Subject: Specialty Quantity Limit Prolia and Biosimilars 1715-H P2024b

Drug

Prolia and Biosimilars

PROLIA  (denosumab)

CONEXXENCE  (denosumab-bnht)

JUBBONTI  (denosumab-bbdz)

OSPOMYV  (denosumab-dssb)

STOBOCLO  (denosumab-bmwo)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Prolia (denosumab) 60 mg/mL single-dose prefilled syringe	1 syringe (60 mg) per 6 months
Conexxence (denosumab-bnht) 60 mg/mL single-dose prefilled syringe	1 syringe (60 mg) per 6 months
Jubbonti (denosumab-bbdz) 60 mg/mL single-dose prefilled syringe	1 syringe (60 mg) per 6 months
Ospomyv (denosumab-dssb) 60 mg/mL single-dose prefilled syringe	1 syringe (60 mg) per 6 months
Stoboclo (denosumab-bmwo) 60 mg/mL single-dose prefilled syringe	1 syringe (60 mg) per 6 months

FDA-Recommended Dosing

60 mg every 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Prolia [package insert]. Thousand Oaks, CA: Amgen Inc.; March 2024.
2. Conexxence [package insert]. Lake Zurich, IL: Fresenius Kabi USA, LLC; March 2025.
3. Jubbonti [package insert]. Princeton, NJ: Sandoz Inc.; March 2024
4. Ospomyv [package insert]. Incheon, South Korea: Samsung Bioepis; February 2025.
5. Stoboclo [package insert]. Incheon, South Korea: Celltrion Inc.; February 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.

May 18, 2025