Pharmacy Prior Authorization Criteria

Ustekinumab

Indications for Prior Authorization

Stelara SC (ustekinumab), Wezlana SC (ustekinumab-auub)

• For diagnosis of Plaque Psoriasis (PsO)
  Indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

• For diagnosis of Psoriatic Arthritis (PsA)
  Indicated for the treatment of patients 6 years or older with active psoriatic arthritis.

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

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

Stelara IV (ustekinumab), Wezlana IV (ustekinumab-auub)

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

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

Criteria

Stelara SC & Wezlana SC 45 mg/0.5 mL

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
• Patient is 6 years of age or older
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

Stelara SC & Wezlana SC 90 mg/1 mL

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
• Patient's weight is greater than 100 kg (220 lbs)
AND
• Patient is 6 years of age or older
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

Stelara SC, Wezlana SC

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

Stelara SC & Wezlana SC 45 mg/0.5 mL

Prior Authorization (Initial Authorization)

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

• Diagnosis of active psoriatic arthritis
AND
• One of the following [4]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Patient is 6 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Stelara SC & Wezlana SC 90 mg/1 mL

Prior Authorization (Initial Authorization)

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

• Diagnosis of active psoriatic arthritis
AND
• One of the following [4]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Diagnosis of co-existent moderate to severe psoriasis [1, 4]
AND
• Patient’s weight is greater than 100 kg (220 lbs)
AND
• Patient is 6 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Stelara SC, Wezlana SC

Prior Authorization (Reauthorization)

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

• 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

Stelara IV, Wezlana IV

Prior Authorization

Length of Approval: 1 Time(s)
For diagnosis of Crohn's Disease

• Diagnosis of moderately to severely active Crohn's disease
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
• corticosteroids (e.g., prednisone)
• methotrexate
AND
• Medication is to be administered as an intravenous induction dose
AND
• Medication induction dosing is in accordance with the United States Food and Drug Administration approved labeled dosing for Crohn's disease:
• 260 mg for patients weighing 55 kg or less
• 390 mg for patients weighing more than 55 kg to 85 kg
• 520 mg for patients weighing more than 85 kg
AND
• Prescribed by or in consultation with a gastroenterologist

Stelara SC, Wezlana SC

Prior Authorization (Initial Authorization)

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

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

Stelara IV, Wezlana IV

Prior Authorization

Length of Approval: 1 Time(s)
For diagnosis of Ulcerative Colitis

• 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, ESR, CRP)
• Dependent on, or refractory to, corticosteroids
AND
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [7, 8]:
• Corticosteroid (e.g., prednisone)
• 6-mercaptopurine
• Azathioprine
• Aminosalicylates (e.g., mesalamine, olsalazine, sulfasalazine)
AND
• Medication is to be administered as an intravenous induction dose
AND
• Medication induction dosing is in accordance with the United States Food and Drug Administration approved labeled dosing for ulcerative colitis:
• 260 mg for patients weighing 55 kg or less
• 390 mg for patients weighing more than 55 kg to 85 kg
• 520 mg for patients weighing more than 85 kg
AND
• Prescribed by or in consultation with a gastroenterologist

Stelara SC, Wezlana SC

Prior Authorization (Initial Authorization)

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

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

Stelara SC, Wezlana SC

Prior Authorization (Reauthorization)

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

• 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

2024-12-27, 2024-12-24, 2024-09-15, 2024-08-08, 2023-11-30, 2023-09-02, 2022-12-07, 2022-10-24, 2022-10-03, 2022-10-03, 2022-09-09, 2021-09-03, 2021-05-26, 2021-05-25, 2021-05-12, 2020-10-20, 2020-09-18, 2019-10-30, 2019-09-26

References

1. Stelara prescribing information. Janssen Biotech, Inc. Horsham PA. March 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.
9. Wezlana prescribing information. Amgen, Inc. Thousand Oaks, CA. October 2023.

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Revision History

• 2024-12-27: Replaced reference to 'stelara' with 'medication' where it also applies to Wezlana.
• 2024-12-24: Addition of Wezlana to existing criteria
• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO. Annual review - Updated ulcerative colitis conventional step verbiage to align with other agents ("Trial and failure, contraindication, or intolerance to one of the following conventional therapies") - no change to clinical intent.
• 2024-08-08: Removal of the QL loading dose notes; no criteria changes
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-09-02: Annual review - no criteria changes
• 2022-12-07: Further clinical detail and criteria added; removal of conventional step from SC UC and CD criteria.
• 2022-10-24: Further clinical detail and criteria added
• 2022-10-03: Annual review - added age criterion for psoriasis; updated psoriatic arthritis indication and criteria to include patients 6 years or older
• 2022-10-03: Annual review - added age criterion for psoriasis; updated psoriatic arthritis indication and criteria to include patients 6 years or older
• 2022-09-09: Annual review - added age criterion for psoriasis; updated psoriatic arthritis indication and criteria to include patients 6 years or older
• 2021-09-03: Annual review
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-12: Background update
• 2020-10-20: Updated TNF inhibitor examples to remove brand names for infliximab
• 2020-09-18: Annual review: Updated psoriasis indication to reflect the recent approval for patients 6 years of age and older; Addition of objective measures to the psoriasis reauthorization criteria; addition of notes for loading dose QL override; reference updates
• 2019-10-30: Updated Crohn's disease indication based on updated PI; details regarding specific patient populations were moved to clinical studies section of the PI. Per call with Janssen Pharmaceuticals on 10/21/19, the FDA requested that information be moved to the clinical studies section.
• 2019-09-26: Annual Review; removed the restriction prohibiting use in combination with a biologic DMARD; for Stelara 90 mg/1 mL, for the psoriatic arthritis indication, added a requirement for a diagnosis of co-existent moderate to severe psoriasis.

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