Subject: Specialty Quantity Limit Repatha-Praluent 1777-H P2022

Policy:

       I.  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.

 
II.  COVERED QUANTITIES

Medication	Standard Limit	Exception Limit*	FDA-recommended dosing
Repatha  140 mg syringe or  SureClick  autoinjector	2 syringes/  SureClick  per 28 days	N/A	Established cardiovascular disease  or primary hyperlipidemia:  140 mg every 2 weeks or 420 mg  once monthly.    Homozygous familial  hypercholesterolemia:  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.
Repatha  420 mg   Pushtronex  system	1 injection  per 28 days	2 injections  per 28 days
Praluent  75 mg pen	2 pens  per 28 days	N/A	Established cardiovascular disease  or primary hyperlipidemia,  including HeFH:  75 mg once every 2 weeks or  300 mg once every 4 weeks.  If the LDL-C response is  inadequate, dosage may be  adjusted to 150 mg every 2  weeks.    HeFH undergoing LDL apheresis  or HoFH:  150 mg once every 2 weeks.
Praluent  150 mg  syringe/pen	2 syringes/pens  per 28 days	N/A

* 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. Repatha [package insert]. Thousand Oaks, CA: Amgen, Inc.; September 2021.
2. Praluent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; April 2021.

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