Subject: tolvaptan-Samsca 2181-A SGM P2023

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: Ascend Laboratories, LLC; May 2022.
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 11, 2023