Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Infliximab (Remicade) or Infliximab Biosimilar (Avsola,Inflectra or Renflexis)
Infliximab (Remicade) or an infliximab biosimilar (Avsola, Inflectra or Renflexis), may be considered medically necessary when an individual meets criteria for ANY ONE of the following indications:
Ankylosing Spondylitis (AS)
- The individual is 18 years of age or older with active AS; and
- Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated; or
Crohn's Disease (CD)
- The individual is 18 years of age or older with moderately to severely active CD; or
- Treatment of individuals 18 years of age or older with a history of moderately to severely active CD now in remission; and
- Treatment with at least one (1) immunosuppressant (e.g., corticosteroids, azathioprine, 6-mercaptopurine or methotrexate) was ineffective or not tolerated or all immunosuppressants are contraindicated; or
Pediatric Crohn's Disease (CD)
- The individual is 6 to 17 years of age with moderately to severely active CD; or
- Treatment of pediatric individuals 6 to 17 years of age with a history of moderately to severely active CD now in remission; and
- Treatment with at least one (1) immunosuppressant (e.g., corticosteroids, azathioprine, 6-mercaptopurine or methotrexate) was ineffective or not tolerated or all immunosuppressants are contraindicated; or
Fistulizing Crohn's Disease (CD)
- Treatment of individual 18 years of age or older with active or history of fistulizing CD; or
Juvenile Rheumatoid Arthritis (JRA)/Juvenile Idiopathic Arthritis (JIA)
- The treatment of individuals who have had an inadequate response to one (1) or more disease-modifying antirheumatic drugs (DMARDs); or
Plaque Psoriasis
- The individual is 18 years of age or older with chronic, severe (i.e., extensive and/or disabling) plaque psoriasis; and
- Individual's plaque psoriasis has been present for more than six (6) months with a minimum body surface involvement of 10% (In individuals with severe disease, localized psoriasis in sensitive areas such as palmar, plantar, and genitalia would meet the 10% body surface involvement definition); and
- Individual has failed to adequately respond to standard systemic agents (e.g., methotrexate, cyclosporine); or
- Individual has failed to adequately respond to standard phototherapy (e.g., PUVA, UVB); or
Psoriatic Arthritis (PsA)
- Spinal or axial Psoriatic Arthritis (PsA)
- Treatment of individuals 18 years of age or older with predominant spinal or axial PsA; and
- Treatment with at least one (1) NSAID was ineffective or not tolerated or all NSAIDs are contraindicated; or
- Psoriatic Arthritis (PsA) without spinal or axial disease
- Treatment of individuals 18 years of age or older diagnosed with PsA. Active articular disease is defined as five or more swollen and tender joints and either C reactive protein levels of at least 15 mg/l and/or morning stiffness lasting 45 minutes or longer; and
- Treatment with at least one (1) non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine or cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; and
- Individual has active plaque psoriasis with at least one target lesion at least two (2) cm in diameter; or
- Enthesitis and/or dactylitis associated Psoriatic Arthritis PsA
- The individual is 18 years of age or older with active enthesitis and/or dactylitis associated with PsA; and
- Treatment with at least one (1) NSAID or local glucocorticoid injection was ineffective or not tolerated or all NSAIDs and all local glucocorticoid injections are contraindicated; or
Rheumatoid arthritis (RA)
- The individual is 18 years of age or older with moderately to severely active RA; and
- Used in combination with methotrexate in individuals who have had an inadequate response to methotrexate, as standard therapy; or
Ulcerative Colitis (UC)
- The individual is 18 years of age or older with moderately to severely active UC; or
- The individual is 18 years of age or older with a history of moderately to severely active UC now in remission; and
- The individual is currently pregnant or planning to become pregnant; or
- Treatment with at least one (1) immunosuppressant (e.g., corticosteroids azathioprine, or 6-mercaptopurine) was ineffective or not tolerated,
or all immunosuppressants are contraindicated; or
- The individual requires chronic steroid therapy; or
Pediatric ulcerative colitis (UC)
- The individual is six (6) years of age or older with moderately to severely active UC; or
- The individual is six (6) years of age or older with a history of moderately to severely active UC now in remission; and
- Individual is currently pregnant or planning to become pregnant; or
- Treatment with at least one (1) immunosuppressant (e.g., corticosteroids, azathioprine, or 6-mercaptopurine) was ineffective or not tolerated, or all immunosuppressants are contraindicated; or
Non-infectious Uveitis
- The individual has non-infectious uveitis; and
- Individual has chronic, recurrent, treatment-refractory or vision-threatening disease; and
- 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]).
The use of infliximab (Remicade) or an infliximab biosimilar (Avsola, Inflectra and Renflexis), for any other indication is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support its use for any other indications.
Procedure Codes
