Subject: Specialty Quantity Limit Repatha-Praluent 1777-H P2024
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/mL pre-filled
syringe or SureClick autoinjector
|
3 syringes/ autoinjectors
per 28 days
|
6 syringes/ autoinjectors
per 28 days
|
Established cardiovascular disease, primary
hyperlipidemia, including heterozygous familial
hypercholesterolemia (HeFH):
• 140 mg every 2 weeks or 420 mg once monthly
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.
|
|
Repatha 420 mg/3.5 mL
Pushtronex system
|
1 injection per 28 days
|
2 injections per 28 days
|
|
Praluent 75 mg/mL pre-filled pen
|
2 pens per 28 days
|
N/A
|
Adults
Established cardiovascular disease or primary
hyperlipidemia, including HeFH:
• 75 mg every 2 weeks or 300 mg 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 every 2 weeks
Pediatrics 8 years and older with HeFH
• < 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.
• ≥ 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.
|
|
Praluent 150 mg/mL pre-filled pen
|
2 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:
- Repatha [package insert]. Thousand Oaks, CA: Amgen, Inc.; September 2021.
- 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.
June 09, 2024
