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.
Certolizumab (Cimzia) lyophilized powder administered by a healthcare provider may be considered medically necessary when an individual meets the following criteria:
Ankylosing Spondylitis (AS)
- The individual is 18 years of age or older with active AS; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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 two different NSAIDs used in the treatment of AS for at least a 4-week total trial; or
- The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity 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 for the treatment of AS; 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 will NOT be using certolizumab (Cimzia) with another biologic immunomodulator.
Crohn’s Disease (CD):
- The individual is 18 years of age and older with moderately to severely active CD; and
- ONE of the following:
- The individual is currently pregnant; or
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) used in the treatment of CD 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., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) 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 DrugDex with 1 or 2a level of evidence for the treatment of CD; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using certolizumab (Cimzia) with another biologic immunomodulator agent.
Psoriatic Arthritis (PsA):
- The individual is 18 years of age and older with active PsA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA 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., cyclosporine, leflunomide, methotrexate, sulfasalazine) 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 apremilast (Otezla) that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence 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 will NOT be using certolizumab (Cimzia) with another biologic immunomodulator or apremilast (Otezla).
Non-radiographic Axial Spondyloarthritis (nr-axSpA)
- The individual is 18 years of age and older with active nr-axSpA; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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 two different NSAIDs used in the treatment of nr-axSpA for at least a 4-week total trial; or
- The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to all NSAIDs used in the treatment of nr-axSpA; 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 nr-axSpA; 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 will NOT be using certolizumab (Cimzia) with another biologic immunomodulator agent.
Plaque Psoriasis (PS)
- The individual is 18 years of age or older with moderately to severely active PS; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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 (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months; or
- The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of PS; or
- The individual has severe active 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 has concomitant severe psoriatic arthritis (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’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 for the treatment of PS; 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 will NOT be using certolizumab (Cimzia) 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
- ONE of the following:
- Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with certolizumab (Cimzia) (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 will NOT be using certolizumab (Cimzia) with another biologic immunomodulator.
The use of certolizumab (Cimzia) lyophilized powder for any other indications than those listed in this policy is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of certolizumab (Cimzia) for other indications.
Procedure Codes