Subject: Pomalyst 2234-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.
A. FDA-Approved Indications
1. Treatment of multiple myeloma, in combination with dexamethasone, in patients who have received at
least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated
disease progression on or within 60 days of completion of their last therapy
2. Treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active
antiretroviral therapy (HAART) or in adult patients with KS who are HIV-negative
B. Compendial Uses
1. Systemic light chain amyloidosis
2. Primary central nervous system lymphoma
3. POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome
Refer to section II, Criteria for Initial Approval, for additional approvable regimens
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Multiple myeloma
Authorization of 12 months may be granted for treatment of multiple myeloma when all of the following
criteria are met:
1. The member has previously received at least two prior therapies for multiple myeloma including an
immunomodulatory agent and proteasome inhibitor.
2. The requested medication will be used in one of the following regimens:
i. In combination with daratumumab and dexamethasone
ii. In combination with elotuzumab and dexamethasone
iii. In combination with ixazomib and dexamethasone
iv. In combination with bortezomib and dexamethasone
v. In combination with carfilzomib and dexamethasone
vi. In combination with cyclophosphamide and dexamethasone
vii. In combination with isatuximab-irfc and dexamethasone
viii. In combination with dexamethasone
ix. In combination with selinexor and dexamethasone
x. As a single agent
B. Systemic light chain amyloidosis
Authorization of 12 months may be granted for treatment of relapsed or refractory systemic light chain
amyloidosis in combination with dexamethasone.
C. Kaposi Sarcoma
Authorization of 12 months may be granted for the treatment of Kaposi sarcoma when either of the
following criteria are met:
1. Will be used in combination with antiretroviral therapy for the treatment of AIDS-related Kaposi sarcoma
2. Member is HIV-negative
D. Primary central nervous system lymphoma
Authorization of 12 months may be granted for treatment of primary central nervous system lymphoma
as a single agent.
E. POEMS syndrome
Authorization of 12 months may be granted for treatment of POEMS syndrome in combination
with dexamethasone.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Pomalyst [package insert]. Summit, NJ: Celgene Corporation; December 2020.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 4, 2021.
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.
April 16, 2022
