Subject: Mulpleta 2990-A SGM P2022

Drug

MULPLETA  (lusutrombopag)

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
            Mulpleta is indicated for the treatment of thrombocytopenia in
            adult patients with chronic liver disease who are scheduled to
            undergo a procedure.

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

 
    II.   DOCUMENTATION

           Submission of the following information is necessary to initiate
           the prior authorization review for thrombocytopenia in chronic
           liver disease: pretreatment platelet count.

 
   III.  EXCLUSIONS

           Coverage will not be provided for members with the following
           exclusion: concomitant use of Mulpleta with other
           thrombopoietin receptor agonists (e.g., Doptelet, Promacta,
           Nplate) or with spleen tyrosine kinase inhibitors (e.g.,
           Tavalisse).

 
     IV.  PRESCRIBER SPECIALTIES

            This medication must be prescribed by or in consultation with a
            hematologist, hepatologist or gastroenterologist

 
      V.  CRITERIA FOR INITIAL APPROVAL

           Thrombocytopenia in chronic liver disease
           Authorization of 30 days may be granted for treatment of
           thrombocytopenia in members with chronic liver disease when
           both of the following criteria are met:
           1.  Member has an untransfused platelet count of less than 50 x
                10⁹/L taken within 14 days of the request.
           2.  Member is scheduled to undergo a procedure.

 
    VI.  CONTINUATION OF THERAPY

           Thrombocytopenia in chronic liver disease
           Continuation of therapy, defined as use beyond the initial
           approval for same procedure, is not approvable. All members
           (including new members) requesting authorization due to newly
           scheduled procedure must meet all initial authorization criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Mulpleta [package insert]. Florham Park, NJ: Shionogi Inc.; April 2020.

 

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.

January 31, 2023