This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Infliximab (Remicade) or an infliximab biosimilar, may be considered medically necessary for patients who meet ANY ONE of the following criteria:

Crohn's disease

• Infliximab (Remicade) is to be used for the reduction in signs and symptoms and inducing and maintaining clinical remission in individuals with moderately to severely active Crohn's disease; and
• Treatment with at least two (2) immunosuppressant (e.g., corticosteroids, azathioprine, 6-mercaptopurine or methotrexate) was ineffective or not tolerated or all immunosuppressants are contraindicated.

Pediatric Crohn's disease

• Infliximab (Remicade) is to be used for the reduction in signs and symptoms and inducing and maintaining clinical remission in pediatric patients ages six (6) to 17 with moderately to severely active Crohn's disease; 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.

Fistulizing Crohn's disease

• Infliximab (Remicade) is to be used for the reduction in the number of draining enterocutaneous and rectovaginal fistulas, and maintaining fistula closure in patients with fistulizing Crohn's disease.

The use of infliximab or an infliximab biosimilar for any other indication is considered experimental/investigational, and therefore, non-covered.  Scientific evidence does not support its use for any other indications.

Infliximab (Remicade) or an infliximab biosimilar may be considered medically necessary for individuals who meet ANY ONE of the following conditions:

Rheumatoid arthritis

• Infliximab (Remicade) is to be used in combination with methotrexate to inhibit the progression of structural damage and improve the physical function of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to methotrexate, as standard therapy.

Juvenile Rheumatoid Arthritis (JRA)/Juvenile Idiopathic Arthritis (JIA)

• Infliximab (Remicade) is to be used for the treatment of individuals who have had an inadequate response to one (1) or more disease-modifying antirheumatic drugs (DMARDS).

Ankylosing Spondylitis

• Infliximab (Remicade) is to be used for the reduction of signs and symptoms in patients with active ankylosing spondylitis; and
• Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated.

Psoriatic arthritis

• Infliximab (Remicade) is to be used for the reduction of signs and symptoms in patients with arthritis, inhibiting the progression of structural damage, and improving physical function. 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 BOTH of the following: 
  • Treatment with at least one (1) non-biologic disease modifying antirheumatic drug (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine or cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; and
  • Patients have active plaque psoriasis with at least one target lesion at least (two) 2 cm in diameter.

The use of infliximab or an inflixmab biosimilar for any other indication is considered experimental/investigational, and therefore, non-covered.  Scientific evidence does not support its use for any other indications.

Infliximab (Remicade) or an infliximab biosimilar  may be considered medically necessary for patients who meet the following criteria:

Ulcerative colitis

• Infliximab (Remicade) is to be used for the reduction of signs and symptoms and, maintaining clinical remission and mucosal healing in individuals with moderately to severely active ulcerative colitis and one (1) of the following; and
• Treatment with at least two (2) immunosuppressants (e.g., corticosteroids azathioprine, or 6-mercaptopurine) was ineffective or not tolerated, or all immunosuppressants are contraindicated; or
• The individual requires continuous steroid therapy.

Infliximab (Remicade) may be considered medically necessary forindividuals who meet the following criteria:

Pediatric ulcerative colitis

• Infliximab (Remicade only) is to be used for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients six (6) years of age and older with moderately to severely active ulcerative colitis; and
• Treatment with at least one (1) immunosuppressant (e.g., corticosteroids, azathioprine, or 6-mercaptopurine) was ineffective or not tolerated, or all immunosuppressants are contraindicated.

Note: Inflixmab-dyyb (Inflectra), infliximab-abda (Renflexis) and infliximab-qbtx (Ixifi) are not FDA approved for the treatment of pediatric ulcerative colitis and is therefore non-covered.

The use of infliximab (Remicade) or an infliximab biosimilar for any other indication is considered experimental/investigational, and therefore, non-covered.  Scientific evidence does not support its use for any other indications.  

Infliximab (Remicade) or an infliximab biosimilar, may be considered medically necessary for patients who meet the following criteria:

Plaque psoriasis

• Infliximab is to be used for the treatment of adult patients with chronic, severe (i.e., extensive and/or disabling) plaque psoriasis; and
• Patient's plaque psoriasis has been present for more than six (6) months with a minimum body surface involvement of 10%*; and
• Patients have failed to adequately respond to standard systemic agents (e.g., methotrexate, cyclosporine); or
• Patients have failed to adequately respond to standard phototherapy (e.g., PUVA, UVB).

*In patients with severe disease, localized psoriasis in sensitive areas such as palmar, plantar, and genitalia would meet the 10% body surface involvement definition.

The use of infliximab, an infliximab biosimilar, for any other indication is considered experimental/investigational, and therefore, non-covered.  Scientific evidence does not support its use for any other indications.  

Infliximab (Remicade) may be considered medically necessary for patients who meet the following criteria:

Non-infectious Uveitis when BOTH of the following criteria are met: 

•  
  • 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 for any other indication is considered experimental/investigational, and therefore, non-covered.  Scientific evidence does not support its use for any other indications.
         
Note: Dosage recommendations per Clinical pharmacology.

Preferred Intravenous Injectable Product(s)

Infliximab (Remicade) and golimumab (Simponi Aria) - for rheumatoid arthritis ONLY

Non-Preferred Intravenous Injectable Product(s)

In order for a request for the non-preferred product, inflixmab-dyyb (Inflectra),  infliximab-abda (Renflexis), or infliximab-qbtx (Ixifi) to be approved for Crohn's disease, pediatric Crohn's disease, fistulizing Crohn's disease, juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, or plaque psoriasis, the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to infliximab (Remicade).

In order for a request for the non-preferred product, inflixmab-dyyb (Inflectra), infliximab-abda (Renflexis), or infliximab-qbtx (Ixifi)  to be approved for rheumatoid arthritis, the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to infliximab (Remicade) or golimumab (Simponi Aria) or both preferred intravenous injectable products are contraindicated.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Evidence based guidelines support the administration of this drug in alternative sites of care such as the home, office or outpatient ambulatory infusion centers. Administration of infusible drugs at alternate sites of care is based upon the professional judgment of the provider, and taken into account the clinical appropriateness for each individual patient.

Infliximab, cA2 (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) administration are is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

07/2017, Infliximab Criteria Revised to Include Inflixmab-abda (Renflexis)
03/2018, Coverage Criteria Established for Infliximab-qbtx (Ixifi)

• Link to Diagnosis Codes

• Link to References