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Infliximab

REMICADE is a tumor necrosis factor (TNF) blocker that may be used and Medically Necessary for treatment of::Crohn’s Disease:

• reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

• reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

Pediatric Crohn’s Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.

Ankylosing Spondylitis: reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.

Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

The use of infliximab may be considered medically necessary for the treatment of Behçet syndrome and Behçet syndrome uveitis when:

patient is 18 years of age or older AND
has had an inadequate response with conventional therapy (i.e., systemic corticosteroids or immunosuppressive agents) OR
has an intolerance or contraindication with conventional therapy OR
if with uveitis has previously received a biologic indicated for uveitis.

The use of infliximab is considered investigational for the following conditions:

systemic juvenile idiopathic arthritis;
rheumatic and autoimmune conditions potentially treatable with tumor necrosis factor a inhibitors:

sarcoidosis;
systemic sclerosis;
Sjögren syndrome;
Kawasaki disease;
Primary sclerosing cholangitis;

vasculitides potentially treatable with tumor necrosis factor α inhibitors:

giant cell arteritis/polymyalgia rheumatic;
granulomatosis with polyangiitis (Wegener granulomatosis);
polyarteritis nodosa;

nonrheumatic musculoskeletal conditions:

arthritis (other than rheumatoid arthritis and psoriatic arthritis);
sacroiliitis (not associated with ankylosing spondylitis or spondyloarthritis;
intra-articular injections;

rheumatic joint disease refractory to tumor necrosis factor α inhibitors.

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