STELARA (ustekinumab)

Office Administration - Intravenous (IV) infusion by vial. (HCPCS code: J3358 per 1 mg)

Self-Administration - Subcutaneous (SC) injection by pre-filled syringes. (HCPCS code: J3357 per 1 mg)

 

Indications for Prior Authorization:

Stelara (ustekinumab) for subcutaneous (SC) use 

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. 

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

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

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

 

Stelara (ustekinumab) for intravenous (IV) use 

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

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

 

Coverage Criteria:

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of moderate to severe PsO; AND
  • Patient is 6 years of age or older; AND
  • Prescribed by or in consultation with a dermatologist; 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
  • For Stelara 90 mg/ml SC injection only: Weight is greater than 100 kg (220 lbs)

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • Patient is 6 years of age or older; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist; AND
  • One of the following:
    • actively inflamed joints 
    • dactylitis 
    • enthesitis 
    • axial disease 
    • active skin and/or nail involvement; AND
  • For Stelara 90 mg/ml SC injection only: Both of the following:
    • Weight is greater than 100 kg (220 lbs)
    • Diagnosis of co-existent moderate to severe psoriasis

 

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):
      • For Stelara intravenous (IV) infusion (induction dose): a single IV infusion will be administered using weight-based dosing to start therapy:
        • Up to 55 kg: 260 mg
        • Greater than 55 kg to 85 kg: 390 mg
        • Greater than 85 kg: 520 mg
      • 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 received Stelara IV induction dose
      • For Stelara subcutaneous (SC) injection (maintenance dose): Stelara 90 mg SC injection will be given 8 weeks after the IV induction dose and continued every 8 weeks thereafter.

 

For diagnosis of Ulcerative Colitis (UC):

  • Documented diagnosis of moderately to severely active UC; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • One of the following:
    • All of the following (medical benefit):
      • For Stelara intravenous (IV) infusion (induction dose): a single IV infusion will be administered using weight-based dosing to start therapy:
        • Up to 55 kg: 260 mg
        • Greater than 55 kg to 85 kg: 390 mg
        • Greater than 85 kg: 520 mg
      • 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, ESR, CRP) 
        • Dependent on, or refractory to, corticosteroids
      • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
        • Corticosteroid (e.g., prednisone) 
        • 6-mercaptopurine 
        • Azathioprine 
        • Aminosalicylates (e.g., mesalamine, olsalazine, sulfasalazine)
    • All of the following (pharmacy benefit):
      • Patient has received Stelara IV induction dose
      • For Stelara subcutaneous (SC) injection (maintenance dose): Stelara 90 mg SC injection will be given 8 weeks after the IV induction dose and continued every 8 weeks thereafter.

 

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 UC, CD:

  • All 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 Stelara 90 mg subcutaneous (SC) injection will be given every 8 weeks.

 

Dosing:

 

PsO (adults and pediatrics 6 years of age or older):

  • Adults:
    • less than or equal to 100 kg: 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
    • greater than 100 kg: 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
  • Pediatric, 6 to 17 years old:
    • less than 60 kg: 0.75 mg/kg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
    • 60 kg to 80 kg: 45 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
    • greater than 100 kg: 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

 

PsA (adults and pediatrics 6 years of age or older):

  • Adults:
    • less than or equal to 100 kg: 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
    • greater than 100 kg with co-existent moderate-to-severe plaque psoriasis: 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
  • Pediatric, 6 to 17 years old:
    • less than 60 kg: 0.75 mg/kg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
    • 60 kg or more: 45 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.
    • greater than 100 kg with co-existent moderate-to-severe plaque psoriasis: 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

 

CD, UC (adults):

  • Induction (IV):
    • Up to 55 kg: 260 mg
    • Greater than 55 kg to 85 kg: 390 mg
    • Greater than 85 kg: 520 mg
  • Maintenance (SC):
    • 90 mg SC injection started 8 weeks after the IV induction dose and continued every 8 weeks thereafter.

 

Coverage Duration:

PsO: 

  • Initial: 1 year
  • Reauthorization: 1 year

PsA:

  • Initial: 1 year
  • Reauthorization: 1 year

CD, UC:

  • Initial IV: 1 time
  • Initial SC: 6 months
  • Reauthorization SC: 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:
  • Do not administer live vaccines or attenuated vaccines concurrently with ustekinumab.
  • Patients should be evaluated for latent tuberculosis infection with a TB skin test. Treatment of latent tuberculosis infection should be initiated prior to therapy with Stelara.

 

Review History:
  • 10/20/2020 - Annual review.
  • 02/16/2021 - Annual review.  Criteria and format updated; removed reference to chart note requirement; removed TB testing requirements; added medical necessity guidance for reauthorization requests; updated approval duration to 1 year.
  • 04/20/2021 - Removed prerequisite for one TNF-blocker for UC and CD.
  • 01/01/2023 - Update prerequisite drugs for PsO, CD, UC; add symptom requirements for PsO, PsA, CD, UC. add reauthorization criteria for all indications; updated coverage duration of initial authorization.

 

References:
  1. Stelara prescribing information. Janssen Biotech, Inc. Horsham PA. August 2022. 
  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: April 20, 2021

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