Subject: Specialty Quantity Limit Stelara 1738-H P2023
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
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
|
|
Stelara
(ustekinumab)
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.
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 11, 2023
