WHA

SKYRIZI (risankizumab-rzaa)

Self-Administration – subcutaneous (SC) injection by prefilled syringe or prefilled pen

Office-Administration – intravenous (IV) infusion by single dose vial

 

Indication for Prior Authorization:

 

Skyrizi for subcutaneous (SC) use: 

Plaque Psoriasis (PsO): Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 

Psoriatic Arthritis (PsA): Indicated for the treatment of active psoriatic arthritis in adults. 

Crohn's Disease (CD): Indicated for the treatment of moderately to severely active Crohn's disease in adults. 

Ulcerative Colitis (UC): Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

 

Skyrizi for intravenous (IV) use: 

Crohn's Disease (CD): Indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis (UC): Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

 

Coverage Criteria:

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of moderate to severe PsO; AND
  • One of the following:
    • Greater than or equal to 3% body surface area involvement 
    • Severe scalp psoriasis 
    • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
  • Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: 
    • corticosteroids (e.g., betamethasone, clobetasol) 
    • vitamin D analogs (e.g., calcitriol, calcipotriene) 
    • tazarotene 
    • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
    • anthralin 
    • coal tar; AND
  • Prescribed by or in consultation with a dermatologist.

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • One of the following:
    • actively inflamed joints 
    • dactylitis 
    • enthesitis 
    • axial disease 
    • active skin and/or nail involvement; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist.

 

For diagnosis of Crohn’s Disease (CD):

  • Documented diagnosis of moderately to severely active CD; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • One of the following:
    • All of the following (medical benefit):
      • Induction dose of 600 mg administered by intravenous (IV) infusion will be given at Week 0, Week 4, and Week 8. 
      • One of the following:
        • Frequent diarrhea and abdominal pain 
        • At least 10% weight loss 
        • Complications such as obstruction, fever, abdominal mass 
        • Abnormal lab values (e.g., C-reactive protein [CRP]) 
        • CD Activity Index (CDAI) greater than 220
      • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
        • 6-mercaptopurine
        • azathioprine
        • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)
        • methotrexate
    • All of the following (pharmacy benefit):
      • Patient has started Skyrizi IV induction doses
      • Maintenance dose of 180 mg or 360 mg administered by subcutaneous (SC) injection will be started at Week 12 and every 8 weeks thereafter.

 

For diagnosis of Ulcerative Colitis (UC):

  • Diagnosis of moderately to severely active ulcerative colitis, AND
  • Prescribed by or in consultation with a gastroenterologist, AND
  • One of the following:
    • All of the following (medical benefit):
      • Will be administered as an intravenous induction dose
      • One of the following:
        • Greater than 6 stools per day 
        • Frequent blood in the stools 
        • Frequent urgency 
        • Presence of ulcers 
        • Abnormal lab values (e.g., hemoglobin, erythrocyte sedimentation rate, C-reactive protein) 
        • Dependent on, or refractory to, corticosteroids 
      • Trial and failure, contraindication, or intolerance to one of the following conventional therapies:
        • 6-mercaptopurine 
        • Azathioprine 
        • Corticosteroid (e.g., prednisone) 
        • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine) 
    • All of the following (pharmacy benefit):
      • Will be used as a maintenance dose following the intravenous induction doses

 

Reauthorization Criteria:

 

For diagnosis of PsO:

  • Documentation of positive clinical response to therapy as evidenced by ONE of the following:
    • Reduction the body surface area (BSA) involvement from baseline 
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline 

 

For diagnosis of PsA:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • Reduction in the total active (swollen and tender) joint count from baseline 
    • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline 
    • Reduction in the body surface area (BSA) involvement from baseline 

 

For diagnosis of CD:

  • Both of the following:
    • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
      • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline 
      • Reversal of high fecal output state
    • Dose of 180 mg or 360 mg administered by subcutaneous (SC) injection will be given every 8 weeks.

For diagnosis of Ulcerative Colitis (UC):

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following:
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline 
    • Reversal of high fecal output state
       

 

Dosing:

 

  • PsO, PsA (adults):
    • Skyrizi SC injection:
      • 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
  • CD (adults):
    • Skyrizi IV infusion:
      • 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8.
    • Skyrizi SC injection:
      • 180 mg or 360 mg administered by subcutaneous (SC) injection will be started at Week 12 and every 8 weeks thereafter.
  • UC (adults):
    • Skyrizi IV infusion:
      • 1,200 mg administered by intravenous infusion at least one hour at weeks 0, 4, and 8
    • Skyrizi SC injection:
      • 180 to 360 mg administered by subcutaneous injection will be started at week 12 and every 8 weeks thereafter
         

 

Coverage Duration:

 

PsO, PsA:

  • Initial: 1 year
  • Reauthorization: 1 year

 

CD, UC:

  • Initial (IV induction): 3 months
  • Initial (SC maintenance): 6 months
  • Reauthorization (SC maintenance): 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Skyrizi. Monitor patients for signs and symptoms of active TB during and after Skyrizi treatment. Do not administer Skyrizi to patients with active TB
  • Skyrizi may increase the risk of infections. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer Skyrizi until the infection resolves
  • Avoid the use of live vaccines in patients treated with Skyrizi.

 

Review History:
  • 02/18/2020 – Original review 
  • 07/01/2020 – Criteria updated
  • 12/11/2020 – Annual review. Criteria and format updated
  • 04/20/2021 – Initial approval duration updated from 4 months to 1 year
  • 04/05/2022 – New criteria for new indication of active psoriatic arthritis.
  • 01/01/2023 – Update prerequisite drugs for PsO; add symptom requirements for PsO, PsA; add criteria for CD; add reauthorization criteria for all indications. 
  • 10/01/2024 – Added criteria for new indication of Ulcerative Colitis.

 

References:
  1. Skyrizi Prescribing Information. AbbVie, Inc. North Chicago, IL. June 2024. 
  2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72. 
  3. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70. 
  4. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. 
  5. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517. 
  6. 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(7):2496-2508.
  7. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413. 
  8. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461. 
     

Last review date: September 30, 2024