Subject: Tavalisse 2560-A SGM P2021

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:
        pretreatment and current platelet counts

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.  CRITERIA FOR INITIAL APPROVAL

        Chronic immune thrombocytopenia (ITP)
        Authorization of 12 weeks may be granted to members with chronic  ITP who meet all of the
        following criteria:
        A.   Inadequate response or intolerance to prior therapy (for example, 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 VI).

 V.  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.

Special Notes:

 IV. 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 Adv2019;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 Adv2019;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. CVS Caremark Clinical Programs Review: Focus on Primary Immune Thrombocytopenia Programs; December 2011.
6. CVS Caremark Clinical Programs Review: Focus on Primary Immune Thrombocytopenia Programs; May 2018.
7. 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.
8. CVS Caremark Clinical Programs Review. Focus on Immune Thrombocytopenia (ITP) Programs; August 2020.
9. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Hematology – Immune Thrombocytopenic Purpura (ITP) Clinical Programs. August 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.

February 25, 2022