CurrentCignaPolicy N/A

Entyvio (vedolizumab) prior authorization / patient information

This form governs prior authorization requests and collection of clinical information for Entyvio (vedolizumab) administration for Cigna members, including indications such as Crohn's disease, ulcerative colitis, checkpoint inhibitor–related GI toxicity, and graft-versus-host disease. It affects prescribers, infusion sites, pharmacies, and Cigna review staff.

Policy Summary

PayerCigna

PolicyEntyvio (vedolizumab) prior authorization / patient information

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the indication‑specific prior authorization form with all asterisked patient identifiers, clinical details, prior therapy documentation, J‑code and ICD‑10, and submit via fax to (855) 840-1678 or online; call (800) 882-4462 for urgent requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax

800-882-4462urgent phone

Accredopreferred specialty pharmacy

Indication-specific Coverage Criteria

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Crohn's disease — coverage contingent on indication-specific conditions

Covered when ALL of the following indication-specific conditions are met:

Continuation criteria (current Entyvio use): If currently receiving Entyvio: patient has received >=6 months of therapy AND when assessed by at least one objective measure has experienced a beneficial clinical response from baseline (prior to initiating the requested medication). Examples of objective measures include fecal markers (e.g., fecal lactoferrin, fecal calprotectin), serum markers (e.g., C-reactive protein), imaging studies (MRE, CTE), endoscopic assessment, and/or reduced dose of corticosteroids.>= 6 months

Answer No if patient has received less than 6 months or is restarting therapy

Initial or <6 months therapy — prior therapy pathway: If not currently receiving Entyvio or receiving <6 months: patient has tried systemic corticosteroids, or is currently on systemic corticosteroids, or corticosteroids are contraindicated; OR has tried one conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate). A trial of mesalamine does not count as systemic therapy.

Form captures additional branching logic regarding biologic exposure and surgical/fistula status

Prior biologic requirement / exceptions: If no prior biologic other than the requested drug: document whether patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas, or has had ileocolonic resection (to reduce chance of recurrence); a biosimilar of the requested biologic does not count as prior biologic therapy.

Requested medication must be prescribed by or in consultation with a gastroenterologist

Ulcerative colitis — coverage contingent on indication-specific conditions

Covered when ALL of the following indication-specific conditions are met:

Continuation criteria (current Entyvio use): If currently receiving Entyvio: patient has received >=6 months of therapy AND when assessed by at least one objective measure has experienced a beneficial clinical response from baseline (prior to initiating the requested medication). Examples of objective measures include fecal markers (e.g., fecal calprotectin), serum markers (e.g., C-reactive protein), endoscopic assessment, and/or reduced dose of corticosteroids.>= 6 months

Answer No if patient has received less than 6 months or is restarting therapy

Prescriber requirement for new starts: If not currently receiving Entyvio or receiving <6 months: the medication must be prescribed by or in consultation with a gastroenterologist.

Checkpoint inhibitor–related GI toxicity — coverage contingent on indication-specific conditions

Covered when ALL of the following indication-specific conditions are met:

Continuation criteria (current Entyvio use): If currently receiving Entyvio: patient has received >=6 months of therapy AND when assessed by at least one objective measure has experienced a beneficial clinical response from baseline. Examples of objective measures include improvement or normalization of serum markers (e.g., CRP), fecal markers (e.g., fecal calprotectin), endoscopic assessment, and/or reduced corticosteroid dose.>= 6 months

Answer No if patient has received less than 6 months or is restarting therapy

Initial therapy criteria: If not currently receiving Entyvio or receiving <6 months: prescriber documents that the patient developed gastrointestinal toxicity while receiving a checkpoint inhibitor AND the patient remains symptomatic despite a trial of at least one systemic corticosteroid (examples: methylprednisolone, prednisone).

Medication must be prescribed by or in consultation with a gastroenterologist or an oncologist

Graft-versus-host disease — coverage contingent on indication-specific conditions

Covered when ALL of the following indication-specific conditions are met:

Continuation criteria (current Entyvio use): If currently receiving Entyvio: patient has received >=1 month of therapy AND when assessed by at least one objective measure has experienced a beneficial clinical response from baseline (prior to initiating Entyvio). Examples of objective measures include improvement on endoscopic assessment, normalization of liver function tests, red blood cell or platelet count, or resolution of fever or rash.>= 1 month

Answer No if patient has received less than 1 month or is restarting therapy

Initial therapy criteria: If not currently receiving Entyvio or receiving <1 month: patient has acute graft-versus-host disease AND has tried at least one systemic medication for GVHD (examples listed on form include corticosteroids such as methylprednisolone, antithymocyte globulin, cyclosporine, tacrolimus, mycophenolate mofetil, ruxolitinib, basiliximab, etanercept, infliximab, sirolimus, pentostatin, tocilizumab).

Medication must be prescribed by or in consultation with an oncologist, hematologist, or a physician affiliated with a transplant center

Per the form, infusion location must be documented and, for some Cigna plans, the medication MUST be administered in the least intensive, medically appropriate setting. The requester must indicate where the drug will be given (home, physician's office, hospital outpatient, or other) and answer whether the patient is a candidate for redirection to an alternate, less intensive setting with assistance from a Specialty Care Options Case Manager. If redirection is not appropriate, a medical necessity rationale should be provided.

Provider Requirements and Prior Authorization Process

Prior Authorization

Prior authorization required for Entyvio

Entyvio (vedolizumab) prior authorization is required. Complete the indication-specific clinical questions on this form, including the requested medication, dose, duration, ICD-10 diagnosis, and urgency. Provide the facility or office information for where the drug will be administered and identify the prescriber and specialty.

Medication Requested (e.g., Entyvio 300 mg vial)
Dose, quantity, frequency, duration of therapy, and J‑code
Indication/diagnosis selection (Crohn's disease, ulcerative colitis, GI toxicity from checkpoint inhibitors, graft‑versus‑host disease, other)
Facility/dispensing/administration details (facility name, state, tax ID, address)
Prescriber specialty and contact information

Documentation Required

Incomplete required fields may prevent response

Incomplete required fields may delay or prevent a response. Due to privacy regulations, Cigna will not be able to respond via fax with the outcome of the review unless all asterisked (*) items on this form are completed.

Ensure all fields marked with an asterisk (*) are completed: physician name, DEA/NPI/TIN, patient name, Cigna ID, date of birth, patient street address, patient phone, and any other asterisked items on the form
If urgent, call Cigna in addition to submitting the form to request expedited review

Documentation Required

Required documentation and submission instructions

Required documentation must be submitted with the prior authorization request. Include patient identifiers and all clinical information to support medical necessity.

Patient identifiers: patient name, Cigna ID, date of birth, patient address, patient phone
Prescriber information: physician name, specialty, DEA/NPI/TIN, office contact, phone, fax, office address
Therapy details: medication requested, dose, quantity, frequency, duration, J‑code, indication (ICD‑10)
Submission options: fax the completed form to the number on the form, submit online at www.covermymeds.com/main/prior-authorization-forms/cigna/, or via SureScripts in the EHR. For urgent requests, call Cigna to expedite

Documentation Required

Prior therapy documentation required

Document prior therapy trials as applicable for the requested indication. Provide dates, agents, doses, responses, and reasons for discontinuation where relevant.

For Crohn's disease and ulcerative colitis: prior use of systemic corticosteroids (or current corticosteroid use or contraindication) and at least one conventional systemic therapy for Crohn's (azathioprine, 6‑mercaptopurine, methotrexate) when applicable
Document trials of at least one biologic other than the requested drug for Crohn's disease, unless contraindicated or other exception applies (examples: adalimumab, certolizumab, infliximab, ustekinumab, risankizumab)
For checkpoint inhibitor–related GI toxicity: documentation of GI toxicity while on checkpoint inhibitor therapy and trial of at least one systemic corticosteroid unless contraindicated
For graft‑versus‑host disease: prior trial of at least one systemic medication for GVHD when applicable (examples: corticosteroids, antithymocyte globulin, tacrolimus, ruxolitinib, infliximab)
If patient is currently receiving Entyvio, document duration of therapy (≥6 months for IBD and checkpoint toxicity; ≥1 month for GVHD) and objective evidence of clinical response (fecal/serum markers, imaging, endoscopy, labs) or lack of response

Definitions and Drug Classes

Checkpoint inhibitor — examples

Examples of checkpoint inhibitorsKeytruda (pembrolizumab), Opdivo (nivolumab), Yervoy (ipilimumab), Tecentriq (atezolizumab), Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab)

Form asks to identify checkpoint‑related GI toxicityRequest form lists ‘Gastrointestinal toxicity associated with checkpoint inhibitor therapy’ as an indication and provides examples of agents

Administration route noted for examplesAll listed checkpoint inhibitor examples are described as intravenous infusion agents on the form

Biologic / targeted synthetic — concurrent use

Concurrent biologic agents (examples)Adalimumab products (Humira, biosimilar), Bimzelx, Cimzia, Cosentyx, etanercept products (Enbrel, biosimilar), Entyvio (SC), Ilumya, infliximab products (Remicade, biosimilar), Kevzara, Kineret, Omvoh, Orencia, rituximab products (Rituxan, biosimilar), Skyrizi, Siliq, Simponi, ustekinumab products (Stelara, biosimilar), Taltz, tocilizumab products (Actemra, biosimilar), Tremfya, Zymfentra

Targeted synthetic oral small molecules (examples)Cibinqo, Leqselvi, Litfulo, Sotyktu, Olumiant, Otezla, Rinvoq (including Rinvoq LQ), Xeljanz (including Xeljanz XR), Velsipity, Zeposia

Form response optionsThe form asks whether Entyvio will be used in combination with a biologic, a targeted synthetic oral small molecule, a conventional synthetic DMARD, or not used in combination

OpenPayer

Entyvio (vedolizumab) prior authorization / patient information

Indication-specific Coverage Criteria

Billing and Diagnosis Codes

Provider Requirements and Prior Authorization Process

Background and Scope

Definitions and Drug Classes