CurrentCignaPolicy v090125

Entyvio (vedolizumab) subcutaneous pen prior authorization

Prior authorization form and requirements for coverage of Entyvio (vedolizumab) subcutaneous pen for patients with Crohn's disease or ulcerative colitis; used by prescribers submitting requests to Cigna Pharmacy Services.

Policy Summary

PayerCigna

PolicyEntyvio (vedolizumab) subcutaneous pen prior authorization

Policy CodePolicy v090125

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete the prior authorization form including indication, prior therapies and response, and whether IV induction has been given or will be given within 2 months of starting subcutaneous therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

Entyvio 108 MGmedication on form

855-840-1678fax to submit

800-882-4462urgent phone

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous Pen

General and indication-specific coverage criteria

Covered when ALL of the following indication-specific criteria and documentation requirements are met:

Prescriber specialty: Medication is prescribed by or in consultation with a gastroenterologist (as indicated on the form)

checkbox on form

IV induction: Patient is currently receiving Entyvio IV or will receive IV induction within 2 months of initiating subcutaneous Entyvio, or has already received IV induction prior to starting subcutaneous therapywithin 2 months

form requires affirmative answer

Duration of prior Entyvio therapy: For continuation requests, patient has received at least 6 months of Entyvio therapy (IV or SC) unless restarting or per form instructions

Policy Summary

PayerCigna

PolicyEntyvio (vedolizumab) subcutaneous pen prior authorization

Policy CodePolicy v090125

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Provider Actions and Prior Authorization Requirements

Prior Authorization
Entyvio (vedolizumab) SC prior authorization
Prior authorization is required for Entyvio (vedolizumab) subcutaneous pen. The prescriber must complete the prior authorization form including the indication, prior therapy and required documentation.
Medication requested (including dose, frequency, duration) and J-code/ICD-10 must be specified.
Completed form must include physician and patient identifiers — all asterisked (*) items (for example: Physician Name, DEA/NPI/TIN, Patient Name, Cigna ID, Date of Birth, Patient and Office contact information).
If required fields marked with an asterisk are incomplete, Cigna may be unable to respond via fax with the outcome of the review.

Documentation Required
Prior therapy requirements (Crohn's disease)
For Crohn's disease, the form requires documentation of prior therapies and response.
Documentation of trial of at least one conventional systemic therapy (examples: azathioprine, 6-mercaptopurine, methotrexate). Note: mesalamine does not count as a systemic therapy.
Documentation of a trial of a biologic for Crohn's disease (examples: adalimumab products, infliximab products, Simponi SC, ustekinumab products). A biosimilar of the requested biologic does not count.
Documentation of prior Entyvio IV or SC use, duration (≥6 months when applicable), objective measures of response (fecal/serum markers, imaging, endoscopy), and whether induction with Entyvio IV is planned or completed within 2 months of initiating SC therapy.

Documentation Required
Provider form completion requirements
Completed form must include all required prescriber and patient information and the medication request details.
Physician identifiers: Physician Name, Specialty, DEA, NPI or TIN, Office Contact Person, Office Phone and Fax, Office Street Address, City/State/Zip.
Patient identifiers: Patient Name, Cigna ID, Date of Birth, Patient Street Address, City/State/Zip, Patient Phone.
Medication details: Medication requested (Entyvio 108 mg/0.68 mL pen), dose, frequency, duration, J-Code, and ICD-10 diagnosis.
Clinical information: Indication, concurrent biologic or targeted therapy use, gastroenterologist involvement, prior medication trials and responses, and attestation with prescriber signature and date.

Denial Risk
Incomplete information risk
Incomplete required (asterisked) patient or prescriber information may prevent Cigna from responding via fax with the outcome of review.
Ensure every field marked with an asterisk (*) on the form is completed before submission to avoid processing delays or lack of faxed outcome.
Required asterisked items include key identifiers for both physician and patient as listed above.

Definitions and Measurement Examples

Biologic examples

Examples of anti-TNF and other monoclonal antibody biologicsAdalimumab products (Humira and biosimilars); infliximab IV products (Remicade and biosimilars); certolizumab, golimumab, and other named anti-TNF agents listed on the form.

Integrin and interleukin-targeting biologicsVedolizumab (Entyvio IV), ustekinumab products (Stelara and biosimilars), vedolizumab SC is the requested formulation on this form.

Other named biologic agents included as examplesBimzelx, Cimzia, Cosentyx (IV or SC), Enbrel (etanercept and biosimilars), Ilumya, Kevzara, Kineret, Omvoh, Orencia, Rituxan (rituximab and biosimilars), Skyrizi, Siliq, Simponi, Taltz, Actemra (tocilizumab), Tremfya, Zymfentra.

Form context for combination therapyThe form asks whether the requested medication will be used in combination with a BIOLOGIC or targeted synthetic oral small molecule drug and lists these biologic examples for that question.

Objective measures of response

Fecal markersFecal lactoferrin and fecal calprotectin cited as examples of objective fecal markers to assess response.

Serum markersC-reactive protein (CRP) cited as an example of a serum marker used to assess inflammatory response.

Clinical/other measuresReduced dose of corticosteroids is included as an example of an objective indicator of clinical improvement.

OpenPayer

Entyvio (vedolizumab) subcutaneous pen prior authorization

Coverage Criteria for Entyvio (vedolizumab) Subcutaneous Pen

Billing and Diagnosis Codes

Provider Actions and Prior Authorization Requirements

Background

Definitions and Measurement Examples