CORONAVIRUS (COVID-19)

Resources on COVID-19 and how BCBSND is responding to help protect all North Dakotans

Infliximab

Section: Injections
Effective Date: April 01, 2020

Description

Infliximab (Remicade) is a murine-human chimeric monoclonal antibody, which binds to and neutralizes the effects of tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory cytokine.

Infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis) are biosimilar murine-human chimeric monoclonal antibodies to infliximab (Remicade). Both Remicade and its biosimilars, inflixmab-dyyb (Inflectra) and infliximab-abda (Renflexis) have the same mechanism of action. Inflixmab-dyyb (Inflectra) and infliximab-abda (Renflexis) are highly similar to, but not interchangeable with the reference product, Remicade.

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 (Inflectra or Renflexis) Intravenous (IV)

Infliximab (Remicade) or an infliximab biosimilar (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 BOTH of the following:
      • 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 one (1) of the following:
    • 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.

The use of infliximab (Remicade) or an infliximab biosimilar (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

J1745
Q5103  Q5104

Reauthorization Criteria for Infliximab (Remicade) or Infliximab Biosimilar (Inflectra or Renflexis) IV

Continuation of therapy with infliximab (Remicade) or infliximab biosimilar (Inflectra or Renflexis) IV may be considered medically necessary when the following criteria is met:

  • The individual has one of the above diagnoses; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.
J1745
Q5103  Q5104

Infliximab (Remicade) IV

Infliximab (Remicade) may be considered medically necessary when an individual meets criteria for ANY ONE of the following indications:

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]);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
  • 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) and infliximab-abda (Renflexis) are not U.S. Food and Drug Administration (FDA) approved for the
treatment of pediatric ulcerative colitis and are therefore not medically necessary/non-covered.

The use of infliximab (Remicade) 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

J1745

Reauthorization Criteria for Infliximab (Remicade) IV

Continuation of therapy with infliximab (Remicade) IV may be considered medically necessary when the following criteria is met:

  • The individual has one of the above diagnoses; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months.

Procedure Codes

J1745

Infliximab is not FDA approved for the treatment of rheumatoid arthritis without methotrexate. However, individual consideration will be given to patients who are unable to tolerate methotrexate (e.g., abnormal liver function, depressed hemopoietic function, etc.).

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for procedure codes J1745, Q5103 or Q5104

H20.041 H20.042 H20.043 H20.049 K50.00 K50.011 K50.012
K50.013 K50.014 K50.018 K50.019 K50.10 K50.111 K50.112
K50.113 K50.114 K50.118 K50.119 K50.80 K50.811 K50.812
K50.813 K50.814 K50.818 K50.819 K50.90 K50.911 K50.912
K50.913 K50.914 K50.918 K50.919 K51.00 K51.011 K51.012
K51.013 K51.014 K51.018 K51.019 K51.20 K51.211 K51.212
K51.213 K51.214 K51.218 K51.219 K51.30 K51.311 K51.312
K51.313 K51.314 K51.318 K51.319 K51.40 K51.411 K51.412
K51.413 K51.414 K51.418 K51.419 K51.50 K51.511 K51.512
K51.513 K51.514 K51.518 K51.519 K51.80 K51.811 K51.812
K51.813 K51.814 K51.818 K51.819 K51.90 K51.911 K51.912
K51.913 K51.914 K51.918 K51.919 L40.0 L40.1 L40.2
L40.3 L40.4 L40.50 L40.51 L40.52 L40.53 L40.54
L40.59 L40.8 L40.9 M05.00 M05.011 M05.012 M05.019
M05.021 M05.022 M05.029 M05.031 M05.032 M05.039 M05.041
M05.042 M05.049 M05.051 M05.052 M05.059 M05.061 M05.062
M05.069 M05.071 M05.072 M05.079 M05.09 M05.10 M05.111
M05.112 M05.119 M05.121 M05.122 M05.129 M05.131 M05.132
M05.139 M05.141 M05.142 M05.149 M05.151 M05.152 M05.159
M05.161 M05.162 M05.169 M05.171 M05.172 M05.179 M05.19
M05.20 M05.211 M05.212 M05.219 M05.221 M05.222 M05.229
M05.231 M05.232 M05.239 M05.241 M05.242 M05.249 M05.251
M05.252 M05.259 M05.261 M05.262 M05.269 M05.271 M05.272
M05.279 M05.29 M05.30 M05.311 M05.312 M05.319 M05.321
M05.322 M05.329 M05.331 M05.332 M05.339 M05.341 M05.342
M05.349 M05.351 M05.352 M05.359 M05.361 M05.362 M05.369
M05.371 M05.372 M05.379 M05.39 M05.40 M05.411 M05.412
M05.419 M05.421 M05.422 M05.429 M05.431 M05.432 M05.439
M05.441 M05.442 M05.449 M05.451 M05.452 M05.459 M05.461
M05.462 M05.469 M05.471 M05.472 M05.479 M05.49 M05.50
M05.511 M05.512 M05.519 M05.521 M05.522 M05.529 M05.531
M05.532 M05.539 M05.541 M05.542 M05.549 M05.551 M05.552
M05.559 M05.561 M05.562 M05.569 M05.571 M05.572 M05.579
M05.59 M05.60 M05.611 M05.612 M05.619 M05.621 M05.622
M05.629 M05.631 M05.632 M05.639 M05.641 M05.642 M05.649
M05.651 M05.652 M05.659 M05.661 M05.662 M05.669 M05.671
M05.672 M05.679 M05.69 M05.70 M05.711 M05.712 M05.719
M05.721 M05.722 M05.729 M05.731 M05.732 M05.739 M05.741
M05.742 M05.749 M05.751 M05.752 M05.759 M05.761 M05.762
M05.769 M05.771 M05.772 M05.779 M05.79 M05.80 M05.811
M05.812 M05.819 M05.821 M05.822 M05.829 M05.831 M05.832
M05.839 M05.841 M05.842 M05.849 M05.851 M05.852 M05.859
M05.861 M05.862 M05.869 M05.871 M05.872 M05.879 M05.89
M05.9 M06.00 M06.011 M06.012 M06.019 M06.021 M06.022
M06.029 M06.031 M06.032 M06.039 M06.041 M06.042 M06.049
M06.051 M06.052 M06.059 M06.061 M06.062 M06.069 M06.071
M06.072 M06.079 M06.08 M06.09 M06.1 M06.20 M06.211
M06.212 M06.219 M06.221 M06.222 M06.229 M06.231 M06.232
M06.239 M06.241 M06.242 M06.249 M06.251 M06.252 M06.259
M06.261 M06.262 M06.269 M06.271 M06.272 M06.279 M06.28
M06.29 M06.30 M06.311 M06.312 M06.319 M06.321 M06.322
M06.329 M06.331 M06.332 M06.339 M06.341 M06.342 M06.349
M06.351 M06.352 M06.359 M06.361 M06.362 M06.369 M06.371
M06.372 M06.379 M06.38 M06.39 M06.4 M06.80 M06.811
M06.812 M06.819 M06.821 M06.822 M06.829 M06.831 M06.832
M06.839 M06.841 M06.842 M06.849 M06.851 M06.852 M06.859
M06.861 M06.862 M06.869 M06.871 M06.872 M06.879 M06.88
M06.89 M06.9 M08.00 M08.011 M08.012 M08.019 M08.021
M08.022 M08.029 M08.031 M08.032 M08.039 M08.041 M08.042
M08.049 M08.051 M08.052 M08.059 M08.061 M08.062 M08.069
M08.071 M08.072 M08.079 M08.08 M08.09 M08.1 M08.20
M08.211 M08.212 M08.219 M08.221 M08.222 M08.229 M08.231
M08.232 M08.239 M08.241 M08.242 M08.249 M08.251 M08.252
M08.259 M08.261 M08.262 M08.269 M08.271 M08.272 M08.279
M08.28 M08.29 M08.3 M08.40 M08.411 M08.412 M08.419
M08.421 M08.422 M08.429 M08.431 M08.432 M08.439 M08.441
M08.442 M08.449 M08.451 M08.452 M08.459 M08.461 M08.462
M08.469 M08.471 M08.472 M08.479 M08.48 M08.80 M08.811
M08.812 M08.819 M08.821 M08.822 M08.829 M08.831 M08.832
M08.839 M08.841 M08.842 M08.849 M08.851 M08.852 M08.859
M08.861 M08.862 M08.869 M08.871 M08.872 M08.879 M08.88
M08.89 M08.90 M08.911 M08.912 M08.919 M08.921 M08.922
M08.929 M08.931 M08.932 M08.939 M08.941 M08.942 M08.949
M08.951 M08.952 M08.959 M08.961 M08.962 M08.969 M08.971
M08.972 M08.979 M08.98 M08.99 M45.0 M45.1 M45.2
M45.3 M45.4 M45.5 M45.6 M45.7 M45.8 M45.9

 

Additional Covered Diagnosis Codes for procedure code J1745

H44.131 
H44.132 H44.133

Professional Statements and Societal Positions Guidelines

The American Uveitis Society recommends infliximab, cA2 (Remicade) in the early management of patients with vision threatening ocular manifestations of Behcet’s disease (a multisystem disorder).

Links