WHA

Tavalisse (fostamatinib)

Indications for Prior Authorization

Tavalisse (fostamatinib)
  • For diagnosis of Chronic Immune Thrombocytopenia (ITP)
    Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Criteria

Tavalisse

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of one of the following:
    • Chronic immune thrombocytopenia (ITP) [A]
    • Relapsed/refractory ITP [3]
    AND
  • Baseline platelet count is less than 30,000/mcL [2-4]
    • AND
  • One of the following:
    • Patient has had a prior splenectomy
      • OR
    • Trial and failure, contraindication, or intolerance to ONE of the following: [1-4]
      • Corticosteroids (e.g., prednisone, methylprednisolone)
      • Immune globulins [e.g., Gammagard, immune globulin (human)]
    AND
  • Prescribed by or in consultation with a hematologist/oncologist
Tavalisse

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient demonstrates positive clinical response to therapy as evidenced by an increase in platelet count to a level sufficient to avoid clinically important bleeding

  • Guideline ID
    GL-486498

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Apr 18, 2018

P & T Revisions

1970-01-01, 2025-12-18, 2025-11-04, 2025-01-29, 2024-01-03, 2023-10-26, 2023-01-04, 2022-01-04, 2021-02-09, 2020-01-16

  1. Tavalisse Prescribing Information. Rigel Pharmaceuticals, Inc. South San Francisco, CA. November 2020.
  2. Neunert C, Terrell D, Arnold D, et al. The American Society of Hematology 2019 Evidence-based practice guideline for immune thrombocytopenia. Available at: https://ashpublications.org/bloodadvances/article/3/23/3829/429213/American-Society-of-Hematology-2019-guidelines-for. Accessed January 9, 2025.
  3. Per clinical consult with hematologist/oncologist. June 20, 2018.
  4. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93:921-30.
  5. Immune thrombocytopenia (ITP) in adults: Clinical manifestations and diagnosis. UpToDate Website. Available at: www.uptodate.com. Accessed January 9, 2025.
  1. ITP has previously been called idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, or autoimmune thrombocytopenic purpura (AITP). These terms have been replaced by "immune thrombocytopenia" to reflect the known autoantibody mechanism and the absence of purpura in some patients. [5]
  • 1970-01-01: No criteria changes
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-11-04: Updated initial authorization criteria.
  • 2025-01-29: 2025 Annual Review. No criteria changes. Updated references.
  • 2024-01-03: Annual review: Updated criteria and background.
  • 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-01-04: Annual review: Updated criteria and background.
  • 2022-01-04: 2022 Annual Review - updated prerequisite requirements for ITP and updated background info
  • 2021-02-09: 2021 Annual Review, no changes to criteria.
  • 2020-01-16: 2020 Annual Review - No changes to criteria.