Specialty Quantity Limit Stelara-Wezlana 1738-H P2024 - Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan

Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan

Subject: Specialty Quantity Limit Stelara-Wezlana 1738-H P2024

Drug

STELARA (ustekinumab)

WEZLANA (ustekinumab-auub)

Policy:

I. 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.

II. COVERED QUANTITIES

Medication	Standard Limit	Exception Limit*	FDA-recommended dosing
Stelara (ustekinumab) 130 mg/26 mL single-dose vial	4 vials (1 dose)	N/A	CD, UC intravenous induction • ≤ 55 kg: 260 mg (2 vials) • > 55 kg to 85 kg: 390 mg (3 vials) • > 85 kg: 520 mg (4 vials)
Wezlana (ustekinumab-auub) 130 mg/26 mL single-dose vial	4 vials (1 dose)	N/A
Stelara (ustekinumab) subcutaneous injection 45 mg/0.5 mL single-dose vial/ prefilled syringe	1 vial/syringe per 84 days	2 vials/syringes per 28 days	PsO, adult • ≤ 100 kg: 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks • > 100 kg: 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks PsO, pediatric (6-17 years old): Weight based dosing at the initial dose, 4 weeks later, and then every 12 weeks thereafter • < 60 kg: 0.75 mg/kg • 60 kg to 100 kg: 45 mg • > 100 kg: 90 mg PsA, adult • 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks • > 100 kg with co-existent PsO: 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks PsA, pediatric (6-17 years old): Weight based dosing at the initial dose, 4 weeks later, and then every 12 weeks thereafter • < 60 kg: 0.75 mg/kg • 60 kg or more: 45 mg • > 100 kg with co-existent PsO: 90 mg CD, UC maintenance dose • 90 mg 8 weeks after the initial intravenous dose, then every 8 weeks thereafter CD, UC inadequate response after induction (4 weeks after first maintenance dose) • 90 mg every 4 weeks
Stelara (ustekinumab) subcutaneous injection 90 mg/mL prefilled syringe	1 syringe per 56 days	2 syringes per 28 days
Wezlana (ustekinumab-auub) subcutaneous injection 45 mg/0.5 mL single-dose vial/ prefilled syringe	1 vial/syringe per 84 days	2 vials/syringes per 28 days
Wezlana (ustekinumab-auub) subcutaneous injection 90 mg/mL prefilled syringe	1 syringe per 56 days	2 syringes per 28 days

Abbreviations: PsO = plaque psoriasis; PsA = psoriatic arthritis; CD = Crohn’s disease, UC = ulcerative colitis
*Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Place of Service:

Outpatient

The above policy is based on the following references:

Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; August 2022.
Wezlana [package insert]. Thousand Oaks, CA: Amgen Inc.; October 2023.
In: Lexi-Dugs. Lexi-Comp, Inc. Updated May 22, 2024. Accessed November 23, 2024. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/1650039?cesid=0N48VZJEz3h&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dstelara%26t%3Dname%26acs%3Dfalse%26acq%3Dstelara

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.

June 09, 2024

Additional Information

Clinical Policy Bulletin Notes

Company Information \| Site Map	Aetna.com Home \| Help \| Contact Us \| Search
Web Privacy Statement \| Legal Statement \| Privacy Notices \| Member Disclosure