Subject: tolvaptan-Samsca 2181-A SGM P2024

Drug

SAMSCA  (tolvaptan )

tolvaptan

Policy:

      I.  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 Indication
          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)

          Important Limitations
          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.


    II.  CRITERIA FOR INITIAL APPROVAL

          Hypervolemic/Euvolemic Hyponatremia
          Authorization of 30 days may be granted for members prescribed the requested drug when all
          of the following criteria are met:
          A.  Therapy was initiated (or re-initiated) in the hospital for hypervolemic or euvolemic
               hyponatremia.
          B.  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.
          C.  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]. Parsippany, NJ: Novadoz Pharmaceuticals LLC; March 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 09, 2024