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.
Risankizumab-rzaa (Skyrizi) IV
Risankizumab-rzaa (Skyrizi) IV may be considered medically necessary when an individual meets
ALL
of the following criteria:
Crohn's Disease (CD)
-
The individual has a diagnosis of moderately to severely active CD;
and
-
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 risankizumab-rzaa (Skyrizi) 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., 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 risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for risankizumab-rzaa (Skyrizi) 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).
Ulcerative Colitis (UC)
-
The individual has a diagnosis of moderately to severely active UC;
and
-
ONE of the following:
-
Information has been provided that indicates the individual has been treated with risankizumab-rzaa (Skyrizi) IV (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with risankizumab-rzaa (Skyrizi) 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 is 18 years of age or older;
or
-
The prescriber has provided information in support of using risankizumab-rzaa (Skyrizi) 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., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least three (3)-months;
or
-
The individual has severely active ulcerative colitis;
or
-
The individual has an intolerance or hypersensitivity to one (1) of the conventional agents used in the treatment of UC;
or
-
The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC;
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 UC;
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 risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for risankizumab-rzaa (Skyrizi) 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
-
The individual has another FDA labeled indication for risankizumab-rzaa (Skyrizi) 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 risankizumab-rzaa (Skyrizi) IV;
or
-
The prescriber has provided information in support of using risankizumab-rzaa (Skyrizi) 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 prescribing information for risankizumab-rzaa (Skyrizi) 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 individual will NOT be using risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
- The individual will be using risankizumab-rzaa (Skyrizi) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for risankizumab-rzaa (Skyrizi) 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)
If approved, risankizumab-rzaa (Skyrizi) IV will be allowed as three (3) intravenous infusions over twelve (12) weeks.
The use of risankizumab-rzaa (Skyrizi) 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
