Subject: Ninlaro 2372-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 Indication
Ninlaro is indicated in combination with lenalidomide and
dexamethasone for the treatment of patients with multiple
myeloma who have received at least one prior therapy.
Limitations of Use: Ninlaro is not recommended for use in
the maintenance setting or in newly diagnosed multiple
myeloma in combination with lenalidomide and
dexamethasone outside of controlled clinical trials.
B. Compendial Uses
1. Multiple Myeloma
2. Systemic light chain amyloidosis
3. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
Lymphoma
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 is met:
1. The requested medication is prescribed in combination
with lenalidomide and dexamethasone for non-transplant
candidates for primary therapy or for patients with
relapsed or progressive disease
2. The requested medication is prescribed in combination
with pomalidomide and dexamethasone for patients who
have received at least two prior therapies including an
immunomodulatory agent and a proteasome inhibitor
3. The requested medication is prescribed in combination
with cyclophosphamide and dexamethasone for patients
who have received at least one prior therapy or are a
transplant candidate
B. Systemic Light Chain Amyloidosis
Authorization of 12 months may be granted for treatment
of relapsed or refractory systemic light chain amyloidosis.
C. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
Lymphoma
Authorization of 12 months may be granted for treatment of
Waldenstrom macroglobulinemia/lymphoplasmacytic
lymphoma when the requested medication is prescribed in
combination with rituximab and 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:
- Ninlaro [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; May 2022.
- The NCCN Drugs & Biologics Compendium © 2022 National Comprehensive Cancer Network, Inc. Available at: 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.
May 15, 2023
