Subject: Xpovio 3119-A SGM P2023
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
or refractory 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 as a single agent for the treatment of B-cell
lymphoma when all of the following criteria are met:
1. Member has partially responsive, non-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. HIV-related diffuse large B-cell lymphoma (DLBCL)
b. HIV-related primary effusion lymphoma
c. HIV-related HHV8-positive DLBCL
d. DLBCL, including transformed DLBCL arising from indolent lymphomas
e. High-grade B-cell lymphoma
f. Monomorphic post-transplant lymphoproliferative disorder (B-Cell type)
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® 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed September 28, 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.
May 17, 2024
