STELARA (ustekinumab)

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.