CurrentHawaii Medical Service Association (HMSA)Policy N/A

Vedolizumab (Entyvio) prior authorization for inflammatory bowel disease and ICI-related colitis

Prior authorization form and requirements for Entyvio (intravenous or subcutaneous) used to treat moderately to severely active ulcerative colitis, Crohn's disease, or immune checkpoint inhibitor–related diarrhea/colitis for members whose prescription benefits are administered by CVS Caremark for HMSA.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyVedolizumab (Entyvio) prior authorization for inflammatory bowel disease and ICI-related colitis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the CVS Caremark prior authorization form (including ICD-10 code and selected product) to 1-866-237-5512 for coverage determination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Indications listed (UC, CD, ICI-related colitis)

2Formulations requested (IV, SC)

Prior auth requiredPrior auth required

Fax to CVSFax submission

Coverage Criteria for Vedolizumab (Entyvio)

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Ulcerative Colitis (Initial and Continuation)

Ulcerative colitis — requirements vary by initiation vs continuation and route; covered when specified clinical and administrative conditions are met

UC - General: Patient diagnosed with moderately to severely active ulcerative colitisaffirmative diagnosis

Form asks confirmation of diagnosis

UC - Age: Patient is an adult (18 years or older)>=18 years

Form asks age confirmation

UC - Provider: Requested drug prescribed by or in consultation with a gastroenterologistspecialty = gastroenterologist

Form collects prescriber specialty

UC - Request type and route: Request may be initiation or continuation; route can be IV loading/maintenance or SC maintenance; specific route selection on form determines subsequent questionsroute selected

Form branches depending on IV vs SC and initiation vs continuation

UC - Continuation evidence: For continuation, patient has achieved/maintained remission OR achieved/maintained positive clinical response evidenced by improvement in specified measures (stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, disease activity scores)documented improvement

Multiple measure options listed on form

Crohn's Disease (Initial and Continuation)

Crohn's disease — requirements for initiation vs continuation and route; covered when criteria below are met

CD - General: Patient diagnosed with moderately to severely active Crohn's diseaseaffirmative diagnosis

Form asks confirmation of diagnosis

CD - Age: Patient is an adult (18 years or older)>=18 years

Form asks age confirmation

CD - Provider: Requested drug prescribed by or in consultation with a gastroenterologistspecialty = gastroenterologist

Form collects prescriber specialty

Immune Checkpoint Inhibitor–Related Diarrhea/Colitis

Immune checkpoint inhibitor–related diarrhea/colitis — coverage contingent on specialty consult and prior therapy failure/intolerance/contraindication

ICI - Provider: Requested drug prescribed by or in consultation with a hematologist or oncologistspecialty = hematologist/oncologist

Form asks specialty

ICI - Prior therapy: Patient experienced inadequate response OR intolerance OR contraindication to systemic corticosteroids or infliximabone of the three must be true

Form requires selection to continue to approval questions

ICI - Route: Route may be IV vial or SC syringe/pen as specified on formroute selected

If the provider selects Other as the indication on the prior authorization form, the form does not present any additional condition-specific questions and no further questions will be asked online or on the form. This selection routes the request to a non‑standard review pathway and requires separate clinical documentation to support medical necessity.

Provider Submission and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit a completed HMSA/CVS Caremark Prior Authorization form to CVS Caremark Specialty Programs by fax at 1-866-237-5512. Include the ICD-10 diagnosis code and indicate the product requested (Entyvio IV solution or Entyvio SC Pen). Approvals may be subject to dosing limits per FDA labeling, compendia, or evidence-based guidelines.

Fax: 1-866-237-5512
Specialty Customer Care (questions about prior auth): 1-808-254-4414
CaremarkConnect (eligibility/copay/delivery): 1-800-237-2767
Include ICD-10 code on form
Indicate product selection: Entyvio IV solution or Entyvio SC Pen

Documentation Required

ICI-Related Diarrhea/Colitis Prior Authorization Question

For immune checkpoint inhibitor (ICI)-related diarrhea or colitis, the form requires documentation that the patient has had an inadequate response to, intolerance of, or a contraindication to prior therapies (systemic corticosteroids or infliximab). Ensure the prescriber documents whether the request is being made by or in consultation with a hematologist or oncologist.

Document inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab
Indicate prescribing clinician specialty (hematologist/oncologist)

Documentation Required

Completed Prior Authorization Form with Indication-Specific Documentation Required

A fully completed prior authorization form must be submitted and include the diagnosis and indication-specific documentation (for example: diagnosis of moderately to severely active ulcerative colitis, prior therapies tried, route of administration, age, prescriber specialty, and evidence of clinical response for continuation requests). Use the form questions relevant to the chosen indication (Ulcerative Colitis, Crohn's Disease, ICI-related toxicity, or Other).

Indicate which indication applies and complete the corresponding question set
For UC/Crohn's: document disease activity, prescriber specialty, route of administration, and response to therapy for continuation requests
For continuation of therapy: document clinical response or remission and specific improvements from baseline as applicable

Denial Risk

Consequences of Incomplete Submission

Failure to submit a completed prior authorization form with the required documentation may result in denial of the request. Even when approved, authorizations may be subject to dosing limits, route-specific conditions, or other approval criteria.

Incomplete forms may be denied
Approvals may include dosing or route limits per FDA labeling or guidelines

Key Definitions and Formulations

Entyvio formulations — IV solution and SC pen

Formulation optionsEntyvio is available as an intravenous (IV) solution (vial) and as a subcutaneous (SC) pen (syringe/pen)

Form selection on prior authorization formPrescriber must indicate the requested product: 'Entyvio IV solution' or 'Entyvio SC Pen' on the form

Administration location promptForm asks where the drug is being dispensed and where it is being administered (options include office, home, outpatient hospital, pharmacy, etc.)

Continuation of therapy — evidence required of remission or positive clinical response and measures of improvement

Required evidence for continuationFor continuation, the patient must have achieved or maintained remission OR achieved/maintained a positive clinical response since starting the requested drug

If remission documentedIf 'achieved or maintained remission' is selected, no further questions are required on the form

If positive clinical response documentedIf 'achieved or maintained a positive clinical response' is selected, the form requires specification of which measures improved from baseline (see next item)

Acceptable measures of improvementImprovement may be in stool frequency/diarrhea, rectal bleeding/abdominal pain, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/ultrasound, or improvement on a disease activity scoring tool (e.g., CDAI)

Background

Vedolizumab (Entyvio) is indicated for use in patients with moderately to severely active ulcerative colitis and Crohn’s disease and is also considered for immune checkpoint inhibitor–related diarrhea/colitis when clinically appropriate. The prior authorization form captures the indication, prescriber specialty, route (intravenous or subcutaneous), whether the request is for initiation or continuation, and documentation required to support coverage decisions.

The form specifically asks for prescriber specialty (gastroenterologist for inflammatory bowel disease; hematologist/oncologist for ICI‑related toxicity), age, and the selected route and request type so that the reviewer can apply the correct initiation or continuation criteria. For continuation requests the form requires evidence of remission or a positive clinical response, documented by improvement in disease‑specific measures (for ulcerative colitis: stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, or disease activity scores; for Crohn’s disease: abdominal pain, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance, or CDAI score).

For immune checkpoint inhibitor–related diarrhea/colitis, the form requires that the drug be prescribed by or in consultation with a hematologist/oncologist and asks whether the patient had an inadequate response, intolerance, or contraindication to systemic corticosteroids or infliximab before Entyvio is considered. Providers must complete and fax the completed CVS Caremark prior authorization form (including the ICD‑10 diagnosis code and selected product) to 1‑866‑237‑5512. Documentation supporting the responses must be available for review on request; failure to submit the completed form may prevent coverage and approvals may be subject to dosing limits consistent with labeling and guidelines.

OpenPayer

Vedolizumab (Entyvio) prior authorization for inflammatory bowel disease and ICI-related colitis

Coverage Criteria for Vedolizumab (Entyvio)

Diagnosis and Billing Codes

Provider Submission and Documentation Requirements

Key Definitions and Formulations

Background