Subject: Specialty Quantity Limit Benlysta 3027-H P2025

Drug

BENLYSTA  (belimumab)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the 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
Benlysta (belimumab) 200 mg/mL single-dose prefilled   autoinjector/ single-dose prefilled syringe	4 autoinjectors/syringes per 28 days	8 autoinjectors/syringes per 28 days
Benlysta (belimumab) 120 mg per 5 mL single-dose vial	9 vials per 28 days	Induction dose   •  Up to 100 kg: 27 vials per 28 days   •  Above 100 kg: 51 vials per 28 days   Maintenance dose (above 100 kg): 17 vials per   28 days
Benlysta (belimumab) 400 mg per 20 mL single-dose vial	3 vials per 28 days	Induction dose   •  Up to 100 kg: 9 vials per 28 days   •  Above 100 kg: 15 vials per 28 days   Maintenance dose (above 100 kg): 5 vials per 28   days

FDA-recommended Dosing

Systemic Lupus Erythematosus (SLE)

Adults, subcutaneous

200 mg once weekly

Pediatric patients (5 to less than 18 years of age), subcutaneous

• ≥ 40 kg: 200 mg once weekly
• 15 kg to < 40 kg: 200 mg once every 2 weeks

Adults and pediatric patients 5 years of age and older, intravenous

10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

Lupus Nephritis

Adults, subcutaneous

400 mg once weekly for 4 doses, then 200 mg once weekly thereafter

Adults and pediatric patients 5 years of age and older, intravenous

10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

Place of Service:

Outpatient

The above policy is based on the following references:

1. Benlysta [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; June 2024.

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 07, 2025