Prior Authorization Criteria Entyvio (vedolizumab) Policy Number: C6773-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 09/2014 03/28/2019 03/2/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL J3380 Inj, vedolizumab, 1 mg RxPA Q2 2019 PRODUCTS AFFECTED: Entyvio (vedolizumab) DRUG CLASS: Integrin Receptor Antagonists ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill AVAILABLE DOSAGE FORMS: Entyvio SOLR 300MG (300MG Intravenous Solution) FDA-APPROVED USES: Crohn Disease: Treatment of moderately to severely active Crohn disease in patients who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor-alpha (TNF-alpha) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Ulcerative Colitis: Treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response with, lost response to, were intolerant to a tumor necrosis factor alpha (TNF-alpha) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Documented diagnosis of moderately to severely active ulcerative colitis (UC), OR moderately to severely active Crohn disease (CD) REQUIRED MEDICAL INFORMATION: A. CROHNS DISEASE AND ULCERATIVE COLITIS: 1. A negative tuberculin skin test (TST), or CDC-recommended equivalent, for latent tuberculosis within the last 12 months, OR No evidence of active, severe infections, significant localized infections, or sepsis as documented by a recent evaluation and screening (within the past 30 days) 2. AND Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. � Page 1 of 6 Prior Authorization Criteria 3. Not on concurrent treatment with another TNF-inhibitor, biologic response modifier or biologic agent for an inflammatory condition [e.g., Actemra (tocilizumab), Enbrel (etanercept), Kineret (anakinra), Orencia (abatacept), Remicade (infliximab), Rituxan (rituximab), Simponi (golimumab), Tysabri (natalizumab)] NOTE: Verify member’s current medication fill history or prescription drug profile AND 4. Documentation of inadequate response with, clinically significant adverse effects on, or contraindication to, maximally indicated doses and appropriate duration to the following treatments: (a) TWO of the following agents (at least 1 from each of the following, a and b) a. Anti-inflammatory: Corticosteroids (e.g., prednisone, methylprednisolone, budesonide, hydrocortisone, prednisolone); 5-Aminosalicylic acid derivative agents (e.g., mesalamine, sulfasalazine, balsalazide); OR b. Immunomodulators [e.g. 6-mercaptopurine (6-MP, Purinethol); azathioprine (Imuran); methotrexate; tacrolimus] AND (b) ONE TNF-inhibitor: adalimumab (Humira), certolizumab (Cimzia), or infliximab (Remicade) DURATION OF APPROVAL: Initial authorization: 14 weeks [4 doses (zero, two, six weeks and the first every eight week dose)] *Discontinue therapy if no evidence of therapeutic benefit by week 14, Continuation authorization: 6 months QUANTITY: 300 mg IV every 8 weeks PRESCRIBER REQUIREMENTS: Prescribed by, or in consultation with, a board-certified gastroenterologist or colorectal surgeon. Consultation notes must be submitted for initial request and for continuation of treatment requests at least ONCE annually. AGE RESTRICTIONS: 18 years of age or older GENDER: Male and female CONTINUATION OF THERAPY: A. CROHNS DISEASE AND ULCERATIVE COLITIS: 1. Positive clinical response and remission of disease as evidenced by the following (not an all- inclusive list): ULCERATIVE COLITIS: improvement in signs and symptoms compared to baseline such as- improvement in endoscopic appearance of the mucosa, stool frequency, rectal bleeding, and/ or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score], OR CROHNS DISEASE: improvement in signs and symptoms compared to baseline such as- improvement in endoscopic appearance of the mucosa, stool frequency, rectal bleeding, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extraintestinal complications, use of anti- diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score] AND Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. � Page 2 of 6 Prior Authorization Criteria 2. No evidence of active systemic infections, significant localized infections or sepsis as documented by a recent evaluation and screening (within the past 30 days) AND 3. Documentation confirming member’s current medication has been recently reviewed and there is no concomitant use of CYP2D6 and CYP3A inhibitors (labeled contraindication) AND 4. Member compliance with therapy as verified by Prescriber and member’s medication fill history (review Rx history for compliance) AND 5. Member has not experienced any intolerable adverse effects or drug toxicity [i.e. progressive multifocal leukoencephalopathy (PML); anaphylaxis or other serious allergic reactions, severe infections, jaundice or other evidence of significant liver injury] CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: All other uses of Entyvio (vedolizumab) are considered experimental/investigational and therefore, will follow Molina’s Off-Label policy. Contraindications to Entyvio (vedolizumab) include: Severe hypersensitivity to vedolizumab or any component of the formulation including L-histidine, L-arginine, sucrose, or polysorbate 80. Exclusions for coverage include, but are not limited to: Combination with another biologic agent for an inflammatory condition [e.g., Actemra (tocilizumab), Enbrel (etanercept), Kineret (anakinra), Orencia (abatacept), Remicade (infliximab), Rituxan (rituximab), Simponi (golimumab)]; Currently diagnosed with, or history of, progressive multifocal leukoencephalopathy (PML) OTHER SPECIAL CONSIDERATIONS: None BACKGROUND: Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract of unknown etiology and characterized by a chronic idiopathic inflammation of the intestine and consists of two main forms, ulcerative colitis (UC) and Crohn’s disease (CD). While UC and CD have similar clinical presentations, they differ in the body areas affected. CD is characterized by deeper and more erratic inflammation that can occur throughout the entire digestive tract. In UC, inflammation is continuous and widespread and disturbs the superficial mucosal layer of the large intestine or the colon. Crohn's disease (CD) is a chronic, inflammatory, multisystem disorder of unknown etiology with genetic, immunologic, and environmental influences. CD involves any area of the gastrointestinal tract (GIT) from the oral cavity to the anus, but it is limited primarily to the colon with or without small- intestine disease. Moreover, the inflammation in CD is often described as transmural, damaging each mucosal layer of the GIT, and noncontinuous. Therapy for CD includes medical therapy with pharmacologic agents consisting of 5-aminosalicylates (5-ASA), antibiotics, corticosteroids, immunomodulators, and biologics. Surgery is reserved for patients who are refractory to medical therapy. The key symptoms of CD include abdominal pain, diarrhea, and fatigue. Weight loss, fever, growth failure, anemia, recurrent fistulas, or extraintestinal manifestations (e.g., arthritis, iritis) can also occur. There is no single laboratory test that can make an unequivocal diagnosis of CD. Ulcerative colitis (UC) is a chronic inflammatory condition characterized by relapsing and remitting episodes of inflammation that involves the rectum and colon. The definitive etiology of ulcerative colitis is unknown, but suspected causes are similar to those of CD. Inflammation can be mild, moderate, or severe. UC is limited to the superficial mucosa of the colon. UC more commonly involves the entire colon in children than in adults, who more commonly will have limited left-sided disease.The goals of treatment are to control the acute attacks, prevent recurrent attacks and promote healing of the colon. Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains