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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Mulpleta 2990-A SGM P2023

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: 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:
          A.  Member has an untransfused platelet count of less than 50 x
               109/L taken within 14 days of the request.
          B.  Member is scheduled to undergo a procedure.


   VI.  CONTINUATION OF THERAPY

          Continuation of therapy, defined as use beyond the initial
          approval for the 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.

December 09, 2023
Aetna
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