CurrentCignaPolicy N/A

Intravenous Ustekinumab (IV) Prior Authorization Request Form — Coverage Criteria

This document is a Cigna prior authorization request form for intravenous ustekinumab (and branded biosimilars) used for indications including Crohn's disease and ulcerative colitis; it governs what providers must submit to obtain coverage and affects prescribers, infusion sites, and pharmacies.

Policy Summary

PayerCigna

PolicyIntravenous Ustekinumab (IV) Prior Authorization Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed prior authorization form including medication selection (IV ustekinumab), dose/quantity, duration, J-code, ICD-10 diagnosis, and indication-specific responses to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

855-840-1678fax to submit completed form

800-882-4462phone for urgent requests

Accredonationally preferred specialty pharmacy

Coverage Criteria and Medical Necessity

Form-driven medical necessity documentation

Coverage will be considered when the prescriber provides required documentation and meets indication‑specific prior therapy and prescriber specialty criteria.

Core submission requirements: Completed patient and prescriber identifiers (asterisked items), medication details (dose, quantity, duration, J-code), ICD-10 diagnosis code, and indication selection

Mandatory form fields; required for review

Indication selection: Indication selected from list including Ankylosing Spondylitis, Crohn's Disease, Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis, or other specified diagnosis

Prescriber must select the appropriate indication on the form

Concomitant therapy disclosure: Document whether the requested medication will be used in combination with another biologic, a targeted synthetic oral small molecule drug, or a conventional synthetic DMARD, or indicate that it will NOT be used in combination

Policy Summary

PayerCigna

PolicyIntravenous Ustekinumab (IV) Prior Authorization Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Requests lacking required prior therapy or specialty documentation may be incomplete or not approvable. The form explicitly asks for documentation of prior systemic corticosteroid use, trials of conventional systemic therapy and prior biologic exposure for Crohn’s disease, and whether the request was prescribed by or in consultation with a gastroenterologist for Crohn’s disease and ulcerative colitis. Failure to complete these items or to answer condition-specific questions can lead to denial or a determination of not medically necessary upon review.

Providers should ensure all required fields (patient and prescriber identifiers, medication details including J-code and ICD-10, indication, and responses to the Crohn’s/UC-specific questions) are completed and that gastroenterology consultation/prescribing is documented when requested to avoid processing delays or denials.

Required Provider Actions and Submission Instructions

Prior Authorization

Prior Authorization Submission Requirements

Prior Authorization Required: A completed prior authorization form must be submitted for the requested medication prior to approval. The form must include all asterisked patient and prescriber fields, medication selection (product name), dose, quantity, duration of therapy, J‑code, ICD‑10 diagnosis code, frequency of administration, and patient weight when applicable.

Submit the completed Cigna prior authorization form (all required/asterisked fields).
Include medication name, dose, quantity, duration, J‑code, frequency, ICD‑10, and patient weight (kg or lb).
Provide prescriber identifiers (DEA, NPI or TIN), office contact, and facility/dispensing information when applicable.

Step Therapy

Step Therapy and Prior Treatment History

Step therapy and prior treatment history must be documented on the authorization form. For inflammatory bowel disease indications (Crohn's disease, ulcerative colitis) the form must document prior trials and responses or contraindications.

Document prior use or contraindication of systemic corticosteroids.
Document trial of at least one conventional systemic therapy (examples: azathioprine, 6‑mercaptopurine, methotrexate). Note: mesalamine alone does not meet this requirement for Crohn’s disease.
Document prior biologic therapy trials where required; a biosimilar of the requested biologic does not count as a prior trial of the same biologic class/product.
For Crohn’s/UC, indicate whether medication is for induction therapy and whether prescribed by or in consultation with a gastroenterologist.

Documentation Required

Required Documentation to Support Prior Authorization

Required Documentation to Support Prior Authorization: Provide clinical indication/diagnosis selection on the form, prior therapies (including dates and outcomes), specialty consult notes when requested, and any relevant surgical history (e.g., ileocolonic resection for Crohn’s). Incomplete forms or missing documentation are common reasons for denial.

Complete all patient and prescriber fields marked with an asterisk.
List prior therapies with start/stop dates, reason for discontinuation, and trial adequacy.
Attach specialty consultation notes (gastroenterology) for IBD requests when requested.
For Crohn’s disease, document presence/absence of enterocutaneous or rectovaginal fistulas when applicable.

Denial Risk

Potential Triggers for Denial

Denial Risk: Requests may be denied if prior biologic or conventional therapy trials are not documented, if a gastroenterologist is not involved for IBD indications when required, or if required authorization form elements are missing or incomplete.

Missing documentation of prior systemic corticosteroid or conventional systemic therapy trial for Crohn’s disease.
No documentation of prior biologic trial when required, or use of a biosimilar does not satisfy a prior biologic requirement for the same product.
Authorization form incomplete (missing asterisked fields, medication dose/quantity, J‑code, ICD‑10, prescriber identifiers).

Background and Scope

This prior authorization form is used to document the clinical indication and prior treatment history necessary to support IV ustekinumab infusion for immune-mediated conditions, including Crohn’s disease and ulcerative colitis. It captures whether the request is for induction therapy, whether the prescriber is a gastroenterologist or has consulted one, prior use of systemic corticosteroids, trials of conventional systemic agents (examples provided), and prior biologic exposure—information used to establish medical necessity for infusion therapy.

The form also collects medication-specific information (dose, quantity, duration, and the J-code), ICD-10 diagnosis, and a disclosure about concomitant use with other biologics, targeted synthetic oral small molecules, or conventional DMARDs to inform coverage review.

Terminology and Examples

Biologic — examples listed on form

Examples listed on formadalimumab product (Humira, biosimilar); Bimzelx; Cimzia; Cosentyx (IV or SC); etanercept SC product (Enbrel, biosimilar); Entyvio (IV or SC); Ilumya; infliximab IV products (Remicade, biosimilar); Kevzara; Kineret; Omvoh (IV or SC); Orencia (IV or SC); rituximab IV product (Rituxan, biosimilar); Skyrizi (IV or SC); Siliq; Simponi (IV or SC); Taltz; tocilizumab product (Actemra IV or SC, biosimilar); Tremfya; ustekinumab subcutaneous product (Stelara SC, biosimilar); Zymfentra

ContextForm asks whether the requested medication will be used in combination with a biologic and lists these examples for disclosure.

Implication for coverageConcurrent use with another biologic is queried and may be excluded from coverage depending on policy review.

Targeted synthetic oral small molecule drug — examples listed on form

Examples listed on formCibinqo; Leqselvi; Litfulo; Sotyktu; Olumiant; Otezla; Rinvoq; Rinvoq LQ; Xeljanz; Xeljanz XR; Velsipity; Zeposia

ContextForm asks whether the requested medication will be used in combination with a targeted synthetic oral small molecule drug and provides these examples for disclosure.

Implication for coverageConcurrent use with a targeted synthetic oral small molecule drug is requested on the form and may affect coverage decisions.

OpenPayer

Intravenous Ustekinumab (IV) Prior Authorization Request Form — Coverage Criteria

Coverage Criteria and Medical Necessity

Billing and Diagnosis Codes

Required Provider Actions and Submission Instructions

Background and Scope

Terminology and Examples