Pharmacy Prior Authorization Criteria

Doptelet (avatrombopag)

Indications for Prior Authorization

Doptelet (avatrombopag)

• For diagnosis of Thrombocytopenia in Patients with Chronic Liver Disease (CLD)
  Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

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

Criteria

Doptelet

Prior Authorization

Length of Approval: 1 Month(s)
For diagnosis of Thrombocytopenia in Patients with Chronic Liver Disease (CLD)

• Diagnosis of thrombocytopenia
AND
• Patient has chronic liver disease
AND
• Patient is scheduled to undergo a procedure
AND
• Baseline platelet count is less than 50,000/mcL [1, 5]

Doptelet

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Thrombocytopenia in Patients with Chronic Immune Thrombocytopenia (ITP)

• Diagnosis of one of the following:
• Chronic immune (idiopathic) thrombocytopenic purpura (ITP)
• Relapsed/refractory ITP [3]
AND
• Baseline platelet count is less than 30,000/mcL [2-4]
AND
• Trial and failure, contraindication, or intolerance to at least ONE of the following: [1-4]
• Corticosteroids
• Immunoglobulins
• 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

Doptelet

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Thrombocytopenia in Patients with Chronic Immune Thrombocytopenia (ITP)

• 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

2024-10-29, 2024-01-03, 2023-09-01, 2023-01-08, 2022-01-04, 2021-03-03, 2020-01-16

References

1. Doptelet Prescribing Information. AkaRx, Inc. Durham, NC. July 2021.
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 3, 2024.
3. Per clinical consult with hematologist/oncologist. June 20, 2018.
4. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490.
5. Terrault N, Chen YC, Izumi N, et al. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.

---

Revision History

• 2024-10-29: Removal of trial requirement through Mulpleta
• 2024-01-03: Annual review, no changes to criteria.
• 2023-09-01: 2024 Implementation
• 2023-01-08: 2023 Annual review, no changes to criteria.
• 2022-01-04: 2022 Annual Review - updated prerequisite requirements for ITP and updated background info
• 2021-03-03: 2021 Annual Review, no changes to criteria.
• 2020-01-16: 2020 Annual Review - No changes to criteria.

---