Risankizumab-rzaa (Skyrizi® )

Restricted Product(s)

• risankizumab-rzaa (Skyrizi® ) intravenous infusion for administration by a healthcare professional

FDA Approved Use

• For the treatment of moderately to severely active Crohn’s disease in adults 
• For the treatment of moderately to severely active ulcerative colitis in adults

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD); AND 
   1. The patient is 18 years of age or older; AND 
   2. ONE of the following: 
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months [medical record documentation required]; OR 
      2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD [medical record documentation required]; OR 
      3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD [medical record documentation required]; AND 
   3. ONE of the following: 
      1. The patient has tried and had an inadequate response to an infliximab product AND Stelara® (ustekinumab) [medical record documentation required]; OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH an infliximab product and Stelara® (ustekinumab) [medical record documentation required]; OR 
2. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC); AND 
   1. The patient is 18 years of age or older; AND 
   2. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months [medical record documentation required]; OR 
      2. The patient has severely active ulcerative colitis [medical record documentation required]; OR 
      3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC [medical record documentation required]; OR 
      4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC [medical record documentation required]; AND 
   3. ONE of the following:
      1. The patient has tried and had an inadequate response to an infliximab product AND Stelara® (ustekinumab) [medical record documentation required]; OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to BOTH an infliximab product and Stelara® (ustekinumab) [medical record documentation required]; AND 
3. The request is for initiation of Skyrizi (risankizumab) therapy, and an initial intravenous infusion of Skyrizi (risankizumab) will be administered; AND 
4. The patient will NOT be treated with the 150 mg, 90 mg, 180 mg, or 360 mg dose subcutaneous injection; AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist for CD, UC) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
6. The patient will NOT be using risankizumab-rzaa (Skyrizi® ) in combination with another biologic immunomodulator agent or Zeposia® ; AND 
7. The patient does NOT have any FDA labeled contraindications to risankizumab-rzaa (Skyrizi® ); AND 
8. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND 
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).
   
   Duration of Approval: Crohn’s disease or ulcerative colitis induction (IV): 90 days 

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. Gastroenterology. 2021;160:2496–2508.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

July 2024: Criteria change: Added newly approved indication for moderately to severely active ulcerative colitis in adults, and added associated dosing to FDA label reference table. Minor edits made throughout policy according to updated FDA label.
April 2024: Criteria change: Adjusted duration of approval from 56 days to 90 days to allow time to schedule all induction doses after authorization approval.
September 2023: Criteria change: Removed aminosalicylates, mesalamine, and sulfasalazine from list of conventional agents. Separated out intolerance/hypersensitivity criteria from FDA labeled contraindication criteria for clarity.
January 2023: Coding update: Added HCPCS code J2327 to dosing reference table effective 1/1/2023, deleted C9399, J3490, and J3590 termed 12/31/2022. Other minor formatting updates made with no change to policy intent.
September 2022: Original medical policy criteria issued.