Subject: Pomalyst 2234-A SGM P2022
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
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 combination with carfilzomib
and dexamethasone
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 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; October 2021.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 4, 2022.
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 15, 2023
