Subject: Tavalisse 2560-A SGM P2022

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.  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 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).

 
     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.

 

 

• 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. 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.

January 31, 2023