itching, burning)

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Form Completion Required

Prior authorization form completion required — patient information form specifying product, indication, specialty, and other prerequisites.

Complete all asterisked (*) patient identifier fields to allow outcome notification.
List the specific medication (product name and vial strength), dose, quantity, J-code, ICD-10 diagnosis code, duration, frequency, and patient weight.
Include facility and prescriber dispensing/administration details and indicate if therapy is chronic/long-term.

Step Therapy

Psoriasis Step Therapy

Psoriasis step-therapy requirement — documented trial of at least one traditional systemic agent for ≥3 months unless intolerant; alternatives and exceptions noted.

If not currently receiving ustekinumab and <3 months on requested agent, indicate dermatologist involvement (prescribed by or in consultation).
If patient has not tried a traditional systemic agent, document a 3-month trial of at least one biologic, Otezla/Otezla XR, or Sotyktu OR document intolerance/contraindication to methotrexate.
Document prior biologic therapies (names and durations) — biosimilars of the requested biologic do not count for step requirements.

Documentation Required

Required Documentation on Form

Required documentation on the form — patient identifiers, medication requested (product, dose, quantity, J-code, ICD-10), clinical indication details, specialty consults, and support for prior therapy duration/response.

Provide prescriber specialty, DEA/NPI/TIN, office contact, phone and fax.
Specify medication product, strength, dose, quantity, J-code, frequency, ICD-10, duration, and patient weight.
Attach supporting clinical documentation showing prior therapies tried (names, start/stop dates), trial durations, intolerance or contraindications, and objective measures of response when applicable (eg, fecal calprotectin, CRP, imaging, endoscopy, BSA for psoriasis).
For IBD (Crohn's or UC) and PsA, indicate if prescribing by or in consultation with a gastroenterologist, dermatologist, or rheumatologist as required.

Denial Risk

Potential Triggers for Incomplete Authorization

Potential triggers for incomplete authorization — missing attestations (prescriber specialty/consultation), absent induction dosing documentation for IBD, insufficient prior therapy duration or lack of objective response documentation, and incomplete patient identifiers or medication coding fields.

Incomplete or missing prescriber attestation/signature.
Missing specialty or consultation note when required (dermatology for psoriasis <3 months, gastroenterology for IBD <6 months, rheumatology/dermatology for PsA).
No documentation of induction IV ustekinumab for Crohn's/UC when applicable, or lack of statement that induction will be given within 2 months.
Absent documentation of prior therapy names, durations, or objective measures of response (eg, fecal markers, CRP, imaging, endoscopy, BSA).
Blank or incorrect medication details (product, dose/quantity, J-code, ICD-10) or missing patient identifiers (Cigna ID, DOB, address).

Documentation Required for New Starts

Initial therapy documentation

For patients initiating ustekinumab, the form captures prescriber specialty and induction dosing intent/receipt for IBD.

IBD induction requirement: For Crohn's disease and ulcerative colitis patients not currently on ustekinumab or on <6 months of therapy: require that the prescriber is a gastroenterologist or has consulted a gastroenterologist, and that the patient will receive or has received a single IV induction dose with ustekinumab within 2 months of initiating subcutaneous therapy. If the induction dose has already been given prior to starting SC therapy, answer Yes.

Induction IV dose must be within 2 months of initiating SC ustekinumab or already administered.

On-Therapy / Continuation Documentation

Continuation (on-therapy) documentation

Questions to document ongoing benefit when patient is already receiving ustekinumab.

On-therapy response assessment: If patient already receiving ustekinumab: indicate whether the patient has been on the requested medication for the required minimum duration (>=6 months for Crohn's disease, ulcerative colitis, and PsA; >=3 months for plaque psoriasis) and whether, when assessed by at least one objective measure or standardized disease activity score, the patient has experienced a beneficial clinical response from baseline. If objective measures are not available, document symptomatic improvement in relevant symptoms.

Answering these questions supports continuation authorization.

Step Therapy and Prior Treatment Requirements

Requirement	Details / acceptable alternatives
Trial of traditional systemic agent	At least 1 traditional systemic agent for ≥3 months (examples: methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA also counts).
Exception for intolerance	If intolerant to traditional systemic agents, intolerance documented by prescriber suffices; prescriber asked if contraindication to methotrexate is present.
Alternative prior therapy satisfying step	A prior 3-month trial (or documented intolerance) of a biologic (other than the requested drug), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib) may satisfy the requirement; note biosimilars of the requested biologic do not count.
Specialist involvement when initiating	If not currently receiving the requested ustekinumab product or treated <3 months, medication must be prescribed by or in consultation with a dermatologist.
Assessment of response when ≥3 months on therapy	If the patient has already received ≥3 months of the requested medication, provider must document beneficial clinical response (improvement in body surface area, erythema, induration/thickness, and/or scale) or symptom improvement (eg, decreased pain, itching, burning).

Site of Care / Dispensing Options

Billing Rule

Designate site of care and dispensing source (Accredo preferred)

Indicate on the form where the medication will be obtained or administered: options include Accredo (Cigna's nationally preferred specialty pharmacy), hospital outpatient, retail pharmacy, home infusion/vendor, or physician office stock.

Accredo is listed as Cigna's nationally preferred specialty pharmacy (ordering and contact details provided).
Provide facility/dispensing site details (facility name, address, Tax ID) when applicable.

Product Options and Biosimilars

Note

Select ustekinumab reference product (Selarsdi, Ustekinumab‑ttwe, Yesintek)

Select the exact subcutaneous ustekinumab product requested on the form; available options include Selarsdi, Ustekinumab‑ttwe, and Yesintek (45 mg/0.5 mL).

Choose from Selarsdi 45 mg/0.5 mL, Ustekinumab‑ttwe 45 mg/0.5 mL, Yesintek 45 mg/0.5 mL, or indicate Other.

Background and Clinical Context

Ustekinumab is an interleukin‑12/23 inhibitor used for immune‑mediated conditions including Crohn’s disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. The patient information and prior‑authorization form captures indication‑specific details: prior treatment exposure and duration, prescriber specialty (dermatology, gastroenterology, or rheumatology as applicable), whether an IV induction dose was given or is planned for inflammatory bowel disease, and objective measures or symptom improvement to support continuation or initiation decisions. For on‑therapy assessments the form uses duration thresholds of ≥6 months for Crohn’s disease, ulcerative colitis, and psoriatic arthritis, and ≥3 months for plaque psoriasis to evaluate response.

Definitions

inv-11: Biologic — examples listed

Examples (selected)Adalimumab products (Humira, biosimilars), Bimzelx, Cimzia, Cosentyx, Etanercept products (Enbrel, biosimilars), Entyvio, Ilumya, Infliximab IV products (Remicade, biosimilars), Ilumya, Skyrizi, Tremfya

Additional examplesKevzara, Kineret, Omvoh, Orencia, Rituximab IV products, Siliq, Simponi, Taltz, Tocilizumab products, Zymfentra

Form usageProviders must indicate if the requested medication will be given in combination with a biologic from this examples list