Subject: Specialty Quantity Limit Tremfya 2158-H P2025a

Drug

TREMFYA  (guselkumab)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Tremfya (guselkumab) 100 mg/mL prefilled syringe/   One-press injector	1 syringe/injector per 56 days	2 syringes/injectors per 28 days
Tremfya (guselkumab) 200 mg/2 mL prefilled syringe/pen	1 syringe/pen per 28 days	6 syringes/pens per 56 days
Tremfya (guselkumab) 200 mg/2 mL prefilled pen Induction   Pack for Crohn’s Disease	N/A	3 cartons (6 pens) per 56 days
Tremfya (guselkumab) 200 mg/20 mL single-dose vial	N/A	60 mL (3 vials) per 56 days

FDA-recommended Dosing

Plaque Psoriasis and Psoriatic Arthritis

Loading doses

100 mg subcutaneous injection at week 0 and 4

Maintenance dose

100 mg subcutaneous injection every 8 weeks

Ulcerative Colitis

Induction, intravenous

200 mg at week 0, week 4, and week 8

Maintenance, subcutaneous

100 mg at week 16, and every 8 weeks thereafter, or 200 mg at week 12, and every 4 weeks thereafter

Crohn’s Disease

Induction

• 200 mg by intravenous infusion at week 0, week 4, and week 8, or
• 400 mg by subcutaneous injection at week 0, week 4, and week 8

Maintenance, subcutaneous

100 mg at week 16, and every 8 weeks thereafter, or 200 mg at week 12, and every 4 weeks thereafter

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tremfya [package insert]. Horsham, PA: Janssen Biotech, Inc.; March 2025.

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.

April 15, 2025