CurrentAetnaPolicy N/A

Entyvio (vedolizumab) Injectable Medication Precertification Request Form Coverage Criteria

Aetna precertification request form and clinical data collection tool for Entyvio (vedolizumab) infusions and injections, used by providers to request start or continuation of therapy for members.

Policy Summary

PayerAetna

PolicyEntyvio (vedolizumab) Injectable Medication Precertification Request Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the precertification form with all required fields and supporting clinical documentation for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

Requiredfields required

Aetnapayer contact

FAX 1-888-267-3277precert fax

Coverage Criteria for Entyvio (vedolizumab)

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General requirements: Provider documents diagnosis, prescriber specialty or consultation (gastroenterologist for IBD; hematologist/oncologist for immune checkpoint inhibitor-related colitis as applicable), dose/loading and maintenance schedule, and completion of the precertification form with all required fields.

See form sections A-F and G-H for required fields.

Crohn's disease specific: Patient diagnosed with moderately to severely active or fistulizing Crohn's disease AND either has tried and had an inadequate response to at least one conventional therapy option or has a contraindication/intolerance to at least one conventional therapy; provider documents prior conventional therapies tried and whether patient has prior biologic use.

Form lists conventional therapies (e.g., sulfasalazine, metronidazole, ciprofloxacin, prednisone, budesonide, azathioprine, mercaptopurine, methotrexate, methylprednisolone, rifaximin, tacrolimus) and asks about prior biologic use and fistulizing disease.

Ulcerative colitis specific: Patient diagnosed with moderately to severely active ulcerative colitis AND either has tried and had an inadequate response to at least one conventional therapy option or has a contraindication/intolerance to at least one conventional therapy; provider documents prior conventional therapies tried, prior biologic or targeted synthetic use, and whether hospitalized for acute severe UC.

Form lists conventional therapies (e.g., azathioprine, corticosteroids, cyclosporine, mesalamine agents, mercaptopurine, sulfasalazine, tacrolimus) and queries prior biologic/targeted synthetic exposure and hospitalization for severe UC.

Immune checkpoint inhibitor-related colitis specific: Patient has immune checkpoint inhibitor-related diarrhea or colitis AND the requested drug is prescribed by or in consultation with a hematologist/oncologist, with inadequate response to systemic corticosteroids or a contraindication to systemic corticosteroids; requested quantity must be supported by dosing guidelines in compendia or current literature.

Form asks specifically about steroid response, prescriber specialty, and whether dosing is supported by compendia/literature.

Continuation criteria: For continuation, provider documents date of last treatment, whether the patient has achieved or maintained remission, clinical response or maintenance of remission, and evidence of clinical improvement or low disease activity using signs, symptoms or disease activity measures.

Form requests disease-specific response measures (CDAI, Mayo, CRP, fecal calprotectin, endoscopy findings) and asks if patient receives samples or manufacturer assistance.

Provider Actions and Precertification Requirements

Prior Authorization

Precertification required

Prior authorization (precertification) is required before administering or dispensing Entyvio (vedolizumab). All fields on the precertification request form must be completed and legible; incomplete or illegible fields may prevent review and the plan may request additional information or clarification. Contact Aetna Precertification Notification: Phone: 1-866-752-7021 (TTY: 711). Fax: 1-888-267-3277. For Medicare Advantage Part B, use the Medicare request form.

Aetna Precertification Notification: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
Medicare Advantage Part B: Use Medicare Request Form

Denial Risk

Document prior conventional therapy attempts

For Crohn's disease and ulcerative colitis, the precertification must document prior conventional therapy attempts or reasons for intolerance/contraindication. Indicate diagnosis, gastroenterology involvement (if applicable), history of prior biologic or targeted synthetic therapy, and whether the patient has had an inadequate response to at least one conventional therapy. If a contraindication or intolerance exists, specify which conventional therapy(ies) and the reason.

Crohn's disease: Document loading dose (weeks 0, 2, 6) and maintenance dose/frequency; confirm diagnosis of moderately to severely active or fistulizing CD; document prior biologic use; document inadequate response to or contraindication/intolerance of at least one conventional therapy (select from listed agents).
Ulcerative colitis: Confirm diagnosis of moderately to severely active UC; document gastroenterology involvement; document prior biologic/targeted synthetic use; document hospitalization for acute severe UC if applicable; document inadequate response to or contraindication/intolerance of at least one conventional therapy (select from listed agents).

Documentation Required

Required documentation for precertification

Required documentation for precertification: include complete patient demographics, insurance information, prescriber details, dispensing provider/place of administration, and full clinical information. All required clinical fields must be completed for review.

Patient demographics: First/Last name, address, city, state, ZIP, home/work/cell phone, DOB, allergies, email, weight, height.
Insurance and request details: Start of treatment or continuation dates, primary and secondary ICD-10 codes, product (Entyvio dose and frequency).
Prescriber information: Name, credentials (M.D./D.O./N.P./P.A.), address, phone, fax, state license #, NPI, DEA, UPIN, provider email, office contact and phone, specialty (e.g., Gastroenterologist).
Dispensing provider/place of administration: place of administration (self, physician office, outpatient infusion center, home infusion, etc.), center name and phone, agency name, administration CPT codes if applicable, dispensing provider/pharmacy name, address, phone, fax, TIN/PIN, patient selected choice (physician's office, retail pharmacy, specialty pharmacy).
Clinical information: Use of combination biologics/targeted drugs, adverse events to product and response to conventional interventions, venous access or behavioral/medical stability concerns (with descriptions), and for CD/UC specific fields (dosing schedule, prior biologic use, conventional therapy attempts, contraindications/intolerances, response/remission status).

Documentation Required

Incomplete or illegible fields may prevent precertification review

Incomplete or illegible fields, or missing required clinical documentation (including lack of documentation of prior conventional therapy attempts for Crohn's disease or ulcerative colitis), may delay or prevent precertification approval. The plan may request additional information or clarification prior to rendering a decision.

All fields must be completed and legible for precertification review.
The plan may request additional supporting documentation or clarification if information is missing or unclear.

Background

Vedolizumab (Entyvio) is approved for inflammatory bowel diseases and is addressed on this precertification form for Crohn’s disease and ulcerative colitis, with disease-specific fields that capture loading and maintenance dosing, prior therapy history, and clinical response measures. The form also includes a section for immune checkpoint inhibitor-related diarrhea or colitis, asking about specialty consultation (e.g., hematology/oncology) and response to systemic corticosteroids. These disease-specific data elements support assessment of medical necessity for initiation or continuation of therapy.

Indications Captured on the Form

Indications captured on form

Crohn's diseaseForm captures moderately to severely active or fistulizing Crohn's disease; documents loading dose (weeks 0,2,6), maintenance dosing, prior biologic use, and whether patient had inadequate response to at least one conventional therapy with selectable agents (e.g., sulfasalazine, metronidazole, ciprofloxacin, prednisone, budesonide, azathioprine, mercaptopurine, methotrexate, methylprednisolone, rifaximin, tacrolimus)

Ulcerative colitisForm captures diagnosis of moderately to severely active ulcerative colitis; documents gastroenterology prescribing/consultation, prior biologic or targeted synthetic therapy history, hospitalization for acute severe UC, and whether patient had inadequate response to at least one conventional therapy with selectable agents (e.g., azathioprine, corticosteroids, cyclosporine, mesalamine agents, mercaptopurine, sulfasalazine, tacrolimus)

Immune checkpoint inhibitor-related colitis/diarrheaForm captures prescribing/consultation by hematologist/oncologist, inadequate response to systemic corticosteroids or contraindication to corticosteroids, and whether requested quantity is supported by compendia/literature dosing guidelines (e.g., Micromedex, NCCN)

Primary ICD Code	Primary diagnosis code to be provided by prescriber
Secondary ICD Code	Secondary/other diagnosis code to be provided by prescriber

OpenPayer

Entyvio (vedolizumab) Injectable Medication Precertification Request Form Coverage Criteria

Coverage Criteria for Entyvio (vedolizumab)

Coding

Provider Actions and Precertification Requirements

Background

Indications Captured on the Form