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) intravenous infusion
Tocilizumab (Actemra) intravenous infusion may be considered medically necessary and payable through the medical benefit when an individual meets the criteria for ANY ONE of the following:
Cytokine Release Syndrome (CRS)
- The individual is two (2) years of age and older with severe or life-threatening CRS induced by chimeric antigen receptor T-cell (CAR-T) therapy; 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
- ONE of the following:
- The individual will NOT be using tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for tocilizumab (Actemra) 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).
NOTE: If approved, tocilizumab (Actemra) for CRS is approved for a maximum of 4 doses in one month.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- The individual has a diagnosis of moderately to severely active PJIA; 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
- BOTH of the following:
- ONE of the following:
- The individual is two (2) years of age or older; or
- The prescriber has provided information in support of using tocilizumab (Actemra) for the individual’s age; and
- ONE of the following:
- The individual has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least three (3)-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents 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, or NCCN compendium recommended use of 1 or 2a for the treatment of PJIA; 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
- ONE of the following:
- The individual will NOT be using tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for tocilizumab (Actemra) 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).
Rheumatoid Arthritis (RA)
- The individual has a diagnosis of moderately to severely active RA; 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
- BOTH of the following:
- ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of using tocilizumab (Actemra) for the individual’s age; and
- 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 three (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 three (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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of RA; 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
- ONE of the following:
- The individual will NOT be using tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for tocilizumab (Actemra) 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).
Systemic Juvenile Idiopathic Arthritis (SJIA)
- The individual has a diagnosis of active SJIA; 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
- BOTH of the following:
- ONE of the following:
- The individual is two (2) years of age or older; or
- The prescriber has provided information in support of using tocilizumab (Actemra) for the individual’s age; and
- ONE of the following:
- The individual has tried and had an inadequate response to at least ONE NSAID (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least one (1)-month; or
- The individual has an intolerance or hypersensitivity to NSAIDs used in the treatment of SJIA; or
- The individual has an FDA labeled contraindication to 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) used in the treatment of SJIA for at least three (3)-months; or
- The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of SJIA; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents 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, or NCCN compendium recommended use of 1 or 2a for the treatment of SJIA; 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
- ONE of the following:
- The individual will NOT be using tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for tocilizumab (Actemra) 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).
Giant Cell Arteritis (GCA)
- The individual has a diagnosis of GCA; 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
- BOTH of the following:
- ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of using tocilizumab (Actemra) for the individual’s age; and
- ONE of the following:
- The individual has tried and had 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 an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA; or
- The individual has an FDA labeled contraindication to ALL systemic corticosteroids used in the treatment of GCA; 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 GCA; or
- 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
- ONE of the following:
- The individual will NOT be using tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for tocilizumab (Actemra) 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).
Compendia Sources
Tocilizumab (Actemra) intravenous infusion may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
The use of tocilizumab (Actemra) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
