Subject: Xpovio 3119-A SGM P2022
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered covered benefits provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Xpovio is indicated in combination with bortezomib and
dexamethasone for the treatment of adult patients with
multiple myeloma who have received at least one prior
therapy.
2. Xpovio is indicated in combination with dexamethasone
for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least
four prior therapies and whose disease is refractory to at
least two proteasome inhibitors, at least two
immunomodulatory agents, and an anti-CD38 monoclonal
antibody.
3. Xpovio is indicated for the treatment of adult patients
with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL), not otherwise specified, including DLBCL arising
from follicular lymphoma, after at least 2 lines of
systemic therapy.
B. Compendial Uses
1. Multiple myeloma
2. B-cell lymphomas
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 the treatment
of multiple myeloma in any of the following settings:
1. The requested medication will be used in combination
with dexamethasone for relapsed, refractory, or
progressive disease and all of the following are met:
a. The member has received at least four prior therapy
regimens
b. The member is refractory to at least two proteasome
inhibitors
c. The member is refractory to at least two
immunomodulatory agents
d. The member is refractory to an anti-CD38 monoclonal
antibody
2. The requested medication will be used for relapsed or
progressive disease in combination with any of the
following:
a. Bortezomib and dexamethasone
b. Daratumumab and dexamethasone
c. Carfilzomib and dexamethasone
d. Pomalidomide and dexamethasone, after member has
received at least two prior therapies, including an
immunomodulatory agent and a proteasome inhibitor
B. B-Cell Lymphomas
Authorization of 12 months may be granted for the treatment
of B-cell lymphoma when all of the following criteria are met:
1. Member has partially responsive, progressive, relapsed,
or refractory disease
2. Member has received at least 2 prior lines of systemic
therapy (includes transplant or CAR T-cell therapy)
3. Member has one of the following B-cell lymphoma
subtypes:
a. AIDS-related diffuse large B-cell lymphoma (DLBCL)
b. AIDS-related primary effusion lymphoma
c. AIDS-related HHV8-positive DLBCL
d. DLBCL, including transformed DLBCL arising from
follicular lymphoma
e. High-grade B-cell lymphoma
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:
- Xpovio [package insert]. Newton, MA: Karyopharm Therapeutics Inc.; July 2022.
- The NCCN Drugs & Biologics Compendium® 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed September 30, 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
