Subject: Specialty Quantity Limit tolvaptan-Jynarque 2571-H P2025

Drug

JYNARQUE  (tolvaptan)

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
Jynarque (tolvaptan) Carton 15 mg-15 mg tablets	56 tablets per 28 days
Jynarque (tolvaptan) Carton 30 mg-15 mg tablets	56 tablets per 28 days
Jynarque (tolvaptan) Carton 45 mg-15 mg tablets	56 tablets per 28 days
Jynarque (tolvaptan) Carton 60 mg-30 mg tablets	56 tablets per 28 days
Jynarque (tolvaptan) Carton 90 mg-30 mg tablets	56 tablets per 28 days
Jynarque (tolvaptan) 30 mg tablets (30 count bottle)	30 tablets per 30 days
Jynarque (tolvaptan) 15 mg tablets (30 count bottle)	60 tablets per 30 days

FDA-recommended Dosing

Initial dose is 60 mg orally daily (45 mg on waking and 15 mg 8 hours later). Titrate to 90 mg daily (60 mg on waking and 30 mg 8 hours later) and then to 120 mg daily (90 mg on waking and 30 mg 8 hours later) if tolerated with at least weekly intervals between titrations. Patients may down-titrate based on tolerability.

Co-Administration with Moderate CYP 3A Inhibitors:

Reduce dose per below. Consider further reductions if patient cannot tolerate the reduced dose.

• 120 mg daily: reduce to 60 mg daily (45 mg on waking and 15 mg 8 hours later)
• 90 mg daily: reduce to 45 mg daily (30 mg on waking and 15 mg 8 hours later)
• 60 mg daily: reduce to 30 mg daily (15 mg on waking and 15 mg 8 hours later)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Jynarque [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.; May 2025.
2. Tolvaptan [packate insert]. Naples, FL: Lupin Pharmaceuticals, Inc.; May 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.

April 29, 2026