Subject: Tavalisse 2560-A SGM P2023

Drug

TAVALISSE  (fostamatinib disodium hexahydrate)

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
          Treatment of thrombocytopenia in adult patients with chronic
          immune thrombocytopenia (ITP) who have had an insufficient
          response to a previous treatment.

          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:
          A.  For initial requests: pretreatment platelet count
          B.  For continuation requests: current platelet count


  III.  EXCLUSIONS

          Coverage will not be provided for members with the following
          exclusion: concomitant use of Tavalisse with thrombopoietin
          receptor agonists (e.g., Promacta, Nplate, Doptelet, Mulpleta).


   IV.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a
          hematologist.


     V.  CRITERIA FOR INITIAL APPROVAL

          Chronic immune thrombocytopenia (ITP)
          Authorization of 12 weeks may be granted to members with
          chronic ITP who meet both of the following criteria:
          A.  Inadequate response or intolerance to prior therapy (e.g.,
               corticosteroids or immunoglobulins).
          B.  Untransfused platelet count at any point prior to the initiation
               of the requested medication is less than 30x10⁹/L OR
               30x10⁹/L to 50x10⁹/L with symptomatic bleeding (e.g.,
               significant mucous membrane bleeding, gastrointestinal
               bleeding or trauma) or risk factors for bleeding (see Section
               VII).


   VI.  CONTINUATION OF THERAPY

          Chronic immune thrombocytopenia (ITP)
         A.  Authorization of 3 months may be granted to members with
              current platelet count less than 50x10⁹/L for whom the
              platelet count is not sufficient to prevent clinically important
              bleeding and who have not received a maximal Tavalisse dose
              for at least 8 weeks.
         B.  Authorization of 12 months may be granted to members with
              current platelet count less than 50x10⁹/L for whom the
              current platelet count is sufficient to prevent clinically
              important bleeding.
        C.  Authorization of 12 months may be granted to members with
             current platelet count of 50x10⁹/L to 200x10⁹/L.
        D.  Authorization of 12 months may be granted to members with
             current platelet count greater than 200x10⁹/L to less than or
             equal to 400x10⁹/L for whom Tavalisse dosing will be adjusted
             to achieve a platelet count sufficient to avoid clinically
             important bleeding.


VII.  APPENDIX

          Examples of risk factors for bleeding (not all inclusive)
          •   Undergoing a medical or dental procedure where blood loss is
               anticipated
          •   Comorbidity (e.g., peptic ulcer disease, hypertension)
          •   Mandated anticoagulation therapy
          •   Profession (e.g., construction worker) or lifestyle (e.g., plays
               contact sports) that predisposes patient to trauma

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tavalisse [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; November 2020.
2. Nuenert C, Terrel DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv.2019;3(23):3829–3866. 
3. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv.2019;3(22): 3780–3817. 
4. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11):2386-2393.
5. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult chronic and persistent immune thrombocytopenia: Results of two, phase III, randomized placebo-controlled trials. Am J Hematol. 2018; published online: https://doi.org/10.1002/ajh.25125.

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.

December 09, 2023