Pharmacy Prior Authorization Criteria

Ustekinumab – PA, NF – Standard Default

Indications for Prior Authorization

Stelara SC (ustekinumab), Imuldosa SC (ustekinumab-srlf), Otulfi SC (ustekinumab-aauz), Pyzchiva SC (ustekinumab-ttwe), Selarsdi SC (ustekinumab-aekn), Steqeyma SC (ustekinumab-stba), Yesintek SC (ustekinumab-kfce)

• For diagnosis of Plaque Psoriasis (PsO)
  Indicated for the treatment of adults and pediatric patients 6 years of age and 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 adults and pediatric patients 6 years of age and 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), Imuldosa IV (ustekinumab-srlf), Otulfi IV (ustekinumab-aauz), Pyzchiva IV (ustekinumab-ttwe), Selarsdi IV (ustekinumab-aekn), Steqeyma IV (ustekinumab-stba), Yesintek IV (ustekinumab-kfce)

• 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

Applies to 45 mg/0.5 mL ONLY - Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Initial Authorization)

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

• 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

Applies to 90 mg/1 mL ONLY - Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Initial Authorization)

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

• 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

Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Reauthorization)

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

• 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

Applies to 45 mg/0.5 mL ONLY - Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana* SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
• Paid claims or submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Applies to 90 mg/1 mL ONLY - Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana* SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
• Paid claims or submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Applies to 45 mg/0.5 mL ONLY - Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Initial Authorization)

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

• 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

Applies to 90 mg/1 mL ONLY - Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Initial Authorization)

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

• 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

Yesintek SC

Approve at GPI 10 for Yesintek

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

Applies to 45 mg/0.5 mL ONLY - Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana* SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Applies to 90 mg/1 mL ONLY - Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Stelara* IV, Brand Ustekinumab* IV, Imuldosa* IV, Otulfi* IV, Pyzchiva* IV, Brand Ustekinumab-ttwe* IV, Selarsdi* IV, Brand Ustekinumab-aekn* IV, Steqeyma* IV, Brand Ustekinumab-stba* IV, Wezlana*IV

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

Length of Approval: 1 Time(s)
For diagnosis of Crohn’s disease (CD)

• Submission of medical records (e.g., chart notes) confirming a 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
• 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Yesintek IV

Approve at GPI 10 for Yesintek

Prior Authorization

Length of Approval: 1 Time(s)
For diagnosis of Crohn’s disease (CD)

• 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
• 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

Yesintek SC

Approve at GPI 10 for Yesintek

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
AND
• Will be used as a maintenance dose following the intravenous induction dose
AND
• Prescribed by or in consultation with a gastroenterologist

Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana*SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)

• Submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Yesintek IV

*Approve at GPI 10 for Yesintek

Prior Authorization

Length of Approval: 1 Time(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, ESR, CRP)
• Dependent on, or refractory to, corticosteroids
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* IV, Brand Ustekinumab* IV, Imuldosa* IV, Otulfi* IV, Pyzchiva* IV, Brand Ustekinumab-ttwe* IV, Selarsdi* IV, Brand Ustekinumab-aekn* IV, Steqeyma* IV, Brand Ustekinumab-stba* IV, Wezlana*IV

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
• 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Yesintek SC

Approve at GPI 10 Yesintek

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 dose
AND
• Prescribed by or in consultation with a gastroenterologist

Stelara* SC, Brand Ustekinumab* SC, Imuldosa* SC, Otulfi* SC, Pyzchiva* SC, Brand Ustekinumab-ttwe* SC, Selarsdi* SC, Brand Ustekinumab-aekn*, Steqeyma* SC, Brand Ustekinumab-stba* SC, Wezlana*SC

*If patient meets criteria above, approve at GPI list “OOUSTEKIN” ^If all criteria are met except for trial of Yesintek, pre-approve at GPI 10 for Yesintek

Prior Authorization, Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 3-month trial of Yesintek (ustekinumab-kfce)
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to Yesintek (ustekinumab-kfce)
OR
• Submission of medical records (e.g., chart notes) documenting an allergic reaction to a specific non-active ingredient that is not included in the requested product but is contained in Yesintek (ustekinumab-kfce)

Yesintek SC

Approve at GPI 10 for Yesintek

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of CD & 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

2025-06-10, 2025-05-27, 2025-05-20, 2025-04-30, 2025-04-03, 2025-03-26, 2025-03-07, 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. Imuldosa prescribing information. Accord BioPharma, Inc. Raleigh, NC. October 2024.
10. Otulfi prescribing information. Fresenius Kabi USA, LLC. Lake Zurich, IL. February, 2025.
11. Pyzchiva prescribing information. Sandoz, Inc. Princeton, NJ. December 2024.
12. Selarsdi prescribing information. Alvotech USA, Inc. Leesburg, VA. February 2025.
13. Steqeyma prescribing information. Celltrion USA, Inc. Jersey City, NJ. December 2024.
14. Wezlana prescribing information. Amgen, Inc. Thousand Oaks, CA. October 2023.
15. Yesintek prescribing information. Biocon Biologics, Inc. Cambridge, MA. November, 2024.
16. Ustekinumab prescribing information. Janssen Biotech, Inc. Horsham PA. April 2025.

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Revision History

• 2025-06-10: Moved Stelara & Wezlana (ustekinumab-auub) with other nonpreferred products and added Yesintek as a preferred product; added brand ustekinumab-aekn
• 2025-05-27: Moved Stelara with other nonpreferred products and added Yesintek as a preferred product; added brand ustekinumab-aekn
• 2025-05-20: Addition of unbranded Ustekinumab products
• 2025-04-30: Addition of unbranded Ustekinumab products
• 2025-04-03: Removed conventional step from CD and UC criteria
• 2025-03-26: Addition of nonpreferred biosimilar agents and criteria
• 2025-03-07: Addition of nonpreferred biosimilar agents and criteria
• 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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