Anthem Blue Cross California Entyvio (vedolizumab) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Entyvio (vedolizumab), an integrin receptor antagonist which binds specifically to the α4β7 integrin and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal tissue. Entyvio (vedolizumab) intravenous formulation is approved for the treatment of Crohn’s disease and Ulcerative colitis. The subcutaneous formulation is approved for Ulcerative colitis and can be used for maintenance therapy in those who have completed loading doses with the IV formulation. Crohn’s Disease: According to the American Gastrointestinal Association clinical practice guidelines, evidence supports the use of methotrexate, corticosteroids, tumor necrosis factor inhibitors (TNFi) +/- immunomodulator, ustekinumab, or vedolizumab for induction of remission. Among the biologics, infliximab, adalimumab, ustekinumab, or vedolizumab are recommended or suggested over certolizumab for induction of remission. Evidence supports biologic agents, thiopurines, and methotrexate for maintenance of remission. Ustekinumab and vedolizumab are options for individuals with primary nonresponse to initial treatment with TNFi. Adalimumab, ustekinumab, or vedolizumab may be used in cases where an individual previously responded to infliximab and then lost response (secondary nonresponse). Ulcerative Colitis: For those with moderately to severely active disease, the American College of Gastroenterology (ACG) guidelines strongly recommend induction of remission using oral budesonide MMX, oral systemic corticosteroids, TNFi, tofacitinib or vedolizumab (moderate to high quality evidence). The American Gastroenterological Association (AGA) guidelines define moderate to severe UC as those who are dependent on or refractory to corticosteroids, have severe endoscopic disease activity, or are at high risk of colectomy. AGA strongly recommends biologics (TNFi, vedolizumab, or ustekinumab) or tofacitinib over no treatment in induction and maintenance of remission (moderate quality of evidence). For biologic-naïve individuals, Infliximab or vedolizumab are conditionally recommended over adalimumab for induction of remission (moderate quality evidence). Pediatric Use: Two publications (Conrad 2016, Singh 2016) describe the safety and efficacy of intravenous Entyvio (vedolizumab) in pediatric individuals with Crohn’s disease or ulcerative colitis who had failed prior treatment with conventional therapy or one or more TNFi. Based on the available peer-reviewed literature and views of relevant medical specialists practicing in pediatrics and pediatric gastroenterology, the use of vedolizumab to induce or maintain remission may be considered a treatment option in a subset of the pediatric population 6 years of age or older with Crohn’s disease or ulcerative colitis who are refractory to treatment with conventional drug therapy. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Entyvio (vedolizumab) Initial requests for intravenous Entyvio (vedolizumab) may be approved for the following: I. OR II. Crohn’s disease (CD) when the following criteria are met: A. B. Individual is 6 years of age or older (Conrad 2016, Singh 2016) with moderate to severe CD; AND Individual has had an inadequate response to or is intolerant of conventional therapy (such as systemic corticosteroids or immunosuppressants [such as thiopurines or methotrexate]); OR Individual has a contraindication to systemic corticosteroids or thiopurines or methotrexate. C. Ulcerative colitis (UC) when the following criteria are met: A. Individual is 6 years of age or older (Conrad 2016, Singh 2016) with moderate to severe UC; AND 1 OR III. B. C. Individual has had an inadequate response to or is intolerant of conventional therapy (such as 5-Aminosalicylic acid products, systemic corticosteroids, or immunosuppressants [such as thiopurines]); OR Individual has a contraindication to 5-ASA products or systemic or corticosteroids or thiopurines; Immunotherapy-related toxicities when each of the following criteria are met (NCCN 2A): A. B. Individual is undergoing immune checkpoint inhibitor therapy for a cancer diagnosis; AND Individual is experiencing moderate to severe diarrhea or colitis as a result of immune checkpoint inhibitor treatment; AND C. Symptoms persist despite treatment with steroids. Initial requests for subcutaneous Entyvio (vedolizumab) may be approved for the following: I. Ulcerative colitis (UC) when the following criteria are met: A. B. Individual is 18 years of age or older with moderate to severe UC; AND Individual has completed intravenous induction doses with Entyvio and is using subcutaneous Entyvio for maintenance therapy; OR Individual has been stabilized on intravenous Entyvio maintenance therapy and is switching to maintenance therapy with subcutaneous Entyvio. C. Continuation requests for Entyvio (vedolizumab) [intravenous and subcutaneous] may be approved if the following criteria are met: I. II. Individual has been receiving and is maintained on a stable dose of Entyvio; AND There is confirmation of clinically significant improvement or stabilization in clinical signs and symptoms of the disease. Requests for Entyvio (vedolizumab) may not be approved for the following: I. II. III. In combination with oral or topical JAK inhibitors, ozanimod, deucravacitinib, or any of the following biologic immunomodulators: TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, IL-6 inhibitors, IL-1 inhibitors, ustekinumab, abatacept, rituximab, or natalizumab; OR Active, serious infection or a history of recurrent infections; OR New or worsening neurological signs or symptoms of John Cunningham virus (JCV) infection or risk of progressive multifocal leukoencephalopathy (PML); OR IV. When the above criteria are not met and for all other indications. Quantity Limits Entyvio (vedolizumab) Quantity Limit Entyvio 300 mg/vial*^ Entyvio (vedolizumab) 108 mg/ 0.68 mL prefilled syringe/pen 1 vial per 56 days (8 weeks) 1 syringe/pen every 2 weeks Drug Limit Override Criteria *Initiation of therapy for Crohn’s Disease (CD) or Ulcerative Colitis (UC): May approve up to 2 (two) additional single-use vials (300 mg/vial) in the first 6 weeks (42 days) of treatment. ^For CD or UC, may approve increased dosing, up to 1 vial (300 mg) every 4 weeks if the following criteria are met: I. II. III. IV. V. VI. Individual has been treated with standard maintenance dosing (i.e. every 8 weeks) for at least 2 doses or 16 weeks; AND The increased dosing is being prescribed by or in consultation with a gastroenterologist; AND Individual initially achieved an adequate response to standard maintenance dosing but has subsequently lost response, as determined by the prescriber; OR Individual partially responded but had an inadequate response to standard maintenance dosing as determined by the prescriber; AND Symptoms, if present, are not due to active infections or any other gastrointestinal disorder other than the primary disease; AND Requested dosing does not exceed up to one vial (300 mg) every 4 weeks. Initial approval duration for increased dosing for CD or UC: 16 weeks ^Requests for continued escalated dosing for CD or UC may be approved if the following criteria are met: I. Requested dosing does not exceed up to one vial (300 mg) every 4 weeks; AND 2 II. III. IV. Individual has subsequently regained response or achieved adequate response following increased dosing, as shown by improvement in signs and symptoms of the disease (including but not limited to reduction in stool frequency/bloody stools, improvement abdominal pain, or endoscopic response); AND Individual is not experiencing unacceptable adverse effects from increased dosing; AND Individual will be assessed regularly for dose de-escalation. Continued approval duration for increased dosing for CD or UC: 6 months ^For CD or UC, Increased dosing may not be approved for the following: I. II. Individual has had no response to Entyvio at standard maintenance dosing (i.e. every 8 weeks); OR Individual is requesting dose escalation in absence of signs and symptoms of the disease (for example, requesting based on results of therapeutic drug level or anti-drug antibody testing alone). Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J3380 Injection, vedolizumab, 1 mg [Entyvio] ICD-10 Diagnosis K50.00-K50.919 Crohn’s disease (regional enteritis) K51.00-K51.919 Ulcerative colitis Document History Revised: 11/17/2023