Subject: Mulpleta 2990-A SGM P2021
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. 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.
V. 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:
- 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 15, 2021
