CurrentWashington State Health Care AuthorityPolicy 66.27.00.AJ-6

Cytokine and CAM Antagonists: Integrin Receptor Antagonists

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This policy governs prior authorization and medical-necessity coverage for vedolizumab (Entyvio and Entyvio Pen) for adults with moderate-to-severe Crohn’s disease or ulcerative colitis, including clinical criteria, preferred-drug step therapy, reauthorization, quantity limits, and billing coding.

Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: Integrin Receptor Antagonists

Policy CodePolicy 66.27.00.AJ-6

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionBefore initial vedolizumab approval, document inadequate response or intolerance to two preferred Apple Health Preferred Drug List medications, unless contraindicated or not tolerated.

SourceLink

POLICY UPDATE CHANGES

The policy split Tysabri from the integrin receptor antagonist policy.

The policy updated the number of preferred products required for Crohn’s disease and ulcerative colitis indications.

2Covered disease indications

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CurrentWashington State Health Care AuthorityPolicy 66.27.00.AJ-6

Cytokine and CAM Antagonists: Integrin Receptor Antagonists

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 66.27.00.AJ-6 alerts

Get alerted when Policy 66.27.00.AJ-6 changes without checking for updates manually.

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Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: Integrin Receptor Antagonists

Policy CodePolicy 66.27.00.AJ-6

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionBefore initial vedolizumab approval, document inadequate response or intolerance to two preferred Apple Health Preferred Drug List medications, unless contraindicated or not tolerated.

SourceLink

POLICY UPDATE CHANGES

The policy split Tysabri from the integrin receptor antagonist policy.

The policy updated the number of preferred products required for Crohn’s disease and ulcerative colitis indications.

2Covered disease indications

2 agentsPreferred-agent trials for initial therapy

6 monthsInitial authorization duration

12 monthsReauthorization duration

Coverage Criteria

Initial Therapy: Crohn’s Disease

Covered when all criteria are met:

Initial therapy for Crohn’s disease

Patient and prescriber requirements
- Patient is 18 years of age or older; prescribed by, or in consultation with, a gastroenterologist; and vedolizumab is not used in combination with another Cytokine and CAM medication.age >= 18
Diagnosis
- Diagnosis of moderate-to-severe Crohn’s disease.
Disease-treatment pathway
- Conventional therapy failure
  - Treatment with short-term oral corticosteroids, such as prednisone or methylprednisolone, and at least one immunomodulatory agent, such as methotrexate, azathioprine, or 6-mercaptopurine, has been ineffective; the immunomodulatory agent trial must be at least 12 weeks.minimum trial of 12 weeks for the immunomodulatory agent
- High-risk disease
  - Documentation of high-risk disease, such as symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, CDAI > 450, or Harvey-Bradshaw index > 7.CDAI > 450 or Harvey-Bradshaw index > 7 when applicable
Preferred-drug step therapy
- Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List medications has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks

Reauthorization: Crohn’s Disease

Covered when all criteria are met:

Reauthorization for Crohn’s disease

No combination therapy
- Vedolizumab is not used in combination with another Cytokine and CAM medication.
Clinical response or stability
- Documentation demonstrates disease stability or a positive clinical response, such as improved endoscopic activity, tapering or discontinuation of corticosteroids, fewer liquid stools, less abdominal pain, decreased CDAI, or decreased Harvey-Bradshaw index.

Initial Therapy: Ulcerative Colitis

Covered when all criteria are met:

Initial therapy for ulcerative colitis

Patient and prescriber requirements
- Patient is 18 years of age or older; prescribed by, or in consultation with, a gastroenterologist; and vedolizumab is not used in combination with another Cytokine and CAM medication.age >= 18
Diagnosis
- Diagnosis of moderate-to-severe ulcerative colitis.
Baseline assessment
- Baseline assessments are included, such as stool frequency, endoscopy results, presence of rectal bleeding, and a disease-activity scoring tool.

Reauthorization: Ulcerative Colitis

Covered when all criteria are met:

Reauthorization for ulcerative colitis

No combination therapy
- Vedolizumab is not used in combination with another Cytokine and CAM medication.
Clinical response or stability
- Documentation demonstrates disease stability or a positive clinical response, such as decreased stool frequency, decreased rectal bleeding, improved endoscopic activity, tapering or discontinuation of corticosteroid therapy, or improvement on a disease-activity scoring tool.

Vedolizumab must not be used in combination with another Cytokine and CAM medication. This exclusion applies to both initial coverage and continuation (reauthorization) coverage for Crohn’s disease and ulcerative colitis.

Initial Therapy Authorization

Crohn’s Disease Initial Authorization

Initial therapy for Crohn’s disease is covered when all criteria are met:

Crohn’s disease initial authorization

Patient is 18 years of age or older and vedolizumab is prescribed by, or in consultation with, a gastroenterologist.age >= 18
Vedolizumab is not used in combination with another Cytokine and CAM medication.
Patient has moderate-to-severe Crohn’s disease.
Qualifying disease-treatment pathway

Reauthorization

Crohn’s Disease Reauthorization

Reauthorization is available when all criteria are met:

Crohn’s disease continuation

Vedolizumab is not used in combination with another Cytokine and CAM medication.
Documentation demonstrates disease stability or a positive clinical response, such as improved endoscopic activity, tapering or discontinuation of corticosteroids, fewer liquid stools, less abdominal pain, decreased CDAI, or decreased Harvey-Bradshaw index.

Ulcerative Colitis Reauthorization

Reauthorization is available when all criteria are met:

Ulcerative colitis continuation

Vedolizumab is not used in combination with another Cytokine and CAM medication.

Coding and Clinical Definitions

Covered HCPCS CodesHCPCSCovered

J3380

Injection, vedolizumab, 1 mg; 1 billable unit = 1 mg

Conventional Therapy and Preferred-Agent Trial

Required agentsTwo preferred Cytokine and CAM Apple Health Preferred Drug List medications must each have been ineffective.

ExceptionThe preferred-agent requirement may be met through documented contraindication or intolerance to all applicable preferred medications.

Minimum trialEach preferred-agent trial must be at least 12 weeks.

Crohn’s Disease Activity

CDAI thresholdCrohn’s Disease Activity Index (CDAI) greater than 450.

Harvey-Bradshaw thresholdHarvey-Bradshaw index greater than 7.

Provider Requirements and Decision Risks

Prior Authorization

Prior Authorization for Non-Preferred Drugs

New-to-market drugs in the Cytokine and CAM Apple Health Preferred Drug List class are non-preferred and require prior authorization. Non-preferred agents require documented inadequate response or intolerance to preferred therapy before approval.

If only one preferred agent is available in the class, document inadequate response to that one agent.
If a drug receives a new FDA-approved indication, medical necessity for that indication is reviewed case by case under FDA labeling.

Note

Medical-Necessity Review

Vedolizumab (Entyvio or Entyvio Pen) may be medically necessary when the clinical criteria are met. If all criteria are not met, a clinical reviewer may approve the request case by case when medical necessity is demonstrated; the reviewer may also apply reauthorization criteria.

Clinical review applies to requests that do not fully satisfy the published criteria.
Approval remains subject to applicable documentation and quantity limits.

Policy Background

Vedolizumab is an integrin receptor antagonist used to treat adults with moderate-to-severe Crohn’s disease or ulcerative colitis. Coverage requires documented clinical criteria, including appropriate prior conventional therapy and preferred-agent trials, unless the therapies are contraindicated or not tolerated. Treatment is intended to induce and maintain remission, reduce disease activity, and help prevent inflammatory bowel disease complications.

Defined Clinical Terms

Conventional Corticosteroid Therapy

TherapyShort-term oral corticosteroid therapy, such as prednisone or methylprednisolone.

PurposeUsed to induce remission or alleviate signs and symptoms of a disease flare.

Role in criteriaIncluded as part of conventional therapy for Crohn’s disease.

Immunomodulatory Conventional Therapy

Qualifying agentsAt least one immunomodulatory agent, such as methotrexate, azathioprine, or 6-mercaptopurine.

Minimum trialThe immunomodulator must be tried for at least 12 weeks.

Role in criteria

Preferred-Drug Step Therapy

Step	Requirement	Trial standard	Applicable exceptions
1	Before initial vedolizumab approval, trial two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications.	Each preferred medication must have been ineffective; minimum trial is 12 weeks.	The requirement is waived when all preferred options are contraindicated or not tolerated due to severe adverse reaction. If only one preferred agent exists in the class, failure or intolerance of that one agent is required.

Product Dosing and Quantity Limits

Entyvio Quantity Limits — Crohn’s Disease

IndicationCrohn’s disease.

Induction limit900 BU per 42 days.

Maintenance limit300 BU per 56 days.

Entyvio Quantity Limits — Ulcerative Colitis

IndicationUlcerative colitis.

IV-maintenance induction900 BU per 42 days for patients who will receive IV maintenance doses.

Subcutaneous-maintenance induction600 BU per 14 days for patients who will receive subcutaneous maintenance doses.

Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: Integrin Receptor Antagonists

Policy CodePolicy 66.27.00.AJ-6

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionBefore initial vedolizumab approval, document inadequate response or intolerance to two preferred Apple Health Preferred Drug List medications, unless contraindicated or not tolerated.

SourceLink

On This Page

Conventional therapy failure

Treatment with conventional therapy, such as systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine, has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks

Preferred-drug step therapy

Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List medications has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks

Conventional therapy has been ineffective, unless all conventional options are contraindicated or not tolerated. Conventional therapy includes short-term oral corticosteroids and at least one immunomodulatory agent, with a minimum 12-week immunomodulator trial.

minimum trial of 12 weeks for the immunomodulatory agent

Patient has documented high-risk disease, such as symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, CDAI > 450, or Harvey-Bradshaw index > 7.

Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List medications has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks

Ulcerative Colitis Initial Authorization

Initial therapy for ulcerative colitis is covered when all criteria are met:

Ulcerative colitis initial authorization

Patient is 18 years of age or older and vedolizumab is prescribed by, or in consultation with, a gastroenterologist.age >= 18
Vedolizumab is not used in combination with another Cytokine and CAM medication.
Patient has moderate-to-severe ulcerative colitis.
Baseline assessments are included, such as stool frequency, endoscopy results, presence of rectal bleeding, and a disease-activity scoring tool.
Treatment with conventional therapy, such as systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine, has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks
Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List medications has been ineffective, unless all are contraindicated or not tolerated.minimum trial of 12 weeks

Documentation demonstrates disease stability or a positive clinical response, such as decreased stool frequency, decreased rectal bleeding, improved endoscopic activity, tapering or discontinuation of corticosteroid therapy, or improvement on a disease-activity scoring tool.

Clinical useEither threshold may support documentation of high-risk Crohn’s disease when applicable.

Prior Authorization

New FDA Indication Requires Case-by-Case Review

A new FDA-approved indication for a drug covered by this policy is not automatically covered. Medical necessity for the new indication is determined case by case following the FDA-approved labeling.

Submit the diagnosis, requested indication, FDA labeling support, and clinical rationale for review.

Step Therapy

Two Preferred-Agent Trials Required

Before requesting vedolizumab, document that treatment with two preferred Cytokine and CAM Apple Health PDL medications was each ineffective, unless all applicable preferred agents are contraindicated or not tolerated because of a severe adverse reaction. Each preferred-agent trial must generally be at least 12 weeks.

For Crohn's disease, the two preferred-agent requirement applies in addition to ineffective, contraindicated, or not-tolerated conventional therapy, unless high-risk disease is documented.
For ulcerative colitis, document ineffective conventional therapy, unless all are contraindicated or not tolerated, with a minimum 12-week trial.
If only one preferred agent exists in the class, document inadequate response to that one agent.

Documentation Required

Initial Clinical Documentation

Initial authorization requests must include documentation supporting every applicable clinical criterion and the requested indication.

Patient is 18 years of age or older.
Vedolizumab is prescribed by, or in consultation with, a gastroenterologist.
Vedolizumab is not used in combination with another Cytokine and CAM medication.
Diagnosis and severity of moderate-to-severe Crohn's disease or ulcerative colitis.
For Crohn's disease: ineffective conventional therapy or documented high-risk disease; conventional therapy includes short-term oral corticosteroids and at least one immunomodulatory agent, with a minimum 12-week immunomodulator trial, unless contraindicated or not tolerated.
For ulcerative colitis: ineffective conventional therapy such as systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine, with a minimum 12-week trial, unless contraindicated or not tolerated.
Documentation of two ineffective preferred PDL medication trials, or the applicable contraindication or intolerance exceptions.

Documentation Required

Ulcerative Colitis Baseline Assessment

For an initial ulcerative colitis request, submit baseline disease measurements so the clinical reviewer can assess disease severity and later response to treatment.

Stool frequency.
Endoscopy results.
Presence of rectal bleeding.
A disease-activity scoring tool.

Documentation Required

Document Response for Reauthorization

Reauthorization requests must document that vedolizumab is not being used with another Cytokine and CAM medication and that the patient has stable disease or a positive clinical response.

Crohn's disease examples: improved endoscopic activity, corticosteroid taper or discontinuation, fewer liquid stools, reduced abdominal pain, decreased CDAI, or decreased Harvey-Bradshaw Index.
Ulcerative colitis examples: decreased stool frequency, decreased rectal bleeding, improved endoscopic activity, corticosteroid taper or discontinuation, or improvement on a disease-activity scoring tool.
Initial approval is for 6 months when criteria are met; reauthorization is for 12 months when criteria are met.

Denial Risk

Initial Criteria Not Met: Denial Risk

An initial request may be denied when the required clinical evidence is absent or the initial criteria are not met. The clinical reviewer may consider a case-by-case medical-necessity exception, but approval is not automatic.

Patient is younger than 18 or the prescriber is not a gastroenterologist or consultant gastroenterologist.
The diagnosis, disease severity, conventional-therapy failure, high-risk Crohn's disease, or required preferred-agent trials are not documented.
Required 12-week trials are not completed, and no applicable contraindication or intolerance is documented.
Vedolizumab would be used with another Cytokine and CAM medication.
Required ulcerative-colitis baseline assessments are missing.

Denial Risk

Reauthorization Criteria Not Met: Denial Risk

Continuation authorization may be denied when the request does not document continued safe use and disease stability or a positive response to vedolizumab.

Vedolizumab is being used in combination with another Cytokine and CAM medication.
The record does not demonstrate disease stability or positive clinical response using relevant disease, symptom, endoscopic, or corticosteroid measures.
The reauthorization request lacks supporting clinical documentation.

Billing Rule

Quantity Limits Apply

Requests and claims exceeding the FDA-approved induction or maintenance quantity limits may be denied. Verify the indication, formulation, dosing schedule, and billed units before submission.

Entyvio 300 mg/20 mL vial for Crohn's disease: induction 900 BU per 42 days; maintenance 300 BU per 56 days.
Entyvio 300 mg/20 mL vial for ulcerative colitis: IV-maintenance induction 900 BU per 42 days; SC-maintenance induction 600 BU per 14 days; maintenance 300 BU per 56 days.
Entyvio Pen 108 mg/0.68 mL: after week 6 IV infusion and thereafter when switching, 108 mg subcutaneously every 2 weeks; limit 2 prefilled pens or syringes per 28 days.
Ulcerative-colitis induction differs by planned maintenance: IV maintenance uses 300 mg IV at weeks 0, 2, and 6; SC maintenance uses 300 mg IV at weeks 0 and 2. Maintenance is 300 mg every 8 weeks.

Used as part of conventional therapy for Crohn’s disease.

High-Risk Crohn’s Disease

Persistent diseaseSymptoms despite conventional therapy.

ComplicationsObstruction, abscess, stricture, phlegmon, or fistulas.

Additional featuresResection, extensive bowel involvement, early age of onset, or growth retardation.

Activity measuresCDAI greater than 450 or Harvey-Bradshaw index greater than 7.

Maintenance limit300 BU per 56 days.

Entyvio Pen Quantity Limits

ProductEntyvio Pen 108 mg/0.68 mL solution.

Switching pointAfter the week 6 IV infusion and thereafter if switching.

Maintenance limit2 prefilled pens (PFP) or prefilled syringes (PFS) per 28 days.