Subject: Ninlaro 2372-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 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. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Test results confirming presence of chromosomal translocation t(11;14) where applicable
III. 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 patients who have received at least one prior therapy
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
4. The requested medication is prescribed in combination with venetoclax and
dexamethasone for patients with t(11;14) who have received at least one prior therapy
5. The requested medication is prescribed as a substitute for carfilzomib when used as
primary treatment or treatment for relapsed disease if the patient previously received the
requested medication for primary induction therapy
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.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section III 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 © 2023 National Comprehensive Cancer Network, Inc. Available at: 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.
May 17, 2024
