1 P a g e. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

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1 LENGTH OF AUTHORIZATION: Initial: 3 months for Crohn s or Ulcerative Colitis; 1 year for all other indications. Renewal: 1 year dependent upon medical records supporting response to therapy and review of Rx history. * Prior approval will only be granted for the approved FDA indications listed below. * Must be prescribed by a rheumatologist, gastroenterologist or dermatologist based on the approved FDA indication Routine PDL edit plus Drug FDA Approved Indications Criteria for Approval Actemra (tocilizumab) Rheumatoid Arthritis (RA) (1.1) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.2) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Tried and failed Methotrexate; OR requested medication will be chronic liver disease, or other contraindication); AND Patient has tried and failed another DMARD (other than Methotrexate), such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, gold salts, hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus; Tried and failed Methotrexate; OR requested medication will be chronic liver disease, or other contraindication); AND Patient has tried and failed another DMARD (other than Methotrexate), such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, gold salts, hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus; Tried and failed Methotrexate; OR requested medication will be chronic liver disease, or other contraindication); AND Patient has tried and failed another DMARD (other than Methotrexate), such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, gold salts, hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus; 1 P a g e

2 Cimzia (certolizumab) Reducing signs and symptoms of Crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy Moderately to severely active RA in combination with methotrexate Psoriatic arthritis Trial and failure of a compliant regimen of oral corticosteroids (moderate to severe CD) unless contraindicated or intravenous corticosteroids (severe and fulminant CD or failure to respond to oral corticosteroids), AND Trial and failure of a compliant regimen of azathioprine or mercaptopurine for three consecutive months, AND Trial and failure of a compliant regimen of parenteral methotrexate for three consecutive months hydroxychloroquine, minocycline) Trial and failure of Methotrexate; OR requested medication will be chronic liver disease, or other contraindication) Ankylosing spondylitis Trial and failure of failed an adequate trial of at least two NSAIDs; OR use of NSAIDs is contraindicated in patient Enbrel (etanercept) Rheumatoid Arthritis (RA) Juvenile Idiopathic Arthritis (JIA) in members 2 years and older Psoriatic Arthritis (PsA) Ankylosing spondylitis Humira (adalimumab) Plaque Psoriasis (PsO) in patients 4 years or older Rheumatoid Arthritis (RA) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. 2 P a g e

3 Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS Adult Crohn s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Pediatric Crohn s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6- mercaptopurine, or methotrexate. Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Hidradenitis Suppurativa (HS): The treatment of moderate to severe hidradenitis suppurativa. 3 P a g e

4 Uveitis (UV): The treatment of non-infectious intermediate, posterior and panuveitis in adult patients. Drug FDA Approved Indications Criteria for Approval Kineret (anakinra) Moderately to severely active RA hydroxychloroquine, minocycline) Cryopyrin-Associated Periodic Syndromes (CAPS) Approvable with confirmation of this diagnosis. Treatment of Neonatal-Onset Multisystem Inflammatory Disease Orencia (abatacept) Moderately to severely active RA hydroxychloroquine, minocycline) Juvenile Idiopathic Arthritis (JIA) in members 2 years and older Otezla (apremilast) Adult patients with active psoriatic arthritis Olumiant (baricitinib) Simponi (golimumab) Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies Moderately to severely active Rheumatoid Arthritis (RA) in adults, in combination with methotrexate Active Psoriatic Arthritis (PsA) in adults, alone or in combination with methotrexate Active Ankylosing Spondylitis in adults (AS) Must have a previous failure on a topical psoriasis agent and be a candidates for phototherapy or systemic therapy Patient age 18 years old; AND Use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended methotrexate alone and at least one other DMARD (sulfasalazine, hydroxychloroquine, minocycline). Must be in combination with methotrexate. 4 P a g e

5 Moderately to severely active Ulcerative Colitis Trial and failure of a compliant regimen of oral or rectal aminosalicylates (i.e., sulfasalazine or mesalamine) for two consecutive months, AND Trial and failure of a compliant regimen of oral corticosteroids (for moderate to severe CD) unless contraindicated, or intravenous corticosteroids (for severe and fulminant CD or failure to respond to oral corticosteroids), AND Trial and failure of a compliant regimen of azathioprine or mercaptopurine for three consecutive months Drug FDA Approved Indications Criteria for Approval Xeljanz (tofacitinib) Xeljanz XR (tofacitinib) Cosentyx TM (secukinumab) Otrexup (methotrexate) Mod to severe active RA in adult members who are intolerant or not a candidate to methotrexate or in combination with methotrexate Adult Moderate to severe Plaque Psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Adult patients with active psoriatic arthritis Adult patients with active ankylosing spondylitis Management of members with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pjia), who are intolerant of or had an inadequate response to first-line therapy. Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. hydroxychloroquine, minocycline). Must have a previous failure on a topical psoriasis agent Length of Authorization: 6 months, then renew for 1 year for RA, if compliant and appropriate monitoring occurs. Approve for 6 months for psoriasis. Diagnosis of active rheumatoid arthritis (RA) Has had therapeutic failure to two preferred DMARD agents; AND Diagnosis of polyarticular juvenile idiopathic arthritis (pjia) Has had therapeutic failure to two preferred NSAIDS agents; AND 5 P a g e

6 Diagnosis of Psoriasis Rasuvo TM (methotrexate) Management of severe, active rheumatoid arthritis (RA) Polyarticular juvenile idiopathic arthritis (pjia), who are intolerant of or had an inadequate response to first-line therapy. Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. A therapeutic trial and failure on topical therapies such as topical emollients and/or topical corticosteroids, topical retinoids, topical vitamin D analogs, and topical tacrolimus AND pimecrolimus :AND Length of Authorization: 6 months, then renew for 1 year for RA, if compliant and appropriate monitoring occurs. Approve for 6 months for psoriasis. Diagnosis of active rheumatoid arthritis (RA) Has had therapeutic failure to two preferred DMARD agents; AND Diagnosis of polyarticular juvenile idiopathic arthritis (pjia) Has had therapeutic failure to two preferred NSAIDS agents; AND Diagnosis of Psoriasis A therapeutic trial and failure on topical therapies such as topical emollients and/or topical corticosteroids, topical retinoids, topical vitamin D analogs, and topical tacrolimus AND pimecrolimus :AND Quantity Limit = 4 auto-injectors per month For renewal, patient must be followed by a physician for monitoring of renal and hepatic function and complete blood counts with differential and platelet count. 6 P a g e

7 Taltz Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Routine PDL Patient has tried and failed at least 2 topical treatments, such as corticosteroids, calcipotriene, coal tar, tazarotene, or anthralin; 7 P a g e

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