Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Certolizumab (Cimzia) lyophilized powder
Certolizumab (Cimzia) lyophilized powder administered by a healthcare provider may be considered medically necessary when an individual meets the criteria for
ANY ONE
of the following
:
Axial Spondylarthritis/Ankylosing Spondylitis (AS)
-
The individual has a diagnosis of active AS;
and
-
The individual must have failed a 90-day trial of a TNF inhibitor, as evidenced by paid claims or pharmacy printouts;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
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
-
The individual must have failed a 90-day trial of a TNF inhibitor, as evidenced by paid claims or pharmacy printouts;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
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).
Juvenile Idiopathic Arthritis, Polyarticular (PJIA):
-
The individual is two (2) years of age and older with active PJIA;
and
-
The individual must have failed a 90-day trial of a TNF inhibitor, as evidenced by paid claims or pharmacy printouts;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
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
-
The individual must have failed a 90-day trial of each of the following, as evidenced by paid claims or pharmacy printouts:
-
TNF inhibitor;
and
-
Interleukin (IL) - 17 inhibitor;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
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
-
The individual must have failed a 90-day trial of each of the following, as evidenced by paid claims or pharmacy printouts:
-
TNF inhibitor;
and
-
Interleukin (IL) - 17 inhibitor;
and
-
Clinical justification must be provided why self-administered agents cannot be used (subject to clinical review);
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
-
The individual must have had a 90-day trial of each of the following, as evidenced by paid claims and pharmacy printouts:
-
TNF Inhibitor;
and
-
T-cell Co-stimulation Blocker;
and
-
Clinical justification must be provided why a self-administered agent cannot be used (subject to clinical review);
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);
or
-
The individual has another indication supported in compendia for the requested agent and route of administration with a
current category 1, 2A, or 2B recommendation.
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
