Subject: Aphexda 6157-A SGM P2023
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
Aphexda is indicated in combination with filgrastim (G-CSF
[granulocyte-colony stimulating factor]) to mobilize
hematopoietic stem cells to the peripheral blood for collection
and subsequent autologous transplantation in patients with
multiple myeloma.
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Hematopoietic Stem Cell Mobilization
Authorization of 6 months may be granted in members with
multiple myeloma when all of the following criteria are met:
A. The requested medication will be used to mobilize
hematopoietic stem cells for collection.
B. The requested medication will be administered after the
member has received four daily doses of G-CSF (e.g.,
filgrastim).
C. The requested medication will not be used beyond two doses
or after completion of stem cell harvest/apheresis.
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization
for continuation of therapy must meet all initial authorization
criteria.
Place of Service:
Outpatient
The above policy is based on the following references:
- Aphexda [package insert]. Waltham, MA: BioLineRx USA Inc; September 2023.
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