INFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Ixifi* (infliximabqbtx), Renflexis (infliximab-abda)

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1 Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 6 years of age or older 1. Moderate to severe Crohn s disease (CD) a. Patient has fistulizing disease b. Inadequate response, intolerance, or contraindication to conventional therapy for CD (See Appendix 1) c. Up to date with all vaccinations prior to initiating therapy (pediatric patients) 2. Moderate to severely active Ulcerative Colitis (UC) a. Inadequate response, intolerance, or contraindication to conventional therapy for UC (See Appendix 1) b. Up to date with all vaccinations prior to initiating therapy (pediatric patients) 12 years of age or older 1. Juvenile Idiopathic arthritis (JIA) a. Inadequate response, intolerance, or contraindication to at least a 3- month trial of a self-injectable TNF inhibitor indicated for JIA 18 years of age and older 1. Moderate to severely active Rheumatoid Arthritis (RA) a. Inadequate response, intolerance, or contraindication to at least a 3- month trial of methotrexate despite adequate dosing (i.e., titrated to 20 mg/week) b. Concurrent methotrexate or leflunomide therapy for patients who do not show intolerance to or for whom methotrexate or leflunomide is not contraindicated

2 2. Active Ankylosing Spondylitis (AS) / axial spondyloarthritis a. Inadequate response to at least TWO non-steroidal antiinflammatory drugs (NSAIDs) over a 4-week period in total at maximum recommended or tolerated anti-inflammatory doses 3. Severe Plaque Psoriasis (Ps) a. At least 5% of body surface area (BSA) is affected OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected b. Inadequate response, intolerance, or contraindication to phototherapy or pharmacologic treatment with methotrexate, cyclosporine or acitretin 4. Active Psoriatic Arthritis (PsA) 5. Behçet s syndrome 6. Granulomatosis with polyangiitis (Wegener s granulomatosis) 7. Hidradenitis Suppurativa 8. Pyoderma gangrenosum 9. Sarcoidosis 10. Takayasu s arteritis 11. Uveitis a. Inadequate response, intolerance, or contraindication to a trial of immunosuppressive therapy for uveitis AND ALL of the following: 1. TB test confirming no active tuberculosis or if latent tuberculosis infection is present, treatment for the infection to be started prior to use of Remicade 2. NO active infections 3. NOT to be used in combination with any other biologic DMARD or targeted synthetic DMARD (See Appendix 2)

3 4. Patient is not at risk for HBV infection OR is at risk for HBV infection and HBV infection has been ruled out OR treatment for HBV infection has been initiated 5. NOT given concurrently with live vaccines Prior - Approval Limits Duration 4 months for all diagnoses except Rheumatoid Arthritis (4 cycles per 4 months) 6 months for Rheumatoid Arthritis (5 cycles per 6 months) Prior Approval Renewal Requirements Diagnoses Patient must have ONE of the following: 6 years of age or older 1. Crohn s Disease 2. Ulcerative Colitis 12 years of age and older 1. Juvenile Idiopathic arthritis (JIA) 18 years of age or older 1. Rheumatoid Arthritis (RA) 2. Ankylosing Spondylitis 3. Psoriatic Arthritis 4. Plaque Psoriasis 5. Active Psoriatic Arthritis 6. Behçet s syndrome 7. Granulomatosis with polyangiitis (Wegener s granulomatosis) 8. Hidradenitis Suppurativa 9. Pyoderma gangrenosum 10. Sarcoidosis 11. Takayasu s arteritis 12. Uveitis AND ALL of the following: a. Condition has improved or stabilized

4 b. Absence of active infection (including tuberculosis and hepatitis B virus (HBV)) c. NOT to be used in combination with any other biologic DMARD or targeted synthetic DMARD (See Appendix 2) d. NOT given concurrently with live vaccines Prior Approval Renewal Limits Duration 12 months For all diagnoses except Ankylosing Spondylitis, 7 cycles per year For Ankylosing Spondylitis, 9 cycles per year Please reference tables for specific dosing in vials for initiation and continuation criteria Diagnosis Initiation Continuation All Diagnoses except AS, RA & JIA **note: for CD dosing can go up to 10 4 cycles of treatment for 4 months mg/kg/cycle AS Dosing: 5 mg/kg/cycle RA & JIA Dosing: 3 mg/kg/cycle **note: non-responders can increase to q4 week dosing OR 10 mg/kg/cycle 4 cycles of treatment for 4 months 5 cycles of treatment for 6 months 7 cycles of treatment for 1 year (q 8 weeks) 9 cycles of treatment for 1 year (q 6 weeks) 7 cycles of treatment for 1 year (q 8 weeks) Patient Weight Indication RA & JIA All Diagnoses except RA &JIA Nonresponders: RA, JIA & CD 0 10 kg up to 22 lbs 1 vial/cycle 1 vial/cycle 1 vial/cycle kg lbs 1 vial/cycle 1 vial/cycle 2 vial/cycle kg lbs 1 vial/cycle 2 vial/cycle 3 vial/cycle kg lbs 2 vial/cycle 2 vial/cycle 4 vial/cycle kg lbs 2 vial/cycle 3 vial/cycle 5 vial/cycle kg lbs 2 vial/cycle 3 vial/cycle 6 vial/cycle kg lbs 3 vial/cycle 4 vial/cycle 7 vial/cycle kg lbs 3 vial/cycle 4 vial/cycle 8 vial/cycle

5 81 90 kg lbs 3 vial/cycle 5 vials/cycle 9 vial/cycle kg lbs 4 vial/cycle 5 vials/cycle 10 vial/cycle kg lbs 4 vial/cycle 6 vials/cycle 11 vial/cycle kg lbs 4 vial/cycle 6 vials/cycle 12 vial/cycle kg lbs 4 vial/cycle 7 vials/cycle 13 vial/cycle kg lbs 5 vial/cycle 7 vials/cycle 14 vial/cycle kg lbs 5 vial/cycle 8 vials/cycle 15 vial/cycle (see appendix below)

6 Appendix 1 - List of Conventional Therapies Conventional Therapy Options for CD 1. Mild to moderate disease induction of remission: a. Oral budesonide, oral mesalamine b. Alternatives: metronidazole, ciprofloxacin 2. Mild to moderate disease maintenance of remission: a. Azathioprine, mercaptopurine b. Alternatives: oral budesonide, methotrexate intramuscularly (IM) 3. Moderate to severe disease induction of remission: a. Prednisone, methylprednisolone intravenously (IV) b. Alternatives: methotrexate IM 4. Moderate to severe disease maintenance of remission: a. Azathioprine, mercaptopurine b. Alternative: methotrexate IM 5. Perianal and fistulizing disease induction of remission c. Metronidazole ± ciprofloxacin 6. Perianal and fistulizing disease maintenance of remission d. Azathioprine, mercaptopurine e. Alternative: methotrexate IM Conventional Therapy Options for UC 1. Mild to moderate disease induction of remission: a. Oral mesalamine (e.g., Asacol, Lialda, Pentasa), balsalazide, olsalazine b. Rectal mesalamine (e.g., Canasa, Rowasa) c. Rectal hydrocortisone (e.g., Colocort, Cortifoam) d. Alternatives: prednisone, azathioprine, mercaptopurine, sulfasalazine 2. Mild to moderate disease maintenance of remission: a. Oral mesalamine, balsalazide, olsalazine, rectal mesalamine b. Alternatives: azathioprine, mercaptopurine, sulfasalazine 3. Severe disease induction of remission: a. Prednisone, hydrocortisone IV, methylprednisolone IV b. Alternatives: cyclosporine IV, tacrolimus, sulfasalazine 4. Severe disease maintenance of remission: a. Azathioprine, mercaptopurine b. Alternative: sulfasalazine 5. Pouchitis: a. Metronidazole, ciprofloxacin b. Alternative: rectal mesalamine

7 Appendix 2 Biological disease-modifying antirheumatic drugs (DMARDs) Generic Name Brand Name abatacept Orencia adalimumab Humira anakinra Kineret certolizumab Cimzia etanercept Enbrel golimumab Simponi/Simponi Aria guselkumab Tremfya infliximab Remicade ixekizumab Taltz rituximab Rituxan sarilumab Kevzara secukinumab Cosentyx tocilizumab Actemra ustekinumab Stelara abatacept Orencia Targeted synthetic disease-modifying antirheumatic drugs (DMARDs) Generic Name Brand Name apremilast Otezla tofacitinib Xeljanz