Pharmacy Prior Authorization Criteria

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

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
• Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding
AND
• Trial and failure, contraindication, or intolerance to one of the following: [2]
• Corticosteroids (e.g., dexamethasone, prednisone)
• Immune globulins (e.g., Gammaplex, Gammagard S/D)
• Splenectomy
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 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

P & T Revisions

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

References

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 December 6, 2023.
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 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

• 2024-01-30: 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.

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