Subject: Specialty Quantity Limit Stelara 1738-H P2022

Drug

STELARA  (ustekinumab)

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)
Stelara  (ustekinumab)  subcutaneous  injection  45 mg/0.5 mL  vial/syringe	1 vial/syringe  per 84 days	2 vials/syringes  per 28 days	Psoriasis with or without  co-existent PsA, 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  Psoriasis (6 years and  older)  •    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, without co-existent  plaque psoriasis  •     45 mg initially and         4 weeks later, followed by         45 mg every 12 weeks  CD, UC maintenance dose  •    90 mg 8 weeks after the        initial intravenous dose,        then every 8 weeks        thereafter
Stelara  (ustekinumab)  subcutaneous  injection 90  mg/mL syringe	1 syringe  per 56 days	2 syringes  per 28 days

Abbreviations: 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:

1. Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; December 2020.

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 26, 2022