Tavalisse®

Drug - Tavalisse® (fostamatinib disodium hexahydrate) [Rigel Pharmaceuticals, Inc.]

August 2026

Therapeutic Area - Thrombopoiesis Stimulating Proteins

Initial approval criteria

  • Patient has a diagnosis of chronic (defined as lasting for at least 12 months) immune (idiopathic) thrombocytopenia (ITP) AND BOTH of the following:
    • ONE of the following:
      • Patient has a platelet count less than or equal to 30 X 109/L; OR
      • Patient has a platelet count greater than 30 X 109/L but less than 50 X 109/L AND has symptomatic bleeding and/or an increased risk for bleeding; AND
    • ONE of the following:
      • Patient has tried and had an inadequate response to ONE corticosteroid used for the treatment of ITP; OR
      • Patient has an intolerance or hypersensitivity to ONE corticosteroid used for the treatment of ITP; OR
      • Patient has an FDA labeled contraindication to ALL corticosteroids used for the treatment of ITP; OR
      • Patient has tried and had an inadequate response to another thrombopoietin receptor agonist (e.g., Doptelet, Nplate, Promacta); OR
      • Patient has tried and had an inadequate response to immunoglobulins (IVIg or Anti-D); OR
      • Patient has had an inadequate response to a splenectomy; OR
      • Patient has tried and had an inadequate response to rituximab; AND
  • Patient will NOT use the requested agent in combination with another thrombopoietin receptor agonist (i.e., avatrombopag, lusutrombopag, romiplostim, or eltrombopag); AND
  • Patient does NOT have any FDA labeled contraindications to the requested agent
  • Initial approval is for 3 months

Renewal criteria

  • Patient has a diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
    • Patient’s platelet count is greater than or equal to 50 x 109/L; OR
    • Patient’s platelet count has increased sufficiently to avoid clinically significant bleeding; AND
  • Patient will NOT use the requested agent in combination with another thrombopoietin receptor agonist (i.e., avatrombopag, lusutrombopag, romiplostim, or eltrombopag); AND
  • Patient does NOT have any FDA labeled contraindications to Tavalisse
  • Renewal approval is for 12 months

Quantity limits

  • 100 mg or 150 mg tablets: 60 tablets per 30 days
  • Maximum dose of 150 mg twice daily

Questions

Provider Call Center: (844) 575-7887