Subject: Ninlaro 2372-A SGM P2021
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.
B. Compendial Uses
1. Multiple Myeloma
a) In combination with lenalidomide and dexamethasone as primary therapy for active (symptomatic)
myeloma or disease relapse after 6 months following primary induction therapy with the same regimen
b) In combination with dexamethasone for patients who have received at least one prior therapy for
previously treated myeloma for relapsed or progressive disease
c) In combination with dexamethasone and pomalidomide for patients who have received at least two prior
therapies including an immunomodulatory agent and a proteasome inhibitor and who have demonstrated
disease progression on or within 60 days of completion of the last therapy for previously treated myeloma
for relapsed or progressive disease
d) In combination with cyclophosphamide and dexamethasone for patients who have received at least
one prior therapy previously treated myeloma for relapsed or progressive disease or for patients who
are transplant candidates
e) As maintenance therapy for patients with symptomatic myeloma after response to primary myeloma
therapy or response or stable disease following autologous stem cell transplant
*Refer to Section II, Criteria for Initial Approval, for additional approvable multiple myeloma regimens
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. Ninlaro is prescribed in combination with lenalidomide and dexamethasone
2. Ninlaro is prescribed in combination with dexamethasone for patients with relapsed or progressive disease
3. Ninlaro 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
4. Ninlaro is prescribed as single agent maintenance therapy
5. Ninlaro 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 Ninlaro 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]. Cambridge, MA: Takeda Pharmaceutical Company Limited; March 2021.
- The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed October 4, 2021.
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 16, 2022
