Subject: PCSK9 Inhibitors

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
NP	Praluent®  (alirocumab)	X	X		X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Praluent is subject to precertification. If precertification requirements apply, Aetna considers this medication to be medically necessary for those members who meet the following precertification criteria:

For Praluent

A documented diagnosis of one of the following:

• Heterozygous familial hypercholesterolemia**
• Existing cardiovascular disease defined by a history of an AMI, silent MI, unstable angina, coronary revascularization procedure (PCI or CABG)) or clinically significant atherosclerotic cardiovascular disease diagnosed by invasive or noninvasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography, or nuclear imaging)

AND

• Failure (defined as an LDL-C > 70mg/dl) of 2 different treatment regimens used for at least 4 weeks each, consisting of a high-potency statin (atorvastatin, simvastatin, or rosuvastatin) at the maximum tolerated dose^ in combination with ezetimibe, despite optimal compliance with regimens.

AND

• Praluent will be used in combination with a statin used at the maximum tolerated dose

AND

• Age > 18 years

AND

• Triglycerides are < 400mg/dL

AND

• No history of severe renal impairment (eGFR < 30 ml/min) or severe hepatic impairment

AND

• If female, patient is not pregnant or planning to become pregnant while on therapy

 

Drug	Maximum Daily Dose	Dosage Strength	Quantity Limits
Praluent	300 mg/ml	75 mg/ml; 150 mg/ml	Up to 2 injections in 28 days

Special Notes:

**Diagnosis of Heterozygous familial hypercholesterolemia requires one of the following:

1. Cholesterol level is higher than 190 mg/dl (age > 18 years) either pre-treatment or highest on treatment plus tendon xanthomas, or evidence of these signs in a first or second-degree relative, or
2. DNA-based evidence of an LDL- receptor mutation, apo-B100 or a PCSK9 mutation, or
3. Other genetic typing indicating the presence of heterozygous familial hypercholesterolemia

 

^The dose of statin used should be:

-rosuvastatin 20mg or higher, or

-atorvastatin 40mg or higher, or

-simvastatin 40mg or higher

 

Unless one of the following conditions exist:

                -Adverse effects occurred at higher doses

                -Age over 65

                -Body Mass Index < 18.5

                -Impaired glucose tolerance or elevated fasting glucose exists

-Concomitant use of medications such as cyclosporine, protease inhibitors, ritonavir, clarithromycin, itraconazole, ketoconazole,  erythromycin, nefazodone, ritonavir, simeprevir, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, or ranolazine

 

Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria above must be met in order to obtain coverage of Praluent.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Praluent (alirocumab) package insert. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. July 2015.
2. Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99.

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.

July 31, 2015