Humira (adalimumab) DRUG.00002

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1 Humira (adalimumab) DRUG Override(s) Prior Authorization Quantity Limit Approval Duration 1 year Medications Humira 10 mg/0.2 ml syringe Humira pediatric Crohn s Disease starter pack 40 mg/0.8 ml prefilled syringe Humira 20 mg/0.4 ml syringe Humira 40 mg/0.8 ml pen #^ Humira 40 mg/0.8 ml syringe #^ Quantity Limit 1 pack (28 day supply, one time fill) 2 pens per 28 days Humira Pen - Crohn s/ulcerative 1 pack (28 day supply, one time fill) Colitis/Hidradenitis Suppurativa starter pack 40 mg/0.8 ml prefilled pen * Humira Pen Psoriasis starter pack 40 1 pack (one time fill) mg/0.8 ml^ Override Criteria Initiation of therapy for pediatric Crohn s Disease (CD): Depending on individual s weight, may approve one (1) pediatric or adult Crohn s Disease starter pack up to four (4) additional pens or syringes (40 mg/0.8 ml) in the first month (28 days) of treatment * Initiation of therapy for adult Crohn s Disease (CD)or Ulcerative Colitis (UC): May approve one (1) Crohn s Disease/Ulcerative Colitis starter pack up to four (4) additional pens, autoinjectors or syringes (40 mg/0.8 ml) in the first month (28 days) of treatment. # In the treatment of Rheumatoid Arthritis (RA): May approve up to four (4) syringes autoinjectors or pens (40mg/0.8ml) (up to an additional two (2) syringes, autoinjectors or pens) every 28 days if the individual is unable to take concomitant methotrexate. Initiation of therapy for adult Hidradenitis Suppurativa (HS): May approve 1 (one) Crohn s Disease/Ulcerative Colitis/Hidradenitis Suppurativa starter pack up to 4 (four) additional pens or syringes (40 mg/0.8 ml) in the first month (28 days) of treatment. Maintenance therapy: May approve up to 2 (two) additional pens or syringes (40 mg/0.8 ml) per each 28 days. PAGE 1 of 5 06/18/2017 WEB-PEC

2 + Initiation of therapy for Uveitis (UV): May approve up to 2 (two) additional pens or syringes (40 mg/0.8 ml) in the first month (28 days) of treatment. ^Initiation of therapy for Plaque Psoriasis (Ps): May approve one (1) Psoriasis starter pack up to two (2) additional pens, autoinjectors or syringes (40 mg/0.8 ml) in the first month (28 days) of treatment. APPROVAL CRITERIA I. Individual has been on Humira (adalimumab) in the past 180 days (medication samples/ coupons/ discount cards are excluded from consideration as a trial); II. III. IV. Diagnosis of Rheumatoid Arthritis Individual must meet all of the following: A. Individual must be 18 years of age or older; AND B. Individual must have moderately to severely active rheumatoid arthritis (RA); AND 1. To reduce signs or symptoms; 2. To induce or maintain clinical response; 3. To inhibit the progression of structural damage; 4. To improve physical function; AND contraindication to one or more non-biologic disease-modifying anti-rheumatic agents (DMARDs); Diagnosis of Psoriatic Arthritis Individual must meet the following: A. Individual must be 18 years of age or older; AND B. Individual has active psoriatic arthritis; AND 1. To reduce signs or symptoms; 2. To induce or maintain clinical response; 3. To inhibit the progression of structural damage; 4. To improve physical function; AND D. Individual has failed to respond to, is intolerant of, or has had a medical contraindication to conventional therapy (such as non biologic DMARDs); Diagnosis of Active Ankylosing Spondylitis Individual must meet the following: PAGE 2 of 5 06/18/2017

3 B. Individual has active ankylosing spondylitis; AND C. Agent is used to reduce signs or symptoms of the disease; AND contraindication to conventional therapy (such as NSAIDs or non-biologic DMARDs); V. Diagnosis of Crohn s Disease (CD) Individual must meet the following: A. Individual is 6 years of age or older; AND B. Individual has a diagnosis of moderately to severely active CD; AND C. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy [such as 5-ASA products, sulfasalazine, systemic corticosteroids, or immunosuppressants] or has lost response to or is intolerant to infliximab or infliximab-dyyb, and Humira (adalimumab) is used for one of the following: 1. To reduce signs or symptoms; 2. To induce or maintain clinical remission. VI. VII. Diagnosis of Plaque Psoriasis - Individual must meet all of the following: B. Individual has a diagnosis of chronic moderate to severe (that is, extensive or disabling) plaque psoriasis with either of the following: 1. Plaque psoriasis involving greater than 5% of body surface area (BSA); 2. Plaque psoriasis involving less than or equal to 5% of BSA involving sensitive areas or areas that would significantly impact daily function (such as fingernails, palms, soles of feet, head/neck, or genitalia); AND 1. To reduce signs or symptoms; or 2. To induce or maintain clinical response; AND contraindication to phototherapy or other systemic therapies (such as methotrexate, acitretin, or cyclosporine); Diagnosis of Juvenile Idiopathic Arthritis (JIA) Individual must meet the following: A. Individual has a diagnosis of moderate to severely active juvenile idiopathic arthritis; AND B. Individual is 2 years of age or older; AND PAGE 3 of 5 06/18/2017

4 1. To reduce signs or symptoms; 2. To induce or maintain clinical response; AND contraindication to one or more non-biologic DMARDs. VIII. Diagnosis of Ulcerative Colitis (UC) Individual must meet the following: B. Individual has a diagnosis of moderately to severely active UC; AND C. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as 5-ASA products, sulfasalazine, systemic corticosteroids, or immunosuppressive drugs), and Humira (adalimumab) is used for one of the following: 1. To reduce signs or symptoms; 2. To induce or maintain clinical remission. IX. Non-infectious Uveitis Individual must meet the following: A. Individual has chronic, recurrent, treatment-refractory or vision-threatening disease; AND B. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as corticosteroids or immunosuppressive drugs [for example, azathioprine, cyclosporine, or methotrexate]). X. Hidradenitis Suppurativa (HS) when each of the following criteria are met: B. Individual has moderate to severe HS (Hurley stage II or Hurley stage III disease); AND C. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as oral antibiotics). May not be approved for an individual with ANY of the following: I. In combination with other TNF antagonists; or II. In combination with tofacitinib citrate; or III. In combination with the following non-tnf immunomodulatory drugs: abatacept (Orencia), or Kineret (anakinra); or IV. Tuberculosis, invasive fungal infection, other active serious infections, or a history of recurrent infections; or PAGE 4 of 5 06/18/2017

5 V. Individual has not had a tuberculin skin test (TST), or a CDC-recommended equivalent, to evaluate for latent tuberculosis. or VI. If the above approval criteria are not met and for all other indications. Note: Humira (adalimumab) has a black box warning related to the increased risk of developing serious infections that could result in hospitalization or death. Individuals should be closely monitored for the development of infection during and after treatment with discontinuation of therapy if the individual develops a serious infection or sepsis. Reported infections include: Tuberculosis, invasive fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis), and infections (bacterial, viral, or other) due to opportunistic pathogens (including Legionella and Listeria). The risks and benefits of treatment with Humira should be considered prior to initiating in individuals with chronic or recurrent infection. Humira is not indicated for the use in pediatric individuals due to reports of lymphoma and other malignancies developing in children and adolescents treated with tumor necrosis factor (TNF) blockers. State name Date effective 1. State Specific Mandates Mandate details (including specific bill if applicable) Key References: Clinical Pharmacology [database online]. Tampa, : Gold Standard, Inc.: URL: Updated periodically. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated periodically. Lexi-Comp ONLINE with AHFS, Hudson, Ohio: Lexi-Comp, Inc.; 2016; Updated periodically. PAGE 5 of 5 06/18/2017

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