Subject: Tremfya SGM 2156-A P2026

Drug

TREMFYA  (guselkumab)

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 Indications¹

·        Treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kilograms (kg) with moderate to severe plaque psoriasis (PsO) and who are candidates for systemic therapy or phototherapy

·        Treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis (PsA)

·        Treatment of moderately to severely active ulcerative colitis (UC) in adults

·        Treatment of moderately to severely active Crohn’s disease (CD) in adults

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.

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

Continuation requests

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

Prescriber Specialties

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

·        Plaque psoriasis: dermatologist

·        Psoriatic arthritis: rheumatologist or dermatologist

·        Ulcerative colitis and Crohn’s disease: gastroenterologist

Coverage Criteria

Plaque psoriasis (PsO)^1-6,9

Authorization of 12 months may be granted for members 6 years of age and older weighing at least 40 kg 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 weighing at least 40 kg 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)^1,7-9

Authorization of 12 months may be granted for members 6 years of age and older weighing at least 40 kg 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 and older weighing at least 40 kg for treatment of active psoriatic arthritis when either of the following criteria is met:

·        Member has mild to moderate disease and meets any 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.

Ulcerative colitis (UC)^1,11-13

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

Crohn’s disease (CD)^1,14,15

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

Continuation of Therapy

Plaque psoriasis (PsO)^1-6

Authorization of 12 months may be granted for all members 6 years of age and older weighing at least 40 kg (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)^1,8,9

Authorization of 12 months may be granted for all members 6 years of age and older weighing at least 40 kg (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)

Ulcerative colitis (UC)^1,11-13

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)

Crohn’s disease (CD)^1,14,15

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)

Other¹

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 Leflunomide¹⁰

·        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.      Tremfya [package insert]. Horsham, PA: Janssen Biotech, Inc.; September 2025.

2.     Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.

3.     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.

4.     Reich K, Armstrong, AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. Am J Clin Dermatol. 2017;76(3):418-431.

5.     Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. Am J Clin Dermatol. 2017;76(3):405-417.

6.     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.

7.     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.

8.     Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2018;71:5-32.

9.     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.

10.  Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486.

11.    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.

12.   Rubin DT, Ananthakrishnan AN, Siegel CA, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.

13.   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.

14.   Lichtenstein GR, Loftus EV Jr, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.

15.   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: 2496-2508.

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