Description

Romiplostim (NPLATE) is an injectable thrombopoietin (TPO) mimetic that increases platelet production by binding and activating the TPO receptor, similar to endogenous TPO.

Policy

Romiplostim (NPLATE) may be considered MEDICALLY NECESSARY for treatment of Immune thrombocytopenia (ITP) or Relapsed/refractory ITP when all the following criteria have been met:

1. Baseline platelet count is less than 30,000/mcL
2. Patient’s degree of thrombocytopenia and clinical condition increase the risk of bleeding
3. Trial and failure, contraindication, or intolerance to one of the following:

• Corticosteroids (e.g., dexamethasone, prednisone)
• Immune globulins (e.g., Gammaplex, Gammagard S/D)
• Splenectomy

4. Prescribed by or in consultation with a hematologist/oncologist.

Romiplostim (NPLATE) may be considered MEDICALLY NECESSARY for treatment of hematopoietic syndrome of acute radiation syndrome when all the following criteria have been met:

1. Diagnosis of hematopoietic syndrome of acute radiation syndrome
2. Patient is acutely exposed to myelosuppressive doses of radiation
3. Prescribed by or in consultation with a hematologist/oncologist

Chemotherapy-induced thrombocytopenia (CIT)

1. Oncology diagnosis, receiving active chemotherapy treatment
2. Has had thrombocytopenia (platelets < 100,000/mcL) for more than 3 weeks since last chemotherapy administration.
3. Romiplostim is not used concurrently with other thrombopoietin receptor agonist (e.g., eltrombopag, avatrombopag, lusutrombopag)

Romiplostim (NPLATE) may be considered MEDICALLY NECESSARY when the drug is being used as indicated by National Comprehensive Cancer Network (NCCN) guidelines category 1, 2A, or 2B.

Continuation

Reauthorization of Romiplostim (NPLATE) may be considered MEDICALLY NECESSARY when documentation of positive clinical response to Nplate therapy as evidenced by an increase in platelet count to a level sufficient to avoid clinically important bleeding.

References

1. Nplate prescribing information. Amgen. January 2021.
2. Neunert C, Terrell DR, Arnold DM, et al. The American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood 2019; volume 3 number 23: 3829-3866.
3. National Institute for Health and Care Excellence (2014): Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.
4. Johns Hopkins Bloomberg School of Public Health. Center for Health Security. Clinicians’ Biosecurity News. Analysis of Advanced and Challenges in Clinical Biosecurity. April 2011.
5. CDC Centers for Disease Control and Prevention. Radiation Emergencies. Acute Radiation Syndrome: A Fact Sheet for Clinicians. Accessed at: https://www.cdc.gov/nceh/radiation/emergencies/arsphysicianfactsheet.htm

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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