Policy Applicable
All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.
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.
Secukinumab (Cosentyx) IV
Secukinumab (Cosentyx) IV administered by a healthcare provider may be considered medically necessary when an individual meets the criteria for
ANY ONE
of the following:
Ankylosing Spondylitis (AS)
-
ONE of the following:
-
The individual has tried a self-administered secukinumab (Cosentyx) agent;
or
-
Self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies;
and
-
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 secukinumab (Cosentyx) IV (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with secukinumab (Cosentyx) IV (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's age is within FDA labeling for the requested indication for the requested agent;
or
-
The prescriber has provided information in support of using secukinumab (Cosentyx) IV for the individual's age;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response to two (2) 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 (2) 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 Secukinumab (Cosentyx) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using Secukinumab (Cosentyx) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for secukinumab (Cosentyx) IV 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)
-
ONE of the following:
-
The individual has tried a self-administered secukinumab (Cosentyx) agent;
or
-
Self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies;
and
-
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 secukinumab (Cosentyx) IV (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with secukinumab (Cosentyx) IV (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's age is within FDA labeling for the requested indication for the requested agent;
or
-
The prescriber has provided information in support of using secukinumab (Cosentyx) IV for the individual's age;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response to two (2) different NSAIDs used in the treatment of nr-axSpA for at least a four (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 secukinumab (Cosentyx) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using secukinumab (Cosentyx) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for secukinumab (Cosentyx) IV 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):
-
ONE of the following:
-
The individual has tried a self-administered secukinumab (Cosentyx) agent;
or
-
Self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies;
and
-
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 secukinumab (Cosentyx) IV (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with secukinumab (Cosentyx) IV (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed;
or
-
ALL of the following:
-
ONE of the following:
-
The individual's age is within FDA labeling for the requested indication for the requested agent;
or
-
The prescriber has provided information in support of using secukinumab (Cosentyx) IV 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
-
ONE of the following:
-
BOTH of the following:
-
ONE of the following:
-
The individual has tried and had an inadequate response to one (1) preferred infliximab agent (Inflectra or Renflexis) for the requested indication for at least three (3)-months;
or
-
The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to one (1) preferred infliximab agent (Inflectra or Renflexis) for the requested indication;
or
-
The individual has an FDA labeled contraindication to ALL preferred infliximab agents (Inflectra and Renflexis) for the requested indication;
and
-
ONE of the following:
-
The individual has tried and had an inadequate response golimumab (Simponi Aria) for the requested indication for at least three (3)-months;
or
-
The individual has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to golimumab (Simponi Aria) for the requested indication;
or
-
The individual has an FDA labeled contraindication to golimumab (Simponi Aria) for the requested indication;
or
-
BOTH of the following:
-
The prescriber has provided information indicating why ALL of the preferred agents (Inflectra, Renflexis, and Simponi Aria) are not clinically appropriate for the individual;
and
-
The prescriber has provided a complete list of previously tried agents for the requested indication;
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 secukinumab (Cosentyx) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using secukinumab (Cosentyx) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for secukinumab (Cosentyx) IV 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
-
ONE of the following:
-
The individual has tried a self-administered secukinumab (Cosentyx) agent;
or
-
Self-administration is not appropriate for the individual based on careful assessment of risk for anaphylaxis and mitigation strategies;
and
-
The individual has another FDA labeled indication for secukinumab (Cosentyx) IV;
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 secukinumab (Cosentyx) IV;
or
-
The prescriber has provided information in support of using secukinumab (Cosentyx) IV 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 individual will NOT be using secukinumab (Cosentyx) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using secukinumab (Cosentyx) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for secukinumab (Cosentyx) IV 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 secukinumab (Cosentyx) IV 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
