Subject: Pomalyst 2234-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.
A. FDA-Approved Indications
1. Treatment of multiple myeloma, in combination with dexamethasone, in adult 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 human
immunodeficiency virus (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
4. Multiple myeloma
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 any 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 and the requested
medication will be used in one of the following regimens:
i. In combination with elotuzumab and dexamethasone
ii. In combination with ixazomib and dexamethasone
iii. In combination with bortezomib and dexamethasone
iv. In combination with cyclophosphamide and dexamethasone
v. In combination with isatuximab-irfc and dexamethasone
vi. In combination with dexamethasone
vii. In combination with selinexor and dexamethasone
viii. As a single agent
2. The member has previously received at least one prior therapy for multiple myeloma
including an immunomodulatory agent and a proteasome inhibitor and the requested
medication will be used in combination with daratumumab and dexamethasone
3. The member has previously received at least one prior therapy for multiple myeloma and
the requested medication will be used in one of the following regimens:
i. In combination with carfilzomib and dexamethasone
ii. In combination with elotuzumab and dexamethasone if lenalidomide refractory
iii. In combination with bortezomib and dexamethasone if lenalidomide refractory
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. The requested medication will be used in combination with antiretroviral therapy for the
treatment of HIV-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]. Princeton, NJ: Bristol Myers Squibb Company; March 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 4, 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.
April 17, 2024
