Subject: tolvaptan-Samsca SGM 2181-A P2025

Drug

SAMSCA  (tolvaptan)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1,2

Samsca/tolvaptan is indicated for treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).

Limitations of Use

Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with Samsca/tolvaptan. It has not been established that raising serum sodium with Samsca/tolvaptan provides a symptomatic benefit to patients.

All other indications are considered experimental/investigational and are not medically necessary.

Coverage Criteria

Hypervolemic or Euvolemic Hyponatremia^1-3

Authorization of 30 days may be granted for members prescribed the requested drug when all of the following criteria are met:

• Therapy was initiated (or re-initiated) in the hospital for hypervolemic or euvolemic hyponatremia.
• Serum sodium was less than 125 mEq/L or serum sodium was less than 135 mEq/L with symptoms (e.g., nausea, vomiting, headache, lethargy, confusion) at the time of therapy initiation.
• The member will not receive the requested drug continually for greater than 30 days.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Samsca [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.; April 2021.
2. Tolvaptan [package insert]. Piscataway, NJ: Novadoz Pharmaceuticals LLC; May 2023.
3. Hoorn EJ, Zietse R. Diagnosis and treatment of hyponatremia: Compilation of the guidelines. J Am Soc Nephol. 2017; 28(5):1340-1349.

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 07, 2025