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.
Preferred Agents
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Non-Preferred Agent
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Inflectra (infliximab-dyyb) - Q5103
Renflexis (infliximab-abda) - Q5104
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Avsola (infliximab-axxq) - Q5121
Infliximab - J1745
Remicade (infliximab) - J1745
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Infliximab or an infliximab biosimilar may be considered medically necessary when an individual meets all of the following criteria:
- ONE of the following:
- The requested agent is a preferred agent [i.e., Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda)]; or
- The individual has tried and had an inadequate response to TWO preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] for at least a 3-month trial of each (medical records required); or
- The individual has an intolerance or hypersensitivity to TWO of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] that is not expected to occur with the requested agent (medical records required); or
- The individual has an FDA labeled contraindication to ALL of the preferred agent(s) [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] that is not expected to occur with the requested agent (medical records required); and
- ONE of the following:
- The prescriber has provided documentation that the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- ALL of the following:
- The individual has an FDA labeled indication or an indication that is supported in compendia for the requested agent and route of administration; and
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the individual’s age; and
- ONE of the following:
- The individual has a diagnosis of moderately to severely active rheumatoid arthritis (RA) AND BOTH of the following:
- ONE of the following:
- The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months; or
- The individual has tried and had an inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, or sulfasalazine) used in the treatment of RA for at least 3-months; or
- The individual has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
- The individual has an FDA labeled contraindication to ALL conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of RA; and
- ONE of the following:
- The individual will be taking the requested agent in combination with methotrexate or an alternative DMARD (e.g., leflunomide, hydroxychloroquine, sulfasalazine); or
- The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate AND ALL alternative DMARDs; or
- The individual has a diagnosis of granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) AND ALL of the following:
- The individual has refractory or treatment-resistant GPA; and
- ONE of the following:
- The requested agent will be used in combination with a corticosteroid; or
- The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to corticosteroid therapy; and
- ONE of the following:
- The individual has tried and had an inadequate response to BOTH cyclophosphamide and rituximab for at least 3-months; or
- The individual has an intolerance or hypersensitivity to BOTH cyclophosphamide and rituximab used in the treatment of GPA; or
- The individual has an FDA labeled contraindication to BOTH cyclophosphamide and rituximab used in the treatment of GPA; and
- ONE of the following:
- The individual has tried and had an inadequate response to an alternative immunosuppressive (e.g., azathioprine, methotrexate, mycophenolate mofetil) for at least 3-months; or
- The individual has an intolerance or hypersensitivity to an alternative immunosuppressive used in the treatment of GPA; or
- The individual has an FDA labeled contraindication to ALL alternative immunosuppressive therapy; or
- The individual has a diagnosis of active psoriatic arthritis (PsA) AND ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA; or
- The individual has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
- The individual has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
- The individual’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in compendia for the treatment of PsA; or
- The individual has a diagnosis of chronic severe plaque psoriasis (PS); or
- The individual has a diagnosis of moderately to severely active Crohn’s disease (CD) AND ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of CD; or
- The individual has a diagnosis of moderately to severely active ulcerative colitis (UC) AND ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months; or
- The individual has severely active ulcerative colitis; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of UC; or
- The individual has a diagnosis of active ankylosing spondylitis (AS) AND ONE of the following:
- The individual has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial; or
- The individual has an intolerance or hypersensitivity to TWO different NSAIDs used in the treatment of AS; or
- The individual has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AS; or
- The individual has another FDA labeled indication for the requested agent and route of administration not mentioned previously; or
- The individual has another indication supported in compendia for the requested agent and route of administration not mentioned previously; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist for PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Length of Approval: 12 months
Reauthorization Criteria
Reauthorization of infliximab or an infliximab biosimilar may be considered medically necessary when the following criteria are met:
- ONE of the following:
- The requested agent is a preferred agent [i.e., Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda)]; or
- The individual has tried and had an inadequate response to TWO preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] for at least a 3-month trial of each (medical records required); or
- The individual has an intolerance or hypersensitivity to TWO of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] that is not expected to occur with the requested agent (medical records required); or
- The individual has an FDA labeled contraindication to ALL of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] that is not expected to occur with the requested agent (medical records required); and
- The individual has been previously approved for infliximab or an infliximab biosimilar through the Blue Cross Blue Shield of North Dakota's precertification process; and
- The individual has had clinical benefit with infliximab or an infliximab biosimilar; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist for PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- ONE of the following:
- The individual will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Length of Approval: 12 months
Infliximab or an infliximab biosimilar not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
