Subject: Venclexta 2374-A SGM P2023
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Venclexta is indicated for the treatment of adult patients
with chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL).
2. Venclexta is indicated in combination with azacitidine, or
decitabine, or low-dose cytarabine for the treatment of
newly-diagnosed acute myeloid leukemia (AML) in adults
75 years or older, or who have comorbidities that
preclude use of intensive induction chemotherapy.
B. Compendial Uses
1. Mantle cell lymphoma (MCL)
2. Acute myeloid leukemia (AML)
3. Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
4. Multiple myeloma (MM) with translocation t(11;14)
5. Systemic light chain amyloidosis (SLCA) with
translocation t(11;14)
6. Waldenström Macroglobulinemia/Lymphoplasmacytic
Lymphoma (WM/LPL)
7. Myelodysplastic syndrome (MDS)
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: Documentation of the presence
of translocation t(11,14) and TP53-mutation (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma (CLL/SLL)
Authorization of 12 months may be granted for treatment of
chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) when used as monotherapy, in combination with
rituximab (Rituxan), or in combination with obinutuzumab
(Gazyva).
B. Newly-diagnosed Acute Myeloid Leukemia (AML)
Authorization of 12 months may be granted for treatment of
newly-diagnosed acute myeloid leukemia (AML) when one of
the following criteria is met:
1. Used in combination with decitabine, azacitidine, or low-
dose cytarabine and member meets any of the following:
a. The member is 75 years of age or older.
b. The member has comorbidities that preclude
treatment with intensive induction chemotherapy.
c. The member is 60 years of age or older and is a
candidate for intensive remission induction therapy
with unfavorable-risk cytogenetics.
d. The member is 60 years of age or older and is not a
candidate for intensive remission induction therapy or
declines intensive therapy.
e. The member is 60 years of age or older and will use
Venclexta in a post-induction therapy regimen
following response to a Venclexta-based regimen.
2. Used in combination with azacitidine in a member less
than 60 years of age for alternative induction treatment
with unfavorable risk genetics and TP53-mutation.
C. Relapsed or Refractory Acute Myeloid Leukemia (AML)
Authorization of 12 months may be granted for treatment of
relapsed or refractory acute myeloid leukemia, in
combination with azacitidine, decitabine or low-dose
cytarabine.
D. Mantle Cell Lymphoma (MCL)
Authorization of 12 months may be granted for subsequent
treatment of mantle cell lymphoma, as a single agent or in
combination with rituximab or ibrutinib.
E. Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Authorization of 12 months may be granted for BPDCN, in
combination with azacitidine, decitabine or low-dose
cytarabine.
F. Multiple Myeloma (MM)
Authorization of 12 months may be granted for treatment
of relapsed or progressive multiple myeloma, in combination
with dexamethasone in members with translocation t(11;14).
G. Systemic light chain amyloidosis (SLCA)
Authorization of 12 months may be granted for treatment of
relapsed or refractory systemic light chain amyloidosis with
translocation t(11;14), as a single agent or in combination
with dexamethasone.
H. Waldenström Macroglobulinemia/Lymphoplasmacytic
Lymphoma (WM/LPL)
Authorization of 12 months may be granted for subsequent
treatment of Waldenström
Macroglobulinemia/Lymphoplasmacytic Lymphoma, as a
single agent.
I. Myelodysplastic syndrome (MDS)
Authorization of 12 months may be granted for treatment of
MDS, in combination with azacitidine or decitabine.
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. For members with CLL/SLL who will use Venclexta with
Rituxan, Venclexta will not be used longer than 24 months from
cycle 1 day 1 of Rituxan initiation. For members with CLL/SLL
who will use Venclexta with Gazyva, Venclexta will not be used
longer than 12 cycles.
Place of Service:
Outpatient
The above policy is based on the following references:
- Venclexta® [package insert]. North Chicago, IL: AbbVie Inc.; June 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 3, 2023.
- IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at http://www.micromedexsolutions.com. Accessed January 3, 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.
June 18, 2023
