Subject: Vonjo 5258-A SGM P2024
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 Indication
Vonjo is indicated for the treatment of adults with intermediate or high-risk primary or
secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)
with a platelet count below 50 × 109/L.
B. Compendial Uses
1. Symptomatic low-risk MF with a platelet count <50 × 109/L
2. Symptomatic high-risk MF
3. MF-associated anemia
4. Accelerated phase or blast phase myeloproliferative neoplasms
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:
pretreatment platelet count, where applicable.
III. CRITERIA FOR INITIAL APPROVAL
Myelofibrosis, Myelofibrosis-associated anemia or Myeloproliferative neoplasms
Authorization of 12 months may be granted for the treatment myelofibrosis, myelofibrosis-
associated anemia or myeloproliferative neoplasms when any of the following criteria are met:
A. Member has a platelet count of <50 × 109/L and any of the following:
1. Symptomatic low-risk MF
2. Intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential
thrombocythemia) MF
B. Member has high-risk MF and symptomatic disease (e.g., splenomegaly and other disease-
related symptoms)
C. Member has MF-associated anemia with symptomatic splenomegaly and/or constitutional
symptoms (e.g., fatigue, night sweats, fever, weight loss)
D. Member has accelerated phase or blast phase myeloproliferative neoplasms and the
requested agent will be used as a single agent or 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 and there has been an improvement in symptoms while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Vonjo [package insert]. Seattle, WA: CTI BioPharma Corp.; August 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 4, 2024.
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.
July 20, 2024
