Subject: Specialty Quantity Limit Repatha-Praluent 1777-H P2025

Drug

PRALUENT  (alirocumab)

REPATHA  (evolocumab)

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
Repatha (evolocumab) 140 mg/mL pre-filled syringe   or SureClick autoinjector	3 syringes/autoinjectors per 28 days	6 syringes/autoinjectors per 28 days
Repatha (evolocumab) 420 mg/3.5 mL Pushtronex   system	1 injection per 28 days	2 injections per 28 days
Praluent (alirocumab) 75 mg/mL pre-filled pen	2 pens per 28 days	N/A
Praluent (alirocumab) 150 mg/mL pre-filled pen	2 pens per 28 days	N/A

FDA-recommended Dosing

Repatha

Adults with established cardiovascular disease or with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)

• 140 mg every 2 weeks or 420 mg once monthly

Pediatrics 10 years and older with HeFH

• 140 mg every 2 weeks or 420 mg once monthly

Adults and pediatrics 10 years and older with homozygous familial hypercholesterolemia (HoFH)

• 420 mg once monthly

If a clinically meaningful response is not achieved in 12 weeks, the dosage can be increased to 420 mg every 2 weeks. Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule.

Praluent

Adults

Established cardiovascular disease or primary hyperlipidemia, including HeFH:

• 75 mg every 2 weeks or 300 mg every 4 weeks
• If the low-density lipoprotein-cholesterol (LDL-C) response is inadequate, dosage may be adjusted to 150 mg every 2 weeks.

HeFH undergoing low-density lipoprotein (LDL) apheresis or with HoFH:

• 150 mg every 2 weeks

Pediatrics 8 years and older with HeFH

Less than 50 kg

• 150 mg every 4 weeks
• If the LDL-C response is inadequate, the dosage may be adjusted to 75 mg every 2 weeks.

Greater than or equal to 50 kg

• 300 mg every 4 weeks
• If the LDL-C response is inadequate, the dosage may be adjusted to 150 mg every 2 weeks.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Repatha [package insert]. Thousand Oaks, CA: Amgen, Inc.; November 2024.
2. Praluent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 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.

April 20, 2025