WHA

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.

  • For diagnosis of Treatment of Thrombocytopenia in Pediatric Patients 1 Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP)
    Indicated for the treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or 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 Immune Thrombocytopenia (ITP)

  • Diagnosis of one of the following:
    • Chronic immune thrombocytopenia (ITP)
    • Relapsed/refractory ITP [3]
    • Pediatric patient with persistent ITP
    AND
  • Patient is 6 years of age or older
    • 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 (e.g., prednisone, methylprednisolone)
    • Immunoglobulins [e.g., Gammagard, immune globulin (human)]
    • 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 Sprinkle

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Immune Thrombocytopenia (ITP)

  • Diagnosis of one of the following:
    • Chronic immune thrombocytopenia (ITP)
    • Relapsed/refractory ITP [3]
    • Pediatric patient with persistent ITP
    AND
  • One of the following:
    • Patient is 1 year to less than 6 years of age
      • OR
    • Both of the following:
      • Patient is 6 years of age or older
        • AND
      • Patient is unable to swallow a solid dosage form (e.g., oral tablet, capsule) due to one of the following:
        • Age
        • Physical impairment (e.g., difficulties with motor or oral coordination)
        • Dysphagia
        • Patient is using a feeding tube or nasal gastric tube
    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 (e.g., prednisone, methylprednisolone)
    • Immunoglobulins [e.g., Gammagard, immune globulin (human)]
    • 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, Doptelet Sprinkle

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of 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

  • Guideline ID
    GL-378189

  • Formulary
    premium

  • Effective date
    Nov 1, 2025

  • P&T approval date
    Jul 18, 2018

P & T Revisions

2025-10-01, 2025-02-12, 2024-10-29, 2024-01-03, 2023-09-01, 2023-01-08, 2022-01-04, 2021-03-03, 2020-01-16

  1. Doptelet Prescribing Information. AkaRx, Inc. Durham, NC. July 2025.
  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 February 11, 2025.
  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.
  • 2025-10-01: Adding criteria for Doptelet Sprinkle formulation and updated existing criteria as per latest indication update in prescribing information.
  • 2025-02-12: Annual review; updated “immune (idiopathic) thrombocytopenic purpura (ITP)” to “immune thrombocytopenia (ITP), no change to clinical intent.
  • 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.