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.
Golimumab (Simponi Aria) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:
Ankylosing Spondylitis (AS)
- The individual has a diagnosis of active AS; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with golimumab (Simponi Aria) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with golimumab (Simponi Aria) (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 eighteen (18) years of age or older; or
- The prescriber has provided information in support of using golimumab (Simponi Aria) for the individual’s age; 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use 1 or 2a for the treatment of AS; 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 has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- The individual will NOT be using golimumab (Simponi Aria) in combination with another biologic immunomodulator agent, Zeposia, or Otezla; and
- The individual does NOT have any FDA labeled contraindications to golimumab (Simponi Aria).
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 golimumab (Simponi Aria) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with golimumab (Simponi Aria) (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 golimumab (Simponi Aria) 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 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 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
- The individual has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- The individual will NOT be using golimumab (Simponi Aria) in combination with another biologic immunomodulator agent, Zeposia, or Otezla; and
- The individual does NOT have any FDA labeled contraindications to golimumab (Simponi Aria).
Psoriatic Arthritis (PsA)
- The individual has a diagnosis of active PsA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with golimumab (Simponi Aria) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with golimumab (Simponi Aria) (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 golimumab (Simponi Aria) 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., 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use 1 or 2a for the treatment of PsA; 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 has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- The individual will NOT be using golimumab (Simponi Aria) in combination with another biologic immunomodulator agent, Zeposia or Otezla; and
- The individual does NOT have any FDA labeled contraindications to golimumab (Simponi Aria).
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 golimumab (Simponi Aria) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with golimumab (Simponi Aria) (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 eighteen (18) years of age or older; or
- The prescriber has provided information in support of using golimumab (Simponi Aria) 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) used in the treatment of RA 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use 1 or 2a for the treatment of RA; and
- ONE of the following:
- The individual will be taking golimumab (Simponi Aria) in combination with methotrexate; or
- The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate; 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 has been tested for latent tuberculosis (TB) AND if positive the individual has begun therapy for latent TB; and
- The individual will NOT be using golimumab (Simponi Aria) in combination with another biologic immunomodulator agent, Zeposia, or Otezla; and
- The individual does NOT have any FDA labeled contraindications to golimumab (Simponi Aria).
The use of golimumab (Simponi Aria) for any other indication is considered experimental/investigational and, therefore, non-covered. Scientific evidence has not established the effectiveness for any other indication.
Procedure Codes
