Subject: Stelara and Biosimilars SGM 2010-A P2026

Drug

Stelara and Biosimilars

STELARA  (ustekinumab)

IMULDOSA  (ustekinumab-srlf)

OTULFI  (ustekinumab-aauz)

PYZCHIVA  (ustekinumab-ttwe)

SELARSDI  (ustekinumab-aekn)

STARJEMZA  (ustekinumab-hmny)

STEQEYMA  (ustekinumab-stba)

WEZLANA  (ustekinumab-auub)

YESINTEK  (ustekinumab-kfce)

ustekinumab (unbranded STELARA)  (ustekinumab)

ustekinumab-aauz (unbranded OTULFI)  (ustekinumab-aauz)

ustekinumab-aekn (unbranded SELARSDI)  (ustekinumab-aekn)

ustekinumab-auub (unbranded WEZLANA)  (ustekinumab-auub)

ustekinumab-srlf (unbranded IMULDOSA)  (ustekinumab-srlf)

ustekinumab-stba (unbranded STEQEYMA)  (ustekinumab-stba)

ustekinumab-ttwe (unbranded PYZCHIVA)  (ustekinumab-ttwe)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1-16

·        Moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for phototherapy or systemic therapy

·        Active psoriatic arthritis (PsA) in patients 6 years and older

·        Moderately to severely active Crohn’s disease (CD) in patients 2 years of age and older

·        Moderately to severely active ulcerative colitis (UC) in adults

Compendial Uses^29,31

Immune checkpoint inhibitor-related toxicity

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Plaque psoriasis (PsO)

Initial requests

·        Chart notes or medical record documentation of affected area(s) and body surface area (BSA) affected (if applicable).

·        Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Continuation requests

Chart notes or medical record documentation of decreased body surface area (BSA) affected and/or improvement in signs and symptoms.

Psoriatic arthritis (PsA)

Initial requests

Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Crohn’s disease (CD) and ulcerative colitis (UC)

Continuation requests

Chart notes or medical record documentation supporting positive clinical response to therapy or remission.

Immune checkpoint inhibitor-related toxicity

Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

·        Plaque psoriasis: dermatologist

·        Psoriatic arthritis: rheumatologist or dermatologist

·        Crohn’s disease and ulcerative colitis: gastroenterologist

·        Immune checkpoint inhibitor-related toxicity: gastroenterologist, hematologist, or oncologist

Coverage Criteria

Plaque psoriasis (PsO)^{1-17,22,26,27}

Authorization of 12 months may be granted for members 6 years of age and older who have previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for treatment of moderate to severe plaque psoriasis.

Authorization of 12 months may be granted for members 6 years of age and older for treatment of moderate to severe plaque psoriasis when any of the following criteria is met:

·        Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected.

·        At least 10% of body surface area (BSA) is affected.

·        At least 3% of body surface area (BSA) is affected and the member meets either of the following criteria:

§  Member has had an inadequate response or intolerance to either phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin.

§  Member has a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, and acitretin (see Appendix).

Psoriatic arthritis (PsA)^1-16,25,30

Authorization of 12 months may be granted for members 6 years of age or older who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active psoriatic arthritis.

Authorization of 12 months may be granted for members 6 years of age or older for treatment of active psoriatic arthritis when either of the following criteria is met:

·        Member has mild to moderate disease and meets one of the following criteria:

§  Member has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at an adequate dose and duration.

§  Member has an intolerance or contraindication to methotrexate or leflunomide (see Appendix), or another conventional synthetic drug (e.g., sulfasalazine).

§  Member has enthesitis.

·        Member has severe disease.

Crohn’s disease (CD)^{1-16,20,21,28}

Authorization of 12 months may be granted for treatment of moderately to severely active Crohn’s disease.

Ulcerative colitis (UC)^{1-16,20,23,24}

Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis.

Immune checkpoint inhibitor-related toxicity^29,31

Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related diarrhea or colitis when the member has experienced an inadequate response, intolerance, or has a contraindication to infliximab or vedolizumab.

Continuation of Therapy

Plaque psoriasis (PsO)^{1-17,22,26,27}

Authorization of 12 months may be granted for all members 6 years of age and older (including new members) who are using the requested medication for moderate to severe plaque psoriasis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when either of the following is met:

·        Reduction in body surface area (BSA) affected from baseline

·        Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

Psoriatic arthritis (PsA)^{1-19,25,28,30}

Authorization of 12 months may be granted for all members 6 years of age or older (including new members) who are using the requested medication for psoriatic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

·        Number of swollen joints

·        Number of tender joints

·        Dactylitis

·        Enthesitis

·        Skin and/or nail involvement

·        Functional status

·        C-reactive protein (CRP)

•     Crohn’s Disease (CD)^{1-16,20,21,28}

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

·        Abdominal pain or tenderness

·        Diarrhea

·        Body weight

·        Abdominal mass

·        Hematocrit

·        Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound

·        Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)

Ulcerative colitis^{1-16,20,23,24}

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission.

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

·        Stool frequency

·        Rectal bleeding

·        Urgency of defecation

·        C-reactive protein (CRP)

·        Fecal calprotectin (FC)

·        Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound

·        Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of Severity [UCEIS], Mayo score)

Immune checkpoint inhibitor-related toxicity

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

Other^1-16

For all indications: Member has been evaluated for tuberculosis (TB) infection prior to initiation of treatment with a biologic or targeted synthetic drug associated with an increased risk of TB.

For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Dosage and Administration

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Appendix

Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine, Acitretin, or Leflunomide²⁸

·        Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease

·        Drug interaction

·        Risk of treatment-related toxicity

·        Pregnancy or currently planning pregnancy

·        Breastfeeding

·        Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)

·        Hypersensitivity

·        History of intolerance or adverse event

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; April 2026.

2.     Imuldosa [package insert]. Raleigh, NC: Accord BioPharma Inc.; November 2025.

3.     Otulfi [package insert]. Lake Zurich, IL: Fresenius Kabi USA, LLC; May 2025.

4.     Pyzchiva [package insert]. Princeton, NJ: Sandoz Inc.; November 2025.

5.     Selarsdi [package insert]. Leesburg, VA: Alvotech USA Inc.; December 2025.

6.     Starjemza [package insert]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; May 2025.

7.     Steqeyma [package insert]. Jersey City, NJ: Celltrion USA, Inc.; December 2025.

8.     ustekinumab [package insert]. Horsham, PA: Janssen Biotech, Inc.; April 2025.

9.     ustekinumab-aauz [package insert]. Lake Zurich, IL: Fresenius Kabi USA, LLC; August 2025.

10.  ustekinumab-aekn [package insert]. Leesburg, VA: Alvotech USA Inc.; November 2025.

11.    ustekinumab-auub [package insert]. Thousand Oaks, CA: Amgen Inc.; September 2025.

12.   ustekinumab-srlf [package insert]. Raleigh, NC: Accord BioPharma Inc; November 2025.

13.   ustekinumab-stba [package insert]. Jersey City, NJ: Celltrion USA, Inc.; December 2025.

14.   ustekinumab-ttwe [package insert]. Grand Cayman, Cayman Islands: Quallent Pharmaceuticals Health LLC; March 2025.

15.   Wezlana [package insert]. Thousand Oaks, CA: Amgen Inc.; October 2025.

16.   Yesintek [package insert]. Cambridge, MA: Biocon Biologics Inc.; January 2026.

17.   Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.

18.   Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Annals of the Rheumatic Diseases. 2024;83:706-719.

19.   Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14–ii17.

20. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.

21.   Lichtenstein GR, Loftus EV, Afzali A, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2025;120:1225-1264.

22.  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(4):1029-1072.

23.  Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2025;120:1187-1224.

24.  Singh S, Loftus EV Jr, Limketkai BN, et al. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2024;167(7):1307-1343.

25.  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. doi:10.1002/art.40726.

26.  Menter A, Cordero KM, Davis DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.

27.  Menter A, Gelfand JM, Connor C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6): 1445-86.

28.  Scott FI, Ananthakrishnan AN, Click B, et al. AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease. Gastroenterology. 2025;169(7):1397-1448.

29.  The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 14, 2026.

30. Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.

31.   NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immune Checkpoint Inhibitor-Related Toxicities. Version 1.2026. Available at: www.nccn.org. Accessed January 14, 2026.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 16, 2026