Pharmacy Prior Authorization Criteria

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

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
• Trial and failure, contraindication, or intolerance to ONE of the following: [1-4]
• Corticosteroids (e.g., dexamethasone, prednisone)
• Immune globulins (e.g., Gammaplex, Gammagard S/D)
• Splenectomy
AND
• Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding [3]
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

P & T Revisions

2024-01-03, 2023-10-26, 2023-01-04, 2022-01-04, 2021-02-09, 2020-01-16

References

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 December 4, 2023.
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 December 6, 2023.

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End Notes

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 These terms have been replaced by "immune thrombocytopenia" to reflect the known autoantibody mechanism and the absence of purpura in some patients.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]

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Revision History

• 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.

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