Subject: Vonjo 5258-A SGM P2023

Drug

VONJO  (pacritinib)

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.

          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.

          Compendial Uses
          1.  Symptomatic low-risk MF with a platelet count <50 × 10⁹/L
          2.  Symptomatic high-risk MF with a platelet count >50 × 10⁹/L
          3.  Symptomatic accelerated phase or blast phase
               myelofibrosis/acute myeloid leukemia

          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.


  III.  CRITERIA FOR INITIAL APPROVAL

          Myelofibrosis/Acute Myeloid Leukemia
          Authorization of 12 months may be granted for the treatment
          myelofibrosis/acute myeloid leukemia when any of the following
          criteria are met:
          1.  Member has a platelet count of <50 × 10⁹/L and any of the
               following:
               a.  Symptomatic low-risk MF and has failed treatment with
                    ruxolitinib, peginterferon alfa-2a, or hydroxyurea
               b.  Intermediate or high-risk primary or secondary (post-
                    polycythemia vera or post-essential thrombocythemia) MF
          2.  Member has a platelet count of >50 × 10⁹/L, symptomatic
               disease (e.g., splenomegaly and other disease-related
               symptoms) and any of the following:
               a.  High-risk MF and is a candidate for transplant
               b.  High-risk MF, is not a candidate for transplant, and has
                    failed one prior JAK inhibitor (e.g., ruxolitinib or
                    fedratinib)
               c.  High-risk MF-associated anemia and is not a candidate for
                    transplant
          3.  Member has symptomatic accelerated phase or blast phase
               myelofibrosis/acute myeloid leukemia


   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:

1. Vonjo [package insert]. Seattle, WA: CTI BioPharma Corp.; February 2022.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 6, 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