Pharmacy Prior Authorization Criteria

Skyrizi (risankizumab-rzaa)

Indications for Prior Authorization

Skyrizi SC (risankizumab-rzaa)

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

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

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

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

Skyrizi IV (risankizumab-rzaa)

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

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

Criteria

Skyrizi SC 150 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis

• Diagnosis of moderate to severe plaque psoriasis
AND
• One of the following [2]:
• 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 [3]:
• corticosteroids (e.g., betamethasone, clobetasol)
• vitamin D analogs (e.g., calcitriol, calcipotriene)
• tazarotene
• calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
AND
• Prescribed by or in consultation with a dermatologist

Skyrizi SC 150 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis

• Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1-3]:
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Skyrizi SC 150 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis (PsA)
AND
• One of the following [4]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Skyrizi SC 150 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
• 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

Skyrizi IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Crohn's Disease (CD)

• Diagnosis of moderately to severely active Crohn's disease (CD)
AND
• One of the following [5, 6]:
• 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
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [5, 6]:
• 6-mercaptopurine
• Azathioprine
• Methotrexate
• Corticosteroid (e.g., prednisone)
AND
• Will be administered as an intravenous induction dose
AND
• Prescribed by or in consultation with a gastroenterologist

Skyrizi SC 180 mg, 360 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Crohn's Disease (CD)

• Diagnosis of moderately to severely active Crohn's disease (CD)
AND
• Will be used as a maintenance dose following the intravenous induction doses
AND
• Prescribed by or in consultation with a gastroenterologist

Skyrizi IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• One of the following [7, 8]:
• 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
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [7, 8]:
• 6-mercaptopurine
• Azathioprine
• Corticosteroid (e.g., prednisone)
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
AND
• Will be administered as an intravenous induction dose
AND
• Prescribed by or in consultation with a gastroenterologist

Skyrizi SC 180 mg, 360 mg

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• Will be used as a maintenance dose following the intravenous induction doses
AND
• Prescribed by or in consultation with a gastroenterologist

Skyrizi SC 180 mg, 360 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Crohn's Disease (CD), Ulcerative Colitis (UC)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5-8]:
• 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

P & T Revisions

2024-09-15, 2024-07-31, 2024-05-01, 2023-12-20, 2023-10-12, 2023-10-12, 2023-05-03, 2023-02-01, 2022-10-24, 2022-08-23, 2022-08-03, 2022-05-07, 2022-02-28, 2021-06-30, 2021-05-20, 2020-09-18, 2020-06-10

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.

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Revision History

• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
• 2024-07-31: Added criteria for new indication of Ulcerative Colitis.
• 2024-05-01: Annual review - no criteria changes; background updates
• 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-12: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-12: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-03: Annual review - removed 75 mg strength since it has been discontinued; background updates
• 2023-02-01: Addition of 180 mg strength product
• 2022-10-24: Further clinical detail and criteria added
• 2022-08-23: Addition of criteria for CD
• 2022-08-03: Addition of criteria for CD
• 2022-05-07: Annual review - no criteria changes
• 2022-02-28: Addition of criteria for PsA
• 2021-06-30: Addition of new formulations
• 2021-05-20: Annual review
• 2020-09-18: Addition of objective measures to the psoriasis reauthorization criteria
• 2020-06-10: Annual review - removed drug name from reauth criteria; reference updates

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