CurrentCignaPolicy N/A

Tremfya (guselkumab) IV prior authorization for Crohn's disease and ulcerative colitis

This document is a Cigna prior authorization request form governing coverage review for Tremfya IV (guselkumab) when prescribed for Crohn's disease, ulcerative colitis, or other indications and affects prescribing clinicians and facilities seeking medical benefit coverage.

Policy Summary

PayerCigna

PolicyTremfya (guselkumab) IV prior authorization for Crohn's disease and ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material changes in this revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (or use CoverMyMeds/SureScripts) and include required clinical documentation such as prior therapy dates and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

800.882.4462urgent request phone

855.840.1678fax for completed form

Accredopreferred specialty pharmacy

Coverage Criteria and Clinical Documentation

Clinical documentation elements requested (informational criteria capture)

Coverage assessment requires documentation of the following items as applicable for Crohn's disease or ulcerative colitis:

Induction and prescriber: If used for Crohn's disease (CD) or ulcerative colitis (UC), indicate whether the request is for induction therapy and whether the medication is prescribed by or in consultation with a gastroenterologist.

Form asks checkbox for induction therapy and prescriber specialty.

Prior corticosteroids: For Crohn's disease, document that the patient has tried systemic corticosteroids, is currently on systemic corticosteroids, or that systemic corticosteroids are contraindicated.

Checkbox on form captures this.

Conventional systemic therapy trial: If corticosteroids were not tried or are not applicable, document trial of one other conventional systemic therapy (examples: azathioprine, 6-mercaptopurine, methotrexate). Note: a trial of mesalamine does not count as a systemic agent for Crohn's disease.

Policy Summary

PayerCigna

PolicyTremfya (guselkumab) IV prior authorization for Crohn's disease and ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material changes in this revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (or use CoverMyMeds/SureScripts) and include required clinical documentation such as prior therapy dates and prescriber attestation.

SourceLink

On This Page

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The prior authorization form explicitly indicates that a trial of mesalamine does not count as a systemic agent for Crohn's disease when assessing prior therapy. This clarification appears within the Crohn's disease prior-treatment branching questions and should be used when evaluating whether the member has attempted an adequate conventional systemic therapy before moving to biologic options.

Providers must still complete the patient and prescriber identification fields (asterisked items) on the form as part of the submission package; missing required administrative information can delay review and does not substitute for clinical prior-therapy documentation.

The form does not include explicit "not medically necessary" language. Instead, it collects structured clinical information—prior corticosteroid use, trials of conventional systemic therapy, prior biologic exposure, presence of fistulas, and history of ileocolonic resection—that will inform medical necessity determinations during review.

Because the form relies on branching checkboxes rather than blanket exclusions, reviewers will assess medical necessity based on the documented prior therapies and complicating clinical features. Ensure the form includes complete responses to the prior-therapy questions and all required patient/prescriber identifiers to avoid administrative or clinical denials.

Prior Authorization Requirements and Provider Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tremfya IV. Submit requests online at CoverMyMeds or via SureScripts in your EHR; standard response time is 5 business days. For urgent requests call Cigna to expedite review.

Submission pathways: www.covermymeds.com or SureScripts in EHR
Standard response time: 5 business days
For urgent requests: call Cigna to expedite

Step Therapy

Step Therapy and Prior Treatment Documentation — Crohn's Disease

For Crohn's disease, document whether the medication is for induction therapy and confirm gastroenterology involvement when applicable. Ensure responses to the listed Crohn's-specific prompts are complete: systemic corticosteroid trial or contraindication, trial of one other conventional systemic therapy (examples: azathioprine, 6-mercaptopurine, methotrexate; mesalamine does not count), prior trial of one biologic (exclude biosimilars of the requested biologic), presence of enterocutaneous or rectovaginal fistulas, and history of ileocolonic resection.

Indication: Is use for induction therapy? (Yes/No)
Prescriber: Is the drug prescribed by or in consultation with a gastroenterologist? (Yes/No)
Corticosteroids: Has the patient tried systemic corticosteroids, is currently on them, or are they contraindicated? (Yes/No)
Conventional systemic therapy: Has the patient tried one other conventional systemic agent? (e.g., azathioprine, 6-mercaptopurine, methotrexate) (Yes/No). Note: mesalamine does NOT count.
Prior biologic: Has the patient had a previous trial of one biologic for Crohn's disease other than the requested drug? (Yes/No). Note: biosimilars of the requested biologic do not count.
Fistulas: Does the patient have enterocutaneous (perianal or abdominal) or rectovaginal fistulas? (Yes/No)
Surgery: Has the patient had an ileocolonic resection? (Yes/No)

Documentation Required

Required Documentation and Prescriber Attestation

Complete and sign the attestation and provide full patient and prescriber information. All fields marked with an asterisk (*) are required; incomplete forms may delay review or result in denial. Include facility/administration details when applicable and indicate whether the medication is for a chronic or long-term condition.

Required patient fields: Patient name, Cigna ID, date of birth, patient address, patient phone
Required prescriber fields: Physician name, specialty, DEA/NPI/TIN, office contact, office phone, office fax, office address
Facility/administration info: Facility name, state, tax ID, address if medication will be dispensed/administered
Attestation: Prescriber signature and date required
Chronic use: Indicate if medication is for a chronic/long-term condition

Denial Risk

Incomplete Clinical Criteria for Crohn's Disease — Risk of Delay or Denial

Incomplete clinical criteria for Crohn's disease or missing required documentation may lead to delayed processing or denial. Ensure all Crohn's-specific trial information and the signed attestation are provided; if the patient is currently on the requested drug include dates and how it has been received (samples, out-of-pocket, etc.).

Missing Crohn's trial responses (conventional therapy, biologic trial, corticosteroid status) increases risk of denial
Omittted gastroenterologist consultation or induction-use response may delay approval
If currently on requested drug, provide dates of use and method of receipt (samples, self-pay, etc.)

Definitions and Examples

Biologic — examples listed on the form (selected items)

Examples of adalimumab listedHumira and adalimumab biosimilars

Select anti‑TNF and related biologics listedBimzelx; Cosentyx (IV or SC); etanercept SC products (Enbrel, biosimilar); infliximab IV products (Remicade, biosimilar); Simponi (Aria or SC)

Gut‑targeted and integrin biologics listedEntyvio (IV or SC)

Other monoclonal antibody biologics listedIlumya; Kevzara; Kineret; Omvoh (IV or SC); Orencia (IV or SC); rituximab IV products (Rituxan, biosimilar); Skyrizi (IV or SC); Siliq

Interleukin‑targeting and JAK/other agents listedustekinumab products (Stelara, IV or SC, biosimilar); Taltz; tocilizumab products (Actemra, IV or SC, biosimilar); Tremfya (IV or SC); Zymfentra

OpenPayer

Tremfya (guselkumab) IV prior authorization for Crohn's disease and ulcerative colitis

Coverage Criteria and Clinical Documentation

Requested Medication and Codes

Prior Authorization Requirements and Provider Instructions

Background and Scope

Definitions and Examples