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
Certolizumab (Cimzia) lyophilized powder administered by a healthcare provider may be considered medically necessary
when an individual meets t
he 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 certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder 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 four (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 of 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
-
ONE of the following:
-
The individual will NOT be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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).
Crohn's Disease (CD):
-
The individual has a diagnosis of moderately to severely active CD;
and
-
ONE of the following:
-
Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder for the individual's age;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response to one (1) conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least three (3)-months;
or
-
The individual has an intolerance or hypersensitivity to one (1) 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of CD;
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 certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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).
Non-radiographic Axial Spondyloarthritis (nr-axSpA)
-
The individual has a diagnosis of active nr-axSpA;
and
-
ONE of the following:
-
Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder 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 nr-axSpA for at least a 4-week total trial;
or
-
The individual has an intolerance or hypersensitivity to two (2) different NSAIDs used in the treatment of nr-axSpA;
or
-
The individual has an FDA labeled contraindication 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, or NCCN compendium recommended use of 1 or 2a 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
-
ONE of the following:
-
The individual will NOT be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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).
Plaque Psoriasis (PS)
-
The individual has a diagnosis of moderate to severe PS;
and
-
ONE of the following:
-
Information has been provided that indicates the individual has been treated with certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder for the individual's age;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response to one (1) 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 three (3)-months;
or
-
The individual has an intolerance or hypersensitivity to one (1) conventional agent used in the treatment of PS;
or
-
The individual has an FDA labeled contraindication 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, or NCCN compendium recommended use of 1 or 2a 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
-
ONE of the following:
-
The individual will NOT be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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).
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 certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder for the individual's age;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response to one (1) conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least three (3)-months;
or
-
The individual has an intolerance or hypersensitivity to one (1) 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 of 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
-
ONE of the following:
-
The individual will NOT be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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 certolizumab (Cimzia) lyophilized powder (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with certolizumab (Cimzia) lyophilized powder (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 certolizumab (Cimzia) lyophilized powder 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 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 (1) 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 certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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).
Other
-
The individual has another FDA labeled indication for certolizumab (Cimzia) lyophilized powder;
or
-
The individual has another indication supported in compendia for the requested agent and route of administration;
and
-
If the individual has an FDA approved diagnosis, ONE of the following:
-
The individual's age is within FDA labeling for the requested indication for certolizumab (Cimzia) lyophilized powder;
or
-
The prescriber has provided information in support of using certolizumab (Cimzia) lyophilized powder for the individual's age for the requested indication;
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 prescribing information for certolizumab (Cimzia) lyophilized powder 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).
-
The individual will NOT be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using certolizumab (Cimzia) lyophilized powder in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for certolizumab (Cimzia) lyophilized powder 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)
The use of certolizumab (Cimzia) lyophilized powder 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 Code
