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.
Tocilizumab (Actemra) subcutaneous injection
Tocilizumab (Actemra) subcutaneous injection may be considered medically necessary and payable on the pharmacy benefit when an individual meets the following criteria:
Giant Cell Arteritis (GCA)
- The individual is 18 years of age or older; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and has an inadequate response to systemic corticosteroids (e.g. prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days; or
- The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL systemic corticosteroids; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of GCA; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator agent or apremilast (Otezla).
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- The individual is 2 years of age or older with moderately to severely active PJIA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., azathioprine, cyclosporine, intra-articular glucocorticoids, methotrexate, leflunomide, sulfasalazine, NSAIDs, COX-2 [celecoxib]) used in the treatment of PJIA for at least 3-months; or
- The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide) used in the treatment of PJIA; or
- The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of PJIA; and
- ONE of the following:
- Medication history indicates a trial and inadequate response to adalimumab (Humira) for the treatment of PJIA for at least 3-months, or there is a documented intolerance, FDA labeled contraindication or hypersensitivity to adalimumab (Humira); or
- BOTH of the following:
- The prescriber has provided information indicating why adalimumab (Humira) is not clinically appropriate for the individual; and
- The prescriber has provided a complete list of previously tried agents for PJIA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator agent or apremilast (Otezla).
Rheumatoid Arthritis (RA)
- The individual is 18 years of age or older with moderately to severely active RA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- 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 a documented intolerance, FDA labeled contraindication or hypersensitivity 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 DrugDex with 1 or 2a level of evidence for the treatment of RA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator or apremilast (Otezla).
Systemic Juvenile Idiopathic Arthritis (SJIA)
- The individual is 2 years of age or older with active SJIA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to NSAIDs (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month; or
- The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL NSAIDs used in the treatment of SJIA; or
- The individual has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids, azathioprine, cyclosporine, tacrolimus) used in the treatment of SJIA for at least 3-months; or
- The individual has an intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA; or
- The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of SJIA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator agent or apremilast (Otezla).
Tocilizumab (Actemra) intravenous infusion
Tocilizumab (Actemra) intravenous infusion may be considered medically necessary and payable through the medical benefit when an individual meets the following criteria:
Cytokine Release Syndrome (CRS)
- The individual is two (2) years of age or older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra).
If approved, tocilizumab (Actemra) for CRS is approved for a maximum of 4 doses in one month.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- The individual is 2 years of age or older with moderately to severely active PJIA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., azathioprine, cyclosporine, intra-articular glucocorticoids, methotrexate, leflunomide, sulfasalazine, NSAIDs, COX-2 [celecoxib]) used in the treatment of PJIA for at least 3-months; or
- The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide) used in the treatment of PJIA; or
- The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of PJIA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator agent or apremilast (Otezla).
Rheumatoid Arthritis (RA)
- The individual is 18 years of age or older with moderately to severely active RA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- 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 a documented intolerance, FDA labeled contraindication or hypersensitivity 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 DrugDex with 1 or 2a level of evidence for the treatment of RA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator or apremilast (Otezla).
Systemic Juvenile Idiopathic Arthritis (SJIA)
- The individual is 2 years of age or older with active SJIA; and
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to NSAIDs (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month; or
- The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL NSAIDs used in the treatment of SJIA; or
- The individual has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids, azathioprine, cyclosporine, tacrolimus) used in the treatment of SJIA for at least 3-months; or
- The individual has an intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA; or
- The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of SJIA; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to tocilizumab (Actemra); and
- The individual will NOT be using tocilizumab (Actemra) in combination with another biologic immunomodulator agent or apremilast (Otezla).
The use of tocilizumab (Actemra) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence has not established the effectiveness for any other indication.
Procedure Codes