Ilaris will be approved when BOTH of the following are met:

    1. ONE of the following:

        A. The patient has been diagnosed with Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)

OR

        B. The patient has been diagnosed with Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)

OR

        C. The patient has been diagnosed with Familial Mediterranean Fever (FMF) AND ONE of the following:

            i. The patient has tried and had an inadequate response to colchicine

OR

            ii. The patient has an intolerance or hypersensitivity to colchicine

OR

            iii. The patient has an FDA labeled contraindication to colchicine

OR

        D. The patient has been diagnosed with Cryopyrin-Associated Periodic Syndrome (CAPS) including Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) AND the patient is at least 4 years of age

OR

        E. The patient has been diagnosed with active Systemic Juvenile Idiopathic Arthritis (SJIA)

AND ALL of the following:

            i. The patient is at least 2 years of age

AND

            ii. The patient has documented active systemic features (e.g., ongoing fever, evanescent erythematous rash, generalized lymphadenopathy, 1 or more joints with active arthritis, hepatomegaly, splenomegaly, serositis)

AND

            iii. ONE of the following:

                a. The patient has tried and had an inadequate response to at least ONE prerequisite medication (e.g., glucocorticosteroids, prescription oral NSAIDs, methotrexate, leflunomide)

OR

                b. The patient has an intolerance or hypersensitivity to at least ONE prerequisite medication

OR

                c. The patient has an FDA labeled contraindication to at least ONE prerequisite medication

OR

        F. The patient has a diagnosis of adult onset Still’s disease

OR

        G. The patient has been diagnosed with acute gouty arthritis AND ONE of the following:

                i. The patient has tried and had an inadequate response to at least TWO conventional first-line medications (e.g., prescription oral NSAIDs, colchicine, systemic corticosteroids)

OR

                ii. The patient has an intolerance or hypersensitivity to at least TWO conventional first-line medications

OR

                iii. The patient has an FDA labeled contraindication to at least TWO conventional first-line medications

AND

    2. The patient will NOT be using the requested medication in combination with another biologic medication

Length of approval: 12 months