Subject: Specialty Quantity Limit Orladeyo 4401-H P2025a

Drug

ORLADEYO  (berotralstat)

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
Orladeyo (berotralstat) 110 mg capsules	1 carton (28 capsules) per 28 days
Orladeyo (berotralstat) 150 mg capsules	1 carton (28 capsules) per 28 days
Orladeyo (berotralstat) 72 mg oral pellets	1 carton (28 packets) per 28 days
Orladeyo (berotralstat) 96 mg oral pellets	1 carton (28 packets) per 28 days
Orladeyo (berotralstat) 108 mg oral pellets	1 carton (28 packets) per 28 days
Orladeyo (berotralstat) 132 mg oral pellets	1 carton (28 packets) per 28 days

FDA-recommended Dosing

Recommended Dose

1. In adults and pediatric patients 12 years of age and older:

• 150 mg orally once daily.

2. In pediatric patients 2 years to less than 12 years of age:

• Dose is based on the patient’s body weight.

Body Weight (kg)	Recommended Dosage of Orladeyo Oral Pellets
12 kg to less than 24 kg	72 mg (one packet) once daily
24 kg to less than 32 kg	96 mg (one packet) once daily
32 kg to less than 40 kg	108 mg (one packet) once daily
40 kg or greater	132 mg (one packet) once daily

Dose Reduction

Moderate or severe hepatic impairment (Child-Pugh Class B or C)

1. In adults and pediatric patients 12 years of age and older:

• 110 mg orally once daily.

2. In pediatric patients 2 years to less than 12 years of age:

• Avoid use of Orladeyo.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Orladeyo [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc.; December 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.

February 14, 2026