WHA

Nplate (romiplostim)

Indications for Prior Authorization

Nplate (romiplostim)
  • For diagnosis of Immune Thrombocytopenia (ITP)
    Indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

    Limitations of Use: - Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. - Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. - Nplate should not be used in an attempt to normalize platelet counts.

  • For diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome
    Indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation.

Criteria

Nplate

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)
For diagnosis of Immune Thrombocytopenia (ITP)

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

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
Nplate

Prior Authorization

Length of Approval: 14 Day(s)
For diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome

  • Diagnosis of hematopoietic syndrome of acute radiation syndrome
    • AND
  • Patient is acutely exposed to myelosuppressive doses of radiation
    • AND
  • Prescribed by or in consultation with a hematologist/oncologist

  • Guideline ID
    GL-486301

  • Formulary
    premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Apr 7, 2009

P & T Revisions

1970-01-01, 2025-12-18, 2025-11-05, 2025-01-09, 2024-01-30, 2023-10-26, 2023-02-01, 2022-02-03, 2021-09-27, 2021-05-21, 2021-03-31, 2021-02-03, 2020-01-29

  1. Nplate Prescribing Information. Amgen Inc. Thousand Oaks, CA. February 2022.
  2. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immume thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008; 371:395-403.
  3. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Available at: https://ashpublications.org/bloodadvances/article/3/23/3829/429213/American-Society-of-Hematology-2019-guidelines-for. Accessed January 8 2025.
  4. Per clinical consult with hematologist/oncologist, June 20, 2018.
  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 change, bulk copy oRX-EHB
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-11-05: Updated initial authorization criteria for ITP indication.
  • 2025-01-09: 2025 Annual Review. Background updates only.
  • 2024-01-30: Annual review: Background updates.
  • 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-02-01: Annual review: Background updates.
  • 2022-02-03: Annual review: Background updates.
  • 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-03-31: Added criteria for new indication of Hematopoietic Syndrome of Acute Radiation Syndrome
  • 2021-02-03: Annual review: Updated reauthorization criteria and background.
  • 2020-01-29: Annual Review: Added new GPI, revised diagnosis, added drug examples, updated terminology, and formatting/background updates.